Therapeutic Misconception and the Ethics of Sham Surgery Controls in PD Research

PD 研究中的治疗误解和假手术控制伦理

• 批准号: 8026012
• 负责人: Scott Y Kim
• 金额: $ 32.84万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8026012
• 关键词: Accounting; Address; Affect; Attitude; Benefits and Risks; Cell Transplants; Clinical Trials; Complex; Consent; Consent Forms; Controlled Study; Data; Decision Making; Disease; Elderly; Elements; Enrollment; Ethical Issues; Ethicists; Ethics; Future; Gene Transfer; Health; Human Subject Research; Individual; Informed Consent; Intervention; Intervention Trial; Interview; Learning; Masks; Methods; Mission; Motivation; National Institute of Neurological Disorders and Stroke; Nature; Neurodegenerative Disorders; Neurologic; Operative Surgical Procedures; Parkinson Disease; Participant; Patients; Perception; Process; Protocols documentation; Research; Research Ethics; Research Subjects; Risk; Screening procedure; Structure; Study Subject; Techniques; Testing; Therapeutic; Work; base; control trial; design; expectation; insight; neurosurgery; novel; older patient; prospective; sham surgery; therapeutic misconception

DESCRIPTION (provided by applicant): Ethicists have raised concerns that elderly patients with a progressively debilitating disease such as Parkinson's disease (PD) may be too vulnerable for research that involves novel, invasive interventions (such as gene transfer and cell transplants) that use a controversial masking design, i.e., sham neurosurgical controls. A common ethical concern is that the subjects' desire for therapeutic benefit may compromise the quality of their decisions. Are these subjects laboring under a therapeutic misconception (TM), a phenomenon in which subjects conflate research with individualized treatment, or some related phenomena, e.g., seriously misestimating the risks and benefits of research participation? There is an increasing number of PD clinical trials proposing the sham control design, so this important ethical issue will continue to arise. This project proposes to study enrollees and decliners of four actual PD neurosurgical clinical trials that involve a sham surgery control. Because there is no standard method for assessing TM and indeed because it remains a controversial and evolving issue, this project's main aim is to describe in depth from the subjects' perspective their decision whether to participate in such studies. A semi-structured interview method (Conditional Probe Interview) has been developed to provide an in depth account of the subjects' motivations, expectations, understanding, and decision-making process-emphasizing the subjects' rationale for each and the relationship between them. We will conduct a combination of prospective and retrospective interviews; those subjects who decline after screening interviews will also be interviewed. Enrollees of the trials will also be followed longitudinally, so any changes in motivations, attitudes, or understanding can be assessed. A unique focus of this project is that the analysis will emphasize the entirety of the subject's narrative as the context for analyzing specific statements that may or may not indicate TM related phenomena. Thus, the subject becomes the primary unit of analysis in the interpretation of individual statements. A complementary qualitative and quantitative analytic approach will be used. By providing an in depth, context-sensitive account of how seriously ill neurological patients make participation decisions regarding research involving sham neurosurgery controls, this project will (1) provide invaluable insights for optimizing informed consent practices for future sham surgery controlled trials; and (2) clarify the key controversial aspects, and the complex contours of, TM and related phenomena. PUBLIC HEALTH RELEVANCE: This project addresses the ethical challenges of human subject research when subjects with serious illnesses are enrolled in clinical trials involving sham surgery controls. In particular, it will enhance the mission of NINDS by focusing on the ethics of sham surgery controls in Parkinson's disease neurosurgical trials-a design that is increasingly used in testing novel surgical interventions for PD. Specifically, the results of this study will provide important insights into how to minimize or even eliminate serious misconceptions or misunderstandings on the part of participants that may compromise the quality of their consent.

描述（由申请人提供）：伦理学家提出了一个问题，即患有进行性衰弱疾病（如帕金森病（PD））的老年患者可能太容易受到涉及使用有争议的掩蔽设计的新型侵入性干预（如基因转移和细胞移植）的研究的影响，即，假神经外科对照。一个常见的伦理问题是，受试者对治疗益处的渴望可能会损害他们决定的质量。这些受试者是否在治疗误解（TM）下工作，这是一种受试者将研究与个体化治疗混为一谈的现象，还是一些相关现象，例如，严重错误估计参与研究的风险和收益？越来越多的PD临床试验提出了假对照设计，因此这一重要的伦理问题将继续出现。本项目拟研究四个实际PD神经外科临床试验的入组者和下降者，这些试验涉及假手术对照。由于没有评估TM的标准方法，而且确实因为它仍然是一个有争议和不断发展的问题，本项目的主要目的是从受试者的角度深入描述他们是否参与此类研究的决定。一个半结构化的访谈方法（条件探测访谈）已经开发，以提供一个深入的科目的动机，期望，理解和决策过程，强调科目的每一个和它们之间的关系的基本原理。我们将进行前瞻性和回顾性访谈相结合;筛选访谈后拒绝的受试者也将接受访谈。试验的入组者也将被纵向跟踪，因此可以评估动机，态度或理解的任何变化。这个项目的一个独特的重点是，分析将强调主体的叙述的整体作为分析特定陈述的背景，这些陈述可能会或可能不会表明TM相关的现象。因此，主体成为解释个别陈述的主要分析单位。将采用一种互补的定性和定量分析方法。通过提供一个深入的，上下文敏感的帐户，重病神经系统患者如何作出参与决策的研究，涉及假神经外科手术对照，该项目将（1）提供宝贵的见解，优化知情同意的做法，为未来的假手术对照试验;（2）澄清的关键有争议的方面，和复杂的轮廓，TM和相关现象。公共卫生相关性：该项目解决了当患有严重疾病的受试者参加涉及假手术对照的临床试验时，人类受试者研究的伦理挑战。特别是，它将加强NINDS的使命，通过关注帕金森病神经外科试验中假手术对照的伦理学-一种越来越多地用于测试PD新手术干预的设计。具体来说，本研究的结果将为如何最大限度地减少甚至消除参与者可能损害其同意质量的严重误解或误解提供重要见解。