Do surrogate decision makers provide accurate consent for intensive care research?

CONTEXT: ICU patients are often rendered incapable of making decisions as a result of their illness. The accuracy with which patients’ surrogates consent to research on their behalf is not known. OBJECTIVE: To determine if surrogate decision makers provide accurate consent for intensive care research. DESIGN: Cross-sectional, paired, face-to-face interviews. SETTING: A large, managed-care, cardiac surgery service. PATIENTS AND PATICIPANTS: One hundred elective cardiac surgery patients and their self-appointed surrogates were enrolled. INTERVENTION: Patients agreed or declined to provide informed consent to two hypothetical research trials. One trial represented minimal risk to those enrolled; the other trial represented greater-than-minimal risk. Surrogates attempted to predict the patients’ responses. Main outcome measures: The accuracy of surrogate consent was analyzed in a fashion analogous to the evaluation of a diagnostic test. Predictors of accuracy were evaluated using multiple logistic regression. RESULTS: Overall surrogate positive predictive value for the low-risk study was 84.0% and for the high-risk study was 79.7% (p = 0.72, McNemar test). Predictors of accurate consent were not consistent across the two studies. CONCLUSIONS: Surrogate decision makers for critical-care research resulted in false-positive consent rates of 16 to 20.3%. Further assessment and evaluation of the practice of surrogate consent for intensive care research is, therefore, recommended.

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