Development of a Core Outcome Set for use in randomised controlled trials in adult epilepsy.

Development of a Core Outcome Set (COS) for use in randomised controlled trials in adult epilepsy.

No COS currently exists for drug trials in adult epilepsy, we aim to:
1. Identify outcome reporting and measurement instrument use in existing RCTs evaluating drug treatments for adults with epilepsy.
2. Assess whether outcomes measured in RCTs align with the priorities of key stakeholders.
3. Development of a COS for use in RCTs in adults with epilepsy.
4. Achieve international consensus on the most appropriate measurement tools for priority outcomes.

More information can be found on the study website www.epsetproject.org

Contributors

Dr James Mitchell, The Walton Centre NHS FT, Liverpool, UK.

Professor Tony Marson, Institute of Translational Medicine, University of Liverpool, UK.

Professor Paula Williamson, Institute of Translational Medicine, University of Liverpool, UK.

Dr Adam Noble, Institute of Population Health Sciences, University of Liverpool, UK.

Further Study Information

Current Stage: Ongoing
Date: September 2020 - September 2023
Funding source(s): Association of British Neurologists and Guarantors of Brain Charity


Health Area

Disease Category: Neurology

Disease Name: Epilepsy

Target Population

Age Range: 16 - 100

Sex: Either

Nature of Intervention: Drug

Stakeholders Involved

- Consumers (patients)
- Clinical experts
- Researchers
- Charities
- Consumers (caregivers)
- Methodologists
- Patient/ support group representatives
- Service providers

Study Type

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

Method(s)

- Consensus meeting
- Delphi process
- Systematic review

Phase 1 of the study will identify current use of outcomes and measurement instruments by undertaking a targeted systematic review of RCTs evaluating pharmacological interventions in adults with epilepsy.

Phase 2 will focus on which outcomes are important to patients, by building on our pilot work aggregating existing qualitative research investigating what is important for adults with epilepsy.

Phase 3 will derive an international consensus, using Delphi surveys, identifying the most important outcomes among stakeholders. Stakeholders will include adults with epilepsy, carers, health care professionals and researchers. Stratified sampling will be used to ensure that views are obtained from a broad range of adults with epilepsy. An online video consensus meeting with be convened to ratify a final Core Outcome Set.

Phase 4 will facilitate Core Outcome Set implementation. We will perform a review of the evidence for measurement properties for each measurement instrument being used to already assess outcomes. The evidence synthesised will be taken to a second online meeting to obtain consensus on which measurement tools should be used in future RCTs as a minimum.