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Novel hearing therapeutics are rapidly progressing along the innovation pathway and into the clinical trial domain. Because these trials are new to the hearing community, they come with challenges in terms of trial design, regulation and delivery. In this paper, we address the key scientific and operational issues and outline the opportunities for interdisciplinary and international collaboration these trials offer. Vital to the future successful implementation of these therapeutics is to evaluate their potential for adoption into healthcare systems, including consideration of their health economic value. This requires early engagement with all stakeholder groups along the hearing innovation pathway. • Novel hearing loss therapies are rapidly progressing along the translational pathway. • To develop precision medicine for inner ear disorders, precision diagnosis is needed. • There is an urgent need for large-scale genotype–phenotype studies. • Clinical trials capability and capacity must increase in line with this growing field. • For implementation, it is vital to consider health economics and service impact. [ABSTRACT FROM AUTHOR]

Objectives: To investigate the predictors of general practitioner (GP) consultation and antibiotic use in those developing sore throat.Methods: We conducted a prospective population-based cohort study on 4461 participants in two rounds (2010-11) from 1897 households.Results: Participants reported 2193 sore throat illnesses, giving a community sore throat incidence of 1.57/ person-year. 13% of sore throat illnesses led to a GP consultation and 56% of these consultations led to antibiotic use. Participants most likely to have sore throats included women and children (e.g. school compared with retirement age); adjusted incidence rate ratio (aIRR) of 1.33 and 1.52, respectively. Participants with sore throat were more likely to consult their GP if they were preschool compared with retirement age [adjusted OR (aOR) 3.22], had more days of sore throat (aOR 1.11), reported more severe pain (aOR 4.24) or reported fever (aOR 3.82). Antibiotics were more often used by chronically ill individuals (aOR 1.78), those reporting severe pain (aOR 4.14), those reporting fever (aOR 2.58) or children with earache (aOR 1.85). Among those who consulted, males and adults who reported feeling anxious were more likely to use antibiotics; aOR 1.87 and 5.36, respectively.Conclusions: Only 1 in 10 people who have a sore throat see a doctor and more than half of those attending get antibiotics. Further efforts to curb antibiotic use should focus on reducing initial GP consultations through public information promoting safe self-management, targeted at groups identified above as most likely to attend with sore throats. [ABSTRACT FROM AUTHOR]

Background The surgical insertion of Ventilation Tubes (VTs) for the management of persistent bilateral Otitis Media with Effusion (OME) in children remains a contentious issue due to the varying opinions regarding the risks and benefits of this procedure. The aim of this study was to evaluate the economic impact of VTs insertion for the management of persistent bilateral OME in children, providing an additional perspective on the management of one of the commonest medical conditions of childhood. Methods A decision-tree model was constructed to assess the cost-effectiveness of VTs strategy compared with the Hearing Aids (HAs) alone and HAs plus VTs strategies. The model used data from published sources, and assumed a 2-year time horizon and UK NHS perspective for costs. Outcomes were computed as Quality-Adjusted Life-Years (QALYs) by attaching a utility value to the total potential gains in Hearing Level in decibels (dBHL) over 12 and 24 months. Modelling uncertainty in the specification of decision-tree probabilities and QALYs was performed through Monte Carlo simulation. Expected Value of Perfect Information (EVPI) and partial EVPI (EVPPI) analyses were conducted to estimate the potential value of future research and uncertainty associated with the key parameters. Results The VTs strategy was more effective and less costly when compared with the HAs plus VTs strategy, while the incremental cost-effectiveness ratio for the VTs strategy compared with the HAs strategy was £5,086 per QALY gained. At the willingness-to-pay threshold of £20,000 per QALY, the probability that the VTs strategy is likely to be more cost-effective was 0.58. The EVPI value at population level of around £9.5 million at the willingness-to-pay threshold of £20,000 indicated that future research in this area is potentially worthwhile, while the EVPPI analysis indicated considerable uncertainty surrounding the parameters used for computing the QALYs for which more precise estimates would be most valuable. Conclusions The VTs strategy is a cost-effective option when compared with the HAs alone and HAs plus VTs strategies, but the need for additional information from future study is evident to inform this surgical treatment choice. Future studies of surgical and non-surgical treatment of OME in childhood should evaluate the economic impact of pertinent interventions to provide greater context. [ABSTRACT FROM AUTHOR]

In this study the reliability and validity of generic and disease-specific questionnaires has been assessed focusing on responsiveness. This is part of a study on the effects of recurrent acute otitis media (rAOM) on functional health status (FHS) and health-related quality of life (HRQoL) in 383 children with rAOM participating in a randomized clinical trial. The following generic questionnaires were studied: 1. RAND general health rating index, 2. Functional Status Questionnaire (FSQ Generic and FSQ Specific), 3. TNO-AZL Infant Quality of Life (TAIQOL), and the following disease-specific questionnaires: 1. Otitis Media-6 (OM-6), 2. Numerical rating scales (NRS) for child and caregiver (NRS Child and NRS Caregiver), and 3. a new Family Functioning Questionnaire (FFQ). Reliability was good to excellent (Cronbach’s α range 0.80–0.90, intraclass correlation coefficient range 0.76–0.93). Moderate to strong correlations were found between the questionnaires as well as between questionnaires and relevant clinical indicators ( r = 0.29–0.49), demonstrating construct validity. Discriminant validity for children with few versus frequent episodes of acute otitis media per year was good for most questionnaires ( P < 0.004) but poor for the otitis media-related subscales of the TAIQOL ( P = 0.10–0.97) and both NRS ( P = 0.22 and 0.48). Except for the TAIQOL subscales, change scores were significant ( P < 0.003) for generic and disease-specific questionnaires. Effect sizes were somewhat higher for disease-specific compared to generic questionnaires (0.55–0.95 versus 0.32–0.60) except for the TAIQOL subscales, which showed very poor sensitivity to change. Anchor-based methods resulted in a somewhat larger range of estimates of MCID than distribution-based methods. Combining distribution-based and anchor-based methods resulted in similar ranges for the minimally clinical important differences for generic and disease-specific questionnaires: 2–15 points on a 0–100 scale. Apart from the generic TAIQOL subscales, both generic and disease-specific questionnaires used in this study showed good psychometric qualities and responsiveness for use in clinical studies on children with rAOM. [ABSTRACT FROM AUTHOR]

Background: Current opinions regarding the management of acute otitis media (AOM) in children vary across Western countries. With antibiotic resistance rising and more evidence regarding the limited clinical efficacy of antibiotics becoming available, interest in managing AOM other than with antibiotics is renewed. Objectives: To compare international rates of antibiotic prescription and surgery for AOM. To provide current evidence regarding the efficacy of various treatment options for AOM and their potential complications. Methods: Qualitative (narrative) review. Results: The percentage of patients given antibiotics for AOM varies from 31% in The Netherlands to more than 90% in most other Western countries. The 1998 prevalence of penicillin-resistant S. pneumoniae strains, on the other hand, ranges from 3% in The Netherlands to 53% in France. The surgical rate for tympanostomy tubes varies from 2 per 1000 children per year in the United Kingdom to 20 per 1000 in The Netherlands. The benefit of both antibiotic and surgical therapy in AOM appears to be limited, with numbers needed to treat ranging from 8 to 25 for antibiotic therapy, depending on the definition of outcome. Conclusions: International rates of antibiotic prescription and surgery for AOM vary strongly, which can be explained largely by the lack of uniform evidence-based guidelines. International debates with the aim of overcoming cultural differences regarding the management of otitis media, and of reaching agreement on guidelines on the basis of current evidence are necessary. [Copyright &y& Elsevier]

Background: Although primarily considered a childhood disease, acute otitis media (AOM) also occurs in adults. Data on the burden of this condition in adults are, however, scarce.Objective: To explore the primary care incidence and current management of AOM in adults.Methods: All patients aged 15 and older included in the routine health care database of the Julius General Practitioners' Network were followed from 2015 to 2018 (contributing to a total of 1 261 575 person-years). We extracted data on AOM episodes, AOM-related consultations, comorbidities, and antibiotic and analgesic prescriptions.Results: Five thousand three hundred and fifty-eight patients experienced one or more AOM episodes (total number of AOM episodes: 6667; mean 1.2 per patient). The overall AOM incidence was 5.3/1000 person-years and was fairly stable over the study period. Incidence was particularly high in atopic patients (7.3/1000 person-years) and declined with age (from 7.1 in patients 15-39 years of age to 2.7/1000 person-years in those aged 64 years and older). Oral antibiotics, predominantly amoxicillin, were prescribed in 46%, and topical antibiotics in 21% of all episodes.Conclusion: Over the past years, the incidence of AOM in adults in primary care has been stable. Oral antibiotic prescription rates resemble those in children with AOM, whereas a remarkably high topical antibiotic prescription rate was observed. Future prognostic research should inform on the need and feasibility of prospective studies into the best management strategy in this condition. [ABSTRACT FROM AUTHOR]

Recent breakthroughs in our understanding of sensorineural hearing loss etiology have encouraged the identification of novel hearing therapeutics, paving the way for precision hearing medicine. Critical to this field is the curation of health resources on hearing data. A systematic review of the literature was conducted to map existing (inter)national and regional datasets that include hearing data to inform the development of future hearing repositories. Systematic literature review was performed adhering to Preferred Reporting Items for Systematic Review and Meta-Analysis recommendations. Databases, including those from gray literature, were searched to identify publications reporting on phenotypic and/or genotypic hearing data in May 2019. The databases reviewed were Medline, PubMed, Embase databases, and Google Scholar. Publications on local datasets were excluded. All hearing datasets identified in the screening process were noted. For each dataset, geography, context, objective, period of time run, numbers and demographics of participants, genomic data, hearing measures and instruments used were extracted and cataloged. One hundred and eighty-eight datasets were identified, containing hearing data on populations ranging from 100 to 1.39 million individuals, and all extracted data have been cataloged. This searchable resource has been made accessible online. This unique catalog provides an overview of existing datasets that contain valuable information on hearing. This can be used to inform the development of national and international patient data repositories for hearing loss and guide strategic collaboration between key stakeholder groups, pivotal to the delivery and development of sensorineural hearing loss precision diagnostics and treatments. [ABSTRACT FROM AUTHOR]

Background: For unclarified reasons, parents tend to be cautious about administering analgesics to their children, potentially leading to suboptimal management of AOM symptoms. We aim to understand parents' views and expectations of pain management in acute otitis media (AOM) in children. Methods: Qualitative study alongside a cluster-randomised controlled trial (PIM-POM study) aimed at optimising pain management in childhood AOM. We purposefully sampled 14 parents of children diagnosed with AOM by their GP, who were recruited to the trial between November 2017 and May 2018. Semi-structured interviews were held at home in the first two weeks after trial enrollment. Interviews were audio-recorded, transcribed and analyzed thematically. Results: Parents experienced difficulties in recognising earache and other symptoms of an ear infection. They consulted the GP for a diagnosis, for reassurance and for management advice. Parents shared that, prior to consultation, they had insufficient knowledge of the benefits of correctly dosed pain medication at regularly scheduled intervals. Parents valued the GP's advice on pain management, and were happy to accept pain medication as standalone therapy, provided that the GP explained why antibiotics would not be needed. Parents' views and expectations of pain management in AOM were shaped by previous experiences of AOM within their family; those with a positive experience of pain medication are more likely to use it in subsequent AOM episodes. Conclusions: Parents of children with AOM consult the GP to help cope with uncertainties in recognising symptoms of AOM, and to receive management advice. It is important that GPs are aware of parents' lack of understanding of the role of pain medication in managing AOM, and that they address this during the consultation. Trial registration: Netherlands Trial Register, identifier NTR4920 (registration date: 19 December 2014). [ABSTRACT FROM AUTHOR]

Background midlife hearing loss is a potentially modifiable risk factor for dementia. Addressing comorbid hearing loss and cognitive impairment in services for older adults may offer opportunities to reduce dementia risk. Objective to explore current practice and views amongst UK professionals regarding hearing assessment and care in memory clinics and cognitive assessment and care in hearing aid clinics. Methods national survey study. Between July 2021 and March 2022, we distributed the online survey link via email and via QR codes at conferences to professionals working in National Health Service (NHS) memory services and audiologists working in NHS and private adult audiology services. We present descriptive statistics. Results 135 professionals working in NHS memory services and 156 audiologists (68% NHS, 32% private sector) responded. Of those working in memory services, 79% estimate that >25% of their patients have significant hearing difficulties; 98% think it useful to ask about hearing difficulties and 91% do so; 56% think it useful to perform a hearing test in clinic but only 4% do so. Of audiologists, 36% estimate that >25% of their older adult patients have significant memory problems; 90% think it useful to perform cognitive assessments, but only 4% do so. Main barriers cited are lack of training, time and resources. Conclusions although professionals working in memory and audiology services felt addressing this comorbidity would be useful, current practice varies and does not generally address it. These results inform future research into operational solutions to integrating memory and audiology services. [ABSTRACT FROM AUTHOR]

An abstract of the "A Randomized Trial of Adenotonsillectomy for Childhood Sleep Apnea," by C. L. Marcus et al. in the 2013 issue of the "New England Journal of Medicine" is presented.

Background: The surgical insertion of Ventilation Tubes (VTs) for the management of persistent bilateral Otitis Media with Effusion (OME) in children remains a contentious issue due to the varying opinions regarding the risks and benefits of this procedure. The aim of this study was to evaluate the economic impact of VTs insertion for the management of persistent bilateral OME in children, providing an additional perspective on the management of one of the commonest medical conditions of childhood.Methods: A decision-tree model was constructed to assess the cost-effectiveness of VTs strategy compared with the Hearing Aids (HAs) alone and HAs plus VTs strategies. The model used data from published sources, and assumed a 2-year time horizon and UK NHS perspective for costs. Outcomes were computed as Quality-Adjusted Life-Years (QALYs) by attaching a utility value to the total potential gains in Hearing Level in decibels (dBHL) over 12 and 24 months. Modelling uncertainty in the specification of decision-tree probabilities and QALYs was performed through Monte Carlo simulation. Expected Value of Perfect Information (EVPI) and partial EVPI (EVPPI) analyses were conducted to estimate the potential value of future research and uncertainty associated with the key parameters.Results: The VTs strategy was more effective and less costly when compared with the HAs plus VTs strategy, while the incremental cost-effectiveness ratio for the VTs strategy compared with the HAs strategy was £ 5,086 per QALY gained. At the willingness-to-pay threshold of £ 20,000 per QALY, the probability that the VTs strategy is likely to be more cost-effective was 0.58. The EVPI value at population level of around £ 9.5 million at the willingness-to-pay threshold of £ 20,000 indicated that future research in this area is potentially worthwhile, while the EVPPI analysis indicated considerable uncertainty surrounding the parameters used for computing the QALYs for which more precise estimates would be most valuable.Conclusions: The VTs strategy is a cost-effective option when compared with the HAs alone and HAs plus VTs strategies, but the need for additional information from future study is evident to inform this surgical treatment choice. Future studies of surgical and non-surgical treatment of OME in childhood should evaluate the economic impact of pertinent interventions to provide greater context. [ABSTRACT FROM AUTHOR]

The authors reflect on the study titled "Incidence and clinical variables associated with streptococcal throat infections: a prospective diagnostic cohort study" by P. Little and colleagues published in a 2012 issue of the "British Journal of General Practice." Topics include diagnosis of group A β-haemolytic streptococcal (GABHS) infections in primary medical care, risks factors associated with acute sore throat patients, and limitations in diagnosing streptococcal pharyngitis.

Background: Despite recent clinical guideline development, the best pathway of care for children with symptoms of obstructive sleep-disordered breathing (oSDB) is still debated. This systematic review aims to map the research in childhood oSDB that has been conducted so far to support further guideline development, identify evidence gaps, and guide future research.Methods: A systematic search was performed in PubMed, EMBASE, and the Cochrane Library from inception to November 26, 2015. All publications on childhood oSDB were included, irrespective of type and language. The annual number of publications in the field of oSDB was counted over all years; for those published since January 1, 2011 (ie, the date of the latest literature search of the American Academy of Pediatrics guideline), total and annual numbers of publications across main research themes and methodologies were calculated.Results: Of the 7,637 unique records retrieved, 5,871 publications were eligible for inclusion. There was an increase in annual publications since 2000, with 46% published since 2011. Most publications (61%) focused on individual treatment modalities, incidence, or prognosis. Few publications (2.7%) focused on health service delivery, outcomes, and health economics. Observational studies composed 78.5% of publications, 2.4% were randomized controlled trials, and 0.4% used a qualitative approach as their main methodology.Conclusions: A recent surge in research activity into childhood oSDB has improved the knowledge base for this condition; however, the lack of health services, health economics, and outcomes research impacts the applicability of evidence informing current guidance and leaves important questions for future research.Registration: PROSPERO: registration number CRD42015029291. [ABSTRACT FROM AUTHOR]

: Objectives The aim of this study was to test the hypothesis that trimethoprim/sulfamethoxazole selects for integron-positive and multidrug-resistant Enterobacteriaceae in the intestinal flora. : Methods During 1 year of follow-up, antibiotic susceptibility and the presence of integrons were determined in faecal Enterobacteriaceae isolated from 99 children with chronic active otitis media, randomly assigned to treatment with trimethoprim/sulfamethoxazole or placebo (http://www.clinicaltrials.gov/; trial registration number NCT00189098). : Results At 6 and 12 weeks of follow-up, 32 (91%) and 24 (67%) children in the trimethoprim/sulfamethoxazole group carried trimethoprim/sulfamethoxazole-resistant Enterobacteriaceae versus 10 (21%) and 8 (17%) children in the placebo group [rate differences (RDs): 70 (95% CI: 55; 85) and 50 (95% CI: 31; 69)], respectively. Multiresistance also increased during trimethoprim/sulfamethoxazole treatment. At 6 weeks of follow-up, the integron prevalence was 26 (79%) in the trimethoprim/sulfamethoxazole group and 10 (22%) in the placebo group [RD: 57 (95% CI: 39; 75)]. After 12 weeks the integron prevalence, and after 1 year the susceptibility levels, had returned to baseline values. : Conclusions Initially, trimethoprim/sulfamethoxazole usage was strongly associated with the appearance of integron-positive (multi)drug-resistant Enterobacteriaceae in the intestinal flora. After prolonged exposure to trimethoprim/sulfamethoxazole, however, this population of Enterobacteriaceae was substituted by a population with non-integron-associated resistance mechanisms. After trimethoprim/sulfamethoxazole was discontinued, susceptibility rates to all antibiotics returned to baseline levels. [ABSTRACT FROM AUTHOR]

Presents a response by Anne G. M. Schilder, Maroeska M. Rovers, E. Henriette van den Akker, Birgit K. van Staaij, and Arno W. Hoes, to letters to the editor about their article, "Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomized controlled trial," in the September 18, 2004 issue.

We comprehensively summarized the cohort evidence to date on adult-onset hearing loss as risk factor for incident cognitive impairment and dementia, and examined the evidence for dose-response, risk for various dementia subtypes, and other moderators. Previous meta-analyses were less comprehensive. We included cohort studies with participants without dementia and with hearing assessments at baseline, minimum 2 years follow-up and incident cognitive outcomes. We used random-effect models and subgroup and meta-regression on moderator analyses. We identified fifty studies (N=1,548,754). Hearing loss (yes/no) was associated with incident dementia risk (HR=1.35 [95% CI = 1.26 – 1.45), mild cognitive impairment (MCI HR=1.29 [95% CI = 1.11 – 1.50]), cognitive decline not specified as MCI or dementia (HR=1.29 [95% CI = 1.17 – 1.42]), and Alzheimer's disease dementia (ADD, HR=1.56 [95% CI = 1.30 – 1.87]), but not with vascular dementia (HR, 1.30 [95% CI = 0.83 – 2.05]). Each 10-decibel worsening of hearing was associated with a 16% increase in dementia risk (95% CI = 1.07 – 1.27). The effect of hearing loss did not vary across potential moderators. Cohort studies consistently support that adult-onset hearing loss increases the risk of incident cognitive decline, dementia, MCI, and ADD. • We summarize evidence on adult-onset hearing loss as a risk factor for dementia. • Hearing loss increases risk of incident cognitive impairment, dementia, and Alzheimer's disease. • Risk of dementia increases by 16 % for each 10-decibel worsening of hearing. • The impact of hearing loss on dementia does not vary across dementia subtypes or other moderators. [ABSTRACT FROM AUTHOR]

Background: Flexible nasendoscopy (FNE) is an invaluable multi-disciplinary tool for upper aerodigestive tract (UADT) examination. During the COVID-19 pandemic concerns were raised that FNE had the potential of generating aerosols resulting in human cross-contamination when performed on SARS-COV2 carriers. In the UK, and other European countries, national guidelines were issued restricting FNE to essential cases. We surveyed ENT-UK members and Royal College of Speech and Language Therapists (RCSLT) members to determine the impact of the COVID-19 pandemic (first peak) on FNE practice in the UK. Methods: An observational internet-based survey constructed in accordance to the CHERRIES checklist and setup in SurveyMonkey of FNE practice amongst UK-based ENT surgeons and speech and language therapists in community clinics, the outpatient department, inpatient wards, ICU, emergency department and operating theatres (through the NHS and private sector) prior to, during and following the first COVID-19 wave in the UK. Results: 314 responses collected (24% response rate), 82% from ENT clinicians, 17% from SLTs and 1% from other allied healthcare professionals. Overall, there has been a large reduction in the volume and indications for FNE during the first peak of the COVID-19 pandemic with limited recovery by mid-August 2020. Cancer and airway assessments were impacted less. A wide range of FNE protocols influenced by local factors are reported, varying in endoscope preference, Personal Protective Equipment (PPE) and sterilization methods. Where dedicated Aerosol Generating Procedure (AGP) rooms were unavailable, clinicians resorted to window opening and variable room "down-time" between patients. Endoscope preference reflected availability and user familiarity, ENT trainees favoring the use of single-use video endoscopes. Conclusion: Despite national guidance, local practice of FNE remains interrupted and highly variable in the UK. A collaborative inter-disciplinary approach is required to re-introduce FNE safely in volume across healthcare settings, re-establishing timely endoscopic diagnosis and pre-pandemic levels of patient care. [ABSTRACT FROM AUTHOR]

Gene therapy for monogenic hearing loss is on the horizon. The first trials in patients with Auditory Neuropathy Spectrum Disorder (ANSD) due to pathogenic variants in the Otoferlin (OTOF) gene will open this year. In the UK, the new NHS Genomic Medicine Service (GMS) offers genetic testing in each child diagnosed with congenital or early onset sensorineural hearing loss. This survey study aims to map preexisting clinical pathways for the diagnosis and management of children with ANSD and identify opportunities for improvement in early identification of OTOF - related ANSD. A Google form with 24 questions in English covering the ANSD clinical pathway was developed with clinicians involved in the diagnosis and management ANSD. The survey was disseminated via email to all Lead clinicians of NHS Tertiary Paediatric Audiology and Cochlear Implant Services within the UK. Data was received from 27 (34 %) NHS Tertiary Paediatric Audiology Services and 8 (n = 57 %) Paediatric Cochlear Implant Services. Services follow existing national guidance and provide multidisciplinary care with structured patient pathways for referral, diagnosis, and management of children with ANSD and multidisciplinary input throughout. Clinicians are aware of the genetic causes of ANSD and new processes for genetic testing, but do not uniformly refer children with ANSD for testing for OTOF pathogenic variants. As such, they had difficulty estimating numbers of children with OTOF pathogenic variants under their care. Those results highlight the urgency of implementing hearing gene panel sequencing for all children with ANSD to provide opportunities for early diagnosis and candidacy for OTOF gene therapy trials. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess people's perceptions of their personal risk, population prevalence and perceived severity in relation to three key health conditions (cancer, heart disease and hearing loss), gauge the size of any misperceptions, and identify correlates of such misperceptions. This study was a cross-sectional survey. A total of 10,401 adults representative of the UK population were participated in the study. Clear majorities of people incorrectly believe that they are at greater personal risk of cancer (>75%), that cancer is more prevalent in the population (>50%) and that cancer is more disabling (>65%), than either heart disease or hearing loss. In turn, people consistently regard their personal risk of hearing loss, the population prevalence of hearing loss and the severity of hearing loss as lower than either cancer or heart disease. Multiple regression analyses showed inconsistent patterns of relationships between people's beliefs, sociodemographic characteristics and their health behaviours. Accuracy in beliefs about cancer, heart disease and hearing loss is low, and the relationships between these beliefs, their potential antecedents and consequences are complex. Policy makers should ensure close adherence to evidence or risk-making decisions that are costly both in financial terms and in terms of suboptimal population subjective well-being. [ABSTRACT FROM AUTHOR]

Objective. To determine age-specific antibiotic prescription and referral rates in preschool children diagnosed with acute respiratory tract infection (RTI) in primary care. Design. Retrospective cohort study. Setting. Research database of the Netherlands University Medical Center Utrecht Primary Care Network. Subjects. All children aged 0–5 years within the database were included, covering 1998 to 2002 (18,801 child-years). Main outcome measures. Antibiotic prescription and referral rates were determined as percentage of children with at least one prescription or referral within a year, as total number of prescriptions per 1000 child-years, and as percentage of all RTI episodes. Results. Antibiotics, mostly beta-lactam (80%) and macrolides (16%), were prescribed in 35% of RTI episodes. Annually 13% of the children received at least one antibiotic following an RTI. Antibiotics were prescribed in more than half of episodes of LRTI, sinusitis, AOM, and acute tonsillitis, and in 12–15% of episodes of asthma exacerbation, acute laryngitis, influenza acute, and acute upper respiratory infection (including common cold and pharyngitis). Almost 98% of RTIs were managed in primary care. On average 1% of the children were referred to a paediatrician or ENT specialist following RTI per year, especially after AOM (59% of referrals). Compared with older children, those under two years of age were more often treated with antibiotics (relative risk [RR] 1.4, 95% CI 1.3–1.6) and referred (RR 2.3; 95% CI 1.8–3.0). Conclusion. In the Netherlands most episodes of RTIs in preschool children were managed in primary care and this often involves prescription of antibiotics. Children younger than two years of age receive more often antibiotics for RTI and are also referred more, especially for AOM. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To develop an easily applicable prediction rule for asthma in young adulthood using childhood characteristics. Methods: A total of 1,055 out of 1,328 members of a Dutch birth cohort were followed from 2 to 21 years of age. Univariate and multivariate logistic regression analyses were used to evaluate the predictive value of childhood characteristics on asthma at 21 years of age. A prognostic function was developed, and the area under the receiving operating characteristic (ROC) curve was used to estimate the predictive ability of the prognostic models. Results: Of the 693 responding subjects, 86 (12%) were diagnosed with asthma. Independent prognostic factors at ages 2 and 4 years were female gender (odds ratios (OR) 1.9 and 2.1; 95% confidence intervals (CI) 1.2–3.2 and 1.3–2.5), smoking mother (OR 1.6 and 1.6; CI 1.0–2.7 and 1.0–2.6), lower respiratory tract illness (OR 1.9 and 2.4; CI 1.0–3.6 and 1.4–4.0), and atopic parents (OR 2.1 and 1.9; CI 1.3–3.4 and 1.2–3.1). The predictive power of both models was poor; area under ROC curve was 0.66 and 0.68, respectively. Conclusion: Asthma in young adulthood could not be predicted satisfactorily based on childhood characteristics. Nevertheless, we propose that this method is further tested as a tool to predict development of asthma. [Copyright &y& Elsevier]

Summary: Background: Opinions about otitis media (OM) as an illness and about the need for antibiotic or surgical treatment vary internationally. It is not known how this is to be explained, whether by cultural differences or by other factors, such as variation in environmental risk factors for OM. Objectives: To report on variation in environmental risk factors for OM across Western countries, and on the organisation of health care in these countries. Methods: Main environmental risk factors for OM were identified by searching Pubmed. Data on the distribution of these risk factors and the organisation of health care across countries were obtained from the OECD and WHO websites. Results: Main risk factors for OM were day-care, number of siblings, smoking, breastfeeding, birth weight, socio-economic status (SES) and air pollution. Data were available for several European countries, the United State, Canada and Australia. Large international differences were found regarding the proportion of children attending day-care (Sweden 75% versus Italy 6%) and being breastfed at age 6 months (Norway 80% versus Poland 6%), and the rate of female smokers (Germany, France and Norway 30–40% versus Portugal <10%). Conclusion: It appears that differences in risk factor exposure between populations are often overshadowed by other culturally or demographically significant factors. Attempts to discern these factors within populations and between countries may be important in the management of OM and warrants further study. [Copyright &y& Elsevier]

BACKGROUND. Reported trends regarding the incidence of otitis media and antibiotic prescription rates are inconsistent. OBJECTIVE. Our goal was to assess changes in incidence of consultation rates, antibiotic prescription, and referral rates for otitis media in children over the years 1995-2003. METHODS. A cohort study including all children aged 0 to 13 years within the research database of the Netherlands University Medical Center Utrecht Primary Care Network covering the period 1995-2003. Otitis media diagnoses were recorded according to the International Classification of Primary Care codes and antibiotic prescription according to the Anatomic Therapeutic Chemical Classification System codes. Otitis media incidence rates were calculated as episodes per 1000 person-years. Antibiotic prescription and referral rates were calculated per 100 otitis media episodes. RESULTS. From 1995 to 2003, the overall general practitioner consultation rates for acute otitis media and otitis media with effusion declined by 9% and 34%, respectively. In children aged 2 to 6 years and those aged 6 to 13 years, the incidence rates of acute otitis media and otitis media with effusion declined by 15% and 41% and 40% and 48%, respectively. In children <2 years of age, the incidence rates of acute otitis media and otitis media with effusion increased by 46% and 66%, respectively. Antibiotic prescription rates for acute otitis media and otitis media with effusion increased by 45% and 25%, respectively. The referral rate for acute otitis media did not change, whereas the referral rate for otitis media with effusion increased by 45%. CONCLUSIONS. Consultation rates for otitis media have changed considerably over the last decade, and so have antibiotic prescriptions and specialist referrals. The rising antibiotic prescription rate for otitis media causes concern, because this may induce increasing medical costs and antibiotic resistance. [ABSTRACT FROM AUTHOR]

Background. We recently showed that vaccination with a 7-valent pneumococcal conjugate vaccine (PCV7) followed by a 23-valent pneumococcal polysaccharide vaccine (PPSV23) failed to prevent new episodes of acute otitis media (AOM) in previously unvaccinated toddlers and children with a history of recurrent AOM. We describe in detail the impact of pneumococcal vaccinations on nasopharyngeal carriage of S. pneumoniae in this study population. Methods. The impact of vaccination with PCV7 followed by PPSV23 on pneumococcal nasopharyngeal carriage was studied in a prospective, randomized trial involving 383 children (age range, 1–7 years) with previous AOM. Nasopharyngeal swab specimens were collected at the time of first vaccination and at 6–7-month intervals during the 26-month follow-up period. Results. Overall, pneumococcal carriage rates did not diminish, remaining at ∼50% in both PCV7/PPSV23 and control vaccinees. A significant shift from conjugate vaccine-to nonconjugate vaccine-type pneumococci was observed in children aged 1–2 years, who received the conjugate vaccine twice before the polysaccharide vaccine was administered. Conjugate vaccine serotype carriage was not influenced in older children, who received the conjugate vaccine once before receiving the polysaccharide booster. Conclusions. The administration of conjugate vaccines at least twice also after 2 years of age may be mandatory for reducing the carriage of conjugate vaccine serotypes in children with recurrent AOM. Polysaccharide booster vaccination did not affect nasopharyngeal colonization with serotypes not included in the conjugate vaccine. [ABSTRACT FROM AUTHOR]

It is known that insertion of ventilation tubes can cause damage to the tympanic membrane and hearing deterioration in the long term. To investigate long-term effects of recurrent otitis media and of ventilation tube insertion, we used a study group (n = 358 subjects), with or without a history of otitis media and/or ventilation tube insertion, derived from a birth cohort that had been followed for 16 years. At 18 years of age, a standardized audiometric and otoscopic examination was performed. We found that ventilation tube insertion in childhood was associated with a mean persistent hearing loss in young adults of about 5 to 10 dB at the group level with a sensorineural component of 3 to 4 dB. This hearing loss could not be explained by the disease load of otitis media in childhood. Repeated insertions of ventilation tubes caused a greater deterioration of hearing than did a single insertion. Structural changes of the tympanic membrane were a mediating factor in the causal relationship between ventilation tube insertion and hearing loss. We conclude that ventilation tube insertion in childhood may induce hearing deterioration in the long term. [ABSTRACT FROM AUTHOR]

Background: Fever is an important physical sign in infectious diseases in childhood. Daily assessment of fever may be used to monitor the occurrence of infections for research purposes. The infrared tympanic membrane thermometer (ITT) seems ideal for measuring central body temperature. Its accuracy, however, is still debated, and the feasibility of daily temperature measurements with an ITT has not been described. Objective: To determine the accuracy and feasibility of daily infrared tympanic membrane temperature measurements at home. Methods: Tympanic membrane temperature was measured by the Braun Pro 3000, rectal temperature by the Omron MC 63. To establish the accuracy of the ITT, rectal and tympanic membrane temperature measurements were performed in 41 children, aged 2–10 years. To establish the feasibility of daily infrared tympanic temperature measurements at home, parents of 21 children performed daily measurements for 2 weeks. Results: With fever defined as a body temperature of ≥38.0 °C, sensitivity was 93.3%, specificity 92%, positive predictive value 87.5%, negative predictive value 95.8%, and the concordance rate 92.5%. Most of the parents found the instructions for the use of the ITT clear (93%) and the ITT easy to use (86%). During the test period of 2 weeks the technique of the tympanic membrane temperature measurements remained adequate in 93% of the parents. Conclusion: The tympanic membrane temperature measured by the Braun Pro 3000 accurately reflects rectal temperature, validly assesses the presence of fever in children, and is easy to use. The Braun ITT therefore is an adequate tool to assess fever and may be used both in a clinical setting and for research purposes. [Copyright &y& Elsevier]

Background: Within-consultation recruitment to primary care trials is challenging. Ensuring procedures are efficient and self-explanatory is the key to optimising recruitment. Trial recruitment software that integrates with the electronic health record to support and partially automate procedures is becoming more common. If it works well, such software can support greater participation and more efficient trial designs. An innovative electronic trial recruitment and outcomes software was designed to support recruitment to the Runny Ear randomised controlled trial, comparing topical, oral and delayed antibiotic treatment for acute otitis media with discharge in children. A qualitative evaluation investigated the views and experiences of primary care staff using this trial software. Methods: Staff were purposively sampled in relation to site, role and whether the practice successfully recruited patients. In-depth interviews were conducted using a flexible topic guide, audio recorded and transcribed. Data were analysed thematically. Results: Sixteen staff were interviewed, including GPs, practice managers, information technology (IT) leads and research staff. GPs wanted trial software that automatically captures patient data. However, the experience of getting the software to work within the limited and complex IT infrastructure of primary care was frustrating and time consuming. Installation was reliant on practice level IT expertise, which varied between practices. Although most had external IT support, this rarely included supported for research IT. Arrangements for approving new software varied across practices and often, but not always, required authorisation from Clinical Commissioning Groups. Conclusions: Primary care IT systems are not solely under the control of individual practices or CCGs or the National Health Service. Rather they are part of a complex system that spans all three and is influenced by semi-autonomous stakeholders operating at different levels. This led to time consuming and sometimes insurmountable barriers to installation at the practice level. These need to be addressed if software supporting efficient research in primary care is to become a reality. [ABSTRACT FROM AUTHOR]

Background: Acute otitis media (AOM) is among the most common paediatric conditions managed in primary care. Most recent estimates of the cost of AOM date from a decade ago and lack a full societal perspective. We therefore explored the societal cost of childhood AOM in the Netherlands within the setting of a trial comparing the effectiveness of an intervention aimed at educating general practitioners (GPs) about pain management in AOM compared to usual care.Methods: Economic analysis alongside a cluster randomised controlled trial conducted between February 2015 and May 2018 in 37 practices (94 GPs). In total, 224 children with AOM were included of which 223 (99%) completed the trial (intervention: n = 94; control: n = 129). The cost of AOM due to health care costs, patient and family costs, and productivity losses by parent caregivers were retrieved from study diaries and primary care electronic health records, during 28-day follow-up. We calculated mean cost (€ and $) per AOM episode per patient with standard deviations (SD, in €) regardless of study group assignment because there was no clinical effect of the trial intervention. In sensitivity analysis, we calculated cost in the intervention and usual care group, after exclusion of extreme outliers.Results: Mean total AOM cost per patient were €565.93 or $638.78 (SD €1071.01); nearly 90% of these costs were due to productivity losses experienced by parents. After exclusion of outliers, AOM cost was €526.70 or $594.50 (SD €987.96) and similar in the intervention and usual care groups: €516.10 or $582.53 (SD €949.69) and €534.55 or $603.36 (SD €920.55) respectively.Conclusions: At €566 or $639 per episode, societal cost of AOM is higher than previously known and mainly driven by productivity losses by children's parents. Considering its high incidence, AOM poses a significant economic burden that extends beyond direct medical costs.Trial Registration: Netherlands Trial Register no. NTR4920: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4920 . [ABSTRACT FROM AUTHOR]

Background: Randomised controlled trials (RCTs) are considered the 'gold standard' of medical evidence; however, recruitment can be challenging. The MACRO trial is a NIHR-funded RCT for chronic rhinosinusitis (CRS) addressing the challenge of comparing surgery, antibiotics and placebo. The embedded MACRO conversation study (MCS) used qualitative research techniques pioneered by the University of Bristol QuinteT team to explore recruitment issues during the pilot phase, to maximise recruitment in the main trial.Methods: Setting: Five outpatient Ear Nose and Throat (ENT) departments recruiting for the pilot phase of the MACRO trial (ISRCTN Number: 36962030, prospectively registered 17 October 2018). We conducted a thematic analysis of telephone interviews with 18 recruiters and 19 patients and 61 audio-recordings of recruitment conversations. We reviewed screening and recruitment data and mapped patient pathways at participating sites. We presented preliminary findings to individual site teams. Group discussions enabled further exploration of issues, evolving strategies and potential solutions. Findings were reported back to the funder and used together with recruitment data to justify progression to the main trial.Results: Recruitment in the MACRO pilot trial began slowly but accelerated in time to progress successfully to the main trial. Research nurse involvement was pivotal to successful recruitment. Engaging the wider network of clinical colleagues emerged as an important factor, ensuring the patient pathway through primary and secondary care did not inadvertently affect trial eligibility. The most common reason for patients declining participation was treatment preference. Good patient-clinician relationships engendered trust and supported patient decision-making. Overall, trial involvement appeared clearly presented by recruiters, possibly influenced by pre-trial training. The weakest area of understanding for patients appeared to be trial medications. A clear presentation of medical and surgical treatment options, together with checking patient understanding, had the potential to allay patient concerns.Conclusion: The MACRO conversation study contributed to the learning process of optimising recruitment by helping to identify and address recruitment issues. Although some issues were trial-specific, others have applicability to many clinical trial situations. Using qualitative research techniques to identify/explore barriers and facilitators to recruitment may be valuable during the pilot phase of many RCTs including those with complex designs. [ABSTRACT FROM AUTHOR]

Background: Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with orally administered antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops, or 'delayed' orally administered antibiotics, could be at least as effective and safe as immediate orally administered antibiotics for children with AOMd.Methods/design: REST is a pragmatic, three-arm, individually randomised, non-inferiority trial being conducted in 175 GP practices across the United Kingdom (UK). The study aims to recruit 399 children aged (≥ 12 months and < 16 years) presenting to their GP with AOMd. Children will be randomised to one of three arms: immediate ciprofloxacin 0.3% eardrops; delayed orally administered amoxicillin (clarithromycin if penicillin allergic) or immediate orally administered amoxicillin (clarithromycin). Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform. Integrated within the primary care electronic medical records it provides automatic eligibility checking, part-filling of e-CRFs, study workflow management and routine NHS follow-up data collection. The primary outcome is time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ). Secondary outcomes, including cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes, will be collected at day-14 and at 3 months.Discussion: It is unclear whether prescribing orally administered antibiotics to children with AOMd results in a reduction in symptoms or a shorter duration of illness. The REST trial should allow us to compare the non-inferiority of: immediate topically administered ciprofloxacin ear drops, or delayed orally administered amoxicillin (clarithromycin) against immediate orally administered amoxicillin (clarithromycin). We aim to recruit 399 patients from 175 practices in the UK. Using the TRANSFoRm software to randomise participants to the trial will enable recruitment for a relatively uncommon condition.Trial Registration: Name of Registry: ISCRTN Registration Number: ISRCTN12873692. This contains all items required to comply with the World Health Organization Trial Registration Data Set Date of Registration: 24 April 2018 Name of Registry: EudraCT Registration Number: 2017-003635-10 Date of Registration: 6 September 2017. [ABSTRACT FROM AUTHOR]

This Review outlines the development of DNA-based therapeutics for treatment of hearing loss, and in particular, considers the potential to utilize the properties of recombinant neurotrophins to improve cochlear auditory (spiral ganglion) neuron survival and repair. This potential to reduce spiral ganglion neuron death and indeed re-grow the auditory nerve fibres has been the subject of considerable pre-clinical evaluation over decades with the view of improving the neural interface with cochlear implants. This provides the context for discussion about the development of a novel means of using cochlear implant electrode arrays for gene electrotransfer. Mesenchymal cells which line the cochlear perilymphatic compartment can be selectively transfected with (naked) plasmid DNA using array - based gene electrotransfer, termed 'close-field electroporation'. This technology is able to drive expression of brain derived neurotrophic factor (BDNF) in the deafened guinea pig model, causing re-growth of the spiral ganglion peripheral neurites towards the mesenchymla cells, and hence into close proximity with cochlear implant electrodes within scala tympani. This was associated with functional enhancement of the cochlear implant neural interface (lower neural recruitment thresholds and expanded dynamic range, measured using electrically - evoked auditory brainstem responses). The basis for the efficiency of close-field electroporation arises from the compression of the electric field in proximity to the ganged cochlear implant electrodes. The regions close to the array with highest field strength corresponded closely to the distribution of bioreporter cells (adherent human embryonic kidney (HEK293)) expressing green fluorescent reporter protein (GFP) following gene electrotransfer. The optimization of the gene electrotransfer parameters using this cell-based model correlated closely with in vitro and in vivo cochlear gene delivery outcomes. The migration of the cochlear implant electrode array-based gene electrotransfer platform towards a clinical trial for neurotrophin-based enhancement of cochlear implants is supported by availability of a novel regulatory compliant mini-plasmid DNA backbone (pFAR4; plasmid Free of Antibiotic Resistance v.4) which could be used to package a 'humanized' neurotrophin expression cassette. A reporter cassette packaged into pFAR4 produced prominent GFP expression in the guinea pig basal turn perilymphatic scalae. More broadly, close-field gene electrotransfer may lend itself to a spectrum of potential DNA therapeutics applications benefitting from titratable, localised, delivery of naked DNA, for gene augmentation, targeted gene regulation, or gene substitution strategies. • Cochlear mesenchymal cells can be targeted for gene electrotransfer via electric field compression using cochlear implants. • Regeneration of cochlear peripheral neurites after neurotrophin gene augmentation via bionic array-based electrotransfer. • Local recombinant neurotrophin expression enhances neural recruitment and electrically evoked auditory brainstem responses. • Bionic array directed gene electrotransfer requires low voltages albeit higher than existing cochlear implant capabilities. • Regulatory-permissive mini-plasmids free of antibiotic resistance genes achieve efficient gene expression in the cochlea. [ABSTRACT FROM AUTHOR]

Objective: To plot the nasal cycle using unilateral peak nasal inspiratory flow (UPNIF) and unilateral minimal cross‐sectional area (UMCA) readings demonstrating a linear relationship in normal nasal function. Additionally, to determine how this changes in abnormal nasal function. Design: A cross‐sectional study measuring UPNIF and UMCA in controls demonstrating normal nasal function and in patients with nasal obstruction. Setting: Royal National Throat Nose and Ear Hospital, London. Participants: A total of 39 participants, 26 controls and 13 patients, were recruited. Controls exhibited normal nasal function with SNOT‐22 <5. Patients nasal obstruction symptoms secondary to inflammation or structural abnormality with SNOT‐22 >9. Main Outcome Measures and Results: Airflow rates and resistance values were derived from UPNIF and UMCA measurements respectively based on Poiseuille's laws. Ratios between right and left UPNIF and UMCA values were taken to adjust for confounding factors. The relationship of 1/Resistance Ratio and Airflow Rate Ratio demonstrated a linear of direct proportionality of strong correlation and statistical significance (correlation coefficient = 0.76, P « 0.01). This suggests that data points from controls with a normal nasal cycle lie closely along the regressed line, whilst those lying significantly away were shown to belong to patients with nasal dysfunction. Olfactory dysfunction appears to be a sensitive discriminator in predicting this. Conclusion: This study demonstrates the directly proportional relationship of 1/Resistance Ratio and Airflow Rate Ratio in normal nasal function. Furthermore, nasal pathology can be predicted if data points lie significantly outside these normal limits. Further studies are needed to validate exact normal and abnormal thresholds. [ABSTRACT FROM AUTHOR]

Highlights • Pneumococcal conjugate vaccination (PCV) in infancy is widely implemented globally. • PCV may impact pneumococcal AOM episodes occurring during early childhood. • Our study suggests that PCV postpones the onset and reduces the risk of first AOM. • PCV however did not affect AOM recurrences in children up to the age of four years. Abstract Background It has been hypothesized that widespread implementation of pneumococcal conjugate vaccination (PCV) in infancy reduces early AOM and thereby prevents further AOM episodes and associated health care resource use. Methods We tested this hypothesis by applying an extension of the original Cox proportional hazards model (Prentice, Williams and Petersons' total time) to individual AOM episodes recorded in pseudonymised primary care electronic health records of 18,237 Dutch children born between 2004 and 2015. Children were assigned to three groups: no-PCV (January 2004-March 2006), PCV7 (April 2006-February 2011) and PCV10 (March 2011-February 2015). Results Of the 18,237 newborns, 6967 (38%) experienced at least one GP-diagnosed AOM episode up to the age of four years (median age at first AOM: 12 months, interquartile range: 12; total number of AOM episodes: 14,689). Time-to-first AOM was longest in the PCV10 group compared with the PCV7 and no-PCV groups (log rank test: P < 0.001); in these groups 30% had experienced a first AOM at 20, 17 and 15 months, respectively. Children in the PCV10 group had a 21% lower risk of experiencing a first AOM episode than those in the no-PCV group (hazard ratio (HR): 0.79, 95% confidence interval (CI): 0.72–0.86), while the effect was less pronounced for the PCV7 group (HR: 0.94, 95% CI: 0.87–1.02). Neither PCV7 nor PCV10 reduced the risk of AOM recurrences. Compared to no-PCV, HRs for overall AOM were 1.00 (95% CI: 0.95–1.06) and 0.89 (95% CI: 0.84–0.95) for PCV7 and PCV10, respectively. Conclusion Our cohort study suggests that PCV postpones the onset and reduces the risk of first AOM without affecting recurrences. The impact of PCV on overall AOM in children up to the age of four years seems therefore largely attributable to the prevention of a first AOM episode. [ABSTRACT FROM AUTHOR]

Objectives: To scope current service provision across England for management of otitis media with effusion and hearing loss in children with Down syndrome; to explore professional decision‐making about managing otitis media with effusion and hearing loss; and to explore patient and public views on the direction of future research. Design: Mixed methods including a service evaluation of NHS clinical practice through a structured telephone survey; a qualitative study of professional decision‐making with in‐depth interviews collected and analysed using grounded theory methods; patient/public involvement consultations. Participants: Twenty‐one audiology services in England took part in the evaluation; 10 professionals participated in the qualitative study; 21 family members, 10 adults with Down syndrome and representatives from two charities contributed to the consultations. Results: There was variation across services in the frequency of routine hearing surveillance, approaches to managing conductive hearing loss in infancy and provision of hearing aids and grommets. There was variation in how professionals describe their decision‐making, reflecting individual treatment preferences, differing approaches to professional remit and institutional factors. The consultations identified that research should focus on improving practical support for managing the condition and supporting decision‐making about interventions. Conclusions: There is system‐level variation in the provision of services and individual‐level variation in how professionals make clinical decisions. As a consequence, there is inequity of access to hearing health care for children with Down syndrome. Future research should focus on developing core outcomes for research and care, and on improving decision support for families. [ABSTRACT FROM AUTHOR]

Purpose: Annual influenza immunization in medical risk groups is recommended in many countries. Recent evidence suggests that repeated inactivated influenza vaccine (IIV) immunization throughout childhood may impair long-term immunity against influenza. We assessed whether prior immunization altered the effect of IIV in children with preexisting medical conditions on primary care-diagnosed respiratory illness (RI) episodes during the influenza season.Methods: Electronic records of IIV-immunized children who met the criteria for annual IIV immunization according to Dutch guidelines were extracted from a primary care database from 2004 to 2015. For each year, we collected information on IIV immunization status, primary care-attended RI episodes (including influenza-like illness, acute RI, and asthma exacerbation), and potential confounders. Generalized estimating equations were used to model the association between prior IIV and occurrence of at least one RI episode during the influenza season, with "current year immunized but without IIV history" as reference group.Results: A total of 4,183 children (follow-up duration: 11,493 child-years) were IIV immunized at least once. Adjusted estimates showed lower odds for RI in current year-immunized children with prior IIV compared with those without (odds ratio [OR] = 0.61; 95% CI, 0.47-0.78 for "current year immunized and one IIV in previous 2 years"; OR = 0.85; 95% CI, 0.68-1.07 for "current year immunized and ≥2 IIVs in previous 3 years, including prior year").Conclusion: Repeated IIV immunization in children with preexisting medical conditions has no negative impact on, and may even increase, long-term protection against RI episodes diagnosed during the influenza season in primary care. [ABSTRACT FROM AUTHOR]

Objectives: To identify United Kingdom (UK)-specific research priorities in the field of bone conduction hearing devices (BCHDs).Method: Narrative summary of the discussions and outcomes of a UK BCHD research workshop. The workshop was organized on 8 September 2016 under the auspices of the National Institute for Health Research (NIHR) Clinical Research Network (CRN) ENT Specialty group and Royal College of Surgeons (RCS) Clinical Research Initiative. Representatives from a wide range of patient and professional groups from the UK and abroad were invited to attend. Main outcome measures were research priorities and approaches in the field of BCHDs.Results: Key research questions in the field of BCHDs are as follows: (1) What are the existing national BCHD practices? (2) What are the patient information and support needs on BCHDs? (3) Which outcomes should be measured across clinical studies in the field of BCHDs? The workshop suggested the following approaches to address these priorities: (1) a service evaluation of current UK BCHD practice; development of a national registry of BCHDs; (2) qualitative research to understand patient information and support needs; development of patient decision support tools; (3) development of core outcome sets for BCHDs.Discussion: Building upon the framework of the recent UK Research Agenda for ENT, Hearing and Balance, patients and professionals defined key UK-specific research priorities and approaches in the field of BCHDs. This approach promotes engagement, buy-in, national collaboration and thereby value of future BCHD research. [ABSTRACT FROM AUTHOR]

Objective To provide recommendations for the workup of hearing loss in the pediatric patient. Methods Expert opinion by the members of the International Pediatric Otolaryngology Group. Results Consensus recommendations include initial screening and diagnosis as well as the workup of sensorineural, conductive and mixed hearing loss in children. The consensus statement discusses the role of genetic testing and imaging and provides algorithms to guide the workup of children with hearing loss. Conclusion The workup of children with hearing loss can be guided by the recommendations provided herein. [ABSTRACT FROM AUTHOR]

Objective: Antibiotic treatment of acute otitis media (AOM) has been suggested to increase the risk of future AOM episodes by causing unfavorable shifts in microbial flora. Because current evidence on this topic is inconclusive and long-term follow-up data are scarce, we wanted to estimate the effect of antibiotic treatment for a first AOM episode occurring during infancy on AOM recurrences and AOM-related health care utilization later in life. Methods: We obtained demographic information and risk factors from data of the Wheezing Illnesses Study Leidsche Rijn, a prospective birth cohort study in which all healthy newborns born in Leidsche Rijn (between 2001 and 2012), The Netherlands, were enrolled. These data were linked to children’s primary care electronic health records up to the age of four. Children with at least one family physician-diagnosed AOM episode before the age of two were included in analyses. The exposure of interest was the prescription of oral antibiotics (yes vs no) for a child’s first AOM episode before the age of two years. Results: 848 children were included in analyses and 512 (60%) children were prescribed antibiotics for their first AOM episode. Antibiotic treatment was not associated with an increased risk of total AOM recurrences (adjusted rate ratio: 0.94, 95% CI: 0.78–1.13), recurrent AOM (≥3 episodes in 6 months or ≥4 in one year; adjusted risk ratio: 0.79, 95% CI: 0.57–1.11), or with increased AOM-related health care utilization during children’s first four years of life. Conclusions: Oral antibiotic treatment of a first AOM episode occurring during infancy does not affect the number of AOM recurrences and AOM-related health care utilization later in life. This information can be used when weighing the pros and cons of various AOM treatment options. [ABSTRACT FROM AUTHOR]

An abstract of the article "An evaluation of the NHS Clinical Commissioning Policy on Bone Anchored Hearing Aids" by Rishi Mandavia and colleagues is presented.

An abstract of the article "Key factors for developing a Successful UK-Surgical Ear Implant Registry" by Rishi Mandavia and others is presented.

Objective To provide recommendations for the comprehensive management of young infants who present with signs or symptoms concerning for laryngomalacia. Methods Expert opinion by the members of the International Pediatric Otolaryngology Group (IPOG). Results Consensus recommendations include initial care and triage recommendations for health care providers who commonly evaluate young infants with noisy breathing. The consensus statement also provides comprehensive care recommendations for otolaryngologists who manage young infants with laryngomalacia including: evaluation and treatment considerations for commonly debated issues in laryngomalacia, initial work-up of infants presenting with inspiratory stridor, treatment recommendations based on disease severity, management of the infant with feeding difficulties, post-surgical treatment management recommendations, and suggestions for acid suppression therapy. Conclusion Laryngomalacia care consensus recommendations are aimed at improving patient-centered care in infants with laryngomalacia. [ABSTRACT FROM AUTHOR]

Objectives To develop consensus recommendations for peri-operative tracheotomy care in pediatric patients. Methods Expert opinion by the members of the International Pediatric Otolaryngology Group (IPOG). The mission of the IPOG is to develop expertise-based consensus recommendations for the management of pediatric otolaryngologic disorders with the goal of improving patient care. The consensus recommendations herein represent the first publication by the group. Results Consensus recommendations including pre-operative, intra-operative, and post-operative considerations, as well as sedation and nutrition management are described. These recommendations are based on the collective opinion of the IPOG members and are targeted to (i) otolaryngologists who perform tracheotomies on pediatric patients, (ii) intensivists who are involved in the shared-care of these patients, and (iii) allied health professionals. Conclusion Pediatric peri-operative tracheotomy care consensus recommendations are aimed at improving patient-centered care in this patient population. [ABSTRACT FROM AUTHOR]

Background: Most estimates of the incidence of acute otitis media (AOM) are based on general practitioner (GP) or pediatrician diagnoses. It is likely that these figures underestimate the community incidence of AOM since parents do not visit their doctor every time their child suffers from acute ear symptoms. The impact of these symptom episodes may be substantial since they affect the child’s quality of life and parents’ productivity. Methods: To determine AOM symptoms in the community, we measured parent-reported AOM symptoms daily for 12 consecutive months in 1,260 children participating in a prospective birth cohort in the Netherlands. The mean age of these children was at study enrollment 0.9 months (standard deviation 0.6). A parent-reported AOM symptom episode was defined as fever (temperature 38˚C or above) plus at least one of the following symptoms: ear pain and ear discharge. These febrile AOM symptom episodes were linked to GP-consultations and diagnoses in the GP electronic health records. Results: With an estimated 624 parent-reported symptom episodes per 1,000 child-years (95% CI: 577 to 674) incidence of febrile AOM symptoms during the child’s first year is high. The GP was consulted in half of these symptom episodes and AOM was diagnosed in 49% of these consultations. Conclusions and Relevance: The incidence of febrile AOM symptoms in the first year of life is high in Dutch children and leads to a GP-consultation in only half of the cases. This suggests that AOM symptomatology in the community is underestimated when focusing on GP-diagnosed AOM episodes alone, since a considerable proportion of febrile AOM symptom episodes are treated symptomatically by parents at home and do not come to the attention of the GP. Having data on community AOM symptomatology available for each country is important when the potential impact of preventive and therapeutic interventions for AOM are studied. [ABSTRACT FROM AUTHOR]

The article presents a study which investigated unwarranted variation in ventilation tube insertions for otitis media with effusion in children in England. Topics include derivation of estimates using Monte Carlo simulation, expected number of children that would be expected to benefit from ventilation tubes for otitis media with effusion yearly, and the observed number of ventilation tubes for otitis media with effusion-associated diagnoses.

Antibiotics are among the most important interventions in healthcare. Resistance of bacteria to antibiotics threatens the effectiveness of treatment. Systematic reviews of antibiotic treatments often do not address resistance to antibiotics even when data are available in the original studies. This omission creates a skewed view, which emphasizes short-term efficacy and ignores the long-term consequences to the patient and other people. We offer a framework for addressing antibiotic resistance in systematic reviews. We suggest that the data on background resistance in the original trials should be reported and taken into account when interpreting results. Data on emergence of resistance (whether in the body reservoirs or in the bacteria causing infection) are important outcomes. Emergence of resistance should be taken into account when interpreting the evidence on antibiotic treatment in randomized controlled trials or systematic reviews. [ABSTRACT FROM AUTHOR]

Background Daycare attendance is an established risk factor for upper respiratory tract infections (URTI) and acute otitis media (AOM). Whether this results in higher use of healthcare resources during childhood remains unknown. We aim to assess the effect of first year daycare attendance on the timing and use of healthcare resources for URTI and AOM episodes during early childhood. Methods In the Wheezing-Illnesses-STudy-LEidsche-Rijn birth cohort, 2,217 children were prospectively followed up to age six years. Children were categorized according to first-year daycare attendance (yes versus no) and age at entry when applicable (age 0 to 2 months, 3 to 5 months and 6 to 12 months). Information on general practitioner (GP) diagnosed URTI and AOM, GP consultations, antibiotic prescriptions and specialist referral was collected from medical records. Daycare attendance was recorded by monthly questionnaires during the first year of life. Results First-year daycare attendees and non-attendees had similar total six-year rates of GPdiagnosed URTI and AOM episodes (59/100 child-years, 95% confidence interval 57 to 61 versus 56/100 child-years, 53 to 59). Daycare attendees had more GP-diagnosed URTI and AOM episodes before the age of one year and fewer beyond the age of four years than nonattendees (Pinteraction <0.001). Daycare attendees had higher total six-year rates for GP consultation (adjusted rate ratio 1.15, 1.00 to 1.31) and higher risk for specialist referrals (hazard ratio:1.43, 1.01 to 2.03). The number of antibiotic prescriptions in the first six years of life was only significantly increased among children who entered daycare between six to twelve months of age (rate ratio 1.32, 1.04 to 1.67). This subgroup of child-care attendees also had the highest overall URTI and AOM incidence rates, GP consultation rates and risk for specialist referral. Conclusions Children who enter daycare in the first year of life, have URTI and AOM at an earlier age, leading to higher use of healthcare resources compared to non-attendees, especially when entering daycare between six to twelve months. These findings emphasize the need for improved prevention strategies in daycare facilities to lower infection rates at the early ages. [ABSTRACT FROM AUTHOR]

The article presents a study on the effectiveness of antibiotic-glucocorticoid eardrops and oral antibiotics as a treatment for acute otorrhea in children with tympanostomy tubes. It discusses the methods used in the study, the duration of the initial otorrhea episode, complications and adverse events related to the treatments.

We have previously found that non-typeable Haemophilus influenzae (NTHi) collected from the middle ear of children with otitis media (OM) exhibit increased levels of complement resistance compared to NTHi collected from the nasopharynx. However, it is unknown whether bacteria develop complement resistance in the middle ear, or whether resistance is present when residing in the nasopharynx. The objective of this study was to investigate whether the levels of complement resistance of isolates collected from the middle ear were similar to those of isolates from the nasopharynx with an identical MLST type. We included 62 children with recurrent acute OM, chronic OM with effusion or acute tympanostomy tube otorrhea. NTHi was simultaneously isolated from the nasopharynx and middle ear fluid. MLST, resistance to complement-mediated killing, IgG binding, IgM binding and phosphorylcholine expression was determined. In 41 children, NTHi isolated from the middle ear and nasopharynx showed to have an identical MLST type. Isolates collected from the middle ear showed a highly similar level of complement resistance and IgM binding with isolates collected from the nasopharynx, whereas this was not the case for IgG binding and phosphorylcholine incorporation into lipooligosaccharide. Resistance to complement-mediated killing and IgM binding of NTHi isolates with an identical MLST type collected from the middle ear and nasopharynx of children with OM was highly similar. [ABSTRACT FROM AUTHOR]

Purpose: Although common in children with tympanostomy tubes, the current incidence of tympanostomy tube otorrhea (TTO) is uncertain. TTO is generally a sign of otitis media, when middle ear fluid drains through the tube. Predictors for otitis media are therefore suggested to have predictive value for the occurrence of TTO. Objective: To determine the incidence of TTO and its predictors. Methods: We performed a cohort study, using a parental web-based questionnaire to retrospectively collect data on TTO episodes and its potential predictors from children younger than 10 years of age with tympanostomy tubes. Results: Of the 1,184 children included in analyses (total duration of time since tube placement was 768 person years with a mean of 7.8 months per child), 616 children (52%) experienced one or more episodes of TTO. 137 children (12%) had TTO within the calendar month of tube placement. 597 (50%) children had one or more acute TTO episodes (duration <4 weeks) and 46 children (4%) one or more chronic TTO episodes (duration ≥4 weeks). 146 children (12%) experienced recurrent TTO episodes. Accounting for time since tube placement, 67% of children developed one or more TTO episodes in the year following tube placement. Young age, recurrent acute otitis media being the indication for tube placement, a recent history of recurrent upper respiratory tract infections and the presence of older siblings were independently associated with the future occurrence of TTO, and can therefore be seen as predictors for TTO. Conclusions: Our survey confirms that otorrhea is a common sequela in children with tympanostomy tubes, which occurrence can be predicted by age, medical history and presence of older siblings. [ABSTRACT FROM AUTHOR]

Abstract: Objective: (a) To establish whether disease-related, child-related, and physician-related factors are independently associated with specialist referral in young children with recurrent RTI, and (b) to evaluate whether general practitioners (GPs) follow current guidelines regarding these referrals. Methods: Electronic GP records of children under 24month of age, born 2002–2008, were reviewed for RTI episodes using ICPC codes. Child-related factors were extracted from the prospective WHISTLER birth-cohort in which a considerable part of children had been enrolled. To evaluate guideline adherence, referral data were compared to national guideline recommendations. Results: Consultations for 2532 RTI episodes (1041 children) were assessed. Seventy-eight children were referred for recurrent RTI (3.1% of RTI episodes; 7.5% of children). Disease factors were the main determinants of referral: number (OR 1.7 [CI 1.7–1.7]) and severity of previous RTI episodes (OR 2.2 [CI 1.6–2.8]), and duration of RTI episode (OR 1.7 [CI 1.7–1.8]). The non-disease factors daycare attendance (OR 1.3 [CI 1.0–1.7]) and 5–10 years working experience as a GP compared with <5 years (OR 0.37 [CI 0.27–0.50]) were also associated. Fifty-seven percent of referrals for recurrent RTI were made in accordance with national guidelines. Conclusions: Referral of children for recurrent RTI was primarily determined by frequency, severity, and duration of RTIs; the influence of non-disease factors was limited. Just over half of referrals were made in accordance with guidelines. [Copyright &y& Elsevier]