Clinically important change in tinnitus sensation after stapedotomy.

Background: When measuring the treatment effect in tinnitus with multi-item outcome instruments, it is crucial for both clinical and research purposes to take into consideration clinical importance of the outcome scores. The aim of the present study is to determine minimal important change (MIC) in tinnitus which is clinically meaningful to patients with otosclerosis.

Methods: The study population was 95 patients with otosclerosis, suffering from tinnitus. They completed the Tinnitus Functional Index before stapedotomy and 3 months after the surgery. The minimal important change was estimated with the Clinical Global Impression Scale as the external criterion (anchor). The mean change method and the receiver operating characteristic (ROC) method were used to determine minimal important change in tinnitus sensation.

Results: The improvement in tinnitus after stapedotomy was reported by 69.4% of the patients with otosclerosis. Minimal important change in tinnitus was estimated as reduction of 8.8 points in the Tinnitus Functional Index.

Conclusions: The anchor-based approach using an external criterion (anchor) allows to determine change in tinnitus sensation which is meaningful to patients after stapedotomy. The value of 8.8 points in Tinnitus Functional Index could be used as benchmark of stapedotomy effectiveness in otosclerosis patients suffering from tinnitus. Hearing difficulties comorbid with tinnitus could affect the perception of tinnitus change.