Abstracts

Rationale: A Core Outcome Set (COS) is a standardised list of outcomes that should be reported as a minimum in all trials. It is developed using consensus methods to ensure that it includes what is important to patients as well as healthcare professionals and researchers. In epilepsy, the choice of outcome measures varies widely among existing studies, particularly in randomised controlled trials (RCT). This diminishes opportunities for informed decision making, contributes to research waste and is a barrier to integrating findings from multiple RCTs in systematic reviews and meta analyses. COS facilitate the undertaking of trials that are relevant to patients and health services and help standardise trial methodology so more meaningful results can be obtained from systematic review and meta-analysis.

Methods: Given that no COS for adults with epilepsy currently exists, we are developing an internationally derived COS specific to adult epilepsy treatment trials.

We have undertaken a rapid review of the qualitative literature exploring experiences of people with epilepsy (PWE), to identify core concepts that map to potential measurable outcomes. This work represents the views of over 2000 PWE and 600 carers across 6 continents. We have also undertaken rapid review of outcomes already measured in phase 3 and phase 4 epilepsy specific RCTs registered on the clinicaltrials.gov website to generate a long list of potential measurable outcomes to take to an international consensus process.

International stakeholder groups involved include health care professionals, PWE and researchers. Consensus will be ascertained by a two-round online modified Delphi survey and virtual consensus meeting to ratify a final COS that is representative of all stakeholder views.

Results: The results of the COS will be used to inform the recommendation of specific measurement instruments to measure each of the outcomes identified as core. Methods outlined by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative will be utilised.

Conclusions: Developing a COS for adults with epilepsy and deriving international consensus will ensure that meaningful outcomes are measured in future RCTs, ensure that the results of trials are relevant to the needs of PWE, reduce research waste and ensure that the results of trials assessing the same treatment can be combined in meaningful ways. The findings will also have ramifications for how we measure outcomes for PWE in clinical practice.

Funding: Please list any funding that was received in support of this abstract.: JM is a Clinical Research Training Fellow funded by the Association of British Neurologists and Guarantors of Brain Charity, UK.