key: cord-0855819-bb0rsbi1
authors: Schell, C. O.; Khalid, K.; Wharton-Smith, A.; Oliwa, J. N.; Sawe, H. R.; Roy, N.; Sanga, A.; Marshall, J. C.; Rylance, J.; Hanson, C.; Kayambankadzanja,; R., Jirwe; M., Baker; T.,
title: Essential Emergency and Critical Care - a consensus among global clinical experts
date: 2021-03-20
journal: nan
DOI: 10.1101/2021.03.18.21253191
sha: 237e4a894bb5152dc4065ec15328c38346cb59ac
doc_id: 855819
cord_uid: bb0rsbi1

Background Globally, critical illness results in millions of deaths every year. Although many of these deaths are potentially preventable, the basic, life-saving care of critically ill patients can be overlooked in health systems. Essential and Emergency Care (EECC) has been devised as the care that should be provided to all critically ill patients in all hospitals in the world. EECC includes the effective care of low-cost and low-complexity for the identification and timely treatment of critically ill patients across all medical specialities. This study aimed to specify the content of EECC and additionally, given the surge of critical illness in the ongoing pandemic, the essential diagnosis-specific care for critically ill patients with COVID-19. Methods A Delphi process was conducted to seek consensus (>90% agreement) among a diverse panel of global clinical experts. The panel was asked to iteratively rate proposed treatments and actions based on previous guidelines and the WHO Basic Emergency Care. The output from the Delphi was adapted iteratively with specialist reviewers into a coherent, user-friendly, and feasible EECC package of clinical processes plus a list of hospital resource requirements. Results The 272 experts in the Delphi panel had clinical experience in different acute medical specialties from 59 countries and from all resource settings. The agreed EECC package contains 40 clinical processes and 67 hospital readiness requirements. The essential diagnosis-specific care of critically ill COVID-19 patients has an additional 7 clinical processes and 9 hospital readiness requirements. Conclusion The study has specified the content of the essential emergency and critical care that should be provided to all critically ill patients. Implementation of EECC could be an effective strategy to reduce preventable deaths worldwide. As critically ill patients have high mortality rates in all hospital settings, especially where trained staff or resources are limited, even small improvements would have a large impact on survival. EECC has a vital role in the effective scale-up of oxygen and other care for critically ill patients in the COVID-19 pandemic. Policy makers should prioritise EECC, increase its coverage in hospitals, and include EECC as a component of universal health coverage.

Background Globally, critical illness results in millions of deaths every year. Although many of these deaths are potentially preventable, the basic, life-saving care of critically ill patients can be overlooked in health systems. Essential and Emergency Care (EECC) has been devised as the care that should be provided to all critically ill patients in all hospitals in the world. EECC includes the effective care of low-cost and low-complexity for the identification and timely treatment of critically ill patients across all medical specialities. This study aimed to specify the content of EECC and additionally, given the surge of critical illness in the ongoing pandemic, the essential diagnosis-specific care for critically ill patients with COVID-19.

A Delphi process was conducted to seek consensus (>90% agreement) among a diverse panel of global clinical experts. The panel was asked to iteratively rate proposed treatments and actions based on previous guidelines and the WHO's Basic Emergency Care. The output from the Delphi was adapted iteratively with specialist reviewers into a coherent, user-friendly, and feasible EECC package of clinical processes plus a list of hospital resource requirements.

The 272 experts in the Delphi panel had clinical experience in different acute medical specialties from 59 countries and from all resource settings. The agreed EECC package contains 40 clinical processes and 67 hospital readiness requirements. The essential diagnosis-specific care of critically ill COVID-19 patients has an additional 7 clinical processes and 9 hospital readiness requirements.

The study has specified the content of the essential emergency and critical care that should be provided to all critically ill patients. Implementation of EECC could be an effective strategy to reduce preventable deaths worldwide. As critically ill patients have high mortality rates in all hospital settings, especially where trained staff or resources are limited, even small improvements would have a large impact on survival. EECC has a vital role in the effective scale-up of oxygen and other care for critically ill patients in the COVID-19 pandemic. Policy makers should prioritise EECC, increase its coverage in hospitals, and include EECC as a component of universal health coverage.

Critical illness, when defined as a state of ill health with vital organ dysfunction and a high risk of imminent death, is common in hospitals throughout the world. [1] [2] [3] [4] It is the most severe form of acute illness due to any underlying condition and results in millions of deaths globally every year. 4 The COVID-19 pandemic has led to increased morbidity and mortality with a surge in critical illness globally. [5] [6] [7] Many of the deaths due to critical illness are potentially preventable. [8] [9] [10] In critical illness, the patient's airway, breathing, or circulation may become compromised, and early identification of the problem and timely care can be lifesaving. Unfortunately, this care is frequently a neglected part of healthcare. The basic, life-saving clinical processes may be overlooked in specialised care 10 and in both settings of high 11, 12 and low resources. 13, 14 In hospitals all over the world, guidelines, equipment, and routines focusing on the care of critically ill patients, are often missing for adult 15 and paediatric patients 16 , in emergency units, 17 in wards 18 and in intensive care units. 19 Improving the way healthcare manages critical illness could save many lives. 16, 20, 21 To improve outcomes for critically ill patients by means that are feasible to deliver in all hospital settings, the Essential Emergency and Critical Care (EECC) concept was devised. 22 EECC is defined as the care that should be provided to all critically ill patients in all hospitals in the world. It is distinguished by three principles. First, priority to those with the most urgent clinical need, including both early identification and timely care. Second, provision of the life-saving treatments that support and stabilise failing vital organ functions. And third, a focus on effective care of low cost and low complexity.

The clinical processes in EECC and the resources required for those processes has not previously been specified. As critically ill patients can be suffering from any underlying condition, EECC is conceptualised to be integrated into all acute clinical specialties. We therefore sought consensus among a diverse group of global clinical experts with the aim of specifying the content of EECC. An additional aim, given the ongoing pandemic, was consensus around the essential diagnosis-specific care for critically ill patients with COVID-19.

The study used three phases. (Figure 1 ) Firstly, a consensus was sought about the treatments and actions in EECC using a Delphi technique. 23 Secondly, the output from the Delphi was adjusted into a coherent, user-friendly, and feasible package of clinical processes. And thirdly, a list of requirements for hospitals to be ready to provide the care was developed. The study was approved by the London School of Hygiene and Tropical Medicine Research Ethics Committee (Ref: 22575). 

An online, three-round modified Delphi process was conducted in November and December 2020. The Delphi method uses anonymous responses from an expert panel to iteratively posed questions and controlled feedback to reach consensus on the topic of interest. 23 A Delphi process was chosen for this study as EECC is new, its content has not been previously specified and a large group of diverse experts was required.

To be part of the panel, experts needed to have clinical experience of caring for critically ill patients. To ensure the involvement of a diverse range of experts, it was decided that at least 50% of the invitations to participate in the panel should be sent to experts with substantial experience of working in low-and middle-income countries, and there should be a balance between clinical experience (work in general wards, emergency units, intensive is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint

The copyright holder for this this version posted March 20, 2021. ; https://doi.org/10.1101/2021.03.18.21253191 doi: medRxiv preprint care units); specialty (paediatrics, obstetrics, medicine, surgery, intensive care, anaesthesia and emergency care); profession (doctors, nurses, other health professionals); location, and gender. A list of potential participants was made from a mapping of stakeholders, the literature across all acute medical specialties, the researchers' networks and additional purposive and snowball sampling for under-represented groups. Additionally, a link to a screening survey was sent to global professional networks, specialist societies and on social media to identify further potential participants. A total of 895 experts were invited to participate, and those who accepted provided written informed consent.

EECC consists of clinical processes of care. To enable rating by the Delphi panel, clinical processes were disassembled into individual "treatments & actions" (T&A). The T&A concern the identification of critical illness; care of critical illness; and the diagnosis-specific care of critically ill COVID-19 patients. To be included, all T&A were required to meet two a-priori defined criteria: effectiveness* and feasibility*. Additionally, universality* was required for the identification and care of critical illness and relevance* was required for the diagnosisspecific care of critically ill COVID-19. A draft list of potential T&A was developed based on clinical guidelines and tools from related specialties [24] [25] [26] [27] [28] [29] [30] [31] [32] [33] [34] [35] [36] and aligned with the WHO's Basic Emergency Care. 37 The draft list was revised by specialist reviewers -a group of senior clinicians, researchers, and policy makers, with expertise in paediatrics, medicine, emergency medicine, anaesthesia and intensive care, critical care nursing, obstetrics and gynaecology, and surgery.

Three Delphi rounds were deemed sufficient to address the aim while avoiding attrition and poor response rates. A four-point Likert scale (strongly disagree, disagree, agree, strongly agree) with a 'do-not know' option was used for the panel to rate their opinion about the inclusion of each T&A in EECC. [38] [39] [40] Consensus was achieved when more than 90% of respondents selected "agree" or "strongly agree", excluding "don't know" responses. The experts were able to provide free-text comments, which were analysed to identify appropriate, relevant changes to the wording of T&A for clarity of understanding, and to identify newly proposed T&A. After the first round, newly proposed T&A that fulfilled the EECC criteria for potential inclusion were revised after input from the specialist reviewers and included for assessment by the panel. T&A that did not reach consensus in the previous round were presented for re-assessment in rounds two and three, together with a visual representation of the spread of previous responses.

Effectiveness: Established or proven to be safe and to reduce mortality. (compression to stop bleeding is effective; treating with leech therapy is not).

Feasibility: Low-cost and low complexity. Possible to provide in a low-staffed, low-resourced setting without the immediate presence of a doctor (placing a comatose patient in the recovery position (lateral position) is feasible; continuous haemodialysis is not).

Universality: Supports vital organ function rather than being the definitive care of a diagnosis. (IV fluids for shock are universal; thrombolytic therapy is not).

Relevance: Established or proven to be a treatment for COVID-19. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint

The copyright holder for this this version posted March 20, 2021. ; https://doi.org/10.1101/2021.03.18.21253191 doi: medRxiv preprint As the Delphi panel was so diverse, it was considered that there may be different opinions about the inclusion of T&As between experts with particular a-priori defined characteristics. These subgroups of experts were those with work experience in a low-income country or not; those who are doctors or not; those with clinical experience in emergency care and those without; and those with clinical experience in intensive care and those without. The levels of agreement in each subgroup were assessed and presented for all the T&As that reached consensus.

After the Delphi, slight adjustments were made to the wording of the T&A that had reached consensus to ensure language consistency. Additional minor modifications were suggested that reassembled the T&A back into clinical processes to increase overall coherence and feasibility of the EECC package, with the goal of user-friendliness for implementation and quality improvement work. The adjustments were done in an iterative process with the same specialist reviewers as in Phase One to ensure relevance for all acute medical specialties. The final package of clinical processes was organised into those relevant for identification, for care, and general processes.

A provisional list of hospital readiness requirements for the provision of the clinical processes were developed using existing WHO tools, guidelines for related specialties, facility preparedness lists 29, 31, 32, 34, 35, 37, 41, 42 and the experience and knowledge of the study team. The specialist reviewers provided iterative input into the provisional list, approving suggested items, adding relevant items from their clinical specialties, and suggesting modifications. Based on previous work and consultation with health economists and procurement experts, the final list of requirements was arranged into eight categories: equipment, consumables, drugs, human resources, training, routines, guidelines and infrastructure.

. CC-BY-NC-ND 4.0 International license It is made available under a perpetuity.

is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint 

Of the 895 invited experts, 269 participated in the first round of the Delphi when the majority of the decisions were made (30% response rate). In Round Two, 228 experts participated (85% of those in Round One) and Round Three included 194 experts (85% of those in Round Two). The panel comprised experts from diverse resource settings, clinical settings, specialties and professions ( Table 1 ). The panel included experts from 59 countries ( Figure 2 ) and 38% were female. N is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint Of the 57 T&A for EECC in Round One, consensus was reached for 49. In Round Two, 29 newly proposed T&A were added to the eight remaining from Round One, of which two had been re-worded for clarity. Out of these 37, consensus was reached for 17. The remaining 20, of which another two had been re-worded for clarity, were included in Round Three. Consensus was reached for nine of the final 20 T&A. In total, consensus was reached for 75 out of 86 proposed T&A, including 54 of the original 57. (Supplementary table 1) Of the seven T&A for the essential diagnosis-specific care of critically ill COVID-19 in Round One, all reached consensus for inclusion. In Round Two, two newly proposed T&A were added. Neither of these reached consensus in Round Two or Round Three.

Analyses of participant sub-groups did not reveal substantial divergence from the overall results. For the T&A that reached 90% agreement in the panel, agreement was not below 80% in any subgroup. (Supplementary tables 2-4 

After the Delphi, the T&A that had reached consensus were reassembled into a final userfriendly and feasible package of EECC containing 40 clinical processes -30 identification and care processes and 10 general processes. (Panel 1) All T&A for the care of critical illness were included, with some rewording and reordering. Eleven T&A for the identification of critical illness were not included, so that the package could be feasible for triage in all hospitals, and were added as an addendum (outside the remit of EECC), in order to underscore their importance in settings where staff have sufficient time and expertise.

The list of hospital readiness requirements for EECC contained 67 items, (fourteen for identification and 53 for essential care). (Panel 2) . CC-BY-NC-ND 4.0 International license It is made available under a perpetuity.

is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint The essential diagnosis-specific care of critically ill COVID-19 patients consisted of an additional seven clinical processes and nine hospital readiness requirements. (Panel 3)

Critical illness is identified as soon as possible so timely care can be provided. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint 

Optimizing the patient's position (eg. sitting-up or prone) Oxygen therapy using nasal prongs, facemask, or mask with a reservoir bag (non rebreathing mask) Bag-valve-mask ventilation in threatened or manifest respiratory arrest 

Stabilizing the cervical spine in possible cervical spine injury Appropriate antibiotics for sepsis Treatment of pain and anxiety (eg. with needs-based psychological support, medication) Keeping the patient warm using blankets and other means (including skin-to-skin care for babies) Feeding (including breastfeeding for babies), naso-gastric feeding and dextrose for nutrition and to avoid hypoglycaemia Prevention of delirium (eg. sleep hygiene, provision of the patient's glasses or hearing aid) Regular turning of immobilised patients Mobilising the patient as early as possible is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint 

Care is provided according to these general processes:

1. Assistance from additional or senior staff is sought when a critically ill patient is identified 2. Essential Emergency and Critical Care (EECC) is respectful and patient-centred 3. EECC is provided without considering the patient's ability to pay 4. Critically ill patients are cared-for in locations that facilitate observation and care (eg. designated beds, a bay or a unit for critically ill patients) 5. Infection, Prevention and Control (IPC) measures are used including hand hygiene and separation of patients with a suspected or confirmed contagious disease from those without 6. Communication is clear, including:  Within the care team when a patient is identified as critically ill (eg. verbal communication, at staff handovers, visible colour-coding)  Within the care team about the planned EECC (eg. continue oxygen therapy, give intravenous fluids)  Documentation in the patient notes about the vital signs, when critical illness has been identified and the treatments and actions conducted  Effective and respectful communication with the patient and family 7. If there is poor response to treatment, or if the patient deteriorates, other indicated EECC clinical processes are used 8. Clinical processes are discontinued that are no longer indicated (eg. if a patient improves or if they are deemed to no longer be in the patient's best interest) 9. It is recognised when EECC alone is not sufficient to manage the critical illness 10. EECC is integrated with care that is outside the scope of EECC (eg. the need for prompt investigations, definitive treatment of underlying conditions including following disease-specific best-practice guidelines, end-of-life care, referral) is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint

The copyright holder for this this version posted March 20, 2021. ; https://doi.org/10.1101/2021.03.18.21253191 doi: medRxiv preprint

1. The Essential Emergency and Critical Care (EECC) clinical processes as specified for all critical illnesses 2. Personal Protective Equipment (PPE) that is appropriate for COVID-19 as part of Infection, Prevention and Control (IPC) 3. Monitoring oxygen saturation using pulse oximetry at least every 6 hours, unless otherwise prescribed 4. Intermittent prone positioning 5. Low molecular weight heparin or other anticoagulant 6. Corticosteroid 7. Antibiotics in patients with suspected bacterial superinfection

Critically ill patients with COVID-19 require the same hospital readiness for EECC as other critically ill patients. For the provision of the essential diagnosis specific care of critically ill patients with COVID-19, the following additional items are required: 

We have specified the content of essential emergency and critical care (EECC) based on consensus among global clinical experts. While the EECC approach is new, the included clinical processes are commonly used in the care of sick patients and can be seen in WHO publications and specialist society standards and guidelines. 26, [29] [30] [31] [32] 35, 37, 43 The contribution of this study is the specification of a baseline bundle of care interventions that should be provided when needed to all critically ill patients in all hospitals in the world. This marks a break from previous guidelines that tend to be specialty-specific, condition-specific or location-specific, or specify care that may be too complex and costly to provide in all hospital settings.

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is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint The EECC approach EECC is an approach that supports priority-setting in health systems. In this regard, it has parallels to the approaches used in the WHO's essential medicines list, 34 Emergency Triage and Treatment for children 29 and Universal Health Coverage. 33 EECC emphasises the identification and care of the critically ill, and the provision of the life-saving supportive care of that is low-cost and of low complexity. 22 EECC can be seen as a unifying concept for such aspects of patient management found in WHO and specialist guidelines, triage, early warning systems and rapid response teams. 25, 26, 37, 44, 45 To maintain focus on life-saving supportive care and to be useful across all specialties, EECC does not include the definitive care of the underlying diagnoses. Instead, EECC is intended to complement speciality-based care and existing guidelines and does not aim to include all the care a patient needs -as well as EECC, patients should receive other care such as diagnostics, definitive and symptomatic care of their condition, additional nursing care, and if available, higher levels of emergency and critical care. It seeks to provide a means to bridge the commonly found quality gap between the current care of critical illness and best-practice guidelines. 10, 46 To ensure feasibility in settings with restricted human resources, EECC is designed for task-sharing between health professionals. It should be noted that not all the EECC clinical processes will be needed in the care of every critically ill patient -they should be seen as essential "tools in the tool-box" for health workers to use when required. To operationalise the EECC approach, it is intended that the content specified here is used to develop tools for quality monitoring, teaching and integration into other guidelines and recommendations.

The basic clinical processes specified in EECC have been overlooked in healthcare. 11, 13, 16, 17, 47 In the UK, half of patients received substandard basic organ support prior to ICU admission 12 and 31% of preventable deaths were associated with absent clinical monitoring. 11 In Malawi, 75% of children dying from pneumonia in hospital did not receive oxygen. 48 The usual organisational set-up of health services may be one underlying reason for this. Specialist units with a primary function of delivering the definitive management for one disease group may under-estimate the effort needed to maintain core processes and competences in the supportive management of critically ill patients. Innovative and specialised treatments and technologies may become preferred to those that are basic and long-standing. 49 By targeting a feasible, lowest baseline quality for critically ill patients throughout hospital settings, EECC provides a complimentary approach to the current organisation that safeguards the provision of basic life-saving actions, enhancing the impact of hospital care for all acute conditions. EECC in the COVID-19 pandemic EECC has added importance in a situation causing a substantial amount of severe disease and the Delphi panel agreed that EECC should be part of the care of critically ill patients with COVID-19. In addition, the agreed essential diagnostic-specific care for COVID-19 can assist in decisions about the priorities of care when the pandemic threatens to overwhelm available resources. All of the COVID-19 specific processes are well established and are included in the WHO COVID-19 clinical management guidance 27 . The WHO guidance, and others, 50 additionally include recommendations for advanced critical care (such as is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint

The copyright holder for this this version posted March 20, 2021. ; https://doi.org/10.1101/2021.03.18.21253191 doi: medRxiv preprint mechanical ventilation, vasopressors and extracorporeal oxygenation), which may be difficult to rapidly scale-up in settings of low resources. Advanced critical care can be necessary to save the lives of some patients, but has a high cost per recovery 51, 52 and risks diverting scarce resources to a few individuals. [53] [54] [55] Fortunately the focus has shifted in the global pandemic response from advanced critical care towards securing basic oxygen delivery systems 56,57 underscored by statements from the WHO and other partners. 58, 59 The impact of this shift, in and beyond the pandemic, could be even greater if the necessary processes for the effective use of oxygen and other care specified in EECC were included in the scale-up.

Our use of a consensus method with a large expert panel from diverse clinical and resource settings, specialties, and geographical locations gives the specified content legitimacy. The high response rate for this type of study during an ongoing pandemic illustrates the interest that experts had in the project's aims. The high level of consensus (>90%) for the included clinical processes promotes confidence in the final package. However, the Delphi method does have limitations. It is expert-opinion based and is limited by the make-up of the panel. Only English language speakers were included, experts were not included from all countries, and the expedited timeline of the project due to the need for results that could impact the global response to the COVID-19 pandemic may have excluded experts who could have provided additional input. The initial content presented to the panel was aligned with the WHO and other initiatives, and developed by a diverse specialist team, but the possibility remains that alternative methods would have led to a different output. The study did not address the underlying evidence-base for the included clinical processes, the impact, or the potential opportunity costs of increasing the coverage of EECC in hospitals -such systemwide effects warrant careful evaluation during EECC implementation. It should be noted that, while policy makers were involved throughout the process, the EECC content has not been ratified by the WHO or governmental ministries of health -the method has been primarily scientific. The findings should be seen as the first version of the EECC content, as recommended by global clinicians and researchers, one that could be incorporated into WHO and other global and national programmes and that should subsequently be improved and updated as new knowledge arises.

Implementation of EECC could be an effective strategy as part of the current calls to save lives through improved quality of care in health systems 60 -a "low-hanging fruit". Critically ill patients have high mortality rates in all hospital settings, especially where trained staff or resources are limited, and even small improvements in outcomes would have a large impact. EECC has great potential in the ongoing COVID-19 pandemic, for the care of the surge of critically ill patients and for optimising the impact of the efforts to scale-up oxygen. Policy makers at global, national and regional levels aiming to reduce preventable deaths should focus on improved coverage of EECC and inclusion of EECC as part of universal health coverage. 33 . CC-BY-NC-ND 4.0 International license It is made available under a perpetuity.

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The copyright holder for this this version posted March 20, 2021. ; https://doi.org/10.1101/2021.03.18.21253191 doi: medRxiv preprint

The content of essential emergency and critical care -and the essential care of critically ill COVID-19 patients -has been specified using an inclusive global consensus. The content consists of effective, low-cost, and low-complexity life-saving care that is still frequently overlooked. The time has come to ensure that all patients in the world receive this care. 

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