@article{Imran:2021:10.1136/bmjopen-2021-049093,
author = {Imran, M and Kwakkenbos, L and McCall, SJ and McCord, KA and Frobert, O and Hemkens, LG and Zwarenstein, M and Relton, C and Rice, DB and Langan, SM and Benchimol, E and Thabane, L and Campbell, MK and Sampson, M and Erlinge, D and Verkooijen, HM and Moher, D and Boutron, I and Ravaud, P and Nicholl, J and Uher, R and Sauve, M and Fletcher, J and Torgerson, D and Gale, C and Juszczak, E and Thombs, BD},
doi = {10.1136/bmjopen-2021-049093},
journal = {BMJ Open},
title = {Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE)},
url = {http://dx.doi.org/10.1136/bmjopen-2021-049093},
volume = {11},
year = {2021}
}

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TY  - JOUR
AB  - Objectives: Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist.Methods: The development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist.Results: 27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report.Conclusion: Uptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using coh
AU  - Imran,M
AU  - Kwakkenbos,L
AU  - McCall,SJ
AU  - McCord,KA
AU  - Frobert,O
AU  - Hemkens,LG
AU  - Zwarenstein,M
AU  - Relton,C
AU  - Rice,DB
AU  - Langan,SM
AU  - Benchimol,E
AU  - Thabane,L
AU  - Campbell,MK
AU  - Sampson,M
AU  - Erlinge,D
AU  - Verkooijen,HM
AU  - Moher,D
AU  - Boutron,I
AU  - Ravaud,P
AU  - Nicholl,J
AU  - Uher,R
AU  - Sauve,M
AU  - Fletcher,J
AU  - Torgerson,D
AU  - Gale,C
AU  - Juszczak,E
AU  - Thombs,BD
DO  - 10.1136/bmjopen-2021-049093
PY  - 2021///
SN  - 2044-6055
TI  - Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE)
T2  - BMJ Open
UR  - http://dx.doi.org/10.1136/bmjopen-2021-049093
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000653854500001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - http://hdl.handle.net/10044/1/89412
VL  - 11
ER  - 

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