Abstract WP336: Global Variation in the Representation of Women in Contemporary Acute Stroke Trials
Introduction: Women have historically been underrepresented in RCTs of cardiovascular disease. We undertook a review of acute stroke RCTs to determine whether women were equitably represented and whether any sex disparity varied across geographic region. Methods: We searched for papers describing primary results of acute stroke RCTs published 2013-2018 in 9 major journals and abstracted the proportion of trial participants that were women (PPW). We then searched for incidence studies from the geographic regions in which trial enrollment took place and estimated the proportion of incident strokes occurring in women (PSW) in each region (i.e., North America, Europe, Asia Pacific, Multiple Regions). We quantified the representation of women using the enrollment disparity difference (EDD) calculated as the absolute difference between the two proportions (i.e., PSW - PPW). An EDD greater than 0 indicated a disparity in favor of men. We pooled EDDs from individual RCTs using random effects meta-analysis to estimate overall and region-specific disparities. Results: Among 60 trials the PPW ranged from 33.8% to 56.9% (median 44.7%). The overall pooled EDD was 0.07 (95% CI=0.06-0.08, Q p<0.001, I 2 =85.8%) (Figure), indicating that 7% more men were included in the trials, relative to the underlying incidence. A statistically significant EDD existed in all regions; the magnitude was largest for RCTs with enrollment from Asia Pacific (EDD=0.11, 95% CI=0.10-0.13) and Multiple Regions (EDD=0.10, 95% CI=0.08-0.12) and smallest among North American and European trials (EDD 0.04 and 0.06, respectively). All region-specific summary estimates showed significant between study heterogeneity apart from Asia (Q p=0.102, I 2 =38.4%). Conclusions: Women were underrepresented globally in contemporary acute stroke RCTs; the magnitude of the disparity differed between regions. Future research should focus on trial eligibility criteria that may contribute to this disparity.