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澄清Mantle-Haenszel风险差异估计器在随机临床试验中的作用

Xiaoyu Qiu¹, Yuhan Qian², Jaehwan Yi³

¹Department of Statistics, University of Michigan, Ann Arbor, MI 48105, United States.

|October 31, 2025

概括

曼特尔-汉泽尔 (Mantel-Haenszel,MH) 风险差异估计器现在可以在临床试验中一致估计平均治疗效果,即使不假设各层面的风险差异是恒定的. 这种灵活的方法增强了共变量调整方法.

科学领域:

生物统计学生物统计学
临床试验方法论临床试验方法论
流行病学流行病学

背景情况:

曼特尔-汉泽尔 (Mantel-Haenszel,简称MH) 风险差异估计器传统上假设各层的风险差异均.
这种假设限制了其在随机临床试验 (RCT) 中的应用,因为风险差异可能会有所不同.
现代观点将 MH 估计器视为 RCT 中的共变量调整方法.

研究的目的:

为了放松MH估计器的常见风险差异假设.
证明MH估计器在RCT中能够一致估计平均治疗效果 (ATE).
为 MH 估计器开发一个统一的强大的方差估计器.

主要方法:

放松MH风险差异估计器的同质性假设.
将MH估计器视为RCT的共变量调整技术.
在大层,稀疏层和混合模式的非对称设置下分析估计器属性.
提出一个统一的,强大的差异估计器.

主要成果:

MH风险差异估计器在对风险差异变化的合理限制下始终估计ATE.
拟议的强大的差异估计器在各种非对称模式中显示了可证明的一致性.
这些发现扩展到MH测试,后分层和多重治疗设置.

结论:

MH风险差异估计器提供了一个灵活的方法,用于RCT中的共变量调整.
宽松的假设和新的差异估计器提高了MH方法的可靠性和适用性.
该研究通过模拟和临床示例提供理论见解和经验验证.

关键词:

平均治疗效果平均治疗效果同变量调整的调整.不同比例的比例差异.强大的差异估计估计.分层的2 × 2表格.

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