CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): Checklist with explanation and elaboration

Linda Kwakkenbos; Mahrukh Imran; Stephen J. McCall; Kimberly A. McCord; Ole Fröbert; Lars G. Hemkens; Merrick Zwarenstein; Clare Relton; Danielle B. Rice; Sinéad M. Langan; Eric I. Benchimol; Lehana Thabane; Marion K. Campbell; Margaret Sampson; David Erlinge; Helena M. Verkooijen; David Moher; Isabelle Boutron; Philippe Ravaud; Jon Nicholl; Rudolf Uher; Maureen Sauvé; John Fletcher; David Torgerson; Chris Gale; Edmund Juszczak; Brett D. Thombs

doi:10.1136/bmj.n857

CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): Checklist with explanation and elaboration

Linda Kwakkenbos, Mahrukh Imran, Stephen J. McCall, Kimberly A. McCord, Ole Fröbert, Lars G. Hemkens, Merrick Zwarenstein, Clare Relton, Danielle B. Rice, Sinéad M. Langan, Eric I. Benchimol, Lehana Thabane, Marion K. Campbell, Margaret Sampson, David Erlinge, Helena M. Verkooijen, David Moher, Isabelle Boutron, Philippe Ravaud, Jon NichollRudolf Uher, Maureen Sauvé, John Fletcher, David Torgerson, Chris Gale, Edmund Juszczak, Brett D. Thombs^*

^*Corresponding author for this work

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

81 Citations (Scopus)

Abstract

Randomised controlled trials are increasingly conducted as embedded, nested, or using cohorts or routinely collected data, including registries, electronic health records, and administrative databases, to assess if participants are eligible for the trial and to facilitate recruitment, to deliver an embedded intervention, to collect trial outcome data, or a combination of these purposes. This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE). The extension was developed to look at the unique characteristics of trials conducted with these types of data with the goal of improving reporting quality in the long term by setting standards early in the process of uptake of these trial designs. The extension was developed with a sequential approach, including a Delphi survey, a consensus meeting, and piloting of the checklist. The checklist was informed by the CONSORT 2010 statement and two reporting guidelines for observational studies, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement and the REporting of studies Conducted using Observational Routinely collected Data (RECORD) statement. The extension includes eight items modified from the CONSORT 2010 statement and five new items. Reporting items with explanations and examples are provided, including key aspects of trials conducted using cohorts or routinely collected data that require specific reporting considerations.

Original language	English
Article number	n857
Journal	The BMJ
Volume	373
ISSN	0959-8146
DOIs	https://doi.org/10.1136/bmj.n857
Publication status	Published - 29 Apr 2021
Externally published	Yes

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Kwakkenbos, L., Imran, M., McCall, S. J., McCord, K. A., Fröbert, O., Hemkens, L. G., Zwarenstein, M., Relton, C., Rice, D. B., Langan, S. M., Benchimol, E. I., Thabane, L., Campbell, M. K., Sampson, M., Erlinge, D., Verkooijen, H. M., Moher, D., Boutron, I., Ravaud, P., ... Thombs, B. D. (2021). CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): Checklist with explanation and elaboration. The BMJ, 373, Article n857. https://doi.org/10.1136/bmj.n857

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title = "CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): Checklist with explanation and elaboration",

abstract = "Randomised controlled trials are increasingly conducted as embedded, nested, or using cohorts or routinely collected data, including registries, electronic health records, and administrative databases, to assess if participants are eligible for the trial and to facilitate recruitment, to deliver an embedded intervention, to collect trial outcome data, or a combination of these purposes. This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE). The extension was developed to look at the unique characteristics of trials conducted with these types of data with the goal of improving reporting quality in the long term by setting standards early in the process of uptake of these trial designs. The extension was developed with a sequential approach, including a Delphi survey, a consensus meeting, and piloting of the checklist. The checklist was informed by the CONSORT 2010 statement and two reporting guidelines for observational studies, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement and the REporting of studies Conducted using Observational Routinely collected Data (RECORD) statement. The extension includes eight items modified from the CONSORT 2010 statement and five new items. Reporting items with explanations and examples are provided, including key aspects of trials conducted using cohorts or routinely collected data that require specific reporting considerations.",

author = "Linda Kwakkenbos and Mahrukh Imran and McCall, {Stephen J.} and McCord, {Kimberly A.} and Ole Fr{\"o}bert and Hemkens, {Lars G.} and Merrick Zwarenstein and Clare Relton and Rice, {Danielle B.} and Langan, {Sin{\'e}ad M.} and Benchimol, {Eric I.} and Lehana Thabane and Campbell, {Marion K.} and Margaret Sampson and David Erlinge and Verkooijen, {Helena M.} and David Moher and Isabelle Boutron and Philippe Ravaud and Jon Nicholl and Rudolf Uher and Maureen Sauv{\'e} and John Fletcher and David Torgerson and Chris Gale and Edmund Juszczak and Thombs, {Brett D.}",

note = "Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2021",

month = apr,

day = "29",

doi = "10.1136/bmj.n857",

language = "English",

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Kwakkenbos, L, Imran, M, McCall, SJ, McCord, KA, Fröbert, O, Hemkens, LG, Zwarenstein, M, Relton, C, Rice, DB, Langan, SM, Benchimol, EI, Thabane, L, Campbell, MK, Sampson, M, Erlinge, D, Verkooijen, HM, Moher, D, Boutron, I, Ravaud, P, Nicholl, J, Uher, R, Sauvé, M, Fletcher, J, Torgerson, D, Gale, C, Juszczak, E & Thombs, BD 2021, 'CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): Checklist with explanation and elaboration', The BMJ, vol. 373, n857. https://doi.org/10.1136/bmj.n857

CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): Checklist with explanation and elaboration. / Kwakkenbos, Linda; Imran, Mahrukh; McCall, Stephen J. et al.
In: The BMJ, Vol. 373, n857, 29.04.2021.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

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T2 - Checklist with explanation and elaboration

AU - Kwakkenbos, Linda

AU - Imran, Mahrukh

AU - McCall, Stephen J.

AU - McCord, Kimberly A.

AU - Fröbert, Ole

AU - Hemkens, Lars G.

AU - Zwarenstein, Merrick

AU - Relton, Clare

AU - Rice, Danielle B.

AU - Langan, Sinéad M.

AU - Benchimol, Eric I.

AU - Thabane, Lehana

AU - Campbell, Marion K.

AU - Sampson, Margaret

AU - Erlinge, David

AU - Verkooijen, Helena M.

AU - Moher, David

AU - Boutron, Isabelle

AU - Ravaud, Philippe

AU - Nicholl, Jon

AU - Uher, Rudolf

AU - Sauvé, Maureen

AU - Fletcher, John

AU - Torgerson, David

AU - Gale, Chris

AU - Juszczak, Edmund

AU - Thombs, Brett D.

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U2 - 10.1136/bmj.n857

DO - 10.1136/bmj.n857

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SN - 0959-8146

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JO - The BMJ

JF - The BMJ

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ER -

CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): Checklist with explanation and elaboration

Abstract

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