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病情 (SPARC-V) 计划将主要关注 尽管 VNS 首次获得美国食品和药物管理局 (FDA) 认证。 2001年在耐药性癫痫方面获得批准，2005年在难以治疗的抑郁症方面获得第二个适应症， VNS 对公共健康的影响微乎其微，超过 125,000 人正在使用临床 VNS。 与符合 VNS 资格的人群规模相比，其接受率相对较低，这表明患者感知到了 VNS VNS 是一种独特的侵入性形式。 神经调节需要通过手术将 VNS 治疗脉冲发生器植入胸壁和 向迷走神经提供间歇性电刺激的隧道电极不同于其他电极。 与电休克治疗 (ECT) 相比，电神经调节的形式具有独特的侵入性。 和深部脑刺激（DBS），因为它通过脑神经而不是间接影响大脑 皮质刺激，因此不需要像后者那样进行开颅手术，此外，还需要足够的 VNS 治疗。 与其他形式的电神经调节相比，ECT 诱导反应延迟 1 个月的顺序和 DBS 最早在设备激活的同一天就诱导运动反应。 反应轨迹在神经调节中产生伦理问题，特别是该技术值得 进一步考虑以了解 VNS 医疗保健决策。 REVEAL/SPARC-V 提供了观察大量预期植入的独特机会 该研究将招募寻求 VNS 治疗癫痫和难以治疗的抑郁症的成年人。 并在植入后观察它们，以表征 VNS 对周围系统（例如 除了临床反应之外，这些患者还提供心血管、免疫或代谢系统。 独特的机会来描述以前未经审查的道德问题和 VNS 的看法，同时 技术准备开发用于其他外围适应症。 我们提出了一种混合方法评估来描述可能影响 VNS 的特定道德因素 VNS 对其当前适应症的可接受性，并主动评估这些因素以发现新兴适应症 在一系列发展焦点小组之后，进入半结构化访谈阶段。 评估 VNS 在抑郁症、癫痫和预期外周适应症方面的伦理考虑 此外，我们将使用调查来进行主题分析。 评估耻辱感、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）。这项工作将对 VNS 的道德审查做出重大贡献。 我们的提案将为更好地采用 VNS 治疗中枢神经系统疾病和 周围器官疾病。