Research ethics review during the COVID-19 pandemic: An international study.

Research ethics review committees (ERCs) worldwide faced daunting challenges during the COVID-19 pandemic. There was a need to balance rapid turnaround with rigorous evaluation of high-risk research protocols in the context of considerable uncertainty. This study explored the experiences and performance of ERCs during the pandemic. We conducted an anonymous, cross-sectional, global online survey of chairs (or their delegates) of ERCs who were involved in the review of COVID-19-related research protocols after March 2020. The survey ran from October 2022 to February 2023 and consisted of 50 items, with opportunities for descriptive responses to open-ended questions. Two hundred and three participants [130 from high-income countries (HICs) and 73 from low- and middle-income countries (LMICs)] completed our survey. Respondents came from diverse entities and organizations from 48 countries (19 HICs and 29 LMICs) in all World Health Organization regions. Responses show little of the increased global funding for COVID-19 research was allotted to the operation of ERCs. Few ERCs had pre-existing internal policies to address operation during public health emergencies, but almost half used existing guidelines. Most ERCs modified existing procedures or designed and implemented new ones but had not evaluated the success of these changes. Participants overwhelmingly endorsed permanently implementing several of them. Few ERCs added new members but non-member experts were consulted; quorum was generally achieved. Collaboration among ERCs was infrequent, but reviews conducted by external ERCs were recognized and validated. Review volume increased during the pandemic, with COVID-19-related studies being prioritized. Most protocol reviews were reported as taking less than three weeks. One-third of respondents reported external pressure on their ERCs from different stakeholders to approve or reject specific COVID-19-related protocols. ERC members faced significant challenges to keep their committees functioning during the pandemic. Our findings can inform ERC approaches towards future public health emergencies. To our knowledge, this is the first international, COVID-19-related study of its kind.

What are effective vaccine distribution approaches for equity-deserving and high-risk populations during COVID-19? Exploring best practices and recommendations in Canada: protocol for a mixed-methods multiple case codesign study.

INTRODUCTION: The WHO has stated that vaccine hesitancy is a serious threat to overcoming COVID-19. Vaccine hesitancy among underserved and at-risk communities is an ongoing challenge in Canada. Public confidence in vaccine safety and effectiveness and the principles of equity need to be considered in vaccine distribution. In Canada, governments of each province or territory manage their own healthcare system, providing an opportunity to compare and contrast distribution strategies. The overarching objective of this study is to identify effective vaccine distribution approaches and advance knowledge on how to design and implement various strategies to meet the different needs of underserved communities. METHODS AND ANALYSIS: Multiple case studies in seven Canadian provinces will be conducted using a mixed-methods design. The study will be informed by Experience-Based CoDesign techniques and theoretically guided by the Socio-Ecological Model and the Vaccine Hesitancy Matrix frameworks. Phase 1 will involve a policy document review to systematically explore the vaccine distribution strategy over time in each jurisdiction. This will inform the second phase, which will involve (2a) semistructured, in-depth interviews with policymakers, public health officials, researchers, providers, groups representing patients, researchers and stakeholders and (2b) an analysis of population-based administrative health data of vaccine administration. Integration of qualitative and quantitative data will inform the identification of effective vaccine distribution approaches for various populations. Informed by this evidence, phase 3 of the study will involve conducting focus groups with multiple stakeholders to codesign recommendations for the design and implementation of effective vaccine delivery strategies for equity-deserving and at-risk populations. ETHICS AND DISSEMINATION: This study is approved by the University of Toronto's Health Sciences Research Ethics Board (#42643), University of British Columbia Behavioural Research Ethics Board (#H22-01750-A002), Research Ethics Board of the Nova Scotia Health Authority (#48272), Newfoundland and Labrador Health Research Ethics Board (#2022.126), Conjoint Health Research Ethics Board, University of Calgary (REB22-0207), and University of Manitoba Health Research Board (H2022-239). The outcome of this study will be to produce a series of recommendations for implementing future vaccine distribution approaches from the perspective of various stakeholders, including equity-deserving and at-risk populations.

Defining the capabilities and competencies of high-performing family physicians: a mixed methods study.

INTRODUCTION: High-performing primary care is recognised as the foundation of an effective and efficient healthcare system. Many medical graduates report they are not prepared for independent practice. To date, no research has been conducted to identify the key capabilities and competencies of high-performing family medicine graduates in Canada. This pilot project aims to identify the capabilities and competencies of high-performing early-career family physicians in Ontario, Canada, and explore opportunities for enhancing learning, teaching and assessment within family medicine residency programmes. METHODS AND ANALYSIS: Employing a mixed-methods explanatory sequential study design, this research will use a theory-driven Professional Capability Framework, previously validated in studies across nine professions, to guide the investigation. The first (quantitative) phase involves surveying ~50 high-performing early-career family physicians identified as high performing by educators, colleagues and leaders. The objective of the survey is to identify the key competencies and personal, interpersonal and cognitive capabilities of high-performing family physicians. The second (qualitative) phase involves conducting workshops with stakeholders, including educators, professional associations, regulators and colleges, to test the veracity of the results. Quantitative data will be analysed using descriptive statistics, and qualitative data will be analysed using Braun and Clarke's thematic analysis. The first and second phases will identify the key capabilities and competencies required to confidently adapt to the independent practice of comprehensive family medicine and inform fit-for-purpose educational strategies for teaching, learning and assessment. ETHICS AND DISSEMINATION: The study is approved by the University of Toronto's Health Sciences Research Ethics Board (#41799). Research findings will be discussed with professional bodies, educators responsible for family medicine curricula and universities. Study findings will also be disseminated through academic conferences and academic publications in peer-reviewed journals. Project summaries and infographics will be developed and disseminated to key stakeholders.

What is the role of primary care in the COVID-19 vaccine roll-out and the barriers and facilitators to an equitable vaccine roll-out? A rapid scoping review of nine jurisdictions.

OBJECTIVES: This study aimed to: (1) examine the experience of nine global jurisdictions that engaged primary care providers (PCPs) to administer COVID-19 vaccines during the pandemic; (2) describe how vaccine hesitancy and principles of equity were incorporated in the COVID-19 vaccine roll-out strategies and (3) identify the barriers and facilitators to the vaccine roll-out. DESIGN: Rapid scoping review. DATA SOURCES: Searches took place in MEDLINE, CINAHL, Embase, the Cochrane Library, SCOPUS and PsycINFO, Google, and the websites of national health departments. Searches and analyses took place from May 2021 to July 2021. RESULTS: Sixty-two documents met the inclusion criteria (35=grey literature; 56% and 27=peer reviewed; 44%). This review found that the vaccine distribution approach started at hospitals in almost all jurisdictions. In some jurisdictions, PCPs were engaged at the beginning, and the majority included PCPs over time. In many jurisdictions, equity was considered in the prioritisation policies for various marginalised communities. However, vaccine hesitancy was not explicitly considered in the design of vaccine distribution approaches. The barriers to the roll-out of vaccines included personal, organisational and contextual factors. The vaccine roll-out strategy was facilitated by establishing policies and processes for pandemic preparedness, well-established and coordinated information systems, primary care interventions, adequate supply of providers, education and training of providers, and effective communications strategy. CONCLUSIONS: Empirical evidence is lacking on the impact of a primary care-led vaccine distribution approach on vaccine hesitancy, adoption and equity. Future vaccine distribution approaches need to be informed by further research evaluating vaccine distribution approaches and their impact on patient and population outcomes.

Global inequity creates local insufficiency: A qualitative study of COVID-19 vaccine implementation challenges in low-and-middle-income countries.

INTRODUCTION: The COVID-19 pandemic has amplified pre-existing challenges to health promotion and care across the world, and particularly in low- and middle-income countries (LMICs). This qualitative study draws on data from a panel of immunisation experts and uses a novel framework of vaccine delivery domains to explore perspectives from those who live and work in these settings on the challenges to implementing COVID-19 vaccine programs in LMICs. METHODS: We conducted a thematic content analysis of 96 participant free text replies to questions from Round I of a three-round Delphi consensus study amongst global experts on COVID-19 vaccine implementation. RESULTS: Participant responses highlighted challenges to vaccine program implementation including issues related to equity; governance, decision-making, and financing; regulatory structures, planning, and coordination; prioritisation, demand generation, and communication; vaccine, cold chain, logistics, and infrastructure; service delivery, human resources, and supplies; and surveillance, monitoring, and evaluation. CONCLUSION: We reflect on our findings in light of global efforts to address vaccine inequity and emphasise three key areas salient to improving vaccination efforts during novel infectious disease outbreaks: 1) Ensuring safe and sustainable service delivery in communities and at points of care; 2) Strengthening systems for end-to-end delivery of vaccines, therapeutics, diagnostics, and essential supplies; 3) Transforming structural paradigms towards vaccine equity.

How the Suboxone Education Programme presented as a solution to risks in the Canadian opioid crisis: a critical discourse analysis.

OBJECTIVES: Pharmaceutical industry involvement in medical education, research and clinical practice can lead to conflicts of interest. Within this context, this study examined how the 'Suboxone Education Programme', developed and delivered by a pharmaceutical company as part of a federally regulated risk management program, was presented as a solution to various kinds of risks relating to opioid use in public documents from medical institutions across Canada. SETTING: These documents were issued during the Canadian opioid crisis, a time when the involvement of industry in health policy was being widely questioned given industry's role in driving the overprescribing of opioid analgesics and contributing to population-level harms. DESIGN: A critical discourse analysis of 69 documents collected between July 2020 and May 2021 referencing the Suboxone Education Program spanning 13 years (2007-2021) from medical, nursing and pharmacy institutions sourced from every Canadian province and territory. Discursive themes were identified through iterative and duplicate analyses using a semistructured data extraction instrument. RESULTS: Documents characterised the Programme as addressing iatrogenic risks from overprescribing opioid analgesics, environmental risks from a toxic street drug supply and pharmacological risks relating to the dominant therapeutic alternative of methadone. The programme was identified as being able to address these risks by providing mechanisms to surveil healthcare professionals and to facilitate the prescribing of Suboxone. Medical institutions legitimised the Suboxone Education Programme by lending their regulatory, epidemiological and professional authority. CONCLUSIONS: Addressing risk is considered as a central, moral responsibility of contemporary healthcare services. In this case, moral imperatives to address opioid crisis-related risks overrode other ethical concerns regarding conflicts of interest between industry and public welfare. Failing to address these conflicts potentially imperils efforts of mitigating population health harms by propagating an important driving force of the opioid crisis.

WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations.

While the degree of COVID-19 vaccine accessibility and uptake varies at both national and global levels, increasing vaccination coverage raises questions regarding the standard of prevention that ought to apply to different settings where COVID-19 vaccine trials are hosted. A WHO Expert Group has developed guidance on the ethical implications of conducting placebo-controlled trials in the context of expanding global COVID-19 vaccine coverage. The guidance also considers alternative trial designs to placebo controlled trials in the context of prototype vaccines, modified vaccines, and next generation vaccines.

Chronic Pain and Opioid Prescribing: Three Ways for Navigating Complexity at the Clinical‒Population Health Interface.

Clinically focused interventions for people living with pain, such as health professional education, clinical decision support systems, prescription drug monitoring programs, and multidisciplinary care to support opioid tapering, have all been promoted as important solutions to the North American opioid crisis. Yet none have so far delivered substantive beneficial opioid-related population health outcomes. In fact, while total opioid prescribing has leveled off or reduced in many jurisdictions, population-level harms from opioids have continued to increase dramatically. We attribute this failure partly to a poor recognition of the epistemic and ethical complexities at the interface of clinical and population health. We draw on a framework of knowledge networks in wicked problems to identify 3 strategies to help navigate these complexities: (1) designing and evaluating clinically focused interventions as complex interventions, (2) reformulating evidence to make population health dynamics apparent, and (3) appealing to the inseparability of facts and values to support decision-making in uncertainty. We advocate that applying these strategies will better equip clinically focused interventions as complements to structural and public health interventions to achieve the desired beneficial population health effects. (Am J Public Health. 2022;112(S1):S56-S65. https://doi.org/10.2105/AJPH.2021.306500).

Identifying priority challenges and solutions for COVID-19 vaccine delivery in low- and middle-income countries: A modified Delphi study.

BACKGROUND: The rapid implementation of global COVID-19 vaccination programs has surfaced many challenges and inequities, particularly in low- and middle-income countries (LMICs). However, there continues to be a lack of consensus on which challenges are global priorities for action, and how to best respond to them. This study uses consensus-based methods to identify and rank the most important challenges and solutions for implementation of COVID-19 vaccination programs in LMICs. METHODS: We conducted a three-round modified Delphi study with a global panel of vaccine delivery experts. In Round I, panelists identified broad topical challenges and solutions. Responses were collated and coded into distinct items. Through two further rounds of structured, iterative surveys panelists reviewed and ranked the identified items. Responses were analyzed qualitatively and quantitatively to achieve consensus on the most important COVID-19 vaccine delivery challenges and solutions. RESULTS: Of the 426 invited panelists, 96 completed Round I, 56 completed Round II, and 39 completed Round III. Across all three rounds there was equal representation by gender, and panelists reported work experience in all World Bank regions and across a variety of content areas and organizations. Of the 64 initially identified items, the panel achieved consensus on three challenges and 10 solutions. Challenges fell under themes of structural factors and infrastructure and human and material resources, while solutions also included items within themes of communication, community engagement, and access and planning, processes, and operations. CONCLUSION: COVID-19 vaccine delivery is challenged by long-standing and structural inequities that disadvantage health service delivery in LMICs. These findings can, and should, be used by global health organizations to efficiently and optimally direct resources to respond to these key challenges and solutions.

Use of evidence in acute stroke decision-making: Implications for evidence-based medicine.

RATIONALE, AIMS AND OBJECTIVES: Evidence-Based Medicine proposes a prescriptive model of physician decision-making in which 'best evidence' is used to guide best practice. And yet, proponents of EBM acknowledge that EBM fails to offer a systematic theory of physician decision-making. METHODS: In this paper, we explore how physicians from the neurology and emergency medicine communities have responded to an evolving body of evidence surrounding the acute treatment of patients with ischemic stroke. Through analysis of this case study, we argue that EBM's vision of evidence-based medical decision-making fails to appreciate a process that we have termed epistemic evaluation. RESULTS AND CONCLUSIONS: Physicians are required to interpret and apply any knowledge-even what EBM would term 'best evidence'-in light of their own knowledge, background and experience. This is consequential for EBM as understanding what physicians do and why they do it would appear to be essential to achieving optimal practice in accordance with best evidence.

A rapid scoping review of end-of-life conversations with frail older adults in Canada.

OBJECTIVE: To explore what is known about end-of-life (EOL) conversations with frail older adults across all settings including primary care in Canada, and to understand the barriers to, and recommendations for, EOL conversations. DATA SOURCES: Comprehensive searches were conducted in CINAHL (EBSCO), Embase (Ovid), MEDLINE (Ovid), AgeLine (EBSCO), Sociological Abstracts (ProQuest), and Applied Social Sciences Index and Abstracts (ProQuest). Searches used text words and subject headings (eg, MeSH, Emtree) related to 3 concepts: frailty, Canada, and EOL conversations. STUDY SELECTION: Twenty-one English-language articles were selected (ie, 4 reviews, 10 commentaries, 3 quantitative studies, 3 qualitative studies, 1 mixed-methods study) that included information about EOL conversations with frail older adults in the Canadian health care context. SYNTHESIS: In terms of having EOL conversations with frail older adults, this study found that many clinicians do not often and adequately discuss frailty and impending death with their older patients. Moreover, patients and their care partners do not have enough knowledge about frailty and death to make informed EOL decisions, leading to patients choosing more aggressive therapies instead of care focused on symptom management. In terms of barriers to EOL discussions, common barriers included a lack of trust between clinician and patient, inadequate EOL training for clinicians, and ineffective clinician communication with patients and families. Recommendations for improving EOL conversations include regular screening for frailty to prompt conversations about care and the use of an interprofessional approach. CONCLUSION: More empirical research is needed that uses exploratory methods to shed light on the contextual factors that may act as a barrier to EOL conversations. More research is also needed on the roles and responsibilities of interprofessional teams in screening for frailty and engaging in EOL conversations. Moreover, there is a need to better understand how frail older patients and their families want EOL conversations to unfold and what best facilitates these conversations.

Why does continuity of care with family doctors matter? Review and qualitative synthesis of patient and physician perspectives.

OBJECTIVE: To summarize and synthesize qualitative studies that report patient and physician perspectives on continuity of care in family practice. DATA SOURCES: MEDLINE (Ovid), EMBASE (Ovid), and PsycInfo (Ovid) were searched for qualitative primary research reporting perspectives of patients, physicians, or both, on continuity of care in family practice. STUDY SELECTION: English-language qualitative studies were selected (eg, interviews, focus groups, mixed methods) that were conducted in Canada, the United States, the United Kingdom, the European Union, New Zealand, or Australia. SYNTHESIS: Themes were extracted, summarized, and synthesized. Six overarching themes emerged: continuity of care enables person-centred care; continuity of care increases quality of care; continuity of care leads to greater confidence in medical decision making; continuity of care comes with drawbacks; the absence of continuity of care may lead to medical and psychological harm; and continuity of care can foster greater joy and meaning in a physician's work. Out of the 6 themes, patients and physicians shared the first 5. CONCLUSION: To the authors' knowledge, this is the first qualitative review reporting the unique perspectives of both patients and family physicians on continuity of care. The findings add nuanced insight to the importance of continuity of care in family practice.

Examine the association between key determinants identified by the chronic disease indicator framework and multimorbidity by rural and urban settings.

BACKGROUND: Multimorbidity, often defined as having two or more chronic conditions is a global phenomenon. This study examined the association between key determinants identified by the chronic disease indicator framework and multimorbidity by rural and urban settings. The prevalence of individual diseases was also investigated by age and sex. METHODS: The Canada Community Health Survey and linked health administrative databases were used to examine the association between multimorbidity, sociodemographic, behavioral, and other risk factors in the province of Ontario. A multivariable logistic regression model was used to conduct the main analysis. RESULTS: Analyses were stratified by age (20-64 and 65-95) and area of residence (rural and urban). A total sample of n = 174,938 residents between the ages of 20-95 were examined in the Ontario province, of which 18.2% (n = 31,896) were multimorbid with 2 chronic conditions, and 23.4% (n = 40,883) with 3+ chronic conditions. Females had a higher prevalence of 2 conditions (17.9% versus 14.6%) and 3+ conditions (19.7% vs. 15.6%) relative to males. Out of all examined variables, poor self-perception of health, age, Body Mass Index, and income were most significantly associated with multimorbidity. Smoking was a significant risk factor in urban settings but not rural, while drinking was significant in rural and not urban settings. Income inequality was associated with multimorbidity with greater magnitude in rural areas. Prevalence of multimorbidity and having three or more chronic conditions were highest among low-income populations. CONCLUSION: Interventions targeting population weight, age/sex specific disease burdens, and additional focus on stable income are encouraged.

Evaluation of a package of risk-based pharmaceutical and lifestyle interventions in patients with hypertension and/or diabetes in rural China: A pragmatic cluster randomised controlled trial.

BACKGROUND: Primary prevention of cardiovascular disease (CVD) requires adequate control of hypertension and diabetes. We designed and implemented pharmaceutical and healthy lifestyle interventions for patients with diabetes and/or hypertension in rural primary care, and assessed their effectiveness at reducing severe CVD events. METHODS AND FINDINGS: We used a pragmatic, parallel group, 2-arm, controlled, superiority, cluster trial design. We randomised 67 township hospitals in Zhejiang Province, China, to intervention (34) or control (33). A total of 31,326 participants were recruited, with 15,380 in the intervention arm and 15,946 in the control arm. Participants had no known CVD and were either patients with hypertension and a 10-year CVD risk of 20% or higher, or patients with type 2 diabetes regardless of their CVD risk. The intervention included prescription of a standardised package of medicines, individual advice on lifestyle change, and adherence support. Control was usual hypertension and diabetes care. In both arms, as usual in China, most outpatient drug costs were out of pocket. The primary outcome was severe CVD events, including coronary heart disease and stroke, during 36 months of follow-up, as recorded by the CVD surveillance system. The study was implemented between December 2013 and May 2017. A total of 13,385 (87%) and 14,745 (92%) participated in the intervention and control arms, respectively. Their mean age was 64 years, 51% were women, and 90% were farmers. Of all participants, 64% were diagnosed with hypertension with or without diabetes, and 36% were diagnosed with diabetes only. All township hospitals and participants completed the 36-month follow-up. At 36 months, there were 762 and 874 severe CVD events in the intervention and control arms, respectively, yielding a non-significant effect on CVD incidence rate (1.92 and 2.01 per 100 person-years, respectively; crude incidence rate ratio = 0.90 [95% CI: 0.74, 1.08; P = 0.259]). We observed significant, but small, differences in the change from baseline to follow-up for systolic blood pressure (-1.44 mm Hg [95% CI: -2.26, -0.62; P < 0.001]) and diastolic blood pressure (-1.29 mm Hg [95% CI: -1.77, -0.80; P < 0.001]) in the intervention arm compared to the control arm. Self-reported adherence to recommended medicines was significantly higher in the intervention arm compared with the control arm at 36 months. No safety concerns were identified. Main study limitations include all participants being informed about their high CVD risk at baseline, non-blinding of participants, and the relatively short follow-up period available for judging potential changes in rates of CVD events. CONCLUSIONS: The comprehensive package of pharmaceutical and healthy lifestyle interventions did not reduce severe CVD events over 36 months. Improving health system factors such as universal coverage for the cost of essential medicines is required for successful risk-based CVD prevention programmes. TRIAL REGISTRATION: ISRCTN registry ISRCTN58988083.

Top five ethical lessons of COVID-19 that the world must learn.

As the world reflects upon one year since the first cases of coronavirus disease 2019 (COVID-19) and prepare for and experience surges in cases, it is important to identify the most crucial ethical issues that might lie ahead so that countries are able to plan accordingly. Some ethical issues are rather obvious to predict, such as the ethical issues surrounding the use of immunity certificates, contact tracing, and the fair allocation of vaccines globally. Yet, the most significant ethical challenge that the world must address in the next year and beyond is to ensure that we learn the ethical lessons of the first year of this pandemic. Learning from our collective experiences thus far constitutes our greatest moral obligation. Appreciating that decision-making in the context of a pandemic is constrained by unprecedented complexity and uncertainty, beginning in June 2020, an international group of 17 experts in bioethics spanning 15 countries (including low-, middle-, and high-income countries) met virtually to identify what we considered to be the most significant ethical challenges and accompanying lessons faced thus far in the COVID-19 pandemic. Once collected, the group met over the course of several virtual meetings to identify challenges and lessons that are analytically distinct in order to identify common ethical themes under which different challenges and lessons could be grouped. The result, described in this paper, is what this expert group consider to be the top five ethical lessons from the initial experience with COVID-19 that must be learned.

Beyond multimorbidity: What can we learn from complexity science?

Multimorbidity - the occurrence of two or more long-term conditions in an individual - is a major global concern, placing a huge burden on healthcare systems, physicians, and patients. It challenges the current biomedical paradigm, in particular conventional evidence-based medicine's dominant focus on single-conditions. Patients' heterogeneous range of clinical presentations tend to escape characterization by traditional means of classification, and optimal management cannot be deduced from clinical practice guidelines. In this article, we argue that person-focused care based in complexity science may be a transformational lens through which to view multimorbidity, to complement the specialism focus on each particular disease. The approach offers an integrated and coherent perspective on the person's living environment, relationships, somatic, emotional and cognitive experiences and physiological function. The underlying principles include non-linearity, tipping points, emergence, importance of initial conditions, contextual factors and co-evolution, and the presence of patterned outcomes. From a clinical perspective, complexity science has important implications at the theoretical, practice and policy levels. Three essential questions emerge: (1) What matters to patients? (2) How can we integrate, personalize and prioritize care for whole people, given the constraints of their socio-ecological circumstances? (3) What needs to change at the practice and policy levels to deliver what matters to patients? These questions have no simple answers, but complexity science principles suggest a way to integrate understanding of biological, biographical and contextual factors, to guide an integrated approach to the care of people with multimorbidity.

The granting of emergency use designation to COVID-19 candidate vaccines: implications for COVID-19 vaccine trials.

An efficacious COVID-19 vaccine is currently the world's leading research priority. Several nations have indicated that if there is a compelling case for use of a vaccine before it is licensed, they would be prepared to authorise its emergency use or conditional approval on public health grounds. As of Dec 1, 2020, several developers of leading COVID-19 candidate vaccines have indicated that they have applied, or intend to apply, for emergency authorisation for their vaccines. Should candidate vaccines attain emergency use designation and be programmatically deployed before their phase 3 trials conclude, such a strategy could have far reaching consequences for COVID-19 vaccine research and the effective control of the COVID-19 pandemic. These issues merit careful consideration.

National primary care responses to COVID-19: a rapid review of the literature.

OBJECTIVE: The aim of this review, conducted in April 2020, is to examine available national primary care guidelines for COVID-19 and to explore the ways in which these guidelines support primary care facilities in responding to the demands of the COVID-19 pandemic. DESIGN: Rapid review and narrative synthesis. DATA SOURCES: PubMed, Embase and Google, as well as the websites of relevant national health departments, were searched from 1 January 2020 to 24 April 2020. ELIGIBILITY CRITERIA: Documents included must be issued by a national health authority, must be specific to COVID-19 care, directed at healthcare workers or managers, and must refer to the role of primary care in the COVID-19 response. RESULTS: We identified 17 documents from 14 countries. An adapted framework on primary care challenges and responses to pandemic influenza framed our analysis. Guidelines generally reported on COVID-19 service delivery and mostly made specific recommendations for ensuring continued delivery of essential primary care services through telehealth or other virtual care modalities. Few offered guidance to support surveillance as a public health function. All offered guidance on implementing outbreak control measures, largely through flexible and coordinated organisational models with partners from various sectors. There was a lack of guidance to support supply chain management and practice resilience in primary care, and lack of personal protective equipment represents a serious threat to the provision of quality care during the pandemic. CONCLUSIONS: Current national primary care guidelines for COVID-19 provide guidance on infection control and minimising the risk of spread in primary care practices, while supporting the use of new technology and coordinated partnerships. However, to ensure primary care practice resilience and quality of care are upheld, guidelines must offer recommendations on supply chain management and operational continuity, supported by adequate resources.