RESUMO
BACKGROUND: Education and advice is provided for tinnitus management in all UK audiology clinics. Sound therapy, including provision of hearing aids may be offered, but this is often dependent on a clinician's decision rather than UK policy. This inconsistent management reflects a lack of evidence around the effectiveness of hearing aids for tinnitus. This open-label, two-arm multicentre randomised controlled feasibility trial gathered data around recruitment, acceptability and outcome assessments to determine the feasibility of conducting a large randomised controlled trial investigating the effectiveness of hearing aids for tinnitus management. METHODS: Adults referred to audiology for tinnitus, with an aidable hearing loss were recruited at five UK audiology clinics. They were randomised 1:1 to either education and advice (treatment as usual (TAU), n = 41) or TAU plus hearing aids (n = 42). Outcomes were collected by questionnaires 12 weeks after randomisation. After participation, interviews were conducted with a subset of both participants and clinicians from each trial centre. RESULTS: Eighty three participants from five sites were randomised. Non-aidable hearing loss was the main reason for ineligibility to participate in the trial reported by the sites. Seventy three percent of participants returned the 12-week questionnaires, with return rates by site ranging from 61 to 100%. Fifteen out of 33 participants (45%) reported using hearing aids for the clinician-recommended time, or longer, during the day. The Tinnitus Functional Index (TFI) was the outcome measure most responsive to change. The majority of participants also agreed it was relevant to their tinnitus and hearing loss. Qualitative data demonstrated that the trial was acceptable to participants. Feedback from clinicians revealed a potential lack of equipoise. It also highlighted the differences in referral and treatment pathways between departments and differences in audiometric criteria for fitting hearing aids. Health economic measures were well completed for those returned. No change in health-related quality of life was observed. Costs were higher in the intervention arm, but self-reports of healthcare service use indicated participant confusion in treatment pathways. CONCLUSIONS: This feasibility trial is the first step towards obtaining high quality evidence to determine potential clinical effectiveness and cost effectiveness of hearing aids for tinnitus versus usual care. A definitive trial was deemed to be feasible, with some modifications based on feasibility findings and using the TFI as the primary outcome. This trial was funded by the National Institute for Health Research, Research for Patient Benefit Programme (PB-PG-0816-20,014) and registered with ISRCTN (ISRCTN14218416).
RESUMO
BACKGROUND: The most common management strategy for tinnitus provided in the UK audiology clinics is education and advice. This may also be combined with some form of sound therapy (e.g. digital hearing aids). While education and advice is generally provided by all clinics, there is a marked variability in provision of hearing aids that depends very much on clinical decisions. A recent Cochrane review concluded a lack of evidence to support or refute hearing aid use as a routine intervention for people with tinnitus and hearing loss. This lack of evidence is reflected in the inconsistency of tinnitus management in the UK. The aim of the HUSH trial is to determine the feasibility of conducting a definitive randomised controlled trial (RCT) of the effectiveness and cost-effectiveness of hearing aids for adults with tinnitus and hearing loss. METHODS: This is a multicentre randomised controlled feasibility trial. Up to 100 adults, aged 18 and over, presenting to 5 UK audiology clinics with a complaint of tinnitus and measurable hearing loss are being randomised to receive either (i) education and advice (treatment as usual) or (ii) education and advice with digital hearing aids. Feasibility outcomes are being collected around recruitment, retention, patient and healthcare professional acceptability and clinical outcome assessment. Outcomes are being collected via postal questionnaire at 12 weeks post baseline. A nested interview study will supplement clinical and other outcome data, providing a detailed understanding of participants' and audiologists' experience of both tinnitus management and the research processes. DISCUSSION: This feasibility trial will help us to (i) determine if it is feasible to conduct a multicentre RCT comparing treatment as usual and treatment as usual plus digital hearing aids; (ii) optimise the design of a future definitive, multicentre RCT; and (iii) inform which outcome(s) is/are relevant for patients. This work presents an important first step in determining the effectiveness of hearing aids as a tinnitus management strategy. TRIAL REGISTRATION: ISRCTN, ISRCTN14218416. Registered on 30 July 2018.