A Berkel

A Manca

A Strzelczyk

AH Briggs

Albert P Aldenkamp

Alfons GH Kessels

AS Kaufman

BA Zupec-Kania

BV Maydell

Danielle AJE Lambrechts

Debby Postulart

DK Walker

DL Keene

DM MC Nair

EG Neal

EH Kossoff

EM Scholte

EP Vining

F Lefevre

G Coppola

GJ Devilly

HA Carpay

HC Kang

J Freeman

JA Barber

JB Oostenbrink

JG Hendriksen

JM Freeman

Jos GM Hendriksen

K Beery

L Forsgren

LM Dunn

LM Lamers

M Fekkes

M Leonardi

M Pugliatti

MA Koopmanschap

Marian HJM Majoie

ME Goossens

MF O'Donoghue

MJJC Poos

N Hoeymans

P Dolan

P Kankirawatana

Reina JA de Kinderen

RH Caraballo

RS Fisher

S Ramsey

Silvia MAA Evers

SR Sinha

T Vogels

WC Alpherts

BMC Neurology

English

PubMed

Springer - Publisher Connector

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

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

de Kinderen, Reina J. A.

Lambrechts, Danielle A. J. E.

Postulart, Debby

Kessels, Alfons G. H.

Hendriksen, Jos G. M.

Aldenkamp, Albert P.

Evers, Silvia M. A. A.

Majoie, Marian H. J. M.

NARCIS 

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Maastricht University Research Portal

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

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Springer - Publisher Connector

Maastricht University Research Portal