Journal article
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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 857.6KB, Terms of use)
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- Publisher copy:
- 10.1136/bmj.n857
Authors
- Publisher:
- BMJ Publishing Group
- Journal:
- BMJ More from this journal
- Volume:
- 373
- Article number:
- 857
- Publication date:
- 2021-04-29
- Acceptance date:
- 2021-03-29
- DOI:
- EISSN:
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0959-8138
- ISSN:
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1759-2151
- Language:
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English
- Keywords:
- Pubs id:
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1174365
- Local pid:
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pubs:1174365
- Deposit date:
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2021-05-06
- ARK identifier:
Terms of use
- Copyright holder:
- L Kwakkenbos et al.
- Copyright date:
- 2021
- Rights statement:
- This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.
- Licence:
- CC Attribution (CC BY)
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