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

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. Trials were...

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Veröffentlicht in:Journal of clinical epidemiology 2021-09, Vol.137, p.45-57
Hauptverfasser: 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
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container_end_page 57
container_issue
container_start_page 45
container_title Journal of clinical epidemiology
container_volume 137
creator 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
description 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. 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. 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%. 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.
doi_str_mv 10.1016/j.jclinepi.2021.03.021
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subjects Abstracting and Indexing - standards
Clinical trials
Data quality
Database searching
Epidemiology
Ethics
Humans
Intervention
National libraries
Occupational health
Pragmatic Clinical Trials as Topic - methods
Pragmatic Clinical Trials as Topic - standards
Pragmatic trials
Pragmatism
Registration
Registries
Reporting
Research Design - standards
Trial design
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
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