Ability of family members to predict patient's consent to critical care research.
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.
Ciroldi
Magali
M
Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Medical Intensive Care Unit and Biostatistics Department, Saint-Louis Teaching Hospital, Paris, France.
Cariou
Alain
A
Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Medical Intensive Care Unit, Cochin Teaching Hospital, Paris, France.
Adrie
Christophe
C
Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Medical-Surgical ICU, Delafontain Hospital, Saint-Denis, France.
Annane
Djilali
D
Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Raymond Poincaré Teaching Hospital, Garches, France.
Castelain
Vincent
V
Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Strasbourg Teaching Hospital, Strasbourg, France.
Cohen
Yves
Y
Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Avicenne Teaching Hospital, Bobigny, France.
Delahaye
Arnaud
A
Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.
Joly
Luc Marie
LM
Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.
Galliot
Richard
R
Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Pontoise Hospital, Pontoise, France.
Garrouste-Orgeas
Maité
M
Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Saint-Joseph Hospital, Paris, France.
Papazian
Laurent
L
Saint Marguerite Teaching Hospital, Marseille, France.
Michel
Fabrice
F
Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.
Barnes
Nancy Kenstish
NK
Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Medical Intensive Care Unit and Biostatistics Department, Saint-Louis Teaching Hospital, Paris, France.
Schlemmer
Benoit
B
Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Medical Intensive Care Unit and Biostatistics Department, Saint-Louis Teaching Hospital, Paris, France.
Pochard
Frédéric
F
Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France.|Medical Intensive Care Unit and Biostatistics Department, Saint-Louis Teaching Hospital, Paris, France.
Azoulay
Elie
E
Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France. elie.azoulay@sla.ap-hop-paris.fr.|Medical Intensive Care Unit and Biostatistics Department, Saint-Louis Teaching Hospital, Paris, France. elie.azoulay@sla.ap-hop-paris.fr.
D000328:Adult; D000368:Aged; D003422:Critical Care; D005190:Family / Q000523:psychology*; D005260:Female; D005602:France; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D010817:Physician-Patient Relations; D011446:Prospective Studies; D019727:Proxy / Q000523:psychology*; D012106:Research