对集群随机混合型2型有效性实施研究的功率和样本大小计算
Melody A Owen1, Geoffrey M Curran2, Justin D Smith3
1Center for Methods in Implementation and Prevention Science, Yale University, New Haven, Connecticut, USA.
Statistics in medicine
|February 11, 2025
概括
2型混合研究需要新的统计方法来计算集群随机试验中的样本大小. 新的方法,包括扩展的结合结果和单一的1度自由度测试,为这些复杂的研究设计提供了最强大的统计能力.
科学领域:
- 生物统计学 生物统计学
- 实施科学 实施科学
- 临床试验 临床试验
背景情况:
- 混合型2类研究同样优先考虑干预的有效性和实施结果.
- 这些研究往往采用集群随机设计,带来诸如多重测试之类的统计挑战.
- 在这种情况下,标准的统计方法不足以供电和计算样本大小.
研究的目的:
- 描述可用于有效驱动混合型2型研究的可用设计方法.
- 为集群随机化混合型2型设计提供可靠的样本大小计算方法,具有二进制结果.
- 扩展现有方法,以考虑混合型2类研究中的聚类.
主要方法:
- 通过文献搜索,发现了18篇有关混合型2研究设计的相关出版物.
- 确定了五种统计方法,其中两种方法被扩展,包括聚类.
- 用现实世界的例子 (CIRCL-芝加哥) 描述和说明了动力供电的程序.
主要成果:
- 与传统的p值调整方法相比,联合测试显示出更高的功率.
- 扩展组合结果和单一的1度自由度测试被发现是最强大的.
- 该研究为混合型2集群随机试验中的样本大小计算提供了实际指导.
结论:
- 有效的混合型2研究设计需要新的统计方法.
- 扩展的结合结果和单一的1度自由度测试为集群随机设置中的二进制结果提供了优越的功率.
- 这些方法提高了复杂的实施研究样本大小计算的可靠性.
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