Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Department of Medicine, McMaster University, Hamilton, Canada.
Eur J Heart Fail. 2021 Jan;23(1):15-24. doi: 10.1002/ejhf.2034. Epub 2020 Nov 16.
To evaluate temporal trends in the enrolment of females in randomized controlled trials (RCTs) of heart failure with reduced ejection fraction (HFrEF) published in high-impact journals, and assess RCT characteristics associated with under-enrolment.
We searched MEDLINE, EMBASE and CINAHL for studies published from January 2000 to May 2019 in journals with impact factor ≥10. We included RCTs that recruited adults with HFrEF. We used a 20% threshold below the sex distribution of HFrEF to define under-enrolment. We used multivariable logistic regression to assess trial characteristics independently associated with under-enrolment. We included 317 RCTs. Among the 183 097 participants, mean (standard deviation) age was 63.0 (7.0) years and 25.5% were female. Females were under-enrolled in 71.6% [95% confidence interval (CI) 66.6-76.6%] of the RCTs; enrolment did not increase significantly between 2000-2019. Sex-related eligibility criteria [odds ratio (OR) 2.05, 95% CI 1.01-4.16; P = 0.046]; recruitment in ambulatory settings (OR 2.56, 95% CI 1.37-4.81; P = 0.003); trial coordination in North America (OR 4.44, 95% CI 1.09-18.07; P = 0.037), Europe (OR 6.79, 95% CI 1.63-27.39; P = 0.018) and Asia (OR 9.33, 95% CI 1.40-12.40; P = 0.033); drug (OR 1.76, 95% CI 1.96-7.36; P < 0.001) and device/surgical interventions (OR 1.69, 95% CI 1.16-9.43; P = 0.002); and men in first and last authorship position (OR 1.32, 95% CI 1.12-3.54; P = 0.047) were associated with under-enrolment of females.
Females were under-enrolled relative to disease distribution in a majority of high-impact HFrEF RCTs, with no change in temporal trends between 2000 and 2019. Trial characteristics and gender of trial leaders were associated with under-enrolment.
评估在高影响力期刊上发表的射血分数降低的心力衰竭（HFrEF）随机对照试验（RCT）中女性入组的时间趋势，并评估与女性入组不足相关的 RCT 特征。
我们在具有影响因子≥10 的期刊上，从 2000 年 1 月至 2019 年 5 月，在 MEDLINE、EMBASE 和 CINAHL 中搜索研究。我们纳入了招募 HFrEF 成年患者的 RCT。我们使用低于 HFrEF 性别分布 20%的阈值来定义女性入组不足。我们使用多变量逻辑回归来评估与女性入组不足独立相关的试验特征。我们纳入了 317 项 RCT。在 183097 名参与者中，平均（标准差）年龄为 63.0（7.0）岁，25.5%为女性。71.6%（95%置信区间 66.6-76.6%）的 RCT 中女性入组不足；2000-2019 年间，入组人数并未显著增加。与性别相关的入选标准[比值比（OR）2.05，95%置信区间 1.01-4.16；P=0.046]；在门诊环境中进行招募（OR 2.56，95%置信区间 1.37-4.81；P=0.003）；北美（OR 4.44，95%置信区间 1.09-18.07；P=0.037）、欧洲（OR 6.79，95%置信区间 1.63-27.39；P=0.018）和亚洲（OR 9.33，95%置信区间 1.40-12.40；P=0.033）的试验协调；药物（OR 1.76，95%置信区间 1.96-7.36；P<0.001）和器械/手术干预（OR 1.69，95%置信区间 1.16-9.43；P=0.002）；以及第一作者和最后作者为男性（OR 1.32，95%置信区间 1.12-3.54；P=0.047）与女性入组不足相关。
在大多数高影响力的 HFrEF RCT 中，女性的入组比例相对于疾病分布较低，2000 年至 2019 年期间，时间趋势没有变化。试验特征和试验负责人的性别与女性入组不足有关。
