集群随机试验设计用于建模时间变化的干预效应
Kenneth Menglin Lee1, Yin Bun Cheung1,2,3
1Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore, Singapore.
Statistics in medicine
|November 10, 2023
概括
步集群随机试验 (SW-CRTs) 当干预效应随着时间的推移而变化时,可以产生偏差的结果. 像基线平行CRT (PB-CRT) 这样的替代设计提供了更有效的时间干预 (TOI) 效应估计.
科学领域:
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
- 医疗保健服务研究 医疗服务研究
背景情况:
- 阶梯集群随机试验 (SW-CRTs) 经常假设持续的干预效应,如果效应随着暴露时间的变化而变化,这可能导致偏差.
- 在SW-CRT中进行干预时间 (TOI) 影响估计,可以解释干预效应的变化,但由于异构分类差异,面临挑战.
研究的目的:
- 为了比较不同集群随机试验 (CRT) 设计在估计时间干预 (TOI) 效果方面的效率.
- 为了评估SW-CRT,并行CRT (P-CRT),与基线并行CRT (PB-CRT) 和与基线并行CRT和全暴露期 (PBAE-CRT) 的性能,用于TOI效应建模.
主要方法:
- 在不同CRT设计中推导和比较TOI效应的方差估计器.
- 与恒定效应模型相比,P-CRT和PB-CRT的相同时间平均TOI效应变异和点估计器的证明.
- 模拟研究使用来自医院撤资研究的数据来比较TOI效应估计.
主要成果:
- 该SW-CRT显示为早期TOI效应的最有效估计器.
- 一般来说,PB-CRT为长期和时间平均 TOI 影响提供了最有效的估计器.
- 时间平均的TOI效应估计器相当于P-CRT和PB-CRT中的恒定效应模型.
结论:
- 当结合TOI效应时,PB-CRT设计是建模随时间变化的干预效应的更合适选择.
- 选择合适的CRT设计对于准确估计时间变化的干预效应至关重要.
- 这些发现为优化基于预期干预效应性质的CRT设计选择提供了指导.
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