Cook D, Walter S, Freitag A, Guyatt G, Devitt H, Meade M, Griffith L, Sarabia A, Fuller H, Turner M, Gough K
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
J Crit Care. 1998 Dec;13(4):159-63. doi: 10.1016/s0883-9441(98)90000-4.
The purpose of this study was to evaluate an adjudication strategy for diagnosing ventilator-associated pneumonia (VAP) in a randomized trial.
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.
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.
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.
本研究旨在评估在一项随机试验中诊断呼吸机相关性肺炎（VAP）的判定策略。
在一项硫糖铝与雷尼替丁的双盲试验中，四组判定人员中的一组对每例临床疑似VAP病例进行检查。护士和医生记录以及所有相关实验室数据以五名患者为一组分配给每组判定人员。每组中的每位读者确定患者是否患有VAP；分歧通过共识讨论解决。
VAP的总体未调整研究比值比为0.82（P = 0.21），表明与雷尼替丁相比，硫糖铝治疗的肺炎发生率有降低趋势。经判定组调整后的比值比为0.85（P = 0.27）。判定为VAP阳性的病例组比例在50%至92%之间；每组读者之间的粗略一致性在50%至82%之间。当判定人员意见不一致时，在两组中最终共识在两位判定人员的初始意见之间平均分配；在另外两组中，最终决定反映了一种占主导地位的初始意见。判定所有疑似VAP患者的人员时间为74天。
虽然对VAP等结果进行判定很耗时，但一致的决策需要严格的标准、培训和校准。患者应通过随机分配被分配到判定小组。
