妇女在心房移除随机对照试验中的代表性:系统性审查
Eh Khaing1, Ahmad Aroudaky2, Danielle Dircks3
1University of Nebraska Omaha Omaha NE USA.
Journal of the American Heart Association
|January 10, 2025
概括
妇女在心房动 (AF) 移除临床试验中代表性不足. 这限制了试验结果适用于患有AF的女性的适用性,她们往往有更多的并发症.
科学领域:
- 心血管医学 心血管医学
- 临床试验 临床试验
- 健康中的性别差异
背景情况:
- 心血管疾病研究中的性别差异是一个公认的问题.
- 以前的研究表明,在心血管随机对照试验 (RCT) 中,女性的代表可能不足.
研究的目的:
- 评估女性参与心房动 (AF) 除RCT的比例.
- 确定与这些试验中女性代表人数不足相关的潜在风险.
主要方法:
- 在PubMed和Embase的系统文献搜索中,针对2015年至2022年间发表的AF切除RCT进行了系统的文献搜索.
- 对参与者人口统计学的分析,重点关注女性的比例.
- 与女性比例较高和较低的试验之间的参与者特征的比较.
主要成果:
- 在147个AF切除RCT (30,055名参与者) 中,只有10个试验实现了50%以上的女性入学率.
- 妇女的中位数比例为31.5%,从2015年到2022年没有观察到显著变化.
- 与女性入学率较高的试验包括年长的患者,患有更多的高血压,但不那么持久的AF和较小的左心房大小.
- 排除标准影响了2857%的孕妇/哺乳期妇女和4.1%的生育年龄妇女的试验.
结论:
- 妇女在当代AF切除RCT中仍然代表性不足.
- 参与这些试验的女性往往出现更多的并发症和较不发达的AF.
- 这种代表性不足和不同的并发症概况限制了试验结果对AF女性更广泛的人口的概括性.
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