Mary B. Meikle

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 severity, loudness, and depression.

Answers to questionnaires filled out by 436 patients who visited our tinnitus clinic were analyzed. Patients were asked to report the presence or absence of depression and to rate the loudness and severity of their tinnitus. Responses to questions about tinnitus loudness and severity from 121 patients who reported current depression were compared with responses from 285 patients who reported no history of depression. There was no significant difference in reported loudness of tinnitus between patients with and without depression. However, patients with current depression scored significantly higher than patients without depression on all 12 questions relating to tinnitus severity. We conclude that depression and tinnitus severity are linked in some patients. Treatment of depression with medications and psychotherapy is likely to reduce tinnitus severity for many of these patients.

The Perceived Severity of Tinnitus: Some Observations Concerning a Large Population of Tinnitus Clinic Patients

Detailed information about tinnitus was obtained from over 1800 patients attending a tinnitus clinic. Patients rated their tinnitus severity on a scale from 1 to 10 and also provided information concerning the quality, duration, localization, and other attributes of their tinnitus. In addition to standard audiometric tests, patients received tests for tinnitus pitch, loudness, maskability, and residual inhibition, and provided a brief medical history. The severity ratings of over 90% were at or above the scale value of 5. There was no correlation between rated severity and the loudness of tinnitus (obtained by a loudness balance procedure using external sounds matching the tinnitus pitch), thus confirming earlier observations. The severity also was not related to the type, quality, or pitch of tinnitus sound heard. However, severity ratings were highly correlated with incidence of sleep disturbance. Additional observations concerning relationships between perceived severity and other patient characteristics are discussed.

Clinical trial to compare tinnitus masking and tinnitus retraining therapy

Conclusion: Both tinnitus masking (TM) and tinnitus retraining therapy (TRT) can be effective therapies for amelioration of tinnitus. TM may be more effective for patients in the short term, but with continued treatment TRT may produce the greatest effects. Objectives: Although TM and TRT have been used for many years, research has not documented definitively the efficacy of these methods. The present study was a controlled clinical trial to prospectively evaluate the clinical efficacy of these two methods for US military veterans with severe tinnitus. Subjects and methods: Over 800 veterans were screened to ensure that enrolled patients had tinnitus of sufficient severity to justify 18 months of individualized treatment. Qualifying patients (n=123) were placed quasi-randomly (alternating placement) into treatment with either TM or TRT. Treatment was administered at 0, 3, 6, 12, and 18 months. Outcomes of treatment were evaluated primarily using three self-administered tinnitus questionnaires (Tinnitus Handicap Inventory, Tinnitus Handicap Questionnaire, Tinnitus Severity Index). Results: Findings are presented from the three written questionnaires with respect to three categories of patients: describing tinnitus as a ‘moderate,’ ‘big,’ and ‘very big’ problem at baseline. Based on effect sizes, both groups showed considerable improvement overall. In general, TM effects remained fairly constant over time while TRT effects improved incrementally. For the patients with a ‘moderate’ and ‘big’ problem, TM provided the greatest benefit at 3 and 6 months; benefit to these TRT patients was slightly greater at 12 months, and much greater at 18 months. For patients with a ‘very big’ problem, TM provided the greatest benefit at 3 months. For these latter patients, results were about the same between groups at 6 months, and improvement for TRT was much greater at 12 months, with further gains at 18 months.

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.

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.

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 patients primary care physician. Dosages and guidelines for administering alprazolam are presented.

Assessment of tinnitus: measurement of treatment outcomes.

There is a wide range of assessment techniques for tinnitus, but no consensus has developed concerning how best to measure either the presenting features of tinnitus or the effects of tinnitus treatments. Standardization of reliable and valid tinnitus measures would provide many advantages including improving the uniformity of diagnostic and screening criteria between clinics and facilitating comparison of treatment outcomes obtained at different sites. This chapter attempts to clarify issues involved in developing self-report questionnaires for the assessment of tinnitus. While the tinnitus questionnaires that are currently available provide valuable information on which to base diagnostic and screening decisions, they were not originally developed in such a way as to maximize their sensitivity to treatment-related changes in tinnitus. As a result, their construct validity for measuring treatment benefit has not received appropriate attention. In this paper, special emphasis is devoted to the use of effect sizes as an estimate of the ability of questionnaires (and their individual items) to measure changes associated with treatment. We discuss the criteria relevant to evaluating the effectiveness of a questionnaire for diagnostic purposes vs. for treatment-evaluation purposes, and we present a detailed illustration of how the various criteria have been applied in a recent questionnaire development effort.

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.

ELECTRONIC ACCESS TO TINNITUS DATA : THE OREGON TINNITUS DATA ARCHIVE

The recently published Oregon Tinnitus Data Archive can be viewed by anyone with Internet access and World Wide Web browser software. A dynamically changing document to be amplified and upgraded in future versions, at present the Archive summarizes records from 1630 patients with tinnitus seen between 1982 and 1992 at the Tinnitus Clinic of the Oregon Health Sciences University. The Archive has many features of standard journal publications but also has added advantages of extensive appendixes and other background information, as well as the ease of use and flexibility offered by hypertext documents. The data in the Archive can be used for a variety of clinical and research purposes such as development of prevalence estimates for medical conditions or etiologic circumstances associated with tinnitus, testing of clinical impressions and other hypotheses, and efforts to identify risk factors and possible causal agents for tinnitus.