A core outcome set for childhood epilepsy treated with ketogenic diet
Research type
Research Study
Full title
Core Outcomes for Refractory childhood Epilepsy treated with Ketogenic Diet Therapy. The CORE-KDT study.
IRAS ID
251380
Contact name
Jennifer Carroll
Contact email
Sponsor organisation
The University of Plymouth
Clinicaltrials.gov Identifier
0116, Core Outcome Measures in effectiveness Trials Initiative database
Duration of Study in the UK
2 years, 5 months, 28 days
Research summary
A core outcome set defines the minimum outcomes that should be included in clinical trials, audit or practice. The aim being to increase quality and relevance of research by ensuring consistency in the measurement and reporting of outcomes. Core outcome sets have been developed for a variety of disease states and treatments. However, there is no established set of core outcomes for refractory childhood epilepsy (persistent seizures despite treatment with multiple anti-epileptic drugs) treated with ketogenic diet therapy. A ketogenic diet is a high fat, low carbohydrate therapeutic diet used to treat epilepsy when medications fail. Core outcome sets should be developed with service users to ensure the outcomes measured are relevant to patients and clinical practice. Potential core outcomes might include seizure frequency, side effects of ketogenic diet therapy and health related quality of life outcomes such as cognition and behaviour, hospital admissions and reduced medication load.
This study consists of four phases. Firstly, a scoping review of the literature has established which outcomes are measured in trials of epilepsy treated with ketogenic diet therapy (completed February 2019). Secondly, interviews with parents and carers will aim to identify the outcomes of importance to these stakeholders. Phase 3 will see a comprehensive list of outcomes collated from the first two phases, grouped into domains. Phase 4 will invite parents, health care professionals and researchers to participate in a two round online Delphi survey to rate the importance of the presented outcomes. A Delphi survey gathers the collective opinion of a group. Following which, the core outcome set will be agreed at a face to face consensus meeting. Ethical approval is sought for phase 2 and 4.
This study will guide outcome measurement in future studies of childhood epilepsy treated with ketogenic diet therapy and clinical practice through audit and service evaluation.
REC name
London - Surrey Research Ethics Committee
REC reference
19/LO/1680
Date of REC Opinion
5 Nov 2019
REC opinion
Further Information Favourable Opinion