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Protocol for a multi-centre randomised controlled stand-alone feasibility trial to assess potential effectiveness and cost-effectiveness of digital hearing aids in patients with tinnitus and hearing loss (the HUSH trial)
Pilot and Feasibility Studies Pub Date : 2020-03-27 , DOI: 10.1186/s40814-020-00582-5
Rachel H Haines 1 , Jennifer White 1 , Garry Meakin 1 , Wei Tan 1 , Trish Hepburn 1 , Paul Leighton 2 , Chloi Theriou 3 , David Stockdale 4 , Christine Almey 5 , Richard Nicholson 6 , Deborah A Hall 3, 7 , Magdalena Sereda 3, 7
Affiliation  

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. 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. 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. ISRCTN, ISRCTN14218416. Registered on 30 July 2018.

中文翻译:

评估数字助听器在耳鸣和听力损失患者中的潜在有效性和成本效益的多中心随机对照独立可行性试验方案(HUSH 试验)

英国听力学诊所提供的最常见的耳鸣管理策略是教育和建议。这也可以与某种形式的声音疗法(例如数字助听器)相结合。虽然所有诊所通常都提供教育和建议,但助听器的提供存在显着差异,这在很大程度上取决于临床决策。最近的 Cochrane 综述得出结论,缺乏证据支持或反驳使用助听器作为耳鸣和听力损失患者的常规干预措施。这种缺乏证据反映在英国耳鸣管理的不一致。HUSH 试验的目的是确定对患有耳鸣和听力损失的成年人进行助听器有效性和成本效益的最终随机对照试验 (RCT) 的可行性。这是一项多中心随机对照可行性试验。多达 100 名年龄在 18 岁及以上的成年人,在 5 个英国听力诊所就诊,主诉耳鸣和可测量的听力损失,他们被随机分配接受(i)教育和建议(照常治疗)或(ii)教育和建议数字助听器。正在围绕招聘、保留、患者和医疗保健专业人员的可接受性和临床结果评估收集可行性结果。在基线后 12 周通过邮寄问卷收集结果。嵌套访谈研究将补充临床和其他结果数据,详细了解参与者和听力学家在耳鸣管理和研究过程方面的经验。这项可行性试验将帮助我们 (i) 确定进行多中心 RCT 比较照常治疗和照常治疗加数字助听器是否可行;(ii) 优化未来确定性、多中心 RCT 的设计;(iii) 告知哪些结果与患者相关。这项工作为确定助听器作为耳鸣管理策略的有效性迈出了重要的第一步。ISRCTN,ISRCTN14218416。于 2018 年 7 月 30 日注册。ISRCTN14218416。于 2018 年 7 月 30 日注册。ISRCTN14218416。于 2018 年 7 月 30 日注册。
更新日期:2020-04-22
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