ORCID
- Mary Hickson: 0000-0001-7996-0095
- Avril Collinson: 0000-0001-5046-7344
Abstract
PurposeClinical trials on childhood epilepsy treated with ketogenic diet (KD) use a wide range of outcomes, however, patients and decision-makers often do not perceive the outcomes used as the most important. We sought parental opinion on outcomes of importance and compared these to outcomes reported in published research.MethodsEthical approval (London-Surrey-REC19/LO/1680). A scoping review identified outcomes reported in previous studies of childhood epilepsy and KD. Parents were recruited from nine KD centres (UK), charities and social media (international), then interviewed (Jan-April 2020) to explore priority outcomes. Content analysis identified all outcomes in transcripts. Parent identified outcomes were compared with those in the scoping review. Outcomes were collated and grouped into domains according to the COMET Taxonomy.ResultsOf 2663 articles;147 met inclusion criteria. 921 verbatim outcomes were sorted into 90 discrete outcomes, reduced to 70 in consultation with the study advisory group, then classified into 21 domains. Parents (n = 21) identified 39 outcomes as important from the scoping review and seven new outcomes. They prioritised both physiological and functional outcomes in contrast to past studies, which prioritised physiological outcomes.ConclusionLittle consistency exists in the outcomes used in childhood epilepsy and KD research. Those traditionally used do not adequately reflect parents’ important outcomes for their child. Clinical trials should consider the broader priorities of parents when choosing outcomes, in particular, functional outcomes. Identified outcomes will inform an international two-round Delphi-study with parent, professional and researcher participants to develop a core outcome set for this clinical area (COMET registration #1116).
DOI Link
Publication Date
2022-01-01
Publication Title
Seizure - European Journal of Epilepsy
Volume
99
ISSN
1532-2688
Acceptance Date
2022-05-10
Deposit Date
2022-06-20
Embargo Period
2022-08-03
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
First Page
54
Last Page
67
Recommended Citation
Carroll, J., Martin-McGill, K., Cross, J., Hickson, M., Williams, E., Aldridge, V., & Collinson, A. (2022) 'Core outcome set development for childhood epilepsy treated with ketogenic diet therapy: Results of a scoping review and parent interviews', Seizure - European Journal of Epilepsy, 99, pp. 54-67. Available at: 10.1016/j.seizure.2022.05.009
