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.
Data quality
Database searching
Intervention
Pragmatic trials
Registration
Reporting
Trial design
Journal
Journal of clinical epidemiology
ISSN: 1878-5921
Titre abrégé: J Clin Epidemiol
Pays: United States
ID NLM: 8801383
Informations de publication
Date de publication:
09 2021
09 2021
Historique:
received:
17
08
2020
revised:
24
02
2021
accepted:
18
03
2021
pubmed:
1
4
2021
medline:
11
11
2021
entrez:
31
3
2021
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 33789151
pii: S0895-4356(21)00103-7
doi: 10.1016/j.jclinepi.2021.03.021
pmc: PMC8996736
mid: NIHMS1791998
pii:
doi:
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
45-57Subventions
Organisme : NIA NIH HHS
ID : U54 AG063546
Pays : United States
Organisme : CIHR
ID : PJT-153045
Pays : Canada
Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.
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