Spiering A E, van Ommen A M L N, Roeters van Lennep J E, Appelman Y, Reue K, Onland-Moret N C, den Ruijter H M
Laboratory of Experimental Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
Department of Human Genetics, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, United States.
Int J Cardiol Heart Vasc. 2024 Nov 8;55:101547. doi: 10.1016/j.ijcha.2024.101547. eCollection 2024 Dec.
Cardiovascular disease is the leading cause of death in women worldwide. Yet, women are often underrepresented in cardiovascular clinical trials. Trial characteristics may influence the participation of women. For instance, trials are often entitled with an acronym, which might be perceived as gendered. We aimed to investigate if the perceived gender of the acronym and other trial characteristics affect the representation of female patients in cardiovascular trials.
We searched ClinicalTrials.gov for randomized controlled trials in cardiovascular disease named with an acronym. Cardiovascular patients (n = 148) scored the perceived gender of the acronym of 148 identified trials. Prevalence ratios (PR) were calculated with Poisson regression to link trial characteristics to representation of female patients in the trials.
In 62 % of trials, female patients were underrepresented relative to the disease population. There was no improvement over time in proportion of trials with adequate representation. A third of acronyms was classified as gendered. The perceived gender did not affect representation of female patients (PR 1.01; 95% CI 0.95 - 1.08; P = 0.68). A woman as first and/or last author (PR 1.22; 95% CI 1.07 - 1.38; P = 0.002) and recruitment in an outpatient setting (PR 1.15; 95% CI 1.02 - 1.29; P = 0.01) were associated with a higher prevalence of adequate representation of female patients.
Representation of female patients in cardiovascular trials does not depend on the perceived gender of the trial acronym but is improved in trials under female leadership in out-patient settings. Our findings may direct efforts towards increasing representation of female patients in cardiovascular trials.
心血管疾病是全球女性的首要死因。然而，女性在心血管临床试验中的代表性往往不足。试验特征可能会影响女性的参与度。例如，试验通常以首字母缩略词命名，这可能会被认为带有性别色彩。我们旨在研究首字母缩略词的感知性别以及其他试验特征是否会影响心血管试验中女性患者的代表性。
我们在ClinicalTrials.gov上搜索了以首字母缩略词命名的心血管疾病随机对照试验。148名心血管疾病患者对148项已识别试验的首字母缩略词的感知性别进行了评分。采用泊松回归计算患病率比（PR），以将试验特征与试验中女性患者的代表性联系起来。
在62%的试验中，女性患者相对于疾病人群的代表性不足。随着时间的推移，具有足够代表性的试验比例没有改善。三分之一的首字母缩略词被归类为带有性别色彩。感知性别并未影响女性患者的代表性（PR 1.01；95%置信区间0.95 - 1.08；P = 0.68）。女性作为第一作者和/或最后作者（PR 1.22；95%置信区间1.07 - 1.38；P = 0.002）以及在门诊环境中招募患者（PR 1.15；95%置信区间1.02 - 1.29；P = 0.01）与女性患者足够代表性的较高患病率相关。
心血管试验中女性患者的代表性并不取决于试验首字母缩略词的感知性别，而是在门诊环境中由女性领导的试验中有所改善。我们的研究结果可能会指导人们努力提高心血管试验中女性患者的代表性。
