The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus.

OBJECTIVES: Chronic subjective tinnitus is a prevalent condition that causes significant distress to millions of Americans. Effective tinnitus treatments are urgently needed, but evaluating them is hampered by the lack of standardized measures that are validated for both intake assessment and evaluation of treatment outcomes. This work was designed to develop a new self-report questionnaire, the Tinnitus Functional Index (TFI), that would have documented validity both for scaling the severity and negative impact of tinnitus for use in intake assessment and for measuring treatment-related changes in tinnitus (responsiveness) and that would provide comprehensive coverage of multiple tinnitus severity domains. DESIGN: To use preexisting knowledge concerning tinnitus-related problems, an Item Selection Panel (17 expert judges) surveyed the content (175 items) of nine widely used tinnitus questionnaires. From those items, the Panel identified 13 separate domains of tinnitus distress and selected 70 items most likely to be responsive to treatment effects. Eliminating redundant items while retaining good content validity and adding new items to achieve the recommended minimum of 3 to 4 items per domain yielded 43 items, which were then used for constructing TFI Prototype 1.Prototype 1 was tested at five clinics. The 326 participants included consecutive patients receiving tinnitus treatment who provided informed consent-constituting a convenience sample. Construct validity of Prototype 1 as an outcome measure was evaluated by measuring responsiveness of the overall scale and its individual items at 3 and 6 mo follow-up with 65 and 42 participants, respectively. Using a predetermined list of criteria, the 30 best-functioning items were selected for constructing TFI Prototype 2.Prototype 2 was tested at four clinics with 347 participants, including 155 and 86 who provided 3 and 6 mo follow-up data, respectively. Analyses were the same as for Prototype 1. Results were used to select the 25 best-functioning items for the final TFI. RESULTS: Both prototypes and the final TFI displayed strong measurement properties, with few missing data, high validity for scaling of tinnitus severity, and good reliability. All TFI versions exhibited the same eight factors characterizing tinnitus severity and negative impact. Responsiveness, evaluated by computing effect sizes for responses at follow-up, was satisfactory in all TFI versions.In the final TFI, Cronbach's alpha was 0.97 and test-retest reliability 0.78. Convergent validity (r = 0.86 with Tinnitus Handicap Inventory [THI]; r = 0.75 with Visual Analog Scale [VAS]) and discriminant validity (r = 0.56 with Beck Depression Inventory-Primary Care [BDI-PC]) were good. The final TFI was successful at detecting improvement from the initial clinic visit to 3 mo with moderate to large effect sizes and from initial to 6 mo with large effect sizes. Effect sizes for the TFI were generally larger than those obtained for the VAS and THI. After careful evaluation, a 13-point reduction was considered a preliminary criterion for meaningful reduction in TFI outcome scores. CONCLUSIONS: The TFI should be useful in both clinical and research settings because of its responsiveness to treatment-related change, validity for scaling the overall severity of tinnitus, and comprehensive coverage of multiple domains of tinnitus severity.

Tinnitus outcomes assessment.

Over the past two decades, recognition has grown that measures for evaluating treatment outcomes must be designed specifically to have high responsiveness. With that in mind, four major types of tinnitus measures are reviewed, including psychoacoustic measures, self-report questionnaires concerning functional effects of tinnitus, various rating scales, and global outcome measures. Nine commonly used tinnitus questionnaires, developed in the period 1980-2000, are reviewed. Because of many similarities between tinnitus and pain, comparisons between pain and tinnitus measures are discussed, and recommendations that have been made for developing a core set of measures to evaluate treatment-related changes in pain are presented as providing a fruitful path for developing a core set of measures for tinnitus. Finally, the importance of having both immediately obtainable outcome measures (psychoacoustic, rating scales, or single global measures) and longer term measures (questionnaires covering the negative effects of tinnitus) is emphasized for further work in tinnitus outcomes assessment.

Outcomes of clinical trial: tinnitus masking versus tinnitus retraining therapy.

A controlled clinical study was conducted to evaluate prospectively the clinical efficacy of tinnitus masking (TM) and tinnitus retraining therapy (TRT) in military veterans having clinically significant tinnitus. Qualifying patients were placed into the two groups in an alternating manner (to avoid selection bias), and treatment was administered at 0, 3, 6, 12, and 18 months. Outcomes of treatment were evaluated using three self-administered tinnitus questionnaires (Tinnitus Handicap Inventory, Tinnitus Handicap Questionnaire, Tinnitus Severity Index) and the verbally administered TRT interview forms. Findings are presented from the three written questionnaires, and from two of the interview questions (percentage time aware of, and annoyed by, tinnitus). Outcomes were analyzed on an intent-to-treat basis, using a multilevel modeling approach. Of the 123 patients enrolled, 118 were included in the analysis. Both groups showed significant declines (improvements) on these measures, with the TRT decline being significantly greater than for TM. The greater declines in TRT compared to TM occurred most strongly in patients who began treatment with a "very big" tinnitus problem. When patients began treatment with a "moderate" tinnitus problem, the benefits of TRT compared to TM were more modest.

Tinnitus: clinical measurement.

Clinical measurement of tinnitus is necessary for (1) establishing adequate diagnostic information, (2) selection of appropriate treatment, and (3) quantitative documentation of treatment effects. This article describes standardized methods for measuring tinnitus pitch, loudness, maskability, and residual inhibition. These methods have been used in the Tinnitus Clinic, Oregon Health & Science University, since the 1970s. Summary data for all four measures, obtained from over 1600 Tinnitus Clinic patients, are presented here in tabular form to demonstrate the nature and range of variability within the tinnitus patient population.

Masking devices and alprazolam treatment for tinnitus.

Effective tinnitus relief can be achieved in a large percentage of patients using appropriately selected wearable devices that provide masking of the tinnitus. Guidelines are presented for selecting between three types of devices for that purpose: (1) tinnitus maskers; (2) hearing aids; and (3) tinnitus instruments (units that combine hearing aid and masker in the same case). For patients whose tinnitus cannot be masked, oral administration of alprazolam may be an effective alternative, which should be done with the knowledge and cooperation of the patient's primary care physician. Dosages and guidelines for administering alprazolam are presented.

Transmeatal low-power laser irradiation for tinnitus.

OBJECTIVE: To evaluate effectiveness of 60-mW laser irradiation in the treatment of tinnitus. STUDY DESIGN: Prospective, randomized double-blind study. METHODS: This investigation included 68 ears in 45 patients with disabling unilateral or bilateral tinnitus. The active or placebo laser treatment was administered transmeatally once a week for 6 minutes. Laser irradiation was performed four times during a 4-week period. A questionnaire was administered to evaluate the loudness, duration, quality, and annoyance of tinnitus before and after irradiation. The loudness and pitch match for tinnitus were obtained, and distortion product otoacoustic emissions were also examined. RESULTS: No significant difference was observed between the active and placebo laser groups with regard to outcome of loudness, duration, quality, and annoyance of tinnitus. In one patient who received active laser treatment, acute hearing deterioration occurred after the third irradiation. CONCLUSION: Transmeatal low-power laser irradiation with 60 mW is not effective for the treatment of tinnitus.