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刺激外周活动以缓解疾病（SPARC-V）计划将主要关注 颈部迷走神经刺激（VNS）。尽管VNS实现了其第一个食品和药物管理局（FDA） 2001年在抗药性癫痫中清除，2005年在难以治疗的抑郁症中清除， VNS对公众健康的影响微乎其微。超过12.5万人正在使用临床VNS。这 与适合VNS的人群规模成比例的相对较低的摄取表明患者认为VNS 对这项技术的道德关注很差或未得到解决。VNS是一种独特的侵入性 神经调节需要将VNS治疗脉冲发生器手术植入胸壁， 将间歇性电刺激传递到迷走神经的隧道电极。VNS与其他不同 电神经调节的形式在其侵入性方面是独一无二的。与电休克治疗（ECT）相比 和脑深部电刺激（DBS），因为它通过脑神经间接影响大脑，而不是通过脑神经刺激大脑。 因此它不需要像后者那样进行开颅手术。此外，适当的VNS治疗 与其他形式的电神经调节相比，ECT诱导的反应延迟， 1个月的顺序和DBS诱导运动反应早在器械激活的同一天。旷日持久的 反应轨迹在神经调节中产生了伦理问题，特别是这项技术值得关注。 进一步考虑，以了解VNS医疗保健决策。 REVEAL/SPARC-V提供了一个独特的机会来观察预期植入的大量人群 在VNS该研究将招募寻求VNS治疗癫痫和难以治疗抑郁症的成年人 并在植入后观察它们，以表征VNS对周围系统的影响，如 心血管、免疫或代谢系统，以及它们的临床反应。这些患者提供了一个 独特的机会来描述以前未经审查的道德问题和对VNS的看法， 准备开发用于其它外周适应症的技术。 我们提出了一种混合方法的评估，以表征VNS的具体道德因素，可以影响 VNS对于其当前适应症的可接受性，并积极评估这些因素对于新出现的适应症， 外周疾病状态。经过一系列的发展焦点小组，半结构化面试阶段 评估VNS在抑郁症、癫痫和前瞻性外周适应症中的伦理考虑， 医生、病人和他们的照顾者，并进行专题分析。此外，我们将使用调查 评估对耻辱、可接受性、风险、益处、侵入性和护理障碍的看法的方法 （定义为医疗决策指标）。这项工作将至关重要地有助于欠审查的伦理VNS。 我们的建议将为更好地采用VNS治疗中枢神经系统疾病奠定基础， 外周器官疾病