Core Health Outcomes In Childhood Epilepsy (CHOICE)
Research type
Research Study
Full title
CHOICE: Core Health Outcomes in Childhood Epilepsy Development of a core outcome set for clinical trials in young people with rolandic epilepsy. Phase 2: Delphi survey & face-to-face consensus meetings.
IRAS ID
235804
Contact name
Deb Pal
Contact email
Sponsor organisation
Kings College London
Clinicaltrials.gov Identifier
TRLS-D-17-00373R1, Initial Protocol of CHOICE in the journal Trials (submitted 06/10/17)
Duration of Study in the UK
1 years, 2 months, 18 days
Research summary
Epilepsy can be briefly defined as a persisting tendency for seizures. The most common childhood epilepsy is rolandic epilepsy (RE) whereby the onset is roughly around 7 years of age, with seizures ceasing by adolescence. A typical primary outcome in trials evaluating interventions of epilepsy is freedom or reduction in seizures. However, a balance is required between seizure control and potential side effects from antiepileptic drugs and the impact this may have on children. Trials have been poor at reporting how side effects from treatment for seizures affect the child’s quality of life. Quality of life aspects that might be useful to take into account include the child’s learning, mental health and social support.
The main aim of this study is to produce a ‘core outcome set’ (COS) for treatment and trials in childhood epilepsy. The COMET Initiative (Core Outcome Measures in Effectiveness Trials www.cometinitiative.org) is a guidance body for developing and reporting core outcome measures. COMET highlight the importance of integrating patient relevant outcomes within sets (1). This projects aims to agree which outcomes should be included in the COS by conducting a Delphi process and face-to-face consensus meetings involving children (8-16 years) with epilepsy, parents and professionals (e.g. paediatricians, neurologists).
The Delphi process involves 3 sequential rounds of questionnaires with feedback given between each round, and is a well described method for reaching consensus. The outcomes included in the Delphi questionnaires will be derived from the results of a literature review and results from an advisory panel of children with epilepsy and parents. The outcomes selected through the Delphi survey will be ratified for inclusion in a final COS consensus meeting involving all stakeholder groups.
Patient and family involvement in this study is vital because it is the patients themselves who are subject to the benefits and potential risks of treatments used in routine clinical practice and those under investigation in clinical trials. The involvement of children and families in the process of selecting core outcomes is essential because the benefits and potential risks of treatment are directly relevant to them. Establishing a COS will help to ensure that results from future trials can be combined to gain clearer understanding of which treatments are best for children, taking into account quality of life in research studies.
(1) Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E and Tugwell P. Developing core outcome sets for clinical trials: issues to consider. Trials 2012 13:132.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
18/NE/0014
Date of REC Opinion
9 Jan 2018
REC opinion
Favourable Opinion