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Trial registration in Latin America and the Caribbean's: Study of randomized trials published in 2010
- Source :
- JOURNAL OF CLINICAL EPIDEMIOLOGY, r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau, instname
- Publication Year :
- 2012
- Publisher :
- ELSEVIER SCIENCE INC, 2012.
-
Abstract
- Objective: To determine the prevalence of trial registration in randomized controlled trials (RCTs) published in 2010 (PUBMED/LILACS) from Latin America and the Caribbean's (LAC) and to compare methodological characteristics between registered and nonregistered RCTs. Study Design and Setting: A search for detecting RCTs in which at least the first/contact author had a LAC's affiliation was made. We determined if RCTs were registered in the International Clinical Trial Registry Platform (ICTRP). Data were independently extracted by two authors. The risk of bias (RoB) was assessed in all registered RCTs (n = 89) and in a sample of nonregistered RCTs (n = 237). Results: The search identified 1,695 references; 526 RCTs from 19 countries were included. 16.9% (89/526) of RCTs were registered in the ICTRP; however, only 21 (4.0%) were prospectively registered. A significant difference was found in the overall assessment of the RoB between registered and nonregistered RCTs. Overall, registered RCTs were multinational, had larger sample size and longer follow-up, and reported more frequently information on funding, conflict of interests, and ethic issues. No significant differences were found when analyzing prospectively registered RCTs. Conclusion: This study shows that trial registration rates are still low in LAC and the quality of reporting needs to be improved. © 2012 Elsevier Inc. All rights reserved.
- Subjects :
- conflict of interest
prevalence
South and Central America
registration
Risk Factors
publishing
cross-sectional study
follow up
Humans
controlled study
human
Registries
randomized controlled trial (topic)
bibliographic database
Randomized Controlled Trials as Topic
register
article
Medline
risk assessment
standard
Central America
clinical assessment
Databases, Bibliographic
sample size
publication
Cross-Sectional Studies
Latin America
health care quality
priority journal
risk factor
Caribbean Region
medical ethics
statistics
Bias (Epidemiology)
multicenter study (topic)
epidemiology
prospective study
Subjects
Details
- ISSN :
- 08954356
- Database :
- OpenAIRE
- Journal :
- JOURNAL OF CLINICAL EPIDEMIOLOGY, r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau, instname
- Accession number :
- edsair.RECOLECTA.....28ea06029a569d101eb474a50c92e214