Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE)

Forskningsoutput: TidskriftsbidragArtikel i vetenskaplig tidskrift


Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist. The development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist. 27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report. Uptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using cohorts and routinely collected data.


  • Mahrukh Imran
  • Linda Kwakkenbos
  • 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
  • Lady Davis Institute for Medical Research
  • Radboud University Nijmegen
  • University of Oxford
  • American University of Beirut
  • University of Aberdeen
  • Örebro University
  • University of Western Ontario
  • Queen Mary University
  • McGill University
  • London School of Hygiene and Tropical Medicine
  • University of Ottawa
  • Children's Hospital of Eastern Ontario
  • McMaster University
  • University Medical Center Utrecht
  • Utrecht University
  • Ottawa Hospital Research Institute
  • Institut Gustave Roussy
  • Hopital Hotel-Dieu AP-H
  • Paris Diderot University
  • British Medical Journal
  • University of York
  • Imperial College London
  • University of Nottingham
  • University of Basel
  • University of Sheffield
  • Dalhousie University
  • Scleroderma Canada

Ämnesklassifikation (UKÄ) – OBLIGATORISK

  • Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi


TidskriftBMJ Open
Utgåva nummer4
StatusPublished - 2021 apr 29
Peer review utfördJa