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Protocol for a cluster randomised controlled trial comparing structured Follow-up And Monitoring Of new USers of NHS hearing aids to usual care: the FAMOUS trial
Background
Hearing loss is a prevalent condition that impacts on social, mental and physical health, and has a significant economic burden. Hearing aids can improve the quality of life for those living with hearing loss; however, low and inconsistent use remains common. Within the National Health Service (NHS), follow-up care for new hearing aid users is highly variable and often lacks structure, which may contribute to low use. The FAMOUS trial investigates whether a structured care model for follow-up, combined with evidence-based behaviour change interventions, improves hearing aid use compared to usual care.
Methods
FAMOUS is a multi-centre, two-arm parallel-group cluster randomised controlled trial (CRCT) with integral internal pilot, economic, and process evaluations. The trial involves 36 NHS audiology services and compares two types of follow-up for new adult hearing aid users: structured care, which includes personalised action plans, early monitoring, and routine follow-up at 6 weeks post-fitting, to usual care, which includes the offer of a follow-up 6–12 weeks after fitting. Recruitment is conducted through participating services over 3 months, with pseudo-anonymised routine data collected from electronic medical records of all patients who attend. Consent and outcomes are then collected from patients at 12 weeks post-fitting. For patients who provide consent to future contact, the primary outcome (self-reported daily hearing aid use) is collected at 12 months post-fitting. Secondary outcomes (quality-of-life (QoL), hearing-related disability, and economic measures) are collected at both timepoints. Qualitative interviews with a subset of patients and hearing professionals in the intervention arm will assess the acceptability and implementation of the intervention. Statistical analyses, including mixed-effects regression modelling, will be conducted under an intention-to-treat framework.
Discussion
FAMOUS addresses a critical evidence gap regarding the potential benefits of follow-up care for new hearing aid users. If the intervention is successful, it can be rolled out nationally using existing facilities with limited impact on resources, identified in the economic analysis, and would improve hearing aid use and quality of life for those living with hearing loss.
Trial registration
Prospectively registered with the International Standard Randomised Controlled Trial Number (ISRCTN) 10589817. Date of registration: 01/09/2022.
Journal Article
Some Considerations for the Use of the Abbreviated Profile of Hearing Aid Benefit (APHAB) as a Hearing-Aid Outcome Measure
The Abbreviated Profile of Hearing Aid Benefit (APHAB) has been one of the most frequently used patient-reported outcome measures (PROMs) since its inception 30 years ago. For the APHAB, single-valued 95% critical differences have been presented for the identification and interpretation of meaningful benefits in research and in the clinic. A narrative literature review of studies that used the global APHAB score as a hearing-aid outcome measure showed that the average benefit varied directly with the average unaided baseline score for each measure. Next, data from 584 older adults enrolled in our recently completed randomized controlled hearing-aid trial were examined. The same dependence of benefit scores on unaided baseline scores was observed in these data. Regression to the mean made relatively minor contributions to the observed dependence of APHAB scores on baseline unaided scores. These results indicate that the application of a single value for the 95% critical difference is not valid for the interpretation of APHAB scores. Rather, baseline-specific benefit criteria are needed. Based on these results, baseline-specific Minimal Detectable Differences (MDDs; or 95% critical differences) and Minimal Clinically Important Differences (MCIDs) using both distribution-based and anchor-based approaches were generated for the APHAB-global score.
Journal Article
Sound Localization in Single-Sided Deafness; Outcomes of a Randomized Controlled Trial on the Comparison Between Cochlear Implantation, Bone Conduction Devices, and Contralateral Routing of Signals Hearing Aids
There is currently a lack of prospective studies comparing multiple treatment options for single-sided deafness (SSD) in terms of long-term sound localization outcomes. This randomized controlled trial (RCT) aims to compare the objective and subjective sound localization abilities of SSD patients treated with a cochlear implant (CI), a bone conduction device (BCD), a contralateral routing of signals (CROS) hearing aid, or no treatment after two years of follow-up. About 120 eligible patients were randomized to cochlear implantation or to a trial period with first a BCD on a headband, then a CROS (or vice versa). After the trial periods, participants opted for a surgically implanted BCD, a CROS, or no treatment. Sound localization accuracy (in three configurations, calculated as percentage correct and root-mean squared error in degrees) and subjective spatial hearing (subscale of the Speech, Spatial and Qualities of hearing (SSQ) questionnaire) were assessed at baseline and after 24 months of follow-up. At the start of follow-up, 28 participants were implanted with a CI, 25 with a BCD, 34 chose a CROS, and 26 opted for no treatment. Participants in the CI group showed better sound localization accuracy and subjective spatial hearing compared to participants in the BCD, CROS, and no-treatment groups at 24 months. Participants in the CI and CROS groups showed improved subjective spatial hearing at 24 months compared to baseline. To conclude, CI outperformed the BCD, CROS, and no-treatment groups in terms of sound localization accuracy and subjective spatial hearing in SSD patients.
TRIAL REGISTRATION Netherlands Trial Register (https://onderzoekmetmensen.nl): NL4457, CINGLE trial.
Journal Article
Sound : a very short introduction
Sound is integral to how we experience the world, in the form of noise as well as music. But what is sound? What is the physical basis of pitch and harmony? And how are sound waves exploited in musical instruments? In this book Mike Goldsmith looks at the science of sound and explores sound in different contexts, covering the audible and inaudible, sound underground and underwater, acoustic and electric, and hearing in humans and animals. He also considers the problem of sound out of place - noise and its reduction.
Book
A multicenter study on objective and subjective benefits with a transcutaneous bone-anchored hearing aid device: first Nordic results
Examination of objective as well as subjective outcomes with a new transcutaneous bone-anchored hearing aid device. The study was designed as a prospective multicenter consecutive case-series study involving tertiary referral centers at two Danish University Hospitals. A total of 23 patients were implanted. Three were lost to follow-up. Patients had single-sided deafness, conductive or mixed hearing loss. Intervention: Rehabilitative. Aided and unaided sound field hearing was evaluated objectively using (1) pure warble tone thresholds, (2) pure-tone average (PTA4), (3) speech discrimination score (SDS) in quiet, and (4) speech reception threshold 50% at 70 dB SPL noise level (SRT50%). Subjective benefit was evaluated by three validated questionnaires: (1) the IOI-HA, (2) the SSQ-12, and (3) a questionnaire evaluating both the frequency and the duration of hearing aid usage. The mean aided PTA4 was lowered by 14.7 dB. SDS was increased by 37.5% at 50 dB SPL, SRT50% in noise improved 1.4 dB. Aided thresholds improved insignificantly at frequencies above 2 kHz. 52.9% of the patients used their device every day, and 76.5% used the device at least 5 days a week. Mean IOI-HA score was 3.4, corresponding to a good benefit. In SSQ-12, “quality of hearing” scored especially high. Patients with a conductive and/or mixed hearing loss benefitted the most. This device demonstrates a significant subjective hearing benefit 8 month post surgery. In patients with conductive and/or mixed hearing losses, patient satisfaction and frequency of use were high. Objective gain measures showed less promising results especially in patients with single-sided deafness (SSD) compared to other bone conduction devices.
Journal Article
Focusing on Positive Listening Experiences Improves Speech Intelligibility in Experienced Hearing Aid Users
Negativity bias is a cognitive bias that results in negative events being perceptually more salient than positive ones. For hearing care, this means that hearing aid benefits can potentially be overshadowed by adverse experiences. Research has shown that sustaining focus on positive experiences has the potential to mitigate negativity bias. The purpose of the current study was to investigate whether a positive focus (PF) intervention can improve speech-in-noise abilities for experienced hearing aid users. Thirty participants were randomly allocated to a control or PF group (N = 2 × 15). Prior to hearing aid fitting, all participants filled out the short form of the Speech, Spatial and Qualities of Hearing scale (SSQ12) based on their own hearing aids. At the first visit, they were fitted with study hearing aids, and speech-in-noise testing was performed. Both groups then wore the study hearing aids for two weeks and sent daily text messages reporting hours of hearing aid use to an experimenter. In addition, the PF group was instructed to focus on positive listening experiences and to also report them in the daily text messages. After the 2-week trial, all participants filled out the SSQ12 questionnaire based on the study hearing aids and completed the speech-in-noise testing again. Speech-in-noise performance and SSQ12 Qualities score were improved for the PF group but not for the control group. This finding indicates that the PF intervention can improve subjective and objective hearing aid benefits.
Journal Article