Adjudication-related processes are underreported and lack standardization in clinical trials of venous thromboembolism: a systematic review.

Details

Serval ID
serval:BIB_8BDA235D9CA8
Type
Article: article from journal or magazin.
Collection
Publications
Title
Adjudication-related processes are underreported and lack standardization in clinical trials of venous thromboembolism: a systematic review.
Journal
Journal of clinical epidemiology
Author(s)
Stuck A.K., Fuhrer E., Limacher A., Méan M., Aujesky D.
ISSN
1878-5921 (Electronic)
ISSN-L
0895-4356
Publication state
Published
Issued date
03/2014
Peer-reviewed
Oui
Volume
67
Number
3
Pages
278-284
Language
english
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't ; Review
Publication Status: ppublish
Abstract
Although the use of an adjudication committee (AC) for outcomes is recommended in randomized controlled trials, there are limited data on the process of adjudication. We therefore aimed to assess whether the reporting of the adjudication process in venous thromboembolism (VTE) trials meets existing quality standards and which characteristics of trials influence the use of an AC.
We systematically searched MEDLINE and the Cochrane Library from January 1, 2003, to June 1, 2012, for randomized controlled trials on VTE. We abstracted information about characteristics and quality of trials and reporting of adjudication processes. We used stepwise backward logistic regression model to identify trial characteristics independently associated with the use of an AC.
We included 161 trials. Of these, 68.9% (111 of 161) reported the use of an AC. Overall, 99.1% (110 of 111) of trials with an AC used independent or blinded ACs, 14.4% (16 of 111) reported how the adjudication decision was reached within the AC, and 4.5% (5 of 111) reported on whether the reliability of adjudication was assessed. In multivariate analyses, multicenter trials [odds ratio (OR), 8.6; 95% confidence interval (CI): 2.7, 27.8], use of a data safety-monitoring board (OR, 3.7; 95% CI: 1.2, 11.6), and VTE as the primary outcome (OR, 5.7; 95% CI: 1.7, 19.4) were associated with the use of an AC. Trials without random allocation concealment (OR, 0.3; 95% CI: 0.1, 0.8) and open-label trials (OR, 0.3; 95% CI: 0.1, 1.0) were less likely to report an AC.
Recommended processes of adjudication are underreported and lack standardization in VTE-related clinical trials. The use of an AC varies substantially by trial characteristics.

Keywords
Clinical Trials Data Monitoring Committees/standards, Endpoint Determination/standards, Humans, Logistic Models, Randomized Controlled Trials as Topic/methods, Randomized Controlled Trials as Topic/standards, Reproducibility of Results, Research Design, Treatment Outcome, Venous Thromboembolism/therapy
Pubmed
Create date
04/02/2017 16:59
Last modification date
20/08/2019 14:50
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