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Ability of family members to predict patient's consent to critical care research

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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.

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Author information

Authors and Affiliations

  1. Medical Intensive Care Unit, AP-HP, Saint-Louis Teaching Hospital, Paris 7 University, Paris, France

    Magali Ciroldi, Alain Cariou, Christophe Adrie, Djilali Annane, Vincent Castelain, Yves Cohen, Arnaud Delahaye, Luc Marie Joly, Richard Galliot, Maité Garrouste-Orgeas, Fabrice Michel, Nancy Kenstish Barnes, Benoit Schlemmer, Frédéric Pochard & Elie Azoulay

  2. Medical Intensive Care Unit and Biostatistics Department, Saint-Louis Teaching Hospital, Paris, France

    Magali Ciroldi, Nancy Kenstish Barnes, Benoit Schlemmer, Frédéric Pochard & Elie Azoulay

  3. Medical Intensive Care Unit, Cochin Teaching Hospital, Paris, France

    Alain Cariou

  4. Medical-Surgical ICU, Delafontain Hospital, Saint-Denis, France

    Christophe Adrie

  5. Raymond Poincaré Teaching Hospital, Garches, France

    Djilali Annane

  6. Strasbourg Teaching Hospital, Strasbourg, France

    Vincent Castelain

  7. Avicenne Teaching Hospital, Bobigny, France

    Yves Cohen

  8. Saint-Joseph Hospital, Paris, France

    Maité Garrouste-Orgeas

  9. Saint Marguerite Teaching Hospital, Marseille, France

    Laurent Papazian

  10. Pontoise Hospital, Pontoise, France

    Richard Galliot

Authors
  1. Magali Ciroldi
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  2. Alain Cariou
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  3. Christophe Adrie
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  4. Djilali Annane
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  5. Vincent Castelain
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  6. Yves Cohen
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  7. Arnaud Delahaye
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  8. Luc Marie Joly
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  9. Richard Galliot
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  10. Maité Garrouste-Orgeas
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  11. Laurent Papazian
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  12. Fabrice Michel
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  13. Nancy Kenstish Barnes
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  14. Benoit Schlemmer
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  15. Frédéric Pochard
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  16. Elie Azoulay
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Corresponding author

Correspondence to Elie Azoulay.

Additional information

This study was performed on behalf of the Famirea study group. It was supported by grants from the Assistance Publique Hôpitaux de Paris and the French Society for Critical Care Medicine (AOR01004).

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Ciroldi, M., Cariou, A., Adrie, C. et al. Ability of family members to predict patient's consent to critical care research. Intensive Care Med 33, 807–813 (2007). https://doi.org/10.1007/s00134-007-0582-6

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  • DOI: https://doi.org/10.1007/s00134-007-0582-6

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