RT Journal Article
SR Electronic
T1 Representation of Women in Stroke Clinical Trials
JF Neurology
JO Neurology
FD Lippincott Williams & Wilkins
SP e1768
OP e1774
DO 10.1212/WNL.0000000000012767
VO 97
IS 18
A1 Carcel, Cheryl
A1 Harris, Katie
A1 Peters, Sanne A.E.
A1 Sandset, Else Charlotte
A1 Balicki, Grace
A1 Bushnell, Cheryl D.
A1 Howard, Virginia J.
A1 Reeves, Mathew J.
A1 Anderson, Craig S.
A1 Kelly, Peter J.
A1 Woodward, Mark
YR 2021
UL http://n.neurology.org/content/97/18/e1768.abstract
AB Background and Objectives Women have been underrepresented in cardiovascular disease clinical trials but there is less certainty over the level of disparity specifically in stroke. We examined the participation of women in trials according to stroke prevalence in the population.Methods Published randomized controlled trials with ≥100 participants enrolled between 1990 and 2020 were identified from ClinicalTrials.gov. To quantify sex disparities in enrollment, we calculated the participation to prevalence ratio (PPR), defined as the percentage of women participating in a trial vs the prevalence of women in the disease population.Results There were 281 stroke trials eligible for analyses with a total of 588,887 participants, of whom 37.4% were women. Overall, women were represented at a lower proportion relative to their prevalence in the underlying population (mean PPR 0.84; 95% confidence interval [CI] 0.81–0.87). The greatest differences were observed in trials of intracerebral hemorrhage (PPR 0.73; 95% CI 0.71–0.74), trials with a mean age of participants <70 years (PPR 0.81; 95% CI 0.78–0.84), nonacute interventions (PPR 0.80; 95% CI 0.76–0.84), and rehabilitation trials (PPR 0.77; 95% CI 0.71–0.83). These findings did not significantly change over the period from 1990 to 2020 (p for trend = 0.201).Discussion Women are disproportionately underrepresented in stroke trials relative to the burden of disease in the population. Clear guidance and effective implementation strategies are required to improve the inclusion of women and thus broader knowledge of the impact of interventions in clinical trials.CI=confidence interval; GBD=Global Burden of Disease; ICH=intracerebral hemorrhage; PPR=participation to prevalence ratio; SSWM=sample size weighted mean