设计阶段子集群随机试验,并对结果进行基线测量
Kendra Davis-Plourde1,2, Keith Goldfeld3, Heather Allore1,4
1Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut, USA.
Statistics in medicine
|September 24, 2025
概括
本研究介绍了包括基线结果测量的阶段形集群随机试验 (SW-CRTs) 的方法. 这些方法改善了样本大小计算,以便在实施研究中更有效地设计试验.
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
- 公共卫生研究 公共卫生研究
背景情况:
- 逐步集群随机试验 (SW-CRTs) 越来越多地被用于实施和预防研究.
- 现有的SW-CRT样本大小公式通常不考虑基线结果测量.
- 基线结果数据在随机试验和横截面SW-CRT中很常见.
研究的目的:
- 研究将基线结果测量纳入横截面SW-CRT设计的方法.
- 开发和比较不同的统计方法来调整基线结果.
- 为SW-CRT与基线数据的样本大小计算提供指导.
主要方法:
- 开发了三种线性混合建模方法,以调整基线结果测量.
- 对于每个方法,治疗效果估计器的方程公式都得到了推导.
- 模拟研究用于验证功率和样本大小方法.
主要成果:
- 衍生的公式突出了包括基线结果测量的效率增长.
- 调整方法之间的比较为试验设计提供了实际建议.
- 经过验证的方法为SW-CRT与基线数据的精确样本大小计算提供了便利.
结论:
- 将基线结果测量纳入SW-CRT可以提高统计效率.
- 提出的建模方法和样本大小计算为研究人员提供了宝贵的工具.
- 这项工作支持在公共卫生和实施科学方面更强大,更有效的试验设计.
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