Artículos de revistas
Influence of trial registration on reporting quality of randomized trials: Study from highest ranked journals
Registration in:
Journal of Clinical Epidemiology, Volume 63, Issue 11, November 2010, Pages 1216-1222
0895-4356
10.1016/j.jclinepi.2010.01.013
Author
Reveiz, Ludovic
Cortés Jofré, Marcela
Asenjo Lobos, Claudia
Nicita, G.
Ciapponi, A.
Garcıá-Dieguez, M.
Tellez, D.
Delgado, M.
Solá, I.
Ospina, E.
Abstract
Artículo de publicación ISI Objective: To evaluate the reporting quality of key methodological items of randomized control trials (RCTs) in 55 of the highest
ranked journals.
Study Design and Setting: A list of the highest top ranked journals was identified, and a search for detecting RCTs in those journals
was made. Two hundred sixty four journals were screened and 55 of them were identified having at least one RCT. Three RCTs were randomly
selected a priori from each journal; 148 RCTs were finally included. RCTs were assessed by two reviewers using the Consolidated
Standards of Reporting Trials (CONSORT) statement.
Results: Only 11 (8%) RCTs had all items adequately reported. In addition, 36% of RCTs reported that the study was registered in any
trial registry. We found a significant difference in the quality of reporting for baseline characteristics, recruitment, participant’s flow, and
randomization implementation between those studies having reported the registration of their RCT in a trial registry and those that have not.
Adherence to key methodological items of the CONSORT statement was as follows: sample size determination (60%), sequence generation
(49%), allocation concealment (40%), and blinding (25%).
Conclusions: Reporting of varied CONSORT items remains suboptimal. Registration in a trial registry was associated with improved
reporting. Further efforts to enhance RCT registration could contribute to this improvement.