Magali Ciroldi1,2, Alain Cariou1,3, Christophe Adrie1,4, Djilali Annane1,5, Vincent Castelain1,6, Yves Cohen1,7, Arnaud Delahaye1, Luc Marie Joly1, Richard Galliot1,8, Maité Garrouste-Orgeas1,9, Laurent Papazian10, Fabrice Michel1, Nancy Kenstish Barnes1,2, Benoit Schlemmer1,2, Frédéric Pochard1,2, Elie Azoulay11,12. 1. Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France. 2. Medical Intensive Care Unit and Biostatistics Department, Saint-Louis Teaching Hospital, Paris, France. 3. Medical Intensive Care Unit, Cochin Teaching Hospital, Paris, France. 4. Medical-Surgical ICU, Delafontain Hospital, Saint-Denis, France. 5. Raymond Poincaré Teaching Hospital, Garches, France. 6. Strasbourg Teaching Hospital, Strasbourg, France. 7. Avicenne Teaching Hospital, Bobigny, France. 8. Pontoise Hospital, Pontoise, France. 9. Saint-Joseph Hospital, Paris, France. 10. Saint Marguerite Teaching Hospital, Marseille, France. 11. Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France. elie.azoulay@sla.ap-hop-paris.fr. 12. Medical Intensive Care Unit and Biostatistics Department, Saint-Louis Teaching Hospital, Paris, France. elie.azoulay@sla.ap-hop-paris.fr.
Abstract
OBJECTIVE: A European Union Directive provides for the designation of a surrogate who can consent to or refuse inclusion of an incapacitated patient in research studies. The accuracy with which surrogates consent to research on behalf of patients has not been evaluated in the intensive care unit (ICU). METHODS: A prospective multicenter study was conducted in ten ICUs of the French Famirea study group between July and October 2004. Two hypothetical studies were simultaneously submitted to the patient, surrogate, and physician at the time that the patient was discharged to a ward. One study involved minimal risk and the other greater-than-minimal risk to the patients. RESULTS: With the minimal risk study there was patient-surrogate discrepancy in 32% of cases and patient-physician discrepancy in 25%. Corresponding figures with the greater-than-minimal risk study were 42% and 46%. None of the collected variables differed significantly between cases with and without patient-surrogate discrepancy. CONCLUSIONS: Family members designated to serve as surrogate decision makers may fail to accurately consent to research for critically ill patients in one-third to nearly one-half of cases.
OBJECTIVE: A European Union Directive provides for the designation of a surrogate who can consent to or refuse inclusion of an incapacitated patient in research studies. The accuracy with which surrogates consent to research on behalf of patients has not been evaluated in the intensive care unit (ICU). METHODS: A prospective multicenter study was conducted in ten ICUs of the French Famirea study group between July and October 2004. Two hypothetical studies were simultaneously submitted to the patient, surrogate, and physician at the time that the patient was discharged to a ward. One study involved minimal risk and the other greater-than-minimal risk to the patients. RESULTS: With the minimal risk study there was patient-surrogate discrepancy in 32% of cases and patient-physician discrepancy in 25%. Corresponding figures with the greater-than-minimal risk study were 42% and 46%. None of the collected variables differed significantly between cases with and without patient-surrogate discrepancy. CONCLUSIONS: Family members designated to serve as surrogate decision makers may fail to accurately consent to research for critically illpatients in one-third to nearly one-half of cases.
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Authors: Bradley D Freeman; Dragana Bolcic-Jankovic; Carie R Kennedy; Jessica LeBlanc; Alexander Eastman; Jennifer Barillas; Catherine M Wittgen; Kathryn Indsey; Rumel S Mahmood; Brian R Clarridge Journal: AJOB Empir Bioeth Date: 2015-05-01