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 ranitidine, one of four pairs of adjudicators examined each case of clinically suspected VAP. Nurse and physician notes and all relevant laboratory data were allocated to each adjudication pair in groups of five patients. Each reader in the pair decided whether the patient had VAP; differences were resolved 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 ranitidine. The odds ratio adjusted for adjudication pair was 0.85 (P = .27). The proportion of charts adjudicated as VAP positive among pairs ranged from 50% to 92%; crude agreement between readers in each pair varied from 50% to 82%. When adjudicators disagreed, the final consensus was split evenly between the two adjudicators' initial opinions in two pairs; in the other two pairs, the final decision reflected one dominant initial opinion. Personnel 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 decision-making requires strict criteria, training, and calibration. Patients should be assigned to adjudication teams through random allocation.
RCT Entities:
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 ranitidine, one of four pairs of adjudicators examined each case of clinically suspected VAP. Nurse and physician notes and all relevant laboratory data were allocated to each adjudication pair in groups of five patients. Each reader in the pair decided whether the patient had VAP; differences were resolved 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 ranitidine. The odds ratio adjusted for adjudication pair was 0.85 (P = .27). The proportion of charts adjudicated as VAP positive among pairs ranged from 50% to 92%; crude agreement between readers in each pair varied from 50% to 82%. When adjudicators disagreed, the final consensus was split evenly between the two adjudicators' initial opinions in two pairs; in the other two pairs, the final decision reflected one dominant initial opinion. Personnel 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 decision-making requires strict criteria, training, and calibration. Patients should be assigned to adjudication teams through random allocation.
Authors: Nick Daneman; Asgar H Rishu; Wei Xiong; Sean M Bagshaw; Deborah J Cook; Peter Dodek; Richard Hall; Anand Kumar; Francois Lamontagne; Francois Lauzier; John C Marshall; Claudio M Martin; Lauralyn McIntyre; John Muscedere; Steven Reynolds; Henry T Stelfox; Robert A Fowler Journal: Trials Date: 2015-04-18 Impact factor: 2.279
Authors: Nick Daneman; Asgar H Rishu; Ruxandra L Pinto; Yaseen M Arabi; Deborah J Cook; Richard Hall; Shay McGuinness; John Muscedere; Rachael Parke; Steven Reynolds; Benjamin Rogers; Yahya Shehabi; Robert A Fowler Journal: BMJ Open Date: 2020-05-11 Impact factor: 2.692
Authors: Waleed Alhazzani; Gordon Guyatt; John C Marshall; Richard Hall; John Muscedere; Francois Lauzier; Lehana Thabane; Mohammed Alshahrani; Shane W English; Yaseen M Arabi; Adam M Deane; Tim Karachi; Bram Rochwerg; Simon Finfer; Nick Daneman; Nicole Zytaruk; Diane Heel-Ansdell; Deborah Cook; On Behalf Of Journal: Ann Saudi Med Date: 2016 Nov-Dec Impact factor: 1.526