Ben F M Wijnen1, Reina J A de Kinderen2, Danielle A J E Lambrechts3, Debby Postulart4, Albert P Aldenkamp5, Marian H J M Majoie6, Silvia M A A Evers7. 1. Department of Health Services Research, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands; Department of Research and Development, Epilepsy Center Kempenhaeghe, Heeze, The Netherlands. Electronic address: B.wijnen@maastrichtuniversity.nl. 2. Department of Health Services Research, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands; Department of Research and Development, Epilepsy Center Kempenhaeghe, Heeze, The Netherlands; Trimbos Institute, National Institute of Mental Health and Addiction, Utrecht, The Netherlands. 3. Department of Neurology, Academic Center for Epileptology Kempenhaeghe & Maastricht UMC+, Heeze, The Netherlands. 4. Department of Research and Development, Epilepsy Center Kempenhaeghe, Heeze, The Netherlands. 5. Department of Research and Development, Epilepsy Center Kempenhaeghe, Heeze, The Netherlands; Department of Behavioral Sciences, Epilepsy Center Kempenhaeghe, Heeze, The Netherlands; Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands; Faculty of Electrical Engineering, University of Technology, Eindhoven, The Netherlands. 6. Department of Research and Development, Epilepsy Center Kempenhaeghe, Heeze, The Netherlands; Department of Neurology, Academic Center for Epileptology Kempenhaeghe & Maastricht UMC+, Heeze, The Netherlands; Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands; School of Health Professions Education, Faculty of Health, Medicine and Life Sciences, Maastricht University, The Netherlands. 7. Department of Health Services Research, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands; Trimbos Institute, National Institute of Mental Health and Addiction, Utrecht, The Netherlands.
Abstract
OBJECTIVE: To examine long-term retention rate, clinical outcomes, cost-utility and cost-effectiveness of the Ketogenic Diet (KD) compared with care as usual (CAU) in children and adolescents with intractable epilepsy from a societal perspective. METHODS: Participants were randomized into a KD or CAU group. Seizure frequency, quality adjusted life years (QALYs), side-effects, seizure severity, health care costs, production losses, patient and family costs were assessed at baseline and during 16-months of follow-up. Incremental cost-effectiveness ratios (ICERs) (i.e. cost per QALY and cost per responder) and cost-effectiveness acceptability curves are presented. RESULTS:48 children were included in the analyses of this study (26 from KD group). In total, 58% of the KD group completed the follow-up of 16 months; 11 dropped-out for various reasons. At 16 months, 35% of the KD participants had a seizure reduction≥50% from baseline, compared with 18% of the CAU participants. Mean costs per patient in the CAU group were €53,367 (extrapolated) compared to €61,019 per patient in the KD group, resulting in an ICER of €46,564 per responder. Cost per QALY rose well above any acceptable ceiling ratio. At 4-months' follow-up, the KD group showed significantly more gastro-intestinal problems compared to the CAU group. At 16 months, the KD group reported fewer problems compared to CAU. Furthermore, 46.2% of the KD group reported a decrease in severity of their worst seizure compared to 32% of the CAU group. CONCLUSION: The KD group resulted in more responders and showed greater improvement on seizure severity. Furthermore, the KD did not lead to worsening of side-effects other than gastro-intestinal problems (only at 4 months' follow-up). However, as only a minimal difference in QALYs was found between the KD group and the CAU group, the resulting cost per QALY ratios were inconclusive.
RCT Entities:
OBJECTIVE: To examine long-term retention rate, clinical outcomes, cost-utility and cost-effectiveness of the Ketogenic Diet (KD) compared with care as usual (CAU) in children and adolescents with intractable epilepsy from a societal perspective. METHODS:Participants were randomized into a KD or CAU group. Seizure frequency, quality adjusted life years (QALYs), side-effects, seizure severity, health care costs, production losses, patient and family costs were assessed at baseline and during 16-months of follow-up. Incremental cost-effectiveness ratios (ICERs) (i.e. cost per QALY and cost per responder) and cost-effectiveness acceptability curves are presented. RESULTS: 48 children were included in the analyses of this study (26 from KD group). In total, 58% of the KD group completed the follow-up of 16 months; 11 dropped-out for various reasons. At 16 months, 35% of the KD participants had a seizure reduction≥50% from baseline, compared with 18% of the CAUparticipants. Mean costs per patient in the CAU group were €53,367 (extrapolated) compared to €61,019 per patient in the KD group, resulting in an ICER of €46,564 per responder. Cost per QALY rose well above any acceptable ceiling ratio. At 4-months' follow-up, the KD group showed significantly more gastro-intestinal problems compared to the CAU group. At 16 months, the KD group reported fewer problems compared to CAU. Furthermore, 46.2% of the KD group reported a decrease in severity of their worst seizure compared to 32% of the CAU group. CONCLUSION: The KD group resulted in more responders and showed greater improvement on seizure severity. Furthermore, the KD did not lead to worsening of side-effects other than gastro-intestinal problems (only at 4 months' follow-up). However, as only a minimal difference in QALYs was found between the KD group and the CAU group, the resulting cost per QALY ratios were inconclusive.
Authors: Antoine Hone-Blanchet; Botond Antal; Liam McMahon; Andrew Lithen; Nathan A Smith; Steven Stufflebeam; Yi-Fen Yen; Alexander Lin; Bruce G Jenkins; Lilianne R Mujica-Parodi; Eva-Maria Ratai Journal: Neuropsychopharmacology Date: 2022-08-22 Impact factor: 8.294
Authors: Kirsty J Martin-McGill; Cerian F Jackson; Rebecca Bresnahan; Robert G Levy; Paul N Cooper Journal: Cochrane Database Syst Rev Date: 2018-11-07
Authors: A Suraev; N Lintzeris; J Stuart; R C Kevin; R Blackburn; E Richards; J C Arnold; C Ireland; L Todd; D J Allsop; I S McGregor Journal: Sci Rep Date: 2018-07-05 Impact factor: 4.379
Authors: Benjamin Andreas Berk; Rowena Mary Anne Packer; Tsz Hong Law; Annette Wessmann; Andrea Bathen-Nöthen; Tarja Susanna Jokinen; Anna Knebel; Andrea Tipold; Ludovic Pelligand; Holger Andreas Volk Journal: BMC Vet Res Date: 2019-05-30 Impact factor: 2.741
Authors: Anna Winczewska-Wiktor; Adam Sebastian Hirschfeld; Magdalena Badura-Stronka; Paulina Komasińska-Piotrowska; Barbara Steinborn Journal: J Clin Med Date: 2022-01-25 Impact factor: 4.241