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Chest. 2001 Feb;119(2):603-12.

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

Author information

1
Department of Medicine, Kaiser Medical Center, San Francisco, CA 94115, USA. Michael.Coppolino@ncal.kaiperm.org

Abstract

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.

PMID:
11171743
[Indexed for MEDLINE]
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