Introducing the CONsolidated Standards of Reporting Trials (CONSORT) statement for randomised controlled trials (RCTs) using cohorts and routinely collected health dataBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Depts of Family Medicine and Epidemiology/Biostatistics, Western University, London, Canada.
Pragmatic Clinical Trials Unit, Queen Mary University of London, London, United Kingdom.
CHEO, Ottawa, Canada.
Biostatistics Unit (St Joseph's Healthcare)/FSORC, Hamilton, Canada.
Department of Pediatrics and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
University of Aberdeen, Aberdeen, United Kingdom.
University of York, York, United Kingdom.
Department of Cardiology, Lund University, Skane University Hospital, Lund, Sweden.
McGill University, Montreal, Canada.
London School of Hygiene and Tropical Medicine, London, United Kingdom.
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
University of Manchester, Manchester, United Kingdom.
Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
University Medical Center Utrecht, Utrecht, the Netherlands.
Dalhousie Unversity, Department of Psychiatry, Halifax, Canada.
Scleroderma Canada, Hamilton, Canada.
Université de Paris, Paris, France.
Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS-UMR1153), Paris, France.
Lady Davis Institue for Medical Research, Jewish General Hospital, Montreal, Canada.
Imperial College London, London, United Kingdom.
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2019 (English)In: Trials, E-ISSN 1745-6215, Vol. 20, no Suppl. 1, p. 131-131, article id PS9A - O4
Article in journal, Meeting abstract (Other academic) Published
Abstract [en]
Background: Randomised controlled trials (RCTs) are increasingly being conducted using existing sources of data, such as cohorts, administrative databases, disease registries and electronic health records. RCTs conducted using existing data sources require additional information to be reported. This reporting guideline is an extension of the 2010 version of the Consolidated Standards of Reporting Trials (CONSORT) Statement for RCTs using cohorts and routinely collected health data.
Methods: A long-list of potential items for the checklist was identified through two methods: firstly, modifications to the current CONSORT checklist were generated using existing reporting guidelines, including the Reporting of Observational Studies in Epidemiology (STROBE) and REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Secondly, ascoping review of RCTs conducted in the last decade using cohorts and routinely collected health data facilitated the modification and identification of other potential items. Using the long-list, a three-stage Delphi exercise was conducted to assess the importance of each item for inclusion in the final extension checklist, which was finalised at a face-to-face meeting of experts.
Results: A long-list of 27 items was created and 125 experts registered for the three-round Delphi exercise (92, 77 and 62 experts participated in each round respectively). Consensus was reached on 21 out of 27 items. The results of the Delphi exercise informed a face-to-face consensus meeting in May 2019; core items to be included in the extension checklist were finalised at this meeting. Corresponding explanations of extensions and new items with examples of good reporting were developed subsequently.
Conclusion: The guideline checklist can facilitate transparent reporting of RCTs using cohorts and routinely collected health data, to assist evaluations of rigour and reproducibility, enhance understanding of the methodology, and make the results more useful for clinicians, journal editors, reviewers, guideline authors, and funders.
Place, publisher, year, edition, pages
BMC , 2019. Vol. 20, no Suppl. 1, p. 131-131, article id PS9A - O4
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
URN: urn:nbn:se:oru:diva-77762ISI: 000491426300397OAI: oai:DiVA.org:oru-77762DiVA, id: diva2:1367947
Conference
5th International Clinical Trials Methodology Conference (ICTMC 2019), Brighton, UK, October 6-9, 2019
2019-11-052019-11-052024-01-17Bibliographically approved