Core Outcome Measures in Tinnitus: International Delphi (COMIT'ID)
Research type
Research Study
Full title
Establishing Core Outcome Sets for early-phase clinical trials of three intervention strategies to manage chronic subjective tinnitus in adults: An international modified Delphi study
IRAS ID
220112
Contact name
Deb Hall
Contact email
Sponsor organisation
Univeristy of Nottingham
Duration of Study in the UK
0 years, 6 months, 25 days
Research summary
Tinnitus is the experience of sound (ringing, roaring or whistling), in one ear, both ears or in the head without there being an external sound source. Approximately one in ten people in the UK experience tinnitus, with the impact differing from person to person. Some people report sleep disturbance whilst others report concentration difficulties. To date, studies testing tinnitus treatments do not always measure the same aspects, when evaluating treatment. This makes it hard to compare studies and decide which treatments work best. This study aims to collate the opinions of people experiencing tinnitus, healthcare practitioners, researchers and those who fund tinnitus research to work towards an agreement on what is important to measure when deciding if a tinnitus treatment is working.
Because tinnitus treatment comes in very different forms, the research will involve three separate online surveys to look at what is important to measure for each of the three main tinnitus treatment categories; sound-based treatments, psychological treatments and drug-based treatments.
The opinions collected from this research will inform the development of a list of aspects, known as a “Core Domain Set”, for each of the three tinnitus treatment types that must be measured and reported in all future trials of these types of treatment. This will allow findings from different studies to be compared, this will make it easier to find out which treatments work best and why, which will help people to make better choices regarding their treatment.
This study will specifically focus on identifying ‘what’ aspects of tinnitus should be measured. Following this, a set of studies will be required to identify ‘how’ to measure each of the aspects in the list (or ‘outcome domains’). Together, these will create what is referred to as a ‘Core Domain Set’ (what and how) for each treatment type.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
17/WM/0095
Date of REC Opinion
21 Mar 2017
REC opinion
Further Information Favourable Opinion