Effectiveness and cost effectiveness of digital hearing aids in patients with tinnitus and hearing loss: a randomised feasibility trial (THE HUSH Trial)
Abstract 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 ev...
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| Format: | Article |
| Language: | English |
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BMC
2022-11-01
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| Series: | Pilot and Feasibility Studies |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40814-022-01188-9 |
| _version_ | 1828156138577723392 |
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| author | Rachel H. Haines Trish Hepburn Wei Tan Clare Jackson James Lathe Jennifer White Christine Almey Richard Nicholson David Stockdale Paul Leighton Marilyn James Magdalena Sereda |
| author_facet | Rachel H. Haines Trish Hepburn Wei Tan Clare Jackson James Lathe Jennifer White Christine Almey Richard Nicholson David Stockdale Paul Leighton Marilyn James Magdalena Sereda |
| author_sort | Rachel H. Haines |
| collection | DOAJ |
| description | Abstract 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). |
| first_indexed | 2024-04-11T23:05:41Z |
| format | Article |
| id | doaj.art-c95d1148372f4cb7bcd477533fec108e |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-04-11T23:05:41Z |
| publishDate | 2022-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-c95d1148372f4cb7bcd477533fec108e2022-12-22T03:58:02ZengBMCPilot and Feasibility Studies2055-57842022-11-018111610.1186/s40814-022-01188-9Effectiveness and cost effectiveness of digital hearing aids in patients with tinnitus and hearing loss: a randomised feasibility trial (THE HUSH Trial)Rachel H. Haines0Trish Hepburn1Wei Tan2Clare Jackson3James Lathe4Jennifer White5Christine Almey6Richard Nicholson7David Stockdale8Paul Leighton9Marilyn James10Magdalena Sereda11Nottingham Clinical Trials Unit, School of Medicine, University of NottinghamNottingham Clinical Trials Unit, School of Medicine, University of NottinghamNottingham Clinical Trials Unit, School of Medicine, University of NottinghamSchool of Medicine, University of NottinghamNottingham Clinical Trials Unit, School of Medicine, University of NottinghamNottingham Clinical Trials Unit, School of Medicine, University of NottinghamPPI Representative, National Institute for Health and Care Research Nottingham Biomedical Research CentreNottingham University Hospitals NHS TrustBritish Tinnitus AssociationCentre of Evidence Based Dermatology, University of NottinghamNottingham Clinical Trials Unit, School of Medicine, University of NottinghamNational Institute for Health and Care Research Nottingham Biomedical Research CentreAbstract 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).https://doi.org/10.1186/s40814-022-01188-9Randomised controlled trialFeasibilityTinnitusHearing lossHearing aidsOutcomes |
| spellingShingle | Rachel H. Haines Trish Hepburn Wei Tan Clare Jackson James Lathe Jennifer White Christine Almey Richard Nicholson David Stockdale Paul Leighton Marilyn James Magdalena Sereda Effectiveness and cost effectiveness of digital hearing aids in patients with tinnitus and hearing loss: a randomised feasibility trial (THE HUSH Trial) Pilot and Feasibility Studies Randomised controlled trial Feasibility Tinnitus Hearing loss Hearing aids Outcomes |
| title | Effectiveness and cost effectiveness of digital hearing aids in patients with tinnitus and hearing loss: a randomised feasibility trial (THE HUSH Trial) |
| title_full | Effectiveness and cost effectiveness of digital hearing aids in patients with tinnitus and hearing loss: a randomised feasibility trial (THE HUSH Trial) |
| title_fullStr | Effectiveness and cost effectiveness of digital hearing aids in patients with tinnitus and hearing loss: a randomised feasibility trial (THE HUSH Trial) |
| title_full_unstemmed | Effectiveness and cost effectiveness of digital hearing aids in patients with tinnitus and hearing loss: a randomised feasibility trial (THE HUSH Trial) |
| title_short | Effectiveness and cost effectiveness of digital hearing aids in patients with tinnitus and hearing loss: a randomised feasibility trial (THE HUSH Trial) |
| title_sort | effectiveness and cost effectiveness of digital hearing aids in patients with tinnitus and hearing loss a randomised feasibility trial the hush trial |
| topic | Randomised controlled trial Feasibility Tinnitus Hearing loss Hearing aids Outcomes |
| url | https://doi.org/10.1186/s40814-022-01188-9 |
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