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

Karla Hemming¹, Monica Taljaard^{2

3}, Joanne E McKenzie⁴, Richard Hooper⁵, Andrew Copas⁶, Jennifer A Thompson^{6

7}, Mary Dixon-Woods⁸, Adrian Aldcroft⁹, Adelaide Doussau¹⁰, Michael Grayling¹¹, Caroline Kristunas¹², Cory E Goldstein¹³, Marion K Campbell¹⁴, Alan Girling¹⁵, Sandra Eldridge⁵, Mike J Campbell¹⁶, Richard J Lilford¹⁷, Charles Weijer¹³, Andrew B Forbes⁴, Jeremy M Grimshaw^{2

3

18}

Affiliations

¹ Institute of Applied Health Research, University of Birmingham, Birmingham B15 2TT, UK k.hemming@bham.ac.uk.
² Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
³ School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
⁴ School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
⁵ Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
⁶ London Hub for Trials Methodology Research, MRC Clinical Trials Unit at University College London, London, UK.
⁷ Department for Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
⁸ The Healthcare Improvement Studies Institute, University of Cambridge, Cambridge Biomedical Campus, Cambridge, UK.
⁹ BMJ Open, BMJ Publishing Group, London, UK.
¹⁰ Biomedical Ethics Unit, McGill University School of Medicine, Montreal, QC, Canada.
¹¹ MRC Biostatistics Unit, Cambridge, UK.
¹² Department of Health Sciences, University of Leicester, Leicester, UK.
¹³ Rotman Institute of Philosophy, Western University, London, ON, Canada.
¹⁴ Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
¹⁵ Institute of Applied Health Research, University of Birmingham, Birmingham B15 2TT, UK.
¹⁶ ScHARR, University of Sheffield, Sheffield, UK.
¹⁷ University of Warwick, Coventry, UK.
¹⁸ Department of Medicine, University of Ottawa, Ottawa, ON, Canada.

PMID: 30413417
PMCID: PMC6225589
DOI: 10.1136/bmj.k1614

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

Karla Hemming et al. BMJ. 2018.

. 2018 Nov 9:363:k1614.

doi: 10.1136/bmj.k1614.

Authors

Affiliations

¹ Institute of Applied Health Research, University of Birmingham, Birmingham B15 2TT, UK k.hemming@bham.ac.uk.
² Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
³ School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
⁴ School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
⁵ Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
⁶ London Hub for Trials Methodology Research, MRC Clinical Trials Unit at University College London, London, UK.
⁷ Department for Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
⁸ The Healthcare Improvement Studies Institute, University of Cambridge, Cambridge Biomedical Campus, Cambridge, UK.
⁹ BMJ Open, BMJ Publishing Group, London, UK.
¹⁰ Biomedical Ethics Unit, McGill University School of Medicine, Montreal, QC, Canada.
¹¹ MRC Biostatistics Unit, Cambridge, UK.
¹² Department of Health Sciences, University of Leicester, Leicester, UK.
¹³ Rotman Institute of Philosophy, Western University, London, ON, Canada.
¹⁴ Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
¹⁵ Institute of Applied Health Research, University of Birmingham, Birmingham B15 2TT, UK.
¹⁶ ScHARR, University of Sheffield, Sheffield, UK.
¹⁷ University of Warwick, Coventry, UK.
¹⁸ Department of Medicine, University of Ottawa, Ottawa, ON, Canada.

PMID: 30413417
PMCID: PMC6225589
DOI: 10.1136/bmj.k1614

Abstract

This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for the stepped wedge cluster randomised trial (SW-CRT). The SW-CRT involves randomisation of clusters to different sequences that dictate the order (or timing) at which each cluster will switch to the intervention condition. The statement was developed to allow for the unique characteristics of this increasingly used study design. The guideline was developed using a Delphi survey and consensus meeting; and is informed by the CONSORT statements for individual and cluster randomised trials. Reporting items along with explanations and examples are provided. We include a glossary of terms, and explore the key properties of the SW-CRT which require special consideration in their reporting.

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Conflict of interest statement

Competing interests: We have read and understood the BMJ Group policy on declaration of interests and declare the following interests: none. Provenance and peer review: Not commissioned; externally peer reviewed.

Figures

**Fig 1**
Diagram of the standard stepped wedge cluster randomised trial. Note that in designs where participants are measured after a follow-up time from their exposure, then the periods and their representations are defined based on when an individual was exposed and not when measured

**Fig 2**
Example of a diagram of a stepped wedge cluster randomised trial (SW-CRT) from the Riverbank Filtration Trial. Adapted from figure 2 in McGuinness SL, O’Toole JE, Boving TB, et al. Protocol for a cluster randomised stepped wedge trial assessing the impact of a community-level hygiene intervention and a water intervention using riverbank filtration technology on diarrhoeal prevalence in India. *BMJ Open* 2017;7:e015036. doi:10.1136/bmjopen-2016-015036. PubMed PMID:28314746; PubMed Central PMCID:PMC5372111.

**Fig 3**
Specimen flowchart for a stepped wedge cluster randomised trial (SW-CRT) by allocated sequence and period

See this image and copyright information in PMC

References

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 - PubMed
1. Rennie D. CONSORT revised--improving the reporting of randomized trials. JAMA 2001;285:2006-7. 10.1001/jama.285.15.2006 - DOI - PubMed
1. Schulz KF, Altman DG, Moher D, CONSORT Group CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332. 10.1136/bmj.c332 - DOI - PMC - PubMed
1. Campbell MK, Elbourne DR, Altman DG, CONSORT group CONSORT statement: extension to cluster randomised trials. BMJ 2004;328:702-8. 10.1136/bmj.328.7441.702 - 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 stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Research Materials