Paper I: Heterogeneous use of registry data for participant identification and primary outcome ascertainment is found in registry-based randomized controlled trials: A scoping review

Ami Baba; Joanne Tay; Adrian Sammy; William A Douglas; Katherine Goren; Karolin R Krause; Alison H Howie; Julian Little; Maryam Oskoui; Monica Taljaard; Brett D Thombs; Beth K Potter; Nancy J Butcher; Martin Offringa

doi:10.1016/j.jclinepi.2023.04.016

Paper I: Heterogeneous use of registry data for participant identification and primary outcome ascertainment is found in registry-based randomized controlled trials: A scoping review

J Clin Epidemiol. 2023 Jul:159:289-299. doi: 10.1016/j.jclinepi.2023.04.016. Epub 2023 May 3.

Authors

Affiliations

¹ 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.
² Cundill Centre for Child and Youth Depression, Centre for Addiction and Mental Health, 1000 Queen Street W, Toronto, Ontario, Canada M6J 1H4.
³ School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, Canada K1G 5Z3.
⁴ Faculty of Medicine and Health Sciences, Department of Pediatrics, McGill University, 3605 Rue de la Montagne, Montréal, Quebec, Canada H3G 2M1.
⁵ School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, Canada K1G 5Z3; Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, Ontario, Canada K1H 8L6.
⁶ 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.
⁷ 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; Cundill Centre for Child and Youth Depression, Centre for Addiction and Mental Health, 1000 Queen Street W, Toronto, Ontario, Canada M6J 1H4; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, Ontario, Canada M5T 1R8.
⁸ 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. Electronic address: martin.offringa@sickkids.ca.

PMID: 37146658
DOI: 10.1016/j.jclinepi.2023.04.016

Abstract

Objectives: Registry-based randomized controlled trials (RRCTs) have potential to address limitations of traditional clinical trials. To describe their current use, information on planned and published RRCTs was identified and synthesized.

Study design and setting: A scoping review of published RRCT protocols and reports was conducted. Articles published between 2010 and 2021 identified from electronic database searching, a recent review of RRCTs, and targeted searching for recent RRCT protocols (2018-2021) were screened. Data on trial data sources, types of primary outcomes, and how these primary outcomes were described, selected, and reported were extracted.

Results: Ninety RRCT articles (77 reports; 13 protocols) were included. Forty nine (54%) used or planned to rely on registry data for their trial, 26 (29%) used both registry and additional data, and 15 (17%) used the registry solely for recruitment. Primary outcomes were routinely collected from the registry for 66 articles (73%). Only 28 articles (31%) described any methods to promote outcome data quality during or after data collection. Core outcome sets were not used in any of the trials.

Conclusion: With improvements in registry design, outcome selection, measurement, and reporting, future RRCTs may deliver on promises of efficient, high-quality trials that address clinically relevant questions.

Keywords: Best practice; CONSORT; Consort-routine; Randomized controlled trials; Registries; Registry-based randomized controlled trials; Reporting guideline.

Publication types

Review
Research Support, Non-U.S. Gov't

MeSH terms

Humans
Randomized Controlled Trials as Topic
Registries
Routinely Collected Health Data*

Grants and funding

MYG – 171,684/CIHR/Canada