ENROLLING IN DEEP BRAIN STIMULATION RESEARCH FOR DEPRESSION: INFLUENCES ON POTENTIAL SUBJECTS' DECISION MAKING
ENROLLING IN DEEP BRAIN STIMULATION RESEARCH FOR DEPRESSION: INFLUENCES ON POTENTIAL SUBJECTS' DECISION MAKING
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DOI：
10.1002/da.20916
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发表时间：
2012-02-01
影响因子：
7.4
通讯作者：
Dunn, Laura B.
中科院分区：
文献类型：
--
作者：
Christopher, Paul P.;Leykin, Yan;Dunn, Laura B.
背景资料：关于DBS治疗难治性抑郁症（TRD）的早期临床试验的伦理问题包括参与者的入组决定可能是出于对个人利益或风险最小化的不切实际的期望。方法：对考虑参与两项DBS试验的26名成年人样本进行主题分析。对这些潜在DBS试验参与者决策的影响来自对临床研究麦克阿瑟能力评估工具（MacCAT-CR）中提出的问题的回答，这是一种半结构化访谈，旨在评估同意研究的决策能力。结果如下：参与者引用了许多因素作为其入组决策的影响因素，包括认为缺乏其他治疗选择，采取主动的愿望，对DBS作为一种新型治疗的信念，DBS疗效的可能性，希望的改善，DBS或临床试验参与的潜在风险和缺点，以及利他主义。没有一个人表达了一套动机或影响因素，这表明妥协的决策能力或减少决策的非自愿性。结论：这些结果表明，个人决定参加DBS治疗TRD的早期试验是基于一些复杂的，有时是特殊的考虑因素，并且所研究的试验使用了足够强大的知情同意程序。这些研究结果提供了证据表明，DBS的新兴研究领域可以以道德上合理的方式推进，前提是与参与者讨论试验的保障措施和流程得到了认真和积极的实施。抑郁和焦虑29：139-146，2012. (C)2012 Wiley Periodicals，Inc.
Background: Ethical concerns regarding early-phase clinical trials of DBS for treatment-resistant depression (TRD) include the possibility that participants' decisions to enroll might be motivated by unrealistic expectations of personal benefit or minimization of risks. Methods: Thematic analyses were conducted on a sample of 26 adults considering participation in two DBS trials. Influences on the decision making of these potential DBS trial participants were derived from responses to questions posed in the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), a semi-structured interview designed to evaluate decisional capacity to consent to research. Results: Participants cited numerous factors as influential in their enrollment decisions, including perceived lack of other treatment options, desire to take initiative, beliefs about DBS as a novel treatment, possibility of DBS efficacy, hoped-for improvements, potential risks and disadvantages of DBS or clinical trial participation, and altruism. No individual expressed a set of motivations or influencing factors that suggested compromised decision-making capacity or diminished voluntariness of decision making. Conclusions: These results suggest that individuals make the decision to enroll in early-phase trials of DBS for TRD based on a number of complex and sometimes idiosyncratic considerations, and that the trials that were studied utilized sufficiently robust informed consent processes. These findings offer evidence that the emerging research area of DBS can be advanced in an ethically sound manner, provided that safeguards and processes for discussing trials with participants are carefully and proactively enacted. Depression and Anxiety 29: 139-146, 2012. (C) 2012 Wiley Periodicals, Inc.