Core outcome set development for childhood epilepsy treated with ketogenic diet therapy: Results of a scoping review and parent interviews

Purpose: Clinical 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.
Methods: Ethical 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.
Results: Of 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.
Conclusion: Little 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).

Aim

This study aims to identify a comprehensive set of potentially important outcomes which will be prioritised by parents, health professionals and researchers in an international two-round Delphi study to achieve consensus on a core set of outcomes,

Contributors

Jennifer H. Carroll, Kirsty J. Martin-McGill, J. Helen Cross, Mary Hickson, Emma Williams, Val Aldridge, Avril Collinson

Publication

Journal: Seizure: European Journal of Epilepsy
Volume: 99
Issue:
Pages: 54 - 67
Year: 2022
DOI: 10.1016/j.seizure.2022.05.009

Further Study Information

Current Stage: Completed
Date:
Funding source(s): Funding is received from the University of Plymouth and The British Dietetic Association General Education Trust Fund. JHC is supported by the National Institute of Health Research (NIHR) Biomedical Research Centre at Great Ormond Street Hospital.

Health Area

Disease Category: Neurology

Disease Name: Epilepsy

Target Population

Age Range: 18

Sex: Either

Nature of Intervention: Diet and nutrition

Stakeholders Involved

- Consumers (caregivers)

Study Type

- Patient perspectives
- Systematic review of outcomes measured in trials

Method(s)

- Interview
- Systematic review

Systematic review to identify an initial outcome list. The qualitative study used a semi structured interview approach to achieve the primary objective of identifying outcomes of importance to parents and the secondary objective of exploring the families’ experiences of epilepsy and KD therapy.

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