"We are not invited": Australian focus group results on how to improve ethnic diversity in trials.

OBJECTIVES: Lack of ethnic diversity in trials may contribute to health disparities and to inequity in health outcomes. The primary objective was to investigate the experiences and perspectives of ethnically diverse populations about how to improve ethnic diversity in trials. STUDY DESIGN AND SETTING: Qualitative data were collected via 16 focus groups with participants from 21 ethnically diverse communities in Australia. Data collection took place between August and September 2022 in community-based settings in six capital cities: Sydney, Melbourne, Perth, Adelaide, Brisbane, and Darwin, and one rural town: Bordertown (South Australia). RESULTS: One hundred and fifty-eight purposively sampled adults (aged 18-85, 49% women) participated in groups speaking Tamil, Greek, Punjabi, Italian, Mandarin, Cantonese, Karin, Vietnamese, Nepalese, and Arabic; or English-language groups (comprising Fijian, Filipino, African, and two multicultural groups). Only 10 participants had previously taken part in medical research including three in trials. There was support for medical research, including trials; however, most participants had never been invited to participate. To increase ethnic diversity in trial populations, participants recommended recruitment via partnering with communities, translating trial materials and making them culturally accessible using audiovisual ways, promoting retention by minimizing participant burden, establishing trust and rapport between participants and researchers, and sharing individual results. Participants were reluctant to join studies on taboo topics in their communities (eg, sexual health) or in which physical specimens (eg, blood) were needed. Participants said these barriers could be mitigated by communicating about the topic in more culturally cognizant and safe ways, explaining how data would be securely stored, and reinforcing the benefit of medical research to humanity. CONCLUSION: Participants recognized the principal benefits of trials and other medical research, were prepared to take part, and offered suggestions on recruitment, consent, data collection mechanisms, and retention to enable this to occur. Researchers should consider these community insights when designing and conducting trials; and government, regulators, funders, and publishers should allow for greater innovation and flexibility in their processes to enable ethnic diversity in trials to improve.

Factors associated with frequent buprenorphine / naloxone initiation in a national survey of Canadian emergency physicians.

OBJECTIVE: To identify individual and site-related factors associated with frequent emergency department (ED) buprenorphine/naloxone (BUP) initiation. BUP initiation, an effective opioid use disorder (OUD) intervention, varies widely across Canadian EDs. METHODS: We surveyed emergency physicians in 6 Canadian provinces from 2018 to 2019 using bilingual paper and web-based questionnaires. Survey domains included BUP-related practice, demographics, attitudes toward BUP, and site characteristics. We defined frequent BUP initiation (the primary outcome) as at least once per month, high OUD prevalence as at least one OUD patient per shift, and high OUD resources as at least 3 out of the following 5 resources: BUP initiation pathways, BUP in ED, peer navigators, accessible addiction specialists, and accessible follow-up clinics. We excluded responses from sites with <50% participation (to minimize non-responder bias) and those missing the primary outcome. We used univariate analysis to identify associations between frequent BUP initiation and factors of interest, stratifying by OUD prevalence. RESULTS: We excluded 3 responses for missing BUP initiation frequency and 9 for low response rate at one ED. Of the remaining 649 respondents from 34 EDs, 374 (58%) practiced in metropolitan areas, 384 (59%) reported high OUD prevalence, 312 (48%) had high OUD resources, and 161 (25%) initiated BUP frequently. Age, gender, board certification and years in practice were not associated with frequent BUP initiation. Site-specific factors were associated with frequent BUP initiation (high OUD resources [OR 6.91], high OUD prevalence [OR 4.45], and metropolitan location [OR 2.39],) as were individual attitudinal factors (willingness, confidence, and responsibility to initiate BUP.) Similar associations persisted in the high OUD prevalence subgroup. CONCLUSIONS: Individual attitudinal and site-specific factors were associated with frequent BUP initiation. Training to increase physician confidence and increasing OUD resources could increase BUP initiation and benefit ED patients with OUD.

Opioid-related overdose deaths among people experiencing homelessness, 2017 to 2021: A population-based analysis using coroner and health administrative data from Ontario, Canada.

AIMS: To measure the change in proportion of opioid-related overdose deaths attributed to people experiencing homelessness and to compare the opioid-related fatalities between individuals experiencing homelessness and not experiencing homelessness at time of death. DESIGN, SETTING AND PARTICIPANTS: Population-based, time-trend analysis using coroner and health administrative databases from Ontario, Canada from 1 July 2017 and 30 June 2021. MEASUREMENTS: Quarterly proportion of opioid-related overdose deaths attributed to people experiencing homelessness. We also obtained socio-demographic and health characteristics of decedents, health-care encounters preceding death, substances directly contributing to death and circumstances surrounding deaths. FINDINGS: A total of 6644 individuals (median age = 40 years, interquartile range = 31-51; 74.1% male) experienced an accidental opioid-related overdose death, among whom 884 (13.3%) were identified as experiencing homelessness at the time of death. The quarterly proportion of opioid-related overdose deaths attributed to people experiencing homelessness increased from 7.2% (26/359) in July-September 2017 to 16.8% (97/578) by April-June 2021 (trend test P < 0.01). Compared with housed decedents, those experiencing homelessness were younger (61.3 versus 53.1% aged 25-44), had higher prevalence of mental health or substance use disorders (77.1 versus 67.1%) and more often visited hospitals (32.1 versus 24.5%) and emergency departments (82.6 versus 68.5%) in the year prior to death. Fentanyl and its analogues more often directly contributed to death among people experiencing homelessness (94.0 versus 81.4%), as did stimulants (67.4 versus 51.6%); in contrast, methadone was less often present (7.8 versus 12.4%). Individuals experiencing homelessness were more often in the presence of a bystander during the acute toxicity event that led to death (55.8 versus 49.7%); and where another individual was present, more often had a resuscitation attempted (61.7 versus 55.1%) or naloxone administered (41.2 versus 28.9%). CONCLUSIONS: People experiencing homelessness account for an increasing proportion of fatal opioid-related overdoses in Ontario, Canada, reaching nearly one in six such deaths in 2021.

Improving the Reporting of Primary Care Research: Consensus Reporting Items for Studies in Primary Care-the CRISP Statement.

Primary care (PC) is a unique clinical specialty and research discipline with its own perspectives and methods. Research in this field uses varied research methods and study designs to investigate myriad topics. The diversity of PC presents challenges for reporting, and despite the proliferation of reporting guidelines, none focuses specifically on the needs of PC. The Consensus Reporting Items for Studies in Primary Care (CRISP) Checklist guides reporting of PC research to include the information needed by the diverse PC community, including practitioners, patients, and communities. CRISP complements current guidelines to enhance the reporting, dissemination, and application of PC research findings and results. Prior CRISP studies documented opportunities to improve research reporting in this field. Our surveys of the international, interdisciplinary, and interprofessional PC community identified essential items to include in PC research reports. A 2-round Delphi study identified a consensus list of items considered necessary. The CRISP Checklist contains 24 items that describe the research team, patients, study participants, health conditions, clinical encounters, care teams, interventions, study measures, settings of care, and implementation of findings/results in PC. Not every item applies to every study design or topic. The CRISP guidelines inform the design and reporting of (1) studies done by PC researchers, (2) studies done by other investigators in PC populations and settings, and (3) studies intended for application in PC practice. Improved reporting of the context of the clinical services and the process of research is critical to interpreting study findings/results and applying them to diverse populations and varied settings in PC.Annals "Online First" article.

The impact of COVID-19 on opioid toxicity deaths for people who experience incarceration compared to the general population in Ontario: A whole population data linkage study.

BACKGROUND: To inform preparedness and population health action, we need to understand the effects of COVID-19 on health inequities. In this study, we assess the impact of COVID-19 on opioid toxicity deaths among people who experience incarceration compared to others in the general population in Ontario, Canada. METHODS: We conducted a retrospective cohort study for the period of January 1, 2015 to December 31, 2020. We accessed and linked coronial data on all opioid toxicity deaths in Ontario with correctional data for people aged 18 years and older who were incarcerated in a provincial correctional facility. We used data from the Statistics Canada Census to calculate whole population rates. We used an interrupted time series design and segmented regression to assess for change in the level or rate of increase in deaths due to opioid toxicity coinciding with the COVID-19 pandemic. We compared the impact of COVID-19 on the opioid toxicity death rates for people exposed and not exposed to incarceration. RESULTS: Rates of opioid toxicity death increased with a linear positive slope in both persons exposed to incarceration and those not exposed over the study period. The start of COVID-19 measures coincided with a marked upward shift in the trend lines with modification of the effect of COVID-19 by both sex and exposure to incarceration. For persons exposed to incarceration, the risk ratio (RR) was 1.50 (95%CI 1.35-1.69) for males and 1.21 (95%CI 1.06-1.42) for females, and for persons not exposed to incarceration, the RR was 1.25 (95%CI 1.13-1.38) for males and not significant for females. CONCLUSIONS: COVID-19 substantially exacerbated the risk of opioid toxicity death, impacting males and females who experienced incarceration more than those who had not, with an immediate stepwise increase in risk but no change in the rate of increase of risk over time. Public health work, including pandemic preparedness, should consider the specific needs and circumstances of people who experience incarceration.

Efficacy of prescribed opioids for acute pain after being discharged from the emergency department: A systematic review and meta-analysis.

BACKGROUND: Opioids are often prescribed for acute pain to patients discharged from the emergency department (ED), but there is a paucity of data on their short-term use. The purpose of this study was to synthesize the evidence regarding the efficacy of prescribed opioids compared to nonopioid analgesics for acute pain relief in ED-discharged patients. METHODS: MEDLINE, EMBASE, CINAHL, PsycINFO, CENTRAL, and gray literature databases were searched from inception to January 2023. Two independent reviewers selected randomized controlled trials investigating the efficacy of prescribed opioids for ED-discharged patients, extracted data, and assessed risk of bias. Authors were contacted for missing data and to identify additional studies. The primary outcome was the difference in pain intensity scores or pain relief. All meta-analyses used a random-effect model and a sensitivity analysis compared patients treated with codeine versus those treated with other opioids. RESULTS: From 5419 initially screened citations, 46 full texts were evaluated and six studies enrolling 1161 patients were included. Risk of bias was low for five studies. There was no statistically significant difference in pain intensity scores or pain relief between opioids versus nonopioid analgesics (standardized mean difference [SMD] 0.12; 95% confidence interval [CI] -0.10 to 0.34). Contrary to children, adult patients treated with opioid had better pain relief (SMD 0.28, 95% CI 0.13-0.42) compared to nonopioids. In another sensitivity analysis excluding studies using codeine, opioids were more effective than nonopioids (SMD 0.30, 95% CI 0.15-0.45). However, there were more adverse events associated with opioids (odds ratio 2.64, 95% CI 2.04-3.42). CONCLUSIONS: For ED-discharged patients with acute musculoskeletal pain, opioids do not seem to be more effective than nonopioid analgesics. However, this absence of efficacy seems to be driven by codeine, as opioids other than codeine are more effective than nonopioids (mostly NSAIDs). Further prospective studies on the efficacy of short-term opioid use after ED discharge (excluding codeine), measuring patient-centered outcomes, adverse events, and potential misuse, are needed.

Qualitative Exploration of Emergency Department Care Experiences Among People With Opioid Use Disorder.

STUDY OBJECTIVE: We described the experiences and preferences of people with opioid use disorder who access emergency department (ED) services regarding ED care and ED-based interventions. METHODS: Between June and September 2020, we conducted phone or in-person semistructured qualitative interviews with patients recently discharged from 2 urban EDs in Vancouver, BC, Canada, to explore experiences and preferences of ED care and ED-based opioid use disorder interventions. We recruited participants from a cohort of adults with opioid use disorder who were participating in an ED-initiated outreach program. We transcribed audio recordings verbatim. We iteratively developed a thematic coding structure, with interim analyses to assess for thematic saturation. Two team members with lived experience of opioid use provided feedback on content, wording, and analysis throughout the study. RESULTS: We interviewed 19 participants. Participants felt discriminated against for their drug use, which led to poorer perceived health care and downstream ED avoidance. Participants desired to be treated like ED patients who do not use drugs and to be more involved in their ED care. Participants nevertheless felt comfortable discussing their substance use with ED staff and valued continuous ED operating hours. Regarding opioid use disorder treatment, participants supported ED-based buprenorphine/naloxone programs but also suggested additional options (eg, different initiation regimens and settings and other opioid agonist therapies) to facilitate further treatment uptake. CONCLUSION: Based on participant experiences, we recommend addressing potentially stigmatizing practices, increasing patient involvement in their care during ED visits, and increasing access to various opioid use disorder-related treatments and community support.

Limited evidence that emergency department care is more costly than other outpatient settings for low-acuity conditions: a systematic review.

PURPOSE: Caring for patients with low-acuity conditions in Emergency Departments (ED) is often thought to cost more than treating those patients in other ambulatory settings. Understanding the relative cost of care between settings has critical implications for healthcare policy and system design. METHODS: We conducted a systematic review of papers comparing the cost of care for low-acuity and ambulatory care sensitive conditions in ED and other outpatient settings. We searched PubMed, EMBASE, CINAHL, and Web of Science for peer reviewed papers, plus Google for grey literature. We conducted duplicate screening and data extraction, and quality assessment of included studies using an adapted SIGN checklist for economic studies. We calculated an unweighted mean charge ratio across studies and summarized our findings in narrative and tabular format. RESULTS: We identified one study comparing costs. 18 studies assessed physician or facility charges, conducted in the United States, United Kingdom, and Canada, including cohort analyses (5), charge analyses (5), survey (1), and database searches (5) assessing populations ranging from 370 participants to 60 million. Charge ratios ranged from 0.60 to 13.45 with an unweighted mean of 4.20. Most (12) studies were of acceptable quality. CONCLUSION: No studies since 2001 assess the comparative costs of ED versus non-ED care for low-acuity ambulatory conditions. Physician and facility charges for ED care are higher than in other ambulatory settings for low-acuity conditions. Empirical evidence is lacking to support that ED care is more costly than similar care in other ambulatory settings.

RéSUMé: OBJECTIFS: La prise en charge des patients souffrant d'affections de faible gravité dans les services d'urgence est souvent considérée comme plus coûteuse que la prise en charge de ces mêmes patients dans d'autres structures ambulatoires. Comprendre le coût relatif des soins entre les différents environnements a des implications cruciales pour la politique des soins de santé et la conception des systèmes. MéTHODES: Nous avons procédé à un examen systématique des documents comparant le coût des soins pour les affections à faible gravité et les affections sensibles aux soins ambulatoires dans les services d'urgence et dans d'autres établissements de soins ambulatoires. Nous avons effectué des recherches dans PubMed, EMBASE, CINAHL et Web of Science pour les articles évalués par des pairs, ainsi que dans Google pour la littérature grise. Nous avons procédé à une double sélection et à une extraction des données, ainsi qu'à une évaluation de la qualité des études incluses à l'aide d'une liste de contrôle SIGN adaptée aux études économiques. Nous avons calculé un ratio moyen non pondéré pour l'ensemble des études et avons résumé nos conclusions sous forme de texte et de tableau. RéSULTATS: Nous avons identifié une étude comparant les coûts. 18 études ont évalué les frais des médecins ou des établissements, menées aux États-Unis, au Royaume-Uni et au Canada, y compris des analyses de cohortes (5), des analyses de frais (5), des enquêtes (1) et des recherches dans des bases de données (5) évaluant des populations allant de 370 participants à 60 millions de personnes. Les taux d'imputation allaient de 0,60 à 13,45, avec une moyenne non pondérée de 4,20. La plupart des études (12) étaient de qualité acceptable. CONCLUSION: Depuis 2001, aucune étude n'a évalué les coûts comparatifs des soins aux urgences par rapport aux soins hors urgences pour les affections ambulatoires de faible gravité. Les honoraires des médecins et des établissements pour les soins aux urgences sont plus élevés que dans d'autres structures ambulatoires pour les affections de faible gravité. Il n'existe pas de données empiriques permettant d'affirmer que les soins aux urgences sont plus coûteux que des soins similaires dispensés dans d'autres structures ambulatoires.

Validating the Remote First Aid Self-Efficacy Scale for Use in Evaluation and Training of First Responders in Remote Contexts.

INTRODUCTION: The purpose of this study was to investigate the psychometric properties of the remote first aid self-efficacy scale (RFA SES). The RFA SES is a 30-item self-report scale developed in response to emerging evidence showing that self-efficacy is predictive of performance. METHODS: Trained alumni from Wilderness Medical Associates (WMA) training courses and less trained students from Laurentian University (LU) were recruited via email to complete an online questionnaire at 2 different periods (T1 and T2). The questionnaire included demographic questions, the 30-item RFA SES, the 10-item Connor-Davidson resilience scale (CD-RISC), and the 10-item generalized self-efficacy scale (GSES). Data analysis included assessment of the dimensionality, reliability, and validity of the scale. RESULTS: There were 448 alumni from WMA and 1106 students from LU who participated in the study. The RFA SES demonstrated a clear unidimensional structure. The mean interitem correlation was 0.75 at T1. Test-retest reliability (T1 to T2) was high for both the LU group (intraclass correlation [ICC]=0.90) and the WMA group (ICC=0.92). Moderate correlations were found between RFA SES and CD-RISC (r=0.42, P<0.001), a general measure of resilience, and the GSES (r=0.48, P<0.001), a general measure of self-efficacy. Wilderness Medical Associates participants showed higher mean scores than LU students at T1 (t [569]=16.2, P<0.001). CONCLUSIONS: The RFA SES is a unidimensional, reliable, and potentially valid scale. Further research should focus on item reduction followed by additional tests of reliability and validity.

Respiratory infectious disease outbreaks among people experiencing homelessness: a systematic review of prevention and mitigation strategies.

PURPOSE: People experiencing homelessness (PEH) are at increased risk of respiratory infections and associated morbidity and mortality. To characterize optimal intervention strategies, we completed a systematic review of mitigation strategies for PEH to minimize the spread and impact of respiratory infectious disease outbreaks, including COVID-19. METHODS: The study protocol was registered in PROSPERO (#2020 CRD42020208964) and was consistent with the preferred reporting in systematic reviews and meta-analyses guidelines. A search algorithm containing keywords that were synonymous to the terms "Homeless" and "Respiratory Illness" was applied to the six databases. The search concluded on September 22, 2020. Quality assessment was performed at the study level. Steps were conducted by two independent team members. RESULTS: A total of 4468 unique titles were retrieved with 21 meeting criteria for inclusion. Interventions included testing, tracking, screening, infection prevention and control, isolation support, and education. Historically, there has been limited study of intervention strategies specifically for PEH across the world. CONCLUSIONS: Staff and organizations providing services for people experiencing homelessness face specific challenges in adhering to public health guidelines such as physical distancing, isolation, and routine hygiene practices. There is a discrepancy between the burden of infectious diseases among PEH and specific research characterizing optimal intervention strategies to mitigate transmission in the context of shelters. Improving health for people experiencing homelessness necessitates investment in programs scaling existing interventions and research to study new approaches.

Resuscitation simulation among people who are likely to witness opioid overdose: Experiences from the SOONER Trial.

The opioid crisis is a growing public health emergency and increasing resources are being directed towards overdose education. Simulation has emerged as a novel strategy for training overdose response, yet little is known about training non-clinicians in bystander resuscitation. Understanding the perspectives of individuals who are likely to experience or witness opioid overdose is critical to ensure that emergency response is effective. The Surviving Opioid Overdose with Naloxone Education and Resuscitation (SOONER) study evaluates the effectiveness of a novel naloxone education and distribution tool among people who are non-clinicians and likely to witness opioid overdose. Participants' resuscitation skills are evaluated using a realistic overdose simulation as the primary outcome of the trial. The purpose of our study is to describe the experience of participants with the simulation process in the SOONER study. We employed a semi-structured debriefing interview and a follow up qualitative interview to understand the experience of participants with simulation. A qualitative content analysis was performed using data from 21 participants who participated in the SOONER study. Our qualitative analysis identified 5 themes and 17 subthemes which described the experience of participants within the simulation process. These themes included realism, valuing practical experience, improving self-efficacy, gaining new perspective and bidirectional learning. Our analysis found that simulation was a positive and empowering experience for participants in the SOONER trial, most of whom are marginalized in society. Our study supports the notion that expanding simulation-based education to non-clinicians may offer an acceptable and effective way of supplementing current opioid overdose education strategies. Increasing the accessibility of simulation-based education may represent a paradigm shift whereby simulation is transformed from a primarily academic practice into a patient-based community resource.

Corrigendum to "Mixed methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) trial" [Resuscitation Plus 6 (2021) 100131].

[This corrects the article DOI: 10.1016/j.resplu.2021.100131.].

A cross-sectional survey on buprenorphine-naloxone practice and attitudes in 22 Canadian emergency physician groups: a cross-sectional survey.

BACKGROUND: Buprenorphine-naloxone (BUP) initiation in emergency departments improves follow-up and survival among patients with opioid use disorder. We aimed to assess self-reported BUP-related practices and attitudes among emergency physicians. METHODS: We designed a cross-sectional physician survey by adapting a validated questionnaire on opioid harm reduction practices, attitudes and barriers. We recruited physician leads from 6 Canadian provinces to administer surveys to the staff physicians in their emergency department groups between December 2018 and November 2019. We included academic and community non-locum emergency department staff physicians. We excluded responses from emergency department groups with response rates less than 50% to minimize nonresponse bias. Primary (BUP prescribing practices) and secondary (willingness and attitudes) outcomes were analyzed using descriptive statistics. RESULTS: After excluding 1 group for low response (9/26 physicians), 652 of 798 (81.7%) physicians responded from 22 groups serving 34 emergency departments. Among respondents, 64.1% (95% confidence interval [CI] 60.4%-67.8%, emergency department group range 7.1%-100.0%) had prescribed BUP at least once in their career, 38.4% had prescribed it for home initiation and 24.8% prescribed it at least once a month. Overall, 68.9% (95% CI 65.3%-72.4%, emergency department group range 24.1%-97.6%) were willing to administer BUP, 64.2% felt it was a major responsibility and 37.1% felt they understood people who use drugs. Respondents most frequently rated lack of adequate training (58.2%) and lack of time (55.2%) as very important barriers to BUP initiation. INTERPRETATION: Two-thirds of the emergency physicians surveyed prescribed BUP, although only one-quarter did so regularly and one-third prescribed it for home initiation; wide variation between emergency department groups existed. Strategies to increase BUP initiation must address physicians' lack of time and training for BUP initiation and improve their understanding of people who use drugs.

Mixed methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) trial.

AIM: We plan to conduct a randomised clinical trial among people likely to witness opioid overdose to compare the educational effectiveness of point-of-care naloxone distribution with best-available care, by observing participants' resuscitation skills in a simulated overdose. This mixed methods feasibility study aims to assess the effectiveness of recruitment and retention strategies and acceptability of study procedures. METHODS: We implemented candidate-driven recruitment strategies with verbal consent and destigmatizing study materials in a family practice, emergency department, and addictions service. People ≥16 years of age who are likely to witness overdose were randomized to point-of-care naloxone distribution or referral to an existing program. We evaluated participant skills as a responder to a simulated overdose 3-14 days post-recruitment. Retention strategies included flexible scheduling, reminders, cash compensation and refreshments. The primary outcome was recruitment and retention feasibility, defined as the ability to recruit 28 eligible participants in 28 days, with <50% attrition at the outcome simulation. Acceptability of study procedures and motivations for participation were assessed in a semi-structured interview. RESULTS: We enrolled 30 participants over 24 days, and retained 21 participants (70%, 95%CI 56.7-100). The most common motivation for participation was a desire to serve the community or loved ones in distress. Participants reported that study procedures were acceptable and that the outcome simulation provided a supportive and affirming environment. CONCLUSION: The planned trial is ready for implementation. Recruitment and retention is feasible and study processes are acceptable for people who are likely to witness overdose. (Registration: NCT03821649).

Emergency care with lay responders in underserved populations: a systematic review.

OBJECTIVE: To assess the individual and community health effects of task shifting for emergency care in low-resource settings and underserved populations worldwide. METHODS: We systematically searched 13 databases and additional grey literature for studies published between 1984 and 2019. Eligible studies involved emergency care training for laypeople in underserved or low-resource populations, and any quantitative assessment of effects on the health of individuals or communities. We conducted duplicate assessments of study eligibility, data abstraction and quality. We synthesized findings in narrative and tabular format. FINDINGS: Of 19 308 papers retrieved, 34 studies met the inclusion criteria from low- and middle-income countries (21 studies) and underserved populations in high-income countries (13 studies). Targeted emergency conditions included trauma, burns, cardiac arrest, opioid poisoning, malaria, paediatric communicable diseases and malnutrition. Trainees included the general public, non-health-care professionals, volunteers and close contacts of at-risk populations, all trained through in-class, peer and multimodal education and public awareness campaigns. Important clinical and policy outcomes included improvements in community capacity to manage emergencies (14 studies), patient outcomes (13 studies) and community health (seven studies). While substantial effects were observed for programmes to address paediatric malaria, trauma and opioid poisoning, most studies reported modest effect sizes and two reported null results. Most studies were of weak (24 studies) or moderate quality (nine studies). CONCLUSION: First aid education and task shifting to laypeople for emergency care may reduce patient morbidity and mortality and build community capacity to manage health emergencies for a variety of emergency conditions in underserved and low-resource settings.

Experiences of people with opioid use disorder during the COVID-19 pandemic: A qualitative study.

AIM: To capture pandemic experiences of people with opioid use disorder (OUD) to better inform the programs that serve them. DESIGN: We designed, conducted, and analyzed semi-structured qualitative interviews using grounded theory. We conducted interviews until theme saturation was reached and we iteratively developed a codebook of emerging themes. Individuals with lived experience of substance use provided feedback at all steps of the study. SETTING: We conducted phone or in-person interviews in compliance with physical distancing and public health regulations in outdoor Vancouver parks or well-ventilated indoor spaces between June to September 2020. PARTICIPANTS: Using purposive sampling, we recruited participants (n = 19) who were individuals with OUD enrolled in an intensive community outreach program, had visited one of two emergency departments, were over 18, lived within catchment, and were not already receiving opioid agonist therapy. MEASUREMENTS: We audio-recorded interviews, which were later transcribed verbatim and checked for accuracy while removing all identifiers. Interviews explored participants' knowledge of COVID-19 and related safety measures, changes to drug use and healthcare services, and community impacts of COVID-19. RESULTS: One third of participants were women, approximately two thirds had stable housing, and ages ranged between 23 and 59 years old. Participants were knowledgeable on COVID-19 public health measures. Some participants noted that fear decreased social connection and reluctance to help reverse overdoses; others expressed pride in community cohesion during crisis. Several participants mentioned decreased access to housing, harm reduction, and medical care services. Several participants reported using drugs alone more frequently, consuming different or fewer drugs because of supply shortages, or using more drugs to replace lost activities. CONCLUSION: COVID-19 had profound effects on the social lives, access to services, and risk-taking behaviour of people with opioid use disorder. Pandemic public health measures must include risk mitigation strategies to maintain access to critical opioid-related services.

Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement.

Importance: Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, and analytical challenges that can potentially compromise the validity of findings. Numerous randomized trials have required changes in response to the COVID-19 pandemic, but guidance for reporting such modifications is incomplete. Objective: As a joint extension for the CONSORT and SPIRIT reporting guidelines, CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances) aims to improve reporting of trial protocols and completed trials that undergo important modifications in response to extenuating circumstances. Evidence: A panel of 37 international trial investigators, patient representatives, methodologists and statisticians, ethicists, funders, regulators, and journal editors convened to develop the guideline. The panel developed CONSERVE following an accelerated, iterative process between June 2020 and February 2021 involving (1) a rapid literature review of multiple databases (OVID Medline, OVID EMBASE, and EBSCO CINAHL) and gray literature sources from 2003 to March 2021; (2) consensus-based panelist meetings using a modified Delphi process and surveys; and (3) a global survey of trial stakeholders. Findings: The rapid review yielded 41 673 citations, of which 38 titles were relevant, including emerging guidance from regulatory and funding agencies for managing the effects of the COVID-19 pandemic on trials. However, no generalizable guidance for all circumstances in which trials and trial protocols might face unanticipated modifications were identified. The CONSERVE panel used these findings to develop a consensus reporting guidelines following 4 rounds of meetings and surveys. Responses were received from 198 professionals from 34 countries, of whom 90% (n = 178) indicated that they understood the concept definitions and 85.4% (n = 169) indicated that they understood and could use the implementation tool. Feedback from survey respondents was used to finalize the guideline and confirm that the guideline's core concepts were applicable and had utility for the trial community. CONSERVE incorporates an implementation tool and checklists tailored to trial reports and trial protocols for which extenuating circumstances have resulted in important modifications to the intended study procedures. The checklists include 4 sections capturing extenuating circumstances, important modifications, responsible parties, and interim data analyses. Conclusions and Relevance: CONSERVE offers an extension to CONSORT and SPIRIT that could improve the transparency, quality, and completeness of reporting important modifications to trials in extenuating circumstances such as COVID-19.