Adjudicating ventilator-associated pneumonia in a randomized trial of critically ill patients

Purpose: The purpose of this study was to evaluate an adjudication strategy for diagnosing ventilator-associated pneumonia (VAP) in a randomized trial . Materials and Methods: In a double-blind trial of sucralfate versus ranitid ine, one of four pairs of adjudicators examined each case of clinically sus pected VAP. Nurse and physician notes and all relevant laboratory data were allocated to each adjudication pair in groups of five patients, Each reade r in the pair decided whether the patient had VAP; differences were resolve d by consensus discussion. Results: The overall unadjusted study odds ratio for VAP was 0.82 (P =.21) representing a trend toward less pneumonia with sucralfate compared with ra nitidine. The odds ratio adjusted for adjudication pair was 0.85 (P =.27). The proportion of charts adjudicated as VAP positive among pairs ranged fro m 50% to 92%; crude agreement between readers in each pair varied from 50% to 82%. When adjudicators disagreed, the final consensus was split evenly b etween the two adjudicators' initial opinions in two pairs; in the other tw o pairs, the final decision reflected one dominant initial opinion. Personn el time to adjudicate all patients with a suspicion of VAP was 74 days. Conclusions: Though adjudication of outcomes such as VAP is time-consuming, consistent decisionmaking requires strict criteria, training, and calibrat ion. Patients should be assigned to adjudication teams through random alloc ation. Copyright (C) 1998 by W.B. Saunders Company.