Evidence map›Paper›PMID 32231789›Full record

ArticlePilot and feasibility studies2020

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).

Rachel H Haines, Jennifer White, Garry Meakin, Wei Tan, Trish Hepburn, Paul Leighton, Chloi Theriou, David Stockdale, Christine Almey, Richard Nicholson and 2 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 41% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 1 country.

Rachel H Haines1Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
Jennifer White1Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
Garry Meakin1Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
Wei Tan1Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
Trish Hepburn1Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
Paul Leighton2Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.
Chloi Theriou3National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham, UK.
David Stockdale4British Tinnitus Association, Sheffield, UK.
Christine AlmeyPPI Representative, Leicester, UK.
Richard Nicholson6Nottingham University Hospitals NHS Trust, Nottingham, UK.
Deborah A Hall3National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham, UK.
Magdalena Sereda3National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham, UK.
University of Nottingham · GBNottingham Biomedical Research Centre · GBBritish Tinnitus Association · GBNottingham University Hospitals NHS Trust · GB

Funding

Department of Health PB-PG-0816-20014
6 · The paper itself

Abstract

backgroundThe 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.

methodsThis 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 registrationISRCTN, ISRCTN14218416. Registered on 30 July 2018.

Indexed as

FeasibilityHearing aidsHearing lossOutcomesProtocolRandomised controlled trialTinnitus

Identifiers

PMID32231789
PMCPMC7099812
OpenAlexW3013021713

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.