Exploring the Attitudes, Barriers, Concerns, Differences, and Ethics (ABCDEs) of Healthcare Decision Making in Prospective Peripheral Indications for Vagus Nerve Stimulation Patients

探索迷走神经刺激患者预期外周适应症中医疗决策的态度、障碍、担忧、差异和道德 (ABCDE)

• 批准号: 10789644
• 负责人: Lynn E Eberly
• 金额: $ 6.08万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-23 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10789644
• 关键词: Address; Adoption; Adult; Affect; Anatomy; Attitude; Award; Brain; Cardiovascular system; Caregivers; Catalogs; Central Nervous System; Cervical; Chest wall structure; Clinical; Complement; Cranial Nerves; Craniotomy; Data; Data Set; Decision Making; Deep Brain Stimulation; Development; Devices; Disease; Electric Stimulation; Electroconvulsive Therapy; Electrodes; Eligibility Determination; Enrollment; Epilepsy; Ethical Issues; Ethics; Evaluation; Focus Groups; Funding; Gatekeeping; Health Care Ethics; Healthcare; Heart failure; Human; Immune; Immune System Diseases; Immunologics; Implant; Individual; Interview; Intractable Epilepsy; Knowledge; Medical; Mental Depression; Metabolic; Metabolic Diseases; Methods; Motor; Neurologic; Neurologist; Neurosurgeon; Newly Diagnosed; Operative Surgical Procedures; Organ; Parents; Participant; Patient Recruitments; Patients; Perception; Peripheral; Pharmaceutical Preparations; Phase; Physicians; Physiologic pulse; Population; Population Sizes; Process; Psychiatrist; Public Health; Recommendation; Research; Risk; Series; Site; Standardization; Structure; Survey Methodology; System; Technology; Transcranial magnetic stimulation; United States Food and Drug Administration; United States National Institutes of Health; Vagus nerve structure; Work; barrier to care; behavioral health; cranium; depressed patient; design; implantable device; implantation; insight; neuroregulation; physical conditioning; programs; prospective; recruit; response; social stigma; treatment comparison; treatment response; uptake; vagus nerve stimulation

The NIH Stimulating Peripheral Activity to Relieve Conditions (SPARC-V) initiative will primarily focus on cervical vagus nerve stimulation (VNS). Despite VNS achieving its first Food and Drug Administration (FDA) clearance in 2001 in drug resistant epilepsy and a second indication in difficult to treat depression in 2005, VNS has made minimal public health impacts. Over 125,000 individuals are utilizing clinical VNS. This relatively low uptake in proportion to the size of the population eligible for VNS suggests patients perceive VNS poorly or have unaddressed ethical concerns regarding this technology. VNS is a unique form of invasive neuromodulation requiring a VNS therapy pulse generator to be surgically implanted in the chest wall and a tunneled electrode that delivers intermittent electrical stimulation to the vagus nerve. VNS differs from other forms of electrical neuromodulation uniquely in its invasiveness. Compared to electroconvulsive therapy (ECT) and deep brain stimulation (DBS) in that it indirectly affects the brain through a cranial nerve rather than cortical stimulation so it does not require craniotomy like the latter. Additionally, adequate VNS therapy response is delayed compared to other forms of electrical neuromodulation with ECT inducing response in the order of 1 mo and DBS inducing motor response as early as the same day of device activation. The protracted response trajectory generates ethical issues in neuromodulation particular to this technology deserving of further consideration in order to understand VNS healthcare decision making. REVEAL/SPARC-V offers a unique opportunity to observe a large population anticipating implantation with VNS. The study will recruit adults seeking VNS therapy for both epilepsy and difficult to treat depression and observe them after implantation to characterize VNS’s effects on peripheral systems such as the cardiovascular, immunologic or metabolic systems in addition to their clinical response. These patients offer a unique opportunity to characterize previously unexamined ethical issues and perceptions of VNS while the technology is poised to be developed for additional peripheral indications. We propose a mixed-methods evaluation to characterize VNS specific ethical factors that can impact VNS acceptability for its current indications and to proactively assess these factors for emerging indications in peripheral disease states. After a series of development focus groups a semi structured interview phase assess VNS ethical considerations in depression, epilepsy and prospective peripheral indications in groups of physicians, patients and their caregivers and perform thematic analysis. Additionally, we will use survey methods to assess perceptions of stigma, acceptability, risks,benefits,invasiveness, and barriers to care (defined as medical decision metrics). This work will crucially contribute to the under-examined ethics of VNS. Our proposal will set the stage for better adoption of VNS for both central nervous system illnesses and peripheral organ diseases.

NIH刺激外围活动以缓解条件（SPARC-V）倡议将主要重点 在宫颈迷走神经刺激（VNS）上。尽管VNS达到了第一个食品和药物管理局（FDA） 2001年清除耐药性癫痫的清除和2005年难以治疗抑郁症的第二种指示， VNS对公共卫生的影响最小。超过125,000个人正在使用临床VN。这 相关的低摄取与有资格的VN人口的大小成比例的低摄取表明患者感知VNS 关于这项技术的不良或尚未完成的道德问题。 VNS是一种侵入性的独特形式 神经调节需要将VNS治疗脉冲发生器手术植入胸壁和A 将间歇性电刺激向迷走神经传递的隧道电极。 VN与其他 电神经调节的形式在其侵入性方面独特。与电击疗法（ECT）相比 和深脑刺激（DB），因为它通过颅神经间接影响大脑 皮质刺激，因此不需要像以后的颅骨切开术。另外，足够的VNS治疗 与其他形式的电神经调节相比，反应延迟 1 MO和DBS的顺序早在设备激活的同一天就诱导了运动响应。旷日持久 响应轨迹在神经调节中产生道德问题，特定于该技术应得的 进一步考虑以了解VNS医疗保健决策。 揭示/sparc-v提供了一个独特的机会，可以观察大量人口预期植入 与vns。该研究将招募寻求VNS治疗的成年人癫痫和难以治疗抑郁症 并在植入后观察它们，以表征VNS对外围系统的影响 心血管，免疫或代谢系统除了它们的临床反应。这些患者提供 独特的机会来表征以前未见的道德问题和对VN的看法，而 技术被中毒以开发用于其他外围指示。 我们提出了混合方法评估，以表征VNS特定的伦理因素，以影响可能影响 VNS的当前指示可接受性，并主动评估这些因素的因素 外围疾病状态。经过一系列发展焦点后，一个半结构化访谈阶段 评估VNS在抑郁，癫痫和前瞻性外围指示中的伦理考虑因素 医师，患者及其护理人员并进行主题分析。此外，我们将使用调查 评估对污名，可接受性，风险，福利，侵入性和护理障碍的看法的方法 （定义为医疗决策指标）。这项工作将完全有助于VN的伦理不足。 我们的建议将为更好地采用中枢神经系统疾病和 外围器官疾病。