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

Stuck, Anna K; Fuhrer, Evelyn; Limacher, Andreas; Méan, Marie; Aujesky, Drahomir (2014). Adjudication-related processes are underreported and lack standardization in clinical trials of venous thromboembolism: a systematic review. Journal of clinical epidemiology, 67(3), pp. 278-284. Elsevier 10.1016/j.jclinepi.2013.09.011

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern
04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine > Centre of Competence for General Internal Medicine

UniBE Contributor:

Stuck, Anna; Limacher, Andreas; Méan, Marie and Aujesky, Drahomir

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0895-4356

Publisher:

Elsevier

Language:

English

Submitter:

Beatrice Minder Wyssmann

Date Deposited:

28 Feb 2014 10:06

Last Modified:

24 Jan 2017 15:12

Publisher DOI:

10.1016/j.jclinepi.2013.09.011

PubMed ID:

24290147

Uncontrolled Keywords:

Data quality, Data reporting, Outcome adjudication, Outcome assessment, Systematic review, Venous thromboembolism

BORIS DOI:

10.7892/boris.43106

URI:

https://boris.unibe.ch/id/eprint/43106

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