Abstract
BackgroundWhen 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.MethodsThe 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.ResultsThe 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.ConclusionsThe 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.
Highlights
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
It is essential to point out that potentially minimal important change (MIC) in tinnitus could be sensitive to hearing loss, often comorbid with tinnitus. Some patients attribute their problems with hearing solely to tinnitus and it is difficult to determine which hearing difficulties are related to tinnitus and which hearing difficulties are related to hearing loss. We divided these groups by means of the Tinnitus and Hearing Survey (THS), and we showed that the MIC in patients with dominant tinnitus problems could be different from the MIC in patients with dominant hearing difficulties
Endnotes 1Justification for the lack of subjectively perceived improvement of hearing after stapedotomy:For one patient who reported no change in hearing, mean air conduction (AC) threshold for frequencies: 0.5, 1, 2, 4 kHz was 80.0 dB HL before the surgery and it improved to 51.2 dB HL after the surgery
Summary
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. There are different theories about possible cause and way of clinical development of the disease [1,2,3]. It leads to decrease the stapes mobility and changes in oval window could impact in sensorineural component of hearing [4, 5]. 65–90% of patients with otosclerosis experience tinnitus [8,9,10,11,12,13,14,15] It would be useful from clinical point of view to know, if
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