Abstract 14171: Association of Women Authors With Women Enrollment in the Clinical Trials of Atrial Fibrillation

Abstract

Introduction: Women with atrial fibrillation (AF) are more symptomatic, have poorer quality of life and carry a higher risk of stroke than men. Despite this woman have been underrepresented in randomized controlled trials (RCTs) of AF. Hypothesis: Women representation in the author panel might influence enrollment of women in RCTs of AF. Methods: We performed a systematic literature search from 1989 through December 2019 to identify RCTs of AF with a follow-up duration of ≥3 months. The multivariate linear regression model was constructed with the proportion of women enrollment in the RCTs as the dependent variable and the proportion of women in the author panel as a key independent variable. The model was adjusted for publication year, region, sponsor, and type of RCTs (invasive or medical treatment). Results: A total of 134 RCTs (n=149,162) were included. The median number of participants per trial was 205 (IQR, 74-676). The median number of women per trial was 71 (IQR, 27-218). The overall representation of women was 35.1% (95% CI, 32.6-37.6%), which did not improve between 1989 to 2019 (from 27.3% to 29.6%; P=0.10). RCTs of AF were authored by 1,568 authors. The median number of authors per trial publication was 10 (IQR, 7-10). The median number of women authors was 1 (IQR, 0-3). First (93%) and senior (92%) authors were predominantly men. Only 13.3% (n=18) of publications had women as first or senior authors, which did not improve over time (P=0.07). Multivariate model showed that each 1% increase in women in the author panel was associated with 19% increase in women enrollment in RCTs (P=0.02) (Table). Conclusions: Women remained underrepresented both as participants and as authors of RCTs of AF. Higher representation of women in the author panel was associated with higher enrollment of women in RCTs of AF. Efforts to recruitment and retain women AF investigators may be a critical mechanism to help lessen the disparities in both areas.