METHODS: An online survey was disseminated to clinicians working in the audiovestibular field.
RESULTS: Ninety-three respondents participated in the survey. Most professionals were aware of potential vestibulotoxicity associated with cisplatin chemotherapy. Thirty-three percent of the respondents reported that they had seen patients with cisplatin vestibulotoxicity. Forty percent of them were confident in making the diagnosis and in managing the patient in this situation. The prevalence and impact of vestibulotoxicity including practicality of the assessment should be considered when designing an effective vestibulotoxicity screening protocol.
CONCLUSION: This study provides a better understanding of cisplatin vestibulotoxicity from the perspectives of audiovestibular clinicians, which will underpin appropriate detection and management of the condition.
DESIGN: This was a cross-sectional study. Three hundred forty-two members of the public with tinnitus volunteered to complete a survey comprising a series of questionnaires and subscales of questionnaires measuring each of the constructs contained within the Cognitive Behavioral Model of Tinnitus Distress. The optimum factor structure of each measure for the study population was established, and the resulting factors were used to construct a series of path models based on the theoretical model. Path analysis was conducted for each of these, and the goodness of fit of the models was assessed using established fit criteria.
RESULTS: Five of the six path models tested reached the threshold for adequate fit, and further modifications improved the fit of the three most parsimonious of these. The two best-fitting models had comparable fit indices which approached the criteria for good fit (Root Mean Square Error of Approximation = 0.061, Comparative Fit Index = 0.984, Tucker Lewis Index = 0.970 and Root Mean Square Error of Approximation = 0.055, Comparative Fit Index = 0.993, Tucker Lewis Index = 0.982). They differed principally in the placement of tinnitus magnitude and the inclusion/noninclusion of control beliefs.
CONCLUSIONS: There are theoretical arguments to support both a beliefs-driven and a loudness-driven model, and it may be that different configurations of the Cognitive Behavioral Model of Tinnitus Distress are more appropriate to different groups of people with tinnitus. Further investigation of this is needed. This notwithstanding, the present study provides empirical support for a model of tinnitus distress which provides a clinical framework for the development of more effective psychological therapy.
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.
METHODS: Isotropic multiband functional MRI (1.5 mm) with sparse sampling (effective TR = 9000 ms, acquisition duration = 1962 ms) and continuous sampling (TR = 2000 ms) with ANC were compared in 15 normally hearing participants. A sustained broadband noise stimulus was presented to drive activation of both sustained and transient auditory responses within subcortical and cortical auditory regions.
RESULTS: Robust broadband noise-related activity was detected throughout the auditory pathways. Continuous sampling with ANC was found to give a statistically significant advantage over sparse sampling for the detection of the transient (onset) stimulus responses, particularly in the auditory cortex (P < .001) and inferior colliculus (P < .001), whereas gains provided by sparse over continuous ANC for detecting offset and sustained responses were marginal (p ~ 0.05 in superior olivary complex, inferior colliculus, medial geniculate body, and auditory cortex).
CONCLUSIONS: Sparse and continuous ANC multiband functional MRI protocols provide differing advantages for observing the transient (onset and offset) and sustained stimulus responses.
METHODS: Between 2017-2018, a cross-sectional European Tinnitus Survey (ETS) was conducted in 12 European Union nations (Bulgaria, England, France, Germany, Greece, Ireland, Italy, Latvia, Poland, Portugal, Romania, and Spain), using a standardised set of tinnitus-related questions and response options in country-specific languages. We recruited 11,427 adults aged ≥18 years.
FINDINGS: Prevalence of any tinnitus was 14·7% (14·0% in men and 15·2% in women), ranging from 8·7% in Ireland to 28·3% in Bulgaria. Severe tinnitus was found in 1·2% participants (1·0% in men and 1·4% in women), ranging from 0·6% in Ireland to 4·2% in Romania. Tinnitus prevalence significantly increased with increasing age and worsening of hearing status. Healthcare resource use for tinnitus increased with increasing tinnitus symptom severity.
INTERPRETATION: This is the first multinational report of Pan-European tinnitus prevalence using standardised questions. The overall prevalence estimates refine previous findings, although widespread inter-country heterogeneity was noted. The results indicate that more than 1 in 7 adults in the EU have tinnitus. Extrapolating to the overall population, approximately 65 million adults in EU28 have tinnitus, 26 million have bothersome tinnitus and 4 million have severe tinnitus.
FUNDING: National Institute for Health Research, European Union's Horizon 2020, Medical Research Council, and GENDER-Net Co-Plus Fund.
OBJECTIVE: The main objectives of the proposed clinical study are to confirm the efficacy, safety, and tolerability of treatment demonstrated in a previous large-scale study of bimodal auditory and trigeminal nerve (tongue) stimulation (Treatment Evaluation of Neuromodulation for Tinnitus - Stage A1); evaluate the therapeutic effects of adjusting stimulation parameters over time; and determine the contribution of different features of bimodal stimulation in improving tinnitus outcomes.
METHODS: This study will be a prospective, randomized, double-blind, parallel-arm, comparative clinical trial of a 12-week treatment for tinnitus using a Conformité Européenne (CE)-marked device with a pre-post and 12-month follow-up design. Four treatment arms will be investigated, in which each arm consists of two different stimulation settings, with the first setting presented during the first 6 weeks and the second setting presented during the next 6 weeks of treatment. The study will enroll 192 participants, split in a ratio of 80:80:16:16 across the four arms. Participants will be randomized to one of four arms and stratified to minimize baseline variability in four categories: two separate strata for sound level tolerance (using loudness discomfort level as indicators for hyperacusis severity), high tinnitus symptom severity based on the Tinnitus Handicap Inventory (THI), and tinnitus laterality. The primary efficacy endpoints are within-arm changes in THI and Tinnitus Functional Index as well as between-arm changes in THI after 6 weeks of treatment for the full cohort and two subgroups of tinnitus participants (ie, one hyperacusis subgroup and a high tinnitus symptom severity subgroup). Additional efficacy endpoints include within-arm or between-arm changes in THI after 6 or 12 weeks of treatment and in different subgroups of tinnitus participants as well as at posttreatment assessments at 6 weeks, 6 months, and 12 months. Treatment safety, attrition rates, and compliance rates will also be assessed and reported.
RESULTS: This study protocol was approved by the Tallaght University Hospital/St. James's Hospital Joint Research Ethics Committee in Dublin, Ireland. The first participant was enrolled on March 20, 2018. The data collection and database lock are expected to be completed by February 2020, and the data analysis and manuscript submission are expected to be conducted in autumn of 2020.
CONCLUSIONS: The findings of this study will be disseminated to relevant research, clinical, and health services and patient communities through publications in peer-reviewed journals and presentations at scientific and clinical conferences.
TRIAL REGISTRATION: ClinicalTrials.gov NCT03530306; https://clinicaltrials.gov/ct2/show/NCT03530306.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13176.
DESIGN AND STUDY SAMPLE: Three translators were recruited to create the Albanian ESIT-SQ translation following good practice guidelines. Using this questionnaire, data from 107 patients attending otolaryngology clinics in Albania were collected.
RESULTS: Participants reporting various degrees of tinnitus symptom severity had distinct phenotypic characteristics. Application of a random forest approach on this preliminary dataset showed that self-reported hearing difficulty, and tinnitus duration, pitch and temporal manifestation were important variables for predicting tinnitus symptom severity.
CONCLUSIONS: Our study provided an Albanian translation of the ESIT-SQ and demonstrated that it is a useful tool for tinnitus profiling and subgrouping.
STUDY DESIGN: Observational cross-sectional study.
SETTING: Tertiary care center.
PATIENTS: Adult survivors of cancer who had completed cisplatin treatment.
MAIN OUTCOME MEASURES: Patient-reported balance symptoms were evaluated by a semistructured clinical interview. Patients underwent bedside clinical tests including Dynamic Visual Acuity test, Modified Clinical Testing of Sensory Interaction and Balance (CTSIB-m), and vibration sense testing to detect peripheral neuropathy. The video Head Impulse Test (vHIT) of all semicircular canals was performed.
RESULTS: Eleven of 65 patients (17%) reported some balance symptoms after cisplatin therapy, including vertigo, dizziness, unsteadiness, and falls. Vertigo was the most common balance symptom, reported by six patients (9.2%), and the clinical histories of these patients were consistent with benign paroxysmal positional vertigo. Three patients (5%) had abnormal results of the CTSIB-m test, and they were the same patients who reported falls. There was a significant association of peripheral neuropathy detected by vibration test and balance symptoms. All patients had normal vHIT results in all semicircular canals.
CONCLUSIONS: Balance symptoms after cisplatin treatment occurred in 17% of adult cancer survivors. Patients with peripheral neuropathy were more likely to have balance symptoms. The CTSIB-m test is a useful bedside physical examination to identify patients with a high risk of fall. Though there was no vestibular dysfunction detected by the vHIT in cancer survivors after cisplatin therapy, benign paroxysmal positional vertigo was relatively prevalent in this group of patients.
OBJECTIVE: This study aimed to further clarify how the outcome domain concepts should be defined for 5 of the core set: tinnitus intrusiveness, sense of control, acceptance of tinnitus, concentration, and ability to ignore. This step requires a clear and fully elaborated definition for each outcome domain, moving from an abstract or a vague concept to an operationalized and measurable health-related construct, so that a suitable measurement instrument can then be identified.
METHODS: A series of 5 focus group-style semistructured discussions were conducted via a Web-based discussion forum, each open for 2 weeks and ending with a vote. The participants included 148 tinnitus experts who completed a preceding e-Delphi survey that had generated the original set of minimum standards. The participants were health care users living with tinnitus, health care professionals, clinical researchers, commercial representatives, and funders.
RESULTS: The Web discussions led to a revision of all 5 original plain language definitions that had been used in the preceding e-Delphi survey. Each revised definition was voted by 8 to 53 participants and reached the prespecified threshold of 70% consensus for all except tinnitus intrusiveness. Although a single definition was not agreed upon for tinnitus intrusiveness, the majority of participants shared the view that the concept should be sufficiently broad to encapsulate a range of subdomains. The examples included tinnitus awareness, unpleasantness, and impact on different aspects of everyday life. Thematic analysis of the 5 Web-based discussion threads gave important insights into expert interpretations of each core outcome domain, generating an operationalized and measurable health construct in each case.
CONCLUSIONS: The qualitative data gathered during the Web-based discussion forum provided an important in-depth understanding of the health concepts that had raised a debate during earlier face-to-face meetings. The descriptive summaries and definitions provide sufficient operationalization of those concepts to proceed to the second stage of core outcome set development that is to identify and evaluate suitable measurement instruments. This study supports the use of Web-based peer discussion forums in defining health concepts.