Evidence map›Paper›PMID 36397081›Full record

ArticleTrials2022

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 and 12 more

Abstract read
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

James W MitchellAssociation of British Neurologists Clinical Research Fellow, Institute of Systems, Molecular and Integrative Biology (ISMIB), University of Liverpool, Liverpool, UK. james.mitchell@liverpool.ac.uk.ORCID http://orcid.org/0000-0002-6465-0382
Adam NobleHealth Services Research, Institute of Population Health, Policy and Systems, University of Liverpool, Liverpool, UK.
Gus BakerUniversity of Liverpool, Liverpool, UK and Secretary General at International Bureau for Epilepsy, Sandyford, Dublin, Ireland.
Rachel BatchelorThe Oxford Institute of Clinical Psychology Training and Research, University of Oxford, Oxford, UK.
Francesco BrigoDepartment of Neurology, Hospital of Merano (SABES-ASDAA), Merano-Meran, Italy.
Jakob ChristensenDepartment of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Jacqueline FrenchNYU Comprehensive Epilepsy Center, New York, USA.
Antonio Gil-NagelDepartment of Neurology, Hospital Ruber Internacional, Madrid, Spain.
Alla GuekhtMoscow Research and Clinical Center for Neuropsychiatry, Moscow, Russia.
Nathalie JetteDepartment of Neurology, Icahn School of Medicine at Mount Sinai, New York, USA.
Reetta KälviäinenUniversity of Eastern Finland and Kuopio Epilepsy Center, Kuopio University Hospital, Member of EpiCARE ERN, Kuopio, Finland.
John Paul LeachSchool of Medicine, Dentistry & Nursing, University of Glasgow, Glasgow, UK.
Melissa MaguireLeeds Institute of Medical Research, University of Leeds, Leeds, UK.
Terence O'BrienCentral Clinical School, Monash University, Melbourne, Australia.
Felix RosenowEpilepsy Center Frankfurt-Rhine-Main, University Hospital Frankfurt, Goethe-University, Frankfurt, Germany.
Philippe RyvlinDepartment of Clinical Neurosciences, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Phil TittensorThe Royal Wolverhampton NHS Trust and Honorary Lecturer, University of Wolverhampton, Wolverhampton, UK.
Manjari TripathiDepartment of Neurology, Neurosciences Centre, All India Institute of Medical Sciences, New Delhi, India.
Eugen TrinkaDepartment of Neurology, Christian Doppler University Hospital, Paracelsus Medical University Salzburg, Salzburg, Austria.
Samuel WiebeDepartment of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Calgary, Canada.
Paula R WilliamsonDepartment of Biostatistics, University of Liverpool, Liverpool, UK.
Tony MarsonInstitute of Systems, Molecular and Integrative Biology (ISMIB), University of Liverpool, Liverpool, UK.

Funding

Guarantors of Brain ABN Clinical Research Training Fellowship
6 · The paper itself

Abstract

backgroundA 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.

methodsThe 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 .

Indexed as

EpilepsyResearch DesignAdultDelphi TechniqueHumansOutcome Assessment, Health CareSystematic Reviews as TopicClinical trialsConsensusCore outcome setDelphi studyEpilepsyTreatment outcome

Identifiers

PMID36397081
PMCPMC9670528

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.