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

• Published in: Journal of clinical epidemiology 2014-03, Vol.67 (3), p.278-284
• Main Authors: Stuck, Anna K, Fuhrer, Evelyn, Limacher, Andreas, Méan, Marie, Aujesky, Drahomir
• Format: Article
• Language: English
• Subjects: Analysis. Health state; Bias; Biological and medical sciences; Clinical trials; Clinical Trials Data Monitoring Committees - standards; Confidence intervals; Data quality; Data reporting; Drug therapy; Endpoint Determination - standards; Epidemiology; General aspects; Humans; Internal Medicine; Logistic Models; Medical sciences; Methodology; Methods; Mortality; Outcome adjudication; Outcome assessment; Public health. Hygiene; Public health. Hygiene-occupational medicine; Randomized Controlled Trials as Topic - methods; Randomized Controlled Trials as Topic - standards; Reproducibility of Results; Research Design; Standardization; Systematic review; Thromboembolism; Treatment Outcome; Venous thromboembolism; Venous Thromboembolism - therapy
• ISSN: 0895-4356; 1878-5921
• DOI: 10.1016/j.jclinepi.2013.09.011

Abstract Objectives 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. Study Design and Setting 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. Results 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. Conclusion Recommended processes of adjudication are underreported and lack standardization in VTE-related clinical trials. The use of an AC varies substantially by trial characteristics.