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Otitis media with effusion (OME) is a common childhood disease defined as the presence of liquid in the middle ear without signs or symptoms of acute ear infection. Children can be impacted mainly with hearing impairment and/or co-occurring recurrent acute otitis media (AOM) thus requiring treatment. Although many meta-analyses and national guidelines have been issued, management remains difficult to standardize, and use of surgical and medical treatments continue to vary. We convened an international consensus conference as part of the 2017 International Federation of Oto-rhino-laryngological Societies Congress, to identify best practices in OME management. Overall, regional differences were minor and consensual management was obtained on several important issues. At initial assessment, although a thorough medical examination is necessary to seek reflux, allergy or nasal obstruction symptoms; an age-appropriate auditory test is the only assessment required in children without abnormal history. Non-surgical treatments poorly address the underlying problem of an age-dependent dysfunctional Eustachian tube; auto-inflation seems to be the only beneficial, low-risk and low-cost non-surgical therapy. There was a clear international recommendation against using steroids, antibiotics, decongestants or antihistamines to treat OME, because of side-effects, cost issues and no convincing evidence of long-term effectiveness. Decisions to insert tympanostomy ventilation tubes should be based on an auditory test but also take into account the child's context and overall hearing difficulties. Tubes significantly improve hearing and reduce the number of recurrent AOM with effusion while in place. Adjuvant adenoidectomy should be considered in children over four years of age, and in those with significant nasal obstruction or infection., (Copyright © 2018 Elsevier Masson SAS. All rights reserved.)

Purpose: To investigate the statistical relationship between the OM8-30 health-related quality of life measure for children with otitis media with effusion (OME) and measures of health utility (Health Utilities Index [HUI] Mark 3 and Mark 2) and to develop models to estimate HUI3 and HUI2 health utilities from OM8-30 scores., Methods: A placebo-controlled, randomised trial (GNOME) evaluating intranasal mometasone in 217 children with OME provided concurrent responses to OM8-30 and HUI at three time points. Ordinary least squares (OLS), generalised linear models and two-step regression analyses were used to predict HUI3 and HUI2 utilities based on OM8-30 facet and domain scores., Results: OLS models including all nine OM8-30 facets with or without predicted hearing level (HL) produced the best predictions of HUI3 utilities (mean absolute error: 0.134 with HL and 0.132 without; R(2): 0.63 with HL and 0.596 without). An OLS model predicting HUI3 utilities based on the two OM8-30 domain scores, reported hearing difficulties, predicted HL, age and sex also produced accurate predictions., Conclusion: Regression equations predicting HUI3 and HUI2 utilities based on OM8-30 facet and domain scores have been developed. These provide an empirical basis for estimating quality-adjusted life years (QALYs) for interventions in children with OME.

Objective: To determine the clinical effectiveness of topical intranasal corticosteroids in children with bilateral otitis media with effusion., Design: Double blind randomised placebo controlled trial., Setting: 76 Medical Research Council General Practice Research Framework practices throughout the United Kingdom, between 2004 and 2007., Participants: 217 children aged 4-11 years who had at least one practice recorded episode of otitis media or a related ear problem in the previous 12 months, and with bilateral otitis media with effusion confirmed by a research nurse using otoscopy plus micro-tympanometry (B/B or B/C2, modified Jerger types)., Intervention: Mometasone furoate 50 microg or placebo spray given once daily into each nostril for three months., Main Outcome Measures: Proportions of children cured of bilateral otitis media with effusion assessed with tympanometry (C1 or A type) at one month (primary end point), three months, and nine months; adverse events; three month diary symptoms. Results 41% (39/96) of the topical steroid group and 45% (44/98) of the placebo group were cured in one or both ears at one month (difference favouring placebo 4.3% (95% confidence interval -9.3% to 18.1%). Poisson regression was done with adjustment for four pre-specified covariates (clinical severity, P=0.003; atopy, P=0.67; age, P=0.92; season, P=0.71). The adjusted relative risk at one month was 0.97 (95% confidence interval 0.74 to 1.26). At three months, 58% of the topical steroid group and 52% of the placebo group were cured (relative risk 1.23, 0.84 to 1.80). Diary symptoms did not differ between the two groups, and no significant harms were reported., Conclusions: Topical steroids are unlikely to be an effective treatment for otitis media with effusion in general practice. High rates of natural resolution occurred by 1-3 months., Trial Registration: Current Controlled Trials ISRCTN38988331; National Research Register NO575123823; MREC 03/11/073.

Objective: The caseload at secondary care in paediatric otology is largely otitis media with effusion (OME) and highly recurrent acute otitis media (RAOM). Few of these cases merit suspicion for hearing loss beyond the middle ear. The companion paper showed that the air conduction estimated from tympanometry (ACET) formula, derived on a very large clinical sample referred for ear or hearing problems and pre-assessed for a clinical trial, gives usable although only approximate estimates for hearing level (HL) on such a caseload. Tympanometry corresponds to a conductive loss (i.e. air-bone gap) so the HL-ACET discrepancy (HAD) should approximate the bone-conduction (BC) threshold. Clinical criteria might enable HAD to substitute for BC tests where those are infeasible, or to identify those most needing BC tests., Method: ACET had been derived for the 4-frequency binaural average on 3085 cases with tympanometry and air-conduction HL available. On the 2701 of those with BC data at 1kHz, we re-calculated ACET for 1kHz only, and then explored the sensitivity/specificity trade of the discrepancy (HAD) in detecting clinically significant BC levels and the correlation between these measures. We further illustrated the generalization of the formula and cut-off on a small separate retrospective clinical sample., Results: Correlations were moderate in the clinically relevant region. There were five cases of BC> or =30dB in the database. At a HAD cut-off of +5dB, the sift would identify all (nominal 100% sensitivity). For marginal cases, two definitions were adopted (BC> or =25dB and > or =20dB; 9 and 23 cases, respectively). Sift sensitivity remained high (89% and 83%, respectively), and specificity was acceptable (75% for both definitions)., Conclusions: Given tympanometry and air-conduction HL, comparison of HAD with a recommended cut-off gives acceptable sensitivity and specificity for non-OME hearing problems. BC testing can be reserved for probable positive cases, provisionally only 25% of caseload. HAD could temporarily substitute for BC measurement in children too young to accept bone-conduction transducers in awake testing. Where a high proportion of the caseload is expected to have middle ear fluid, ACET and HAD together offer efficient possibilities for best use of available information.

Background: Several aspects of children's health and development are known from empirical studies to be associated with otitis media with effusion (OME; 'glue ear'). The 'diffuse image' has been an obstacle to defining a core set of impacts about which inter-profession and parent-professional communication can be effective., Aims: The study quantifies similarities and differences in how the signs, symptoms, and developmental impact of OME are attributed and construed, between teachers, parents, and ear, nose, and throat (ENT)surgeons., Sample: Convenience samples were achieved of 118 teachers and 154 parents of affected children; 178 ENT surgeons from a professional sampling frame (association membership) responded., Method: Questionnaires elicited the perceived frequency and concern-value of over 30 manifestations of OME--the various signs, symptoms, and behaviours suggested by the literature. Factor scores derived on the combined sample were compared between respondent groups., Results: Teachers assign high importance to education and language problems but, relative to parents, they accord lower importance to continuing hearing problems. Teachers and parents weighted behaviour and balance problems similarly, placing behaviour higher, but balance lower, than the ENT specialists did., Conclusions: (1) A four-factor reduction of simple questionnaire items well defines the domains of impact of OME, and can express the ways in which views of impact differ between teachers, ENT specialists and parents.(2) Considerable differences of perspective exist between the groups examined. (3) In valuing a set of measured outcomes on actual children, or for other policy research, sets of weights are now available to represent the differing perspectives of parents and professionals (e.g. in testing robustness of a conclusion across differing stakeholder perspectives). (4) The research and development need in respect of teachers' involvement with OME could profitably play to existing strengths. This implies the systematic and structured acquisition and evaluation of teacher-provided impact information.

Aims: To identify subgroups of children with otitis media with effusion (OME) that might benefit more than others from treatment with ventilation tubes., Methods: An individual patient data (IPD) meta-analysis on seven randomised controlled trials (n = 1234 children in all), focusing on interactions between treatment and baseline characteristics--hearing level (HL), history of acute otitis media, common colds, attending day-care, gender, age, socioeconomic status, siblings, season, passive smoking, and history of breast feeding. Outcome measures that could be studied were mean time spent with effusion (n = 557), mean hearing levels (n = 557 in studies that randomised children, and n = 180 in studies that randomised ears), and language development (n = 381)., Results: In the trials that treated both ears the only significant interaction was between day-care and surgery, occurring where mean hearing level was the outcome measure. None of the other baseline variables showed an interaction effect with treatment that would justify subgrouping. In the trials that treated only one ear, the baseline hearing level showed a significant but not pervasive interaction with treatment-that is, only with a cut-off of 25 dB HL., Conclusions: The effects of conventional ventilation tubes in children studied so far are small and limited in duration. Observation (watchful waiting) therefore seems to be an adequate management strategy for most children with OME. Ventilation tubes might be used in young children that grow up in an environment with a high infection load (for example, children attending day-care), or in older children with a hearing level of 25 dB HL or greater in both ears persisting for at least 12 weeks.

This article reviews research on the possible linkage of otitis media with effusion (OME) to children's hearing and development, identifies gaps, and directions for research, and discusses implications for healthcare practices. About half of children with an episode of OME experience a mild hearing loss while about 5-10% of children have moderate hearing loss. Recent prospective and randomized clinical trials suggest none to very small negative associations of OME to children's later language development. Based on both retrospective and prospective longitudinal studies, associations between OME and perceiving speech in noise and tasks that require equal binaural hearing have been reported but have not been adequately studied with regard to functional outcomes. Thus, on average, for typically developing children, OME may not be a substantial risk factor for later speech and language development or academic achievement. However, these conclusions should be interpreted cautiously, since most of these studies used OME rather than hearing loss as the independent variable (although hearing loss rather than OME is hypothesized to affect language development) and many studies did not control for important confounding variables such as socioeconomic status (SES).

Objective: To examine whether behavioural or cognitive sequelae of otitis media with effusion (OME) continue into late childhood and the early teens (11-18 years)., Setting: Data from a large multipurpose birth cohort study: the Dunedin multidisciplinary health and development study., Participants: Around 1000 children from the study. The main independent variable of interest was otological status of the child up to age 9., Main Outcome Measures: Parent and teacher rated behaviour problems, including antisocial, neurotic, hyperactive, and inattentive behaviours, and tests of academic achievement including intelligence quotient (IQ), reading, and spelling were available in a high proportion of the cohort at ages 11 to 18 years., Results: After adjustments for covariates such as socioeconomic status, hyperactive and inattentive behaviour problems were evident as late as 15 years, and lower IQ associated with OME remained significant to 13 years. The largest effects were observed for deficits in reading ability between 11 and 18 years., Conclusions: No previous study considering behaviour problems as an outcome has followed children long enough to determine whether some of the early sequelae of OME are still present in the early to late teens. Some developmental sequelae of OME, particularly deficits in reading ability, can persist into late childhood and the early teens.

Objective: The impact of a randomised controlled trial (RCT) upon practice depends on its external validity (generalisability). This paper summarises and illustrates a framework for judging and augmenting external validity, emphasising its application to treatment trials in otitis media with effusion (OME) so as to permit stronger inferences in the future., Methods: The external validity of two surgical trials in the field of OME (TARGET, UK and KNOOP-3, the Netherlands) has been examined within a framework emphasising effect modification, in four specific ways: (1) comparison of the demographic characteristics of the trial population with the domain population; (2) studying the distributions on possible effect modifiers (i.e. variables conditioning the benefit from intervention); (3) studying whether effect modification occurs in the analyses; and (4) comparing outcome measures between the randomised and the eligible but non-randomised children., Results: For neither KNOOP-3 and TARGET were large discrepancies found between randomised and non-randomised children for any of the demographic variables. Differences in distributions along possible effect modifiers were found, but the overlaps were large enough for it still to be possible to study whether these factors indeed modified the outcome. Results for the randomised and non-randomised but eligible patients were similar. The results of both trials therefore appear to be generalisable to their domain populations., Conclusions: A superficial contrast in the results (KNOOP null, TARGET positive) does not amount to a contradiction, because of differences in the clinical question appropriate to the respective age and populations defined. Attention to quality of design and external validity of randomised controlled trials should achieve higher applicability.

Objectives: To evaluate the effect of a risk factor checklist and training video for general practitioners in reducing inter-practice variation and improving the appropriateness of referrals (assessed by their positive predictive value or PPV) of patients with suspected otitis media with effusion (OME or 'glue ear') to secondary care., Methods: Fifty general practices (177 practitioners) from the NHS Trent region and the West of Scotland were cluster-randomised either to a control group (n = 12) or to one of three intervention groups (training video (n = 16), checklist (n = 11), or both (n = 11)). Data on all paediatric ear, nose and throat (ENT) referrals and diagnostic results at ENT clinics were collected for a one-year period pre- and post-intervention. Referral rates for OME and for closely related conditions were calculated for children aged 0-15 years, based on each practice's list size. PPV was defined as the proportion of referrals resulting in bilateral hearing loss > or = 20 dB at the ENT outpatient department., Results: There was a significant improvement in the PPV, adjusted for patients' waiting time between general practitioner (GP) referral and being seen at the ENT department. The improvement in PPV pre- and post-intervention was 15% (95% confidence interval, CI: -12.1% to 41.7%) for the practices receiving both interventions, compared with a degradation of 20% pre- and post-intervention (95% CI: -32.9% to -6.4%) for practices receiving only one intervention and a degradation of 34% for those receiving no intervention., Conclusions: Disseminating a risk factor checklist and training video on glue ear to GPs using a multi-channel approach can improve the quality of referrals to ENT.

Study Objectives: Data were analysed from a large national birth cohort to examine cumulative and interactive prediction from various risk factors for childhood middle ear disease, and to resolve conflicting evidence arising from small and incompletely controlled studies. The large sample size permitted appropriate covariate adjustment to give generality, and permit demographic breakdown of the risk factors., Setting: A large multi-purpose longitudinal birth cohort study of all births in the UK in one week in 1970, with multiple questionnaire sweeps., Participants: Over 13,000 children were entered into the original cohort. Data on over 12,000 children were available at the five year follow up., Main Outcome Measures: For children at 5 years, parent reported data were available on health and social factors including data on two markers for middle ear disease: the occurrence of purulent (nonwax) ear discharge and suspected or confirmed hearing difficulty., Main Results: In those children who had ever had reported hearing difficulty (suspected or confirmed), after control for socioeconomic status, three of the classic factors (male sex, mother's smoking habits since birth, and attending day care) were significantly more frequent. In those who had ever had ear discharge reported, only mother's smoking habit since birth was significantly more frequent. However, it showed an orderly dose response relation. In addition, a derived general child health score was found to be significantly associated with both the middle ear disease markers. Control for this variable in the analysis of those having reported hearing difficulty reduced the effect size of mother's smoking habit, but it remained statistically significant. For reported ear discharge, even after control for the general health score and social index, mother's smoking habits and day care attendance were both significant predictors. Mother's (but not father's) smoking habits and day care attendance were found to be significant risk factors for middle ear disease. Breast feeding effects were weak and did not generally survive statistical control., Conclusions: A child having all three risk factors (attends day care, a mother who smokes, and male sex) is 3.4 times more likely to have problems with hearing than a child who has none, based on cumulative risk. Further studies should focus on preventative risk modification and well specified intervention.

'Watchful waiting' for glue ear in children within primary care as a precursor or alternative to surgery is one of the increasing pressures on general practitioners (GPs) to limit outpatient referrals. An equipment survey questions whether primary care is properly equipped to 'watch', given the limited access to audiological equipment that might objectively underpin a decision on when 'waiting' should end.

Objective: To investigate the effects of a history of otitis media (OM) in childhood on the acoustic reflex threshold (ART) in young adults., Design: Questionnaire responses on childhood ear and hearing problems were obtained from populations of university students. In Study 1, 31 students reporting histories of persistent childhood OM and 34 students with no known OM histories were identified. They received pure-tone audiometry, otomicroscopy, and measurement of ARTs for a 500 Hz pure tone. In Study 2, 20 students with OM histories and 20 students with no known OM histories received pure-tone audiometry, otomicroscopy, and measurement of ARTs for a broadband noise., Results: Subjects with OM histories had higher ARTs than did subjects with no known OM histories. Multiple regression analyses showed that the main variables contributing to elevated reflex thresholds were raised hearing thresholds on the activator ear and tympanic membrane abnormalities on the probe ear., Conclusions: The elevated ARTs in adults with histories of childhood OM result from peripheral sequelae of OM. Further evidence is required to determine any functional significance of these raised reflex thresholds.

A cohort of 946 children who were screened for otitis media with effusion (OME) by serial tympanometry from the age of 2 to 4 years was followed up by otomicroscopy at 7.5 to 8 years of age. At school age, signs of active middle ear disease were present in 2.2% of ears that had been free from OME at preschool age, whereas 12.7% of ears that had suffered from persistent OME and 17.8% of ears that had been treated by a ventilation tube showed signs of active middle ear disease. Otopathologic sequelae (atrophy, tympanosclerosis, atelectasis, and attic retraction) were present in 13.7%, 39.8%, and 87.3% of these ears, respectively. A duration-response effect was found in the association between preschool OME and these sequelae at school age. The high prevalence of otoscopic abnormalities found in this population calls for further follow-up and evaluation of their functional implications.

Risk factors for otitis media with effusion (OME) have proved difficult to apply in selecting persistent cases, or those otherwise requiring intervention. Explanations may include low predictive values of individual factors and the costs of data collection. In this study, profiles on 225 children from conception to age 7 years were compiled from medical and Health Authority records and structured interviews with parents. On the grounds that nearly all cases receiving medical intervention after waiting and onward referral are more than transitory (although many persistent cases will not receive such attention) this was taken as the dependent variable--a marker of persistence. Established risk factors and maternal blood group A were considered singly to predict intervention, then in combination using logistic regression. Maternal blood group A gave a relative risk (RR) for intervention of 2.82. The noted occurrence of an attack of acute otitis media (AOM) before the first birthday gave a RR of 6.13. When these two factors were used together, the RR climbed steeply to 26.77. These findings suggest that further research is justified into the nature of the influence of blood group A on OME, and the use of combinations of risk factors to give enhanced prediction.

It has been suggested that asymmetric or fluctuating hearing in otitis media with effusion (OME) could lead to abnormal binaural hearing. In a cohort of children with tympanogram data obtained at 3-monthly intervals from 2 to 4 years, 6.4% had asymmetric or unilateral B tympanograms on more than half the test occasions, or had 5 or more fluctuations between symmetric and asymmetric tympanograms. Hence there are sufficient cases for studies of sequelae or treatment in unilateral and fluctuating OME. Few of these cases would have received medical attention under a bilateral referral criterion.

Improved test technique by health visitors has been shown to lead to higher accuracy in the screen of hearing aimed traditionally at prelingual sensorineural deafness. However, it gives greatly increased referrals of children having otitis media with effusion (OME) around the end of the first year of life. Two samples of children (n = 29 and 61) were tested in a children's hearing assessment clinic with properly documented testing techniques and trained personnel. The samples were each formed on a fixed population base, one before and one after screen improvements. This enabled characterization of two outcome groups within each sample (severe/persistent enough to refer to ENT vs discharged, despite slight hearing impairment). The average audiometric criterion for onward referral to ENT rose only very little, despite the increased assessment caseload resulting from more detections by the screen. This usefully permitted the conclusion that the number of true cases found due to the screen and assessed as lying beyond a specifiable degree of severity (average cut-off approximately 47 dB(A) or 35 dBHTL) had increased not through lower criteria for referral to ENT, but through the improvements to the screen. The increase was from approximately 0.4% to 1.3% of the base population screened. Thus a change materially enhancing the sensitivity and positive predictive value of a screen considerably enlarges the eventual otological caseload of children with middle-ear disease thought to justify concern at around the end of their first year. If done properly, screening is hence in practical terms about OME, not about prelingual sensorineural hearing impairment. This conclusion presses the urgency of evaluation and consensus on the otological management of the young child with OME.

Communication tactics form part of coping strategies initiated by parents of children with otitis media with effusion (OME). Knowledge of such tactics was elicited from a large sample (N = 574) of parents via open-ended questionnaire items. Using content analysis, these were categorized into 31 tactics producing an overall tactic score for each parent. Parents are generally aware of tactics that directly engage the child, but are less aware of tactics that require the involvement of a third party. Regression-based prediction of broad outcome variables of behaviour, quality of life and reported hearing difficulty was undertaken using the tactics score, child hearing level and parental anxiety as predictors. Increased use of hearing tactics (marginal) and worse parental anxiety were associated with more reported behaviour problems. Less use of tactics and lower anxiety were associated with better ENT-related parental quality of life. Parents with higher tactics scores also reported worse hearing difficulties in their children. These results suggest that parental awareness complicates the use of wider outcomes of OME, but statistical adjustment could be made with tactics score as a control variable. Although the percentage of variance accounted for by these predictive models was relatively small, they provide partial validation of the tactics score. [ABSTRACT FROM AUTHOR]