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在有二元结果的集群随机试验中,用于更合规的平均因果效应的实际推断

Tansy Edwards¹, Jennifer Thompson¹, Charles Opondo²

¹MRC International Statistics and Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.

Clinical trials (London, England)

|October 16, 2025

概括

启动方法准确地估计了集群随机试验中合规者之间的干预效应,即使不合规. 该方法通过提供无偏见的疗效估计来支持治疗意图分析.

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:

在集群随机试验 (CRT) 中的不合规性可能导致在使用治疗意图 (ITT) 分析时低估干预效果.
合规者平均因果效应 (CACE) 提供了公正的疗效估计,但在CRT中提出了推断挑战.

研究的目的:

评估一个务实的引导方法来计算CRT中的CACE置信区间.
在各种不合规和结果流行情景下评估该方法的性能.

主要方法:

模拟的集群随机试验,不同不合规率 (5%-40%) 和相关的集群水平结果.
采用启动方法,考虑聚类来估计CACE及其95%置信区间 (CI).
评估的场景具有足够的集群为80%和90%的功率来检测0.5.5的ITT几率比率的ITT几率比.

主要成果:

引导方法在所有不合规级别的CACE估计中显示了可以忽略的偏差.
对于启动过程的置信区间,没有观察到不足的覆盖率.
对于20-40%的结果患病率,置信区间足够宽,但对于不太常见的结果,太宽了.
与ITT分析相比,功耗损失随着结果流行率的下降而增加,特别是低于20%.

结论:

提议的启动拉链方法是可访问的,并且在计算上是有效的,用于在CRT中估计CACE.
这种方法通过提供可靠的疗效估计,有效地支持治疗意图分析.
它提供了一种有价值的工具,用于评估在集群研究设计中存在不合规的干预措施.

关键词:

坚持性坚持性集群随机试验是指集群的随机试验.符合合规性的合规性是什么符合标准的平均因果效应.

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