M Coppolino1, L Ackerson. 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.
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.
Entities:
Keywords:
Biomedical and Behavioral Research; Empirical Approach
Authors: Sangeeta Mehta; Friederike Quittnat Pelletier; Maedean Brown; Cheryl Ethier; David Wells; Lisa Burry; Rod MacDonald Journal: Intensive Care Med Date: 2011-11-26 Impact factor: 17.440
Authors: Bradley D Freeman; Carie R Kennedy; Dragana Bolcic-Jankovic; Alexander Eastman; Ellen Iverson; Erica Shehane; Aaron Celious; Jennifer Barillas; Brian Clarridge Journal: J Empir Res Hum Res Ethics Date: 2012-02 Impact factor: 1.742