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).

Checklist Consensus Delphi Technique Research Design Routinely Collected Health Data
clinical trials general medicine (see internal medicine) statistics & research methods

Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
29 04 2021
Historique:
entrez: 30 4 2021
pubmed: 1 5 2021
medline: 21 5 2021
Statut: epublish

Résumé

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.

Identifiants

DOI: 10.1136/bmjopen-2021-049093 PMID: 33926985 PMC: PMC8094349
pubmed: 33926985
pii: bmjopen-2021-049093
doi: 10.1136/bmjopen-2021-049093
pmc: PMC8094349
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e049093

Subventions

Organisme : CIHR
ID : PJT156172
Pays : Canada
Organisme : Wellcome Trust
ID : 205039/Z/16/Z
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/N008405/1
Pays : United Kingdom
Organisme : CIHR
Pays : Canada
Organisme : CIHR
ID : PCS-161863
Pays : Canada
Organisme : Wellcome Trust
Pays : United Kingdom

Informations de copyright

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Mahrukh Imran (M)

Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.

Linda Kwakkenbos (L)

Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, Netherlands.

Stephen J McCall (SJ)

National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Center for Research on Population and Health, Faculty of Health Sciences, American University of Beirut, Ras Beirut, Lebanon.
Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.

Kimberly A McCord (KA)

Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.

Ole Fröbert (O)

Faculty of Health, Department of Cardiology, Örebro University, Örebro, Sweden.
ORCID: 0000-0002-5846-345X

Lars G Hemkens (LG)

Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.

Merrick Zwarenstein (M)

Department of Family Medicine, Western University, London, Ontario, Canada.
IC/ES Western, London, Ontario, Canada.

Clare Relton (C)

Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, UK.

Danielle B Rice (DB)

Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.
Department of Psychology, McGill University, Montreal, Quebec, Canada.
ORCID: 0000-0001-5615-7005

Sinéad M Langan (SM)

Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
ORCID: 0000-0002-7022-7441

Eric I Benchimol (EI)

Department of Pediatrics and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
ICES uOttawa, Ottawa, Ontario, Canada.
Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada.

Lehana Thabane (L)

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

Marion K Campbell (MK)

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

Margaret Sampson (M)

Library Services, Children's Hospital of Eastern Ontario, Ontario, Ottawa, Canada.

David Erlinge (D)

Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.

Helena M Verkooijen (HM)

University Medical Center Utrecht, Utrecht, Netherlands.
University of Utrecht, Utrecht, Netherlands.

David Moher (D)

Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
ORCID: 0000-0003-2434-4206

Isabelle Boutron (I)

INSERM, Paris, France.
Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France.
Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.

Philippe Ravaud (P)

INSERM, Paris, France.
Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France.
Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.

Jon Nicholl (J)

School of Health and Related Research, University of Sheffield, Sheffield, UK.

Rudolf Uher (R)

Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada.

Maureen Sauvé (M)

Scleroderma Society of Ontario, Hamilton, Ontario, Canada.
Scleroderma Canada, Hamilton, Ontario, Canada.

John Fletcher (J)

British Medical Journal, London, UK.

David Torgerson (D)

York Trials Unit, Department of Health Sciences, University of York, York, UK.

Chris Gale (C)

Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.
ORCID: 0000-0003-0707-876X

Edmund Juszczak (E)

National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.

Brett D Thombs (BD)

Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada brett.thombs@mcgill.ca.
Departments of Psychiatry; Epidemiology, Biostatistics and Occupational Health; Medicine; and Educational and Counselling Psychology; and Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada.
ORCID: 0000-0002-5644-8432

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Classifications MeSH

questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Liste de contrôle › Methods and results used in the development of...
questionsmedicales.fr › Phénomènes psychologiques › Processus mentaux › Pensée (activité mentale) › Prise de décision › Consensus › Methods and results used in the development of...
questionsmedicales.fr › Sciences de l'information › Analyse des systèmes › Méthode Delphi › Methods and results used in the development of...
questionsmedicales.fr › Disciplines des sciences naturelles › Science › Recherche › Plan de recherche › Methods and results used in the development of...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Recherche sur les services de santé › Données de santé recueillies systématiquement › Methods and results used in the development of...