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)
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,
Tony Marson
Affiliations
James W. Mitchell
Association of British Neurologists Clinical Research Fellow, Institute of Systems, Molecular and Integrative Biology (ISMIB), University of Liverpool
Adam Noble
Health Services Research, Institute of Population Health, Policy and Systems, University of Liverpool
Gus Baker
University of Liverpool, Liverpool, UK and Secretary General at International Bureau for Epilepsy, Sandyford
Rachel Batchelor
The Oxford Institute of Clinical Psychology Training and Research, University of Oxford
Francesco Brigo
Department of Neurology, Hospital of Merano (SABES-ASDAA)
Jakob Christensen
Department of Clinical Medicine, Aarhus University
Jacqueline French
NYU Comprehensive Epilepsy Center
Antonio Gil-Nagel
Department of Neurology, Hospital Ruber Internacional
Alla Guekht
Moscow Research and Clinical Center for Neuropsychiatry
Nathalie Jette
Department of Neurology, Icahn School of Medicine at Mount Sinai
Reetta Kälviäinen
University of Eastern Finland and Kuopio Epilepsy Center, Kuopio University Hospital, Member of EpiCARE ERN
John Paul Leach
School of Medicine, Dentistry & Nursing, University of Glasgow
Melissa Maguire
Leeds Institute of Medical Research, University of Leeds
Terence O’Brien
Central Clinical School, Monash University
Felix Rosenow
Epilepsy Center Frankfurt-Rhine-Main, University Hospital Frankfurt, Goethe-University
Philippe Ryvlin
Department of Clinical Neurosciences, Centre Hospitalier Universitaire Vaudois
Phil Tittensor
The Royal Wolverhampton NHS Trust and Honorary Lecturer, University of Wolverhampton
Manjari Tripathi
Department of Neurology, Neurosciences Centre, All India Institute of Medical Sciences
Eugen Trinka
Department of Neurology, Christian Doppler University Hospital, Paracelsus Medical University Salzburg
Samuel Wiebe
Department of Clinical Neurosciences, Cumming School of Medicine, University of Calgary
Paula R. Williamson
Department of Biostatistics, University of Liverpool
Tony Marson
Institute of Systems, Molecular and Integrative Biology (ISMIB), University of Liverpool
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. Core Outcome Set registration COMET Initiative as study 118 .
