Core Outcomes for Refractory childhood Epilepsy treated with Ketogenic Diet Therapy
The CORE-KDT study
We have recruited:
- parents and carers of children aged 18 years or under with refractory (difficult to treat) epilepsy treated currently, or in the past year with ketogenic diet therapy.
- health professionals with experience working with children with epilepsy and ketogenic diet. For example, but not limited to; paediatric neurologists, paediatricians, neurology registrars, dietitians, epilepsy specialist nurses and neuropsychologists.
- researchers undertaking research into childhood epilepsy and ketogenic diet therapy
The research team extends a big thank you to all parents, professionals and researchers who registered to take part.
What is CORE-KDT?
CORE-KDT is a study aiming to identify a list of the most important outcomes to measure for children with epilepsy treated with the ketogenic diet.
Research often uses seizure control and the side effects of a ketogenic diet as the main way of assessing ketogenic diet therapy (these are known as ‘outcomes’). However, we also think it is vital to consider outcomes that are important to the children receiving treatment and their parents. Other outcomes may include measurements of physical health, mental health and quality of life, to name a few.
Phase 1 of our study assessed the outcomes measured in studies of childhood epilepsy treated with ketogenic diet. Phase 2 involved interviews with parents to explore their views on outcomes and their experiences of epilepsy and the ketogenic diet. A compressive list of outcomes has been identified from these two phases.
Next we will ask parents, health professionals and researchers to take part in an online survey designed to allow large groups of people to come to an agreement (Delphi Survey).
We will bring all these views and opinions together to develop a list of outcomes that everyone can agree on, and which should be measured in future clinical trials and practice.
Take part in the online Delphi Survey
Before you decide to take part, we ask you to read the participant information sheet which you can download here:
- Participant information sheet for parents
- Participant information sheet for researchers and healthcare professionals
Take part in the study
Recruitment is now closed and analysis ongoing.
Ethical Approval
Granted by London Surrey REC ref: 19/LO/1680
Supported by University of Plymouth Faculty Research Ethics Committee (FREIC ref 19/20-1197)
Why do we want to interview parents?
Firstly, we want to understand your experiences of living with your child’s epilepsy and managing the ketogenic diet. Secondly, we want to find out what outcomes you feel we should be assessing for children with epilepsy treated with the ketogenic diet. From the information we gain in these interviews we will collate a long-list of outcome measures that could be useful to assess ketogenic diet therapy.
Read the Matthew's Friends newsletter for an update on our early findings (see page 12).
What is a Delphi survey?
A Delphi survey is a tool to reach a consensus on a topic of interest, in our case outcomes for assessing ketogenic diet therapy. We plan to do our Delphi survey online so people from all over the world can take part.
Parents, researchers and healthcare professionals will score the importance of each outcome on the long-list we developed after the interviews. The survey is anonymous and completed over two rounds. After round one, we will summarise the responses and then invite the same participants to take part in round two. Each person will be able to see the summarised responses and rate the outcomes again.
Each round of the survey will take approximately 20 minutes to complete.
Preliminary results update
We are delighted to share that two posters summarising the progress with the CORE-KDT study were presented at the 7th Global Symposium on Medical Ketogenic Dietary Therapies: Global Keto 2021 in Brighton. The conference was attended by health professionals, researchers, and parents. Both posters were also presented at the British Paediatric Neurology Association 48th annual conference in January 2022.
The first poster, CORE KDT Preliminary results, described the outcomes used in published studies of childhood epilepsy with KD therapy and contrasted these with the outcomes parents report are most important for their child.
The second poster, CORE KDT Qualitative study, explores families’ experiences of epilepsy and KD therapy as told by parents when interviewed. We concluded with five recommendations to help support families with KD therapy.
Posters
CORE KDT Preliminary results poster
CORE KDT Qualitative study poster
Publications
To date three papers have been published from this programme of research and all are freely available with open access.
- The CORE-KDT study: a mixed methods protocol to establish core outcomes for refractory childhood epilepsy treated with ketogenic diet therapy
- Core outcome set development for childhood epilepsy treated with ketogenic diet therapy: Results of a scoping review and parent interviews
- Outcome measurement and reporting in childhood epilepsy treated with ketogenic diet therapy: a scoping review protocol
Read our article published in Complete Nutrition entitled 'Outcomes in paediatric epilepsy treated with ketogenic diet therapy. Can we achieve consensus?'
Meet the research team
Jen Carroll
Jen Carroll is a registered dietitian and was a specialist paediatric ketogenic dietitian in the NHS for over 5 years, supporting many families to undertake the ketogenic diet. She became a lecturer in dietetics in 2014 which she continues today at the University of Plymouth. Jen is an active member of the Ketogenic Dietitians Research Network and is leading the CORE-KDT study in pursuit of a PhD.
‘I am delighted to have the opportunity to lead this research and enable parents’ voices to be heard in the development of this core outcome set’
Dr Avril Collinson
Avril Collinson is the academic lead for the Dietetic and Nutrition team here at the University of Plymouth. She is Director of Studies for Jen’s PhD studies, which is looking at developing a core outcome set for childhood epilepsy treated with a ketogenic diet. She is a registered dietitian and has worked in many different dietetic specialities in the NHS, private practice and overseas.
‘This is a really valuable project which will develop standard outcomes in this area to allow for comparisons between studies and findings’
Professor Mary Hickson
Mary Hickson is Professor of Dietetics at the University of Plymouth. She leads the Dietetics, Human Nutrition and Health Research Group promoting research in all areas of dietetic practice. Mary is a registered dietitian and worked for over 25 years in the NHS.
“This project is crucial to underpin future research in ketogenic diet therapy. It is also vital to ensure the parent voice is heard in the development of such research. I am delighted to support Jen’s PhD studies in this area.”
Professor Helen Cross
Professor Helen Cross is The Prince of Wales’s Chair of Childhood Epilepsy and Honorary Consultant in Paediatric Neurology at UCL Great Ormond Street Institute of Child Health, Great Ormond Street Hospital for Children NHS Trust, London, and Young Epilepsy, Lingfield.
She is currently Clinical Advisor to the Children’s Epilepsy Surgery Services (CESS) (2012-present), Clinical Topic Advisor to the update of the NICE guidelines on the Paediatric epilepsies (2018-2020), Senior NIHR investigator 2016-2020 and elected Treasurer of the ILAE to serve 2017-2021. She is on the Editorial Board of Epileptic Disorders, Epilepsy Research, and European Journal of Paediatric Neurology. Her major research interest is in improving outcomes in early onset epilepsies, using new interventions including the ketogenic diet, publishing the first RCT demonstrating definitive efficacy in 2008.
Emma Williams MBE
CEO/Founder – Matthew’s Friends Charity - Global
Director – Matthew’s Friends Clinics Ltd
Emma Williams set up the Matthew’s Friends charity for medical Ketogenic Dietary Therapies in her son’s name in 2004 due to his incredible response to going on the diet. Working with their international medical advisory board, the organisation works globally with several branches now in operation and in 2011 they opened their own Clinic in the UK treating both children and adults with complex epilepsy and Glut 1 Deficiency Syndrome. They have also run a clinical case series programme for those with Brain tumours. 2016 saw them extend their remit further to include the ‘KetoCollege’ side of the organisation which is a training programme for medical professionals who want to work in this field, with online training tutorials being launched in 2019.
Emma has worked full time in this field for nearly 20 years as well as being mum to Matthew and Alice. She has supported thousands of families and is a leading advocate for medical ketogenic therapies being an International Patron of Diets for Epilepsy in India, as well as serving on the Executive Board for the Global Symposia for Ketogenic Dietary Therapies and from 2017 is leading the dietary therapies team for EpiCARE – the European Reference Network for Rare and Complex Epilepsies.
In June 2013 Emma was recognised by The Queen and awarded an MBE in the Queen’s birthday honours list for her services to children with epilepsy.
“I am so pleased that this work is being undertaken, as a parent of a child that has complex epilepsy and who has used ketogenic dietary therapy for a number of years, it is important that we are involved in future developments”
Val Aldridge
Val Aldridge's experience in nursing began in 1980 through roles in dental and auxiliary nursing. She qualified as an enrolled nurse in 1984, then as a registered nurse in 1990, quickly specialising in coronary care.
"I have 2 children Robyn and Greg, there is only 15 months between them, I thought I would be getting them into school and back to work, that’s when epilepsy decided to take my family down a different path! Greg’s seizures started when he was 4 that is also when his behaviour changed. After 4 years of absolute hell I met Emma and learnt about the diet. I also met Professor Cross on a surgical referral, when surgery was not an option we ended up starting Greg on MCT Ketogenic diet as part of the GOSH trial.
It wasn’t long after, that Emma rang and asked if I would like to be involved with a charity she was thinking of starting up. The ketogenic diet was not just a treatment for Greg but for the whole family. Despite never becoming seizure free he was so much brighter, and when he laughed I realised I had not heard him laugh for a very long time. I dread to think how life would have been had we not had the chance of a dietary treatment.
That is why I have continued to work with Matthew's Friends as assistant co-ordinator and my husband Richard and I became trustees of Matthew's Friends the charity, to make these dietary treatments available to any child or adult wishing to try them. I have also gained a vocational certificate in epilepsy care via distance learning to gain a broader knowledge of epilepsy.
Over the last 15 years I have gained much experience in implementing the dietary treatments personally with Greg, through supporting our families & since 2011 in my role as Ketogenic Assistant in Matthews Friends clinics."
“This is a great opportunity to wrinkle out how success is truly measured on ketogenic therapies. I am very excited to be a part of the project! “
