CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): Checklist with explanation and elaboration

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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.


  • 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
  • Helena M. Verkooijen
  • David Moher
  • Isabelle Boutron
  • Philippe Ravaud
  • Jon Nicholl
  • Rudolf Uher
  • Maureen Sauvé
  • John Fletcher
  • David Torgerson
  • Chris Gale
  • Edmund Juszczak
  • Brett D. Thombs
Enheter & grupper
Externa organisationer
  • Radboud University Nijmegen
  • Lady Davis Institute for Medical Research
  • University of Oxford
  • American University of Beirut
  • Stanford University
  • Berlin Institute of Health (BIH)
  • University of Western Ontario
  • Institute for Clinical Evaluative Sciences (ICES)
  • Queen Mary University
  • McGill University
  • London School of Hygiene and Tropical Medicine
  • University of Toronto
  • SickKids Research Institute
  • McMaster University
  • Children's Hospital of Eastern Ontario
  • University Medical Center Utrecht
  • Utrecht University
  • Ottawa Hospital Research Institute
  • Centre of Epidemiology And Biostatistics Sorbonne Paris Cité Center (CRESS)
  • Assistance Publique des Hôpitaux de Paris
  • University of York
  • Imperial College London
  • University of Nottingham
  • University of Basel
  • Örebro University
  • University of Aberdeen
  • University of Sheffield
  • Dalhousie University
  • Scleroderma Canada
  • British Medical Journal

Ämnesklassifikation (UKÄ) – OBLIGATORISK

  • Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi
TidskriftThe BMJ
StatusPublished - 2021 apr 29
Peer review utfördJa