Research recommendations

National Guideline Centre (UK)

Appendix QResearch recommendations

Q.1. Hearing loss prevalence in people who under-present for hearing loss

Research question: What is the prevalence of hearing loss amongst populations who under-present for possible hearing loss?

Why this is important:

The research question aims to identify the prevalence of hearing loss among populations who may be unaware of their own hearing loss or lack motivation and capability to seek help for this.

A full population prevalence study matched to audiology service usage will help identify populations who under-present for possible hearing loss. The research will also identify factors that can act as red flags to prompt health and social care professionals to proactively consider the possibility of hearing loss.

The evidence review for the NICE guideline on adult hearing loss highlighted significant health benefits for people whose hearing loss is identified and addressed at an early stage, yet people often delay seeking treatment for up to 10 years.¹³³^,¹⁵¹ There are certain groups who are particularly disadvantaged because their health issues lead to a lack of awareness of their deteriorating or suboptimal hearing, or a failure to report their difficulties. These include those with learning (intellectual) disabilities, dementia and mild cognitive impairment.

Given the importance of early detection, this research is urgently needed to identify populations who are under-represented and any factors that would lead healthcare and social care professionals to consider the possibility of hearing loss.

Table

Criteria for selecting high-priority research recommendations.

Q.2. Use of hearing aids and incidence of dementia

Research question: In adults with hearing loss, does the use of hearing aids reduce the incidence of dementia?

Why this is important: In the ageing UK population, the incidence of dementia is increasing. Dementia has considerable long-term costs for people with dementia, their families and the NHS and there is no effective treatment to prevent its progression.

Hearing loss is associated with an increased incidence of dementia. It is estimated that among people with mild to moderate hearing loss the incidence of dementia is double that of people with normal hearing, and that the ratio increases to 5 times that of people with normal hearing in those with severe hearing loss. The cause of this association is unknown; there may be common factors causing both dementia and hearing loss, such as lifestyle, genetic susceptibility, environmental factors or age-related factors such as inflammation and cardiovascular disease. Hearing loss may cause dementia either directly (for example, neuroplastic changes caused by deprivation or increased listening demands) or indirectly via social isolation and depression (which are known be associated with cognitive decline and dementia). Conversely, it is possible that cognitive decline has an impact on sensory function (for example, affecting attention and listening skills). Currently, there is no good evidence to show that hearing loss causes dementia or that hearing aids delay the onset or reduce the incidence of dementia. Hearing aids do, however, have the potential to improve functioning and quality of life, and this could delay the progress of dementia or improve its management.

Table

Criteria for selecting high-priority research recommendations.

Q.3. Earwax

Research question: What is the clinical and cost effectiveness of microsuction compared with irrigation to remove earwax?

Why this is important: A build-up of earwax in the ear canal can cause hearing loss and discomfort, contributes to infections and can lead to stress, social isolation and depression. Moreover, earwax can prevent adequate clinical examination of the ear, delaying investigations and management; GPs cannot check for infection and audiologists cannot test hearing and fit hearing aids if the ear canal is blocked with wax. Excessive earwax accumulation is common, especially in older adults and those who use hearing aids and earbud-type earphones. In the UK, it is estimated that 2.3 million people each year have problems with earwax sufficient to need intervention.

Earwax is usually treated initially with ear drops. However, if this is unsuccessful, the wax can be removed using irrigation (flushing the wax out using water) or microsuction (using a vacuum to suck the wax out under a microscope). There are few studies comparing these different techniques in terms of effectiveness, cost effectiveness and adverse events.

Table

Criteria for selecting high-priority research recommendations.

Q.4. Idiopathic sudden sensorineural hearing loss

Research question: What is the most effective route of administration of steroids as a first-line treatment for idiopathic sudden sensorineural hearing loss?

Why this is important: Idiopathic sudden sensorineural hearing loss (SSNHL) affects approximately 5 to 20 people per 100,000 per year⁸⁰^,¹⁷⁶^,³⁷¹^,⁵²⁸ and accounts for up to 90% of cases of SSNHL. The hearing loss is usually unilateral, can range from mild to total and can be temporary or permanent. Idiopathic SSNHL has a significant impact on people’s lives, causing considerable concern and disability, particularly if there is already a hearing deficit in the other ear.

First-line treatment options for idiopathic SSNHL can include oral steroids, intra tympanic steroid injections or a combination of both. There is a paucity of evidence assessing the effectiveness of these different treatment options. There is heterogeneity in doses and types of steroids and this makes the findings unreliable. Therefore, it is difficult to establish the most clinically and cost effective route of administration of steroids as first-line treatment for idiopathic SSNHL. This has a direct impact on the care provided to people with SSNHL and on our ability to develop robust guidelines and policy.

Table

Criteria for selecting high-priority research recommendations.

Q.5. Decision tools

Research question: What is the clinical and cost effectiveness of person-centred, decision-making tools when agreeing the preferred management strategy for hearing loss in adults?

Why this is important: Hearing aids are effective in managing hearing loss in adults, and are routinely offered as the first-line clinical management for hearing difficulties. However, hearing aids are not always used. This impacts on healthcare resources, and for the individual, the consequences of untreated hearing loss remain, impacting on quality of life. There are a wide range of interventions to address hearing loss (for example, communication strategies, assistive listening devices, personal sound amplification products and auditory training), each with their advantages and limitations.

The systematic review for the NICE guideline on hearing loss found a lack of studies that addressed the benefits of patient-centred decision-making tools. Robust research is needed to establish the clinical and cost effectiveness of patient-centred tools, and to understand how they might best be used in clinical practice. This will inform future guidelines and policy.

Table

Criteria for selecting high-priority research recommendations.

Q.6. Assistive listening devices

Research question: What is the clinical and cost effectiveness of assistive listening devices (ALDs) in supporting adults with hearing loss, compared with other devices, combination of devices or no intervention to support adults with hearing loss?

Why this is important: Hearing loss is highly prevalent. Not all people with hearing loss choose or would benefit from hearing aids, as their individual needs, such as personal safety, may be situation-specific. Assistive listening devices, like hearing aids, make sounds more audible. They cover a range of functions, which can be broadly classified into improving communication (for example, remote microphones, personal sound amplification products (PSAPs), improving listening (for example, television loops), and increasing awareness of environmental sounds (for example, amplification, vibration or flashing lights for doorbell, telephone ring, fire alarm). The systematic review undertaken for the NICE guideline on hearing loss identified a paucity of robust evidence for the clinical or cost effectiveness of ALDs, compared with other devices, combination of devices or no intervention. Evidence that ALDs are clinically effective could enable the design of new patient pathways and service delivery models. This could improve financial efficiency and improve outcomes for patients.

Table

Criteria for selecting high-priority research recommendations.

Q.7. Outcome measures for effectiveness of hearing aid features

Research question: What is the most suitableoutcome measure to use when investigating the clinical and cost effectiveness of directional microphones and adaptive (digital) noise reduction?

Why this is important: The most common complaint of adults with hearing loss is difficulty understanding speech in the presence of background noise or competing speech. Because hearing aids cannot improve deficits in frequency, temporal and spatial resolution, an adult with hearing loss may continue to experience some difficulties, even when wearing hearing aids. The perception, and acceptance, of hearing aids is likely to be improved if they can be shown to improve listening to speech in the presence of background noise.

One hearing aid option that has been developed to distinguish speech from noise, and improve the speech-to-noise ratio (SNR), is the directional microphone. In contrast to omnidirectional microphones, which respond equally well to sounds arriving from all directions, a directional microphone is more sensitive to sounds from one direction (for example, speech coming from directly in front of the hearing aid user), and less sensitive to other directions (for example, background noise from the side or behind the hearing aid user). Directional microphones have the potential to benefit all hearing aid users. A potential disadvantage is that the signal of interest to the hearing aid user may come from a location where the microphone is least sensitive (such as from behind). Modern hearing aids generally have microphones that can be enabled as omnidirectional or directional, usually involving the user selecting a different setting or programme on the hearing aid. Directional microphones have been shown to be efficacious in the research laboratory although their effectiveness in the real world is less clear.

Amplification of background noise can be reduced using digital (or adaptive) noise reduction. The aim of a hearing aid that has adaptive noise reduction is to provide less amplification to noise than to speech. This is achieved by identifying the frequencies (or time) where noise is particularly intense, relative to speech, and applying less amplification. Again, users often have the option of enabling/disabling the noise reduction setting on the hearing aid.

There is a lack of good quality evidence on what is an appropriate primary outcome measure when assessing the real-life effectiveness of directional microphones and adaptive noise reductions. Studies have generally reported benefits in terms of improvements in speech recognition (or SNR) but it is not always clear that this results in real-life benefit. In addition, the SNR remains unchanged with adaptive noise reduction, but there is the potential to improve listener comfort and reduce listening effort, which may prevent decrements in performance over the course of the day.

Table

Criteria for selecting high-priority research recommendations.

Q.8. Monitoring and follow-up for adults with hearing loss

Research question: What is the clinical and cost effectiveness of monitoring and follow-up for adults with hearing loss post-intervention compared with usual care?

Why this is important: The systematic review for the NICE guideline on hearing loss found a lack of evidence to establish the benefits of monitoring and follow-up, how they should be delivered and across what time periods. Robust evidence is needed to establish the clinical and cost effectiveness of monitoring and follow-up, and to understand how and when they might best be used in clinical practice. This will inform future guidelines and policy.

Table

Criteria for selecting high-priority research recommendations.

Publication Details

Copyright

Publisher

National Institute for Health and Care Excellence (NICE), London

NLM Citation

National Guideline Centre (UK). Hearing loss in adults: assessment and management. London: National Institute for Health and Care Excellence (NICE); 2018 Jun. (NICE Guideline, No. 98.) Appendix Q, Research recommendations.

Criteria for selecting high-priority research recommendations

PICO question	Population: Adults aged ≥18 years Intervention: Identifying the prevalence of modifiable hearing loss in different populations particularly within populations who are unable to report their hearing difficulties namely: cognitive impairment; dementia; learning difficulties Comparison: Usage of audiology services Outcomes: Generate intelligence that would lead healthcare and social care professionals to proactively consider the possibility of hearing loss in those populations.
Importance to patients or the population	Improved quality of life and health outcomes in all domains. Reduce health inequalities between populations.
Relevance to NICE guidance	The intention of this research recommendation is to generate robust evidence that would enable NICE to make recommendations to healthcare and social care professionals regarding the possibility of hearing loss in populations who may be unaware of this loss or who are unable to present their hearing difficulties.
Relevance to the NHS	Population benefit: Increased health gain, quality of life Reduced health inequalities Financial incentives: Increased independence, reduction in care requirements
National priorities	Action Plan on hearing loss Commissioning services for people with hearing loss 5 Year Forward View: https://www.england.nhs.uk/wp-content/uploads/2014/10/5yfv-web.pdf DH Annual report on inequalities in health – 2017
Current evidence base	The evidence review for the NICE guideline on hearing loss was unable to identify any studies that identify populations at greater risk of having undetected hearing loss.
Equality	Yes. Directly redresses the growing disparity in health status between different populations
Study design	Prevalence study: identification of undetected hearing loss assessment in different populations and current levels of service usage.
Feasibility	Realistic timescale? Yes Acceptable Cost? Yes Ethical or technical issues? Methodologies for assessment of hearing loss in populations with cognitive impairment of learning difficulties
Other comments	None
Importance	High – Given the evidence about the benefits of early detection, research is urgently needed to identify populations who might be unaware of hearing difficulties in order to minimise the risk of further increasing the health inequality divide.

Criteria for selecting high-priority research recommendations

PICO question	Population: Adult patients Comorbidities and risk factors: Any Sex: Any Ethnic group: All Specific inclusion criteria: New adult referrals with age-related hearing loss Specific exclusion criteria: Pre-existing cognitive impairment or dementia Intervention: Provision of hearing aids Comparison: New adult referrals with age-related hearing loss who do not receive hearing devices Outcome: Incidence of dementia
Importance to patients or the population	Dementia is a distressing disabling condition for patient and carers. It has no specific treatment and can lead to premature death. Conversely, management of hearing loss with hearing aids and good communication strategies are acceptable to many patients. This management has significant benefits to the patient and their associates from the point of view of reducing isolation and depression.
Relevance to NICE guidance	If using hearing aids was to improve functioning and delay the onset or progression of dementia it would be unhesitatingly recommended in future guidelines for hearing loss and dementia as well as becoming widely used in practice. As a result, further investigation would be encouraged into the nature of the relationship between hearing loss and dementia, leading to new approaches to the prevention and management of both conditions.
Relevance to the NHS	Hearing loss itself is associated with greater morbidity and use of healthcare and social care resources, issues that can be alleviated by good management of the hearing loss using hearing aids and other strategies. As the population ages, dementia is one of the most common problems the NHS has to deal with leading to significant costs for residential care. Any approach which can delay the onset of progression of dependence in patients with dementia and thus lead to a reduction in morbidity and use of NHS resources would be of great importance. Analysis for the NICE hearing loss guideline shows the early provision of hearing aids is cost-effective at £4,704 per QALY gained for treating the hearing loss itself. Delaying the onset of dementia by 1 year would have a potential benefit of reducing the disease prevalence by 10% (Lin et al. 2011). ³⁴⁰ The average cost of a care home placement for dementia was £32,000 p.a. in 2012 (Dementia 2012: a national challenge – Alzheimer’s Society). ³⁰⁴ The use of donepezil to treat dementia has an ICER of £7,093 per QALY gained (NICE technology appraisal 217, 2011, updated 2016. ⁴¹¹ “The Committee noted that the key driver of cost effectiveness in the Assessment Group’s model was treatment leading to delay to institutionalisation. This assumption led to less time spent in institutional care and subsequent savings to the NHS/personal social services” (para 4.3.29). The delay to institutionalisation was <2 months.
National priorities	NHS 5-Year Forward View (October 2014) “reduce the risk of dementia […] committed new funding to promote dementia research and treatment.” https://www.england.nhs.uk/wp-content/uploads/2014/10/5yfv-web.pdf National Service Framework for Older People (2001) key aims include: prevent unnecessary hospital admission promote independence NHS Action Plan on Hearing Loss (2015)https://www.england.nhs.uk/2015/03/hearing-loss/ CMO’s Report (March 2014) highlighted need for more research into hearing loss and dementia link. http://www.actiononhearingloss.org.uk/news-and-events/all-regions/news/cmos-report-highlights-need-for-more-research-into-hearing-loss-and-dementia-link.aspx NICE guideline: Dementia, disability and frailty in later life (2015) mid-life approaches to delay or prevent onset: Research recommendation 5.4: How strong are the associations between hearing and visual loss, and sleep patterns and positive and negative health outcomes, in particular the development of dementia, disability and frailty? What are the most effective and cost-effective interventions to protect hearing and vision and improve sleep and what is their effect on the development of dementia, disability and frailty? (Source: Evidence reviews 2 and 3; Expert paper 10)
Current evidence base	Throughout the development of the NICE guideline on hearing loss the committee has had difficulty identifying relevant economic research evidence. The costs of caring for and treating people with dementia are so significant that if it is shown that the condition can be prevented or delayed by hearing aid use, the economic benefits will become obvious. Summary of trials and reviews: a) Lin FR, Metter EJ, O’Brien RJ, Resnick SM, Zonderman AB, Ferrucci L. Hearing loss and incident dementia. Archives of Neurology. 2011; 68(2):214-220 doi:10.1001/archneurol.2010.362. http://archneur.jamanetwork.com/article.aspx?articleid=802291 b) Amieva et al., Self-Reported Hearing Loss, Hearing Aids, and Cognitive Decline in Elderly Adults: A 25-Year Study. J Am Geriatr Soc 63:2099–2104, 2015. https://doi.org/10.1111/jgs.13649 c) Lin FR, Yaffe K, Xia J, Xue QL, Harris TB, Purchase-Helzner E et al. Hearing loss and cognitive decline in older adults. JAMA Internal Medicine. 2013; 173(4):293-299 http://archinte.jamanetwork.com/article.aspx?articleid=1558452 d) Deal JA, Betz J, Yaffe K, Harris T, Purchase-Helzner E, Satterfield S et al. Hearing impairment and incident dementia and cognitive decline in older adults: The health ABC study. Journals of Gerontology Series A-Biological Sciences & Medical Sciences. 2017; 72(5):703-709. DOI: https://doi.org/10.1093/gerona/glw069 e) Dementia 2012: a national challenge. Alzheimer’s Society. https://www.alzheimers.org.uk/downloads/file/1389/alzheimers_society_dementia_2012-_full_report f) Livingston G, Sommerlad A, Orgeta V, et al., Dementia prevention, intervention, and care. The Lancet Commissions. (2017) http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(17)31363-6.pdf
Equality	The NHS Action Plan on Hearing Loss focuses on a range of groups disadvantaged by hearing loss that would benefit from assessment and treatment. These include people with learning disability, veterans, older people, and those at the end of life.
Study design	A significant difficulty arises from the presumed long timescale for the development of dementia in a given population. Although the ideal would be a prospective study (Deal et al. 2016’s duration was 9 years), the use of population based databases over recent years, particularly in general practice and in audiology departments, has led to more readily achievable research scenarios. These might include detailed analysis of very large databases; carefully controlled retrospective studies of populations who have been given hearing aids, observational studies using propensity scores, and matched pair studies. It is important not to be too prescriptive in this respect. The potential for research extends over a wide range of interests, for example Cognitive science Neuroscience Deafness Dementia Speech and language Cross-faculty research should be particularly welcomed.
Feasibility	Can the proposed research be carried out within a realistic timescale? Yes Using alternative study designs, for example, observational, modelling or recruiting high risk groups. A full RCT would be unrealistic in view of the long timescale to see any benefit of treatment and the relatively low incidence of dementia. Would the sample size required to resolve the question be feasible? Yes Recent trials on which to base a power calculation suggest a total of 2,000–3,000 patients may be sufficient. Would the expense needed to resolve the question be warranted? Yes. See NHS benefits, above. Are there any ethical or technical issues? Yes. Care must be taken to avoid withholding hearing aids from people who wish to use them. This important issue would need to be addressed in the design of the research protocol. Considerable publicity has been given recently to the link between hearing loss and dementia. The mixed evidence is already being used commercially in the UK and overseas to drive sale of hearing aids, as if it were a fact. It seems likely that soon not only will it be considered unethical not to offer hearing aids to control groups, but also the number of people choosing not to use aids and thus provide a control group will reduce significantly.
Other comments	Other potential funders: Action on Hearing Loss, Alzheimer’s Society, NIHR.
Importance	High: the research is essential to inform future updates of key recommendations in the hearing loss guideline and other NICE guidance.

Criteria for selecting high-priority research recommendations

PICO question	Population: adults of 18 years or older with occluding earwax Interventions: microsuction or irrigation Comparison: with each other Outcomes: health-related quality of life; adverse effects, wax-related measures, hearing, time to recurrence.
Importance to patients or the population	Newly informed guidance will help identify whether ear irrigation or microsuction is the more clinically or cost-effective treatment for wax removal. This will help provide the best care for patients with earwax. It will help develop patient pathways that will work toward providing equitable and efficient care for patients with earwax.
Relevance to NICE guidance	This research would enable NICE to recommend whether patients with earwax, unresponsive to drops, should be treated using irrigation or microsuction.
Relevance to the NHS	The research would help improve financial efficiency, identifying the most cost-effective strategy for the treatment of a common ENT problem. It would also provide primary care and ENT clinicians with clear information on the most clinically effective treatment option, in an area where uncertainty exists. Robust information on clinical and cost-effectiveness would help develop evidence base guidance and policy, that could help develop an effective, fair and efficient patient pathway.
National priorities	Action Plan on Hearing Loss - https://www.england.nhs.uk/wp-content/uploads/2015/03/act-plan-hearing-loss-upd.pdf Commissioning Services for People with Hearing Loss - https://www.england.nhs.uk/wp-content/uploads/2016/07/HLCF.pdf
Current evidence base	Existing evidence on earwax management strategies are mostly with small sample sizes and inconclusive. There is a lack of evidence on mechanical earwax removal methods including microsuction. There is no trial comparing ear irrigation and microsuction for earwax.
Equality	No equality issues
Study design	Randomised controlled trial, with an associated economic evaluation.
Feasibility	Can the proposed research be carried out in a realistic timescale - Yes Acceptable cost - Yes.
Other comments	None
Importance	High: the research is essential to inform future updates of key recommendations in the hearing loss guideline.

Criteria for selecting high-priority research recommendations

PICO question	Population: Adults ≥18 years with idiopathic SSNHL Exclusion criteria: bilateral SSNHL, underlying cause identified, Previous unsuccessful steroid therapy for this episode of SSNHL Setting: primary or secondary care At first presentation (not salvage or second-line therapy) Interventions and comparisons: oral steroids; IT steroid injections; oral plus IT steroids compared with each other Note: The time from onset of sudden hearing loss to first steroid dose should be recorded and results analysed with this as a variable Outcomes: pure tone audiometry, speech discrimination, quality of life measures, adverse events, for example: gastrointestinal bleeding, mood alteration or psychosis, persistent perforation of tympanum, middle ear infections, ear pain, increased appetite, sleep changes
Importance to patients or the population	Sudden sensorineural hearing loss (SSNHL) is a rapid loss of hearing that can occur over a few hours or up to 3 days. The cause of SSNHL can be found in only 10–15% of patients. The estimated yearly incidence of SSNHL is 5 to 20 cases per 100,000 people. It mostly affects adults in their 40s and 50s and has equal gender distribution. It is an alarming symptom and can have a major impact upon a person’s quality of life. It is important that the best treatment is given to patients with SSNHL as quickly as possible, to ensure the best outcome. The use of steroids as a treatment for idiopathic SSNHL (ISSNHL) is widely debated. About half the people with SSNHL will recover some or all of their hearing spontaneously, usually within 1 to 2 weeks from onset. Whilst there is some published research on the most effective initial treatment for SSNHL the evidence review for the NICE guideline on hearing loss found no robust evidence (numbers too small, inconsistency, risk of bias) to be able to offer confident recommendations about best practice. Several current guidelines suggest the use of oral steroids as initial treatment and increasingly the use of IT steroid injections as a salvage therapy if first-line treatment is not successful. IT therapy is considerably more costly than oral steroids. Patients and doctors are often motivated to ‘do something’ for patients with SSNHL but it is not possible from the evidence to be confident that current practice is effective and that benefits outweigh any potential risks. Patients would benefit from more evidence-based treatment by being offered the initial treatment which offers the best chance of improvement in SSNHL and therefore quality of life. In addition, there would be less chance of patients receiving initial treatments which carry some risks and costs but may have no beneficial effect. Newly informed guidance would help provide fair and equitable care to patients with idiopathic SSNHL. Importantly, it would also help ensure that patients receive the most effective care for a potentially reversible condition that is associated with considerable concern and disability.
Relevance to NICE guidance	This research would enable NICE to recommend the most clinically and cost-effective route of administration of steroids as first-line treatment for idiopathic SSNHL.
Relevance to the NHS	The research would deliver a financial advantage, identifying the most cost-effective strategy for treatment of a common ENT emergency. It would also provide primary care and ENT clinicians with clear information on the most clinically effective treatment option, in an area where considerable uncertainty exists. Robust information on clinical and cost effectiveness would help develop evidence based guidance and policy that could help develop an effective and efficient patient pathway.
National priorities	Action Plan on Hearing Loss - https://www.england.nhs.uk/wp-content/uploads/2015/03/act-plan-hearing-loss-upd.pdf Commissioning Services for People with Hearing Loss - https://www.england.nhs.uk/wp-content/uploads/2016/07/HLCF.pdf
Current evidence base	The current evidence base consists of very few studies with small populations sizes. Moreover, there is considerable disparity amongst the existing research on the doses and types of steroid used as well as definitions of idiopathic SSNHL.
Equality	No equality issues.
Study design	Randomised, placebo-controlled trial, with an associated economic evaluation.
Feasibility	Can the proposed research be carried out in a realistic timescale? - Yes Acceptable cost? - Yes. Are there any ethical or technical issues? – IT steroids need to be administered by ENT registrars or more senior clinicians.
Other comments	None
Importance	High: the research is essential to inform future updates of key recommendations in the guideline.

Criteria for selecting high-priority research recommendations

PICO question	Population: Adults aged ≥18 years with hearing loss Interventions: Patient-centred tools to support decision-making for strategies to manage hearing loss (for example, motivational tools, motivational interviewing, option grids), including new innovations (eHealth, pre-appointment). Comparison: Usual care or other decision-making tools. Outcomes: Hearing-specific health-related quality of life, health-related quality of life, participation, self-efficacy, management strategy adherence and satisfaction.
Importance to patients or the population	Newly informed guidance would help identify whether patient-centred tools, as part of shared decision-making, are effective in facilitating patients’ readiness and motivation to use their chosen management strategies. If effective, this would ultimately improve quality of life for people with hearing loss as well their family members and friends.
Relevance to NICE guidance	This research would provide evidence that would enable NICE to recommend which patient-centred tools were the most clinically and cost effective in promoting shared decision-making.
Relevance to the NHS	This research, if shown to be effective, would improve financial efficiency if management strategies were adhered to. It would provide audiologists with clear information on the most clinically and cost-effective tool to use, as currently there is limited use of such tools. This research would help develop a robust evidence base where currently none exists, and help inform future policy to deliver a more effective and efficient pathway.
National priorities	Action Plan on Hearing Loss - https://www.england.nhs.uk/wp-content/uploads/2015/03/act-plan-hearing-loss-upd.pdf Commissioning Services for People with Hearing Loss - https://www.england.nhs.uk/wp-content/uploads/2016/07/HLCF.pdf British Society of Audiology Practice Guidance (2016) Common principles of Rehabilitation for Adult in Audiology Services http://www.thebsa.org.uk/wp-content/uploads/2016/10/Practice-Guidance-Common-Principles-ofRehabilitation-for-Adults-in-Audiology-Services-2016-3.pdf Kings Fund (2011) Making shared decision-making a reality: No decision about me, without me https://www.kingsfund.org.uk/sites/default/files/Making-shared-decision-making-a-reality-paper-Angela-Coulter-Alf-Collins-July-2011_0.pdf NICE CG138 (2012) Patient experience in adult NHS service https://www.nice.org.uk/guidance/cg138/chapter/1-guidance
Current evidence base	The systematic review undertaken for the NICE guideline on hearing loss did not identify any studies to provide evidence on the effectiveness of patient-centred tools to help with deciding on what management strategies to choose. The current evidence base is therefore almost non-existent.
Equality	No equalities issues.
Study design	Randomised controlled trial, with associated economic evaluation. Qualitative research would highlight the relevance and impact of patient-centred tools for patients, their communication partners and hearing healthcare professionals, and how and when the tools should be used.
Feasibility	Can the proposed research be carried out in a realistic timescale? Yes At an acceptable cost? Yes. Are there any ethical or technical issues? No, other than the control group not having access to the tools.
Other comments	Hearing healthcare professionals, such as audiologists, would need training in how to use the tools effectively. Use of eHealth technologies may be used to pre-empt the decision-making process for patients and their communication partners prior to attending clinic, and throughout the patient pathway.
Importance	High: the research is essential to inform future updates of key recommendations in the guideline Shared decision-making is core to NHS policy (see Kings Fund report ‘Making shared decision-making a reality: No decision about me, without me’ (2011) and NICE guideline CG138 (2012).

Criteria for selecting high-priority research recommendations

PICO question	Population: Adults aged ≥18 years with hearing loss Interventions: Assistive listening devices such as FM devices, telephone/television amplifiers, loop systems (personal or in-built), telecoils, hearing aid apps, bluetooth devices, personal sound amplification products (PSAPs). Comparison: hearing aids or no intervention (such as waiting list control) Outcomes: Hearing-specific health-related quality of life, health-related quality of life, participation, listening ability, speech intelligibility, listening effort, device use and satisfaction.
Importance to patients or the population	Newly informed guidance would help identify which ALDs would improve communication with others and increase awareness of important environmental sounds. This would improve quality of life for people with hearing loss and their family members, and increase connectivity to their environment (for example by alerting them to fire alarms and visitors ringing the doorbell).
Relevance to NICE guidance	This research would provide evidence that would enable NICE to recommend which ALDs are clinically and cost effective in improving communication and quality of life. This could then inform new and innovative models of service delivery.
Relevance to the NHS	This research could enable the design of new patient pathways and service delivery models. This could improve financial efficiency and patient outcomes. The findings would provide audiologists with clear information on the most clinically and cost-effective ALD to use, as currently there is limited use of such technologies. This research would provide a robust evidence base where currently none exists, and help inform future policy to deliver effective and efficient pathways.
National priorities	Action Plan on Hearing Loss (2016)- https://www.england.nhs.uk/wp-content/uploads/2015/03/act-plan-hearing-loss-upd.pdf Commissioning Services for People with Hearing Loss - https://www.england.nhs.uk/wp-content/uploads/2016/07/HLCF.pdf Audiology: Framework of action for Wales, 2017–2020: Integrated framework of care and support for people who are D/deaf or living with hearing loss http://gov.wales/topics/health/publications/health/reports/audiology/?lang=en Quality Standards for Adult Hearing Rehabilitation Services (2016) http://gov.wales/topics/health/professionals/committees/scientific/reports/aud iology-services/?lang=en Quality Standards for Adult Hearing Rehabilitation Services (2009) http://www.gov.scot/Publications/2009/04/27115807/2
Current evidence base	The systematic review undertaken for the NICE guideline on hearing loss only identified 1 low-quality study on the clinical effectiveness of ALDs. The current evidence base is therefore almost non-existent.
Equality	No equality issues.
Study design	Randomised controlled trial, with associated economic evaluation. Qualitative research would highlight the relevance and impact of ALDs for patients, their communication partners and hearing healthcare professionals, patient preference, how and when the devices should be used, and possible models of service delivery.
Feasibility	Can the proposed research be carried out in a realistic timescale? Yes At an acceptable cost? Yes. Are there any ethical or technical issues? No.
Other comments	There are different types of ALDs for different purposes, which may require a number of research studies to answer the question.
Importance	High: the research is essential to inform future updates of key recommendations in the guideline as current research is non-existent.

Criteria for selecting high-priority research recommendations

PICO question	Population: Adults ≥18 years with hearing loss who use hearing aids. Interventions: Directional microphones and adaptive noise reduction. Comparison: No (or disabled) directional microphone or adaptive noise reduction.
Importance to patients or the population	The most common complaint of adults with hearing loss is difficulty understanding speech in the presence of background noise or competing speech. Because hearing aids cannot improve deficits in frequency, temporal and spatial resolution, an adult with hearing loss may continue to experience some difficulties, even when wearing hearing aids. The perception, and acceptance, of hearing aids is likely to be improved if outcome measures can be developed for use when investigating the listening benefits from features such as directional microphones and digital (adaptive) noise reduction.
Relevance to NICE guidance	This research would enable NICE to recommend how the real-world effectiveness of hearing aid features designed to assist in background noise should be assessed and quantified.
Relevance to the NHS	The NHS spends tens of millions of pounds each year buying hearing aids. For this investment it would be useful to optimise benefit.
National priorities	Action Plan on Hearing Loss - https://www.england.nhs.uk/wp-content/uploads/2015/03/act-plan-hearing-loss-upd.pdf Commissioning Services for People with Hearing Loss - https://www.england.nhs.uk/wp-content/uploads/2016/07/HLCF.pdf
Current evidence base	The most common complaint of adults with hearing loss is difficulty understanding speech in the presence of background noise or competing speech. The benefits of hearing aid features designed to improve hearing in background noise are based largely on theoretical advantages and studies of efficacy. Outcome measures need to be identified, or developed, for use when investigating real-work listening benefits of hearing aid features design to provide benefit in background noise.
Equality	No equality issues
Study design	RCTs or blinded within-subject design
Feasibility	No obvious limitation in terms of recruitment or blinding
Other comments	None
Importance	High: the research is essential to inform future updates of key recommendations in the guideline.

Criteria for selecting high-priority research recommendations

PICO question	Population: Adults aged ≥18 years with hearing loss Intervention: Monitoring and follow-up post-intervention or when no intervention is taken up. Comparison: (i) no follow-up (ii) individual follow-up (iii) group follow-up Outcome: Hearing health hearing-specific quality of life, health-related quality of life, participation, intervention adherence (or uptake if no intervention taken up initially) and satisfaction.
Importance to patients or the population	Newly informed guidance would help identify whether monitoring and follow-up are effective in improving outcomes for patients, and at what time periods they should be undertaken, in either individual or group settings.
Relevance to NICE guidance	This research would provide evidence that would enable NICE to make recommendation regarding whether monitoring and follow-up should be undertaken, in what format and across which time periods in the patient pathway. Key questions include what is the optimum interval between an initial hearing assessment followed by hearing aid(s) being fitted and recall for a hearing reassessment with consideration of whether hearing aid(s) should be replaced; and whether hearing aid users should be actively followed up in the intervening period.
Relevance to the NHS	This research, if shown to be effective, would provide ongoing support for patients.
National priorities	Action Plan on Hearing Loss https://www.england.nhs.uk/wp-content/uploads/2015/03/act-plan-hearing-loss-upd.pdf Framework of action for Wales, 2017–2020: Integrated framework of care and support for people who are D/deaf of living with hearing loss http://gov.wales/topics/health/publications/health/reports/audiology/?lang=en Quality Standards for Adult Hearing Rehabilitation Services (2016) http://gov.wales/topics/health/professionals/committees/scientific/reports/aud iology-services/?lang=en Quality Standards for Adult Hearing Rehabilitation Services (2009) http://www.gov.scot/Publications/2009/04/27115807/2
Current evidence base	The systematic review undertaken for the NICE guideline on hearing loss did not identify any studies on how or when to monitor or follow-up patients.
Equality	No equality issues.
Study design	Randomised controlled trial, with associated economic evaluation. Qualitative research would highlight which aspects of monitoring and how and when it is carried out that are beneficial.
Feasibility	Can the proposed research be carried out in a realistic timescale? Yes At an acceptable cost? Yes Are there any ethical or technical issues? None (although withholding all monitoring and follow-up may be unethical as the clinical opinion is that this is beneficial)
Other comments	None
Importance	High: the research is essential to inform future updates of key recommendations in the guideline.