Outcome measures for clinical trials
There’s a recognised need to develop more effective treatments to improve hearing and to provide relief from tinnitus. So far, there’s no guidance about which complaints are important to measure when deciding if a treatment has worked or is safe. This means there is no common practice across experts. An example for hearing is that one study might measure your ability to listen to quite sounds in a noisy background, while another might measure the impact of hearing on your social life. An example for tinnitus is that one study might measure the loudness of your tinnitus, while another might measure how well you are sleeping. We can solve this challenge by agreeing on core set of outcome measures that are always reported in every clinical trial. “Outcome measures” refer to any health-related complaints that are measured in a clinical trial. This would reduce the differences that we see from one study to the next. It would also speed up progress in developing more effective treatments, by reducing the tendency to report only positive findings.
Findings from clinical trials have the potential to impact the way hearing-related problems are managed in the health service. So, it’s very important that the findings of those trials are relevant to patients. This research area puts members of the public and patients at the heart of key decision making to make sure that future research will be more relevant in addressing the most problematic complaints experienced.
This new research area will deliver evidence-based recommendations on what should be outcome measures to drive up the quality and value of clinical trials. Over the next few years, we will focus on the three most common hearing-related conditions: in adults: tinnitus and mild-to-moderate hearing loss and in children: otitis media with effusion (glue ear).
Our first study is an international study in collaboration with the TINNET network which addresses tinnitus : the COMiT’ID study.
The COMIT’ID study is a world-wide study that uses an online ‘Delphi’ survey to collect opinions from members of the public with tinnitus, healthcare practitioners, researchers, commercial representatives and funders of tinnitus research. The survey questions will identify what outcome domains are critical to be measured when deciding if a sound, psychology or drug-based tinnitus treatment was worked.
The findings will work towards the development of three treatment-specific Core Outcome Sets for sound, psychology and drug-based tinnitus treatment. These Core Outcome Sets will be recommended for measurement and reporting in all future clinical trials for these treatment types.
Recruitment for the COMIT’ID study closed in July 2017 with hundreds of members of the public with tinnitus and professionals taking part from all over the world. Data collection is ongoing until October 2017 with results due to be shared in early 2018.