对于将女性纳入临床试验的负面选择偏见
Antonio Landi1, Dik Heg2, Enrico Frigoli3
1Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale (EOC), CH-6900 Lugano, Switzerland; Faculty of Biomedical Sciences, University of Italian Switzerland, Lugano, Switzerland.
International journal of cardiology
|May 5, 2024
概括
由于研究人员在穿皮冠状动脉干预 (PCI) 试验中代表性不足,女性代表性不足.
科学领域:
- 心血管医学 心血管医学
- 临床试验设计 临床试验设计
- 医学研究 公平 公平
背景情况:
- 越来越多的人意识到需要在皮肤穿冠状动脉干预 (PCI) 临床试验中代表女性.
- 现有证据表明,在PCI研究中,妇女的代表性仍然不足.
- 这突显了临床研究包容性的巨大差距.
研究的目的:
- 调查潜在的负面选择偏见,影响女性被纳入PCI随机临床试验.
- 分析导致在试验参与中观察到的性别差异的因素.
- 了解研究人员决定与患者拒绝在这种偏见中的作用.
主要方法:
- 对MASTER DAPT查日志和试验数据的分析.
- 包括2847名连续接受65个地点冠状动脉再血管化的患者.
- 预先指定分析,重点关注高出血风险 (HBR) 和非高出血风险 (HBR) 患者子组.
主要成果:
- 在同意高出血风险 (HBR) 患者中,女性患者的比例较低 (22%对30%).
- 观察到一个显著的性别差距,主要是由于调查人员决定不向女性提供参与.
- 患者拒绝在观察到的女性代表性不足中起到了很小的作用.
结论:
- 在试验中,接受PCI的女性高出血风险 (HBR) 患者的患病率较低.
- 与男性相比,女性参与PCI试验的可能性较低,主要是由于研究人员的偏好.
- 解决调查者偏见对于改善女性在心血管临床试验中的代表性至关重要.
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