Paper II: Thematic framework analysis of registry-based randomized controlled trials provided insights for designing trial ready registriesChild Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Peter Gilgan Centre for Research and Learning, 686 Bay Street, Toronto, Ontario, Canada M5G 0A4.
Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Peter Gilgan Centre for Research and Learning, 686 Bay Street, Toronto, Ontario, Canada M5G 0A4.
Lady Davis Institute for Medical Research, Jewish General Hospital, 3755 Chem. de la Côte-Sainte-Catherine, Montréal, Quebec, Canada H3T 1E2; Departments of Psychiatry; Epidemiology, Biostatistics, and Occupational Health; Medicine; Psychology; and Biomedical Ethics Unit, McGill University, 845 Sherbrooke St W, Montreal, Quebec, Canada H3A 0G4.
School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, Canada K1G 5Z3.
Department of Pediatrics, Faculty of Medicine and Health Sciences, McGill University, 3605 Rue de la Montagne, Montréal, Quebec, Canada H3G 2M1.
Department of Human Genetics, Faculty of Medicine and Health Sciences, McGill University, Canada H3G 1A4.
School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, Canada K1G 5Z3.
School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, Canada K1G 5Z3.
Cundill Centre for Child and Youth Depression, Centre for Addiction and Mental Health, 1000 Queen Street W, Toronto, Ontario, Canada M6J 1H4; Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Peter Gilgan Centre for Research and Learning, 686 Bay Street, Toronto, Ontario, Canada M5G 0A4; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, Ontario, Canada M5T 1R8.
Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Peter Gilgan Centre for Research and Learning, 686 Bay Street, Toronto, Ontario, Canada M5G 0A4; Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College St 4th Floor, Toronto, Ontario, Canada M5T 3M6; Division of Neonatology, The Hospital for Sick Children, University of Toronto, 555 University Avenue, Toronto, Ontario, Canada M5G 1X8.
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2023 (English)In: Journal of Clinical Epidemiology, ISSN 0895-4356, E-ISSN 1878-5921, Vol. 159, p. 330-343Article in journal (Refereed) Published
Abstract [en]
OBJECTIVE: Registry-based randomized controlled trials (RRCTs) are increasingly used, promising to address challenges associated with traditional RCTs. We identified strengths and limitations reported in planned and completed RRCTs to inform future RRCTs.
STUDY DESIGN AND SETTING: We conducted an environmental scan of literature discussing conceptual or methodological strengths and limitations of using registries for trial design and conduct (n=12), followed by an analysis of RRCT protocols (n=13) and reports (n=77) identified from a scoping review. Using framework analysis, we developed and refined a conceptual framework of RRCT-specific strengths and limitations. We mapped and interpreted strengths and limitations discussed by authors of RRCT articles using framework codes and quantified the frequencies at which these were mentioned.
RESULTS: Our conceptual framework identified six main RRCT strengths and four main RRCT limitations. Considering implications for RRCT conduct and design, we formulated ten recommendations for registry designers, administrators, and trialists planning future RRCTs.
CONCLUSION: Consideration and application of empirically underpinned recommendations for future registry design and trial conduct may help trialists utilize registries and RRCTs to their full potential.
Place, publisher, year, edition, pages
Pergamon Press, 2023. Vol. 159, p. 330-343
Keywords [en]
RRCTs, best practice, randomized controlled trials, registries, registry-based randomized controlled trials, strengths and limitations
National Category
Public Health, Global Health and Social Medicine
Identifiers
URN: urn:nbn:se:oru:diva-105869DOI: 10.1016/j.jclinepi.2023.04.015ISI: 001070913800001PubMedID: 37146660Scopus ID: 2-s2.0-85160254956OAI: oai:DiVA.org:oru-105869DiVA, id: diva2:1755303
Note
Funding agencies:
Canadian Institutes of Health Research (CIHR) MYG-171684
Canada Research Chairs
2023-05-082023-05-082025-02-20Bibliographically approved