连续的概率比率和电子过程在更新试验的分析中
Fernando G Zampieri1,2, Alexandre B Cavalcanti1, Peter M B Cahusac3
1Research Institute, Hospital do Coracao (HCor), Sao Paulo, Brazil.
Annals of the American Thoracic Society
|February 24, 2026
概括
由于患者群体的变化,自适应平台试验可能会产生误导性的结果. 有证据的方法揭示了真正的治疗效果和招生动态,为复杂的试验设计提供了诊断工具.
科学领域:
- 临床试验 临床试验
- 生物统计学 生物统计学
- 证据综合 证据综合
背景情况:
- 适应性平台试验面临的挑战是异质人群和非同时招生.
- 在此类试验中,聚合分析可能会误导,因为患者组成随着时间的推移而变化.
研究的目的:
- 在RENOVATE试验中使用证据方法和电子流程量化治疗效果异质性.
- 为了证明招生组成中的时间变化如何在顺序监测中创建统计文物.
主要方法:
- 对RENOVATE试验 (n=1,766) 的二次分析,比较五种人群中的高流量鼻氧 (HFNO) 与非侵入性通风 (NIV).
- 计算的顺序概率比 (SLR) 在7天死亡或输管治疗的群体内的过程.
- 敏感性分析使用了基于条件和随机化的电子流程.
主要成果:
- 在不同人群中观察到大量的治疗效果异质性;心脏性胀显示HFNO益处,而COVID-19表明潜在的危害.
- 聚合的SLR分析显示,由于入学组合的变化,特别是COVID-19期间,出现了V形文物.
- 替代分析与SLR一致,但避免了文物解释.
结论:
- 顺序证据分析有效地揭示了在适应性平台试验中被聚合分析掩盖的治疗异质性.
- 登记组合机械地驱动证据积累轨迹.
- 电子流程作为平台试验的诊断工具,可视化了招生动态和治疗异质性之间的相互作用.
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