阶梯式楔形群随机临床试验：方法概述。
Stepped Wedge Cluster Randomized Trials: A Methodological Overview.
机构信息
Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut, USA; Center for Methods in Implementation and Prevention Science, Yale University, New Haven, Connecticut, USA.
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
出版信息
World Neurosurg. 2022 May;161:323-330. doi: 10.1016/j.wneu.2021.10.136.
BACKGROUND
Stepped wedge cluster randomized trials enable rigorous evaluations of health intervention programs in pragmatic settings. In the present study, we aimed to update neurosurgeon scientists on the design of stepped wedge randomized trials.
METHODS
We have presented an overview of recent methodological developments for stepped wedge designs and included an update on the newer associated methodological tools to aid with future study designs.
RESULTS
We defined the stepped wedge trial design and reviewed the indications for the design in depth. In addition, key considerations, including mainstream methods of analysis and sample size determination, were discussed.
CONCLUSIONS
Stepped wedge designs can be attractive for study intervention programs aiming to improve the delivery of patient care, especially when examining a small number of heterogeneous clusters.
背景
阶梯式楔形群随机试验能够在实际环境中对卫生干预计划进行严格评估。在本研究中，我们旨在为神经外科科学家更新阶梯式楔形随机试验的设计。
方法
我们介绍了阶梯式设计的最新方法学进展，并更新了相关的新方法学工具，以帮助未来的研究设计。
结果
我们定义了阶梯式楔形试验设计，并深入审查了设计的适应证。此外，还讨论了关键的注意事项，包括主流的分析方法和样本量确定方法。
结论
阶梯式楔形设计对于旨在改善患者护理提供的研究干预计划可能具有吸引力，特别是在检查少数异质集群时。
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