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Open Access Study protocol

Research into the (Cost-) effectiveness of the ketogenic diet among children and adolescents with intractable epilepsy: design of a randomized controlled trial

Reina JA de Kinderen12*, Danielle AJE Lambrechts3, Debby Postulart2, Alfons GH Kessels4, Jos GM Hendriksen56, Albert P Aldenkamp2567, Silvia MAA Evers1 and Marian HJM Majoie2367

Author Affiliations

1 Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands

2 Department of Research and Development, Epilepsy Centre Kempenhaeghe, Heeze, The Netherlands

3 Department of Neurology, Epilepsy Centre Kempenhaeghe, Heeze, The Netherlands

4 Department of Clinical Epidemiology and Medical Technology Assessment, University Hospital Maastricht, Maastricht, The Netherlands

5 Department of Behavioral Sciences, Epilepsy Centre Kempenhaeghe, Heeze, The Netherlands

6 Department of Neurology, Maastricht University Medical Centre, Maastricht, The Netherlands

7 Research School of Mental Health & Neuroscience, Maastricht University, Maastricht, The Netherlands

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BMC Neurology 2011, 11:10  doi:10.1186/1471-2377-11-10

Published: 25 January 2011

Abstract

Background

Epilepsy is a neurological disorder, characterized by recurrent unprovoked seizures which have a high impact on the individual as well as on society as a whole. In addition to the economic burden, epilepsy imposes a substantial burden on the patients and their surroundings. Patients with uncontrolled epilepsy depend heavily on informal care and on health care professionals. About 30% of patients suffer from drug-resistant epilepsy. The ketogenic diet can be a treatment of last resort, especially for children. The beneficial effect of the ketogenic diet has been proven, but information is lacking about its cost-effectiveness. In the current study we will evaluate the (cost-) effectiveness of the ketogenic diet in children and adolescents with intractable epilepsy.

Methods/Design

In a RCT we will compare the ketogenic diet with usual care. Embedded in this RCT will be a trial-based and model-based economic evaluation, looking from a societal perspective at the cost-effectiveness and cost-utility of the ketogenic diet versus usual care. Fifty children and adolescents (aged 1-18) with intractable epilepsy will be screened for eligibility before randomization into the intervention or the usual care group. The primary outcome measure is the proportion of children with a 50% or more reduction in seizure frequency. Secondary outcomes include seizure severity, side effects/complaints, neurocognitive, socio-emotional functioning, and quality of life. Costs and productivity losses will be assessed continuously by a prospective diary and a retrospective questionnaire. Measurements will take place during consults at baseline, at 6 weeks and at 4 months after the baseline period, and 3, 6, 9 and 12 months follow-up after the 4 months consult.

Discussion

The proposed research project will be the first study to provide data about the cost-effectiveness of the ketogenic diet for children and adolescents with intractable epilepsy, in comparison with usual care. It is anticipated that positive results in (cost-) effectiveness of the proposed intervention will contribute to the improvement of treatment for epilepsy in children and adolescents and will lead to a smaller burden to society.

Trial registration

The study has been registered with the Netherlands Trial Registry (NTR2498).