The out-of-pocket expenses of people with tinnitus in Europe.

BACKGROUND: Despite the high frequency of tinnitus and its impact on wellbeing, little is known about its economic burden and no data to our knowledge are available on out-of-pocket (OOP) expenses. METHODS: In 2022 a survey was conducted on OOP costs of tinnitus. We enrolled 679 participants with slight, moderate and severe tinnitus in Italy, United Kingdom, Netherlands, Germany and Spain. We estimated annual OOP expenses for tinnitus-related healthcare visits, treatments, medications and alternative medicine practices. Prevalence of tinnitus in the general population, obtained from a representative survey we conducted in Europe in 2017-2018, was used to generalise costs for people with any tinnitus at the national level. RESULTS: OOP expenses were 368€ (95% confidence intervals (CI), 78€-690€), 728€ (95% CI, 316€-1,288€), and 1,492€ (95% CI, 760€-2,688€) for slight, moderate, and severe tinnitus, respectively, with annual expenditure of 565€ for people with any tinnitus: 209€ for healthcare visits, 93€ for treatments, 16€ for drugs, 64€ for hearing supporting systems and 183€ for acupuncture, homeopathy and osteopathy. Individuals with slight, moderate, and severe tinnitus expressed a willingness to invest 1.6, 4.3, and 7.0 times their monthly income, respectively, to achieve complete relief from tinnitus. CONCLUSIONS: This study offers for the first time insights into the OOP expenses incurred by individuals with tinnitus. OOP expenses exhibited substantial variations based on severity status, accounting for more than 17 thousand million€ in the countries considered. In terms of financial burden, these findings align tinnitus to the recognised leading disabilities, including back pain and migraine.

An Albanian translation of a questionnaire for self-reported tinnitus assessment.

OBJECTIVE: To our knowledge, there is no published study investigating the characteristics of people experiencing tinnitus in Albania. Such a study would be important, providing the basis for further research in this region and contributing to a wider understanding of tinnitus heterogeneity across different geographic locations. The main objective of this study was to develop an Albanian translation of a standardised questionnaire for tinnitus research, namely the European School for Interdisciplinary Tinnitus Research-Screening Questionnaire (ESIT-SQ). A secondary objective was to assess its applicability and usefulness by conducting an exploratory survey on a small sample of the Albanian tinnitus population. 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.

A narrative synthesis of research evidence for tinnitus-related complaints as reported by patients and their significant others.

BACKGROUND: There are a large number of assessment tools for tinnitus, with little consensus on what it is important to measure and no preference for a minimum reporting standard. The item content of tinnitus assessment tools should seek to capture relevant impacts of tinnitus on everyday life, but no-one has yet synthesised information about the range of tinnitus complaints. This review is thus the first comprehensive and authoritative collection and synthesis of what adults with tinnitus and their significant others report as problems in their everyday lives caused by tinnitus. METHODS: Electronic searches were conducted in PubMed, Embase, CINAHL, as well as grey literature sources to identify publications from January 1980 to June 2015 in which participants were enrolled because tinnitus was their primary complaint. A manual search of seven relevant journals updated the search to December 2017. Of the 3699 titles identified overall, 84 records (reporting 86 studies) met our inclusion criteria and were taken through to data collection. Coders collated generic and tinnitus-specific complaints reported by people with tinnitus. All relevant data items were then analyzed using an iterative approach to narrative synthesis to form domain groupings representing complaints of tinnitus, which were compared patients and significant others. RESULTS: From the 86 studies analyzed using data collected from 16,381 patients, 42 discrete complaints were identified spanning physical and psychological health, quality of life and negative attributes of the tinnitus sound. This diversity was not captured by any individual study alone. There was good convergence between complaints collected using open- and closed-format questions, with the exception of general moods and perceptual attributes of tinnitus (location, loudness, pitch and unpleasantness); reported only using closed questions. Just two studies addressed data from the perspective of significant others (n = 79), but there was substantial correspondence with the patient framework, especially regarding relationships and social life. CONCLUSIONS: Our findings contribute fundamental new knowledge and a unique resource that enables investigators to appreciate the broad impacts of tinnitus on an individual. Our findings can also be used to guide questions during diagnostic assessment, to evaluate existing tinnitus-specific HR-QoL questionnaires and develop new ones, where necessary. TRIAL REGISTRATION: PROSPERO registration number: CRD42015020629 . Protocol published in BMJ Open. 2016;6e009171.

Integrating Distribution-Based and Anchor-Based Techniques to Identify Minimal Important Change for the Tinnitus Functional Index (TFI) Questionnaire.

The Tinnitus Functional Index (TFI) was developed to be responsive to small treatment-related changes in the impact of tinnitus. Yet, no studies have integrated anchor-based and distribution-based techniques to produce a single Minimal Important Change (MIC) score. Here, we evaluated the responsiveness and interpretability of the TFI, determining for the first time a robust MIC score in a UK clinical population. Two-hundred and fifty-five patients with tinnitus participated in this prospective longitudinal validation study. Distribution-based estimates (Standard Error of Measurement, Smallest Detectable Change and Effect size) and anchor-based estimates of important change (minimal clinically important difference and Receiver Operator Curve optimal value) were calculated and then integrated using a visual anchor-based MIC distribution plot. A reduction in score of -14 was determined as the MIC estimate that exceeds the measurement error, most of the variability and reliably identifies patients demonstrating true improvement. It is therefore recommended that a reduction of 14 points should be used as a minimum change required when calculating statistical power and sample size in tinnitus intervention studies and assessing patients in clinical practice.

Systematic Evaluation of the T30 Neurostimulator Treatment for Tinnitus: A Double-Blind Randomised Placebo-Controlled Trial with Open-Label Extension.

Tinnitus is often triggered by cochlear damage and has been linked with aberrant patterns of neuronal activity. Acoustic Coordinated Reset (CR®) Neuromodulation is a sound therapy hypothesised to reduce tinnitus symptoms by desynchronising pathological brain activity using a portable acoustic device (the T30 neurostimulator). We report results of a pivotal trial to test the efficacy of this intervention. This two-centre, double-blind randomised controlled trial with long-term open-label extension, was undertaken between February 2012 and February 2014 in the UK. Participants were 100 adults with tinnitus as a primary complaint, recruited through hearing clinics and media advertisements. Intervention was the device programmed either with the proprietary sound sequence or placebo algorithm, fit by one of five trained audiologists. Minimisation software provided group allocation (1:1 randomisation), with groups matched for age, gender, hearing loss and tinnitus severity. Allocation was masked from participants and assessors during the trial. The primary measure of efficacy was change in tinnitus symptom severity between groups, measured using the Tinnitus Handicap Questionnaire at 12 weeks. Secondary outcomes were other measures of tinnitus symptom severity, health-related quality of life, and perceptual characteristics (pitch, loudness, bandwidth) at 12 weeks, and Tinnitus Handicap Questionnaire at 36 weeks (open-label extension). A statistician blinded to the allocation conducted an intention-to-treat analysis that employed linear regressions on minimisation variables, trial centre and intervention group, with multiple imputations for missing data. The study was registered on clinicaltrials.gov (NCT01541969). We screened 391 individuals and assigned interventions to 100 eligible participants. The primary outcome was not statistically significant between groups (mean group = -0.45, 95% CI -5.25 to 4.35; p = 0.85), nor were any of the secondary outcomes. Four adverse events occurred during the trial. Analysis of tinnitus symptom severity data collected across the 24-week open-label extension showed no statistically significant within-group changes after 12, 24, or 36 weeks treatment with the proprietary sound sequence. While individual participants may benefit from sound therapy, Acoustic CR® Neuromodulation did not lead to group-mean reductions on tinnitus symptom severity or other measures compared to placebo, or over time.

Developing Future-Ready University Graduates: Nurturing Wellbeing and Life Skills as Well as Academic Talent.

Higher education is starting to embrace its role in promoting student wellbeing and life skills, especially given the concerning levels of poor mental health and uncertainties in the future job market. Yet, many of the published studies evaluating positive educational teaching methods thus far are limited to interventions delivered to small student cohorts and/or imbedded within elective wellbeing courses, and are focussed on developed Western countries. This study addressed this gap by investigating the effectiveness of an institution-wide compulsory course informed by the principles of Seligman's Wellbeing Theory. The course was delivered at a British university in a developing country in Southeast Asia. It purposefully sought to nurture growth-oriented outcomes (including self-awareness, positive emotions, and personal effectiveness) and was taken by an entire cohort of year one undergraduate students. We tested the effectiveness of the curriculum content and staff coaching style in achieving life skills, and evaluated how these perceptions influenced students' subjective wellbeing. A convergent mixed-methods design was used with 350 survey respondents and 11 interviewees. Perceived life skills scores showed a 2.5% improvement at the end of the course. Partial Least Squares Structural Equation Modelling tested the predicted relationships between variables. All relationships were statistically significant, but the influence of course design and educators' style on life skills acquisition (50.8% of the variance) was moderate, while the effect on subjective happiness and life satisfaction (4-5% of the variance) was very weak. Qualitative data indicated that while quantifiable benefits to wellbeing might not be immediate, students did anticipate longer-term benefits for happiness and life satisfaction. This finding suggests that such a novel educational approach is well-received by Asian students and may sow the seeds for future benefit by positively impacting on their skills, behaviours, attitudes, and values. To achieve optimal flourishing at university, we recommend exploring teaching practises that combine positive education with coaching psychology practises.

Defining Symptom Concepts in Chronic Subjective Tinnitus: Web-Based Discussion Forum Study.

BACKGROUND: A minimum standard based upon consensus decision making recommends a core set of tinnitus-specific health complaints (outcome domains) that should be assessed and reported in all clinical trials as this enables comparisons to be made across studies as well as data pooling for meta-analysis. 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.

Recruiting and retaining participants in e-Delphi surveys for core outcome set development: Evaluating the COMiT'ID study.

BACKGROUND: A Core Outcome Set (COS) is an agreed list of outcomes that are measured and reported in all clinical trials for a particular health condition. An 'e-Delphi' is an increasingly popular method for developing a COS whereby stakeholders are consulted via a multi-round online survey to reach agreement regarding the most important outcomes. Many COS studies seek diverse, international input that includes professionals and healthcare users. However, the recruitment and retention of participants can be deterred by various factors (e.g. language barriers and iterative, time-consuming rounds). This report evaluates the effectiveness of recruitment and retention methods used in the Core Outcome Measures in Tinnitus International Delphi (COMiT'ID) study using participant feedback from healthcare users, healthcare practitioners, researchers, commercial representatives and funders. METHODS: A range of methods were applied to recruit participants to the study and maintain engagement over the three rounds. Feedback on recruitment and retention methods was collected using a twenty-item online questionnaire, with free text comments. RESULTS: A personalised email invitation was the most frequent recruitment route, and 719 professionals and healthcare users consented to take part. Retention of each stakeholder group ranged from 76 to 91% completing all three e-Delphi rounds. Feedback was given by 379 respondents. A majority of respondents were satisfied with the study methods that were implemented to promote retention. Over 55% indicated that their overall experience closely matched their expectations at the start of the study, and over 90% felt that their contribution was appreciated. CONCLUSIONS: This report highlights study methods that worked well with respect to recruitment and retention, and those that did not. Findings provide a unique contribution to the growing evidence base of good practice in COS development by demonstrating the relative effectiveness of recruitment and retention methods for an e-Delphi survey. TRIAL REGISTRATION: This project was registered (November 2014) in the database of the Core Outcome Measures in Effectiveness Trials (COMET) initiative. The protocol is published in Trials (doi:10.1186/s13063-017-2123-0).