Applications of Grounded Theory Methodology to Investigate Hearing Loss: A Methodological Qualitative Systematic Review With Developed Guidelines.

OBJECTIVES: Qualitative methodologies are commonly adopted in hearing loss research. Grounded theory methodology is increasingly used to establish novel theories explaining experiences related to hearing loss. Establishing and improving the quality of grounded theory studies has been emphasized as critical to ensuring theoretical trustworthiness. Thus, the primary aim of the present study was to systematically review hearing loss research studies that have applied grounded theory methodology and assess the methodological quality of those grounded theory applications. Secondarily aims were to (i) explore how grounded theory methodology has been applied to investigate hearing loss, and (ii) use the findings of the review to develop a set of guidelines to aid the future high-quality application of grounded theory methodology to hearing loss research. DESIGN: Original peer-reviewed studies applying grounded theory methodology and published in English were identified through systematic searches in 10 databases; Applied Social Sciences Index and Abstracts, British Nursing Index, Cumulative Index to Nursing and Allied Health Literature, EBSCO, Global Health, MEDLINE (OvidSP), PsycINFO, PubMed, Scopus, and Web of Science. The quality of studies was assessed according to 12 grounded theory principles using the Guideline for Reporting, Evaluating, and applying the core principles of Grounded Theory studies (GUREGT) tool. Data were analyzed using qualitative inductive thematic analysis. RESULTS: After the removal of duplicates, 155 articles were retrieved. Of those, 39 met the criteria for inclusion in the systematic review. An increase in the adoption of grounded theory methodology to investigate hearing loss was identified with the number of published studies tripling in the last 5 years. Critical appraisal using the GUREGT tool identified four studies as high-quality. Most included studies were of moderate study quality (n = 25), and 10 were classified as being of low study quality. Using inductive thematic analysis, the included studies investigated one of four areas relating to hearing loss: (a) Living with hearing loss, (b) Identity and hearing loss, (c) Coping strategies for hearing loss, and (d) Audiological counseling and rehabilitation. Analysis also identified four main grounded theory factors frequently overlooked in hearing loss research: the different schools of grounded theory, sampling strategy, sample size, and the depth of grounded theory application. CONCLUSIONS: Use of grounded theory methodology is increasing at a rapid rate in hearing loss research. Despite this, studies conducted in the field to date do not meet and apply the full spectrum of grounded theory principles, as outlined by the GUREGT tool. To improve methodological rigor in future studies using grounded theory, we propose a set of guidelines that address the most commonly overlooked methodological considerations in hearing loss studies to date. The guidelines are designed to aid researchers to achieve high methodological quality in any field, improve qualitative rigor, and promote theoretical credibility.

A Scoping Review of Studies Comparing Outcomes for Children With Severe Hearing Loss Using Hearing Aids to Children With Cochlear Implants.

OBJECTIVES: Clinical practice regarding children's candidature for cochlear implantation varies internationally, albeit with a recent global trend toward implanting children with more residual hearing than in the past. The provision of either hearing aids or cochlear implants can influence a wide range of children's outcomes. However, guidance on eligibility and suitability for implantation is often based on a small number of studies and a limited range of speech perception measures. No recent reviews have catalogued what is known about comparative outcomes for children with severe hearing-loss using hearing aids to children using cochlear implants. This article describes the findings of a scoping review that addressed the question "What research has been conducted comparing cochlear implant outcomes to outcomes in children using hearing aids with severe hearing-loss in the better-hearing ear?" The first objective was to catalogue the characteristics of studies pertinent to these children's candidature for cochlear implantation, to inform families, clinicians, researchers, and policy-makers. The second objective was to identify gaps in the evidence base, to inform future research projects and identify opportunities for evidence synthesis. DESIGN: We included studies comparing separate groups of children using hearing aids to those using cochlear implants and also repeated measures studies comparing outcomes of children with severe hearing loss before and after cochlear implantation. We included any outcomes that might feasibly be influenced by the provision of hearing aids or cochlear implants. We searched the electronic databases Medline, PubMed, and CINAHL, for peer-reviewed journal articles with full-texts written in English, published from July 2007 to October 2019. The scoping methodology followed the approach recommended by the Joanna Briggs Institute regarding study selection, data extraction, and data presentation. RESULTS: Twenty-one eligible studies were identified, conducted across 11 countries. The majority of children studied had either congenital or prelingual hearing loss, with typical cognitive function, experience of spoken language, and most implanted children used one implant. Speech and language development and speech perception were the most frequently assessed outcomes. However, some aspects of these outcomes were sparsely represented including voice, communication and pragmatic skills, and speech perception in complex background noise. Two studies compared literacy, two sound localization, one quality of life, and one psychosocial outcomes. None compared educational attainment, listening fatigue, balance, tinnitus, or music perception. CONCLUSIONS: This scoping review provides a summary of the literature regarding comparative outcomes of children with severe hearing-loss using acoustic hearing aids and children using cochlear implants. Notable gaps in knowledge that could be addressed in future research includes children's quality of life, educational attainment, and complex listening and language outcomes, such as word and sentence understanding in background noise, spatial listening, communication and pragmatic skills. Clinician awareness of this sparse evidence base is important when making management decisions for children with more residual hearing than traditional implant candidates. This review also provides direction for researchers wishing to strengthen the evidence base upon which clinical decisions can be made.

Ginkgo biloba for tinnitus.

BACKGROUND: Tinnitus is a symptom defined as the perception of sound in the absence of an external source. In England alone there are an estimated ¾ million general practice consultations every year where the primary complaint is tinnitus, equating to a major burden on healthcare services. Clinical management strategies include education and advice, relaxation therapy, tinnitus retraining therapy (TRT), cognitive behavioural therapy (CBT), sound enrichment using ear-level sound generators or hearing aids, and drug therapies to manage co-morbid symptoms such as insomnia, anxiety or depression.  OBJECTIVES: To assess the effects of Ginkgo biloba for tinnitus in adults and children. SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL (2022, Issue 6); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 7 June 2022. SELECTION CRITERIA: Randomised controlled trials (RCTs) recruiting adults and children with acute or chronic subjective tinnitus. We included studies where the intervention involved Ginkgo biloba and this was compared to placebo, no intervention, or education and information. Concurrent use of other medication or other treatment was acceptable if used equally in each group. Where an additional intervention was used equally in both groups, we analysed this as a separate comparison. The review included all courses of Ginkgo biloba, regardless of dose regimens or formulations, and for any duration of treatment. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were tinnitus symptom severity measured as a global score on a multi-item tinnitus questionnaire and serious adverse effects (bleeding, seizures). Our secondary outcomes were tinnitus loudness (change in subjective perception), tinnitus intrusiveness, generalised depression, generalised anxiety, health-related quality of life and other adverse effects (gastrointestinal upset, headache, allergic reaction). We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: This review included 12 studies (with a total of  1915 participants). Eleven studies compared the effects of Ginkgo biloba with placebo and one study compared the effects of Ginkgo biloba with hearing aids to hearing aids alone. All included studies were parallel-group RCTs. In general, risk of bias was high or unclear due to selection bias and poor reporting of allocation concealment and blinding of participants, personnel and outcome assessments. Due to heterogeneity in the outcomes measured and measurement methods used, only limited data pooling was possible.  Ginkgo biloba versus placebo When we pooled data from two studies for the primary outcome tinnitus symptom severity, we found that Ginkgo biloba may have little to no effect (Tinnitus Handicap Inventory scores) at three to six months compared to placebo, but the evidence is very uncertain (mean difference (MD) -1.35 (scale 0 to 100), 95% confidence interval (CI) -8.26 to 5.55; 2 studies; 85 participants) (very low-certainty). Ginkgo biloba may result in little to no difference in the risk of bleeding or seizures, with no serious adverse effects reported in either group (4 studies; 1154 participants; low-certainty). For the secondary outcomes, one study found that there may be little to no difference between the effects of Ginkgo biloba and placebo on tinnitus loudness measured with audiometric loudness matching at 12 weeks, but the evidence is very uncertain (MD -4.00 (scale -10 to 140 dB), 95% CI -13.33 to 5.33; 1 study; 73 participants) (very low-certainty). One study found that there may be little to no difference between the effects of Ginkgo biloba and placebo on health-related quality of life measured with the Glasgow Health Status Inventory at three months (MD -0.58 (scale 0 to 100), 95% CI -4.67 to 3.51; 1 study; 60 participants) (low-certainty). Ginkgo biloba may not increase the frequency of other adverse effects (gastrointestinal upset, headache, allergic reaction) at three months compared to placebo (risk ratio 0.91, 95% CI 0.52 to 1.60; 4 studies; 1175 participants) (low-certainty). None of the studies reported the other secondary outcomes of tinnitus intrusiveness or changes in depressive symptoms or depression, anxiety symptoms or generalised anxiety. Gingko biloba with concurrent intervention versus concurrent intervention only One study compared Ginkgo biloba with hearing aids to hearing aids only. It assessed the mean difference in the change in Tinnitus Handicap Inventory scores and tinnitus loudness using a 10-point visual analogue scale (VAS) at three months. The study did not report adverse effects, tinnitus intrusiveness, changes in depressive symptoms or depression, anxiety symptoms or generalised anxiety, or health-related quality of life. This was a single, very small study (22 participants) and for all outcomes the certainty of the evidence was very low. We were unable to draw meaningful conclusions from the numerical results. AUTHORS' CONCLUSIONS: There is uncertainty about the benefits and harms of Ginkgo biloba for the treatment of tinnitus when compared to placebo. We were unable to draw meaningful conclusions regarding the benefits and harms of Ginkgo biloba when used with concurrent intervention (hearing aids). The certainty of the evidence for the reported outcomes, assessed using GRADE, ranged from low to very low. Future research into the effectiveness of Ginkgo biloba in patients with tinnitus should use rigorous methodology. Randomisation and blinding should be of the highest quality, given the subjective nature of tinnitus and the strong likelihood of a placebo response. The CONSORT statement should be used in the design and reporting of future studies. We also recommend the use of validated, patient-centred outcome measures for research in the field of tinnitus.

Tinnitus and stress in adults: a scoping review.

OBJECTIVE: Tinnitus 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. DESIGN: Five-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 SAMPLES: 5699 records were identified in the searching stage and 50 studies were eligible for data extraction. RESULTS: Measurements 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. CONCLUSION: There 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.

A Delphi survey to determine a definition and description of hyperacusis by clinician consensus.

OBJECTIVE: There is currently no singularly accepted definition of hyperacusis. The aim of this study was to determine a definition and description of hyperacusis by clinician consensus. DESIGN: A three-round Delphi survey involving hearing healthcare professionals built towards clinical consensus on a definition of hyperacusis. Round 1 involved three open-ended questions about hyperacusis. Seventy-nine statements were generated on descriptions, impact, sounds, and potential features of hyperacusis. Agreement on the relevance of each statement to defining or describing hyperacusis was then measured in Rounds 2 and 3. General consensus was defined a priori as ≥70% agreement, or ≥90 for clinical decision making. STUDY SAMPLE: Forty-five hearing healthcare professionals were recruited to take part in this study. Forty-one completed Round 1, 36 completed Round 2, and 33 completed Round 3. RESULTS: Consensus was reached on 42/79 statements. From these a consensus definition includes "A reduced tolerance to sound(s) that are perceived as normal to the majority of the population or were perceived as normal to the person before their onset of hyperacusis". A consensus description of hyperacusis was also determined. CONCLUSIONS: This consensus definition of hyperacusis will help to determine the scope of clinical practice guidelines and influence needed research on hyperacusis.

The Prevalence and Severity of Misophonia in a UK Undergraduate Medical Student Population and Validation of the Amsterdam Misophonia Scale.

Misophonia is a condition of abnormal emotional responses to specific auditory stimuli. There is limited information available on the prevalence of this condition. This study aimed to estimate the prevalence of misophonia in an undergraduate medical student population at the University of Nottingham. A secondary aim of this study was to assess the psychometric validity of the Amsterdam Misophonia Scale (A-Miso-S) questionnaire tool in this population. The A-Miso-S was administered online to medical students at the University of Nottingham. To assess the validity of the A-Miso-S, a factor analysis was conducted. To determine prevalence and severity the results of the questionnaire were quantitatively analysed using SPSS. Actor analysis was conducted. Free text responses to one questionnaire item were analysed using a thematic approach. Responses were obtained from 336 individuals. Clinically significant misophonic symptoms appear to be common, effecting 49.1% of the sample population. This is statistically significantly higher prevalence than previous studies have found (p < 0.00001). Using the classification of the A-Miso-S, mild symptoms were seen in 37%, moderate in 12%, severe in 0.3% of participants. No extreme cases were seen. The A-Miso-S was found to be a uni-factorial tool, with good internal consistency. This study has provided new information on misophonia and validity of the A-Miso-S questionnaire in a sample population of UK undergraduate medical students. The results indicate that misophonia is a phenomenon that a significant proportion of medical students experience though only a small subset experience it severely.

Evaluation of a Cognitive Behavioral Model of Tinnitus Distress: A Cross-Sectional Study Using Structural Equation Modeling.

OBJECTIVES: There is a great deal of variation in the extent to which people with tinnitus find it distressing, which cannot be explained solely by differences in perceived loudness. The Cognitive Behavioral Model of Tinnitus Distress proposes that tinnitus becomes and is maintained as a distressing problem due to a process of interaction between negative thoughts, negative emotions, attention and monitoring, safety behavior, and beliefs. This study used path analysis to assess how well different configurations of this model fit using questionnaire data obtained from people with tinnitus. 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.

Cognitive behavioural therapy for tinnitus.

BACKGROUND: Tinnitus affects up to 21% of the adult population with an estimated 1% to 3% experiencing severe problems. Cognitive behavioural therapy (CBT) is a collection of psychological treatments based on the cognitive and behavioural traditions in psychology and often used to treat people suffering from tinnitus. OBJECTIVES: To assess the effects and safety of CBT for tinnitus in adults. SEARCH METHODS: The Cochrane ENT Information Specialist searched the ENT Trials Register; CENTRAL (2019, Issue 11); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 25 November 2019. SELECTION CRITERIA: Randomised controlled trials (RCTs) of CBT versus no intervention, audiological care, tinnitus retraining therapy or any other active treatment in adult participants with tinnitus. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. Our primary outcomes were the impact of tinnitus on disease-specific quality of life and serious adverse effects. Our secondary outcomes were: depression, anxiety, general health-related quality of life, negatively biased interpretations of tinnitus and other adverse effects. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We included 28 studies (mostly from Europe) with a total of 2733 participants. All participants had had tinnitus for at least three months and their average age ranged from 43 to 70 years. The duration of the CBT ranged from 3 to 22 weeks and it was mostly conducted in hospitals or online. There were four comparisons and we were interested in outcomes at end of treatment, and 6 and 12 months follow-up. The results below only refer to outcomes at end of treatment due to an absence of evidence at the other follow-up time points. CBT versus no intervention/wait list control Fourteen studies compared CBT with no intervention/wait list control. For the primary outcome, CBT may reduce the impact of tinnitus on quality of life at treatment end (standardised mean difference (SMD) -0.56, 95% confidence interval (CI) -0.83 to -0.30; 10 studies; 537 participants; low certainty). Re-expressed as a score on the Tinnitus Handicap Inventory (THI; range 0 to 100) this is equivalent to a score 10.91 points lower in the CBT group, with an estimated minimal clinically important difference (MCID) for this scale being 7 points. Seven studies, rated as moderate certainty, either reported or informed us via personal communication about serious adverse effects. CBT probably results in little or no difference in adverse effects: six studies reported none and in one study one participant in the CBT condition worsened (risk ratio (RR) 3.00, 95% CI 0.13 to 69.87). For the secondary outcomes, CBT may result in a slight reduction in depression (SMD -0.34, 95% CI-0.60 to -0.08; 8 studies; 502 participants; low certainty). However, we are uncertain whether CBT reduces anxiety, improves health-related quality of life or reduces negatively biased interpretations of tinnitus (all very low certainty). From seven studies, no other adverse effects were reported (moderate certainty). CBT versus audiological care Three studies compared CBT with audiological care. CBT probably reduces the impact of tinnitus on quality of life when compared with audiological care as measured by the THI (range 0 to 100; mean difference (MD) -5.65, 95% CI -9.79 to -1.50; 3 studies; 444 participants) (moderate certainty; MCID = 7 points). No serious adverse effects occurred in the two included studies reporting these, thus risk ratios were not calculated (moderate certainty). The evidence suggests that CBT may slightly reduce depression but may result in little or no difference in anxiety or health-related quality of life (all low certainty) when compared with audiological care. CBT may reduce negatively biased interpretations of tinnitus when compared with audiological care (low certainty). No other adverse effects were reported for either group (moderate certainty). CBT versus tinnitus retraining therapy (TRT) One study compared CBT with TRT (including bilateral sound generators as per TRT protocol). CBT may reduce the impact of tinnitus on quality of life as measured by the THI when compared with TRT (range 0 to 100) (MD -15.79, 95% CI -27.91 to -3.67; 1 study; 42 participants; low certainty). For serious adverse effects three participants deteriorated during the study: one in the CBT (n = 22) and two in the TRT group (n = 20) (RR 0.45, 95% CI 0.04 to 4.64; low certainty). We are uncertain whether CBT reduces depression and anxiety or improves health-related quality of life (low certainty). CBT may reduce negatively biased interpretations of tinnitus. No data were available for other adverse effects. CBT versus other active control Sixteen studies compared CBT with another active control (e.g. relaxation, information, Internet-based discussion forums). CBT may reduce the impact of tinnitus on quality of life when compared with other active treatments (SMD -0.30, 95% CI -0.55 to -0.05; 12 studies; 966 participants; low certainty). Re-expressed as a THI score this is equivalent to 5.84 points lower in the CBT group than the other active control group (MCID = 7 points). One study reported that three participants deteriorated: one in the CBT and two in the information only group (RR 1.70, 95% CI 0.16 to 18.36; low certainty). CBT may reduce depression and anxiety (both low certainty). We are uncertain whether CBT improves health-related quality of life compared with other control. CBT probably reduces negatively biased interpretations of tinnitus compared with other treatments. No data were available for other adverse effects. AUTHORS' CONCLUSIONS: CBT may be effective in reducing the negative impact that tinnitus can have on quality of life. There is, however, an absence of evidence at 6 or 12 months follow-up. There is also some evidence that adverse effects may be rare in adults with tinnitus receiving CBT, but this could be further investigated. CBT for tinnitus may have small additional benefit in reducing symptoms of depression although uncertainty remains due to concerns about the quality of the evidence. Overall, there is limited evidence for CBT for tinnitus improving anxiety, health-related quality of life or negatively biased interpretations of tinnitus.

Hyperacusis in children: a scoping review.

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.

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

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.

Cochrane corner: Sound therapy (using amplification devices and/or sound generators) for tinnitus.

This Cochrane Corner features "Sound therapy (using amplification devices or sound generators) for tinnitus" published in 2018. Sereda et al. identified eight clinical trials including 590 participants receiving sound therapy for tinnitus. None of the included studies addressed three main comparisons of the review (comparing hearing aids, sound generators and combination devices with a waiting list control group, placebo or education/information only). One study compared patients fitted with sound generators versus those fitted with hearing aids and found no difference between them in their effects on tinnitus symptom severity. The use of both types of device was associated with a clinically significant reduction in tinnitus symptom severity. Three studies compared hearing aids with a sound generator to hearing aids alone and measured tinnitus symptom severity. The use of both types of device was again associated with a clinically significant reduction in tinnitus symptom severity. This Cochrane review shows that both hearing aids and sound generators may be beneficial for reducing tinnitus severity in some patients, but that there is insufficient evidence at this stage to recommend one device over another, or whether these devices offer any improvement over a placebo treatment.

A process for prioritising systematic reviews in tinnitus.

Objective: To develop an innovative prioritisation process to identify topics for new or updated systematic reviews of tinnitus research.Design: A two-stage prioritisation process was devised. First, a scoping review assessed the amount of randomized controlled trial-level evidence available. This enabled development of selection criteria for future reviews, aided the design of template protocol and suggested the scale of work that would be required to conduct these reviews. Second, using the pre-defined primary and secondary criteria, interventions were prioritised for systematic review.Study sample: Searches identified 1080 records. After removal of duplicates and out of scope works, 437 records remained for full data charting.Results: The process was tested, using subjective tinnitus as the clinical condition and using Cochrane as the systematic review platform. The criteria produced by this process identified three high priority reviews: (1) Sound therapy using amplification devices and/or sound generators; (2) Betahistine and (3) Cognitive behaviour therapy. Further secondary priorities were: (4) Gingko biloba, (5) Anxiolytics, (6) Hypnotics, (7) Antiepileptics and (8) Neuromodulation.Conclusions: A process was developed which successfully identified priority areas for Cochrane systematic reviews of interventions for subjective tinnitus. This technique could easily be transferred to other conditions and other types of systematic reviews.

Tinnitus, hearing loss and inflammatory processes in an older Portuguese population.

Objective: Tinnitus is associated with various conditions such as presbycusis, infectious, autoimmune and many other diseases. Our study aims to identify an association between inflammatory markers and the presence of tinnitus or hearing loss (HL).Design: Exploratory study including a structured interview, complete ENT observation, audiological and inflammatory markers evaluation.Study Sample: Sixty women and 54 men (55 to 75 years) from the Portuguese population, with or without sensory presbycusis and/or tinnitus.Results: IL10 levels were significantly lower in participants with tinnitus than in those without tinnitus. Moreover, TGF-ß was lower in older participants (p = 0.034), IL1α was higher in participants with tonal tinnitus (p = 0.033), and IL2 was lower in participants who reported partial or complete residual inhibition (p = 0.019). Additionally, we observed a negative correlation between tinnitus duration and IL10 levels (r= -.281), and between HSP70 levels and tinnitus loudness (r= -.377). TNF-α and HSP70 levels appears to be sensitive to the time when samples were collected (morning or afternoon).Conclusions: The results of our study showing fluctuations in inflammatory markers along the hearing loss process, reinforce the idea that inflammatory mechanisms are involved in hearing loss pathogenesis but also in tinnitus. IL10 levels appear significantly altered in tinnitus but not in hearing loss.

The TinMan study: feasibility trial of a psychologically informed, audiologist-delivered, manualised intervention for tinnitus.

OBJECTIVE: To develop a manualised psychological treatment for tinnitus that could enhance audiologist usual care, and to test feasibility of evaluating it in a randomised controlled trial. DESIGN: Feasibility trial, random allocation of patients to manualised treatment or treatment as usual, and mixed-methods evaluation. Study sample: Senior audiologists, and adults with chronic tinnitus. RESULTS: Recruitment reached 63% after 6 months (feasibility pre-defined as 65%). Only nine patients (47%) were retained for the duration of the trial. Patients reported that the treatment was acceptable and helped reassure them about their tinnitus. Audiologists reported mixed feelings about the kinds of techniques that are presented to them as 'psychologically informed'. Audiologists also reported lacking confidence because the training they had was brief, and stated that more formal supervision would have been helpful to check adherence to the treatment manual. CONCLUSIONS: The study indicate potential barriers to audiologist use of the manual, and that a clinical trial of the intervention is not yet feasible. However, positive indications from outcome measures suggest that further development work would be worthwhile. Refinements to the manual are indicated, and training and supervision arrangements to better support audiologists to use the intervention in the clinic are required. Trial Registration: ISRCTN13059163.

Misophonia: A scoping review of research.

OBJECTIVE: To scope the literature describing misophonia populations, management, and research opportunities. METHOD: Literature searches for research studies describing patients diagnosed with misophonia, defining a patient profile, or outlining development or testing of an intervention for misophonia. A data extraction form was developed and piloted before data from each article were independently charted by two researchers. Researchers then agreed on a final data set for each article. RESULTS: Thirty-one records were included. The misophonia population was described in terms of onset age, triggers, reaction, coping strategies, and comorbid conditions. We identified nine outcome measures. Case studies on treatments included cognitive behavioral therapy, counterconditioning, mindfulness and acceptance, dialectical behavioral therapy, and pharmaceuticals. Future research priorities identified included clarifying the phenomenology and prevalence of misophonia, and randomized controlled trials of treatments. CONCLUSION: Misophonia is under-researched but there are strong foundations for future research to finalize diagnostic criteria, validate outcome measures, and trial treatments.

Combined Amplification and Sound Generation for Tinnitus: A Scoping Review.

OBJECTIVES: In most cases, tinnitus is accompanied by some degree of hearing loss. Current tinnitus management guidelines recognize the importance of addressing hearing difficulties, with hearing aids being a common option. Sound therapy is the preferred mode of audiological tinnitus management in many countries, including in the United Kingdom. Combination instruments provide a further option for those with an aidable hearing loss, as they combine amplification with a sound generation option. The aims of this scoping review were to catalog the existing body of evidence on combined amplification and sound generation for tinnitus and consider opportunities for further research or evidence synthesis. DESIGN: A scoping review is a rigorous way to identify and review an established body of knowledge in the field for suggestive but not definitive findings and gaps in current knowledge. A wide variety of databases were used to ensure that all relevant records within the scope of this review were captured, including gray literature, conference proceedings, dissertations and theses, and peer-reviewed articles. Data were gathered using scoping review methodology and consisted of the following steps: (1) identifying potentially relevant records; (2) selecting relevant records; (3) extracting data; and (4) collating, summarizing, and reporting results. RESULTS: Searches using 20 different databases covered peer-reviewed and gray literature and returned 5959 records. After exclusion of duplicates and works that were out of scope, 89 records remained for further analysis. A large number of records identified varied considerably in methodology, applied management programs, and type of devices. There were significant differences in practice between different countries and clinics regarding candidature and fitting of combination aids, partly driven by the application of different management programs. CONCLUSIONS: Further studies on the use and effects of combined amplification and sound generation for tinnitus are indicated, including further efficacy studies, evidence synthesis, development of guidelines, and recommended procedures that are based on existing knowledge, expert knowledge, and clinical service evaluations.

Patients' and Clinicians' Views of the Psychological Components of Tinnitus Treatment That Could Inform Audiologists' Usual Care: A Delphi Survey.

OBJECTIVES: The aim of this study was to determine which components of psychological therapies are most important and appropriate to inform audiologists' usual care for people with tinnitus. DESIGN: A 39-member panel of patients, audiologists, hearing therapists, and psychologists completed a three-round Delphi survey to reach consensus on essential components of audiologist-delivered psychologically informed care for tinnitus. RESULTS: Consensus (≥80% agreement) was reached on including 76 of 160 components. No components reached consensus for exclusion. The components reaching consensus were predominantly common therapeutic skills such as Socratic questioning and active listening, rather than specific techniques, for example, graded exposure therapy or cognitive restructuring. Consensus on educational components to include largely concerned psychological models of tinnitus rather than neurophysiological information. CONCLUSIONS: The results of this Delphi survey provide a tool to develop audiologists' usual tinnitus care using components that both patients and clinicians agree are important and appropriate to be delivered by an audiologist for adults with tinnitus-related distress. Research is now necessary to test the added effects of these components when delivered by audiologists.

Sound therapy (using amplification devices and/or sound generators) for tinnitus.

BACKGROUND: Tinnitus affects 10% to 15% of the adult population, with about 20% of these experiencing symptoms that negatively affect quality of life. In England alone there are an estimated ¾ million general practice consultations every year where the primary complaint is tinnitus, equating to a major burden on healthcare services. Clinical management strategies include education and advice, relaxation therapy, tinnitus retraining therapy (TRT), cognitive behavioural therapy (CBT), sound enrichment using ear-level sound generators or hearing aids, and drug therapies to manage co-morbid symptoms such as insomnia, anxiety or depression. Hearing aids, sound generators and combination devices (amplification and sound generation within one device) are a component of many tinnitus management programmes and together with information and advice are a first line of management in audiology departments for someone who has tinnitus. OBJECTIVES: To assess the effects of sound therapy (using amplification devices and/or sound generators) for tinnitus in adults. SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL, via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 July 2018. SELECTION CRITERIA: Randomised controlled trials (RCTs) recruiting adults with acute or chronic subjective idiopathic tinnitus. We included studies where the intervention involved hearing aids, sound generators or combination hearing aids and compared them to waiting list control, placebo or education/information only with no device. We also included studies comparing hearing aids to sound generators, combination hearing aids to hearing aids, and combination hearing aids to sound generators. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. Our primary outcomes were tinnitus symptom severity as measured as a global score on multi-item tinnitus questionnaire and significant adverse effects as indicated by an increase in self-reported tinnitus loudness. Our secondary outcomes were depressive symptoms, symptoms of generalised anxiety, health-related quality of life and adverse effects associated with wearing the device such as pain, discomfort, tenderness or skin irritation, or ear infections. We used GRADE to assess the quality of evidence for each outcome; this is indicated in italics. MAIN RESULTS: This review included eight studies (with a total of 590 participants). Seven studies investigated the effects of hearing aids, four combination hearing aids and three sound generators. Seven studies were parallel-group RCTs and one had a cross-over design. In general, risk of bias was unclear due to lack of detail about sequence generation and allocation concealment. There was also little or no use of blinding.No data for our outcomes were available for any of our three main comparisons (comparing hearing aids, sound generators and combination devices with a waiting list control group, placebo or education/information only). Data for our additional comparisons (comparing these devices with each other) were also few, with limited potential for data pooling.Hearing aid only versus sound generator device onlyOne study compared patients fitted with sound generators versus those fitted with hearing aids and found no difference between them in their effects on our primary outcome, tinnitus symptom severity measured with the Tinnitus Handicap Inventory (THI) at 3, 6 or 12 months (low-quality evidence). The use of both types of device was associated with a clinically significant reduction in tinnitus symptom severity.Combination hearing aid versus hearing aid onlyThree studies compared combination hearing aids with hearing aids and measured tinnitus symptom severity using the THI or Tinnitus Functional Index. When we pooled the data we found no difference between them (standardised mean difference -0.15, 95% confidence interval -0.52 to 0.22; three studies; 114 participants) (low-quality evidence). The use of both types of device was again associated with a clinically significant reduction in tinnitus symptom severity.Adverse effects were not assessed in any of the included studies.None of the studies measured the secondary outcomes of depressive symptoms or depression, anxiety symptoms or generalised anxiety, or health-related quality of life as measured by a validated instrument, nor the newly developed core outcomes tinnitus intrusiveness, ability to ignore, concentration, quality of sleep and sense of control. AUTHORS' CONCLUSIONS: There is no evidence to support the superiority of sound therapy for tinnitus over waiting list control, placebo or education/information with no device. There is insufficient evidence to support the superiority or inferiority of any of the sound therapy options (hearing aid, sound generator or combination hearing aid) over each other. The quality of evidence for the reported outcomes, assessed using GRADE, was low. Using a combination device, hearing aid or sound generator might result in little or no difference in tinnitus symptom severity.Future research into the effectiveness of sound therapy in patients with tinnitus should use rigorous methodology. Randomisation and blinding should be of the highest quality, given the subjective nature of tinnitus and the strong likelihood of a placebo response. The CONSORT statement should be used in the design and reporting of future studies. We also recommend the use of validated, patient-centred outcome measures for research in the field of tinnitus.

Barriers to voluntary participation in sport for children: a systematic review.

BACKGROUND: Numerous studies have detailed the physical health benefits of children's participation in sport and a growing body of research also highlights the benefits for mental health. Children who participate in sport have also been shown to be advantaged academically. However, despite the benefits there is evidence that children are leading increasingly sedentary lifestyles and are at greater risk of chronic disease than those with active lifestyles. Sport provides an important means for children to achieve their recommended amount of daily physical activity. This systematic review asks 'what are those barriers to children's participation in sport?' METHODS: Literature searches were carried out in June 2015 using; EMBASE, Medline, CINAHL and SportDiscus using the search terms barrier*, stop*, prevent*, participat*, taking part, Sports/, sport*, "physical education", PE, child*, young person*, adolescen*. These were supplemented with hand searches. A total of 3434 records were identified of which 22 were suitable for inclusion in the review, two additional studies were identified from Google Scholar in November 2016. Both qualitative and quantitative studies were included. Study's included in the review assessed children up to 18 years of age. Study quality was assessed using Critical Appraisal Skills Programme (CASP) tools. RESULTS: Studies took place in the school environment (n = 14), sports club (n = 1), community setting (n = 8) and adolescent care setting (n = 1). Frequently reported barriers across quantitative studies were 'time' (n = 4), 'cost' (n = 3), 'opportunity/accessibility' (n = 3) and 'friends' (n = 2). Frequently reported barriers across qualitative studies were 'time' (n = 6), 'cost' (n = 5), 'not being good at sport' (n = 6) and 'fear of being judged/embarrassed' (n = 6). CONCLUSION: Policy makers, parents and teachers should all be aware that 'cost' and 'time' are key barriers to participation in sport. More local sports opportunities are needed where costs are reduced. Schools and local clubs could better work together to provide more affordable local opportunities to increase children's participation in sport.

Tinnitus services in the United Kingdom: a survey of patient experiences.

BACKGROUND: Tinnitus service provision in the United Kingdom has been investigated from the healthcare provider's perspective demonstrating considerable regional variation particularly regarding availability of psychological treatments. An audiological-based tinnitus service, however, was reportedly available for all tinnitus patients in the UK. The aim of the current study was to define and evaluate nationwide tinnitus healthcare services from the patients' viewpoint. METHODS: Secondary analyses were performed on data from a 33-item questionnaire provided by the British Tinnitus Association. The questionnaire had been distributed via email and social media. RESULTS: Responses from 937 participants who had or had previously experienced tinnitus were analysed. All but one person had at some time consulted their GP. About one in five received medication in primary care. The majority were referred to secondary care, generally an ENT surgeon or audiovestibular physician; some were referred directly to audiological services. In secondary care the majority underwent audiometric testing and over half underwent MRI scanning. Drugs were prescribed less frequently in secondary care. About one third of patients were referred onwards from diagnostic services in secondary care to receive therapeutic interventions for tinnitus. Therapy was generally delivered by an audiologist or hearing therapist. Just under two fifths of people discharged from secondary care returned to their GP, with most returning within one year. Over a third of this group were re-referred to secondary care. Few patients saw a psychologist (2.6%) though some psychological treatments were delivered by appropriately trained audiologists. Negative counselling from healthcare professionals in both primary and secondary care settings was reported. CONCLUSIONS: Although the UK has developed a national service for patients with tinnitus many people find it difficult to access, being blocked at the primary care level or after secondary care diagnostic services. Many of those discharged from secondary care return to their GP within a short space of time and are re-referred to secondary care creating an unsatisfactory and expensive revolving-door pattern of healthcare. Despite psychological treatment modalities having the best evidence base for successful tinnitus management, only a minority of tinnitus patients ever get to meet a psychologist.