McKenzie Joanne E, Taljaard Monica, Hemming Karla, Arnup Sarah J, Giraudeau Bruno, Eldridge Sandra, Hooper Richard, Kahan Brennan C, Li Tianjing, Moher David, Turner Elizabeth L, Grimshaw Jeremy M, Forbes Andrew B
Methods in Evidence Synthesis Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC 3004, Australia
Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
BMJ. 2025 Jan 6;388:e080472. doi: 10.1136/bmj-2024-080472.
This article presents the CONSORT (consolidated standards of reporting trials) extension for cluster randomised crossover trials. A cluster randomised crossover trial involves randomisation of groups of individuals (known as clusters) to different sequences of interventions over time. The design has gained popularity in settings where cluster randomisation is required because it can largely overcome the loss in power due to clustering in parallel cluster trials. However, the design has many methodological complexities, requiring tailored reporting guidance. The guideline was developed using a survey and in-person consensus meeting, informed by a systematic review examining the quality of reporting in cluster randomised crossover trials and relevant CONSORT statements for individual, crossover, cluster, and stepped wedge designs. This article also provides recommended reporting items, along with explanations and examples.
本文介绍了针对整群随机交叉试验的CONSORT（试验报告统一标准）扩展版。整群随机交叉试验涉及将个体组（称为群组）随机分配到不同时间顺序的干预措施中。由于在需要整群随机化的情况下，该设计能够很大程度上克服平行整群试验中因整群效应导致的效能损失，因此受到广泛应用。然而，该设计存在许多方法学上的复杂性，需要有针对性的报告指南。该指南是通过一项调查和面对面的共识会议制定的，参考了一项系统评价，该评价考察了整群随机交叉试验的报告质量以及针对个体、交叉、整群和阶梯楔形设计的相关CONSORT声明。本文还提供了推荐的报告项目以及解释和示例。
