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

doi:10.1136/bmj.k1614

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

Institute of Applied Health Sciences

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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 language	English
Article number	k1614
Journal	BMJ
Volume	363
DOIs	https://doi.org/10.1136/bmj.k1614
Publication status	Published - 9 Nov 2018

Bibliographical note

Acknowledgements
With acknowledgement to those who participated in the Delphi survey and Peter Chilton who provided administrative support.

Funding
This research was funded by the Australian National Health and Medical Research Council (NHMRC) project grant (1108283) and also partly funded by the UK NIHR Collaborations for Leadership in Applied Health Research and Care West Midlands initiative. Mary Dixon-Woods is funded by a Wellcome Trust Senior Investigator award WT097899. Jennifer A Thompson is funded by the Medical Research Council Network of Hubs for Trials Methodology Research (MR/L004933/1-P27). Jeremy Grimshaw holds a Canada Research Chair in Health Knowledge Transfer and Uptake. Charles Weijer holds a Canada Research Chair. Joanne E McKenzie holds an NHMRC Australian Public Health Fellowship (1072366). Karla Hemming holds an NIHR Senior Research Fellowship (SRF-2017-002).

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Reporting of stepped wedge cluster randomised trials
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Hemming, K., Taljaard, M., McKenzie, J. E., Hooper, R., Copas, A., Thompson, J. A., Dixon-Woods, M., Aldcroft, A., Doussau, A., Grayling, M., Kristunas, C., Goldstein, G. E., Campbell, M. K., Girling, A., Eldridge, S., Campbell, M. J., Lilford, R. J., Weijer, C., Forbes, A., & Grimshaw, J. M. (2018). Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ, 363, Article k1614. https://doi.org/10.1136/bmj.k1614

Hemming, K, Taljaard, M, McKenzie, JE, Hooper, R, Copas, A, Thompson, JA, Dixon-Woods, M, Aldcroft, A, Doussau, A, Grayling, M, Kristunas, C, Goldstein, GE, Campbell, MK, Girling, A, Eldridge, S, Campbell, MJ, Lilford, RJ, Weijer, C, Forbes, A & Grimshaw, JM 2018, 'Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration', BMJ, vol. 363, k1614. https://doi.org/10.1136/bmj.k1614

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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.",

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note = "Acknowledgements With acknowledgement to those who participated in the Delphi survey and Peter Chilton who provided administrative support. Funding This research was funded by the Australian National Health and Medical Research Council (NHMRC) project grant (1108283) and also partly funded by the UK NIHR Collaborations for Leadership in Applied Health Research and Care West Midlands initiative. Mary Dixon-Woods is funded by a Wellcome Trust Senior Investigator award WT097899. Jennifer A Thompson is funded by the Medical Research Council Network of Hubs for Trials Methodology Research (MR/L004933/1-P27). Jeremy Grimshaw holds a Canada Research Chair in Health Knowledge Transfer and Uptake. Charles Weijer holds a Canada Research Chair. Joanne E McKenzie holds an NHMRC Australian Public Health Fellowship (1072366). Karla Hemming holds an NIHR Senior Research Fellowship (SRF-2017-002).",

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N2 - 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.

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

Abstract

Bibliographical note

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