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


METHODS
Cross-sectional, paired, face-to-face interviews.


METHODS
A large, managed-care, cardiac surgery service. PATIENTS AND PATICIPANTS: One hundred elective cardiac surgery patients and their self-appointed surrogates were enrolled.


METHODS
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.


METHODS
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.
Coppolino
M
M
Department of Medicine, Kaiser Medical Center, San Francisco, CA 94115, USA. Michael.Coppolino@ncal.kaiperm.org
Ackerson
L
L
D003430:Cross-Sectional Studies; D003657:Decision Making; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D012106:Research; D012680:Sensitivity and Specificity; D020458:Third-Party Consent