Stuart G Nicholls1, Kelly Carroll2, Spencer Phillips Hey3, Merrick Zwarenstein4, Jennifer Zhe Zhang5, Hayden P Nix6, Jamie C Brehaut7, Joanne E McKenzie8, Steve McDonald8, Charles Weijer9, Dean A Fergusson10, Monica Taljaard7. 1. Clinical Epidemiology Program, Ottawa Hospital Research Institute (OHRI). Electronic address: snicholls@ohri.ca. 2. Clinical Epidemiology Program, Ottawa Hospital Research Institute (OHRI). 3. CEO, Prism Analytic Technologies; Cambridge, MA. 4. Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine & Dentistry, Western University, 1151 Richmond Street, London, Ontario, Canada, N6A 3K7; Department of Family Medicine, Western University, London, Canada; Schulich School of Medicine & Dentistry, Western University, London, Canada. 5. School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada. 6. Schulich School of Medicine & Dentistry, Western University, London, Canada. 7. Clinical Epidemiology Program, Ottawa Hospital Research Institute (OHRI); School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada. 8. School of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road, Melbourne, Victoria 3004, Australia. 9. Department of Medicine, Western University, London, Canada; Department of Epidemiology and Biostatistics, Western University, London, Canada; Department of Philosophy, Western University, London, Canada. 10. Clinical Epidemiology Program, Ottawa Hospital Research Institute (OHRI); School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada; Department of Medicine, University of Ottawa, Ottawa, Canada.
Abstract
OBJECTIVE: We established a large database of trials to serve as a resource for future methodological and ethical analyses. Here, we use meta-data to describe the broad landscape of pragmatic trials including research areas, identification as pragmatic, quality of trial registry data and enrolment. STUDY DESIGN AND SETTING: Trials were identified by a validated search filter and included if a primary report of a health-related randomized trial published January 2014-April 2019. Data were collated from MEDLINE, Web of Science, ClinicalTrials.gov, and full text. RESULTS: 4337 eligible trials were identified from 13,065 records, of which 1988 were registered in ClinicalTrials.gov. Research areas were diverse, with the most common being general and internal medicine; public, environmental and occupational health; and health care sciences and services. The term "pragmatic" was seldom used in titles or abstracts. Several domains in ClinicalTrials.gov had questionable data quality. We estimated that one-fifth of trials under-accrued by at least 15%. CONCLUSION: There is a need to improve reporting of pragmatic trials and quality of trial registry data. Under accrual remains a challenge in pragmatic RCTs despite calls for more streamlined recruitment approaches. The diversity of pragmatic trials should be reflected in future ethical analyses.
OBJECTIVE: We established a large database of trials to serve as a resource for future methodological and ethical analyses. Here, we use meta-data to describe the broad landscape of pragmatic trials including research areas, identification as pragmatic, quality of trial registry data and enrolment. STUDY DESIGN AND SETTING: Trials were identified by a validated search filter and included if a primary report of a health-related randomized trial published January 2014-April 2019. Data were collated from MEDLINE, Web of Science, ClinicalTrials.gov, and full text. RESULTS: 4337 eligible trials were identified from 13,065 records, of which 1988 were registered in ClinicalTrials.gov. Research areas were diverse, with the most common being general and internal medicine; public, environmental and occupational health; and health care sciences and services. The term "pragmatic" was seldom used in titles or abstracts. Several domains in ClinicalTrials.gov had questionable data quality. We estimated that one-fifth of trials under-accrued by at least 15%. CONCLUSION: There is a need to improve reporting of pragmatic trials and quality of trial registry data. Under accrual remains a challenge in pragmatic RCTs despite calls for more streamlined recruitment approaches. The diversity of pragmatic trials should be reflected in future ethical analyses.
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