Cisplatin is a widely used chemotherapeutic anti-cancer drug. However, high-dose cisplatin is also known for its dose-limiting toxicities, including irreversible cisplatin-induced hearing loss (CIHL). Sodium thiosulphate (STS) can bind to cisplatin to form an inactive and harmless complex. A topical application is desired, allowing cisplatin to retain its systemic anti-cancer effect.

The SOUND trial is an investigator-initiated randomised controlled multicentre phase III trial to study the efficacy of transtympanic administration of STS against CIHL in a cohort of 100 patients with head and neck cancer treated with cisplatin at a dose of ≥200 mg/m². Each subject will receive transtympanic STS injections in one ear, chosen by randomisation, before each cisplatin infusion. The contralateral ear serves as an internal control. The primary objective is efficacy (ie, clinically relevant benefit) of transtympanic STS injections against CIHL, defined as a difference in threshold shift of ≥10 decibels between baseline and 3 months after treatment in favour of the STS-treated ear. Secondary objectives include the difference in mean threshold shifts on frequencies essential for speech and extended high frequencies, as well as the difference between both ears in the gradation of hearing loss as defined by ototoxicity grading scales.

The medical ethics committee in the Netherlands approved the trial (Clinical Trials Information System (CTIS) 2023-503313-30-00). The results will be disseminated through the CTIS and peer-reviewed scientific journals.

CTIS 2023-503313-30-00 approved by Medical Research Ethics Committee NedMec.

Multiple well-considered but siloed initiatives and programmes exist in Australia to support ear and hearing screening and assessment for Indigenous children. However, the lack of coordination of these programmes leads to inefficiencies in resource allocation and disrupts opportunities to implement a cost-effective, efficient, and easily navigable system of care. Indigenous children experience high prevalence rates of middle ear disease, as well as earlier onset, increased severity and longer infections compared with non-Indigenous children. The aims of this study are to: (1) Understand current ear and hearing screening programmes in three New South Wales communities and evaluate their strengths and limitations, (2) Strengthen, implement and evaluate ear and hearing screening programmes and (3) Identify the barriers and facilitators for scaling strengthened ear and hearing screening programmes nationally and the importance and feasibility of each factor.

A series of desktop searches and co-design workshops will be completed to achieve aim (1) and (2) and the results will be mapped into work-as-done and work-as-imagined using the Functional Resonance Analysis Method. Strengthened screening programmes will be implemented in communities using the criteria from national and international guidance documents and the Practical, Robust, Implementation and Sustainability Model and evaluated. Finally, workshops will be conducted with key stakeholders to identify the barriers and facilitators for scaling strengthened ear and hearing screening programmes nationally and the importance and feasibility of each factor.

This project has received ethics approval from the Aboriginal Health and Medical Research Council Human Research Ethics Committee (Ref: 2350/24). Results will be disseminated to the community through the CEOs of the Aboriginal Community Controlled Health Organisations as well as published in peer-reviewed journals and presented at conferences. The findings from data collected will be used to inform the co-production of an enhanced system for ear and hearing care.

Dysphagia, or difficulty in swallowing, significantly impacts the quality of life of the affected individuals. Diagnostic approaches, including video fluoroscopic swallowing studies and flexible endoscopic evaluation of swallowing, are the most commonly used methods for assessing swallowing function. Recent advancements have led to the development of artificial intelligence (AI), including machine learning (ML) and deep learning (DL), which will provide innovative approaches to dysphagia diagnosis and treatment planning. There is a limited synthesis of literature on AI tools in dysphagia. There is an urgent need for a more rigorous and structured scoping review that can address the existing gaps, provide a more comprehensive evidence synthesis, and establish clearer guidelines for the clinical implementation of AI in assessments and management of dysphagia. This review will include studies focusing on AI tools such as ML, DL and computer vision for assessing and managing dysphagia. The context will be clinical or therapeutic settings, and all language articles will be considered for the review. Studies not involving AI technologies, those without clinical outcomes and ethical approval, and those focusing solely on the paediatric population will be excluded. This scoping review will systematically map and synthesise the existing literature on the use of AI tools for the assessment and management of dysphagia.

This scoping review will follow JBI methodology and PRISMA ScR guidelines. Information to be searched from January 2000 to May 2025 will include MEDLINE (via Ovid), Scopus, CINAHL (via EBSCOhost), Cochrane Library, JBI Evidence Synthesis, ProQuest and Google Scholar. The titles, abstracts and full texts will be screened by two independent reviewers. Data extraction will use a study-specific customised form, with descriptive analysis employed to categorise studies by AI tools and outcomes.

Ethical approval is not mandatory for this scoping review as it does not entail the collection of any individual patient data. Secondary data from publicly accessible research papers will be used. All the data sources will be appropriately cited. The findings will be propagated through peer-reviewed publications and scientific presentations.

Open Science Framework: DOI 10.17605/OSF.IO/DYCE9.

The working-age population (WAP) refers to individuals aged 15–64, who are the main drivers of production. Among the various factors affecting their productivity, hearing loss plays a significant role. However, epidemiological data on hearing loss in the WAP remain limited. The study analyses the global, regional and national situation of hearing loss in the WAP and predicts the disease burden up to 2040.

This study was based on data from the Global Burden of Disease (GBD) 2021 study, covering 204 countries and territories from 1990 to 2021.

The study population included all individuals aged 15–64 years, consistent with the United Nations definition of the WAP and adopted in the GBD 2021 study.

Data on the prevalence and years lived with disability (YLDs) due to hearing loss among the WAP were extracted from the GBD database. The disease burden was represented using both absolute numbers and age-standardised rates (ASRs). Trends were analysed with the estimated annual percentage change (EAPC). Subgroup analyses on sociodemographic index (SDI), gender, disease severity and causes were performed, and projections for 2040 were estimated using the Nordpred model.

Globally, from 1990 to 2021, the number of hearing loss cases in the WAP increased from 558.08 million to 1.04 billion, and the number of YLDs rose from 14.45 million to 26.55 million. In 2021, the prevalence in the WAP was 19 607.24 per 100 000, with YLDs at 501.81 per 100 000. The EAPC shows an upward trend: the change in age-standardised prevalence is 0.11 (95% uncertainty interval (UI 0.10, 0.12), and the change in age-standardised YLDs is 0.10 (95% UI 0.08, 0.11). High SDI regions have the lowest burden of hearing loss globally. At the regional level, as SDI increases, the age-standardised prevalence and YLDs of hearing loss show a downward trend. In contrast, the burden is higher in Oceania, Southeast Asia, South Asia, Eastern Sub-Saharan Africa and East Asia. The top three countries in terms of prevalence and YLDs are Madagascar, Malawi and Kenya. By 2040, the global prevalence and YLDs of hearing loss in the WAP are projected to be 1.31 billion and 33.30 million, respectively, with ASRs of 19 890.33 and 512.27 per 100 000 population.

The burden of hearing loss in the WAP is gradually increasing, with differences in prevalence and YLDs across regions, countries and SDI levels. Continued attention is needed for this vulnerable group’s hearing loss, along with the implementation of effective measures to reduce future burdens.

Sudden sensorineural hearing loss (SSNHL) is an otologic emergency that can profoundly impact patients’ auditory function and quality of life. While conventional treatments like corticosteroids offer moderate efficacy, a proportion of patients experience persistent deficits, highlighting the need for effective adjunctive therapies. Acupuncture has demonstrated therapeutic potential for SSNHL, but the relative efficacy of various acupuncture-related modalities remains unclear. This protocol outlines a systematic review (SR) and network meta-analysis (NMA) aimed at comprehensively evaluating the comparative efficacy of different acupuncture modalities in treating SSNHL.

An extensive literature search across nine databases and five clinical trial registries will be conducted to identify randomised controlled trials investigating acupuncture-related therapies for SSNHL. The primary outcome measure is the change in pure-tone audiometric thresholds. Secondary outcomes include the proportion of recovered patients, tinnitus severity, psychological symptoms and adverse events. Two independent reviewers will perform study selection, data extraction and methodological quality assessment using the Cochrane’s risk of bias (V.2.0) tool. A Bayesian NMA will be employed to compare the relative efficacy among multiple acupuncture modalities. The overall quality of evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation methodology.

As this study will use data from previously published studies, it does not require ethical approval. The findings of this SR and NMA will be disseminated through publication in a peer-reviewed academic journal.

CRD42024525763.

Hearing loss is highly prevalent and impacts many aspects of a person’s life, including communication, social engagement, employment, general health and well-being. Yet, many people do not access hearing healthcare and are unaware of the range of hearing healthcare options available. Barriers to hearing healthcare include poor understanding of hearing loss and its impact; poor knowledge of help-seeking for hearing healthcare options; minimal support to help decide which option is best; and stigma related to hearing loss. These barriers lead to many people not receiving the hearing healthcare they need. Guided by theories of behaviour change and implementation science, HearChoice, an online tailored decision support intervention, has been co-developed to empower adults with hearing difficulties by offering them choice and control over their own hearing healthcare. HearChoice aims to facilitate informed decisions, accessibility and uptake of hearing healthcare, including a wide range of interventions, for adults with hearing difficulties. The objectives of the trial are to evaluate the effectiveness, health economics and feasibility of HearChoice.

This online randomised controlled trial will recruit participants with hearing difficulties across Australia, with an anticipated sample size of 640. Participants will be randomised to either HearChoice (treatment) or an Australia-specific Hearing Option Grid (active control), both delivered online. Outcomes will be assessed at baseline when the interventions will be offered, at 7 days post-intervention (primary endpoint) and at 3 months post-intervention. An email reminder will be sent at 1-month post-intervention. The primary outcome is decisional conflict. Secondary outcomes include measures of readiness and self-efficacy to take action, hearing-related quality of life and empowerment, assessment of the value and impact of HearChoice, work performance and health, and feasibility measures. Primary analysis will compare outcomes between HearChoice and the active control at the primary endpoint.

The study was approved by the Curtin University Human Ethics Committee (HRE2023-0024). All participants will provide written informed consent prior to participation. A broad dissemination plan of the study findings includes peer-reviewed publications, scientific conference presentations, articles and presentations for the wider community and public written in lay and accessible language, and social media.

Australian New Zealand Clinical Trials Registry (ACTRN12624001139561).

Post-surgical care following cochlear implantation is a pivotal part of the rehabilitation journey for cochlear implant (CI) recipients. However, frequent in-clinic visits, particularly in the first year following CI activation, can place a significant burden on CI recipients. Moreover, the growing number of CI recipients may pose a challenge for CI clinics to provide consistent and lifelong care. Cochlear Remote Care is a platform that enables the delivery of post-surgical care through remote hearing assessments and remote video appointments, offering an opportunity to enhance clinic efficiency, eliminate geographical barriers, reduce financial burdens and provide flexible post-surgical options. The primary objective of this study is to compare self-reported hearing ability in daily life among CI recipients who receive post-surgical care through Remote Care with those receiving routine in-clinic care during the first year following CI activation. Additionally, the study will assess the time and costs associated with these care models for both the clinic and patients.

This multi-centre randomised controlled trial is set to be conducted across 11 clinics in the United Kingdom, Italy, the Netherlands, Belgium and Australia, with an anticipated sample size of 148 participants. All participants will be adults with post-lingual deafness and unilateral CIs. Following baseline measurements at 3 months post-activation, participants will be randomly assigned to either in-clinic visits or Remote Care appointments. At six and 12 months after activation, participants will complete a comprehensive battery of audiometric tests and questionnaires on patient-reported outcomes, usability and resource utilisation.

Ethics approval has been obtained for each clinical site. Study findings will be disseminated widely through peer-reviewed publications, lay language summaries and conference presentations.

NCT05552118.

Ventilation tube insertion for paediatric otitis media (POM), including acute otitis media (AOM) and otitis media with effusion (OME), has been signalled in the past for potential unwarranted treatment variation. Quality improvement initiatives, like Audit & Feedback (A&F), often ignore the care pathway when identifying such variation, possibly overestimating variation at a specific care step. To gain more insight into the effect of prior care steps, this study examined (1) the degree of regional variation in each step of the care pathway (general practitioner (GP) contacts, referrals and surgeries) and (2) investigated the effect of adjusting for prior care steps.

Observational study using general practice electronic health record data linked to specialist claims data.

272 790 children ≤12 years with and without POM registered in 320 GP practices between 2017 and 2018.

Using multilevel logistic regression, the degree of regional variation in each step of the POM care pathway was assessed by calculating the coefficient of variation (CV).

The effect of adjusting for prior care steps was determined by estimating correlations between subsequent care steps and analysing the impact on the CV.

Regional variation in POM treatment was larger in each subsequent step in the care pathway (CV POM GP contacts 0.110; referral 0.179; surgery 0.239). In regions with a higher proportion of children with frequent AOM/persistent OME, referral rates were higher (POM: OR: 1.06; 95% CI: 1.02 to 1.11) and surgical rates were higher (for OME only: OR: 1.08; 95% CI: 1.02 to 1.15). Regional variation in referrals and surgery decreased after adjusting for the regional frequent AOM/persistent OME rate (CV referrals POM 0.103 vs 0.128; CV surgery OME 0.047 vs 0.059).

Regional variation is observed in GP contact rates for POM and is larger in referrals and surgeries. Adjusting for the proportion of frequent AOM/persistent OME significantly reduces regional variation in POM treatment. Future A&F should adjust for prior care processes and develop tailored interventions for quality improvement.

Endoscopic sinus surgery is an effective treatment for olfactory dysfunction related to chronic rhinosinusitis (CRS). However, recent studies have shown that most patients with CRS experience a return of olfactory function to preoperative levels within months to a year after surgery. Clinically, olfactory training after sinonasal surgery has been proven beneficial for olfactory recovery. The study aims to explore the effectiveness of olfactory training in treating postoperative olfactory dysfunction in patients with CRS after surgery. Additionally, conventional olfactory training (COT) devices have the drawback of insufficient deposition rates of odourants in the olfactory cleft, leading to poor treatment outcomes. This experiment employs a modified olfactory training (MOT) device based on respiratory pressure and compares its therapeutic effects with the COT device.

This will be a randomised controlled trial. The aim is to investigate the effectiveness of olfactory training in treating postoperative olfactory dysfunction in patients with CRS and to compare the effects of MOT with COT. Participants will be randomly allocated in a 1:1:1 ratio to the MOT group, the COT group and the control group for 12 months. The primary outcome will be the change in the odour threshold, odour discrimination, odour identification and the total threshold, detection and identification score after 12 months of olfactory training. The secondary outcomes will include objective olfactory cleft assessment, the volumes of grey matter, white matter and cerebrospinal fluid, the volume and shape of the olfactory bulb, and the subjective olfactory assessment.

This study protocol has been registered with ClinicalTrials.gov and has received approval from the Peking University Third Hospital Medical Science Research Ethics Committee. The results will be published in scientific peer-reviewed journals.

NCT06837051.

Mild cognitive impairment (MCI) presents a significant risk, with a 75–80% likelihood of progressing to dementia. Despite this high risk, there is currently no straightforward and effective treatment strategy to halt or reverse this progression. Olfactory dysfunction, in conjunction with subjective cognitive decline, offers a crucial opportunity for early intervention in older adults at risk of MCI. Conventional olfactory training (COT) has demonstrated potential in enhancing neuroplasticity, which is vital for cognitive health. Initial studies indicate that modified olfactory training (MOT) may yield superior outcomes compared to COT. Thus, this study aims to evaluate the efficacy of MOT in delaying and preventing the progression of MCI in high-risk individuals.

This randomised, controlled, multicentre, prospective and open-label trial will be conducted at Peking University Third Hospital and enrol 114 participants, who will be randomised 1:1:1 into three groups: MOT, COT and a control group. Standardised assessments will be conducted at baseline, 3 months, 6 months, 12 months and 24 months to measure cognitive and olfactory outcomes. The primary outcomes will be the change in Montreal Cognitive Assessment score, neuroimaging assessments and the Sniffin’ Sticks test score. The secondary outcomes will include olfactory bulb volume and several neuroimaging tests.

This study protocol has been registered with ClinicalTrials.gov and has received approval from the Peking University Third Hospital Medical Science Research Ethics Committee (2023-347-01). The results will be disseminated through publication in scientific peer-reviewed journals.

NCT06821828.

Secondary and tertiary renal hyperparathyroidism (RHPT) are common sequelae of chronic kidney disease and are associated with worse patient mortality and quality of life. Clinical guidelines remain lacking with regard to recommendations for using intraoperative parathyroid hormone (IOPTH) during surgery for RHPT. A prospective randomised study will help evaluate the role of IOPTH in guiding surgery for secondary and tertiary RHPT.

Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism is a pragmatic, multicentre, five-arm, parallel-group, patient-blinded and outcome assessor-blinded prospective pilot trial used to evaluate the feasibility of performing a definitive trial. Eligible participants include adult patients diagnosed with secondary or tertiary hyperparathyroidism who are candidates for subtotal or total parathyroidectomy. Consenting patients will be randomly assigned, through central allocation, in a 1:1:1:1:1 fashion to undergo surgery with IOPTH monitoring (four experimental arms: postexcision IOPTH samples taken at 10, 15, 20 or 25 min) or to undergo surgery without IOPTH monitoring (control arm). The primary feasibility objective is to estimate the percentage of eligible patients that are randomised: ≥70% proceed; 50–69% modify protocol before proceeding;

Ethics approval was obtained from the Hamilton Integrated Research Ethics Board. Pilot trial results will be shared widely through local, national and international academic and clinical networks and will be disseminated through conference presentations and publication in peer-reviewed journals.

NCT06542315, registered on 6 August 2024.