Representation of Women in Randomized Trials in Cardiac Surgery: A Meta‐Analysis

Summary

This meta-analysis of 51 randomized controlled trials in cardiac surgery (25,425 patients total) found that women comprised only 20.8% of enrolled participants, with significant variation by trial characteristics. Women's representation declined from 29.6% in 2000 to 13.1% in 2019, though this decline was largely attributable to trials conducted at Veteran Affairs centres. The authors conclude that the overall proportion of women in cardiac surgery trials is inadequate to generate meaningful estimates of treatment effects specific to female patients.

UK applicability

These findings on trial representation bias in cardiac surgery have direct relevance to UK clinical research governance and regulatory standards, particularly as the National Institute for Health and Care Research and research ethics committees increasingly scrutinise participant diversity in trial design. The trends identified suggest that UK cardiac surgery researchers should examine whether similar representation gaps exist in domestic trials and consider the implications for evidence-based practice in female cardiac surgery patients.

Key measures

Percentage of women enrolled in cardiac surgery RCTs; 95% confidence intervals; stratified analysis by year of publication, geographic region, surgical procedure type, funding source, patient age, and trial characteristics

Outcomes reported

The study quantified the proportion of women enrolled in randomized controlled trials of cardiac surgery procedures published between 2000 and 2020, and examined associations between women's representation and trial characteristics including publication year, geographic location, funding source, and surgical intervention type.

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