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

NIH刺激外周活动缓解状况(SPARC-V)倡议将主要关注 颈迷走神经刺激(VNS)。尽管VNS实现了它的第一个食品和药物管理局(FDA) 2001年在耐药癫痫中获得批准，2005年在难治性抑郁症中获得第二个适应症， VNS对公共卫生的影响微乎其微。超过125,000人正在使用临床VNS。这 与符合VNS条件的人群大小比例相对较低的摄取率表明患者对VNS 对这项技术的不良或未解决的伦理问题。VNS是一种独特的侵入性 神经调节需要一个VNS治疗脉冲发生器被外科植入胸壁和一个 隧道电极向迷走神经提供间歇性电刺激。VNS不同于其他 电神经调节形式的独特之处在于其侵袭性。与电休克治疗(ECT)相比 和深部脑刺激(DBS)，因为它通过脑神经而不是通过 皮质刺激，因此不需要像后者那样开颅手术。此外，适当的VNS治疗 与其他形式的电神经调节相比，ECT诱导的反应是延迟的 1个月的顺序和DBS最早在装置激活的同一天就能诱导运动反应。旷日持久的 反应轨迹在神经调节方面产生了伦理问题，特别是这项技术值得 进一步考虑，以了解VNS医疗决策。 Display/SPARC-V提供了一个独特的机会来观察大量预期植入的人群 使用VNS。这项研究将招募寻求迷走神经刺激治疗癫痫和难治性抑郁症的成年人 并在植入后进行观察，以表征VNS对周围系统的影响 心血管、免疫或代谢系统以及临床反应。这些患者提供了一个 独一无二的机会来描述以前未被审查的道德问题和对VNS的看法，而 准备开发更多外周适应症的技术。 我们提出了一种混合方法评估来表征可能影响VNS的特定伦理因素 VNS对其当前适应症的可接受性，并主动评估这些因素对#年新出现的适应症的影响 外周疾病状态。在一系列发展重点小组之后，半结构化的面试阶段 评估VNS在抑郁症、癫痫和预期外周指征中的伦理考虑 医生、病人和他们的照顾者，并进行主题分析。此外，我们将使用调查 评估污名、可接受性、风险、益处、侵袭性和护理障碍的方法 (定义为医疗决策指标)。这项工作将对未得到充分审查的VNS道德做出至关重要的贡献。 我们的建议将为更好地采用VNS治疗中枢神经系统疾病和 外周器官疾病。

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.