OBJECTIVE:
Establishing a core set of outcomes to be evaluated and reported in intervention trials aims to improve the usefulness of health research. There is no established core outcome set (COS) for childhood epilepsies. The aim of this study was to select a COS to be used in evaluative research of interventions for children with rolandic epilepsy (RE).
METHODS:
We followed guidance from the COMET (Core Outcome Measures in Effectiveness Trials) Initiative. First, we identified outcomes that had been measured in research through a systematic review. Second, young people with RE, parents, and professionals were invited to take part in a Delphi survey in which participants rated the importance of candidate outcomes. Last, a face-to-face meeting was convened to seek consensus on which outcomes were critical to include and to ratify the final COS.
RESULTS:
From 37 eligible papers in the review, we identified and included 48 candidate outcomes in the survey. We sent invitations to 165 people registered to take part in the survey; of these, 102 (62%) completed Round 1, and 80 (78%) completed Round 2 (three young people, 16 parents, 61 professionals). In Round 2 we included four additional outcomes suggested by participants in Round 1. The consensus meeting included two young people, four parents, and nine professionals who were eligible to vote and ratified the COS as 39 outcomes across 10 domains.
SIGNIFICANCE:
Our methodology was a proportionate and pragmatic approach toward producing a COS for evaluating research on interventions aiming to improve the health of children with RE.
Crudgington H1, Rogers M2, Bray L3, Carter B3, Currier J4, Dunkley C5, Gibbon FM6, Hughes D7, Lyle S1, Roberts D4, Tudur Smith C8, Gringras P1,9, Pal DK1,9,10,11, Morris C2.
1
Basic and Clinical Neuroscience Department, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.
2
University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK.
3
Faculty of Health and Social Care, Edge Hill University, Ormskirk, UK.
4
Lay coinvestigator and epilepsy services user, London, UK.
5
Sherwood Forest Hospitals National Health Service Foundation Trust, Sutton-in-Ashfield, UK.
6
Noah's Ark Children's Hospital for Wales, Cardiff and Vale University Health Board, Cardiff, UK.
7
Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.
8
Department of Biostatistics, University of Liverpool, Liverpool, UK.
9
Evelina London Children's Hospital, London, UK.
10
Medical Research Council Centre for Neurodevelopmental Disorders, King's College London, London, UK.
11
King's College Hospital, London, UK.
Disease Category: Neurology
Disease Name: Epilepsy
Age Range: 5 - 16
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- COS for clinical trials or clinical research
- Delphi process
- Systematic review
- Consensus meeting
We followed guidance from the COMET (Core Outcome Measures in Effectiveness Trials) Initiative. First, we identified outcomes that had been measured in research through a systematic review. Second, young people with RE, parents, and professionals were invited to take part in a Delphi survey in which participants rated the importance of candidate outcomes. Last, a face-to-face meeting was convened to seek consensus on which outcomes were critical to include and to ratify the final COS.