Reporting of cluster randomised crossover trials: extension of the CONSORT 2010 statement with explanation and elaboration.
other · Level V
Where this comes from
- Record sourced from PubMed, PMID 39761979.
- Also identified by DOI 10.1136/bmj-2024-080472 and PMC identifier 11701780.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
Abstract
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.