A Single-centre, Non-interventional, Retrospective Study to Describe the IMPACT of AspireSR® for Vagus Nerve Stimulation (VNS) Therapy on Healthcare Resource Utilisation and Clinical Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- LivaNova
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Descriptive comparison of healthcare resource use (HCRU)
研究概览
简要总结
This is a retrospective non-interventional study to describe the HCRU and clinical outcomes before and after AspireSR® device implantation in subjects with drug resistant epilepsy at the Queen Elizabeth Hospital, Birmingham (QEHB).
详细描述
Real-world data on healthcare resource use (HCRU) for subjects with treatment-resistant epilepsy and their clinical outcome prior to- and post-VNS device implantation in the UK are limited.
The current study aims to describe and compare the secondary HCRU and clinical outcomes prior to and following AspireSR® device implantation in subjects with drug resistant epilepsy.
Retrospectively-collected data from hospital medical records (paper-based and/or electronic, as appropriate) will be used to describe subject characteristics, disease control and clinical outcomes. All secondary HCRU data will be extracted from the Hospital Episode Statistics (HES) database by Harvey Walsh Ltd (HW, trading under OPEN VIE). Primary HCRU data will be requested from the subjects' general practitioners (GPs).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years at AspireSR® device implantation.
- •VNS device AspireSR® implantation for the first time or battery change from a previous model to AspireSR® at least 24 months prior to the start of retrospective data collection from medical records.
- •Subjects for whom written informed consent has been provided for researcher access to their medical records and extraction of data from HES (if the subject is living and has capacity to consent) or advice from a consultee (if the subject is living but lacks capacity to consent).
- •Subjects with available medical history for at least 24 months prior to Aspire SR® implantation.
排除标准
- •Living subjects for whom consent for researcher access to medical records and extraction of data from HES has not been obtained.
- •Deceased subjects.
结局指标
主要结局
Descriptive comparison of healthcare resource use (HCRU)
时间窗: 24 months before and after device implantation
Descriptive comparison of secondary HCRU in the 24 month periods before and after AspireSR® device implantation
次要结局
未报告次要终点