key: cord-0004096-c13cv7cj authors: Lingervelder, Deon; Koffijberg, Hendrik; Kusters, Ron; IJzerman, Maarten J. title: Point‐of‐care testing in primary care: A systematic review on implementation aspects addressed in test evaluations date: 2019-08-19 journal: Int J Clin Pract DOI: 10.1111/ijcp.13392 sha: eb828bb9f9c3a58b135f382517a9ebbe65fa6fc6 doc_id: 4096 cord_uid: c13cv7cj OBJECTIVES: There are numerous point‐of‐care tests (POCTs) available on the market, but many of these are not used. This study reviewed literature pertaining to the evaluation/usage of POCTs in primary care, to investigate whether outcomes being reported reflect aspects previously demonstrated to be important for general practitioners (GPs) in the decision to implement a POCT in practice. METHODS: Scopus and Medline were searched to identify studies that evaluated a POCT in primary care. We identified abstracts and full‐texts consisting of applied studies (eg trials, simulations, observational studies) and qualitative studies (eg interviews, surveys). Data were extracted from the included studies, such as the type of study, the extent to which manufacturers were involved in the study, and the biomarker/assay measured by the test(s). Studies were evaluated to summarise the extent to which they reported on, amongst others, clinical utility, user‐friendliness, turnaround‐time and technical performance (aspects previously identified as important). RESULTS: The initial search resulted in 1398 publications, of which 125 met the inclusion criteria. From these studies, 83 POCTs across several disease areas (including cardiovascular disease, venous thromboembolism and respiratory‐tract‐infections) were identified. There was an inconsistency between what is reported in the studies and what GPs consider important. GPs perceive clinical utility as the most important aspect, yet this was rarely included explicitly in test evaluations in the literature, with only 8% of evaluations incorporating it in their analysis/discussion. CONCLUSIONS: This review showed that, despite the growing market and development of new POCTs, studies evaluating such tests fail to report on aspects that GPs find important. To ensure that an evaluation of a POCT is useful to primary care clinicians, future evaluations should not only focus on the technical performance aspects of a test, but also report on the aspects relating to the clinical utility and risks. important, traditional centralised laboratories tend to highlight the quality and reliability of tests above the turn-around-time. 3 For many diseases, care providers and patients increasingly expect patient-focused, specialised diagnostic tests that can be performed quickly, easily and provide results within minutes. 4 This has led to the development of easy-to-use analysers that can be performed at the point of care, more commonly known as pointof-care (POC) testing or near-patient testing. 1 The reason for implementing a POCT will vary according to the setting. In emergency departments or intensive care units, POCTs are used to find test results immediately to help guide life-saving decisions. In resource-limited settings, access to healthcare facilities is typically limited. In such settings, POCTs are beneficial in terms of their ease of use independent from the physical presence of a laboratory. 5 In primary care settings, POCTs are typically used to prevent unnecessary referrals to specialised or secondary care, to guide diagnostic and treatment decisions, and to provide reassurance to patients, for example by excluding an illness. The rapid analysis can also lead to improved clinical performance, since it eliminates the potentially long intervals between the patient's initial examination and the discussion of the test results. 4 The first major systematic review of POCTs in primary care was published more than 20 years ago by Hobbs et al, 6 who concluded that evidence in support of the general introduction of POCTs in general practice was low. Since then, the POC diagnostic market has grown substantially and continues to do so because of the increasing development of new (supporting) technologies such as novel biomarkers, wireless connectivity, nanoparticle techniques and information sharing capabilities. 7 It is expected that the global POC diagnostics market will reach $40.50 billion by 2022. 8 Despite this growing market, primary care clinicians generally are hesitant to implement POCTs in their practice. According to a study on POC blood tests by Jones et al, 9 this is mainly because of concerns about accuracy, over-reliance on tests and limited usefulness. A recent survey of general practitioners (GPs) in the UK, 10 The PRISMA guidelines were followed while carrying out this systematic review of available POCTs for primary care. Since this review aims to identify any POCTs that can be implemented in primary care, all types of primary research studies were included in the initial search. For this reason, it was not required that any specific outcome measure was reported in the initial search and no specific study characteristics or PICO-statement was used as part of the inclusion criteria. The review protocol for this systematic review is provided in Appendix A as a series of steps that were TITLE-ABS-KEY ("POCT" OR "Point of care" OR "Point of care testing" OR "rapid testing" OR "bedside testing" OR "laboratory-independent" OR "near patient testing") AND TITLE-ABS-KEY (diagnos*) AND ALL ("Primary Care" OR "General Pract*" OR "GP" OR "Primary Healthcare" OR "Primary Health Care"). Only publications that met the following inclusion criteria were selected for the review: Publications that explicitly stated that their focus is on remote or rural areas were excluded, even if within a developed country. Publications should be an applied study that evaluates a POCT in terms of its effectiveness, performance, usage or application. This includes qualitative studies (such as surveys and interviews) and modelling studies. Reviews were excluded. After removing duplicate publications from the initial search results, the abstracts were screened to determine whether publications met the inclusion criteria. Publications that undoubtedly failed to meet all of the inclusion criteria, based on the abstract screening, were excluded from the full-text assessment. If there was any doubt on whether or not a publication met the inclusion criteria, it was included for full-text assessment. The abstract screening was performed by one reviewer (DL), and potential issues were discussed with a second reviewer (HK) when required. The full-text assessment of all included publications was performed by one reviewer (DL). The data were extracted manually by one reviewer (DL) from the studies into Microsoft Excel (version 2016) in predefined and labelled columns. The following information was extracted from each of the included publications: 1. The study design, classified according to one of three categories; namely, empirical study (trials, cohort studies, etc), qualitative study (interviews, surveys, etc) or modelling study. 2. If relevant, the country where the study was performed. For multicountry studies, each individual country was counted separately. 3. If applicable, the role that the manufacturer played in the study. This was classified in one of seven categories; namely, (a) manufacturer provided some financial support to the study, (b) manufacturer funded the study, (c) manufacturer provided the analyser/test, (d) manufacturer funded the study and provided the analyser/test, (e) one or more authors are employed by the manufacturer, (f) manufacturer played no part in the study or (g) nothing specified about funding or manufacturer involvement. 4 . The name of the POC device/test that was evaluated. 5. The biomarker/assay that was measured by the POCT. If a study evaluated more than one POCT, a separate data entry (row) was added for each individual test evaluation. During the full-text assessment, each test evaluation study was assessed to summarise the extent to which predefined determinants were being reported on. These determinants were identified previously 12 as key factors that affect the decision to implement a POCT in primary care. All 20 of these determinants are listed in Table 1 . Some of these determinants are not applicable to a POCT specifically, but rather to the disease prevalence and the GP and his practice (Frequency of use, Room for innovation, Risks). For example Frequency of use and Room for innovation are both determinants that are associated directly with the GP's practice, while the impact and Risks of tests would differ between diseases. It is expected that these determinants will not be reported in the evaluations as frequently as some of the others. If there was any uncertainty to the first reviewer (DL) about whether a publication discussed a certain determinant, it was examined by a second reviewer (HK). On occasions when these two reviewers could not agree on a decision, a third reviewer was involved in making a final decision (either RK or MJIJ). The data extracted from the included publications were summarised in both text and table format, before providing a descriptive synthesis of findings. Results were divided according to the biomarker/assay that the test measures. A total of 1398 studies were obtained from the initial search of the After the full-text assessment, 125 studies were included in the final review. Studies were mostly excluded based on full-text assessment because they did not focus on POC diagnostics (n = 81), but instead described a tool, strategy or guideline to support POC testing. The PRISMA flow diagram of the search is presented in Appendix A. The 125 included studies consisted of 112 applied studies, 7 qualitative studies, 5 simulation studies and 1 study that used both applied and qualitative methods. The majority of the studies were applied From the 125 studies in the synthesis set, 195 test evaluations were identified. The percentage that each determinant was reported in the test evaluations are provided in Figure 1 , together with the overall weight of each determinant as found by. 12 The four determinants that were reported the most were turn-around-time (n = 105; 52.2%), technical performance (n = 97; 48.3%), positive predictive value (n = 91; 45.3%) and negative predictive value (n = 89; 44.3%). The determinants reported the least in the evaluations were room for innovation (n = 0; 0%) and risks (n = 1; 0.5%), followed by reimbursement (n = 2; 1.0%), legislations (n = 3; 1.5%) and scientific evidence (n = 3; 1.5%). Each of these POCTs has at least one test evaluation. The most frequently evaluated tests were those measuring HbA1c (n = 14; 16.9%), CRP (n = 6; 7.2%), D-Dimer (n = 6; 7.2%) and Influenza and/ or RSV (n = 6; 7.2%). A haemoglobin A1c (HbA1c) test measures glycated haemoglobin that gives an indication of the average blood glucose level of the past 60-120 days. Seeing as the prevalence of diabetes continues to rise each year, the timely management of HbA1c is particularly important in the primary care pathways of both patients with diabetes and those that remained undiagnosed. 13 In Appendix B, Table B1 , a list of the 14 HbA1c POCTs that were identified during the review is provided, in no particular order. The three most evaluated tests were the DCA Vantage Analyzer (n = 8), the Alere Afininion AS100 Analyzer (n = 6) and the A1CNow system (n = 5). D-dimer is a protein fragment produced when a blood clot dissolves in the body. High levels of d-dimer are therefore typically used to assess the risk of thrombotic episodes and to exclude conditions such as deep vein thrombosis and pulmonary embolism. 15 In Appendix B, Table B3 , a list of the 6 D-Dimer POCTs that were identified during the review is provided. Respiratory syncytial virus (RSV) is a common virus that causes lower respiratory tract infections, especially in infants and toddlers. Since reinfection occurs throughout life, specifically during fall and winter, GPs and emergency departments are typically met with a surge of patient visits during these colder months. 16 Influenza, more commonly known as the flu, is also particularly prevalent in children during winter months, causing a similar seasonal overflow of patients. Influenza is an infectious disease that causes febrile and respiratory illnesses, but typically remains undiagnosed since symptoms overlap significantly with other viral F I G U R E 1 Comparison of determinant weights according to GPs and the percentage of times that each determinant was reported in the literature or bacterial infections. 17 POC devices for RSV and influenza can have a major positive impact on patient care by reducing both unnecessary diagnostic testing and antibiotic prescriptions. 17 A list of 6 POCTs for Influenza and RSV, that were identified during the review is provided in Appendix B, Table B4 . In addition to the above-listed POCTs, there were also tests measuring calprotectin, streptococcus pyogenes, BNP and NT-proBNP, bladder carcinoma, uric acid, INR, IgA deficiency and chlamydia, among others. The majority of these tests had only one evaluation. 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