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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Mitchell, James W ORCID: 0000-0002-6465-0382, Noble, Adam ORCID: 0000-0002-8070-4352, Baker, Gus, Batchelor, Rachel, Brigo, Francesco, Christensen, Jakob, French, Jacqueline, Gil-Nagel, Antonio, Guekht, Alla, Jette, Nathalie et al (show 12 more authors) , Kälviäinen, Reetta, Leach, John Paul, Maguire, Melissa, O'Brien, Terence, Rosenow, Felix, Ryvlin, Philippe, Tittensor, Phil, Tripathi, Manjari, Trinka, Eugen, Wiebe, Samuel, Williamson, Paula R ORCID: 0000-0001-9802-6636 and Marson, Tony ORCID: 0000-0002-6861-8806 (2022) 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, 23 (1). p. 943. ISSN 1745-6215, 1745-6215

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Abstract

<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Discussion</h4>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.<h4>Core outcome set registration</h4>COMET Initiative as study 118 .

Item Type:	Article
Uncontrolled Keywords:	Core outcome set, Epilepsy, Consensus, Delphi study, Treatment outcome, Clinical trials
Divisions:	Faculty of Health & Life Sciences Faculty of Health & Life Sciences > Inst. Population Health Faculty of Health & Life Sciences > Inst. Systems, Molec & Integrative Biology > Inst. Systems, Molec & Integrative Biology
Depositing User:	Symplectic Admin
Date Deposited:	28 Nov 2022 11:13
Last Modified:	22 May 2026 15:27
DOI:	10.1186/s13063-022-06729-4
Related Websites:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3166428
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