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

K. Hemming, M. Taljaard, J. E. McKenzie, R. Hooper, A. Copas, J. A. Thompson, M. Dixon-Woods, A. Aldcroft, A. Doussau, M. Grayling, C. Kristunas, G. E. Goldstein, M. K. Campbell, A. Girling, S. Eldridge, M. J. Campbell, R. J. Lilford, C. Weijer, A. Forbes, J. M. Grimshaw

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Abstract

This document 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 development of this statement was motivated by the unique design characteristics of this study design, including the need to allow for time effects and because the design is increasingly being used. The guideline was developed using a Delphi survey and consensus meeting; and is informed by the CONSORT statements for individually 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.
Original languageEnglish
Article numberk1614
JournalBMJ
Volume363
DOIs
Publication statusPublished - 9 Nov 2018

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Hemming, K., Taljaard, M., McKenzie, J. E., Hooper, R., Copas, A., Thompson, J. A., ... Grimshaw, J. M. (2018). Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ, 363, [k1614]. https://doi.org/10.1136/bmj.k1614