Validation of a new questionnaire measure of tinnitus functioning and disability for use in the UK: the Tinnitus Functional Index (TFI)

The Tinnitus Functional Index (TFI) was developed in the USA as a standard for assessing the functional impact of tinnitus based on eight tinnitus-related domains. The finalised 25-item version was never formally validated. This PhD seeks to assess the psychometric properties of the questionnaire and evaluate its suitability as the tool of choice for use in the diagnostic and outcome assessment of tinnitus for clinical and research purposes in the UK. The primary objectives were to (i) determine whether the TFI is reliable, (ii) verify its factor structure, and (iii) evaluate its responsiveness to treatment-related change. These objectives were evaluated in two UK studies. The first was a prospective multi-centre longitudinal validation study in which 255 NHS patients were recruited from audiology clinics to complete the TFI over four different time points in a nine-month period. The second was a retrospective analysis of data collected on the TFI and a battery of other health questionnaires from 294 members of the general public who had previously participated in two-centre randomised controlled trial of a novel tinnitus device. Approaches to psychometric analysis included classical and modern test theories, including Rasch measurement theory. Both approaches led to similar conclusions. Seven of the eight subscales were reliable and valid in both studies, although not as sensitive as the original developers proposed. Classical testing showed the auditory subscale to be reasonably reliable, but Rasch modelling indicated that it did not measure the functional impact of tinnitus. The overall factor structure was not confirmed. The sleep and auditory subscales did not relate to the other subscales and did not fit the model. My recommendation is to calculate the composite TFI score using only six subscales. The sleep subscale should be scored separately and the auditory subscale should not be used

Hyperacusis questionnaire as a tool for measuring hypersensitivity to sound in a tinnitus research population

Hypersensitivity to external sounds is often comorbid with tinnitus and may be significant for adherence to certain types of tinnitus management. Therefore, a clear measure of sensitivity to sound is important. The aim of this study was to evaluate the validity and reliability of the Hyperacusis Questionnaire (HQ) for use as a measurement tool using data from a sample of 264 adults who took part in tinnitus research. We evaluated the HQ factor structure, internal consistency, convergent and discriminant validity, and floor and ceiling effects. Internal consistency was high (Cronbach’s alpha = 0.88) and moderate correlations were observed between the HQ, uncomfortable loudness levels, and other health questionnaires. Confirmatory factor analysis revealed that the original HQ three-factor solution and a one-factor solution were both a poor fit to the data. Four problematic items were removed and exploratory factor analysis identified a two-factor (attentional and social) solution. The original three-factor structure of the HQ was not confirmed. All fourteen items do not accurately assess hypersensitivity to sound in a tinnitus population. We propose a 10-item (2-factor) version of the HQ, which will need to be confirmed using a new tinnitus and perhaps nontinnitus population

Hyperacusis in children: A scoping review

© 2020 The Author(s). Background: Hyperacusis is a chronic condition commonly defined as a lowered tolerance or increased sensitivity to everyday environmental sounds. It has been viewed as a paediatric disorder which can cause significant impairment to a child's normal functioning. Although clinical guidance highlights the importance of identifying whether the child has intolerance to loud sounds and managing this appropriately, there are currently no assessment or treatment methods that have been designed and tested for use with children with hyperacusis. A review is therefore indicated to consider the profile of children with hyperacusis as a basis for future research into their assessment and treatment. Method: A scoping review methodology was followed with literature searches conducted in Embase, PsychINFO, PubMed CENTRAL, Scopus, Web of Science and Google Scholar. Research articles were included if they reported on research studies describing children diagnosed with hyperacusis, providing clinical profile information, and/or reporting on an assessment or management method for children with a primary complaint of hyperacusis. Data were charted on Excel and verified by a second researcher. Twenty-one research articles were included. Results: Children with hyperacusis are typically described in terms of age at presentation, troublesome sounds, physical sensation, behavioural reactions, coping strategies, comorbid conditions and impact on daily life. Methods of assessing the children include semi-structured interviews, questionnaires, neurological assessment, observation and uncomfortable loudness levels. Management methods include psychological therapy, sound therapy, tinnitus retraining therapy, medication and neuro-rehabilitation. Conclusion: The information we catalogued on various elements of clinical profile, assessment and management can serve as a stepping stone in future research developing questionnaires for clinical measurement of the impact of hyperacusis on children, and the measurement of treatment related change in clinic and in trials. Positive outcomes were noted by the authors following all of the above treatments; future research must compare these and specify the parameters for optimal results

A scoping review to catalogue tinnitus problems in children

© 2019 The Authors Background: The reported prevalence of tinnitus in children is similar to that in adults. However, unlike adults, there is relatively little understanding of the tinnitus-related problems children experience. Knowledge of the problems experienced by adults has led to the development of numerous clinical questionnaires used by health professionals in assessment and treatment practices; to date no child-specific questionnaire measure of tinnitus has been developed. To support development of a questionnaire measure of tinnitus in children, the aim of this scoping review was to catalogue the peer-reviewed and grey scientific literature according to 1) the methods used to identify problems experienced by children with tinnitus, 2) tinnitus-related problems observed in or reported by children, and 3) research recommendations suggested by investigators with regards to tinnitus in children. Methods: A scoping review was conducted following an established methodological framework. Records were included where a tinnitus-related problem was reported in a child 18 years or younger, and tinnitus was reported as the primary complaint. Tinnitus problems were extracted and categorised into problem themes. Results: Thirty-five records met the inclusion criteria for this review. Methods used to identify tinnitus-related problems in children, and the number and range of problems reported, varied across the records. Symptom impact was summarised according to six problem themes; Physical health, Cognitive health, Hearing and listening, Emotional health, Quality of life, and Feeling different/isolated. Identified research recommendations highlighted a demand for more standardised approaches. Conclusions: The findings evidence the detrimental impact tinnitus can have on a child's quality of life and emotional wellbeing. The current British Society of Audiology Tinnitus in Children Practice Guidance recommends management practices to address the most broadly reported problems identified in this review; sleep difficulties, emotional difficulties, and concentration and hearing problems at school. Given the finding of this review, we suggest problems relating to the impact of tinnitus on quality of life and feelings of isolation are also important problem domains to consider when managing a child who has tinnitus. Current variability in the approach to identifying children's tinnitus problems underlines the importance of developing a standardised and dedicated measure of tinnitus in children

An evaluation of paediatric tinnitus services in UK National Health Service audiology departments

© 2020 The Author(s). Background: Whilst evidence indicates many children experience troublesome tinnitus, specialist services for children are far less established than those available for adults. To date, there is limited understanding of how paediatric tinnitus is managed in the UK, and to what extent current practice reflects what is recommended. This service evaluation aimed to 1) profile how tinnitus in children is managed in UK clinical practice, and assess to what extent care provided by services reflects advice included in the British Society of Audiology (BSA) Tinnitus in Children Practice Guidance, 2) collate clinician opinions on how services may be optimised, and 3) identify common problems experienced by children who present with bothersome tinnitus in clinic. Methods: As part of a larger survey, eight questions regarding services for paediatric tinnitus were distributed to UK NHS audiology services via email and social media. Representatives from eighty-seven services responded between July and September 2017. Results: Fifty-three percent of respondents reported that their department provided a paediatric tinnitus service. Among these services, there was widespread use of most BSA recommended assessments and treatments. Less widely used practices were the assessment of mental health (42%), and the use of psychological treatment approaches; cognitive behavioural therapy (CBT) (28%), mindfulness (28%), and narrative therapy (14%). There was varied use of measurement tools to assess tinnitus in children, and a minority of respondents reported using adult tinnitus questionnaires with children. Frequently reported tinnitus-related problems presented by children were sleep difficulties, concentration difficulties at school, situation-specific concentration difficulties, and emotional distress. Conclusions: Approaches used to manage children with troublesome tinnitus in UK NHS services are largely consistent and reflective of the current practice guidance. However, findings from this study indicate specialist staff training, access to child-specific tools, and the treatment and referral of children with tinnitus-related psychological problems represent key areas in need of optimisation

Tinnitus and stress in adults: a scoping review

ObjectiveTinnitus and stress are recurrently reported together. The strength and direction of this relationship is not clear. The aim of this review is to catalogue the evidence of this relationship, how it has been described in adults and which instruments were used.DesignFive-stage framework was followed. An online search of databases and published journals were conducted. The main inclusion criteria were original studies published in English and conducted in an adult human population, in which both tinnitus and stress were measured using different instruments.Study samples5699 records were identified in the searching stage and 50 studies were eligible for data extraction.ResultsMeasurements of perceived stress were most frequently used. Tinnitus patients tend to report louder and more bothersome tinnitus when they are stressed, but not all tinnitus patients associated stress with the onset or the severity of their tinnitus. Any positive correlation reported between stress and tinnitus levels varied in strength according to the used instrument. Post-intervention changes in stress and tinnitus levels showed inconsistency.ConclusionThere is considerable room for further research to study the relationship between stress and tinnitus. We highlight principal issues that should be considered in future studies

Performance of the Tinnitus Functional Index as a diagnostic instrument in a UK clinical population

Objectives: The Tinnitus Functional Index (TFI) has been optimised as a diagnostic tool for quantifying the functional impact of tinnitus in US veteran and civilian groups. However, the TFI has not been evaluated for use in other English-speaking clinical populations despite its increasingly popular uptake. Here, a prospective multi-site longitudinal validation study was conducted to evaluate psychometric properties relevant to the UK clinical population. Guided by quality criteria for the measurement properties of health-related questionnaires, we specifically evaluated three diagnostic properties relating to the degree to which the TFI (i) covers the eight dimensions proposed to be important for diagnosis, (ii) reliably distinguishes individual differences in severity of tinnitus, and (iii) reliably measures the functional impact of tinnitus. We also examine whether clinically meaningful interpretations of the scores can be produced for the UK population. Methods: Twelve National Health Service audiology clinics across the UK recruited 255 tinnitus patients to complete questionnaires at four time-intervals, from initial clinical assessment and then over a nine-month period. Patients completed the TFI, the Tinnitus Handicap Inventory (THI), tinnitus case history questions, a Global rating of Perceived Problem with tinnitus and a Clinical Global Impression of perceived change in tinnitus. Baseline TFI data were used to examine the factor structure, construct validity and interpretability of the TFI. Follow-up TFI data were used to examine reliability. Results: Confirmatory factor analysis suggested that of the eight subscales (factors) initially established for the TFI, the ‘Auditory’ subscale did not contribute to the overall construct ‘functional impact of tinnitus’, and a modified seven-factor model (TFI-22) better fit the variance in the patient scores. Both the global 25-item TFI and the global TFI-22 scores showed exceptionally high internal consistency (α ≥ 0.95), high construct validity with the THI (r = 0.80) and high test-retest reliability (ICC = 0.87). Test-retest agreement however was only deemed to be borderline acceptable (89%). Receiver Operator Characteristic analysis indicated the 25-item TFI and TFI-22 has excellent ability to distinguish between different levels of impact (Area under the curve > 0.7). Conclusion: The TFI was confirmed to cover multiple symptom domains, measuring a multi-domain construct of tinnitus, and satisfies a range of psychometric requirements for a good clinical measure, including having excellent reliability, stability over time and sensitivity to individual differences in tinnitus severity. However, a modified seven-factor structure without the Auditory subscale (TFI-22) is recommended for calculating a global composite score for UK patients. Using patients’ experience and Receiver Operator Characteristic analysis, a grading system was presented which identifies the distinct grades of tinnitus impact in the UK clinical population that is broadly comparable to the US-based system

Device-based interventions that seek to restore bilateral and binaural hearing in adults with single-sided deafness: a conceptual analysis

Single-sided deafness (SSD) is defined by severe-to-profound sensorineural hearing loss in one ear only. This article outlines the etiologies and associated functional, psychological, social, and other consequences of SSD in adulthood. The available hearing aids and auditory implants for SSD are described, alongside an overview of the methods adopted by clinicians and researchers to define and measure their benefits and harms. Current concepts and issues to consider in the field of rerouting and restoring device-based interventions are explored. A contemporary overview of the current challenges in outcome measurement of all available interventions in the field is also provided, and cost effectiveness of SSD interventions is discussed briefly. This article therefore proves a comprehensive summary of the current knowledge on interventions and outcome measurement for SSD for those interested or actively working in the field, and recommendations for future trials. These include recommendations on the timescale of measurements, long-term benefits (or harms), cost utility, and the use of the internationally agreed core outcome domain set for all future clinical trials of device-based interventions for SSD

the COMIT’ID study protocol for using a Delphi process and face-to-face meetings to establish consensus

Background The reporting of outcomes in clinical trials of subjective tinnitus indicates that many different tinnitus-related complaints are of interest to investigators, from perceptual attributes of the sound (e.g. loudness) to psychosocial impacts (e.g. quality of life). Even when considering one type of intervention strategy for subjective tinnitus, there is no agreement about what is critically important for deciding whether a treatment is effective. The main purpose of this observational study is, therefore to, develop Core Outcome Domain Sets for the three different intervention strategies (sound, psychological, and pharmacological) for adults with chronic subjective tinnitus that should be measured and reported in every clinical trial of these interventions. Secondary objectives are to identify the strengths and limitations of our study design for recruiting and reducing attrition of participants, and to explore uptake of the core outcomes. Methods The ‘Core Outcome Measures in Tinnitus: International Delphi’ (COMIT’ID) study will use a mixed-methods approach that incorporates input from health care users at the pre-Delphi stage, a modified three-round Delphi survey and final consensus meetings (one for each intervention). The meetings will generate recommendations by stakeholder representatives on agreed Core Outcome Domain Sets specific to each intervention. A subsequent step will establish a common cross-cutting Core Outcome Domain Set by identifying the common outcome domains included in all three intervention-specific Core Outcome Domain Sets. To address the secondary objectives, we will gather feedback from participants about their experience of taking part in the Delphi process. We aspire to conduct an observational cohort study to evaluate uptake of the core outcomes in published studies at 7 years following Core Outcome Set publication. Discussion The COMIT’ID study aims to develop a Core Outcome Domain Set that is agreed as critically important for deciding whether a treatment for subjective tinnitus is effective. Such a recommendation would help to standardise future clinical trials worldwide and so we will determine if participation increases use of the Core Outcome Set in the long term. Trial registration This project has been registered (November 2014) in the database of the Core Outcome Measures in Effectiveness Trials (COMET) initiative