Background and objective: The stepped wedge cluster randomized trial is a study design increasingly used for public health intervention evaluations. Most previous literature focuses on power calculations for this particular type of cluster randomized trials for continuous outcomes, along with an approximation to this approach for binary outcomes. Although not accurate for binary outcomes, it has been widely used. To improve the approximation for binary outcomes, two new methods for stepped wedge designs (SWDs) of binary outcomes have recently been published. However, these new methods have not been implemented in publicly available software. The objective of this paper is to present power calculation software for SWDs in various settings for both continuous and binary outcomes. Methods: We have developed a SAS macro %swdpwr and an R package swdpwr for power calculation in SWDs. Different scenarios including cross-sectional and cohort designs, binary and continuous outcomes, marginal and conditional models, three link functions, with and without time effects are accommodated in this software. Results: swdpwr provides an efficient tool to support investigators in the design and analysis of stepped wedge cluster randomized trails. swdpwr addresses the implementation gap between newly proposed methodology and their application to obtain more accurate power calculations in SWDs. Conclusions: This user-friendly software makes the new methods more accessible and incorporates as many variations as currently available, which were not supported in other related packages. swdpwr is implemented under two platforms: SAS and R, satisfying the needs of investigators from various backgrounds.
翻译:在二进制结果和目标上, 递增的混合组合随机测试是一种研究设计, 越来越多地用于公共卫生干预评估。 大多数前文文献都侧重于为这种特定类型的分组随机测试为连续结果提供电源计算软件, 以及对于二进制结果的近似方法。 虽然对于二进制结果来说并不准确, 但它被广泛使用。 为了改进二进制结果的近似, 最近公布了两种关于二进制结果的新方法。 但是, 这些新方法还没有在公开的软件中实施。 本文件的目的是为各种环境中的社工基金提供连续和二进制结果的电源计算软件。 方法: 我们开发了一个SAS 宏% swdpwrr和R 软件包 wwdprwrwr, 用于二进制结果的电源计算。 不同的情景包括跨部门和组合设计、 双进制和连续结果、 边际和有条件的模型、 三个连接功能, 以及没有时间效果的软件。 结果: swdporwwwwr 提供了一种有效的工具, 支持调查员在不同环境中设计和分析被提升的组组组组别的设计和分析。, 在最新的用户计算中, 中, 采用了新的系统变换为新的系统。