Global Heath Research Center, Duke Kunshan University, China (X.J., E.G., L.L.Y.).
National Heart Centre Singapore (C.C., C.S.P.L.).
Circulation. 2020 Feb 18;141(7):540-548. doi: 10.1161/CIRCULATIONAHA.119.043594. Epub 2020 Feb 17.
Cardiovascular disease is the leading cause of death among women worldwide, yet, women have historically been underrepresented in cardiovascular trials.
We systematically assessed the participation of women in completed cardiovascular trials registered in ClinicalTrials.gov between 2010 and 2017, and extracted publicly available information including disease type, sponsor type, country, trial size, intervention type, and the demographic characteristics of trial participants. We calculated the female-to-male ratio for each trial and determined the prevalence-adjusted estimates for participation of women by dividing the percentage of women among trial participants by the percentage of women in the disease population (participation prevalence ratio; a ratio of 0.8 to 1.2 suggests comparable prevalence and good representation).
We identified 740 completed cardiovascular trials including a total of 862 652 adults, of whom 38.2% were women. The median female-to-male ratio of each trial was 0.51 (25th quartile, 0.32; 75th quartile, 0.90) overall and varied by age group (1.02 in ≤55 year old group versus 0.40 in the 61- to 65-year-old group), type of intervention (0.44 for procedural trials versus 0.78 for lifestyle intervention trials), disease type (0.34 for acute coronary syndrome versus 3.20 for pulmonary hypertension), region (0.45 for Western Pacific versus 0.55 for the Americas), funding/sponsor type (0.14 for government-funded versus 0.73 for multiple sponsors), and trial size (0.56 for smaller [n≤47] versus 0.49 for larger [n≥399] trials). Relative to their prevalence in the disease population, participation prevalence ratio was higher than 0.8 for hypertension, pulmonary arterial hypertension and lower (participation prevalence ratio 0.48 to 0.78) for arrhythmia, coronary heart disease, acute coronary syndrome, and heart failure trials. The most recent time period (2013 to 2017) saw significant increases in participation prevalence ratios for stroke (=0.007) and heart failure (=0.01) trials compared with previous periods.
Among cardiovascular trials in the current decade, men still predominate overall, but the representation of women varies with disease and trial characteristics, and has improved in stroke and heart failure trials.
心血管疾病是全球女性死亡的主要原因，但女性在心血管试验中的代表性历来不足。
我们系统地评估了 2010 年至 2017 年期间在 ClinicalTrials.gov 注册的已完成的心血管试验中女性的参与情况，并提取了公开可用的信息，包括疾病类型、赞助商类型、国家/地区、试验规模、干预类型以及试验参与者的人口统计学特征。我们为每个试验计算了女性与男性的比例，并通过将试验参与者中的女性百分比除以疾病人群中的女性百分比来确定女性参与的患病率调整估计值（参与患病率比；0.8 至 1.2 的比值表明患病率相当且代表性良好）。
我们确定了 740 项已完成的心血管试验，其中包括 862652 名成年人，其中 38.2%为女性。每个试验的中位数女性与男性比例为 0.51（第 25 个四分位数，0.32；第 75 个四分位数，0.90），并且因年龄组而异（≤55 岁组为 1.02，61 至 65 岁组为 0.40）、干预类型（程序试验为 0.44，生活方式干预试验为 0.78）、疾病类型（急性冠状动脉综合征为 0.34，肺动脉高压为 3.20）、地区（西太平洋为 0.45，美洲为 0.55）、资金/赞助商类型（政府资助为 0.14，多个赞助商为 0.73）和试验规模（n≤47 的较小试验为 0.56，n≥399 的较大试验为 0.49）。与疾病人群中的患病率相比，高血压、肺动脉高压的参与患病率比高于 0.8，心律失常、冠心病、急性冠状动脉综合征和心力衰竭试验的参与患病率比低于 0.8（0.48 至 0.78）。与前几个时期相比，最近的时间（2013 年至 2017 年），中风（=0.007）和心力衰竭（=0.01）试验的参与患病率比显著增加。
在目前十年的心血管试验中，男性总体上仍然占主导地位，但女性的代表性因疾病和试验特征而异，中风和心力衰竭试验的代表性有所提高。
