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- COMIT’ID Study: A world-wide collaboration to standardize the future of tinnitus clinical trials
COMIT’ID Study: A world-wide collaboration to standardize the future of tinnitus clinical trials
Prof Deb Hall, Dr Kathryn Fackrell and Harriet Smith from the National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, call for professionals in sound-, psychology- or drug-based treatments for tinnitus to participate in a world-wide online COMIT’ID Study.
Tinnitus, described as the sensation of ‘ringing’, ‘buzzing’ or ‘hissing’ in the ears or head, affects 1 in 10 adults. There is no simple measurement for tinnitus and it affects each patient in a different way, from difficulties concentrating to sleep disturbance to impact on social activities and relationships. We highlighted in our recent Opinion article, an urgent need to improve standards for measuring and reporting the effect of tinnitus treatments in clinical trials.
This week, Prof Deb Hall presented a solution to this problem as part of her Tonndorf Lecture at the 1st World Tinnitus Congress and the XII International Tinnitus Seminar in Warsaw, Poland. We are proud that our COMIT’ID Study presents a new way of working together across the whole tinnitus community. Deb said “It’s only by systematic and rigorous methodology that those of us who work in tinnitus today can create a strong legacy that we will be proud to hand on to the next generation of researchers and clinicians. One that will have a long-term sustained benefit for patients. My aim is to bring a fresh style of working to the tinnitus community. I invite you as tinnitus experts representing different disciplines, different centres, and different countries to engage with me and support this study. This is the best way for people to take note and listen, and to create the legacy that is so important for the future health of tinnitus research.”
Key problems include:
Heterogeneity in tinnitus clinical trials:
Our review of all tinnitus clinical trials between 2006 and 2015 reported over 130 different ways to measure therapeutic effects. This lack of consistency limits the ability to compare and combine data across studies.
Sometimes, if the trial results obtained are not aligned with what was hoped for, researchers may choose to only publish results for some, and not all, of the outcomes measured. This limits the ability of other investigators to establish a full picture of how effective a treatment is.
Members of the public with tinnitus have not had input into what is measured:
So far, members of the public have not been involved in decisions around which outcomes should be assessed. This means there is a risk that what is being measured is not relevant to the complaints that are most problematic to patients.
Deb’s team is solving this problem through a global project which asks tinnitus experts to have their say in what is critically important to measure to know whether or not a treatment has worked. This COMIT’ID study will create three treatment-specific Core Outcome Sets for sound-, psychology- and pharmacology-based tinnitus treatment. These Core Outcome Sets will be recommended for measurement and reporting in all future tinnitus clinical trials, leaving researchers free to measure additional outcomes if they wish.
Why this research is important?
A Core Outcome Set is the best way to encourage investigators to measure and report a small set of standard measurements so that clinical trial data can be compared, contrasted, and merged across studies. This is one of the best ways to speed up the development of effective treatments.
What is particularly exciting is that we are involving patients in this process too. Their say is just as important as the professionals.
About the COMIT’ID Study:
The COMIT’ID Study will deliver the first output of the project by identifying “what” outcome domains are most important to consider when measuring treatment effect.
The COMIT’ID study uses a research technique known as a “Delphi” survey, designed to gain consensus amongst a broad group of experts. The Delphi technique is a tried and tested consensus method that is increasingly recognized as one of the standard approaches to Core Outcome Set development. The study will involve 3, independent online surveys for each of the three tinnitus treatment types. We’re calling for professional and public tinnitus stakeholders to complete one or more of these surveys, based on their tinnitus treatment experience. Each survey will be followed by an in-person ‘consensus’ meeting with a group of stakeholders to discuss the findings.
Please register to take part
We have had a fantastic response to our call for participants and we have now fully recruited and closed the surveys for both sound and psychology-based tinnitus treatment.
You can still sign up and have your say in our pharmacology-based treatment survey, which remains open until the end of June. If you are a researcher, health professional, commercial/industry representative or funder with specific experience in drug-based tinnitus treatment, we urge you to take part. Members of the public with tinnitus are also invited to participate. We are looking for widespread international input to ensure the results have global relevance.
So far we have recruited 44 out of our target of 60 professionals to have their say on outcomes for pharmacology-based tinnitus treatment.
As you can see, we still have a little way to go to obtain the professional perspective we need, so please sign up and help today!
A summary of what taking part will involve:
You will be asked to complete an online survey starting with round 1 in May and early June, and ending with round 3 in August.
Each round takes about 30 minutes (no more than 60 minutes) and can be completed at home.
Following the survey you will also have the option to take part in our in-person group consensus meeting, held in the UK (expected 06 and 08 Sept 2017).
All professional participants will be acknowledged in resulting publications.
You can download our professional participant information sheet to find out more: http://www.hearing.nihr.ac.uk/images/uploads/docs/20170420_COMITID_Prof_Info_Sht_v3.0.pdf
Or if you are a member of the public with tinnitus you can find more information here: http://www.hearing.nihr.ac.uk/images/uploads/docs/20170420_COMITID_Patient_Info_Sht_v3.0.pdf
You can also visit our website and watch our video about the study: http://www.hearing.nihr.ac.uk/research/tinnitus-online-survey-comitid-study and follow us on Twitter for the latest news: https://twitter.com/comitidstudy?lang=en
Please email firstname.lastname@example.org to confirm your interest
COMIT’ID: Core Outcome Measures in Tinnitus, International Delphi