A Non-interventional Study Describing the Healthcare Resource Utilisation and Clinical Outcomes Associated With LivaNova Vagus Nerve Stimulation Therapy in the UK.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- LivaNova
- 入组人数
- 97
- 试验地点
- 5
- 主要终点
- Change in hospital resource utilization
研究概览
简要总结
This is a UK, multi-center, non-interventional study based on the use of health service administrative and medical records (paper-based and/or electronic, as applicable) along with the use of prospectively collected subject-reported outcomes on experience with use of VNS therapy using validated and bespoke self-completion questionnaires. Data for hospital resource utilisation will be extracted from the Hospital Episode Statistics (HES) database.
详细描述
Failure to control seizures in subjects with treatment resistant epilepsy can have a significant burden on the healthcare system. Vagus Nerve Stimulation (VNS) is an adjunctive treatment for patients with drug resistant epilepsy and is reported to reduce the frequency of seizures in adults and children. However, real-world data on healthcare resource utilization by patients with treatment-resistant epilepsy and their clinical outcomes prior to and post VNS device implantation in the UK are limited. The current study aims to describe the resource utilization and clinical outcomes prior to and following the implantation of different VNS devices (Demipulse®/Aspire HC®, Aspire SR® and SenTiva®) in subjects with drug resistant epilepsy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Living subjects who meet all of the following criteria will be considered for enrolment:
- •Clinical diagnosis of drug resistant epilepsy
- •Subjects who have had their first VNS device (Demipulse®/Aspire HC®, Aspire SR® and SenTiva®) implanted at least 18 months prior to their enrolment in the study data (with no change in generator, battery or lead).
- •For SenTiva® and Aspire SR®, AutoStim was first activated within 1 month of implantation.
- •For SenTiva®, scheduled dosing mode was activated within 1 month of implantation.
- •Subjects must be able and willing to provide informed consent; subjects aged 7-12 years old and 13-15 years old will be provided with appropriate information and consent forms to explain the study in age appropriate language. These subjects will be asked to provide their assent to take part in the study, with consent provided by their parent/carer. Subjects under 7 years will be included in the study with consent from their parent/carer. For adult subjects (≥16 years) lacking the mental capacity to consent, advice about participation will be sought from an appropriate consultee, according to the Mental Capacity Act
- •Adult and paediatric subjects (aged over 2.5 years at study enrolment) with available medical records for at least 12 months prior to VNS device implantation.
排除标准
- •Subjects whose medical records are not available for review.
- •Deceased subjects.
结局指标
主要结局
Change in hospital resource utilization
时间窗: 12-month pre- implantation of VNS device to 18-month post-implantation of VNS device
Description of change in hospital resource utilization from the 12-month period pre- to the 18-month period post-implantation of VNS device in subjects with drug resistant epilepsy.
次要结局
- Initial titration period for each VNS device(18-month period post-implantation of VNS device.)
- Characteristics and demographics of subjects at the time of implantation of VNS Therapy.(Implant procedure)
- Change in Seizure information using ILAE classification(12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device)
- Change of AED treatments(Change from 12-month pre- implantation of VNS device to 18-month post-implantation of VNS device)
- Change in Seizure severity(Change from 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device)
- Change in Seizure frequency(Change from 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device)
- Change in frequency of status epilepticus.(Change from 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device)