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

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

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 fndings 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 efectiveness 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 Efectiveness 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 ratifed 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.

Aim

To develop a COS for use in treatment trials for adults with epilepsy by using the Delphi consensus methodology and an international consensus meeting

Contributors

James W. Mitchell, Adam Noble, Gus Baker, Rachel Batchelor, Francesco Brigo, Jakob Christensen, Jacqueline French, Antonio Gil-Nagel, Alla Guekht, Nathalie Jette, Reetta Kälviäinen, John Paul Leach, Melissa Maguire, Terence O’Brien, Felix Rosenow, Philippe Ryvlin, Phil Tittensor, Manjari Tripathi, Eugen Trinka, Samuel Wiebe, Paula R. Williamson and Tony Marson

Publication

Journal: Trials
Volume: 23
Issue: 943
Pages: -
Year: 2022
DOI: 10.1186/s13063-022-06729-4

Further Study Information

Current Stage: Completed
Date:
Funding source(s): The EPSET Project is funded and supported by an Association of British Neurologists and Guarantors of Brain Research Training Fellowship (awarded to JWM). There are no other funding sources. The views expressed are those of the authors and not necessarily those of the Association of British Neurologists or Guarantors of Brain Charity

Health Area

Disease Category: Neurology

Disease Name: Epilepsy

Target Population

Age Range: 18

Sex: Either

Nature of Intervention: Non-surgical

Stakeholders Involved

Study Type

- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)