Impaired decision-making ability in subjects with Alzheimer's disease and willingness to participate in research
Impaired decision-making ability in subjects with Alzheimer's disease and willingness to participate in research
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DOI：
10.1176/appi.ajp.159.5.797
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发表时间：
2002-05-01
影响因子：
17.7
通讯作者：
Caine, ED
中科院分区：
文献类型：
--
作者：
Kim, SYH;Cox, C;Caine, ED
目的：对于决策障碍者（例如患有阿尔茨海默病的人）参与研究的伦理问题仍然存在。这些人可能对特定研究方案的负担和风险判断不佳，因为即使是完全无行为能力的人也不能在他们反对的情况下参加研究，他们的偏好传达了重要的道德信息。作者研究了认知和决策障碍对阿尔茨海默病患者参与研究意愿的影响。方法。研究人员测量了 34 名患有轻度至轻度/中度阿尔茨海默氏病的受试者和 14 名健康老年人的对照受试者的认知状态、决策能力以及参与不同风险/收益概况的四种假设研究方案的意愿。采用单变量和多变量方法分析认知和决策能力受损对参与研究意愿的影响。结果：对于四种假设方案中的三种，阿尔茨海默病患者和健康对照受试者的参与意愿没有差异。在两组中，随着风险的增加，意愿下降。在阿尔茨海默病组中，决策障碍程度较高往往意味着参与研究的意愿较低，即使在调整了认知障碍、性别和教育程度后也是如此。结论：因阿尔茨海默病导致决策障碍的人作为一个群体能够区分不同风险/收益状况的研究方案。由于决策能力下降可能预示着参与研究的意愿下降，因此阿尔茨海默病研究的知情同意程序应对这种可能性敏感。
Objective: Ethical concerns persist over research participation of decisionally impaired persons, such as those suffering from Alzheimer's disease. Such persons may be poor judges of the burdens and risks of specific research protocols, Since even decisionally incapacitated persons cannot be enrolled in studies against their objection, their preferences convey important ethical information. The authors examined the effects of cognitive and decisional impairment on willingness to participate in research among persons with Alzheimer's disease.Method. Cognitive status, decision-making ability, and willingness to participate in four hypothetical research protocols of varying risk/benefit profiles were measured in 34 subjects with mild to mild/moderate Alzheimer's disease and 14 healthy elderly comparison subjects. Univariate and multivariate methods were used to analyze the effects of impairment in cognitive and decision-making abilities on willingness to participate in research.Results: There were no differences in willingness to participate found between the Alzheimer's and the healthy comparison subjects for three of the four hypothetical protocols. in both groups, willingness declined as risk increased. Within the Alzheimer's disease group, the presence of greater decisional impairment tended to predict less willingness to participate in research, even after adjusting for cognitive impairment, gender, and education.Conclusions: Persons with decisional impairment due to Alzheimer's disease are as a group able to distinguish between research protocols of varying risk/benefit profiles. Because declining decision-making abilities may predict declining willingness to participate in research, informed consent procedures for Alzheimer's disease research should be sensitive to this possibility.