An Unusual Presentation of a Black Discoloration on the Tympanic Membrane of a 10-Year-Old Girl: A Case Report.

This case report details an unusual presentation of unilateral tympanic membrane discoloration in a 10-year-old girl. The mysterious black discoloration was explored by various medical specialties, revealing a complex diagnostic journey due to the lack of evidence for this specific finding. Initially, the patient consulted her primary care physician after inserting a graphite pencil into her left ear canal, but without associated symptoms, she was considered to have returned to her baseline. The abnormal discoloration on the left tympanic membrane was first observed 10 months later, following diagnoses of two episodes of otitis media, otitis externa, and a middle ear effusion over three separate visits. By this time, the patient had been seen by four different medical professionals. The lesion was described as "a blackish discoloration in the posterior superior quadrant of the unperforated tympanic membrane near the umbo." This report underscores the need for thorough evaluation and consideration of atypical presentations when encountering unusual tympanic membrane discolorations.

Paediatric Laryngeal Ultrasound: A Retrospective Cohort Study in Aotearoa New Zealand and an International Survey.

OBJECTIVE: Vocal fold immobility (VFI) is a cause of significant morbidity and mortality in the paediatric population. Laryngoscopy is the current first-line investigation for patients with suspected VFI. Laryngeal ultrasound (LUS) has recently emerged as an alternative method of identifying VFI. Compared to laryngoscopy, LUS is less invasive, does not require anaesthesia, and can be performed by non-otolaryngologists. The objectives of this study are to evaluate LUS as a diagnostic method for the identification of VFI in a cohort of paediatric patients in Aotearoa New Zealand (NZ) and to estimate the frequency of use of LUS in the paediatric population by clinicians around the world. METHODS: A retrospective, single-centre cohort study was performed on all paediatric patients who had undergone laryngoscopy and LUS at Starship Children's Health in Auckland, NZ, between 2020 and 2023. An eight-question survey was also developed and distributed to better understand clinicians' use of LUS in their clinical practice to diagnose paediatric VFI globally. RESULTS: Twenty-nine paediatric patients met the inclusion criteria. LUS demonstrated good sensitivity (80.95%) for detecting VFI and increased to 93.33% for the detection of unilateral VFI. Of the 87 respondents to the survey, 41.38% utilise LUS in their clinical practice in the paediatric population. The main barriers to implementation of LUS as identified by non-users were lack of equipment, expertise, and training. CONCLUSIONS: These findings support the use of LUS as an accurate diagnostic tool for the detection of unilateral VFI. Further studies in non-surgical populations and in patients with bilateral VFI, as well as standardised guidelines for LUS technique and reporting, are required.

Teletherapy to address language disparities in deaf and hard-of-hearing children: study protocol for an inclusive multicentre clinical trial.

INTRODUCTION: Children who are deaf or hard-of-hearing (DHH) are at risk for speech and language delay. Language outcomes are worse in DHH children from lower socioeconomic backgrounds, due in part to disparities in access to specialised speech-language therapy. Teletherapy may help improve access to this specialised care and close this language gap. Inclusion of diverse DHH children in prospective randomised clinical trials has been challenging but is necessary to address disparities and pursue hearing health equity. Stakeholder input regarding decisions on study design elements, including comparator groups, masking, assessments and compensation, is necessary to design inclusive studies. We have designed an inclusive, equitable comparativeness effectiveness trial to address disparities in paediatric hearing health. The specific aims of the study are to determine the effect of access to and utilisation of speech-language teletherapy in addressing language disparities in low-income children who are DHH. METHODS AND ANALYSIS: After stakeholder input and pilot data collection, we designed a randomised clinical trial and concurrent longitudinal cohort trial to be conducted at four tertiary children's hospitals in the USA. Participants will include 210 DHH children aged 0-27 months. 140 of these children will be from lower income households, who will be randomised 1:1 to receive usual care versus usual care plus access to supplemental speech-language teletherapy. 70 children from higher income households will be simultaneously recruited as a comparison cohort. Primary outcome measure will be the Preschool Language Scales Auditory Comprehension subscale standard score, with additional speech, language, hearing and quality of life validated measures as secondary outcomes. ETHICS AND DISSEMINATION: This study was approved by the Institutional Review Boards of the participating sites: the University of California, San Francisco (19-28356), Rady Children's Hospital (804651) and Seattle Children's Hospital (STUDY00003750). Parents of enrolled children will provide written informed consent for their child's participation. Professional and parent stakeholder groups that have been involved throughout the study design will facilitate dissemination and implementation of study findings via publication and through national and regional organisations. TRIAL REGISTRATION NUMBER: NCT04928209.

Impact of tonsillectomy on the efficacy of Alt-RAMEC/PFM treatment protocols in children with class III malocclusion and tonsillar hypertrophy: protocol for a cluster randomised controlled trial.

INTRODUCTION: Orthodontic treatment using face mask protraction combined with an alternate rapid maxillary expansion and constriction/protraction face mask (Alt-RAMEC/PFM) protocol is effective in the early treatment of patients with class III malocclusion, but the stability of treatment outcomes represents a major concern. Previous studies have suggested that tonsillar hypertrophy can be a risk factor for class III malocclusion and tonsillectomy may prompt the normalisation of dentofacial growth. However, these studies had a low-to-moderate level of evidence. This study was designed to identify the impact of tonsillectomy before orthodontic treatment on the efficacy and stability of Alt-RAMEC/PFM protocols and the sleep quality and oral health in children with anterior crossbite and tonsillar hypertrophy. METHODS AND ANALYSIS: This is a two-arm, parallel-group, superiority cluster randomised controlled trial, with four clinics randomly assigned to the surgery-first arm and the orthodontic-first arm in a 1:1 ratio. The Alt-RAMEC protocol involves alternate activation and deactivation of the expander's jet screw over 6 weeks to stimulate maxillary suture distraction. Patients will be instructed to wear the PFM for a minimum of 14 hours per day. The primary outcomes are changes in Wits appraisal and the degree of maxillary advancement from baseline to the end of orthodontic treatment. Lateral cephalometric radiographs, polysomnography, Obstructive Sleep Apnoea-18 questionnaire and Oral Health Impact Profile-14 questionnaire will be traced, collected and measured. We will recruit 96 patients intofor the study. To assess differences, repeated multilevel linear mixed modelling analyses will be used. ETHICS AND DISSEMINATION: This study has been granted ethical approval by the Ethics Committee of the School & Hospital of Stomatology, Wuhan University (approval No. 2023-D10). Written informed consent will be obtained from the participants and their guardians. The results of the trial will be disseminated through academic conferences and journal publications. TRIAL REGISTRATION NUMBER: ChiCTR2300078833.

Extended high-frequency hearing loss among Afro-Colombian adolescents from a rural area in Colombia: a cross-sectional study.

OBJECTIVES: Research trends concerning hearing loss within teen rural populations are limited and current evidence suggests that extended high-frequency audiometry can be a sensitive tool to detect subclinical hearing loss. Moreover, current research emphasises the importance of representing different ethnic populations in science. This study aimed to determine the prevalence of acquired hearing loss through conventional pure-tone (0.25-8 kHz) and extended high frequency (EHF) (9-20 kHz) audiometry in Afro-Colombian adolescents from a rural area in Colombia. DESIGN: Observational, cross-sectional study. PARTICIPANTS: 230 Afro-Colombian adolescents aged 13-17 years who attended high school in a rural population from Cartagena, Colombia. INTERVENTIONS: Otoscopic examination, conventional (0.25-8 kHz) and EHF (9-20 kHz) audiometry tests were performed during February-March 2021. Sociodemographic and associated factor questionnaires were also applied to assess probable factors associated with EHF hearing loss. MAIN OUTCOME MEASURES: Prevalence of acquired hearing loss using conventional and EHF audiometry, and factors associated with hearing loss. RESULTS: Of 230 adolescents who met the eligibility criteria, 133 (57.82%) were female. The mean age was 15.22 years (SD: 1.62). The prevalence of hearing loss in at least one ear assessed with conventional audiometry was 21.30% and with EHF audiometry 14.78%. The main abnormal otoscopic findings included: neotympanum (1.30%), myringosclerosis (0.87%) and monomeric scars (0.43%). Factors associated with a higher probability of EHF hearing loss found through logistic regression were older age (prevalence ratio (PR): 1.45; 95% CI 1.16 to 1.80), attending the 'Picó' four or more times a month (PR: 6.63; 95% CI 2.16 to 20.30), attending bars more than three times a month (PR: 1.14; 95% CI 1.03 to 1.59) and self-reported hearing difficulties (PR: 1.24; 95% CI 1.22 to 4.05). CONCLUSIONS: Our results suggest that acquired hearing loss is already widespread among this young rural population.

Protocol for a comparative cross-sectional study on characterisation of auditory impairment in sickle cell disease and sickle cell trait and its impact on health-related quality of life in Nigeria.

INTRODUCTION: Sickle cell disease (SCD) and sickle cell traits (SCT) are genetically inherited red blood cell disorders common among people of African descent. Nigeria has a high prevalence of SCD, with a prevalence of 2.28%-3% and SCT, 25%-30%. Poorly managed SCD and SCT can lead to sensorineural hearing loss and health-related quality of life (HRQoL) issues. This research aims to assess these possible complications of SCD and SCT in Nigeria. METHODS AND ANALYSIS: The study will use a comparative cross-sectional design at study power 80% to investigate the association between SCD/SCT, hearing impairment and HRQoL. Participants will be divided into two groups: a cohort and a control group. Hearing levels will be assessed through audiometric assessments and categorised by type and severity of hearing impairments using WHO classifications. HRQoL will also be assessed using WHO Disability Assessment Schedule 2.0. Statistical analyses will be performed using the SAS V.9.4, with parametric or non-parametric analysis depending on the distribution. Relationship between key variables will be determined via correlational tests, χ2, Fisher's exact test and multivariable logistic regression analyses. ETHICS AND DISSEMINATION: The proposal has been fully reviewed and registered by the University of Cape Town's Faculty of Health Sciences Human Research Ethics Committee (HREC REF 228/2022) and the University of Abuja Teaching Hospital Human Research Ethics Committee (HREC/PR/2020/08/007). Information dissemination will be through conferences, peer-review publication and personal communications. The Strengthening the Reporting of Observational Studies in Epidemiology statement will be followed in writing the manuscript.

Prevalence and influencing factors of sleep disorders in patients with CRS: a protocol for systematic review and meta-analysis.

BACKGROUND: Chronic rhinosinusitis (CRS) is a common chronic disease that seriously affects patients' quality of life and imposes a heavy physical and mental burden on patients. There is growing evidence that sleep disorders are strongly associated with patients with CRS. However, there is no systematic evidence to clarify the prevalence and influencing factors of sleep disorders in patients with CRS with nasal polyps (NP) (CRSwNP) and CRS without NP (CRSsNP). For this reason, this study will systematically analyse the prevalence of sleep disorders in patients with CRSwNP and CRSsNP and explore the related influencing factors. METHODS AND ANALYSIS: We will electronically search PubMed, Web of Science, Embase, Cochrane, Ovid, Scopus, the China National Knowledge Infrastructure, the Wanfang database, the China Biomedical Literature Database and the China Scientific Journals Database from the establishment of the database to September 2023 to collect the prevalence of sleep disorders in patients with CRSwNP or CRSsNP and related studies on factors affecting sleep disorders. Two researchers will independently conduct literature screening and data extraction and evaluate the quality of the included studies using the Newcastle-Ottawa Quality Scale and Agency for Healthcare Research and Quality scales. The extracted data will be meta-analysed using Review Manager 5.3 and Stata 14.0 software, and the quality of the evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation. Publication bias will be assessed using the funnel plots, Egger's test and Begg's test. ETHICS AND DISSEMINATION: This review will not require ethical approval, as we will only use research data from the published documents. Our final findings will be published in a peer-reviewed, open-access journal for dissemination. PROSPERO REGISTRATION NUMBER: CRD42023446833.

Protocol for the Paediatric Otorrhoea Study (POSt): a multi-methods study to understand the burden of paediatric otorrhoea in the UK.

INTRODUCTION: Paediatric otorrhoea (PO) refers to the leakage of fluid through a perforation in the ear drum, resulting from an infection of the middle ear of a child or young person (CYP). PO frequently results in hearing loss which may lead to developmental delay, restricted communication and reduced educational attainment.Epidemiological information for PO is largely derived from low-income countries. The aim of this study will be to establish the incidence of PO within the UK and to understand the impact of PO on CYP and their families' everyday lives. It will build the foundations for a randomised controlled trial investigating the best antibiotic treatment for PO. METHODS AND ANALYSIS: The study will consist of two work packages. (1) Data from the Clinical Practice Research Datalink (CPRD), January 2005 to July 2021, will be used to determine the incidence of patient presentations with PO to primary care in the UK. It will also explore the current antimicrobial prescribing practice for PO in primary care. (2) Thirty semi-structured interviews will be conducted from 13 July to 31 October 2023 with CYP and their parents/carers to help identify the impact of PO on everyday life, the patient journey and how service users define treatment success. Three medical professional focus groups will be used to understand the current management practice, how treatment success is measured and acceptability to randomise patients. Thematic analysis will be used. ETHICS AND DISSEMINATION: The Health Research Authority, The Health and Social Care Research Ethics Committee (23/NI/0082) and the CPRD's research data governance panel (22_002508) reviewed this study. Results will be disseminated at medical conferences, in peer-reviewed journals and via social media. The study will cocreate a webpage on healthtalk.org, with the Dipex Charity, about PO to ensure members of the public can learn more about the condition. TRIAL REGISTRATION NUMBER: ISRCTN46071200.

Juvenile Ossifying Fibroma and Socioeconomic Barriers to Specialty Care: A Pediatric Case Study.

Juvenile ossifying fibroma (JOF) is a rare benign neoplastic fibro-osseous tumor commonly found in the maxilla and mandible of children usually between the ages of five and 15. Patients often present with aggressive, painless growth which is well demarcated from surrounding bone resulting in severe facial asymmetry. JOFs have high recurrence rates if not completely resected and should therefore be treated by a multidisciplinary team of physicians including a neurosurgeon to assess cranial nerve function. This case describes a child who presented to the ED after being referred by his primary care provider for facial swelling. The patient was diagnosed with JOF and had a delay in care due to a lack of access to multidisciplinary specialties to provide care due to payer difficulties which placed the patient at high risk of complications.

Impact of the COVID-19 pandemic on paediatric otolaryngology: a nationwide study.

Objective: The COVID-19 pandemic profoundly modified the work routine in healthcare; however, its impact on the field of paediatric otorhinolaryngology (ORL) has been rarely investigated. The aim of this study was to assess the impact of COVID-19 on paediatric ORL. Methods: A questionnaire was developed by the Young Otolaryngologists of the Italian Society of ORL-Head and Neck Surgery (GOS). The questionnaire consisted of 26 questions related to workplace and personal paediatric ORL activities. The link was advertised on the official social media platforms and sent by e-mail to 469 Italian otolaryngologists. Results: The questionnaire was completed by 118 responders. During the pandemic, the main reduction was observed for surgical activity (78.8%), followed by outpatient service (16.9%). The conditions that were mostly impacted by a delayed diagnosis were respiratory infections in 45.8% of cases and sensorineural hearing loss in 37.3% of cases. Conclusions: Paediatric ORL was highly impacted by the COVID-19 pandemic, with a significant reduction of surgical and outpatient activities and a delay in time-sensitive diagnosis. Therefore, the implementation of new strategies, such as telemedicine, is recommended.

Children using a unilateral cochlear implant and contralateral hearing aid: bimodal hearing outcomes when one ear is outside the UK (NICE 2009) audiological criteria for cochlear implantation - a single site case-control study.

INTRODUCTION: In the new revised National Institute for Health & Care Excellence (NICE, TA566, 2019) guidelines for cochlear implantation (CI) have clearly stipulated that the hearing loss must be bilateral. Prior to this revision, children and young people (CYP) with asymmetrical thresholds have been considered for unilateral CI when one ear was in audiological criteria. Children with asymmetrical hearing loss represent an important cohort of potential CI candidates, who will continue to be prevented from benefiting from CI unless evidence is produced to support implantation and maximise subsequent benefit.The aim of this study is to evaluate the 'real-life' hearing performance in a group of children who have received a unilateral CI and who have hearing thresholds in the contralateral ear that are outside the current UK NICE 2019 audiological criteria for CI. The contralateral ear will be aided using a conventional hearing aid (HA). The outcomes from this 'bimodal' group will be compared with a group of children who have received bilateral CI, and a group of children using bilateral HA, to extend the current knowledge about the different performance levels between bilateral CI, bilateral HA and bimodal hearing in CYP. METHODS AND ANALYSIS: Thirty CYP aged 6-17 years old, 10 bimodal users, 10 bilateral HA users and 10 bilateral cochlear implant users will be subjected to a test battery consisting of: (1) spatial release from masking, (2) complex pitch direction discrimination, (3) melodic identification, (4) perception of prosodic features in speech and (5) TEN test. Subjects will be tested in their optimal device modality. Standard demographic and hearing health information will be collected. In the absence of comparable published data to power the study, sample size was determined on pragmatic grounds. Tests are exploratory and for hypothesis generating purposes. Therefore, the standard criterion of p<0.05 will be used. ETHICS AND DISSEMINATION: This has been approved by the Health Research Authority and NHS REC within the UK (22/EM/0104). Industry funding was secured via a competitive researcher-led grant application process. Trial results will be subject to publication according to the definition of the outcome presented in this protocol.

'Real-life' benefit of hearing preservation cochlear implantation in the paediatric population: a single-site case-control study.

INTRODUCTION: Cochlear implantation with hearing preservation (HPCI) has allowed a cochlear implant (CI) electrode to be implanted while trying to preserve residual acoustic low-frequency hearing. The concept arises from the importance of this low-frequency information and the limitations of a CI in several auditory domains. The combination of electrical hearing with either preserved acoustic hearing or amplified 'natural' hearing has the potential to address these issues and enable children with HPCI to closely follow normal auditory development.The aim of this study is to evaluate the 'real-life' benefit of preserved acoustic low-frequency hearing in children with a CI, understand the benefits of preserved natural hearing in complex listening situations and so enable parents and children to make an informed choice about implantation. Ultimately, helping to ensure the maximum number of children benefit from this life-changing intervention. METHODS AND ANALYSIS: Nineteen ears in children and young people aged 6-17 years old with 'successful' HPCI will be subjected to a test battery consisting of: (1) spatial release from masking; (2) complex pitch direction discrimination; (3) melodic identification; (4) perception of prosodic features in speech and (5) threshold equalising noise test. Subjects will be tested in the electro-acoustic stimulation (EAS)/electro-natural stimulation (ENS) and the electric-only (ES) condition, thereby acting as their own control group. Standard demographic and hearing health information will be collected. In the absence of comparable published data to power the study, sample size was determined on pragmatic grounds. Tests are exploratory and for hypothesis-generating purposes. Therefore, the standard criterion of p<0.05 will be used. ETHICS AND DISSEMINATION: This study has been approved by the Health Research Authority and NHS Research Ethics Committee (REC) within the UK (22/EM/0017). Industry funding was secured via a competitive researcher-led grant application process. Trial results will be subject to publication according to the definition of the outcome presented in this protocol.

Effectiveness and costs of a low-threshold hearing screening programme (HörGeist) for individuals with intellectual disabilities: protocol for a screening study.

INTRODUCTION: Individuals with intellectual disabilities (ID) often suffer from hearing loss, in most cases undiagnosed or inappropriately treated. The implementation of a programme of systematic hearing screening, diagnostics, therapy initiation or allocation and long-term monitoring within the living environments of individuals with ID (nurseries, schools, workshops, homes), therefore, seems beneficial. METHODS AND ANALYSIS: The study aims to assess the effectiveness and costs of a low-threshold screening programme for individuals with ID. Within this programme 1050 individuals with ID of all ages will undergo hearing screening and an immediate reference diagnosis in their living environment (outreach cohort). The recruitment of participants in the outreach group will take place within 158 institutions, for example, schools, kindergartens and places of living or work. If an individual fails the screening assessment, subsequent full audiometric diagnostics will follow and, if hearing loss is confirmed, initiation of therapy or referral to and monitoring of such therapy. A control cohort of 141 participants will receive an invitation from their health insurance provider via their family for the same procedure but within a clinic (clinical cohort). A second screening measurement will be performed with both cohorts 1 year later and the previous therapy outcome will be checked. It is hypothesised that this programme leads to a relevant reduction in the number of untreated or inadequately treated cases of hearing loss and strengthens the communication skills of the newly or better-treated individuals. Secondary outcomes include the age-dependent prevalence of hearing loss in individuals with ID, the costs associated with this programme, cost of illness before-and-after enrolment and modelling of the programme's cost-effectiveness compared with regular care. ETHICS AND DISSEMINATION: The study has been approved by the Institutional Ethics Review Board of the Medical Association of Westphalia-Lippe and the University of Münster (No. 2020-843 f-S). Participants or guardians will provide written informed consent. Findings will be disseminated through presentations, peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: DRKS00024804.

Associations between autistic traits and early ear and upper respiratory signs: a prospective observational study of the Avon Longitudinal Study of Parents and Children (ALSPAC) geographically defined childhood population.

OBJECTIVE: To determine whether early ear and upper respiratory signs are associated with the development of high levels of autistic traits or diagnosed autism. DESIGN: Longitudinal birth cohort: Avon Longitudinal Study of Parents and Children (ALSPAC). SETTING: Area centred on the city of Bristol in Southwest England. Eligible pregnant women resident in the area with expected date of delivery between April 1991 and December 1992 inclusive. PARTICIPANTS: 10 000+ young children followed throughout their first 4 years. Their mothers completed three questionnaires between 18-42 months recording the frequency of nine different signs and symptoms relating to the upper respiratory system, as well as ear and hearing problems. OUTCOME MEASURES: Primary-high levels of autism traits (social communication, coherent speech, sociability, and repetitive behaviour); secondary-diagnosed autism. RESULTS: Early evidence of mouth breathing, snoring, pulling/poking ears, ears going red, hearing worse during a cold, and rarely listening were associated with high scores on each autism trait and with a diagnosis of autism. There was also evidence of associations of pus or sticky mucus discharge from ears, especially with autism and with poor coherent speech. Adjustment for 10 environmental characteristics made little difference to the results, and substantially more adjusted associations were at p<0.001 than expected by chance (41 observed; 0.01 expected). For example, for discharge of pus or sticky mucus from ears the adjusted odds ratio (aOR) for autism at 30 months was 3.29 (95% CI 1.85 to 5.86, p<0.001), and for impaired hearing during a cold the aOR was 2.18 (95% CI 1.43 to 3.31, p<0.001). CONCLUSIONS: Very young children exhibiting common ear and upper respiratory signs appear to have an increased risk of a subsequent diagnosis of autism or demonstrated high levels of autism traits. Results suggest the need for identification and management of ear, nose and throat conditions in autistic children and may provide possible indicators of causal mechanisms.

Congenital Laryngeal Cyst as a Rare Cause of Stridor in Infants: Two Case Reports.

Congenital laryngeal cysts are a rare cause of stridor in infants. These cysts may have serious clinical implications if not promptly recognized. A small laryngeal cyst may remain asymptomatic. However, if large, it can block the laryngeal inlet leading to acute airway obstruction, which is potentially life-threatening. In pediatric patients presenting with respiratory distress, prompt diagnosis and surgical management are crucial to avoid infant morbidity and mortality. We describe two cases of laryngeal vallecular cysts in infants and their management in our clinical practice.

Effectiveness of analgesic ear drops as add-on treatment to oral analgesics in children with acute otitis media: study protocol of the OPTIMA pragmatic randomised controlled trial.

INTRODUCTION: Ear pain is the most prominent symptom of childhood acute otitis media (AOM). To control the pain and reduce reliance on antibiotics, evidence of effectiveness for alternative interventions is urgently needed. This trial aims to investigate whether analgesic ear drops added to usual care provide superior ear pain relief over usual care alone in children presenting to primary care with AOM. METHODS AND ANALYSIS: This is a pragmatic, two-arm, individually randomised, open, superiority trial with cost-effectiveness analysis and nested mixed-methods process evaluation in general practices in the Netherlands. We aim to recruit 300 children aged 1-6 years with a general practitioner (GP) diagnosis of AOM and ear pain. Children will be randomly allocated (ratio 1:1) to either (1) lidocaine hydrochloride 5 mg/g ear drops (Otalgan) one to two drops up to six times daily for a maximum of 7 days in addition to usual care (oral analgesics, with/without antibiotics); or (2) usual care. Parents will complete a symptom diary for 4 weeks as well as generic and disease-specific quality of life questionnaires at baseline and 4 weeks. The primary outcome is the parent-reported ear pain score (0-10) over the first 3 days. Secondary outcomes include proportion of children consuming antibiotics, oral analgesic use and overall symptom burden in the first 7 days; number of days with ear pain, number of GP reconsultations and subsequent antibiotic prescribing, adverse events, complications of AOM and cost-effectiveness during 4-week follow-up; generic and disease-specific quality of life at 4 weeks; parents' and GPs' views and experiences with treatment acceptability, usability and satisfaction. ETHICS AND DISSEMINATION: The Medical Research Ethics Committee Utrecht, the Netherlands, has approved the protocol (21-447/G-D). All parents/guardians of participants will provide written informed consent. Study results will be submitted for publication in peer-reviewed medical journals and presented at relevant (inter)national scientific meetings. TRIAL REGISTRATION: The Netherlands Trial Register: NL9500; date of registration: 28 May 2021. At the time of publication of the study protocol paper, we were unable to make any amendments to the trial registration record in the Netherlands Trial Register. The addition of a data sharing plan was required to adhere to the International Committee of Medical Journal Editors guidelines. The trial was therefore reregistered in ClinicalTrials.gov (NCT05651633; date of registration: 15 December 2022). This second registration is for modification purposes only and the Netherlands Trial Register record (NL9500) should be regarded as the primary trial registration.

Listening effort and downstream effects due to hearing loss in children and young people: an online quantitative questionnaire-based observational study.

INTRODUCTION: The clinical application of listening effort (LE) is challenging due to the lack of consensus regarding measuring the concept. Correlational analysis between different measuring instruments shows conditional and weak relationships, indicating they capture different dimensions of LE. Current research has suggested possible links between LE and downstream consequences such as fatigue, stress and confidence. One way to clinically measure LE would be to focus on its corollaries. Further research is needed to explore whether tools used to measure these downstream effects can be applied to capture LE. This study explores using existing questionnaire-based outcome instruments to evaluate LE and its associated consequences in children and young people (CYP), with and without hearing loss. METHODS AND ANALYSIS: One hundred CYP aged 12-17 years with normal hearing and a range of hearing loss levels will be invited to complete a series of online questionnaires (Speech, Spatial and Qualities, Vanderbilt Fatigue Scale-Child, Perceived Stress Scale and Rosenberg Self-Esteem Scale) and a hearing test (Digits in Noise). They will complete the questionnaires at two time points (1) at the end of a rest day and (2) at the end of a workday. Standard demographic and hearing health information will be collected. The sample size was determined pragmatically due to a lack of comparable published data to power the study. Tests are exploratory and for generating hypotheses; therefore, the standard criterion of p<0.05 will be used. ETHICS AND DISSEMINATION: This study has been reviewed within the funding organisation (Cochlear Research and Development Limited) by an independent and relevant peer reviewer/committee. This study has had a favourable ethics committee review by both NHS ethics and University of Manchester ethics. The study will be disseminated through newsletters, publication and presentations at conferences. The results will be made available to participants on request.

Providing care for children with tracheostomies: a qualitative interview study with parents and health professionals.

OBJECTIVES: To explore the experience of caring for children with tracheostomies from the perspectives of parents and health professional caregivers. DESIGN: Qualitative semistructured interview study. SETTING: One region in England covered by a tertiary care centre that includes urban and remote rural areas and has a high level of deprivation. PARTICIPANTS: A purposive sample of health professionals and parents who care for children who have, or have had, tracheostomies and who received care at the tertiary care centre. INTERVENTION: Interviews undertaken by telephone or video link. PRIMARY AND SECONDARY OUTCOME MEASURES: Qualitative reflexive thematic analysis with QSR Nvivo 12. RESULTS: This paper outlines key determinants and mediators of the experiences of caregiving and the impact on psychological and physical health and quality of life of parents and their families, confidence of healthcare providers and perceived quality of care. For parents, access to care packages and respite care at home as well as communication and relationships with healthcare providers are key mediators of their experience of caregiving, whereas for health professionals, an essential influence is multidisciplinary team working and support. We also highlight a range of challenges focused on the shared care space, including: a lack of standardisation in access to different support teams, care packages and respite care, irregular training and updates, and differences in health provider expertise and experiences across departments and shift patterns, exacerbated in some settings by limited contact with children with tracheostomies. CONCLUSIONS: Understanding the experiences of caregiving can help inform measures to support caregivers and improve quality standards. Our findings suggest there is a need to facilitate further standardisation of care and support available for parent caregivers and that this may be transferable to other regions. Potential solutions to be explored could include the development of a paediatric tracheostomy service specification, increasing use of paediatric tracheostomy specialist nurse roles, and addressing the emotional and psychological support needs of caregivers.