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.

Comparing stroke rehabilitation inpatients and clinical trials eligibility criteria: A secondary chart review analysis revealing that most patients could have been excluded from rehabilitation trials based on comorbidity status.

Background: The generalizability of treatments examined in rehabilitation randomized controls trials (RCTs) partly depend on the similarity between trial subjects and a stroke rehabilitation inpatient population. The aim of this study was to determine the proportion of stroke rehabilitation inpatients that would have been eligible or ineligible to participate in published stroke RCTs. Methods: This was a secondary analysis of chart review data collected as part of an independent quality improvement initiative. Data pertaining to the characteristics of stroke rehabilitation inpatients (e.g. age, cognitive impairment, previous stroke, comorbidities) were extracted from the medical charts of patients consecutively admitted to an inpatient stroke rehabilitation unit at a large urban rehabilitation hospital in Canada. Using the exclusion criteria categories of stroke RCTs identified from a systematic scoping review of 428 RCTs, we identified how many stroke rehabilitation inpatients would have been eligible or ineligible to participate in stroke RCTs based on their age, cognitive impairment, previous stroke and presence of comorbidities. Results: In total, 110 stroke rehabilitation inpatients were included. Twenty-four percent of patients were 80 years of age or older, 84.5% had queries or concerns regarding patient cognitive abilities, 28.0% had a previous stroke, and 31.8% had a severe stroke. Stroke rehabilitation inpatients had six comorbidities on average. Based on these factors, most stroke rehabilitation inpatients could have been excluded from stroke RCTs, with cognitive impairment the most common RCT exclusion criteria. Conclusions: Changes to the design of RCTs would support the development of clinical practice guidelines that reflect stroke rehabilitation inpatient characteristics, enhancing equity, diversity, and inclusion within samples and the generalizability of results.

Expediting approval for medical countermeasures to address high burden disease: an ethical justification to move beyond emergency use authorisation.

Addressing global health crises requires a receptive and expedient policy environment to minimise delays in making available potentially life-saving technologies. Over time, the policy environment has adapted to ensure that communities have expedited access to promising technologies, such as vaccines, that can mitigate morbidity and mortality. Emergency authorisations are one such policy mechanism. While these have been employed successfully for several diseases, such as influenza, Ebola and COVID-19, the policy mechanism is tied to contexts where key bodies have designated the disease an 'emergency', whereas no equivalent mechanism exists for those failing to acquire the designation (eg, malaria and tuberculosis). In this paper, we examine ethical issues associated with emergency authorisations. We argue that there is no moral difference between those diseases considered emergencies and many that fail to be designated as such with respect to impact on affected communities. Thus, tying access to an expedient policy mechanism for approval to an emergency designation is ethically unjustified-it should be based on considerations of risks and benefits, the disease burden and the values of the communities that carry those risks and not contingent on if the disease is designated an emergency. We suggest the need to further enhance the policy environment to ensure access to similar expedited approval programmes irrespective of if a disease is an emergency. Levelling the field for access to expedited approval programmes across diseases can help in moving towards achieving global health equity but is not a panacea.

The impact of eHealth on relationships and trust in primary care: a review of reviews.

BACKGROUND: Given the increasing integration of digital health technologies in team-based primary care, this review aimed at understanding the impact of eHealth on patient-provider and provider-provider relationships. METHODS: A review of reviews was conducted on three databases to identify papers published in English from 2008 onwards. The impact of different types of eHealth on relationships and trust and the factors influencing the impact were thematically analyzed. RESULTS: A total of 79 reviews were included. Patient-provider relationships were discussed more frequently as compared to provider-provider relationships. Communication systems like telemedicine were the most discussed type of technology. eHealth was found to have both positive and negative impacts on relationships and/or trust. This impact was influenced by a range of patient-related, provider-related, technology-related, and organizational factors, such as patient sociodemographics, provider communication skills, technology design, and organizational technology implementation, respectively. CONCLUSIONS: Recommendations are provided for effective and equitable technology selection, application, and training to optimize the impact of eHealth on relationships and trust. The review findings can inform providers' and policymakers' decision-making around the use of eHealth in primary care delivery to facilitate relationship-building.

Preparing ethical review systems for emergencies: next steps.

Ethical review systems need to build on their experiences of COVID-19 research to enhance their preparedness for future pandemics. Recommendations from representatives from over twenty countries include: improving relationships across the research ecosystem; demonstrating willingness to reform and adapt systems and processes; and making the case robustly for better resourcing.

"I don't see the whole picture of their health": a critical ethnography of constraints to interprofessional collaboration in end-of-life conversations in primary care.

CONTEXT: Interprofessional collaboration is recommended in caring for frail older adults in primary care, yet little is known about how interprofessional teams approach end-of-life (EOL) conversations with these patients. OBJECTIVE: To understand the factors shaping nurses' and allied health clinicians' involvement, or lack of involvement in EOL conversations in the primary care of frail older adults. METHODS/SETTING: A critical ethnography of a large interprofessional urban Family Health Team in Ontario, Canada. Data production included observations of clinicians in their day-to-day activities excluding direct patient care; one-to-one semi-structured interviews with clinicians; and document review. Analysis involved coding data using an interprofessional collaboration framework as well as an analysis of the normative logics influencing practice. PARTICIPANTS: Interprofessional clinicians (n = 20) who cared for mildly to severely frail patients (Clinical Frailty Scale) at the Family Health Team. RESULTS: Findings suggest primary care nurses and allied health clinicians have the knowledge, skills, and inclination to engage frail older adults in EOL conversations. However, the culture of the clinic prioritizes biomedical care, and normalizes nurses and allied health clinicians providing episodic task-based care, which limits the possibility for these clinicians' engagement in EOL conversations. The barriers to nurses' and allied health clinicians' involvement in EOL conversations are rooted in neoliberal-biomedical ideologies that shapes the way primary care is governed and practiced. CONCLUSIONS: Our findings help to explain why taking an individual-level approach to addressing the challenge of delayed or avoided EOL conversations, is unlikely to result in practice change. Instead, primary care teams can work to critique and redevelop quality indicators and funding models in ways that promote meaningful interprofessional practice that recognize the expertise of nursing and allied health clinicians in providing high quality primary care to frail older patients, including EOL conversations.

Identifying clusters of coexisting conditions and outcomes among adults admitted to hospital with community-acquired pneumonia: a multicentre cohort study.

BACKGROUND: Little is known about patterns of coexisting conditions and their influence on clinical care or outcomes in adults admitted to hospital for community-acquired pneumonia (CAP). We sought to evaluate how coexisting conditions cluster in this population to advance understanding of how multimorbidity affects CAP. METHODS: We studied 11 085 adults admitted to hospital with CAP at 7 hospitals in Ontario, Canada. Using cluster analysis, we identified patient subgroups based on clustering of comorbidities in the Charlson Comorbidity Index. We derived and replicated cluster analyses in independent cohorts (derivation sample 2010-2015, replication sample 2015-2017), then combined these into a total cohort for final cluster analyses. We described differences in medications, imaging and outcomes. RESULTS: Patients clustered into 7 subgroups. The low comorbidity subgroup (n = 3052, 27.5%) had no comorbidities. The DM-HF-Pulm subgroup had prevalent diabetes, heart failure and chronic lung disease (n = 1710, 15.4%). One disease category defined each remaining subgroup, as follows: pulmonary (n = 1621, 14.6%), diabetes (n = 1281, 11.6%), heart failure (n = 1370, 12.4%), dementia (n = 1038, 9.4%) and cancer (n = 1013, 9.1%). Corticosteroid use ranged from 11.5% to 64.9% in the dementia and pulmonary subgroups, respectively. Piperacillin-tazobactam use ranged from 9.1% to 28.0% in the pulmonary and cancer subgroups, respectively. The use of thoracic computed tomography ranged from 5.7% to 36.3% in the dementia and cancer subgroups, respectively. Adjusting for patient factors, the risk of in-hospital death was greater in the cancer (adjusted odds ratio [OR] 3.12, 95% confidence interval [CI] 2.44-3.99), dementia (adjusted OR 1.57, 95% CI 1.05-2.35), heart failure (adjusted OR 1.66, 95% CI 1.35-2.03) and DM-HF-Pulm subgroups (adjusted OR 1.35, 95% CI 1.12-1.61), and lower in the diabetes subgroup (adjusted OR 0.67, 95% CI 0.50-0.89), compared with the low comorbidity group. INTERPRETATION: Patients admitted to hospital with CAP cluster into clinically recognizable subgroups based on coexisting conditions. Clinical care and outcomes vary among these subgroups with little evidence to guide decision-making, highlighting opportunities for research to personalize care.

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.

Meme Science, Pandemic Preparedness, and the Trajectory of Failure.

In this paper I analyse the implications of "flattening" the curve for long-term care residents in the Province of Ontario, Canada during the first wave of the SARS-CoV-2/COVID-19 pandemic. I then question what the role of healthcare systems are in the response to public health emergencies and problematize their status as entities in need of protection. The ethical implications of this are discussed in light of potential challenges raised by climate change.

The importance of getting the ethics right in a pandemic treaty.

The COVID-19 pandemic revealed numerous weaknesses in pandemic preparedness and response, including underfunding, inadequate surveillance, and inequitable distribution of countermeasures. To overcome these weaknesses for future pandemics, WHO released a zero draft of a pandemic treaty in February, 2023, and subsequently a revised bureau's text in May, 2023. COVID-19 made clear that pandemic prevention, preparedness, and response reflect choices and value judgements. These decisions are therefore not a purely scientific or technical exercise, but are fundamentally grounded in ethics. The latest treaty draft reflects these ethical considerations by including a section entitled Guiding Principles and Approaches. Most of these principles are ethical-they establish core values that undergird the treaty. Unfortunately, the treaty draft's set of principles are numerous, overlapping, and show inadequate coherence and consistency. We propose two improvements to this section of the draft pandemic treaty. First, key guiding ethical principles should be clearer and more precise than they currently are. Second, the link between ethical principles and policy implementation should be clearly established and define boundaries on acceptable interpretation, ensuring that signatories abide by these principles.

A Proposed Curricular Framework for an Interprofessional Approach to Deprescribing.

Deprescribing involves reducing or stopping medications that are causing more harm than good or are no longer needed. It is an important approach to managing polypharmacy, yet healthcare professionals identify many barriers. We present a proposed pre-licensure competency framework that describes essential knowledge, teaching strategies, and assessment protocols to promote interprofessional deprescribing skills. The framework considers how to involve patients and care partners in deprescribing decisions. An action plan and example curriculum mapping exercise are included to help educators assess their curricula, and select and implement these concepts and strategies within their programs to ensure learners graduate with competencies to manage increasingly complex medication regimens as people age. Supplementary Information: The online version contains supplementary material available at 10.1007/s40670-022-01704-9.

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.

Chronic Struggle: An Institutional Ethnography of Chronic Pain and Marginalization.

There have been several recent calls to re-think chronic pain in response to the growing awareness of social inequities that impact the prevalence of chronic pain and its management. This in turn has resulted in new explorations of suffering as it relates to pain. While laudable, many of these clinically oriented accounts are abstract and often fail to offer a critical theoretical understanding of social and structural inequities. To truly rethink pain, we must also reconsider suffering, beginning in the everyday expert knowledge of people with chronic pain who can offer insights in relation to their bodies and also the organization of the social circumstances in which they live. Our team undertook a sociological approach known as institutional ethnography (IE) to explicate the work of people in managing lives beset by chronic pain and the inequities that stem from marginalization. In keeping with our critical paradigm, we describe participant accounts as situated, rather than lived, to de-emphasize the individual in favour of the social and relational. Through our analysis, we offer a new concept of chronic struggle to capture how pain, illness, economic deprivation, and suffering constitute a knot of experience that people living with chronic pain are obliged to simplify in order to fit existing logics of medicine. Our goal is to identify the social organization of chronic pain care which underpins experience in order to situate the social as political rather than medical or individual. PERSPECTIVE: This article explicates the health work of people living with chronic pain and marginalization, drawing on their situated experience. We offer the concept of chronic struggle as a conceptualization that allows us to bring into clear view the social organization of chronic pain in which the social is visible as political and structural rather than medical or individual.

A good death: non-negotiable personal conditions for clinicians, healthcare administrators and support staff.

OBJECTIVES: To ask all clinical, administrative and support staff affiliated with a large network of healthcare facilities to identify the conditions that they consider as non-negotiable for their own deaths to be regarded as good. METHODS: All 3495 staff of a healthcare network were asked to rank 10 conditions according to how non-negotiable they would be for themselves during their final 3 months or few hours for their own deaths to be considered as good. They were also asked about whether they had thought about their own death in the last 3 months, if they had a will, believed in God, and in the possibility of a good death, and the intensity of their fear of death. RESULTS: 2971 (85%) completed the survey. Most were female (79%) and clinical staff (65%). 93% believed in God, 60% had thought about their death recently, 33% had an intense fear of death, and 4% had a will. 64% considered a good death possible. Participants ranked dying at a preferred place, emotional support from family and friends and relief from physical symptoms as their top priorities. The lowest ranked conditions were (from the bottom) relief from psychological distress, performance of rituals and the right to terminate life. There were no statistically significant differences across genders or individual occupational groups. CONCLUSION: Most of conditions for a good death of interest to healthcare professionals could be provided without sophisticated medical infrastructure or specialised knowledge, opening the door for new support services to make it possible for everyone, anywhere.

On the same page? A qualitative study of shared mental models in an interprofessional, inter-organizational team implementing goal-oriented care.

Goal-oriented care is an approach to care delivery that uses patient-identified goals to drive care planning. Implementing goal-oriented care requires team members to cognitively shift the focus from "what is the matter" to "what matters to patients," and align their mental models of what it means to care for patients. Yet, no empirical studies of goal-oriented care apply evidence from the cognitive sciences, such as Shared Mental Model (SMM) theory. We conducted a qualitative case study of an interprofessional team that adopted goal-oriented care in Vermont, US (n = 18). Guided by SMM theory, we distinguished between task-related and team-related mental models. We used framework analysis and qualitative content analysis to determine mental model content and similarity. The most shared content areas were operationalizing goal-oriented care, engaging in formal and informal communication, taking a "whole-person" approach, taking a team approach, and building trusting relationships with patients and with other team members. Trust was the only construct that spanned both task and team mental model categories, highlighting the importance of both intra-team trust and provider-patient trust to the implementation of goal-oriented care. Team members developed SMMs through training, regular meetings, and interactions during care delivery. This study provides insight into the cognitive mechanisms that underlie team-based goal-oriented care delivery, which can be used to inform implementation, training content, and future research.