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The Canadian province of Ontario introduced universal influenza immunization in 2000, offering free vaccines to the entire population. We compared changes in rates of influenza-associated respiratory antibiotic prescriptions before and after universal immunization in Ontario with corresponding changes in other provinces. Universal influenza immunization is associated with reduced influenza-associated antibiotic prescriptions. [ABSTRACT FROM AUTHOR]

Are restrictive measures and duties to care ethically reasonably acceptable to faith-based organizations? This study describes the perceptions of individually interviewed spiritual leaders of the disease control measures used during the recent SARS outbreak in Toronto. Four central themes were identified: the relationship between religious obligation and civic responsibilities; the role of faith-based organizations in supporting public health restrictive measures; the reciprocal obligations of public health and religious communities during restrictions; and justifiable limits to duties to care. We conclude that, within certain constraints, spiritual leaders find restrictive measures ethically reasonable and that spiritual leaders can play an important role during pandemic and epidemic control planning. Public health officials should therefore include them in the early and ongoing deliberations of the criteria and logistics for implementation during public health emergencies. [ABSTRACT FROM PUBLISHER]

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) [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: To identify the ethical challenges associated with the development and implementation of new tuberculosis (TB) drugs and diagnostics. Methods: Twenty-three semi-structured qualitative interviews conducted between December 2015 and September 2016 with programme administrators, healthcare workers, advocates, policymakers, and funders based in the Americas, Europe, and Africa. Interviews were analysed using thematic analysis. Results: Divergent interests and responsibilities, coupled with power imbalances, are a primary source of ethical challenges; the uncertain risk profiles of new drugs present an additional one. Although this challenge can be partially mitigated through stringent pharmacovigilance, respondents highlighted that high-burden countries tend to lack the resources to facilitate safe implementation. Increased advocacy and community engagement are considered an ethical imperative for future TB development and implementation. Conclusions: This project helps identify some of the ethical challenges of new TB technologies. It demonstrates that investigating ethical challenges through qualitative research is one way to apprehend the difficulty of implementing new TB technologies. Addressing this difficulty will require that those in positions of power reconsider their interests in relation to disempowered communities. Policy implications: Efforts to build consensus regarding what values should underpin the global governance of TB research, prevention, and care are essential to facilitate the ethical implementation of new TB technologies. [ABSTRACT FROM AUTHOR]

Experience of emergency use authorisations for investigational Ebola virus vaccines in Guinea and the Democratic Republic of the Congo (DRC) can elucidate key lessons that can guide ethical emergency use authorisations for COVID-19 vaccines. A second key difference concerns the perverse influence of geopolitics and vaccine nationalism that plagues the COVID-19 vaccine landscape unlike that of Ebola virus vaccines in 2016. 2017, published online May 30. https://doi.org/10.1038/nature.2017.22024 6 WHO Second Ebola vaccine to complement "ring vaccination" given green light in DRC. https://www.who.int/news-room/detail/23-09-2019-second-ebola-vaccine-to-complement-ring-vaccination-given-green-light-in-drc Sept 23, 2019, 7 WHO Four countries in the African region license vaccine in milestone for Ebola prevention. [Extracted from the article]

An introduction is presented in which the authors discuss various reports within the issue on topics related to the role of philosophy in discussions of medicine and health care including the state of evidence-based medicine (EBM), the role of political and economic factors in shaping the research agenda, and the methodological limits of randomized trials and the hierarchy of evidence.

Looks at the ethical questions raised by the outbreak of SARS in Toronto, Canada. Identification of the key ethical issues; List of the ten key ethical values; Ethics of quarantine; Individual privacy versus the public need to know; Duty of care; Collateral damage; Lesson to be learned from Canada's experience.

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., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Salamanca-Buentello et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., (© 2021 John Wiley & Sons Ltd.)

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., Competing Interests: Authors declare no competing interests., (Copyright: © 2022 Ariyarajah et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

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., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper: [All members of the WHO Access to COVID-19 Tools Accelerator Ethics and Governance Working Group declared their interests according to WHO standard procedures. None of the interests declared were found to be significant.]., (Copyright © 2022. Published by Elsevier Ltd.)

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., (Copyright © 2021 the College of Family Physicians of Canada.)

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., (© 2021 John Wiley & Sons, Ltd.)

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., (Copyright © 2021 the College of Family Physicians of Canada.)

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., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

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., Competing Interests: No competing interests were disclosed., (Copyright: © 2021 Smith MJ et al.)

The most powerful lesson learned from the 2013-2016 outbreak of Ebola in West Africa was that we do not learn our lessons. A common sentiment at the time was that Ebola served as a "wake-up call"-an alarm which signalled that an outbreak of that magnitude should never have occurred and that we are ill-prepared globally to prevent and respond to them when they do. Pledges were made that we must learn from the outbreak before we were faced with another. Nearly five years later the world is in the grips of a pandemic of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes coronavirus disease 2019 (COVID-19). It is therefore of no surprise that we are now yet again hearing that the COVID-19 pandemic serves as the "wake-up call" we need and that there are many lessons to be learned to better prepare us for future outbreaks. Will anything be different this time around? We argue that nothing will fundamentally change unless we truly understand and appreciate the nature of the lessons we should learn from these outbreaks. Our past failures must be understood as moral failures that offer moral lessons. Unless we appreciate that we have a defect in our collective moral attitude toward remediating the conditions that precipitate the emergence of outbreaks, we will never truly learn.

Purpose: Despite the public health successes of newborn bloodspot screening, uncertainty associated with variant forms of primary screening targets has led to discrepancies in medical management. This study explored health-care providers' approaches to managing atypical forms of inherited metabolic diseases (IMDs) in the absence of evidence-based guidelines., Methods: Semistructured telephone interviews were conducted with metabolic specialists. 3-Methylcrotonyl CoA deficiency and variant forms of phenylketonuria, biotinidase deficiency, and fatty acid oxidation disorders were considered. Data were analyzed inductively and deductively using a novel taxonomy of uncertainty., Results: Health-care providers (n = 12) navigate diagnostic, prognostic, and therapeutic challenges of uncertainty while interpreting patient and family attitudes, preferences, and ideas in the care of children with these result types. Participants explained the limits of classifying mild and atypical metabolic phenotypes. Participants also described the challenge of finding balance between cautious care and overmedicalization. Developing consistent care plans and honest communication with families were perceived as effective strategies when navigating uncertainty., Conclusion: Providers' experiences suggest a need for transparent and accessible guidelines that account for challenges associated with uncertainty generated by screening. Timely consideration of this challenge is warranted with increasing emergence of genotype-first approaches to screening.

Objective: To investigate the experiences of family caregivers who participated in an innovative model of interprofessional team-based care specifically designed for elderly patients with complex care needs., Design: Qualitative study., Setting: Large academic family practice in Toronto, Ont., Participants: Family caregivers of elderly patients who had attended the IMPACT (Interprofessional Model of Practice for Aging and Complex Treatments) clinic (N = 13)., Methods: Individual semistructured interviews, which were conducted face-to-face, audiorecorded, transcribed verbatim, and analyzed using the constant comparative method., Main Findings: Family caregivers who attended the IMPACT clinic believed it enhanced caregiver experience and capacity. Caregivers experienced increased validation and engagement with the treatment team. Feelings of isolation were reduced, resulting in increased confidence and greater feelings of empowerment in their caregiver role., Conclusion: While the needs and value of caregivers are increasingly acknowledged, health care teams continue to struggle with how to relate to and engage with family caregivers-how best to support them and work with them in the context of their family members' care. Interprofessional teams who adopt the IMPACT model-providing synchronous, real-time interventions that include the caregiver-can facilitate increased caregiver capacity, confidence, and empowerment., (Copyright© the College of Family Physicians of Canada.)

Conveying the uncertainty inherent in clinical practice has rightly become a focus of medical training. To date, much of the emphasis aims to encourage trainees to acknowledge and accept uncertainty. Intolerance of uncertainty is associated with medical student distress and a tendency in clinicians toward overtreatment. The authors argue that a deeper, philosophical understanding of the nature of uncertainty would allow students and clinicians to move beyond simple acceptance to explicating and mitigating uncertainty in practice.Uncertainty in clinical medicine can be categorized philosophically as moral, metaphysical, and epistemic uncertainty. Philosophers of medicine-in a way analogous to ethicists a half century ago-can be brought into medical education and medical practice to help students and physicians explore the epistemic and metaphysical roots of clinical uncertainty. Such an approach does not require medical students to master philosophy and should not involve adding new course work to an already-crowded medical curriculum. Rather, the goal is to provide students with the language and reasoning skills to recognize, evaluate, and mitigate uncertainty as it arises. The authors suggest ways in which philosophical concepts can be introduced in a practical fashion into a variety of currently existing educational formats. Bringing the philosophy of medicine into medical education promises not only to improve the training of physicians but, ultimately, to lead to more mindful clinical practice, to the benefit of physicians and patients alike.

Background: Inappropriate antibiotic prescribing causes widespread serious health problems. To reduce prescribing of antibiotics in Chinese primary care to children with upper respiratory tract infections (URTIs), we developed an intervention comprising clinical guidelines, monthly prescribing review meetings, doctor-patient communication skills training, and education materials for caregivers. We previously evaluated our intervention using an unblinded cluster-randomised controlled trial (cRCT) in 25 primary care facilities across two rural counties. When our trial ended at the 6-month follow-up period, we found that the intervention had reduced antibiotic prescribing for childhood URTIs by 29 percentage points (pp) (95% CI -42 to -16)., Methods and Findings: In this long-term follow-up study, we collected our trial outcomes from the one county (14 facilities and 1:1 cluster randomisation ratio) that had electronic records available 12 months after the trial ended, at the 18-month follow-up period. Our primary outcome was the antibiotic prescription rate (APR)-the percentage of outpatient prescriptions containing any antibiotic(s) for children aged 2 to 14 years who had a primary diagnosis of a URTI and had no other illness requiring antibiotics. We also conducted 15 in-depth interviews to understand how interventions were sustained. In intervention facilities, the APR was 84% (1,171 out of 1,400) at baseline, 37% (515 out of 1,380) at 6 months, and 54% (2,748 out of 5,084) at 18 months, and in control facilities, it was 76% (1,063 out of 1,400), 77% (1,084 out of 1,400), and 75% (2,772 out of 3,685), respectively. After adjusting for patient and prescribing doctor covariates, compared to the baseline intervention-control difference, the difference at 6 months represented a 6-month intervention-arm reduction in the APR of -49 pp (95% CI -63 to -35; P < 0.0001), and compared to the baseline difference, the difference at 18 months represented an 18-month intervention-arm reduction in the APR of -36 pp (95% CI -55 to -17; P < 0.0001). Compared to the 6-month intervention-control difference, the difference at 18 months represented no change in the APR: 13 pp (95% CI -7 to 33; P = 0.21). Factors reported to sustain reductions in antibiotic prescribing included doctors' improved knowledge and communication skills and focused prescription review meetings, whereas lack of supervision and monitoring may be associated with relapse. Key limitations were not including all clusters from the trial and not collecting returned visits or sepsis cases., Conclusions: Our intervention was associated with sustained and substantial reductions in antibiotic prescribing at the end of the intervention period and 12 months later. Our intervention may be adapted to similar resource-poor settings., Trial Registration: ISRCTN registry ISRCTN14340536., Competing Interests: The authors have declared that no competing interests exist.

Objectives: 'Social justice' and 'health equity' are core values in public health. Yet, despite their normative character, the numerous normative accounts of social justice and equity are rarely acknowledged, meaning that these values are often unaccompanied by an explanation of what they require in practice. The objective of this study was to bridge this normative scholarship with information about how these 'core values' are integrated and interpreted by Canadian public health policy-makers., Methods: Twenty qualitative interviews with public health policy-makers recruited from public health organizations in Canada, analyzed using an 'empirical ethics' methodology that combined empirical data with normative ethical analysis involving theories of justice., Findings: Participants viewed health equity and social justice as distinct, where the former was perceived as 'clearer'. Health equity was conceptualized as focusing attention to 'proximal' disparities in access to services and 'materialistic' determinants of health, whereas social justice was conceptualized as focusing on structural issues that lead to disadvantage. Health equity was characterized as 'neutral' and 'comfortable', whereas social justice was characterized as 'political' and 'uncomfortable'., Conclusion: These findings indicate that health equity dominates the discursive space wherein justice-based considerations are brought to bear on public health activities. As a result, 'uncomfortable' justice-based considerations of power imbalances and systematic disadvantage can be eschewed in practice in favour of attending to 'proximal' inequities. These findings reveal the problematic ways in which considerations of justice and equity are, and are not, being taken up in public health policy, which in turn may have negative implications for the public's health.

Background: There is growing reliance on unpaid caregivers to provide support to people with care needs. Integrated care approaches that aim to coordinate primary care with community care known as community based primary health care (CBPHC) has been a key policy initiative across health systems; however most attention has been paid to the needs of patients and not caregivers. The objective of this paper was to explore the unmet needs of caregivers of older adults with complex care needs receiving CBPHC., Methods: This qualitative descriptive study entailed one-to-one interviews with 80 caregivers from Canada and New Zealand where roles, experiences and needs were explored. Interview text related to unmet need was reviewed inductively and core themes identified., Results: Three themes were identified across CBPHC sites: unrecognized role; lack of personal resources; and no breaks even when services are in place., Conclusions: To support caregivers, models of care such as CBPHC need to look beyond the patient to meaningfully engage caregivers, address their needs and recognize the insight they hold. This knowledge needs to be valued as a key source of evidence to inform developments in health and social care.

Background: Inappropriate antibiotic prescribing contributes to the generation of drug resistance worldwide, and is particularly common in China. We assessed the effectiveness of an antimicrobial stewardship programme aiming to reduce inappropriate antibiotic prescribing in paediatric outpatients by targeting providers and caregivers in primary care hospitals in rural China., Methods: We did a pragmatic, cluster-randomised controlled trial with a 6-month intervention period. Clusters were primary care township hospitals in two counties of Guangxi province in China, which were randomly allocated to the intervention group or the control group (in a 1:1 ratio in Rong county and in a 5:6 ratio in Liujiang county). Randomisation was stratified by county. Eligible participants were children aged 2-14 years who attended a township hospital as an outpatient and were given a prescription following a primary diagnosis of an upper respiratory tract infection. The intervention included clinician guidelines and training on appropriate prescribing, monthly prescribing peer-review meetings, and brief caregiver education. In hospitals allocated to the control group, usual care was provided, with antibiotics prescribed at the individual clinician's discretion. Patients were masked to their allocated treatment group but doctors were not. The primary outcome was the antibiotic prescription rate in children attending the hospitals, defined as the cluster-level proportion of prescriptions for upper respiratory tract infections in 2-14-year-old outpatients, issued during the final 3 months of the 6-month intervention period (endline), that included one or more antibiotics. The outcome was based on prescription records and analysed by modified intention-to-treat. This study is registered with the ISRCTN registry, number ISRCTN14340536., Findings: We recruited all 25 eligible township hospitals in the two counties (14 hospitals in Rong county and 11 in Liujiang county), and randomly allocated 12 to the intervention group and 13 to the control group. We implemented the intervention in three internal pilot clusters between July 1, 2015, and Dec 31, 2015, and in the remaining nine intervention clusters between Oct 1, 2016 and March 31, 2016. Between baseline (the 3 months before implementation of the intervention) and endline (the final 3 months of the 6-month intervention period) the antibiotic prescription rate at the individual level decreased from 82% (1936/2349) to 40% (943/2351) in the intervention group, and from 75% (1922/2548) to 70% (1782/2552) in the control group. After adjusting for the baseline antibiotic prescription rate, stratum (county), and potentially confounding patient and prescribing doctor covariates, this endline difference between the groups represented an intervention effect (absolute risk reduction in antibiotic prescribing) of -29% (95% CI -42 to -16; p=0·0002)., Interpretation: In China's primary care setting, pragmatic interventions on antimicrobial stewardship targeting providers and caregivers substantially reduced prescribing of antibiotics for childhood upper respiratory tract infections., Funding: Department of International Development (UKAID) through Communicable Diseases Health Service Delivery., (Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Naturalistic theories of disease appeal to concepts of biological function, and use the notion of dysfunction as the basis of their definitions. Debates in the philosophy of biology demonstrate how attributing functions in organisms and establishing the function-dysfunction distinction is by no means straightforward. This problematization of functional ascription has undermined naturalistic theories and led some authors to abandon the concept of dysfunction, favoring instead definitions based in normative criteria or phenomenological approaches. Although this work has enhanced our understanding of disease and illness, we need not necessarily abandon naturalistic concepts of function and dysfunction in the disease debate. This article attempts to move towards a new naturalistic theory of disease that overcomes the limitations of previous definitions and offers advantages in the clinical setting. Our approach involves a re-evaluation of concepts of biological function employed by naturalistic theories. Drawing on recent insights from the philosophy of biology, we develop a contextual and evaluative account of function that is better suited to clinical medicine and remains consistent with contemporary naturalism. We also show how an updated naturalistic view shares important affinities with normativist and phenomenological positions, suggesting a possibility for consilience in the disease debate.

This paper explores the notion of reciprocity in the context of active pulmonary and laryngeal tuberculosis (TB) treatment and related control policies and practices. We seek to do three things: First, we sketch the background to contemporary global TB care and suggest that poverty is a key feature when considering the treatment of TB patients. We use two examples from TB care to explore the role of reciprocity: isolation and the use of novel TB drugs. Second, we explore alternative means of justifying the use of reciprocity through appeal to different moral and political theoretical traditions (i.e., virtue ethics, deontology, and consequentialism). We suggest that each theory can be used to provide reasons to take reciprocity seriously as an independent moral concept, despite any other differences. Third, we explore general meanings and uses of the concept of reciprocity, with the primary intention of demonstrating that it cannot be simply reduced to other more frequently invoked moral concepts such as beneficence or justice. We argue that reciprocity can function as a mid-level principle in public health, and generally, captures a core social obligation arising once an individual or group is burdened as a result of acting for the benefit of others (even if they derive a benefit themselves). We conclude that while more needs to be explored in relation to the theoretical justification and application of reciprocity, sufficient arguments can be made for it to be taken more seriously as a key principle within public health ethics and bioethics more generally.

The exercise of identifying lessons in the aftermath of a major public health emergency is of immense importance for the improvement of global public health emergency preparedness and response. Despite the persistence of the Ebola Virus Disease (EVD) outbreak in West Africa, it seems that the Ebola 'lessons learned' exercise is now in full swing. On our assessment, a significant shortcoming plagues recent articulations of lessons learned, particularly among those emerging from organizational reflections. In this article we argue that, despite not being recognized as such, the vast majority of lessons proffered in this literature should be understood as ethical lessons stemming from moral failures, and that any improvements in future global public health emergency preparedness and response are in large part dependent on acknowledging this fact and adjusting priorities, policies and practices accordingly such that they align with values that better ensure these moral failures are not repeated and that new moral failures do not arise. We cannot continue to fiddle at the margins without critically reflecting on our repeated moral failings and committing ourselves to a set of values that engenders an approach to global public health emergencies that embodies a sense of solidarity and global justice., (© The Author 2015. Published by Oxford University Press. Available online at www.phe.oxfordjournals.org.)

The aim of this article is to create a space for historical thinking in medical practice. To this end, we draw on the ideas of R.G. Collingwood (1889-1943), the renowned British philosopher of history, and explore the implications of his philosophy for clinical medicine. We show how Collingwood's philosophy provides a compelling argument for the re-centring of medical practice around the patient history as a means of restoring to the clinical encounter the human meaning that is too often lost in modern medicine. Furthermore, we examine how Collingwood's historical thinking offers a patient-centred epistemology and a more pluralistic concept of evidence that includes the qualitative, narrative evidence necessary for human understanding. We suggest that clinical medicine can benefit from Collingwood's historical thinking, and, more generally, illustrates how a philosophy of medicine that draws on diverse sources from the humanities offers a richer, more empathetic clinical practice., (© 2015 John Wiley & Sons, Ltd.)

In this essay, I respond to the critique of my work by Professor Miles Little., (© 2014 John Wiley & Sons, Ltd.)

The evolving Ebola epidemic in West Africa is unprecedented in its size and scope, requiring the rapid mobilization of resources. It is too early to determine all of the ethical challenges associated with the outbreak, but these should be monitored closely. Two issues that can be discussed are (1) the decision to implement and evaluate unregistered agents to determine therapeutic or prophylactic safety and efficacy and (2) the justification behind this decision. In this paper, I argue that it is not compassionate use that justifies this decision and suggest three lines of reasoning to support the decision.

A commentary on "Ethics and Evidence in Medical Debates: The Case of Recombinant Activated Factor VII," by Narcyz Ghinea, Wendy Lipworth, Ian Kerridge, Miles Little, and Richard O. Day, in the March-April 2014 issue., (© 2014 by The Hastings Center.)

Public health is intimately related to social justice, which is why practice and research in the field seek to improve the social determinants of health. Despite the best intentions of those working in public health, however, some policies and practices inadvertently further disadvantage pre-existing marginalized populations. In this paper, we provide a diagnosis of possible reasons why this phenomenon might occur. We posit that the challenges associated with further marginalizing certain populations stem from a) not acknowledging the normative aspects of apparently objective data, b) a misunderstanding and an uncritical alignment of public health goals with the ethics theory of utilitarianism, and c) assuming that those working in public health might be able to fully understand the experiences of marginalized populations. It is our view that the trend of public consultation with marginalized persons, the explicit teaching of ethics and philosophy of science in graduate departments of public health, and the increased use of health equity impact assessments might help protect against public health policies and practices that disadvantage marginalized populations.

Problem Addressed: The growing number of elderly patients with multiple chronic conditions presents an urgent challenge in primary care. Current practice models are not well suited to addressing the complex health care needs of this patient population., Objective of Program: The primary objective of the IMPACT (Interprofessional Model of Practice for Aging and Complex Treatments) clinic was to design and evaluate a new interprofessional model of care for community-dwelling seniors with complex health care needs. A secondary objective was to explore the potential of this new model as an interprofessional training opportunity., Program Description: The IMPACT clinic is an innovative new model of interprofessional primary care for elderly patients with complex health care needs. The comprehensive team comprises family physicians, a community nurse, a pharmacist, a physiotherapist, an occupational therapist, a dietitian, and a community social worker. The model is designed to accommodate trainees from each discipline. Patient appointments are 1.5 to 2 hours in length, during which time a diverse range of medical, functional, and psychosocial issues are investigated by the full interprofessional team., Conclusion: The IMPACT model is congruent with ongoing policy initiatives in primary care reform and enhanced community-based care for seniors. The clinic has been pilot-tested in 1 family practice unit and modeled at 3 other sites with positive feedback from patients and families, clinicians, and trainees. Evaluation data indicate that interprofessional primary care models hold great promise for the growing challenge of managing complex chronic disease.

Background: Osteoporosis is a highly prevalent and costly disease associated with aging. Previous studies have indicated low intervention rates in primary care; however, there is little research investigating the prescribing patterns of osteoporosis medications by primary-care physicians., Methods: We conducted a population-based retrospective cohort study to examine trends in osteoporosis medication utilization in primary care between 1 January 2000 and 31 December 2009 in Ontario, Canada. All Ontario residents aged 65 years or older and eligible for public health coverage were included in the analysis (∼1.46 million residents in 2000, ∼1.75 million residents in 2009)., Results: Analysis of 10-year data indicates a trend toward higher utilization of osteoporosis medications among elderly primary-care patients. In 2000, 100 038 unique patients were prescribed an osteoporosis medication by a family physician; by 2009, this number increased to 301 679. Age-group analyses suggest an inverted U-shaped pattern, whereby utilization rates increase with advancing age and then decline for the oldest age groups. Utilization rates were the lowest for the 100+ age group., Conclusions: This study indicates increased utilization of osteoporosis-related medications among elderly primary-care patients over a recent 10-year time period. It is unclear whether the observed increase in utilization is due to higher rates of osteoporosis. Further research is needed to determine the appropriateness of this higher utilization.