title: Adjudication-related processes are underreported and lack standardization in clinical trials of venous thromboembolism: a systematic review.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Recommended processes of adjudication are underreported and lack standardization in VTE-related clinical trials. The use of an AC varies substantially by trial characteristics.
authors.affiliation: Division of General Internal Medicine, University Hospital of Bern, 3010 Bern, Switzerland. Electronic address: anna.stuck@insel.ch.
authors.forename: Anna K
authors.initials: AK
authors.lastname: Stuck
authors.affiliation: Division of General Internal Medicine, University Hospital of Bern, 3010 Bern, Switzerland.
authors.forename: Evelyn
authors.initials: E
authors.lastname: Fuhrer
authors.affiliation: CTU Bern, Department of Clinical Research, University of Bern, Finkenhubelweg 11, 3012 Bern, Switzerland; Institute of Social and Preventive Medicine (ISPM), University of Bern, Finkenhubelweg 11, 3012 Bern, Switzerland.
authors.forename: Andreas
authors.initials: A
authors.lastname: Limacher
authors.affiliation: Division of General Internal Medicine, University Hospital of Bern, 3010 Bern, Switzerland.
authors.forename: Marie
authors.initials: M
authors.lastname: Méan
authors.affiliation: Division of General Internal Medicine, University Hospital of Bern, 3010 Bern, Switzerland.
authors.forename: Drahomir
authors.initials: D
authors.lastname: Aujesky
mesh_terms: D026661:Clinical Trials Data Monitoring Committees / Q000592:standards*; D023381:Endpoint Determination / Q000592:standards*; D006801:Humans; D016015:Logistic Models; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards*; D015203:Reproducibility of Results; D012107:Research Design; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000628:therapy*
keywords: Data quality; Data reporting; Outcome adjudication; Outcome assessment; Systematic review; Venous thromboembolism