Derek J. Hoare

Systematic review and meta-analyses of randomized controlled trials examining tinnitus management.

To evaluate the existing level of evidence for tinnitus management strategies identified in the UK Department of Healths Good Practice Guideline.

Management of tinnitus in English NHS audiology departments: an evaluation of current practice

Rationale, aim and objective In 2009, the UK Department of Health formalized recommended National Health Service practices for the management of tinnitus from primary care onwards. It is timely therefore to evaluate the perceived practicality, utility and impact of those guidelines in the context of current practice. Methods We surveyed current practice by posting a 36-item questionnaire to all audiology and hearing therapy staff that we were able to identify as being involved in tinnitus patient care in England. Results In total, 138 out of 351 clinicians responded (39% response rate). The findings indicate a consensus opinion that management should be tailored to individual symptom profiles but that there is little standardization of assessment procedures or tools in use. Conclusions While the lack of standardized practice might provide flexibility to meet local demand, it has drawbacks. It makes it difficult to ascertain key standards of best practice, it complicates the process of clinical audit, it implies unequal patient access to care, and it limits the implementation of translational research outcomes. We recommend that core elements of practice should be standardized, including use of a validated tinnitus questionnaires and an agreed pathway for decision making to better understand the rationale for management strategies offered.

A scientific cognitive-behavioral model of tinnitus: novel conceptualizations of tinnitus distress

The importance of psychological factors in tinnitus distress has been formally recognized for almost three decades. The psychological understanding of why tinnitus can be a distressing condition posits that it becomes problematic when it acquires an emotive significance through cognitive processes. Principle therapeutic efforts are directed at reducing or removing the cognitive (and behavioral) obstacles to habituation. Here, the evidence relevant to a new psychological model of tinnitus is critically reviewed. The model posits that patients’ interpretations of tinnitus and the changes in behavior that result are given a central role in creating and maintaining distress. The importance of selective attention and the possibility that this leads to distorted perception of tinnitus is highlighted. From this body of evidence, we propose a coherent cognitive-behavioral model of tinnitus distress that is more in keeping with contemporary psychological theories of clinical problems (particularly that of insomnia) and which postulates a number of behavioral processes that are seen as cognitively mediated. This new model provides testable hypotheses to guide future research to unravel the complex mechanisms underpinning tinnitus distress. It is also well suited to define individual symptomatology and to provide a framework for the delivery of cognitive-behavioral therapy.

The efficacy of auditory perceptual training for tinnitus: a systematic review

Auditory perceptual training affects neural plasticity and so represents a potential strategy for tinnitus management. We assessed the effects of auditory perceptual training on tinnitus perception and/or its intrusiveness via a systematic review of published literature. An electronic database search using the keywords ‘tinnitus and learning’ or ‘tinnitus and training’ was conducted, updated by a hand search. The ten studies identified were reviewed independently by two reviewers, data were extracted, study quality was assessed according to a number of specific criteria and the information was synthesised using a narrative approach. Nine out of the ten studies reported some significant change in either self-reported or psychoacoustic outcome measures after auditory training. However, all studies were quality rated as providing low or moderate levels of evidence for an effect. We identify a need for appropriately randomised and controlled studies that will generate high-quality unbiased and generalisable evidence to ascertain whether or not auditory perceptual training has a clinically relevant effect on tinnitus.

Clinical Guidelines and Practice: A Commentary on the Complexity of Tinnitus Management

Subjective tinnitus is an enigmatic and chronic condition that is predominantly managed as symptomatic. Little high-level evidence exists for the efficacy and specificity of the various tinnitus management strategies currently used, and this is reflected in documents that aim to guide clinicians. As a consequence, there are clear gaps in evidence-based practice linking diagnosis to the most effective management strategies as well as a general lack of consensus about which are appropriate strategies for assessment and management. Several guidelines have been produced from research efforts and from expert opinion. All recommend standardization of assessment and a range of management options but do not yet provide a means to link the two. The authors call for clinicians, scientists, and policy makers to work together to address this barrier to good practice.

Sound therapy for tinnitus management: Practicable options

BACKGROUND The authors reviewed practicable options of sound therapy for tinnitus, the evidence base for each option, and the implications of each option for the patient and for clinical practice. PURPOSE To provide a general guide to selecting sound therapy options in clinical practice. INTERVENTION Practicable sound therapy options. DATA COLLECTION AND ANALYSIS Where available, peer-reviewed empirical studies, conference proceedings, and review studies were examined. Material relevant to the purpose was summarized in a narrative. RESULTS The number of peer-reviewed publications pertaining to each sound therapy option reviewed varied significantly (from none to over 10). Overall there is currently insufficient evidence to support or refute the routine use of individual sound therapy options. It is likely, however, that sound therapy combined with education and counseling is generally helpful to patients. CONCLUSIONS Clinicians need to be guided by the patients point of care, patient motivation and expectations of sound therapy, and the acceptability of the intervention both in terms of the sound stimuli they are to use and whether they are willing to use sound extensively or intermittently. Clinicians should also clarify to patients the role sound therapy is expected to play in the management plan.

Primary care for tinnitus: practice and opinion among GPs in England

Rationale, aim and objective Effective tinnitus management starts with appropriate general practitioner (GP) triage, which in England can be guided by the Department of Healths Good Practice Guide (GPG). Despite the prevalence of the condition, there has never been a systematic survey of its management in primary care in England. We aimed to evaluate how people with tinnitus are assessed and managed in general practice, noting variation in practice across GPs and health authorities, and evaluating how closely typical practice aligns to the GPG for tinnitus. Methods A nine-item postal questionnaire was sent to 2000 GPs randomly selected to proportionally represent the number of primary care trusts and strategic health authorities in England. Results We received 368 responses. Responses indicated a mix of frequent and infrequent practices, for example, 90% of GPs assessed the impact of tinnitus on quality of life, but fewer examined cranial nerves (38%) or assessed for a carotid bruit (26%) during a tinnitus consultation. In the management of tinnitus, 83% routinely removed earwax, and 87% provided information-based advice. In contrast, only 4% of responders would offer antidepressant drugs or psychological therapies. Thematic analysis revealed a desire for concise training on tinnitus management. Conclusions GP assessment and management of tinnitus represents potential inequity of service for tinnitus patients. While the GPG aims to promote equity of care, it is only referred to by a minority of clinicians and so its utility for guiding service delivery is questionable. Although some GPs highlighted little demand for tinnitus management within their practice, many others expressed an unmet need for specific and concise GP training on tinnitus management. Further work should therefore evaluate current informational resources and propose effective modes of delivering educational updates.

Psychometric properties of the Tinnitus Functional Index (TFI): Assessment in a UK research volunteer population

Objectives Questionnaires are essential for measuring tinnitus severity and intervention-related change but there is no standard instrument used routinely in research settings. Most tinnitus questionnaires are optimised for measuring severity but not change. However, the Tinnitus Functional Index (TFI) claims to be optimised for both. It has not however been fully validated for research purposes. Here we evaluate the relevant psychometric properties of the TFI, specifically the questionnaire factor structure, reproducibility, validity and responsiveness guided by quality criteria for the measurement properties of health-related questionnaires. Methods The study involved a retrospective analysis of data collected for 294 members of the general public who participated in a randomised controlled trial of a novel tinnitus device (ClinicalTrials.gov Identifier: NCT01541969). Participants completed up to eight commonly used assessment questionnaires including the TFI, Tinnitus Handicap Inventory (THI), Tinnitus Handicap Questionnaire (THQ), a Visual Analogue Scale of loudness (VAS-Loudness), Percentage Annoyance question, the Becks Depression Inventory (BDI), Becks Anxiety Inventory (BAI), and the World Health Organisation Quality of Life-Bref (WHOQOL-BREF). A series of analyses assessed the study objectives. Forty four participants completed the TFI at a second visit (within 7–21 days and before receiving any intervention) providing data for reproducibility assessments. Results The 8-factor structure was not fully confirmed for this general (non-clinical) population. Whilst it was acceptable standalone subscale, the ‘auditory’ factor showed poor loading with the higher order factor ‘functional impact of tinnitus’. Reproducibility assessments for the overall TFI indicate high internal consistency (α = 0.80) and extremely high reliability (ICC: 0.91), whilst agreement was borderline acceptable (93%). Construct validity was demonstrated by high correlations between scores on the TFI and THI (r = 0.82) and THQ (r = 0.82), moderate correlations with VAS-L (r = 0.46), PR-A (r = 0.58), BDI (r = 0.57), BAI (r = 0.39) and WHOQOL (r = −0.48). Floor effects were observed for more than 50% of the items. A smallest detectable change score of 22.4 is proposed for the TFI global score. Conclusion Even though the proposed 8-factor structure was not fully confirmed for this population, the TFI appears to cover multiple symptom domains, and to measure the construct of tinnitus with an excellent reliability in distinguishing between patients. While the TFI may discriminate those whose tinnitus is not a problem, floor effects in many items means it is less appropriate as a measure of change in this subgroup. Further investigation is needed to determine whether these effects are relevant in other populations.

Evaluation of the acoustic coordinated reset (CR ®) neuromodulation therapy for tinnitus: study protocol for a double-blind randomized placebo-controlled trial

BackgroundCurrent theories of tinnitus assume that the phantom sound is generated either through increased spontaneous activity of neurons in the auditory brain, or through pathological temporal firing patterns of the spontaneous neuronal discharge, or a combination of both factors. With this in mind, Tass and colleagues recently tested a number of temporally patterned acoustic stimulation strategies in a proof of concept study. Potential therapeutic sound regimes were derived according to a paradigm assumed to disrupt hypersynchronous neuronal activity, and promote plasticity mechanisms that stabilize a state of asynchronous spontaneous activity. This would correspond to a permanent reduction of tinnitus. The proof of concept study, conducted in Germany, confirmed the safety of the acoustic stimuli for use in tinnitus, and exploratory results indicated modulation of tinnitus-related pathological synchronous activity with potential therapeutic benefit. The most effective stimulation paradigm is now in clinical use as a sound therapy device, the acoustic coordinated reset (CR®) neuromodulation (Adaptive Neuromodulation GmbH (ANM), Köln, Germany).Methods/DesignTo measure the efficacy of CR® neuromodulation, we devised a powered, two-center, randomized controlled trial (RCT) compliant with the reporting standards defined in the Consolidated Standards of Reporting Trials (CONSORT) Statement. The RCT design also addresses the recent call for international standards within the tinnitus community for high-quality clinical trials. The design uses a between-subjects comparison with minimized allocation of participants to treatment and placebo groups. A minimization approach was selected to ensure that the two groups are balanced with respect to age, gender, hearing, and baseline tinnitus severity. The protocol ensures double blinding, with crossover of the placebo group to receive the proprietary intervention after 12 weeks. The primary endpoints are the pre- and post-treatment measures that provide the primary measures of efficacy, namely a validated and sensitive questionnaire measure of the functional impact of tinnitus. The trial is also designed to capture secondary changes in tinnitus handicap, quality (pitch, loudness, bandwidth), and changes in tinnitus-related pathological synchronous brain activity using electroencephalography (EEG).DiscussionThis RCT was designed to provide a confident high-level estimate of the efficacy of sound therapy using CR® neuromodulation compared to a well-matched placebo intervention, and uniquely in terms of sound therapy, examine the physiological effects of the intervention against its putative mechanism of action.Trial registrationClinicalTrials.gov, NCT01541969

The consequences of tinnitus and tinnitus severity on cognition: A review of the behavioural evidence

People with tinnitus report anecdotal difficulties in mental concentration and psychological treatments for tinnitus advise on concentration difficulties and how to manage them. Yet the literature lacks any coherent discussion about what precise theoretical cognitive constructs might be mediating reported concentration problems. This review addresses this gap by describing and critically appraising the behavioural evidence for the effects of tinnitus on cognitive performance (namely working memory and attention). Empirical evidence is somewhat limited, but there is some support that tinnitus interferes with executive attention, and mixed support that it impairs working memory and selective attention. We highlight a number of methodological considerations to help drive the field forward and we propose a putative model of the complex inter-relationships between tinnitus, cognition and confounding factors. This model provides a basis for hypothesis testing.