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 journalArticlepeer-review

3 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.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 languageEnglish
Article numbern857
Number of pages20
JournalBMJ
Volume373
DOIs
Publication statusPublished - 29 Apr 2021

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