Methodological aspects of clinical trials in tinnitus: A proposal for an international standard

Landgrebe, Michael; Azevedo, Andréia Aparecida de; Baguley, David; Bauer, Carol A.; Cacace, Anthony T.; Coelho, Cláudia; Dornhoffer, John L.; Figueiredo, Ricardo Rodrigues; Flor, Herta; Hajak, Goeran; Heyning, Paul Van de; Hiller, Wolfgang; Khedr, Eman M.; Kleinjung, Tobias; Koller, Michael; Laínez, José Miguel; Londero, Alain; Martin, William H.; Mennemeier, Mark; Piccirillo, Jay F.; Ridder, Dirk De; Rupprecht, Rainer; Searchfield, Grant D.; Vanneste, Sven; Zeman, Florian; Langguth, Berthold

doi:10.1016/j.jpsychores.2012.05.002

Cited by 163 publications

(133 citation statements)

References 106 publications

(115 reference statements)

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“…22,30 The heterogeneity of tinnitus in aetiology, patho physiology, and clinical characteristics probably exacerbates the variable population response to tinnitus manage ment. 31,32 An eff ective classifi cation system informed by the pathophysiological mechanisms underlying individual tinnitus symptoms would be a ground-breaking step towards personalised rehabilitation. 32 Further basic research address ing the pathophysiology of tinnitus in animals and people therefore has an important clinical rationale.…”

Section: Pathophysiological Mechanismsmentioning

confidence: 99%

“…31,32 An eff ective classifi cation system informed by the pathophysiological mechanisms underlying individual tinnitus symptoms would be a ground-breaking step towards personalised rehabilitation. 32 Further basic research address ing the pathophysiology of tinnitus in animals and people therefore has an important clinical rationale.…”

Section: Pathophysiological Mechanismsmentioning

confidence: 99%

“…The few studies reported are generally poorly designed, and no standard outcome measure has been widely adopted. 32 The individual elements have been investigated, but again the evidence base is poor. In a systematic review, the effi cacy of sound therapy approaches was inconclusive, 40 though for many clinicians the practice of fi tting hearing aids for individuals with tinnitus associated with hearing loss is axiomatic.…”

Section: Standard Treatmentsmentioning

confidence: 99%

“…Several research groups have made suggestions for methodological standards in tinnitus trials, to stimulate debate about how to improve methods and reporting, 32,101 drawing attention to guidelines for good clinical practice and reporting (eg, CONSORT 102 ).…”

Section: Clinical Trials In Tinnitusmentioning

confidence: 99%

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Tinnitus

Baguley¹,

McFerran²,

Hall³

2013

The Lancet

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1,018

911

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Tinnitus is a common medical symptom that can be debilitating. Risk factors include hearing loss, ototoxic medication, head injury, and depression. At presentation, the possibilities of otological disease, anxiety, and depression should be considered. No eff ective drug treatments are available, although much research is underway into mechanisms and possible treatments. Surgical intervention for any otological pathology associated with tinnitus might be eff ective for that condition, but the tinnitus can persist. Available treatments include hearing aids when hearing loss is identifi ed (even mild or unilateral), wide-band sound therapy, and counselling. Cognitive behavioural therapy (CBT) is indicated for some patients, but availability of tinnitus-specifi c CBT in the UK is poor. The evidence base is strongest for a combination of sound therapy and CBT-based counselling, although clinical trials are constrained by the heterogeneity of patients with tinnitus.

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Section: Pathophysiological Mechanismsmentioning

confidence: 99%

Section: Pathophysiological Mechanismsmentioning

confidence: 99%

Section: Standard Treatmentsmentioning

confidence: 99%

Section: Clinical Trials In Tinnitusmentioning

confidence: 99%

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Tinnitus

Baguley¹,

McFerran²,

Hall³

2013

The Lancet

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1,018

911

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“…Commissioning, clinical and research guidelines all recommend that the outcome of tinnitus management is measured using a validated questionnaire [8,10,20]. Respondents indicated that most departments (132, 83%) use some form of validated questionnaire as an outcome measure.…”

Section: How Management Outcome Is Assessedmentioning

confidence: 99%

Equity and person-centeredness in provision of tinnitus services in UK National Health Service audiology departments

Hoare

Broomhead

Stockdale

et al. 2015

EJPCH

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Rationale, aim and objective: Chronic tinnitus is a prevalent condition broadly managed using individualised sound-based interventions, individualised or group education, counselling, or cognitive therapies. In the UK, therapy is largely delivered by audiologists or hearing therapists and, where available, clinical psychologists and physicians. Changes in the structure of the health service necessitate ongoing evaluation to monitor equity and person-centeredness of care. The purpose of the current evaluation was to describe provision and explore diversities in the services provided for tinnitus patients across the four countries of the UK and consider these relative to current commissioning and clinical practice guidelines. Method: A 37 item questionnaire was devised and distributed via email and social media to reach audiology departments in the UK and 147 valid responses were acquired during the 3 month period of the evaluation. Results: The structure and provision of tinnitus services varies widely across the four countries of the United Kingdom in terms of which clinicians provide the services. Outside of England there was no report of clinical psychology or audiovestibular physician involvement in services. There is also variability in access to psychological therapy or support (little training in CBT in Scotland and none in Northern Ireland), self-help groups (little involvement but interest from clinicians) and devices (e.g., one quarter of departments do not currently offer combination hearing aid devices for tinnitus). Clinicians are increasingly using validated questionnaires to evaluate the effectiveness of tinnitus management in their departments. Conclusions: Training in and the provision of psychological support for tinnitus patients by audiologists is particularly a concern for Scotland and Northern Ireland and has implications for the person-centeredness of audiology services. Capacity and need for research in paediatric tinnitus, combination devices, non-ear level sound devices and audiologist-delivered psychological therapy, are noted.

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