Adjudicating ventilator-associated pneumonia in a randomized trial of critically ill patients.
OBJECTIVE
The purpose of this study was to evaluate an adjudication strategy for diagnosing ventilator-associated pneumonia (VAP) in a randomized trial.


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.
Cook
D
D
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Walter
S
S
Freitag
A
A
Guyatt
G
G
Devitt
H
H
Meade
M
M
Griffith
L
L
Sarabia
A
A
Fuller
H
H
Turner
M
M
Gough
K
K
D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D015982:Bias; D016638:Critical Illness; D003428:Cross Infection / Q000175:diagnosis* / Q000209:etiology* / Q000517:prevention & control; D004311:Double-Blind Method; D006801:Humans; D015337:Multicenter Studies as Topic / Q000592:standards; D010043:Outcome and Process Assessment, Health Care; D011014:Pneumonia / Q000175:diagnosis* / Q000209:etiology* / Q000517:prevention & control; D011367:Professional Staff Committees / Q000458:organization & administration*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D011899:Ranitidine / Q000627:therapeutic use; D015203:Reproducibility of Results; D012121:Respiration, Artificial / Q000009:adverse effects*; D013392:Sucralfate / Q000627:therapeutic use
D000897:Anti-Ulcer Agents; D013392:Sucralfate; D011899:Ranitidine