Surrogate and patient discrepancy regarding consent for critical care research

• DOI: 10.1097/ccm.0b013e318258ff19
• Publication Date: 2012-06-23T06:51:08Z
• Authors: Julia T. Newman; Alexandra Smart; Tyler R. Reese; Andre Williams; Marc Moss
• Keywords: Surrogate endpoint

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