@article{Kwakkenbos:2021:10.1136/bmj.n857,
author = {Kwakkenbos, L and Imran, M and McCall, SJ and Mc, Cord KA and Frobert, O and Hemkens, LG and Zwarenstein, M and Relton, C and Rice, DB and Langan, SM and Benchimol, EI 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 Flectcher, J and Torgerson, D and Gale, C and Jusczcak, E and Thombs, BD},
doi = {10.1136/bmj.n857},
journal = {BMJ: British Medical Journal},
title = {CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration},
url = {http://dx.doi.org/10.1136/bmj.n857},
volume = {373},
year = {2021}
}

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TY  - JOUR
AB  - 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.
AU  - Kwakkenbos,L
AU  - Imran,M
AU  - McCall,SJ
AU  - Mc,Cord KA
AU  - Frobert,O
AU  - Hemkens,LG
AU  - Zwarenstein,M
AU  - Relton,C
AU  - Rice,DB
AU  - Langan,SM
AU  - Benchimol,EI
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  - Flectcher,J
AU  - Torgerson,D
AU  - Gale,C
AU  - Jusczcak,E
AU  - Thombs,BD
DO  - 10.1136/bmj.n857
PY  - 2021///
SN  - 0959-535X
TI  - CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration
T2  - BMJ: British Medical Journal
UR  - http://dx.doi.org/10.1136/bmj.n857
UR  - http://hdl.handle.net/10044/1/89183
VL  - 373
ER  - 

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