女性在中风临床试验中的代表性：对涉及超过 50 万名参与者的 281 项试验的综述。
Representation of Women in Stroke Clinical Trials: A Review of 281 Trials Involving More Than 500,000 Participants.
机构信息
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.
出版信息
Neurology. 2021 Nov 2;97(18):e1768-e1774. doi: 10.1212/WNL.0000000000012767. Epub 2021 Oct 13.
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 ( 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.
背景与目的
女性在心血管疾病临床试验中的代表性不足，但在中风方面，其差异程度的确定性较低。我们根据人群中中风的患病率来研究女性在试验中的参与情况。
方法
从 ClinicalTrials.gov 中确定了 1990 年至 2020 年期间发表的、有≥100 名参与者的随机对照试验。为了量化入组时的性别差异，我们计算了参与率与患病率之比（PPR），定义为试验中女性的比例与疾病人群中女性的患病率之比。
结果
共有 281 项中风试验符合分析条件，共有 588887 名参与者，其中 37.4%为女性。总体而言，女性的代表性低于其在基础人群中的患病率（平均 PPR 0.84；95%置信区间[CI]0.81-0.87）。在脑出血试验（PPR 0.73；95%CI0.71-0.74）、参与者平均年龄<70 岁的试验（PPR 0.81；95%CI0.78-0.84）、非急性干预试验（PPR 0.80；95%CI0.76-0.84）和康复试验（PPR 0.77；95%CI0.71-0.83）中观察到的差异最大。这些发现并没有随着时间的推移（1990 年至 2020 年）而显著变化（趋势=0.201）。
讨论
与人群中疾病的负担相比，女性在中风试验中的代表性不足。需要明确的指导和有效的实施策略来提高女性的纳入率，从而更广泛地了解临床试验中干预措施的影响。
Zotero 插件