The COMiT'ID Study: Developing Core Outcome Domains Sets for Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults.
Deborah A Hall, Harriet Smith, Alice Hibbert and 7 others
PMID 30488765WHAT IT FOUND
For tinnitus trials, core outcomes differ by treatment.
Sound trials: ability to ignore, concentration, sense of control, sleep, intrusiveness. Psychology trials: acceptance, mood, negative thoughts and beliefs, control, intrusiveness. Drug trials: intrusiveness, loudness. These are trial reporting standards, not proof treatments work.
Key findings
01For sound-based tinnitus trials, the agreed core domains were ability to ignore, concentration, sense of control, quality of sleep and tinnitus intrusiveness.
02For psychology-based tinnitus trials, the agreed core domains were acceptance of tinnitus, mood, negative thoughts/beliefs, sense of control and tinnitus intrusiveness.
03For pharmacology-based tinnitus trials, the agreed core domains were tinnitus intrusiveness and tinnitus loudness.
STILL TO COME
How it was doneWhat they found
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What it does not show
Most participants were from English-speaking countries and Europe, with low numbers from Africa, Asia and South America. The study materials were in English. Face-to-face meetings were held in the United Kingdom, which made participation from distant countries difficult. The final vote response was lower than earlier rounds. The paper reports only what should be measured, not how it should be measured. It is a consensus development study, not a trial of treatment effectiveness. The recommendations are for early-phase trials and may not be the primary outcomes for every trial.
Declared interests
Funded by European Cooperation in Science and Technology Action and National Institute for Health Research.
The easy way to misread this
Do not read these domains as evidence that a treatment works. They are minimum outcomes for trials, not tested clinical tools or treatment recommendations.