考量样本大小,以评估与性别相关的治疗效应
Sanne A E Peters1,2, Mark Woodward2,3, Hester M den Ruijter4
1Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, PO Box 85500, Utrecht, 3508 GA, The Netherlands.
European heart journal
|January 22, 2026
概括
随机对照试验 (RCT) 需要更大的样本大小,以确保女性.
科学领域:
- 心血管疾病研究研究
- 临床试验方法论 临床试验方法论
- 健康 公平 卫生 公平
背景情况:
- 随机对照试验 (RCT) 对于评估新的医疗干预措施至关重要.
- 然而,RCT经常招募有限的人口,引发了人们对概括性的担忧,特别是对于心血管疾病研究中的女性等代表性不足的群体.
- 本研究探讨了代表性参与RCT的必要性.
研究的目的:
- 定义女性在心血管RCT中的代表性参与.
- 确定对代表性参与和知识贡献的样本规模要求.
- 评估需要的样本大小,以评估性别特异性治疗效果.
主要方法:
- 从ADVANCE和LoDoCo2心血管试验中分析试验数据.
- 计算样本大小要求:代表性参与,代表性对知识的贡献,以及检测性*治疗相互作用.
- 在这些目标中比较样本大小需求.
主要成果:
- 实现代表性参与和对知识的贡献需要适度增加样本大小,主要受到基于性别的疾病患病率的影响.
- 然而,为了使RCT能够检测治疗效果中的性别差异,需要非常大的样本大小.
- 目前的RCT可能缺乏识别关键的性别特异性治疗变异的能力.
结论:
- 努力增加妇女在RCT中的参与,对于制定指导方针和临床决策至关重要.
- 然而,仅仅提高代表性是不足以检测治疗有效性的性别差异.
- 机制研究对于补充RCT至关重要,为性别特异性治疗反应提供见解,并优化对所有患者的护理.
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