Ability of family members to predict patient's consent to critical care research
Ability of family members to predict patient's consent to critical care research
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DOI：
10.1007/s00134-007-0582-6
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发表时间：
2007-05-01
影响因子：
38.9
通讯作者：
Azoulay, Elie
中科院分区：
文献类型：
--
作者：
Ciroldi, Magali;Cariou, Alain;Azoulay, Elie
目的：欧盟指令规定指定代理人，代理人可以同意或拒绝将无行为能力的患者纳入研究。在重症监护病房（ICU）中，代理人代表患者同意研究的准确性尚未得到评估。方法：2004年7月至10月对法国Famirea研究组的10例icu进行前瞻性多中心研究。两项假设的研究同时提交给患者，代理和医生的时候，病人出院到病房。一项研究对患者的风险最小，另一项研究对患者的风险大于最小。结果：在最小风险研究中，32%的病例存在患者-代理人差异，25%的病例存在患者-医生差异。高于最低风险研究的相应数据为42%和46%。收集到的变量在有和没有患者-替代物差异的病例之间没有显著差异。结论：在三分之一到近一半的病例中，指定作为替代决策者的家庭成员可能无法准确地同意危重患者的研究。
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.