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

Karla Hemming, Monica Taljaard, Joanne E McKenzie, Richard Hooper, Andrew Copas, Jennifer A Thompson, Mary Dixon-Woods, Adrian Aldcroft, Adelaide Doussau, Michael Grayling, Caroline Kristunas, Cory E Goldstein, Marion K Campbell, Alan Girling, Sandra Eldridge, Mike J Campbell, Richard J Lilford, Charles Weijer, Andrew B Forbes, Jeremy M Grimshaw, Karla Hemming, Monica Taljaard, Joanne E McKenzie, Richard Hooper, Andrew Copas, Jennifer A Thompson, Mary Dixon-Woods, Adrian Aldcroft, Adelaide Doussau, Michael Grayling, Caroline Kristunas, Cory E Goldstein, Marion K Campbell, Alan Girling, Sandra Eldridge, Mike J Campbell, Richard J Lilford, Charles Weijer, Andrew B Forbes, Jeremy M Grimshaw

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.

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

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