Pediatric Deep Brain Stimulation: Neuroethics and Decision Making: Training Supplement

项目摘要 脑深部电刺激（DBS）和自适应DBS系统目前用于肌张力障碍、癫痫、 和抽动秽语综合征，其用途正在扩大到其他神经精神疾病。然而，没有 经验神经伦理学研究，重点是儿科DBS（pDBS），也没有任何决策支持工具来指导 家庭和临床医生通过这个艰难的决策过程。未成年人（<18岁）的DBS提高了 具有挑战性的伦理问题，包括DBS对发展中未成年人的代理和个人身份的影响， 临床和心理社会风险和益处的适当平衡，负责任的代理决策，角色 未成年人参与决策，并获得未成年人的知情同意。神经伦理学的实证研究 因此，有必要制定明智的政策来管理这些道德问题。决策支持工具或“决策 艾滋病”（DA）在这种复杂的临床背景下也是至关重要的，因为它们已被证明会增加患者 对干预措施的理解，风险认知的准确性，促进决策更加一致 与患者的价值观，并改善与临床医生的沟通。 这项研究的长期目标是制定出具有道德意义和道德合理性的管理计划 和工具，以解决紧迫的神经伦理学问题所提出的临床使用侵入性神经调节， 未成年人我们将研究神经伦理学问题（目标1）和家庭的决策和信息需求（目标2） 通过与pDBS利益相关者进行深入的半结构化访谈，了解运动障碍（肌张力障碍） 和精神障碍（强迫症; OCD）。肌张力障碍是最常见的应用 pDBS和FDA人道主义器械豁免（HDE）规定DBS用于难治性未成年人 肌张力障碍强迫症是目前FDA批准使用DBS治疗的唯一精神疾病， HDE（成人）和超过100，000名儿童患有难治性强迫症。我们将采访1） 接受DBS治疗肌张力障碍的未成年人，接受DBS治疗难治性肌张力障碍的未成年人， 拒绝，未成年人与难治性肌张力障碍谁可能是DBS的候选人; 2）照顾者的每一个 上述三组儿科患者;和3）难治性 肌张力障碍我们还将采访1）患有难治性强迫症的未成年人，如果可以的话，他们可能是DBS的候选人， 2)他们的照顾者，和3）具有相关专业的临床医生。最后，我们将开发决策辅助（DA）， 考虑DBS治疗肌张力障碍的护理人员，pDBS的最常见用途（目标3）。这位检察官将 神经伦理学问题（目标1）和决策需求（目标2），并将根据渥太华决定制定 支持框架和国际患者决策辅助标准。这项研究填补了一个关键的空白， 提供有关家庭、未成年人和临床医生面临的伦理问题和权衡的关键信息 在考虑pDBS时，它也是做出明智的、以患者为中心的决策的重要资源。

Project Summary Deep brain stimulation (DBS) and adaptive DBS systems are currently used in children with dystonia, epilepsy, and Tourette Syndrome, and its use is expanding to other neuropsychiatric conditions. Yet, there is no empirical neuroethics research that focuses on pediatric DBS (pDBS) nor any decision support tools to guide families and clinicians through this difficult decision-making process. DBS in minors (<18 years old) raises challenging ethical issues including the impact of DBS on agency and personal identity in developing minors, proper balance of clinical and psychosocial risks and benefits, responsible surrogate decision making, the role of minors in decision making, and obtaining informed assent from minors. Empirical neuroethics research is necessary to develop informed policies to manage these ethical issues. Decision support tools or “decision aids” (DA) are also critical in this complex clinical context because they have been shown to increase patient understanding of interventions, accuracy of risk perceptions, promote decisions that are more aligned with patients’ values, and improve communication with clinicians. The long-term goal of this research is to develop empirically-informed and ethically-justified management plans and tools for addressing pressing neuroethics issues raised by the clinical use of invasive neuromodulation in minors. We will examine neuroethics issues (Aim 1) and decisional and informational needs of families (Aim 2) by conducting in-depth semi-structured interviews with pDBS stakeholders for a movement disorder (dystonia) and a psychiatric disorder (obsessive-compulsive disorder; OCD). Dystonia is the most common application of pDBS and there is an FDA humanitarian device exemption (HDE) for the use of DBS in minors with refractory dystonia. OCD is currently the only psychiatric disorder for which the FDA has approved the use of DBS under an HDE (for adults) and more than 100,000 children in the U.S. suffer from refractory OCD. We will interview 1) minors who underwent DBS for dystonia, minors for whom DBS for refractory dystonia was offered but declined, minors with refractory dystonia who may be DBS candidates; 2) caregivers of each of the three groups of pediatric patients listed above; and 3) clinicians of pediatric patients with refractory dystonia. We will also interview 1) minors with refractory OCD who could be DBS candidates if it was available, 2) their caregivers, and 3) clinicians with relevant specialties. Finally, we will develop a decision aid (DA) for caregivers considering DBS for dystonia, the most common use of pDBS (Aim 3). This DA will address neuroethics issues (Aim 1) and decisional needs (Aim 2) and will be developed using the Ottawa Decision Support Framework and the International Patient Decision Aids Standards. This study fills a critical gap by providing key information about the ethical issues and tradeoffs facing families, minors, and clinicians alike when considering pDBS, as well as an important resource for making informed, patient-centered decisions.