Protocol for the development of an international Core Outcome Set for treatment trials in adults with epilepsy: the EPilepsy outcome Set for Effectiveness Trials Project (EPSET).

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Authors
Tittensor, Phil
Issue Date
2022-11-17
Journal
Type
Peer-Reviewed Publication
Article
Keywords
Delphi Technique
Epilepsy
Outcome assessment
Research design
Clinical trial
Consensus
Treatment outcome
Qualitative study
Peer-reviewed article
Systematic review
Journal Title
Trials
Volume
23
Issue
1
Begin page
943
End page
Abstract
Background: A Core Outcome Set (COS) is a standardised list of outcomes that should be reported as a minimum in all clinical trials. In epilepsy, the choice of outcomes varies widely among existing studies, particularly in clinical trials. This diminishes opportunities for informed decision-making, contributes to research waste and is a barrier to integrating findings in systematic reviews and meta-analyses. Furthermore, the outcomes currently being measured may not reflect what is important to people with epilepsy. Therefore, we aim to develop a COS specific to clinical effectiveness research for adults with epilepsy using Delphi consensus methodology. Methods: The EPSET Study will comprise of three phases and follow the core methodological principles as outlined by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. Phase 1 will include two focused literature reviews to identify candidate outcomes from the qualitative literature and current outcome measurement practice in phase III and phase IV clinical trials. Phase 2 aims to achieve international consensus to define which outcomes should be measured as a minimum in future trials, using a Delphi process including an online consensus meeting involving key stakeholders. Phase 3 will involve dissemination of the ratified COS to facilitate uptake in future trials and the planning of further research to identify the most appropriate measurement instruments to use to capture the COS in research practice. Discussion: Harmonising outcome measurement across future clinical trials should ensure that the outcomes measured are relevant to patients and health services, and allow for more meaningful results to be obtained.
Citation
Mitchell JW, Noble A, Baker G, Batchelor R, Brigo F, Christensen J, French J, Gil-Nagel A, Guekht A, Jette N, Kälviäinen R, Leach JP, Maguire M, O'Brien T, Rosenow F, Ryvlin P, Tittensor P, Tripathi M, Trinka E, Wiebe S, Williamson PR, Marson T. Protocol for the development of an international Core Outcome Set for treatment trials in adults with epilepsy: the EPilepsy outcome Set for Effectiveness Trials Project (EPSET). Trials. 2022 Nov 17;23(1):943. doi: 10.1186/s13063-022-06729-4. PMID: 36397081; PMCID: PMC9670528.