IMPACT of AspireSR® for VNS Therapy on Healthcare Resource Utilisation and Clinical Outcomes.

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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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.

Conditions
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Epilepsy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Living subjects for whom consent for researcher access to medical records and extraction of data from HES has not been obtained. Deceased subjects.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1 (new insertions cohort)<br>Subjects who have had Aspire SR® implanted as their first VNS model. | |
| Cohort 2 (battery change cohort)<br>Subjects who have had their VNS battery changed from a previous model to Aspire SR®. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive comparison of healthcare resource use (HCRU) | Descriptive comparison of secondary HCRU in the 24 month periods before and after AspireSR® device implantation | 24 months before and after device implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VNS, Drug Resistant Epilepsy, Vagus Nerve Stimulation, AspireSR®, Health Care Utilization, DRE