Occupational Stress, Burnout, and Depression in Women in Healthcare During COVID-19 Pandemic: Rapid Scoping Review.

Objectives: The overall objectives of this rapid scoping review are to (a) identify the common triggers of stress, burnout, and depression faced by women in health care during the COVID-19 pandemic, and (b) explore individual-, organizational-, and systems-level interventions that can support the well-being of women HCWs during a pandemic. Design: This scoping review is registered on Open Science Framework (OSF) and was guided by the JBI guide to scoping reviews and reported using the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) extension to scoping reviews. A systematic search of literature databases (Medline, EMBASE, CINAHL, PsycInfo and ERIC) was conducted from inception until June 12, 2020. Two reviewers independently assessed full-text articles according to predefined criteria. Interventions: We included review articles and primary studies that reported on stress, burnout, and depression in HCWs; that primarily focused on women; and that included the percentage or number of women included. All English language studies from any geographical setting where COVID-19 has affected the population were reviewed. Primary and secondary outcome measures: Studies reporting on mental health outcomes (e.g., stress, burnout, and depression in HCWs), interventions to support mental health well-being were included. Results: Of the 2,803 papers found, 28 were included. The triggers of stress, burnout and depression are grouped under individual-, organizational-, and systems-level factors. There is a limited amount of evidence on effective interventions that prevents anxiety, stress, burnout and depression during a pandemic. Conclusions: Our preliminary findings show that women HCWs are at increased risk for stress, burnout, and depression during the COVID-19 pandemic. These negative outcomes are triggered by individual level factors such as lack of social support; family status; organizational factors such as access to personal protective equipment or high workload; and systems-level factors such as prevalence of COVID-19, rapidly changing public health guidelines, and a lack of recognition at work.

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.