Core Outcome Measures in Effectiveness Trials

Core Health Outcomes In Childhood Epilepsy (CHOICE)

General Information

Summary:
To improve the effectiveness of health research, establishing a core set of outcomes to be evaluated and reported in trials of interventions for particular conditions would be useful. At current, there is no established set of core outcomes for childhood epilepsies. Epilepsy covers a range of conditions and syndromes but can be defined as a persisting tendency for seizures. Our focus is on rolandic epilepsy (RE) often known as ‘childhood epilepsy with centrotemporal spikes’ whereby the onset is typically 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, balance is required between seizure control and potential side effects from antiepileptic drugs and the impact this may have on children. Health-related quality of life has become a focus for research with recognition that epilepsy-specific quality-of-life is not solely determined by seizures, but more influenced by the child’s learning, mental health and social support.

Development of a core outcome set should include the view of patients, carers and health professionals. Cochrane reviewers recommend a focus on longer-term outcomes alongside psychosocial and quality of life outcomes. The aim of this work is to collaborate and consult with young people with epilepsy, parents, charities and health and education psychology to:

(i) Identify what outcomes to measure
(ii) Decide how to measure the outcomes

Primary objective: Propose a core outcome set for evaluative trials but may also inform decisions about outcomes to be measured in audits and routinely collected data.

Contributors:
Christopher Morris MSc DPhil, Senior Research Fellow in Child Health, PenCRU &
PenCLAHRC, University of Exeter Medical School, UK

Deb K Pal MA MSc PhD MRCP, Professor of Paediatric Epilepsy, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK,

Colin Dunkley BSC, MBCHB, MRCPCH, Consultant Paediatrician, Sherwood Forest
Hospitals NHS Foundation Trust, Sutton in Ashfield, UK

Frances M Gibbon BMedSci MB ChB MRCPCH Consultant Paediatric Neurologist, Noah’s Ark Children’s Hospital for Wales, Cardiff and Vale University Health
Board, Cardiff, UK

Janet Currier MA, lay co-investigator & epilepsy services user, UK

Deborah Roberts lay co-investigator & epilepsy services user, UK

Morwenna Rogers BSc (Hons) MSc, Information Specialist, PenCLAHRC, University of Exeter Medical School, UK

Bernie Carter PhD, Professor of Children’s Nursing, Edge Hill University, UK

Dyfrig Hughes PhD MRPharmS FFRPS FBPhS FLSW, Professor of Pharmacoeconomics, Centre for Health Economics and Medicines Evaluation, Bangor University, UK

Catrin Tudur Smith BSc, MSc, PhD, Professor of Biostatistics, MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, UK

Paula Williamson BSc PhD, Professor of Medical Statistics, MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, UK

Paul Gringras MSc MRCPCH, Professor of Paediatric Sleep Medicine, Evelina London Children’s Hospital and King’s College London, UK.

Lucy Bray BA (Hons), MSc, PhD, Reader in Children, Young People and Families, Edge Hill University, UK

Holly Crudgington Bsc (Hons) Msc, Research Worker Basic and Clinical Neuroscience, King’s College London, UK.

Further Study Information

Current Stage:
Ongoing
Date:
October 2017 - April 2019
Funding source(s):
NIHR Progamme Grants for Applied Research RP-PG-0615-20007

Health Area

Disease Category
Neurology

Disease Name
Epilepsy

Target Population

Age Range
5 - 16

Sex
Either


Nature / type of Intervention
Not specified

Method(s)

Delphi process
Focus group(s)
Literature review
Semi structured discussion
Survey
Systematic review
Advisory Groups

- Seek NHS Health Research Authority and informed consent from participants
- Study focuses on school-age children 5-16 years old with Rolandic Epilepsy. Will be involving children, young people and parents as meaningful partners in carrying out the research.
- Phase One: Systematic reviews and primary research studies that identify outcomes of any intervention where the aim is to improve the health of children with epilepsy and is not limited to drugs.
- Phase Two: Rating importance of outcome domains using a Delphi survey.
- Phase Three: How to measure Key outcomes with reference to published guidance. Appraise peer-reviewed evidence of measurement properties of those measures with reference to criteria for acceptable measurement properties.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)

Study Type

COS for clinical trials or clinical research
COS for practice

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