Stopped: The study was terminated by the sponsor due to persistent delays in recruitment and data availability, including access to the healthcare resource utilization database, which made it difficult to generate meaningful outcomes.
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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in hospital resource utilization
Timeframe: 12-month pre- implantation of VNS device to 18-month post-implantation of VNS device