Scientific Publications Database

Article Title: 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
Authors: Nicholls, Stuart G.; Carroll, Kelly; Hey, Spencer Phillips; Zwarenstein, Merrick; Zhang, Jennifer Zhe; Nix, Hayden P.; Brehaut, Jamie C.; McKenzie, Joanne E.; McDonald, Steve; Weijer, Charles; Fergusson, Dean A.; Taljaard, Monica
Journal: JOURNAL OF CLINICAL EPIDEMIOLOGY Volume 137
Date of Publication:2021
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. (c) 2021 Elsevier Inc. All rights reserved.