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)Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Department of Family Medicine, Western University, London, Ontario, Canada; IC/ES Western, London, Ontario, Canada.
Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, UK.
Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada.
Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
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.
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Library Services, Children's Hospital of Eastern Ontario, Ontario, Ottawa, Canada.
Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
University Medical Center Utrecht, Utrecht, Netherlands; University of Utrecht, Utrecht, Netherlands.
Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
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.
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.
School of Health and Related Research, University of Sheffield, Sheffield, UK.
Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada.
Scleroderma Society of Ontario, Hamilton, Ontario, Canada; Scleroderma Canada, Hamilton, Ontario, Canada.
British Medical Journal, London, UK.
York Trials Unit, Department of Health Sciences, University of York, York, UK.
Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.
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.
Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada; Departments of Psychiatry, Epidemiology, Biostatistics and Occupational Health, Medicine and Educational and Counselling Psychology and Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada.
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2021 (English)In: BMJ Open, E-ISSN 2044-6055, Vol. 11, no 4, article id e049093
Article in journal (Refereed) Published
Abstract [en]
OBJECTIVES: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2021. Vol. 11, no 4, article id e049093
Keywords [en]
Clinical trials, general medicine (see internal medicine), statistics & research methods
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
URN: urn:nbn:se:oru:diva-91650DOI: 10.1136/bmjopen-2021-049093ISI: 000653854500001PubMedID: 33926985Scopus ID: 2-s2.0-85105164105OAI: oai:DiVA.org:oru-91650DiVA, id: diva2:1553089
Note
Funding Agencies:
Canadian Institutes of Health Research (CIHR) PJT156172 PCS-161863
National Institute for Health Research (NIHR)
Canadian Institutes of Health Research (CIHR)
Wellcome Senior Clinical Fellowship in Science 205039/Z/16/Z
Canadian Institutes of Health Research (CIHR)
Canadian Association of Gastroenterology and Crohn's and Colitis Canada
Career Enhancement Program of the Canadian Child Health Clinician Scientist Program
Canada Research Chairs 231397
UK Medical Research Council through a Clinician Scientist Fellowship
2021-05-072021-05-072024-01-16Bibliographically approved