Core Outcome Measures in Tinnitus – Electrical Stimulation
Research type
Research Study
Full title
Establishing a Core Outcome Set for early-phase clinical trials of electrical stimulation interventions to manage chronic subjective tinnitus in adults: a Modified e-Delphi survey
IRAS ID
297045
Contact name
Magdalena Sereda
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
0 years, 4 months, 2 days
Research summary
Tinnitus is the sensation of noise perceived in the ears or head. Tinnitus is a symptom that can be chronic and disabling for some. It is associated with a diverse range of complaints, including perceived loudness, sleep problems, difficulties in listening and concentration, effects on psychological well-being, daily life and on general health. Each of these complaints could be defined as a domain of tinnitus.
An outcome is a measurement used to assess the effectiveness or side effects of an intervention. Outcomes collected in trials of tinnitus include tinnitus intrusiveness and tinnitus loudness. A set of outcome domains and instruments that has been agreed upon for a health condition is called a Core Outcome Set. The purpose of a Core Outcome Set is to provide a group of outcomes to be measured in every trial of a particular type of intervention in a specific area of health- in this case, electrical stimulation-based interventions for tinnitus.
Many interventions for tinnitus are being tested, including electrical stimulation. Each of these intervention strategies are aimed at alleviating different outcome domains of tinnitus.
Our project consists of an e-Delphi survey that comprises a series of two sequential questionnaires or ‘rounds’ aiming to obtain a consensus of opinion from professional and healthcare users. Each survey round will contain a questionnaire that includes the final long list of categorised outcome domains.
For each questionnaire item, participants will be asked to think about the importance of each tinnitus outcome domain and indicate how important it is to measure when deciding if an electrical stimulation-based tinnitus treatment is working.
After the questionnaire rounds, an online meeting will be held to establish consensus on which outcomes should be included in the final Core Outcome Set.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0143
Date of REC Opinion
3 Aug 2021
REC opinion
Further Information Favourable Opinion