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). κ 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.
From the Division of Pulmonary Sciences and Critical Care Medicine (JTN, AS, TRR, MM), Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado; and Division of Biostatistics and Bioinformatics (AW), National Jewish Health, Denver, Colorado.
All the authors had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
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Supported, in part, by NIH grant K24-HL-089223.
The authors have not disclosed any potential conflicts of interest.
Address requests for reprints to: Marc Moss, MD, University of Colorado, Denver, Division of Pulmonary Sciences and Critical Care Medicine, RC2, C-272, 12700 E, 19th Avenue, Aurora, CO 80045. E-mail: email@example.com