Epilepsy is estimated to affect 530,000 children across the UK and US. Approximately one third of whom will have refractory epilepsy and continue to experience seizures despite treatment with multiple anti-epileptic drugs. Ketogenic diet therapy (KDT) is a well-established treatment for refractory epilepsy with more than 50% of treated children achieving greater than 50% seizure reduction. Typically seizure reduction or seizure freedom are the primary outcome choices. However, a more holistic approach might also consider health related quality of life outcomes such as reduced hospitalisation, reduced medication load, associated side effects and cost, improved behaviour and cognition and side effects of KDT. Treatment with KDT can have a significant impact on functioning and quality of life, yet such outcomes are inconsistently measured and reported between trials.
A core outcome set (COS) defines the minimum outcomes that should be included in clinical trials, audit or practice. There is currently no established set of core outcomes for childhood epilepsy treated with KDT. We intend to develop a core outcome set in partnership with expert health care professionals in the clinical area, parents and carers. Other stakeholders such as charity organisations or industry partners will be involved. This patient centred approach will ensure the outcomes are relevant to patients, clinical research and practice.
Jennifer Carroll (principal investigator), Lecturer in Dietetics, School of Health Professions, Faculty of Health and Human Sciences, University of Plymouth, UK.
Professor Helen Cross, The Prince of Wales’s Chair of Childhood Epilepsy & Head of Developmental Neurosciences Programme, Clinical Neurosciences, UCL-Great Ormond Street-Institute of Child Health, University College London, UK.
Dr Avril Collinson, Associate Professor & Academic Lead Dietetics, School of Health Professions, Faculty of Health and Human Sciences, University of Plymouth, UK.
Professor Mary Hickson, Professor of Dietetics, School of Health Professions, Faculty of Health and Human Sciences, University of Plymouth, UK.
Emma Williams, Matthew's Friends Charity & Clinics, UK.
Val Aldridge, Matthew's Friends Charity & Clinics, UK.
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Literature review
- Systematic review
NHS Health Research Authority ethical approval will be sought and informed consent from participants. This is a mixed methods study with four distinct phases.
Phase one: Systematic review of the literature to identify outcomes in studies of children with epilepsy treated with ketogenic diet therapy (KDT).
Phase two: Semi structured qualitative interviews with approximately 30 parents and carers of children with epilepsy treated with KDT.
Phase three: Define outcome domains based on the findings of the systematic review and qualitative interviews.
Phase four: 2 arm anonymous Delphi process whereby health care professionals (arm 1) and parents and carers (arm 2) rate the importance of the outcome domains. It is expected that two Delphi rounds will be undertaken. Finally a consensus meeting where both stakeholder groups are represented will be held and the core outcome set for childhood epilepsy treated with KDT agreed.