Cheryl Carcel1, Katie Harris2, Sanne A E Peters2, Else Charlotte Sandset2, Grace Balicki2, Cheryl D Bushnell2, Virginia J Howard2, Mathew J Reeves2, Craig S Anderson2, Peter J Kelly2, Mark Woodward2. 1. From The George Institute for Global Health (C.C., K.H., S.A.E.P., G.B., C.S.A., M.W.), University of New South Wales; Sydney School of Public Health (C.C., C.S.A.), Sydney Medical School, The University of Sydney, New South Wales, Australia; The George Institute for Global Health (S.A.E.P., M.W.), Imperial College London, UK; Julius Center for Health Sciences and Primary Care (S.A.E.P.), University Medical Center Utrecht, the Netherlands; Department of Neurology (E.C.S.), Oslo University Hospital; Department of Research and Development (E.C.S.), The Norwegian Air Ambulance Foundation, Oslo, Norway; Department of Neurology (C.D.B.), Wake Forest School of Medicine, Winston-Salem, NC; Department of Epidemiology (V.J.H.), School of Public Health, University of Alabama at Birmingham; Department of Epidemiology and Biostatistics (M.J.R.), Michigan State University, East Lansing; The George Institute China (C.S.A.), Peking University Health Science Center, Beijing; Stroke Service/Department of Neurology (P.J.K.), Mater University Hospital/University College, Dublin, Ireland; and Department of Epidemiology (M.W.), Johns Hopkins University, Baltimore MD. ccarcel@georgeinstitute.org.au. 2. From The George Institute for Global Health (C.C., K.H., S.A.E.P., G.B., C.S.A., M.W.), University of New South Wales; Sydney School of Public Health (C.C., C.S.A.), Sydney Medical School, The University of Sydney, New South Wales, Australia; The George Institute for Global Health (S.A.E.P., M.W.), Imperial College London, UK; Julius Center for Health Sciences and Primary Care (S.A.E.P.), University Medical Center Utrecht, the Netherlands; Department of Neurology (E.C.S.), Oslo University Hospital; Department of Research and Development (E.C.S.), The Norwegian Air Ambulance Foundation, Oslo, Norway; Department of Neurology (C.D.B.), Wake Forest School of Medicine, Winston-Salem, NC; Department of Epidemiology (V.J.H.), School of Public Health, University of Alabama at Birmingham; Department of Epidemiology and Biostatistics (M.J.R.), Michigan State University, East Lansing; The George Institute China (C.S.A.), Peking University Health Science Center, Beijing; Stroke Service/Department of Neurology (P.J.K.), Mater University Hospital/University College, Dublin, Ireland; and Department of Epidemiology (M.W.), Johns Hopkins University, Baltimore MD.
Abstract
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.
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.
Authors: Joshua Cohen; Jennifer Wright-Berryman; Lesley Rohlfs; Douglas Trocinski; LaMonica Daniel; Thomas W Klatt Journal: Front Digit Health Date: 2022-02-02