A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies

Background: : Public Health Emergencies (PHE) demand expeditious research responses to evaluate new or repurposed therapies and prevention strategies. Alternative Design Trials (ADTs) and Adaptive Platform Trials (APTs) have enabled efficient large-scale testing of biomedical interventions during recent PHEs. Design features of these trials may have implications for engagement and/or informed consent processes. We aimed to rapidly review evidence on engagement and informed consent for ADTs and APTs during PHE to consider what (if any) recommendations can inform practice. Method: : In 2022, we searched 8 prominent databases for relevant peer reviewed publications and guidelines for ADTs/APTs in PHE contexts. Articles were selected based on pre-identified inclusion and exclusion criteria. We reviewed protocols and informed consent documents for a sample of large platform trials and consulted with key informants from ADTs/APT trial teams. Data were extracted and summarised using narrative synthesis. Results: Of the 49 articles included, 10 were guidance documents, 14 discussed engagement, 10 discussed informed consent, and 15 discussed both. Included articles addressed ADTs delivered during the West African Ebola epidemic and APTs delivered during COVID-19. PHE clinical research guidance documents highlight the value of ADTs/APTs and the importance of community engagement, but do not provide practice-specific guidance for engagement or informed consent. Engagement and consent practice for ADTs conducted during the West African Ebola epidemic have been well-documented. For COVID-19, engagement and consent practice was described for APTs primarily delivered in high income countries with well-developed health service structures. A key consideration is strong communication of the complexity of trial design in clear, accessible ways. Conclusion: We highlight key considerations for best practice in community engagement and informed consent relevant to ADTs and APTs for PHEs which may helpfully be included in future guidance. Protocol The review protocol is published online at Prospero on 15/06/2022: registration number CRD42022334170.

Acceptability of Telehealth for Gender-Affirming Care in Transgender and Gender Diverse Youth and Their Caregivers.

Gender-affirming care (GAC) is critical to the well-being of transgender and gender diverse youth and was limited by COVID-19 stay-at-home orders. Telehealth created opportunities for youth to continue receiving lifesaving care. We examined the attitudes of patients (n=21) and caregivers (n=38) receiving telehealth-delivered GAC (TGAC) from May to July 2020. Participants completed surveys after telehealth visits. Descriptive statistics compared telehealth with in-person visits across key domains. Overall, 86.5% of patients and 95.4% of caregivers were satisfied with medical TGAC and 94.3% and 93.3% were satisfied with behavioral health TGAC. Future research should determine the effectiveness of TGAC and identify areas for improvement.

Psychosocial impact of COVID-19 on caregivers and adolescents and young adult survivors of childhood cancer.

BACKGROUND: Caregivers and adolescents and young adult (AYA) cancer survivors may be at greater psychosocial risk from the COVID-19 pandemic than healthy peers due to complex and traumatic medical histories. This study describes COVID-19-related event exposures, impact, and distress among a large sample of caregivers and AYA cancer survivors and the relationship of these variables to demographic and cancer characteristics. PROCEDURE: From May 2020 to December 2021, 422 caregivers and 531 AYA survivors completed the COVID-19 Exposures and Family Impact Survey (CEFIS) and CEFIS-AYA, respectively. Total COVID-19-related exposures, average COVID-19-related impact, and COVID-19-related distress were calculated. Conventional content analysis was used to analyze free-text responses about the negative and positive effects of COVID-19. RESULTS: Caregivers and AYA reported an average of 7.4-7.8 COVID-19 exposures to pandemic-related events and a slightly negative impact of COVID-19 across psychosocial domains, with some positive impacts reported. COVID-19-related distress was moderate and clinically meaningful (4.9-5.2/10) for AYA and caregivers. Racial and ethnically minoritized AYA and caregivers reported higher COVID-19-related distress than non-Hispanic white caregivers. For AYA, distress was also higher among female, college-age (18-22 years), and long-term survivors compared with males, younger AYA, White and those recently off treatment. CEFIS outcomes remained relatively stable over time. CONCLUSIONS: COVID-19 had a significant and consistent negative impact on caregivers and AYA survivors. Racial and ethnically minoritized families and female, college-age, and long-term AYA survivors may require additional psychosocial support. Assessing for COVID-19 impact and distress is important in pediatric oncology to evaluate adjustment and plan targeted interventions.

Humans not heroes: Canadian emergency physician experiences during the early COVID-19 pandemic.

BACKGROUND: The pandemic has upended much clinical care, irrevocably changing our health systems and thrusting emergency physicians into a time of great uncertainty and change. This study is a follow-up to a survey that examined the early pandemic experience among Canadian emergency physicians and aimed to qualitatively describe the experiences of these physicians during the global pandemic. The study was conducted at a time when Canadian COVID-19 case numbers were low. METHODS: The investigators engaged in an interview-based study that used an interpretive description analytic technique, sensitised by the principles of phenomenology. One-to-one interviews were conducted, transcribed and then analysed to establish a codebook, which was subsequently grouped into key themes. Results underwent source triangulation (with survey data from a similar period) and investigator-driven audit trail analysis. RESULTS: A total of 16 interviews (11 female, 5 male) were conducted between May and September 2020. The isolated themes on emergency physicians' experiences during the early pandemic included: (1) disruption and loss of emergency department shift work; (2) stress of COVID-19 uncertainty and information bombardment; (3) increased team bonding; (4) greater personal life stress; (5) concern for patients' isolation, miscommunication and disconnection from care; (6) emotional distress. CONCLUSIONS: Canadian emergency physicians experienced emotional and psychological distress during the early COVID-19 pandemic, at a time when COVID-19 prevalence was low. This study's findings could guide future interventions to protect emergency physicians against pandemic-related distress.

COVID-19 Exposure and Family Impact Scales for Adolescents and Young Adults.

OBJECTIVE: To understand the impact of the coronavirus disease 2019 (COVID-19) pandemic on adolescents and young adults (AYAs), we adapted the COVID-19 Exposure and Family Impact Scales (CEFIS; Kazak et al., 2021) for AYAs. Here, we report on the development, structure, and psychometric properties of the CEFIS-AYA. METHODS: The CEFIS-AYA was developed by a multidisciplinary, multi-institutional team using a rapid iterative process. Data from 3,912 AYAs from 21 programs at 16 institutions across the United States were collected from May 2020 to April 2021. We examined the underlying structure of the CEFIS-AYA using principal component analysis (PCA), calculated internal consistencies, and explored differences in scores by gender and age. RESULTS: Participants reported exposure to a range of COVID-19-related events (M = 9.08 events, of 28). On the bidirectional 4-point Impact scale, mean item scores were mostly above the midpoint, indicating a slightly negative impact. Kuder-Richardson 20/Cronbach's Alpha was good for Exposure (α = .76) and excellent for Impact (α = .93). PCA identified seven factors for Exposure (Severe COVID-19, Loss of Income, Limited Access to Essentials, COVID-19 Exposure, Disruptions to Activities, Disruptions to Living Conditions, and Designation as an Essential Worker) and five for Impact (Self and Family Relationships, Physical Well-Being, Emotional Well-Being, Social Well-Being, and Distress). Gender and age differences in CEFIS-AYA scores were identified. DISCUSSION: Initial reliability data are strong and support use of the CEFIS-AYA for measuring the effect of the COVID-19 pandemic on AYAs in research and clinical care.

Canadian emergency medicine physician burnout: a survey of Canadian emergency physicians during the second wave of the COVID-19 pandemic.

OBJECTIVES: A previous survey of Canadian emergency medicine (EM) physicians during the first wave of the COVID-19 pandemic documented less than 20% experienced high levels of burnout. This study examined the experience of a similar group of physicians during the second pandemic wave. We reported the associations between burnout and physician age, gender, having children at home and training route. METHODS: This study utilized a national survey of Canadian emergency physicians. We collected data on demographics and measured burnout using the Maslach Burnout Inventory (MBI). Multiple logistic regression models identified associations between the emotional exhaustion and depersonalization domains of the MBI and EM physician demographics (age, gender, children living at home, and training route). RESULTS: Between November 25, 2020, and February 4, 2021, 416 emergency physicians completed the survey, representing all Provinces or Territories in Canada (except Nunavut). The mean participant age was 44, 53% were male, 64% had children living at home and 41% were FRCPC and 41% CCFP-EM trained. Sixty percent reported high burnout (either high emotional exhaustion and/or high depersonalization). Increasing age was associated with lower emotional exhaustion and depersonalization; female or nonbinary gender was associated with an increase in emotional exhaustion; and having children living at home was associated with lower depersonalization. CONCLUSIONS: Most Canadian emergency physicians participating in our study during the COVID-19 pandemic reported high burnout levels. Younger physicians and female physicians were more likely than their coworkers to report high burnout levels. Hospitals should address emergency physician burnout during the pandemic because it is a threat to quality of patient care and retention of the workforce for the future.

RéSUMé: OBJECTIFS: Une enquête précédente sur les médecins d'urgence canadiens pendant la première vague de la pandémie de COVID-19 a montré que moins de 20 % d'entre eux souffraient de niveaux élevés d'épuisement professionnel. Cette étude a examiné l'expérience d'un groupe similaire de médecins au cours de la deuxième vague et a rapporté les associations entre l'épuisement professionnel et l'âge du médecin, son sexe, le fait d'avoir des enfants à la maison et le parcours de formation. MéTHODES: Cette étude s'est appuyée sur une enquête nationale auprès des médecins d'urgence canadiens. Nous avons recueilli des données démographiques et mesuré le burnout à l'aide du Maslach Burnout Inventory (MBI). De multiples modèles de régression logistique ont identifié des associations entre les domaines de l'épuisement émotionnel et de la dépersonnalisation du MBI et les données démographiques des médecins de la médecine d'urgence (âge, sexe, enfants vivant à la maison et parcours de formation). RéSULTATS: Entre le 25 novembre 2020 et le 4 février 2021, 416 médecins urgentistes ont répondu au sondage, représentant toutes les provinces ou territoires du Canada (sauf le Nunavut). L'âge moyen des participants était de 44 ans, 53% étaient des hommes, 64% avaient des enfants vivant à la maison et 41% étaient formés FRCPC et 41% CMFC-MU. Soixante pour cent ont signalé un épuisement professionnel élevé (soit un épuisement émotionnel élevé et/ou une dépersonnalisation élevée). L'augmentation de l'âge était associée à une diminution de l'épuisement émotionnel et de la dépersonnalisation ; le sexe féminin ou non binaire était associé à une augmentation de l'épuisement émotionnel ; et le fait d'avoir des enfants vivant à la maison était associé à une diminution de la dépersonnalisation. CONCLUSIONS: La plupart des médecins urgentistes canadiens ayant participé à notre étude pendant la pandémie de COVID-19 ont signalé des niveaux élevés d'épuisement professionnel. Les médecins plus jeunes et les femmes médecins étaient plus susceptibles que leurs collègues de déclarer des niveaux élevés d'épuisement professionnel. Les hôpitaux doivent s'attaquer au problème de l'épuisement professionnel des médecins urgentistes pendant la pandémie, car il constitue une menace pour la qualité des soins aux patients et la rétention de la main-d'œuvre pour l'avenir.

Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial.

The efficacy of convalescent plasma for coronavirus disease 2019 (COVID-19) is unclear. Although most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content could influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 d of respiratory symptom onset ( NCT04348656 ). Patients were allocated 2:1 to 500 ml of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 d. Exploratory analyses of the effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. In total, 940 patients were randomized, and 921 patients were included in the intention-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) patients in the convalescent plasma arm and 86/307 (28.0%) patients in the standard of care arm-relative risk (RR) = 1.16 (95% confidence interval (CI) 0.94-1.43, P = 0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% versus 26.4%; RR = 1.27, 95% CI 1.02-1.57, P = 0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standardized log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (odds ratio (OR) = 0.74, 95% CI 0.57-0.95 and OR = 0.66, 95% CI 0.50-0.87, respectively), whereas IgG against the full transmembrane spike protein increased it (OR = 1.53, 95% CI 1.14-2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 d in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care.

Acceptability, Feasibility, and Quality of Telehealth for Adolescent Health Care Delivery During the COVID-19 Pandemic: Cross-sectional Study of Patient and Family Experiences.

BACKGROUND: Data regarding the acceptability, feasibility, and quality of telehealth among adolescents and young adults (AYA) and their parents and caregivers (caregivers) are lacking. OBJECTIVE: The aim of this study was to assess the noninferiority of telehealth versus in-person visits by comparing acceptability with respect to efficiency, effectiveness, equity, patient-centeredness, and confidentiality. METHODS: Cross-sectional web-based surveys were sent to caregivers and AYA following video visits within an Adolescent Medicine subspecialty clinic in May-July 2020. Proportions of AYA and caregivers who rated telehealth as noninferior were compared using chi-squared tests. Feasibility was assessed via items measuring technical difficulties. Deductive thematic analysis using the Institute of Medicine dimensions of health care quality was used to code open-ended question responses. RESULTS: Survey response rates were 20.5% (55/268) for AYA and 21.8% (123/563) for caregivers. The majority of the respondents were White cisgender females. Most AYA and caregivers rated telehealth as noninferior to in-person visits with respect to confidentiality, communication, medication management, and mental health care. A higher proportion of AYA compared to caregivers found telehealth inferior with respect to confidentiality (11/51, 22% vs 3/118, 2.5%, P<.001). One-quarter (14/55) of the AYA patients and 31.7% (39/123) of the caregivers reported technical difficulties. The dominant themes in the qualitative data included advantages of telehealth for efficiency and equity of health care delivery. However, respondents' concerns included reduced safety and effectiveness of care, particularly for patients with eating disorders, owing to lack of hands-on examinations, collection of vital signs, and laboratory testing. CONCLUSIONS: Telehealth was highly acceptable among AYA and caregivers. Future optimization should include improving privacy, ameliorating technical difficulties, and standardizing at-home methods of obtaining patient data to assure patient safety.

Methodological and Practical Considerations in Rapid Qualitative Research: Lessons Learned From a Team-Based Global Study During COVID-19 Pandemic

Rapid qualitative research (RQR) studies are increasingly employed to inform decision-making in public health emergencies. Despite this trend, there remains a lack of clarity around what these studies actually involve in terms of methodological processes and practical considerations or challenges. Our team conducted a global RQR study during the COVID-19 pandemic. In this article, we provide a detailed account of our methodological processes and decisions taken related to ethics, study design, and analysis. We describe how we navigated limitations on time and resources. We draw attention to several elements that operated as facilitators to the rapid launch and completion of this study. Rendering methodological considerations and rationales for specific RQR studies explicit and available for consideration by others can contribute to the validity of RQR, support further discussion and development of RQR methods, and make findings for particular studies more credible. [ABSTRACT FROM AUTHOR] Copyright of International Journal of Qualitative Methods is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Reflections of methodological and ethical challenges in conducting research during COVID-19 involving resettled refugee youth in Canada.

Research involving migrant youth involves navigating and negotiating complex challenges in order to uphold their rights and dignity, but also all while maintaining scientific rigour. COVID-19 has changed the global landscape within many domains and has increasingly highlighted inequities that exist. With restrictions focusing on maintaining physical distancing set in place to curb the spread of the virus, conducting in-person research becomes complicated. This article reflects on the ethical and methodological challenges encountered when conducting qualitative research during the pandemic with Syrian migrant youth who are resettled in Canada. The three areas discussed from the study are recruitment, informed consent and managing the interviews. Special attention to culture as being part of the study's methodology as an active reflexive process is also highlighted. The goal of this article is to contribute to the growing understanding of complexities of conducting research during COVID-19 with populations which have layered vulnerabilities, such as migrant youth. This article hopes that the reflections may help future researchers in conducting their research during this pandemic by being cognizant of both the ethical and methodological challenges discussed.

Convalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial.

BACKGROUND: Convalescent plasma has been used for numerous viral diseases including influenza, severe acute respiratory syndrome, Middle East respiratory syndrome and Ebola virus; however, evidence to support its use is weak. SARS-CoV-2 is a novel coronavirus responsible for the 2019 global pandemic of COVID-19 community acquired pneumonia. We have undertaken a randomized controlled trial to assess the efficacy and safety of COVID-19 convalescent plasma (CCP) in patients with SARS-CoV-2 infection. METHODS: CONCOR-1 is an open-label, multicentre, randomized trial. Inclusion criteria include the following: patients > 16 years, admitted to hospital with COVID-19 infection, receiving supplemental oxygen for respiratory complications of COVID-19, and availability of blood group compatible CCP. Exclusion criteria are : onset of respiratory symptoms more than 12 days prior to randomization, intubated or imminent plan for intubation, and previous severe reactions to plasma. Consenting patients are randomized 2:1 to receive either approximately 500 mL of CCP or standard of care. CCP is collected from donors who have recovered from COVID-19 and who have detectable anti-SARS-CoV-2 antibodies quantified serologically. The primary outcome is intubation or death at day 30. Secondary outcomes include ventilator-free days, length of stay in intensive care or hospital, transfusion reactions, serious adverse events, and reduction in SARS-CoV-2 viral load. Exploratory analyses include patients who received CCP containing high titre antibodies. A sample size of 1200 patients gives 80% power to detect a 25% relative risk reduction assuming a 30% baseline risk of intubation or death at 30 days (two-sided test; α = 0.05). An interim analysis and sample size re-estimation will be done by an unblinded independent biostatistician after primary outcome data are available for 50% of the target recruitment (n = 600). DISCUSSION: This trial will determine whether CCP will reduce intubation or death non-intubated adults with COVID-19. The trial will also provide information on the role of and thresholds for SARS-CoV-2 antibody titres and neutralization assays for donor qualification. TRIAL REGISTRATION: Clinicaltrials.gov NCT04348656 . Registered on 16 April 2020.

Dying in honour: experiences of end-of-life palliative care during the 2013–2016 Ebola outbreak in Guinea

With no cure and a high mortality rate, Ebola virus disease (EVD) outbreaks require preparedness for the provision of end-of-life palliative care. This qualitative study is part of a larger project on palliative care in humanitarian contexts. Its goal was to document and deepen understanding of experiences and expectations related to end-of-life palliative care for patients infected with Ebola virus disease (EVD) in West African Ebola treatment centres (ETCs) during the 2013–2016 epidemic. It consisted of 15 in-depth semi-structured interviews with individuals impacted by EVD in a Guinean ETC: either as patients in an ETC, healthcare providers, healthcare providers who were also EVD patients at one point, family relations who visited patients who died in an ETC, or providers of spiritual support to patients and family. Analysis was team based and applied an interpretive descriptive approach. Healthcare delivery in humanitarian emergencies must remain respectful of patient preferences but also local and contextual values and norms. Of key importance in the Guinean context is the culturally valued experience of “dying in honour”. This involves accompaniment to facilitate a peaceful death, the possibility of passing on final messages to family members, prayer, and particular practices to enact respect for the bodies of the deceased. Participants emphasized several challenges to such death in Ebola treatment centres (ETCs), as well as practices they deemed helpful to alleviating dying patients’ suffering. An overarching message in participants’ accounts was that ideally more would have been done for the dying in ETCs. Building on participants’ accounts, we outline a number of considerations for optimizing end-of-life palliative care during current and future public health emergencies, including for COVID-19.

Exploring Instagram To Promote Student Engagement in an Online Didactic Environment.

The COVID-19 pandemic has forced higher-education institutions to shift to nearly 100% online delivery of didactic coursework nationally. Besides the stress and isolation that many students experience simply due to the physical distancing requirements imposed by the crisis, students new to learning in an online environment may feel further isolated and disengaged from the course content. Consequently, we explored the use of an existing online social networking tool, Instagram, to enhance students' engagement with online course material. In this study, students enrolled in both undergraduate and graduate online science courses were invited to participate. Course instructors posted materials related to the topics covered in the course weekly sessions, including links to news reports, cartoons, and short quizzes. At the conclusion of each course, a questionnaire focusing on the students' experience was distributed to all participants. Results from the survey showed that the weekly Instagram posts allowed students to feel more engaged with the course content and connected with the course instructors and classmates. However, some students reported that the posts were not helpful or that they did not feel comfortable using social networking tools for education purposes due to privacy concerns. In this article, we provide tips for how to improve the effectiveness of using social networking tools to augment didactic online courses.

WHO guidance on ethics in outbreaks and the COVID-19 pandemic: a critical appraisal.

In 2016, following pandemic influenza threats and the 2014-2016 Ebola virus disease outbreaks, the WHO developed a guidance document for managing ethical issues in infectious disease outbreaks. In this article, we analyse some ethical issues that have had a predominant role in decision making in response to the current COVID-19 pandemic but were absent or not addressed in the same ways in the 2016 guidance document. A pandemic results in a health crisis and social and political crises both nationally and globally. The ethical implications of these global effects should be properly identified so that appropriate actions can be taken globally and not just in national isolation. Our analysis, which is a starting point to test the broader relevance of the 2016 WHO document that remains the only available guidance document applicable globally, concludes that the WHO guidance should be updated to provide reasoned and thoughtful comprehensive ethics advice for the sound management of the current and future pandemics.

Canadian emergency physician psychological distress and burnout during the first 10 weeks of COVID-19: A mixed-methods study.

Objectives: The aim of this study was to report burnout time trends and describe the psychological effects of working as a Canadian emergency physician during the first weeks of the coronavirus disease 2019 (COVID-19) pandemic. Methods: This was a mixed-methods study. Emergency physicians completed a weekly online survey. The primary outcome was physician burnout as measured by the emotional exhaustion and depersonalization items, from the Maslach Burnout Inventory. We captured data on work patterns, aerosolizing procedures, testing and diagnosis of COVID-19. Each week participants entered free text explaining their experiences and well-being. Results: There were 468 participants who worked in 143 Canadian hospitals. Burnout levels did not significantly change over time (emotional exhaustion P = 0.632, depersonalization P = 0.155). Three participants were diagnosed with COVID-19. Being tested for COVID-19 (odds ratio [OR] 11.5, 95% confidence interval [CI] 3.1-42.5) and the number of shifts worked (OR 1.3, 95% CI 1.1-1.5 per additional shift) were associated with high emotional exhaustion. Having been tested for COVID-19 (OR 4.3, 95% CI 1.1-17.8) was also associated with high depersonalization. Personal safety, academic and educational work, personal protective equipment, the workforce, patient volumes, work patterns, and work environment had an impact on physician well-being. A new financial reality and contrasting negative and positive experiences affected participants' psychological health. Conclusion: Emergency physician burnout levels remained stable during the initial 10 weeks of this pandemic. The impact of COVID-19 on the work environment and personal perceptions and fears about the impact on lifestyle have affected physician well-being.