Assessing outcomes of tinnitus intervention.

BACKGROUND: It has been estimated that as many as 50 million Americans do experience or have experienced tinnitus. For approximately 12 million of these individuals, tinnitus makes it impossible for them to carry out normal everyday activities without limitation. These are the patients that present to audiology clinics for assessment and management. The tinnitus evaluation includes the measurement of acoustical characteristics of tinnitus and the impact that this impairment has on health-related quality of life (HRQoL). Tinnitus is a disorder that often occurs as a result of auditory system impairment. The impairment for some can impart an activity limitation and a participation restriction (i.e., tinnitus-related disability or handicap, respectively). The goal of tinnitus management is to reduce, or eliminate, activity limitations and participation restrictions by reducing or eliminating a patient's perception of tinnitus or their reaction to tinnitus. Implicit in this statement is the assumption that there exist standardized measures for quantifying the patient's tinnitus perception and their reaction to it. If there existed stable and responsive standardized tinnitus measures, then it would be possible to compare a patient's tinnitus experience at different time points (e.g., before and after treatment) to assess, for example, treatment efficacy. PURPOSE: The purposes of the current review are to (1) describe psychometric standards used to select outcome measurement tools; (2) discuss available measurement techniques and their application to tinnitus evaluation and treatment-related assessment within the domains established by the World Health Organization's International Classification of Functioning, Disability and Health; (3) list and briefly describe self-report tinnitus questionnaires; (4) describe how valuation of tinnitus treatment can be assessed using economic models of treatment effectiveness; and (5) provide future directions including the development of a tinnitus outcomes test battery and treatment-related study designs. RESEARCH DESIGN: Retrospective literature review CONCLUSIONS: Although psychometrically robust measures of tinnitus HRQoL do exist, there is no unanimity in, for example, what tests should be included in the tinnitus assessment, and how studies of HRQoL should be conducted. The current authors suggest that future studies employ more rigorous designs and contain (minimally) the following characteristics: (1) utilization of randomized control groups and blinding; (2) appropriate statistical testing including "dropouts" that should be used in an "intention to treat" analysis rather than elimination from the final data set; (3) long-term follow-up assessment to evaluate responsiveness; (4) appropriate inclusion criteria to avoid "ceiling" and "floor" effects; and (5) suitable sample sizes based on the application of power analyses.

A comparison of benefit and economic value between two sound therapy tinnitus management options.

BACKGROUND: Sound therapy coupled with appropriate counseling has gained widespread acceptance in the audiological management of tinnitus. For many years, ear level sound generators (SGs) have been used to provide masking relief and to promote tinnitus habituation. More recently, an alternative treatment device was introduced, the Neuromonics Tinnitus Treatment (NTT), which employs spectrally-modified music in an acoustic desensitization approach in order to help patients overcome the disturbing consequences of tinnitus. It is unknown, however, if one treatment plan is more efficacious and cost-effective in comparison to the other. In today's economic climate, it has become critical that clinicians justify the value of tinnitus treatment devices in relation to observed benefit. PURPOSE: To determine perceived benefit from, and economic value associated with, two forms of sound therapy, namely, SGs and NTT. RESEARCH DESIGN: Retrospective between-subject clinical study. STUDY SAMPLE: A sample of convenience comprised of 56 patients drawn from the Tinnitus Management Clinic at the Cleveland Clinic participated. Twenty-three patients selected SGs, and 33 patients selected NTT as their preferred sound therapy treatment option. DATA COLLECTION AND ANALYSIS: Sound therapy benefit was quantified using the Tinnitus Handicap Inventory (THI). The questionnaire was administered before and 6 mo after initiation of tinnitus treatment. Prior to device fitting, all patients participated in a 1.5 hr group education session about tinnitus and its management. Economic value comparisons between sound therapy options were made using a cost-effectiveness analysis (CEA) and cost-utility analysis (CUA). RESULTS: THI scores indicated a significant improvement (p < 0.001) in tinnitus reduction for both treatment types between a pre- and 6 mo postfitting interval, yet there were no differences (p > 0.05) between the treatment alternatives at baseline or 6 mo postfitting. The magnitude of improvement for both SGs and NTT was dependent on initial perceived tinnitus handicap. Based on the CEA and CUA economic analyses alone, it appears that the SGs may be the more cost-effective alternative; however, the magnitude of economic value is a function of preexisting perceived tinnitus activity limitation/participation restriction. CONCLUSIONS: Both SGs and NTT provide significant reduction in perceived tinnitus handicap, with benefit being more pronounced for those patients having greater tinnitus problems at the beginning of therapy. Although the economic models favored the SGs over the NTT, there are several other critical factors that clinicians must take into account when recommending a specific sound therapy option. These include initial tinnitus severity complaints and a number of patient preference variables such as sound preference, listening acceptability, and lifestyle.

Benefit From, Satisfaction With, and Cost-Effectiveness of Three Different Hearing Aid Technologies.

Clinical decision-making has become more complex as newer, more costly, hearing aid (HA) technologies become available. The expanding array of more expensive HAs demands that clinical researchers continue to justify the value of these instruments relative to the substantial increase in cost to both the provider and consumer.In the present report, 25 current conventional HA users with adult onset of sensorineural hearing loss were fitted with: (a) a one-channel linear HA; (b) a two-channel, nonlinear HA; and (c) a seven-band, two-channel digital signal processing (DSP) HA. All instruments were mini behind-the-ear units with identifying information removed from the cases. Subjects wore each HA for at least a 1-month period.A set of laboratory (Speech Perception in Noise [SPIN] test; audibility index calculated from real-ear measurements) and self-report (Abbreviated Profile of Hearing Aid Benefit; Hearing Handicap Inventory for the Elderly/Adults; Knowles Hearing Aid Satisfaction Survey; preference ratings) outcome measures were used to evaluate the benefit from, satisfaction with, and cost-effectiveness of each test HA. As expected, there were statistically significant differences between unaided and aided conditions across HAs.Although the DSP instrument yielded significantly higher word recognition scores on the SPIN test, no differences were observed among the test HAs for the standardized self-report measures. In contrast, however, more than 75% of the subjects preferred the "higher end" instruments. Yet, 33% of the subjects changed their preference for the "higher end" instruments after being informed of costs. A cost-effectiveness model for evaluating the relationship between HA retail purchase price and improvements in performance/benefit is presented.