Reporting of cluster randomised crossover trials: extension of the CONSORT 2010 statement with explanation and elaboration

Joanne E McKenzie¹, Monica Taljaard^{2

3}, Karla Hemming⁴, Sarah J Arnup⁵, Bruno Giraudeau^{6

7}, Sandra Eldridge⁸, Richard Hooper⁸, Brennan C Kahan⁹, Tianjing Li¹⁰, David Moher^{3

11}, Elizabeth L Turner^{12

13}, Jeremy M Grimshaw^{2

3

14}, Andrew B Forbes¹⁵

Affiliations

"V体育官网入口" Affiliations

¹ Methods in Evidence Synthesis Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC 3004, Australia joanne.mckenzie@qiuluzeuv.cn.
² Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
³ School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
⁴ Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
⁵ Methods in Evidence Synthesis Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC 3004, Australia.
⁶ University of Tours, University of Nantes, INSERM SPHERE U1246, Tours, France.
⁷ INSERM CIC, CHRU de Tours, Tours, France.
⁸ Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
⁹ MRC Clinical Trials Unit at University College London, London, UK.
¹⁰ Department of Ophthalmology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
¹¹ Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
¹² Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.
¹³ Duke Global Health Institute, Duke University, Durham, NC, USA.
¹⁴ Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
¹⁵ Biostatistics Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.

Reporting of cluster randomised crossover trials: extension of the CONSORT 2010 statement with explanation and elaboration

"VSports最新版本" Joanne E McKenzie et al. BMJ. 2025.

. 2025 Jan 6:388:e080472.

doi: 10.1136/bmj-2024-080472.

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Affiliations

¹ Methods in Evidence Synthesis Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC 3004, Australia joanne.mckenzie@qiuluzeuv.cn.
² Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
³ School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
⁴ Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
⁵ Methods in Evidence Synthesis Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC 3004, Australia.
⁶ University of Tours, University of Nantes, INSERM SPHERE U1246, Tours, France.
⁷ INSERM CIC, CHRU de Tours, Tours, France.
⁸ Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
⁹ MRC Clinical Trials Unit at University College London, London, UK.
¹⁰ Department of Ophthalmology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
¹¹ Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
¹² Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.
¹³ Duke Global Health Institute, Duke University, Durham, NC, USA.
¹⁴ Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
¹⁵ Biostatistics Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.

PMID: 39761979
PMCID: PMC11701780
DOI: 10.1136/bmj-2024-080472 (VSports)

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. VSports手机版.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www. icmje. org/disclosure-of-interest/ and declare: support for the consensus meeting and for some authors from research funding organisations in the funding statement above; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work V体育安卓版.

Figures

**Fig 1**
Three different designs for cluster randomised crossover trials. Large boxes represent clusters (or groups of clusters), with different colours representing different treatments. Internal boxes represent participants, with changes in grey shading from period to period representing different participants across periods (ie, cross sectional design). (A) Standard cross sectional design (indicated by different grey shading of internal boxes across periods) with two treatments, two periods, two sequences (AB, BA). (B) Standard cohort design (indicated by the same grey shading of internal boxes across periods) with two treatments, two periods, two sequences (AB, BA). (C) Cross sectional design with two treatments, four periods, two sequences (ABAB, BABA)

**Fig 2**
Summary of five step process used to develop the CONSORT CRXO extension for cluster randomised crossover trials (CRXO). Further details are available in supplementary materials 1

**Fig 3**
Diagram of the realised design from the MedBridge trial. AIM=acute internal medicine; ASN=acute stroke and neurology; DN=diabetes and nephrology; IM=internal medicine. Adapted from reference 28 with permission

**Fig 4**
Example of dates of treatment periods and washout periods for each cluster in a cluster randomised crossover trial. Adapted from reference 26 with permission from Elsevier. *Two university hospitals and two non-university hospitals were additionally recruited in 2012. †One non-university hospital withdrew at time of crossover to second study period. ‡Two non-university hospitals, randomised to sequence multiple bed room/single bed room, withdrew after randomisation

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References

1. Goodman SN, Fanelli D, Ioannidis JP. What does research reproducibility mean? Sci Transl Med 2016;8:341ps12. 10.1126/scitranslmed.aaf5027 - DOI - PubMed
1. Begg C, Cho M, Eastwood S, et al. . Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996;276:637-9. 10.1001/jama.1996.03540080059030 - DOI (V体育平台登录) - PubMed
1. Moher D, Hopewell S, Schulz KF, et al. . CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869. 10.1136/bmj.c869 - DOI - PMC - PubMed
1. Dwan K, Li T, Altman DG, Elbourne D. CONSORT 2010 statement: extension to randomised crossover trials. BMJ 2019;366:l4378. 10.1136/bmj.l4378 - "VSports手机版" DOI - PMC - PubMed
1. Campbell MK, Piaggio G, Elbourne DR, Altman DG, CONSORT Group . Consort 2010 statement: extension to cluster randomised trials. BMJ 2012;345:e5661. 10.1136/bmj.e5661 - DOI - PubMed

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Reporting of cluster randomised crossover trials: extension of the CONSORT 2010 statement with explanation and elaboration

"V体育官网入口" Affiliations

Reporting of cluster randomised crossover trials: extension of the CONSORT 2010 statement with explanation and elaboration

V体育安卓版 - Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

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