A review of pragmatic trials found a high degree of diversity in design and scope, deficiencies in reporting and trial registry data, and poor indexing

Stuart G Nicholls; Kelly Carroll; Spencer Phillips Hey; Merrick Zwarenstein; Jennifer Zhe Zhang; Hayden P Nix; Jamie C Brehaut; Joanne E McKenzie; Steve McDonald; Charles Weijer; Dean A Fergusson; Monica Taljaard

doi:10.1016/j.jclinepi.2021.03.021

A review of pragmatic trials found a high degree of diversity in design and scope, deficiencies in reporting and trial registry data, and poor indexing

J Clin Epidemiol. 2021 Sep:137:45-57. doi: 10.1016/j.jclinepi.2021.03.021. Epub 2021 Mar 28.

Authors

Affiliations

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.

Keywords: Data quality; Database searching; Intervention; Pragmatic trials; Registration; Reporting; Trial design.

Publication types

Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Review

MeSH terms

Abstracting and Indexing / standards*
Humans
Pragmatic Clinical Trials as Topic / methods*
Pragmatic Clinical Trials as Topic / standards*
Registries*
Research Design / standards*

Abstract

Publication types

MeSH terms

Grants and funding