Reporting of Results by Sex in Randomized Controlled Trials of Acute Stroke Therapies (2010-2020)

Abstract

Background and purpose: When reporting primary results from randomized controlled trials, recommendations include reporting results by sex. We reviewed the reporting of results by sex in contemporary acute stroke randomized controlled trials.

Methods: We searched MEDLINE for articles reporting the primary results of phase 2 or 3 stroke randomized controlled trials published between 2010 and June 2020 in one of nine major clinical journals. Eligible trials were restricted to those with a therapeutic intervention initiated within one month of stroke onset. Of primary interest was the reporting of results by sex for the primary outcome. We performed bivariate analyses using Fisher exact tests to identify study-level factors associated with reporting by sex and investigated temporal trends using an exact test for trend.

Results: Of the 115 studies identified, primary results were reported by sex in 37% (n=42). Reporting varied significantly by journal, with the New England Journal of Medicine (61%) and Lancet journals (40%) having the highest rates (P=0.03). Reporting also differed significantly by geographic region (21% Europe versus 48% Americas, P=0.03), trial phase (13% phase 2 versus 40% phase 3, P=0.05), and sample size (24% <250 participants versus 61% >750 participants, P<0.01). Although not statistically significant (P=0.11), there was a temporal trend in favor of greater reporting among later publications (25% 2010–2012 versus 48% 2019–2020).

Conclusions: Although reporting of primary trial results by sex improved from 2010 to 2020, the prevalence of reporting in major journals is still low. Further efforts are required to encourage journals and authors to comply with current reporting recommendations.

Keywords: randomized controlled trials; sex distribution; sex-specific outcomes.