Women are underrepresented by up to 5.3 percentage points in studies of acute stroke, an underrepresentation that may be caused by studies with strict age limit inclusion criteria, according to research from JAMA Neurology.
A team of researchers from the United States and Australia performed a meta-analysis of 115 randomized Phase 2 and 3 clinical trials that included patients with stroke and / or transient ischemic attacks. All studies looked at treatment for stroke that began within one month of the onset of the stroke.
In the analysis, the study directors evaluated the enrollment disparity difference (EDD), the absolute difference between the female study participants and the proportion of strokes that occurred in women.
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The pooled analysis included 121,105 patients who were randomly assigned to active intervention or placebo or other therapy. Approximately 43.4% (n = 52,522) of the participants in these studies were women. The study examiners found that women were under-recruited by around 5.3 percentage points, which is confirmed by the EDD summary of the random effects of -0.053 (95% CI, -0.065 to -0.040).
Overall, the gender disparity was observed across all geographic regions, types of intervention, and types of stroke apart from subarachnoid hemorrhage (EDD, 0.117; 95% CI, 0.084–0.150).
In an analysis that excluded studies on subarachnoid hemorrhage, the overall EDD was -0.067 (95% CI, -0.078 to -0.057), suggesting that women underrepresented in stroke studies by 6.7 percentage points relative to the total post-stroke population were.
In addition, an upper age limit of 80 years or younger as an admission criterion for the study correlated with a 6 percentage point reduction in female enrollment in a multivariable meta-regression analysis (β, -0.061; 95% CI, -0.099 to -0.023 ).
This study may have been constrained by its meta-regression model due to the potential for residual confusion at the patient or study level.
While “more research is needed to pinpoint the causes of the [under-enrollment] of women in studies on acute strokes ”, the study researchers concluded that“ authors who set an upper age limit as an admission criterion should provide a clear justification for this. ”
reference
Strong B, Pudar J, Thrift AG, et al. Gender differences in enrollment in recent randomized clinical trials of acute stroke: a meta-analysis. Published online April 26, 2021. JAMA Neurol. doi: 10.1001 / jamaneurol.2021.0873
