Evaluating the Effectiveness and Cost-Effectiveness of Seizure Dogs in Persons With Medically Refractory Epilepsy in the Netherlands: Study Protocol for a Stepped Wedge Randomized Controlled Trial (EPISODE)
| Autor: | Wester, V., Groot, S. de, Kanters, T., Wagner, L., Ardesch, J., Ramos, I.C., Enders-Slegers, M.J., Ruiter, M. de, Cessie, S. le, J. los, Papageorgiou, G., Exel, J. van, Versteegh, M., Mourits, J.M.H., Hurk-van Schadewijk, J.A.G.M. van den, Wit, U. de, Marell, H.M.G., Verhoeven, H., EPISODE-Team |
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| Přispěvatelé: | Health Economics (HE), Health Technology Assessment (HTA), Epidemiology, Applied Economics, Department of Clinical Psychology, RS-Research Line Clinical psychology (part of IIESB program) |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
HUMAN HEALTH STRESS economic evaluation Cost effectiveness stepped wedge randomized controlled trial SUDDEN UNEXPECTED DEATH lcsh:RC346-429 law.invention 03 medical and health sciences Epilepsy 0302 clinical medicine Quality of life Randomized controlled trial law PEOPLE QUALITY-OF-LIFE seizure dog Medicine 030212 general & internal medicine Reimbursement Disease burden lcsh:Neurology. Diseases of the nervous system RISK business.industry MORTALITY Caregiver burden refractory epilepsy medicine.disease PREVALENCE Neurology Economic evaluation Emergency medicine ALERT DOGS Neurology (clinical) PET OWNERSHIP business 030217 neurology & neurosurgery study protocol |
| Zdroj: | Frontiers in Neurology, 11(3). Frontiers Media S.A. Frontiers in Neurology, 11. FRONTIERS MEDIA SA Frontiers in Neurology, 11:3. Frontiers Media S.A. Wester, V, de Groot, S, Kanters, T, Wagner, L, Ardesch, J, Corro Ramos, I, Enders-Slegers, M-J, de Ruiter, M, le Cessie, S, Los, J, Papageorgiou, G, van Exel, J & Versteegh, M 2020, ' Evaluating the Effectiveness and Cost-Effectiveness of Seizure Dogs in Persons With Medically Refractory Epilepsy in the Netherlands : Study Protocol for a Stepped Wedge Randomized Controlled Trial (EPISODE) ', Frontiers in Neurology, vol. 11, 3 . https://doi.org/10.3389/fneur.2020.00003 Frontiers in Neurology Frontiers in Neurology, Vol 11 (2020) |
| ISSN: | 1664-2295 |
| DOI: | 10.3389/fneur.2020.00003 |
| Popis: | Background: Epilepsy is associated with a high disease burden, impacting the lives of people with epilepsy and their caregivers and family. Persons with medically refractory epilepsy experience the greatest burden, suffering from profound physical, psychological, and social consequences. Anecdotal evidence suggests these persons may benefit from a seizure dog. As the training of a seizure dog is a substantial investment, their accessibility is limited in the absence of collective reimbursement as is seen in the Netherlands. Despite sustained interest in seizure dogs, scientific knowledge on their benefits and costs remains scarce. To substantiate reimbursement decisions stronger evidence is required. The EPISODE study aims to provide this evidence by evaluating the effectiveness and cost-effectiveness of seizure dogs in adults with medically refractory epilepsy. Methods: The study is designed as a stepped wedge randomized controlled trial that compares the use of seizure dogs in addition to usual care, with usual care alone. The study includes adults with epilepsy for whom current treatment options failed to achieve seizure freedom. Seizure frequency of participants should be at least two seizures per week, and the seizures should be associated with a high risk of injury or dysfunction. During the 3 year follow-up period, participants receive a seizure dog in a randomized order. Outcome measures are taken at multiple time points both before and after receiving the seizure dog. Seizure frequency is the primary outcome of the study and will be recorded continuously using a seizure diary. Questionnaires measuring seizure severity, quality of life, well-being, resource use, productivity, social participation, and caregiver burden will be completed at baseline and every 3 months thereafter. The study is designed to include a minimum of 25 participants. Discussion: This protocol describes the first randomized controlled trial on seizure dogs. The study will provide comprehensive data on the effectiveness and cost-effectiveness of seizure dogs in adults with medically refractory epilepsy. Broader benefits of seizure dogs for persons with epilepsy and their caregivers are taken into account, as well as the welfare of the dogs. The findings of the study can be used to inform decision-makers on the reimbursement of seizure dogs. |
| Databáze: | OpenAIRE |
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