Background and objective

Stepped wedge trials (SWTs) are a type of cluster-randomized trial that are commonly used to evaluate health care interventions. Most SWT-related software packages have restrictive assumptions about the study design and correlation structure of the data. The objective of this paper is to present a package and corresponding web-based graphical user interface (GUI) that provide researchers with another, more flexible option for SWT design and analysis.

Methods

We developed an $\mathsf{R}$ package swCRTdesign (‘stepped wedge Cluster Randomized Trial design’), which uses a random effects model to account for correlation in the data induced by a SWT design. Possible sources of correlation include clusters, time within clusters, and treatment within clusters.

Results

swCRTdesign allows a user to calculate power, simulate SWT data to streamline simulation studies (e.g. to estimate power), and create descriptive summaries and plots. Additionally, a GUI, developed using shiny, is available to calculate power and create power curves and design plots.

Conclusions

The swCRTdesign package accommodates a wide variety of SWT designs, and makes it easy to account for some sources of correlation which are not found in other packages. The user-friendly web-based GUI makes some swCRTdesign features accessible to researchers not familiar with $\mathsf{R}$. These two resources will make appropriately complex SWT calculations more accessible to scientists from a wide variety of backgrounds.

中文翻译：

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swCRTdesign：用于阶梯式楔形试验设计和分析的 R 软件包。

背景和目标

阶梯楔形试验 (SWT) 是一种集群随机试验，通常用于评估医疗保健干预措施。大多数与 SWT 相关的软件包对研究设计和数据的相关结构都有限制性的假设。本文的目的是提出一个软件包和相应的基于 Web 的图形用户界面 (GUI)，为研究人员提供另一种更灵活的 SWT 设计和分析选项。

方法

我们开发了一个$\mathsf{R}$软件包swCRTdesign（“阶梯楔形簇随机试验设计”），它使用随机效应模型来说明 SWT 设计引起的数据中的相关性。可能的相关性来源包括集群、集群内的时间和集群内的处理。

结果

swCRTdesign允许用户计算功率，模拟 SWT 数据以简化模拟研究（例如估算功率），并创建描述性摘要和绘图。此外，使用shiny开发的 GUI可用于计算功率并创建功率曲线和设计图。

结论

swCRTdesign包可容纳多种 SWT 设计，并且可以很容易地解释其他包中没有的一些相关性来源。用户友好的基于 Web 的 GUI 使不熟悉的研究人员可以访问一些swCRTdesign功能$\mathsf{R}$. 这两个资源将使来自不同背景的科学家更容易获得适当复杂的 SWT 计算。