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.Well designed and conducted randomised controlled trials are the so called gold standard of healthcare intervention research.123 The use of reporting guidelines, including the Consolidated Standards of Reporting Trials (CONSORT) statement, improves the transparency and completeness of publications of the results of randomised controlled trials.4567 The CONSORT 2010 statement facilitates critical appraisal and interpretation of randomised controlled trials by providing guidance to authors on a minimum set of items that should be reported for all …
| Original language | English |
|---|---|
| Article number | n857 |
| Number of pages | 20 |
| Journal | BMJ |
| Volume | 373 |
| DOIs | |
| Publication status | Published - 29 Apr 2021 |
Bibliographical note
Funding: The development of the CONSORT extension for randomised controlled trials conducted using cohorts and routinely collecteddata (CONSORT-ROUTINE) was funded by grants from the Canadian Institutes of Health Research (PI BDT, Co-Is OF, CR, LK, and EJ, No PJT-156172; PI BDT, Co-I LK, No PCS-161863) and from the United Kingdom National Institute of Health Research (NIHR) Clinical Trials on 4 May 2021 at University of Aberdeen. Protected by copyright. http://www.bmj.com/ BMJ: first published as 10.1136/bmj.n857 on 29 April 2021. Downloaded from Research Methods and Reporting
the bmj | BMJ 2021;373:n857 | doi: 10.1136/bmj.n857 19 Unit Support Funding (PI EJ, Co-PI CG, supported salary of SJM). The
views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care.
DBR was supported by a Vanier CIHR Graduate Scholarship. SML was supported by a Wellcome Senior Clinical Fellowship in Science
(205039/Z/16/Z). EIB was supported by a New Investigator Award from the Canadian Institutes of Health Research, Canadian Association
of Gastroenterology, and Crohn’s and Colitis Canada. He was also supported by the Career Enhancement Program of the Canadian Child
Health Clinician Scientist Program. DM was supported by a University Research Chair (uOttawa). RU was supported by the Canada Research Chairs Program (Award No 231397). CG was supported by the UK Medical Research Council through a Clinician Scientist Fellowship. BDT
was supported by a Tier 1 Canada Research Chair.