对横截面阶梯集群随机试验的功率计算,具有时间到事件终点
Mary Ryan Baumann1,2, Denise Esserman3,4, Monica Taljaard5,6
1Department of Population Health Sciences, University of Wisconsin-Madison, Madison, WI 53726, United States.
Biometrics
|June 25, 2025
概括
研究人员开发了新的功率计算方法,用于阶段形集群随机试验 (SW-CRT),具有时间到事件结果. 这解决了试验设计中的差距,确保了对审查数据分析的足够能力.
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:
- 逐步集群随机试验 (SW-CRTs) 越来越多地用于医疗保健研究.
- 在SW-CRT的设计阶段,确保足够的统计能力至关重要.
- 现有的功率计算方法对于有审查的时间到事件结果的SW-CRT是有限的.
研究的目的:
- 提出在横截面SW-CRT中进行功率计算的新方法,并对时间到事件结果进行审查.
- 导出一个强大的三明治方差的明确表达式,以简化功率计算.
- 开发基于沃尔德和强大的分数测试的功率公式.
主要方法:
- 为分析横截面SW-CRT提出了一个分层边缘Cox模型.
- 一个明确的表达式为强大的三明治变异性是衍生出来的.
- 功率公式是在假设恒定相关性参数的情况下开发的,并通过模拟进行验证.
主要成果:
- 提出的方法可以在没有计算密集型模拟的情况下进行功率计算.
- 基于沃尔德和强大的得分测试的功率公式是衍生的.
- 模拟证实了在各种有限样本场景下方法的有效性.
结论:
- 开发的方法为SW-CRT中的功率和样本大小计算提供了计算效率高的方法,使用时间到事件数据.
- 该研究提供了实用工具,包括R Shiny应用程序,以帮助研究人员设计SW-CRT.
- 这些进步将提高SW-CRT的严谨性和可行性,以时间到事件终点评估干预措施.
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