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

Research output: Contribution to journal › Article

26 Citations (Scopus)

3 Downloads (Pure)

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

Fingerprint

Cite this

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

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

In: BMJ, Vol. 363, k1614, 09.11.2018.

Research output: Contribution to journal › Article

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

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. / Reporting of stepped wedge cluster randomised trials : extension of the CONSORT 2010 statement with explanation and elaboration. In: BMJ. 2018 ; Vol. 363.

@article{9e5aadb5e6354102bcba11998a68c467,

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

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.",

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

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).",

year = "2018",

month = "11",

day = "9",

doi = "10.1136/bmj.k1614",

language = "English",

volume = "363",

journal = "BMJ",

issn = "0959-8146",

publisher = "BMJ Publishing Group",

}

TY - JOUR

T1 - Reporting of stepped wedge cluster randomised trials

T2 - extension of the CONSORT 2010 statement with explanation and elaboration

AU - Hemming, K.

AU - Taljaard, M.

AU - McKenzie, J. E.

AU - Hooper, R.

AU - Copas, A.

AU - Thompson, J. A.

AU - Dixon-Woods, M.

AU - Aldcroft, A.

AU - Doussau, A.

AU - Grayling, M.

AU - Kristunas, C.

AU - Goldstein, G. E.

AU - Campbell, M. K.

AU - Girling, A.

AU - Eldridge, S.

AU - Campbell, M. J.

AU - Lilford, R. J.

AU - Weijer, C.

AU - Forbes, A.

AU - Grimshaw, J. M.

N1 - 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).

PY - 2018/11/9

Y1 - 2018/11/9

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.

AB - 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.

U2 - 10.1136/bmj.k1614

DO - 10.1136/bmj.k1614

M3 - Article

C2 - 30413417

VL - 363

JO - BMJ

JF - BMJ

SN - 0959-8146

M1 - k1614

ER -

Access to Document

10.1136/bmj.k1614Licence: CC BY-NC

Reporting of stepped wedge cluster randomised trials
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Final published version, 681 KBLicence: CC BY-NC