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外部试点集群随机试验的样本大小确定与二元可行性结果:一个教程

K Hemming¹, M Taljaard^2,3, E Gkini⁴

¹Institute of Applied Health Research, University of Birmingham, Birmingham, UK. k.hemming@bham.ac.uk.

Pilot and feasibility studies

|September 19, 2023

概括

为了证明试点试验的样本大小,需要特定的方法,而不是标准的有效性测试. 本研究为试点集群试验提供了指导,重点关注可行性结果,并为研究人员提供实用工具.

科学领域:

生物统计学生物统计学
临床试验设计临床试验设计
医疗保健服务研究医疗服务研究

背景情况:

试点试验需要证明样本大小的合理性,但目前的方法往往被错误地应用.
传统的样本大小方法不适合试点试验,试点试验侧重于可行性,而不是有效性.
可行性目标,通常是二进制的,为随后的全面试验提供样本大小的信息.

研究的目的:

为了证明外部试点集群试验的样本大小合理性,估计二元可行性结果.
在这种情况下,为样本大小计算提供实用工具和公式.
报告可行性结果的集群内部相关系数.

主要方法:

在试点集群试验中为各种场景开发样本大小计算公式.
创建一个R Shiny应用程序来实现拟议的样本大小方法.
从现有数据中编制可行性结果的集群内部相关系数.

主要成果:

试点集群试验的样本大小计算取决于集群的数量,集群大小和可行性结果的集群内相关系数 (ICC).
可行性结果可能显示出比临床结果更大的ICC,现有数据有限.
外部试点集群试验的效率可以通过增加集群数量和减少每个集群的观测量来提高,除非ICC非常低.

结论:

本教程提供了一个框架,用于证明试点集群试验中的样本大小,重点关注二进制可行性结果.
提供的R Shiny应用程序有助于这些样本大小方法的实际应用.
了解可行性结果的ICC对于优化试点集群试验设计和效率至关重要.

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