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Fulltext One Size Does Not Fit All: Developing Common Standards for Outcomes in Early-Phase Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults

Hall DA, Hibbert A, Smith H, Haider HF, Londero A, Mazurek B, et al.

Trends Hear, 2019;23:2331216518824827.
PMID: 30803389 DOI: 10.1177/2331216518824827

Good practice in clinical trials advocates common standards for assessing and reporting condition-specific complaints ("outcome domains"). For tinnitus, there is no common standard. The Core Outcome Measures in Tinnitus International Delphi (COMiT'ID) study created recommendations that are relevant to the most common intervention approaches for chronic subjective tinnitus in adults using consensus methods. Here, the objectives were to examine why it is important to tailor outcome domain selection to the tinnitus intervention that is being evaluated in the clinical trial and to demonstrate that the COMiT'ID recommendations are robust. The COMiT'ID study used an online three-round Delphi method with three separate surveys for sound-, psychology-, and pharmacology-based interventions. Survey data were analyzed to assess quality and confidence in the consensus achieved across surveys and stakeholder groups and between survey rounds. Results found participants were highly discriminatory in their decision-making. Of the 34 outcome domains reaching the prespecified consensus definition in the final round, 17 (50%) were unique to one intervention, while only 12 (35%) were common to all three. Robustness was demonstrated by an acceptable level of agreement across and within stakeholder groups, across survey rounds, across medical specialties (for the health-care practitioners), and across health-care users with varying tinnitus duration. There were few dissenting voices, and results showed no attrition bias. In conclusion, there is compelling evidence that one set of outcomes does not fit all therapeutic aims. Our analyses evidence robust decisions by the electronic Delphi process, leading to recommendations for three unique intervention-specific outcome domain sets. This provides an important starting point for standardization.

Matched MeSH terms: Tinnitus/therapy*
Fulltext Eagle's syndrome

Subramaniam S, Abd Majid MD

Med J Malaysia, 2003 Mar;58(1):139-41.
PMID: 14556342

Eagle's syndrome is an uncommon condition resulting from an elongated styloid process, which causes cervico facial pain, tinnitus and otalgia. A 48-year-old female presented to the clinic with bilateral upper neck pain radiating to the ears with tinnitus for almost one-year duration. Examination of the oral cavity revealed atrophic tonsils and palpable bony projection deep in the tonsillar fossa. Plain lateral neck X-ray and CT scan confirmed the presence of bilateral elongated styloid processes, which were subsequently resected surgically through an oropharyngeal approach. The patient was asymptomatic at follow up at 2 years.

Matched MeSH terms: Tinnitus/therapy
Fulltext The COMiT'ID Study: Developing Core Outcome Domains Sets for Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults

Hall DA, Smith H, Hibbert A, Colley V, Haider HF, Horobin A, et al.

Trends Hear, 2018;22:2331216518814384.
PMID: 30488765 DOI: 10.1177/2331216518814384

Subjective tinnitus is a chronic heterogeneous condition that is typically managed using intervention approaches based on sound devices, psychologically informed therapies, or pharmaceutical products. For clinical trials, there are currently no common standards for assessing or reporting intervention efficacy. This article reports on the first of two steps to establish a common standard, which identifies what specific tinnitus-related complaints ("outcome domains") are critical and important to assess in all clinical trials to determine whether an intervention has worked. Using purposive sampling, 719 international health-care users with tinnitus, health-care professionals, clinical researchers, commercial representatives, and funders were recruited. Eligibility was primarily determined by experience of one of the three interventions of interest. Following recommended procedures for gaining consensus, three intervention-specific, three-round, Delphi surveys were delivered online. Each Delphi survey was followed by an in-person consensus meeting. Viewpoints and votes involved all stakeholder groups, with approximately a 1:1 ratio of health-care users to professionals. "Tinnitus intrusiveness" was voted in for all three interventions. For sound-based interventions, the minimum set included "ability to ignore," "concentration," "quality of sleep," and "sense of control." For psychology-based interventions, the minimum set included "acceptance of tinnitus," "mood," "negative thoughts and beliefs," and "sense of control." For pharmacology-based interventions, "tinnitus loudness" was the only additional core outcome domain. The second step will next identify how those outcome domains should best be measured. The uptake of these intervention-specific standards in clinical trials will improve research quality, enhance clinical decision-making, and facilitate meta-analysis in systematic reviews.

Matched MeSH terms: Tinnitus/therapy*
Standardized questions in English for estimating tinnitus prevalence and severity, hearing difficulty and usage of healthcare resources, and their translation into 11 European languages

Biswas R, Lugo A, Gallus S, Akeroyd MA, Hall DA

Hear Res, 2019 06;377:330-338.
PMID: 30853349 DOI: 10.1016/j.heares.2019.02.008

INTRODUCTION: Prevalence estimates depend largely on the nature of the question asked to define the presence of the health condition, and the literature on the population burden of tinnitus and hearing difficulties is no different in this respect. The lack of standardized questions for data collection limits comparison across studies and across countries. The purpose of this short Technical Note is to report the first attempt to establish a set of standard questions developed for use in population-based surveys, and their adaptation and translation from English into 11 European languages.
METHODS: Four questions and their corresponding response options were adapted from existing population-based surveys to assess tinnitus prevalence, tinnitus symptom severity, use of healthcare resources for tinnitus and hearing difficulty. The translated versions (Bulgarian, French, German, Greek, Italian, Latvian, Polish, Portuguese, Romanian, Russian, and Spanish) were generated using recognized methods to achieve a "world-for-world" translation.
RESULTS: Translated versions were produced with acceptable functional equivalence to the original English-language version, as judged by a small panel of bilingual speakers who participated in the online field testing.
CONCLUSION: This work is the first of its kind to promote multi-national standardization by creating a set of tools that can readily be used across countries. These are currently being used in a European-wide study of tinnitus prevalence, and have wider application across English- and Spanish speaking countries including the Americas and Oceania.

Matched MeSH terms: Tinnitus/therapy