The ethics of research on deep brain stimulation for depression: decisional capacity and therapeutic misconception

The ethics of research on deep brain stimulation for depression: decisional capacity and therapeutic misconception
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DOI:
10.1111/j.1749-6632.2012.06596.x
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发表时间:
2012-01-01
期刊:
BRAIN STIMULATION IN NEUROLOGY AND PSYCHIATRY
影响因子:
--
通讯作者:
Appelbaum, Paul S.
Appelbaum, Paul S.
中科院分区:
其他
文献类型:
--
作者:
Fisher, Carl Erik;Dunn, Laura B.;Appelbaum, Paul S.

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深部脑刺激(DBS)治疗难治性抑郁症的研究似乎很有希望,但人们对严重抑郁症患者的决策能力以及他们对研究的潜在误解提出了担忧。我们使用麦克阿瑟临床研究能力评估工具(MacArthur Competence Assessment Tool for Clinical research, MacCAT-CR)对31名DBS研究参与者进行了评估,这是一种经过验证的能力测量方法,并使用了一种测量治疗误解的量表,这种误解发生在受试者不认识治疗和临床研究之间的关键差异时。探讨与基线抑郁症状的相关性。受试者在MacCAT-CR上的表现很好,但治疗上的误解仍然很明显。基线抑郁评分与治疗误解总分之间存在显著的相关性。对开放式提示的回答揭示了与风险、收益和个性化预期相关的令人放心和担忧的陈述。即使是严重抑郁症患者也没有表现出同意DBS研究的能力受损。然而,治疗上的误解仍然普遍存在。
Research on deep brain stimulation (DBS) for treatment-resistant depression appears promising, but concerns have been raised about the decisional capacity of severely depressed patients and their potential misconceptions about the research. We assessed 31 DBS research participants with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), a well-validated capacity measure, and with a scale to measure therapeutic misconception, which occurs when subjects do not recognize key differences between treatment and clinical research. Correlations with baseline depressive symptoms were explored. Subjects' performance on the MacCAT-CR was excellent, but therapeutic misconception was still apparent. A trend toward significance was found in the correlation between baseline depression ratings and total therapeutic misconception score. Responses to open-ended prompts revealed both reassuring and concerning statements related to expectations of risk, benefit, and individualization. Even severely depressed patients did not manifest impairments in their capacity to consent to DBS research. Therapeutic misconception, however, remained prevalent.