Surrogate and patient discrepancy regarding consent for critical care research

Objective:Critically ill patients frequently display impaired decision-making capacity due to their underlying illness and the use of sedating medications. Healthcare providers often rely on surrogates to make decisions for medical care and participation in clinical research. However, the accuracy of surrogate decisions for a variety of critical care research studies is poorly understood. Design:Cross-sectional observational study. Setting:Academic medical center. Patients:Medical intensive care unit patients and their designated surrogates. Intervention:Patients were asked whether they would consent to participate in hypothetical research studies of increasing complexity, and surrogates independently indicated whether they would consent to enroll the patient in the same scenarios. Results:Overall, 69 medical intensive care unit patients were enrolled into the study. The majority of surrogates were either the spouse (58%) or parent (22%) of the patient. The percentage of patients that would agree to participate in a research study and the percentage of surrogates that would agree to have the patient enrolled into a research study both declined as the risk of the study increased (p < .001 for both analyses). In addition, the overall discrepancy, the false-negative rates, and the false-positive rates between patient and surrogates were greater as the risk of the study increased (p < .001, p < .001, and p = .049, respectively). &kgr; values for all seven scenarios demonstrated less-than-moderate agreement (range 0.03–0.41). Conclusions:There are significant discrepancies in the willingness to participate in various types of clinical research proposals between critically ill patients and their surrogate decision makers. The results of this study raise concerns about the use of surrogate consent for inclusion of critically ill patients into research protocols.

[1]  Alan R. Tait,et al.  Evaluation of a prototype interactive consent program for pediatric clinical trials: a pilot study , 2012, J. Am. Medical Informatics Assoc..

[2]  Paul Slovic,et al.  Affect, risk, and decision making. , 2005, Health psychology : official journal of the Division of Health Psychology, American Psychological Association.

[3]  G. Koren,et al.  Informed Consent in Pediatric Research , 2015, Pediatric Drugs.

[4]  G. Bernard,et al.  Recommendations for informed consent forms for critical care clinical trials* , 2005, Critical care medicine.

[5]  D. Annane,et al.  A 3-level prognostic classification in septic shock based on cortisol levels and cortisol response to corticotropin. , 2000, JAMA.

[6]  F. Lemaire Informed consent for and regulation of critical care research , 2008, Current opinion in critical care.

[7]  P Slovic,et al.  Public perception of the risk ofblood transfusion , 2000, Transfusion.

[8]  Arthur S Slutsky,et al.  Functional disability 5 years after acute respiratory distress syndrome. , 2011, The New England journal of medicine.

[9]  R. Hopkins,et al.  Long-term neurocognitive function after critical illness. , 2006, Chest.

[10]  É. Azoulay,et al.  Ability of family members to predict patient's consent to critical care research , 2007, Intensive Care Medicine.

[11]  H. Smithline,et al.  Do patients with acute medical conditions have the capacity to give informed consent for emergency medicine research? , 1999, Academic emergency medicine : official journal of the Society for Academic Emergency Medicine.

[12]  J. Berger,et al.  Surrogate Decision Making: Reconciling Ethical Theory and Clinical Practice , 2008, Annals of Internal Medicine.

[13]  D. Wendler,et al.  The accuracy of surrogate decision makers: a systematic review. , 2006, Archives of internal medicine.

[14]  E. Ely,et al.  Six-month neuropsychological outcome of medical intensive care unit patients , 2003, Critical care medicine.

[15]  J. R. Williams,et al.  Bioethics for clinicians: 1. Consent. , 1996, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[16]  C. Beck,et al.  Surrogate Decision-Making and Related Issues , 2003, Alzheimer disease and associated disorders.

[17]  M. Gong,et al.  Surrogate consent for research involving adults with impaired decision making: Survey of Institutional Review Board practices , 2010, Critical care medicine.

[18]  L. Ackerson,et al.  Do surrogate decision makers provide accurate consent for intensive care research? , 2001, Chest.

[19]  P. Slovic,et al.  A psychological study of the inverse relationship between perceived risk and perceived benefit. , 1994, Risk analysis : an official publication of the Society for Risk Analysis.

[20]  L. Dunn,et al.  Research ethics issues in geriatric psychiatry. , 2009, The Psychiatric clinics of North America.

[21]  J. Berger Is best interests a relevant decision making standard for enrolling non-capacitated subjects into clinical research? , 2010, Journal of Medical Ethics.

[22]  M. Yarborough Adults Are Not Big Children: Examining Surrogate Consent to Research Using Adults with Dementia , 2002, Cambridge Quarterly of Healthcare Ethics.

[23]  D. Cook,et al.  The ethical conduct of clinical research involving critically ill patients in the United States and Canada: principles and recommendations. , 2004, American journal of respiratory and critical care medicine.

[24]  P. Appelbaum Consent in Impaired Populations , 2010, Current neurology and neuroscience reports.

[25]  S. Mehta,et al.  Why substitute decision makers provide or decline consent for ICU research studies: a questionnaire study , 2011, Intensive Care Medicine.

[26]  Arthur S Slutsky,et al.  One-year outcomes in survivors of the acute respiratory distress syndrome. , 2003, The New England journal of medicine.