Women ‘substantially less represented’ in AF clinical trials
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A meta-analysis of atrial fibrillation trials shows women were substantially less represented than men, with an absolute difference of 12.5 percentage points relative to the general population of people with AF, researchers reported.
In an analysis of more than 140 randomized controlled trials assessing AF outcomes, researchers also found that only one-quarter of trials reported sex-specific primary endpoint results.
“Given the well-established importance of sex in the epidemiology of AF, the underrepresentation of women in randomized controlled trials of therapies for patients with AF might undermine their generalizability and consequently the validity of the evidence guiding treatment of women,” Jean Jacques Noubiap, MD, MMed, of the Centre for Heart Rhythm Disorders at the University of Adelaide and Royal Adelaide Hospital, Australia, and colleagues wrote in the study background. “Furthermore, reporting of trial results in women and men separately is essential to determine when sex-specific therapeutic strategies should be applied.”
Noubiap and colleagues analyzed data from 142 randomized controlled trials assessing AF in 133,532 participants, published from 2011 to November 2021. Researchers measured enrollment of women using the enrollment disparity difference, defined as the difference between the proportion of women in the trial and the proportion of women with AF in the underlying general population, obtained from the Global Burden of Disease. Researchers also determined the proportion of trials that included sex-stratified results.
The findings were published in the Journal of Cardiovascular Electrophysiology.
Using a random-effects model, the summary enrollment disparity difference was –0.125 (95% CI, –0.143 to –0.108), indicating that women were underenrolled in AF trials by 12.5 percentage points.
Enrollment of women was higher in trials with a larger sample size (< 250 participants vs. > 750 participants; adjusted OR = 1.065, 95% CI, 1.008-1.125), as well as trials with an older mean age (aOR = 1.006; 95% CI; 1.002-1.009). Enrollment of women was lower in trials conducted in North America compared with Europe, with an aOR of 0.945 (95% CI, 0.898-0.995).
Only 25.4% of trials reported outcomes by sex; of these, 80.6% performed statistical testing of the sex-by-treatment interaction.
“Despite recent progress, females remain substantially less represented in randomized clinical trials of AF,” the researchers wrote. “This calls into question the generalizability of these trials and the validity of the evidence guiding the treatment of females. More efforts are needed to increase female enrollment, with a special attention in trials conducted in Northern America and those with lower sample size.”
The researchers noted that sex-stratified reporting of primary outcomes infrequently occurs in randomized controlled trials of AF and “reporting by sex should become a requirement in journals’ reporting guidelines ... to reduce the sex disparity observed in enrollment and reporting of major trials in AF.”
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