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2019 HSR&D/QUERI National Conference Abstract

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1074 — Evidence Map: reporting of results by sex or gender in randomized controlled trials with women Veteran participants (2008-2018)

Lead/Presenter: Elisheva (Elizabeth) Danan,  COIN - Minneapolis
All Authors: Danan ER (Center for Care Delivery and Outcomes Research, Minneapolis VA), Ullman K (Center for Care Delivery and Outcomes Research, Minneapolis VA), Klap RS (Center for the Study of Healthcare Innovation, Implementation & Policy, Greater Los Angeles VA) Yano EM (Center for the Study of Healthcare Innovation, Implementation & Policy, Greater Los Angeles VA) Krebs EE (Center for Care Delivery and Outcomes Research, Minneapolis VA)

Objectives:
Higher participation of women in randomized controlled trials (RCTs) has not led to significantly improved reporting of sex-stratified results. Grouping male and female study subjects together can overestimate benefits and underestimate harms for men or women due to biologic (sex) or sociocultural (gender) differences in response to the intervention. Because women comprise an extreme minority of living Veterans (10%), the challenge of conducting clinical research that is meaningfully applicable to women is intensified for studies related to Veterans' health. We compared the characteristics of RCTs with women Veteran participants that did or did not report results by sex or gender. Our objective was to assess how sex and gender are addressed in research with women Veterans.

Methods:
We extended our prior women's health evidence map with a systematic search for RCTs with women Veterans, published 2008-2018. We compared characteristics of RCTs that reported results by sex or gender with those of RCTs that did not, and reviewed methodology and reporting of sex/gender analyses.

Results:
We assessed 1,820 abstracts for relevance and included 45 unique RCTs that met eligibility criteria. Five trials included only women and 40 included both male and female Veteran participants (median 14.3% women). Publications increased over time, as did the number reporting results by sex or gender. Ten studies (25%) reported results by sex or gender. These trials were larger (median study size n = 343.5 vs. n = 125.5) and included a higher median proportion of female participants (16.8% vs. 11.2%) than studies without sex/gender results. Ten of 11 trials that tested pharmacologic or device interventions did not report sex-specific results.

Implications:
Women Veterans are increasingly participating in RCTs, but results are infrequently reported by sex or gender. Trials of pharmacologic or device interventions may be targets for future reporting requirements.

Impacts:
Action by various stakeholders could improve sex and gender sensitivity in Veteran research. We suggest that funders set expectations, then track and publicly report women's participation in trials. Journal editors should adopt and enforce sex/gender reporting guidelines. Investigators should seek training and use existing resources for the conduct, analysis, and reporting of sex- and gender-equitable research.