Equity Considerations in COVID-19 Vaccination Studies of Individuals With Autoimmune Inflammatory Rheumatic Diseases.

OBJECTIVE: We sought to examine the extent to which populations experiencing inequities were considered in studies of COVID-19 vaccination in individuals with autoimmune inflammatory rheumatic diseases (AIRDs). METHODS: We included all studies (n = 19) from an ongoing Cochrane living systematic review on COVID-19 vaccination in patients with AIRDs. We used the PROGRESS-Plus framework (place of residence, race/ethnicity, occupation, gender/sex, religion, education, socioeconomic status, and social capital, plus: age, multimorbidity, and health literacy) to identify factors that stratify health outcomes. We assessed equity considerations in relation to differences in COVID-19 baseline risk, eligibility criteria, description of participant characteristics and attrition, controlling for confounding factors, subgroup analyses, and applicability of findings. RESULTS: All 19 studies were cohort studies that followed individuals with AIRDs after vaccination. Three studies (16%) described differences in baseline risk for COVID-19 across age. Two studies (11%) defined eligibility criteria based on occupation and age. All 19 studies described participant age and sex. Twelve studies (67%) controlled for age and/or sex as confounders. Eight studies (47%) conducted subgroup analyses across at least 1 PROGRESS-Plus factor, most commonly age. Ten studies (53%) interpreted applicability in relation to at least 1 PROGRESS-Plus factor, most commonly age (47%), then ethnicity (16%), sex (16%), and multimorbidity (11%). CONCLUSION: Sex and age were the most frequently considered PROGRESS-Plus factors in studies of COVID-19 vaccination in individuals with AIRDs. The generalizability of evidence to populations experiencing inequities is uncertain. Future COVID-19 vaccine studies should report participant characteristics in more detail to inform guideline recommendations.

Effects of virtual postoperative postdischarge care in patients undergoing lung resection during the COVID-19 pandemic

Background: The COVID-19 pandemic has impacted the landscape of health care delivery, including a significant uptake in the use of virtual medicine. In our institution, this includes virtual visits for routine postoperative follow-up in patients undergoing major lung resections. The aim of this study was to evaluate the effects of COVID-19 on postoperative outcomes, and whether virtual follow-ups are associated with worse postoperative outcomes compared with in-person visits. Methods: A retrospective, single-centre propensity-matched cohort analysis was conducted. Patients undergoing anatomic lung resections were included. Outcomes of interest included 60-day readmission, emergency department (ED) visits, mortality, and complication rates. Initial analysis compared pre-COVID-19 (January-December 2019) patients to those receiving either inperson or virtual follow-up during the pandemic (March 2020February 2021). Secondary analysis compared COVID-19-era patients receiving mixed in-person/virtual follow-up (hybrid) to those receiving completely virtual care (no in-person visits). Results: In total, 1282 patients were assessed for eligibility. After propensity matching, 128 patients were included in the COVID-19-era group, and 212 patients in the pre-COVID-19 group. Baseline characteristics were similar in both groups. Initial analysis showed no statistically significant differences between COVID-19-era and pre-COVID-19 patients in terms of 60-day readmission (5.5% v. 7.5%, p = 0.57), ED visits (4.7% v. 6.6%, p = 0.77), mortality (0.8% v. 0.0%, p = 0.99), or complications. After subdividing patients with hybrid v. completely virtual follow-up, there was no significant difference in any outcome of interest (p > 0.05 for all). Conclusion: In our experience, early postoperative outcomes during the COVID-19 era were not inferior to those before COVID-19. Furthermore, evaluation of the impact of complete virtual follow-up for patients undergoing anatomic lung resection showed no significant differences in clinical outcomes compared with routine inperson follow up, suggesting that postoperative, postdischarge care might not be compromised by eliminating routine inperson assessments after major lung surgery.

Improving social justice in observational studies: protocol for the development of a global and Indigenous STROBE-equity reporting guideline.

BACKGROUND: Addressing persistent and pervasive health inequities is a global moral imperative, which has been highlighted and magnified by the societal and health impacts of the COVID-19 pandemic. Observational studies can aid our understanding of the impact of health and structural oppression based on the intersection of gender, race, ethnicity, age and other factors, as they frequently collect this data. However, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline, does not provide guidance related to reporting of health equity. The goal of this project is to develop a STROBE-Equity reporting guideline extension. METHODS: We assembled a diverse team across multiple domains, including gender, age, ethnicity, Indigenous background, disciplines, geographies, lived experience of health inequity and decision-making organizations. Using an inclusive, integrated knowledge translation approach, we will implement a five-phase plan which will include: (1) assessing the reporting of health equity in published observational studies, (2) seeking wide international feedback on items to improve reporting of health equity, (3) establishing consensus amongst knowledge users and researchers, (4) evaluating in partnership with Indigenous contributors the relevance to Indigenous peoples who have globally experienced the oppressive legacy of colonization, and (5) widely disseminating and seeking endorsement from relevant knowledge users. We will seek input from external collaborators using social media, mailing lists and other communication channels. DISCUSSION: Achieving global imperatives such as the Sustainable Development Goals (e.g., SDG 10 Reduced inequalities, SDG 3 Good health and wellbeing) requires advancing health equity in research. The implementation of the STROBE-Equity guidelines will enable a better awareness and understanding of health inequities through better reporting. We will broadly disseminate the reporting guideline with tools to enable adoption and use by journal editors, authors, and funding agencies, using diverse strategies tailored to specific audiences.

Obesity and weight change during the COVID-19 pandemic in children and adults: A systematic review and meta-analysis.

Many obesity risk factors have increased during the COVID-19 pandemic, including physical inactivity, poor diet, stress, and poverty. The aim of this systematic review was to evaluate the impact of the COVID-19 pandemic, as well as associated lockdowns or restrictions, on weight change in children and adults. We searched five databases from January 2020 to November 2021. We included only longitudinal studies with measures from before and during the pandemic that evaluated the change in weight, body mass index (BMI) (or BMI z-scores for children), waist circumference, or the prevalence of obesity. Random effects meta-analyses were conducted to obtain pooled estimates of the mean difference in outcomes. Subgroups were evaluated for age groups and diabetes or obesity at baseline. The risk of bias was assessed using a modified version of the Newcastle-Ottawa Scale, and the certainty of the evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. A total of 74 studies were included (3,213,776 total participants): 31 studies of children, 41 studies of adults, and 2 studies of children and adults. In children, the pooled mean difference was 1.65 kg (95% confidence interval [CI]: 0.40, 2.90; 9 studies) for weight and 0.13 (95% CI 0.10, 0.17; 20 studies) for BMI z-scores, and the prevalence of obesity increased by 2% (95% CI 1%, 3%; 12 studies). In adults, the pooled mean difference was 0.93 kg (95% CI 0.54, 1.33; 27 studies) for weight and 0.38 kg/m2 (95% CI 0.21, 0.55; 25 studies) for BMI, and the prevalence of obesity increased by 1% (95% CI 0%, 3%; 11 studies). In children and adults, the pooled mean difference for waist circumference was 1.03 cm (95% CI -0.08, 2.15; 4 studies). There was considerable heterogeneity observed for all outcomes in both children and adults, and the certainty of evidence assessed using GRADE was very low for all outcomes. During the first year of the COVID-19 pandemic, small but potentially clinically significant increases in weight gain, BMI, and increased prevalence of obesity in both children and adults were observed. Increases were greater in children, and targeted prevention interventions may be warranted.

Knowledge mobilization activities to support decision-making by youth, parents, and adults using a systematic and living map of evidence and recommendations on COVID-19: protocol for three randomized controlled trials and qualitative user-experience studies.

INTRODUCTION: The COVID-19 pandemic underlined that guidelines and recommendations must be made more accessible and more understandable to the general public to improve health outcomes. The objective of this study is to evaluate, quantify, and compare the public's understanding, usability, satisfaction, intention to implement, and preference for different ways of presenting COVID-19 health recommendations derived from the COVID-19 Living Map of Recommendations and Gateway to Contextualization (RecMap). METHODS AND ANALYSIS: This is a protocol for a multi-method study. Through an online survey, we will conduct pragmatic allocation-concealed, blinded superiority randomized controlled trials (RCTs) in three populations to test alternative formats of presenting health recommendations: adults, parents, and youth, with at least 240 participants in each population. Prior to initiating the RCT, our interventions will have been refined with relevant stakeholder input. The intervention arm will receive a plain language recommendation (PLR) format while the control arm will receive the corresponding original recommendation format as originally published by the guideline organizations (standard language version). Our primary outcome is understanding, and our secondary outcomes are accessibility and usability, satisfaction, intended behavior, and preference for the recommendation formats. Each population's results will be analyzed separately. However, we are planning a meta-analysis of the results across populations. At the end of each survey, participants will be invited to participate in an optional one-on-one, virtual semi-structured interview to explore their user experience. All interviews will be transcribed and analyzed using the principles of thematic analysis and a hybrid inductive and deductive approach. ETHICS AND DISSEMINATION: Through Clinical Trials Ontario, the Hamilton Integrated Research Ethics Board has reviewed and approved this protocol (Project ID: 3856). The University of Alberta has approved the parent portion of the trial (Project ID:00114894). Findings from this study will be disseminated through open-access publications in peer-reviewed journals and using social media. TRIAL REGISTRATION: Clinicaltrials.gov NCT05358990 . Registered on May 3, 2022.

Mobile Health-Supported Virtual Reality and Group Problem Management Plus: Protocol for a Cluster Randomized Trial Among Urban Refugee and Displaced Youth in Kampala, Uganda (Tushirikiane4MH, Supporting Each Other for Mental Health).

BACKGROUND: Although mental health challenges disproportionately affect people in humanitarian contexts, most refugee youth do not receive the mental health support needed. Uganda is the largest refugee-hosting nation in Africa, hosting over 1.58 million refugees in 2022, with more than 111,000 living in the city of Kampala. There is limited information about effective and feasible interventions to improve mental health outcomes and mental health literacy, and to reduce mental health stigma among urban refugee adolescents and youth in low- and middle-income countries (LMICs). Virtual reality (VR) is a promising approach to reduce stigma and improve mental health and coping, yet such interventions have not yet been tested in LMICs where most forcibly displaced people reside. Group Problem Management Plus (GPM+) is a scalable brief psychological transdiagnostic intervention for people experiencing a range of adversities, but has not been tested with adolescents and youth to date. Further, mobile health (mHealth) strategies have demonstrated promise in promoting mental health literacy. OBJECTIVE: The aim of this study is to evaluate the feasibility and effectiveness of two youth-tailored mental health interventions (VR alone and VR combined with GMP+) in comparison with the standard of care in improving mental health outcomes among refugee and displaced youth aged 16-24 years in Kampala, Uganda. METHODS: A three-arm cluster randomized controlled trial will be implemented across five informal settlements grouped into three sites, based on proximity, and randomized in a 1:1:1 design. Approximately 330 adolescents (110 per cluster) are enrolled and will be followed for approximately 16 weeks. Data will be collected at three time points: baseline enrollment, 8 weeks following enrollment, and 16 weeks after enrollment. Primary (depression) and secondary outcomes (mental health literacy, attitudes toward mental help-seeking, adaptive coping, mental health stigma, mental well-being, level of functioning) will be evaluated. RESULTS: The study will be conducted in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study has received ethical approval from the University of Toronto (#40965; May 12, 2021), Mildmay Uganda Research Ethics Committee (MUREC-2021-41; June 24, 2021), and Uganda National Council for Science & Technology (SS1021ES; January 1, 2022). A qualitative formative phase was conducted using focus groups and in-depth, semistructured key informant interviews to understand contextual factors influencing mental well-being among urban refugee and displaced youth. Qualitative findings will inform the VR intervention, SMS text check-in messages, and the adaptation of GPM+. Intervention development was conducted in collaboration with refugee youth peer navigators. The trial launched in June 2022 and the final follow-up survey will be conducted in November 2022. CONCLUSIONS: This study will contribute to the knowledge of youth-tailored mental health intervention strategies for urban refugee and displaced youth living in informal settlements in LMIC contexts. Findings will be shared in peer-reviewed publications, conference presentations, and with community dissemination. TRIAL REGISTRATION: ClinicalTrials.gov NCT05187689; https://clinicaltrials.gov/ct2/show/NCT05187689. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42342.

Coronavirus disease 2019 vaccine effectiveness among a population-based cohort of people living with HIV.

OBJECTIVE: People with HIV were underrepresented in coronavirus disease 2019 (COVID-19) vaccine clinical trials. We estimated vaccine effectiveness (VE) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection for the BNT162b2, mRNA-1273, and ChAdOx1 vaccines among a population-based cohort of people with HIV in Ontario, Canada. DESIGN: Test-negative design. METHODS: We identified people with HIV aged ≥19 years who were tested for SARS-CoV-2 by RT-PCR between December 14, 2020 (first availability of COVID-19 vaccines) and November 21, 2021 (pre-Omicron circulation). Outcomes included any infection, symptomatic infection, and COVID-19-related hospitalization/death. We compared the odds of vaccination between test-positive cases and test-negative controls using multivariable logistic regression with adjustment for age, sex, region, calendar time, SARS-CoV-2 test histories, influenza vaccination, comorbidities, and neighborhood-level socio-economic status. VE was derived as (1 - adjusted odds ratio) × 100%. RESULTS: Among 21 023 adults living with HIV, there were 801 (8.3%) test-positive cases and 8,879 (91.7%) test-negative controls. 20.1% cases and 47.8% of controls received ≥1 COVID-19 vaccine dose; among two-dose recipients, 93.4% received ≥1 mRNA dose. Two-dose VE ≥7 days before specimen collection was 82% (95% confidence interval [CI] = 74-87%) against any infection, 94% (95% CI = 82-98%) against symptomatic infection, and 97% (95% CI = 85-100%) against hospitalization/death. Against any infection, VE declined from 86% (95% CI = 77-92%) within 7-59 days after the second dose to 66% (95% CI = -15-90%) after ≥180 days; we did not observe evidence of waning protection for other outcomes. CONCLUSION: Two doses of COVID-19 vaccine offered substantial protection against symptomatic illness and hospitalization/death in people with HIV prior to the emergence of the Omicron variant. Our findings do not support a broad conclusion that COVID-19 VE is lower among people with HIV in populations that, for the most part, are attending HIV care, taking antiretroviral medication, and are virally suppressed.

CARLoquium 2022

The Chiropractic Academy for Research Leadership (CARL) is an innovative program that provides mentorship, training, and leadership opportunities to the next generation of chiropractic researchers through an open application process. The first CARLoquium was launched by in 2021 by the CARL Fellows as a means to meet and disseminate research findings from the chiropractic community during the COVID-19 pandemic with the second CARLoquium held virtually in March 2022. To date, the conference has featured numerous keynote speakers, hundreds of s and continues to provide a cost-effective avenue for our researcher community to gather.

An evaluation of the COVID-19 recommendation map identified diverging clinical and public health guidance.

OBJECTIVES: To describe divergence between actionable statements issued by coronavirus disease 2019 (COVID-19) guideline developers cataloged on the "COVID-19 Recommendations and Gateway to Contextualization" platform. STUDY DESIGN AND SETTING: We defined divergence as at least two comparable actionable statements with different explicit judgments of strength, direction, or subgroup consideration of the population or intervention. We applied a content analysis to compare guideline development methods for a sample of diverging statements and to evaluate factors associated with divergence. RESULTS: Of the 138 guidelines evaluated, 85 (62%) contained at least one statement that diverged from another guideline. We identified 223 diverging statements in these 85 guidelines. We grouped statements into 66 clusters. Each cluster addressed the same population, intervention, and comparator group or just similar interventions. Clinical practice statements were more likely to diverge in an explicit judgment of strength or direction compared to public health statements. Statements were more likely to diverge in strength than direction. The date of publication, used evidence, interpretation of evidence, and contextualization considerations were associated with divergence. CONCLUSION: More than half of the assessed guidelines issued at least one diverging statement. This study helps in understanding the types of differences between guidelines issuing comparable statements and factors associated with their divergence.

A multistakeholder development process to prioritize and translate COVID-19 health recommendations for patients, caregivers and the public. A case study of the COVID-19 recommendation map.

BACKGROUND AND OBJECTIVES: To develop a digital communication tool to improve the implementation of up-to-date COVID-19 recommendations. Specifically, to improve patient, caregiver and public understanding of healthcare recommendations on prevention, diagnoses and treatment. METHODS: Multi-stakeholder engagement design. In conjunction with the COVID-19 Recommendations and Gateway to Contextualization RecMap, we co-developed a stakeholder prioritization, drafting and editing process to enhance guideline communication and understanding. RESULTS: This paper presents the multi-stakeholder development process with three distinct plain language recommendation formats: formal recommendation, good practice statement, and additional guidance. Our case study of COVID-19 plain language recommendations PLRs addresses both public health interventions (e.g., vaccination, face masks) and clinical interventions (e.g., home pulse oximetry). CONCLUSION: This paper presents a novel approach to engaging stakeholders in improving the communication and understanding of published guidelines during the COVID-19 pandemic.

Delirium and other neuropsychiatric manifestations of COVID-19 infection in people with preexisting psychiatric disorders: a systematic review.

BACKGROUND: Psychiatric disorders increase risk of neuropsychiatric disease and poor outcomes, yet little is known about the neuropsychiatric manifestations of COVID-19 in the psychiatric population. The primary objective is to synthesize neuropsychiatric outcomes of COVID-19 in people with preexisting psychiatric disorders. METHODS: Data were collected during an ongoing review of the impact of pandemics on people with existing psychiatric disorders. All study designs and gray literature were included. Medline, PsychInfo, CINAHL, EMBASE, and MedRx were searched from inception to September 1 2020. Risk of bias was assessed using a published tool that can accommodate all study types. Two independent authors screened the studies and extracted data. Data were narratively synthesized, as there were insufficient data to meta-analyze. Evidence was appraised according to GRADE. RESULTS: Four case reports were included, comprising 13 participants from three countries. Many large-sample, relevant papers were omitted for not reporting psychiatric history, despite reporting other comorbidities. Included participants (n = 13) were hospitalized with COVID-19 and appeared to meet criteria for delirium. Myoclonus, rigidity, and alogia were also reported. The most commonly reported preexisting psychiatric diagnoses were mood disorders, schizophrenia, and alcohol use disorder. CONCLUSIONS: People with preexisting psychiatric disorders may experience delirium, rigidity, myoclonus, and alogia during COVID-19 infection; although higher quality and longitudinal data are needed to better understand these phenomena. Relevant COVID-19 literature does not always report psychiatric history, despite heightened neuropsychiatric vulnerability within this population. TRIAL REGISTRATION:  PROSPERO (CRD42020179611).

Kukaa Salama (Staying Safe): study protocol for a pre/post-trial of an interactive mHealth intervention for increasing COVID-19 prevention practices with urban refugee youth in Kampala, Uganda.

INTRODUCTION: With over 82.4 million forcibly displaced persons worldwide, there remains an urgent need to better describe culturally, contextually and age-tailored strategies for preventing COVID-19 in humanitarian contexts. Knowledge gaps are particularly pronounced for urban refugees who experience poverty, overcrowded living conditions and poor sanitation access that constrain the ability to practise COVID-19 mitigation strategies such as physical distancing and frequent hand washing. With over 1.4 million refugees, Uganda is sub-Saharan Africa's largest refugee hosting nation. More than 90 000 of Uganda's refugees live in Kampala, most in informal settlements, and 27% are aged 15-24 years old. There is an urgent need for tailored COVID-19 responses with urban refugee adolescents and youth. This study aims to evaluate the effectiveness of an 8-week interactive informational mobile health intervention on COVID-19 prevention practices among refugee and displaced youth aged 16-24 years in Kampala, Uganda. METHODS AND ANALYSIS: We will conduct a pre-test/post-test study nested within a larger cluster randomised trial. Approximately 385 youth participants will be enrolled and followed for 6 months. Data will be collected at three time points: before the intervention (time 1); immediately after the intervention (time 2) and at 16-week follow-up (time 3). The primary outcome (self-efficacy to practise COVID-19 prevention measures) and secondary outcomes (COVID-19 risk awareness, attitudes, norms and self-regulation practices; depression; sexual and reproductive health practices; food and water security; COVID-19 vaccine acceptability) will be evaluated using descriptive statistics and regression analyses. ETHICS AND DISSEMINATION: This study has been approved by the University of Toronto Research Ethics Board, the Mildmay Uganda Research Ethics Committee, and the Uganda National Council for Science & Technology. The results will be published in peer-reviewed journals, and findings communicated through reports and conference presentations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04631367).

The prevalence and correlates of depression before and after the COVID-19 pandemic declaration among urban refugee adolescents and youth in informal settlements in Kampala, Uganda: A longitudinal cohort study.

PURPOSE: There is scant research examining urban refugee youth mental health outcomes, including potential impacts of the COVID-19 pandemic. We examine prevalence and ecosocial risk factors of depression in the periods before and after the COVID-19 pandemic declaration among urban refugee youth in Kampala, Uganda. METHODS: Data from a cohort of refugee youth (n = 367) aged 16-24 years were collected in periods before (February 2020) and after (December 2020) the WHO COVID-19 pandemic declaration. We developed crude and adjusted generalized estimating equation logistic regression models to examine demographic and ecosocial factors (food insecurity, social support, intimate partner violence) associated with depression, and include time-ecosocial interactions to examine if associations differed before and after the pandemic declaration. RESULTS: The prevalence of depression was high, but there was no significant difference before (27.5%), and after (28.9%) the pandemic declaration (P = .583). In adjusted models, food insecurity (aOR: 2.54; 95% CI: 1.21-5.33) and experiencing violence (aOR: 2.53; 95% CI: 1.07-5.96) were associated with increased depression, and social support was associated with decreased depression (aOR: 0.85; 95% CI: 0.81-0.89). CONCLUSIONS: These findings highlight the urgent need for interventions to address chronic depression, food insecurity, and ongoing effects of violence exposure among urban refugee youth in Kampala.

A taxonomy and framework for identifying and developing actionable statements in guidelines suggests avoiding informal recommendations.

OBJECTIVE: To propose a taxonomy and framework that identifies and presents actionable statements in guidelines. STUDY DESIGN AND SETTING: We took an iterative approach reviewing case studies of guidelines produced by the World Health Organization and the American Society of Hematology to develop an initial conceptual framework. We then tested it using randomly selected recommendations from published guidelines addressing COVID-19 from different organizations, evaluated its results, and refined it before retesting. The urgency and availability of evidence for development of these recommendations varied. We consulted with experts in research methodology and guideline developers to improve the final framework. RESULTS: The resulting taxonomy and framework distinguishes five types of actional statements: formal recommendations; research recommendations; good practice statements; implementation considerations, tools and tips; and informal recommendations. These statements should respond to a priori established criteria and require a clear structure and recognizable presentation in a guideline. Most importantly, this framework identifies informal recommendations that differ from formal recommendations by how they consider evidence and in their development process. CONCLUSION: The identification, standardization and explicit labelling of actionable statements according to the framework may support guideline developers to create actionable statements with clear intent, avoid informal recommendations and improve their understanding and implementation by users.

Improving Social Justice in COVID-19 Health Research: Interim Guidelines for Reporting Health Equity in Observational Studies.

The COVID-19 pandemic has highlighted the global imperative to address health inequities. Observational studies are a valuable source of evidence for real-world effects and impacts of implementing COVID-19 policies on the redistribution of inequities. We assembled a diverse global multi-disciplinary team to develop interim guidance for improving transparency in reporting health equity in COVID-19 observational studies. We identified 14 areas in the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist that need additional detail to encourage transparent reporting of health equity. We searched for examples of COVID-19 observational studies that analysed and reported health equity analysis across one or more social determinants of health. We engaged with Indigenous stakeholders and others groups experiencing health inequities to co-produce this guidance and to bring an intersectional lens. Taking health equity and social determinants of health into account contributes to the clinical and epidemiological understanding of the disease, identifying specific needs and supporting decision-making processes. Stakeholders are encouraged to consider using this guidance on observational research to help provide evidence to close the inequitable gaps in health outcomes.

Coronavirus Disease 2019 and Antimicrobial Resistance: Parallel and Interacting Health Emergencies.

The coronavirus disease 2019 (COVID-19) pandemic and antimicrobial resistance (AMR) are parallel and interacting health emergencies that provide the opportunity for mutual learning. As their measures and consequences are comparable, the COVID-19 pandemic helps to illustrate the potential long-term impact of AMR, which is less acute but not less crucial. They may also impact each other as there is a push to use existing antimicrobials to treat critically ill COVID-19 patients in the absence of specific treatments. Attempts to manage the spread of COVID-19 may also lead to a slowdown in AMR. Understanding how COVID-19 affects AMR trends and what we can expect if these trends remain the same or worsen will help us to plan the next steps for tackling AMR. Researchers should start collecting data to measure the impact of current COVID-19 policies and programs on AMR.

Corticosteroids in COVID-19 and non-COVID-19 ARDS: a systematic review and meta-analysis.

PURPOSE: Corticosteroids are now recommended for patients with severe COVID-19 including those with COVID-related ARDS. This has generated renewed interest regarding whether corticosteroids should be used in non-COVID ARDS as well. The objective of this study was to summarize all RCTs examining the use of corticosteroids in ARDS. METHODS: The protocol of this study was pre-registered on PROSPERO (CRD42020200659). We searched online databases including MEDLINE, EMBASE, CDC library of COVID research, CINAHL, and COCHRANE. We included RCTs that compared the effect of corticosteroids to placebo or usual care in adult patients with ARDS, including patients with COVID-19. Three reviewers abstracted data independently and in duplicate using a pre-specified standardized form. We assessed individual study risk of bias using the revised Cochrane ROB-2 tool and rated certainty in outcomes using GRADE methodology. We pooled data using a random effects model. The main outcome for this review was 28-day-mortality. RESULTS: We included 18 RCTs enrolling 2826 patients. The use of corticosteroids probably reduced mortality in patients with ARDS of any etiology (2740 patients in 16 trials, RR 0.82, 95% CI 0.72-0.95, ARR 8.0%, 95% CI 2.2-12.5%, moderate certainty). Patients who received a longer course of corticosteroids (over 7 days) had higher rates of survival compared to a shorter course. CONCLUSION: The use of corticosteroids probably reduces mortality in patients with ARDS. This effect was consistent between patients with COVID-19 and non-COVID-19 ARDS, corticosteroid types, and dosage.

Mobile Health-Supported HIV Self-Testing Strategy Among Urban Refugee and Displaced Youth in Kampala, Uganda: Protocol for a Cluster Randomized Trial (Tushirikiane, Supporting Each Other).

BACKGROUND: HIV is the leading cause of mortality among youth in sub-Saharan Africa. Uganda hosts over 1.43 million refugees, and more than 83,000 live in Kampala, largely in informal settlements. There is limited information about HIV testing uptake and preferences among urban refugee and displaced youth. HIV self-testing is a promising method for increasing testing uptake. Further, mobile health (mHealth) interventions have been effective in increasing HIV testing uptake and could be particularly useful among youth. OBJECTIVE: This study aims to evaluate the feasibility and effectiveness of two HIV self-testing implementation strategies (HIV self-testing intervention alone and HIV self-testing combined with an mHealth intervention) in comparison with the HIV testing standard of care in terms of HIV testing outcomes among refugee/displaced youth aged 16 to 24 years in Kampala, Uganda. METHODS: A three-arm cluster randomized controlled trial will be implemented across five informal settlements grouped into three sites, based on proximity, and randomization will be performed with a 1:1:1 method. Approximately 450 adolescents (150 per cluster) will be enrolled and followed for 12 months. Data will be collected at the following three time points: baseline enrollment, 8 months after enrollment, and 12 months after enrollment. Primary outcomes (HIV testing frequency, HIV status knowledge, linkage to confirmatory testing, and linkage to HIV care) and secondary outcomes (depression, condom use efficacy, consistent condom use, sexual relationship power, HIV stigma, and adolescent sexual and reproductive health stigma) will be evaluated. RESULTS: The study has been conducted in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study has received ethical approval from the University of Toronto (June 14, 2019), Mildmay Uganda (November 11, 2019), and the Uganda National Council for Science and Technology (August 3, 2020). The Tushirikiane trial launched in February 2020, recruiting a total of 452 participants. Data collection was paused for 8 months due to COVID-19. Data collection for wave 2 resumed in November 2020, and as of December 10, 2020, a total of 295 participants have been followed-up. The third, and final, wave of data collection will be conducted between February and March 2021. CONCLUSIONS: This study will contribute to the knowledge of differentiated HIV testing implementation strategies for urban refugee and displaced youth living in informal settlements. We will share the findings in peer-reviewed manuscripts and conference presentations. TRIAL REGISTRATION: ClinicalTrials.gov NCT04504097; https://clinicaltrials.gov/ct2/show/NCT04504097. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26192.

Comparison of four COVID-19 screening strategies to facilitate early case identification within the homeless shelter population: A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: 1. To compare the effectiveness of four different surveillance strategies in detecting COVID-19 within the homeless shelter population. 2. To assess the participant adherence over time for each surveillance method. TRIAL DESIGN: This is a prospective cluster-randomized study to compare the effectiveness of four different surveillance regimens across eight homeless shelters in the city of Hamilton. PARTICIPANTS: Participants will include both residents of, and the staff working within, the homeless shelters. All participants aged 18 or older who consent to the study and are able to collect a swab sample (where relevant) are eligible for the study. The study will take place across eight homeless shelters (four men-only and four women-only) in the City of Hamilton in Ontario, Canada. INTERVENTION AND COMPARATOR GROUPS: The comparator group will receive active daily surveillance of symptoms and testing will only be completed in symptomatic participants (i.e. those who fail screening or who seek care for potential COVID-19 related symptoms). The three intervention arms will all receive active daily surveillance of symptoms and testing of symptomatic participants (as in the comparator group) in addition to one of the following: 1. Once weekly self-collected oral swabs (OS) regardless of symptoms using written and visual instructions. 2. Once weekly self-collected oral-nares swab (O-NS) regardless of symptoms using written and visual instructions. 3. Once weekly nurse collected nasopharyngeal swab (NPS) regardless of symptoms. Participants will follow verbal and written instructions for the collection of OS and O-NS specimens. For OS collection, participants are instructed to first moisten the swab on their tongue, insert the swab between the cheek and the lower gums and rotate the swab three times. This is repeated on the other side. For O-NS collection, after oral collection, the swab is inserted comfortably (about 2-3 cm) into one nostril, parallel to the floor and turned three times, then repeated in the other nostril. NPS specimens were collected by the nurse following standard of care procedure. All swabs were placed into a viral inactivation medium and transported to the laboratory for COVID-19 testing. Briefly, total nucleic acid was extracted from specimens and then amplified by RT-PCR for the UTR and Envelope genes of SARS-CoV-2 and the human RNase P gene, which is used as a sample adequacy marker. MAIN OUTCOMES: 1. PRIMARY OUTCOME: COVID-19 detection rate, i.e. the number of new positive cases over the study period of 8 weeks in each arm of the study. 2. SECONDARY OUTCOMES: Qualitative assessment of study enrollment over 8 weeks. Percentage of participants who performed 50% or more of the weekly swabs in the intervention arms in the 8 week study period. RANDOMIZATION: We will use a computer-generated random assignment list to randomize the shelters to one of four interventions. Shelters were stratified by gender, and the simple randomization scheme was applied within each stratum. The randomization scheme was created using WinPEPI. BLINDING: This is an open-label study in which neither participants nor assessors are blinded. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): Since we are including our total sample frame, a sample size estimation at the cluster level is not required. However, if we succeed to enroll 50 participants per shelter from 8 shelters (n=400), and the detection rate is 3 times higher in the intervention groups (0.15) than in the comparator groups (0.05), we will have 90% power to detect a statistically significant and clinically important difference at a type I error rate of alpha=0.05 (one tailed), assuming an intraclass correlation of ~0.008. These computations were done using WinPEPI, and informed by conservative estimates from other studies on respiratory illness in the homeless (see Full protocol). TRIAL STATUS: The protocol version number is 3.0. Recruitment began on April 17, 2020 and is ongoing. Due to low numbers of COVID cases in the community and shelter system during the initial study period, the trial was extended. The estimated date for the end of the extended recruitment period is Feb 1, 2021. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov on June 18, 2020 with the identifier NCT04438070 . FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

A/C study protocol: a cross-sectional study of HIV epidemiology among African, Caribbean and Black people in Ontario

INTRODUCTION: African, Caribbean and Black (ACB) communities are disproportionately infected by HIV in Ontario, Canada. They constitute only 5% of the population of Ontario yet account for 25% of new diagnoses of HIV. The aim of this study is to understand underlying factors that augment the HIV risk in ACB communities and to inform policy and practice in Ontario. METHODS AND ANALYSIS: We will conduct a cross-sectional study of first-generation and second-generation ACB adults aged 15-64 in Toronto (n=1000) and Ottawa (n=500) and collect data on sociodemographic information, sexual behaviours, substance use, blood donation, access and use of health services and HIV-related care. We will use dried blood spot testing to determine the incidence and prevalence of HIV infection among ACB people, and link participant data to administrative databases to investigate health service access and use. Factors associated with key outcomes (HIV infection, testing behaviours, knowledge about HIV transmission and acquisition, HIV vulnerability, access and use of health services) will be evaluated using generalised linear mixed models, adjusted for relevant covariates. ETHICS AND DISSEMINATION: This study has been reviewed and approved by the following Research Ethics Boards: Toronto Public Health, Ottawa Public Health, Laurentian University;the University of Ottawa and the University of Toronto. Our findings will be disseminated as community reports, fact sheets, digital stories, oral and poster presentations, peer-reviewed manuscripts and social media.