Division of Pulmonary Sciences and Critical Care Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado 80045, USA.
Crit Care Med. 2012 Sep;40(9):2590-4. doi: 10.1097/CCM.0b013e318258ff19.
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.
Cross-sectional observational study.
Academic medical center.
Medical intensive care unit patients and their designated surrogates.
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.
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).
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.
危重症患者常因基础疾病和镇静药物的使用而导致决策能力受损。医疗保健提供者通常依赖代理人来做出医疗和参与临床研究的决策。然而，对于各种重症监护研究，代理人决策的准确性知之甚少。
横断面观察性研究。
学术医疗中心。
重症监护病房的患者及其指定的代理人。
患者被问及他们是否愿意同意参与假设研究，研究的复杂性逐渐增加，而代理人则独立表示他们是否愿意同意将患者纳入相同的场景。
总体而言，研究纳入了 69 名重症监护病房患者。代理人多数是患者的配偶（58%）或父母（22%）。随着研究风险的增加，同意参与研究的患者比例和同意让患者参与研究的代理人比例均下降（两种分析均 p <.001）。此外，随着研究风险的增加，患者和代理人之间的总体差异、假阴性率和假阳性率也增加（均 p <.001，p <.001 和 p =.049）。七个场景的κ 值均显示出中等以下的一致性（范围为 0.03-0.41）。
危重症患者及其代理人在参与各种类型的临床研究方案方面存在显著差异。这项研究的结果引发了对使用代理人同意将危重症患者纳入研究方案的担忧。
