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Background This study aimed to develop and validate a deep learning (DL) model to identify atelectasis and attic retraction pocket in cases of otitis media with effusion (OME) using multi-center otoscopic images. Method A total of 6393 OME otoscopic images from three centers were used to develop and validate a DL model for detecting atelectasis and attic retraction pocket. A threefold random cross-validation procedure was adopted to divide the dataset into training validation sets on a patient level. A team of otologists was assigned to diagnose and characterize atelectasis and attic retraction pocket in otoscopic images. Receiver operating characteristic (ROC) curves, including area under the ROC curve (AUC), accuracy, sensitivity, and specificity were used to assess the performance of the DL model. Class Activation Mapping (CAM) illustrated the discriminative regions in the otoscopic images. Results Among all OME otoscopic images, 3564 (55.74%) were identified with attic retraction pocket, and 2460 (38.48%) with atelectasis. The diagnostic DL model of attic retraction pocket and atelectasis achieved a threefold cross-validation accuracy of 89% and 79%, AUC of 0.89 and 0.87, a sensitivity of 0.93 and 0.71, and a specificity of 0.62 and 0.84, respectively. Larger and deeper cases of atelectasis and attic retraction pocket showed greater weight, based on the red color depicted in the heat map of CAM. Conclusion The DL algorithm could be employed to identify atelectasis and attic retraction pocket in otoscopic images of OME, and as a tool to assist in the accurate diagnosis of OME.

Background Otitis media with effusion (OME) is common and occurs at disproportionately higher rates among Indigenous children. Left untreated, OME can negatively affect language, development, learning, and health and wellbeing throughout the life-course. Currently, OME care includes observation for 3 months followed by consideration of surgical ventilation tube insertion. The use of a non-invasive, low-cost nasal balloon autoinflation device has been found beneficial in other populations but has not been investigated among Aboriginal and Torres Strait Islander children. Methods/design This multi-centre, open-label, randomised controlled trial will determine the effectiveness of nasal balloon autoinflation compared to no nasal balloon autoinflation, for the treatment of OME among Aboriginal and Torres Strait Islander children in Australia. Children aged 3–16 years with unilateral or bilateral OME are being recruited from Aboriginal Health Services and the community. The primary outcome is the proportion of children showing tympanometric improvement of OME at 1 month. Improvement is defined as a change from bilateral type B tympanograms to at least one type A or C1 tympanogram, or from unilateral type B tympanogram to type A or C1 tympanogram in the index ear, without deterioration (type A or C1 to type C2, C3, or B tympanogram) in the contralateral ear. A sample size of 340 children (170 in each group) at 1 month will detect an absolute difference of 15% between groups with 80% power at 5% significance. Anticipating a 15% loss to follow-up, 400 children will be randomised. The primary analysis will be by intention to treat. Secondary outcomes include tympanometric changes at 3 and 6 months, hearing at 3 months, ear health-related quality of life (OMQ-14), and cost-effectiveness. A process evaluation including perspectives of parents or carers, health care providers, and researchers on trial implementation will also be undertaken. Discussion INFLATE will answer the important clinical question of whether nasal balloon autoinflation is an effective and acceptable treatment for Aboriginal and Torres Strait Islander children with OME. INFLATE will help fill the evidence gap for safe, low-cost, accessible OME therapies. Trial registration Australia New Zealand Clinical Trials Registry ACTRN12617001652369 . Registered on 22 December 2017. The Australia New Zealand Clinical Trials Registry is a primary registry of the WHO ICTRP network and includes all items from the WHO Trial Registration data set. Retrospective registration.

Otitis media (OM) is amongst the most common childhood diseases and is associated with multiple microbial pathogens within the middle ear. Global and temporal monitoring of predominant bacterial pathogens is important to inform new treatment strategies, vaccine development and to monitor the impact of vaccine implementation to improve progress toward global OM prevention. A systematic review of published reports of microbiology of acute otitis media (AOM) and otitis media with effusion (OME) from January, 1970 to August 2014, was performed using PubMed databases. This review confirmed that Streptococcus pneumoniae and Haemophilus influenzae, remain the predominant bacterial pathogens, with S. pneumoniae the predominant bacterium in the majority reports from AOM patients. In contrast, H. influenzae was the predominant bacterium for patients experiencing chronic OME, recurrent AOM and AOM with treatment failure. This result was consistent, even where improved detection sensitivity from the use of polymerase chain reaction (PCR) rather than bacterial culture was conducted. On average, PCR analyses increased the frequency of detection of S. pneumoniae and H. influenzae 3.2 fold compared to culture, whilst Moraxella catarrhalis was 4.5 times more frequently identified by PCR. Molecular methods can also improve monitoring of regional changes in the serotypes and identification frequency of S. pneumoniae and H. influenzae over time or after vaccine implementation, such as after introduction of the 7-valent pneumococcal conjugate vaccine. Globally, S. pneumoniae and H. influenzae remain the predominant otopathogens associated with OM as identified through bacterial culture; however, molecular methods continue to improve the frequency and accuracy of detection of individual serotypes. Ongoing monitoring with appropriate detection methods for OM pathogens can support development of improved vaccines to provide protection from the complex combination of otopathogens within the middle ear, ultimately aiming to reduce the risk of chronic and recurrent OM in vulnerable populations.

Background Otitis media with effusion is the major cause of acquired hearing problems in children. Some of the affected children need surgery with ventilation tubes in the tympanic membrane to reduce ear complaints and to improve hearing, middle ear function, and health-related quality of life. This is one of the most common ambulatory surgeries performed on children. Postoperative controls are needed to assess that the tubes are functional, to evaluate whether hearing loss has been improved, and to handle potential complications. The follow-up may continue for years and are usually done by otolaryngologists. Nevertheless, there exist no evidence-based guidelines concerning the level of expertise needed for postoperative controls of the ventilation tubes. The aim of this protocol is to describe the ConVenTu study that evaluates whether postoperative controls performed by general practitioners (GPs) represent a safe and sufficient alternative to controls performed by otolaryngologists. Methods/design Multicenter randomized non-inferiority study conducted in clinical settings in seven hospitals located in Norway. Discharged children with ventilation tubes, aged 3–10 years, are allocated randomly to receive postoperative controls by either an otolaryngologist at the hospital where they had ventilation tube surgery or their regular GP. Study participants are enrolled consecutively until 200 patients are included in each group. Two years after surgery, we will compare the pure tone average of hearing thresholds (primary endpoint) and middle ear function, complication rate, health-related quality of life and the parents’ evaluations of the postoperative care (secondary endpoints). Discussion This protocol describes the first randomized non-inferiority study of GPs performing postoperative controls after surgery with ventilation tubes. Results from this study may be utilized for deriving evidence-based clinical practice guidelines of the level of postoperative controls after ventilation tube surgery which is safe and sufficient. Trial registration ClinicalTrials.gov NCT02831985 . Registered on 13 July 2016

Childhood acute otitis media (AOM) is highly prevalent. Its usual sequela of middle ear effusion (MEE) can lead to conductive hearing loss, for which surgery is commonly used. To evaluate the efficacy of an osteopathic manipulative treatment (OMT) protocol on MEE resolution following an episode of AOM. The authors hypothesized that OMT provided adjunctively to standard care for young children with AOM would reduce the duration of MEE following the onset of AOM. We compared standard care only (SCO) and standard care plus OMT (SC+OMT) for the duration of MEE following AOM. Patients were aged 6 months to 2 years. The SC+OMT group received OMT during 3 weekly visits. Weekly tympanometric and acoustic reflectometer (AR) readings were obtained from all patients. There were 52 patients enrolled, with 43 completing the study and 9 dropping out. No demographic differences were noted. Only ears from each patient with abnormal tympanograms at entry were included. There were 76 ears in the tympanogram analysis (38 from SCO; 38 from SC+OMT) and 61 ears in the AR data analysis (31 from SCO; 30 from SC+OMT). Dependence of bilateral ear disease noted in AR readings was accounted for in statistical analysis. Tympanogram data demonstrated a statistically significant improvement in MEE at visit 3 in patients in the SC+OMT group (odds ratio, 2.98; 95% confidence interval, 1.16, 7.62; χ test for independence, =.02). The AR data analysis showed statistically significant improvement at visit 3 for the SC+OMT group ( =2.05; =.02). There was no statistically significant change in MEE before or immediately after the OMT protocol. A standardized OMT protocol administered adjunctively with standard care for patients with AOM may result in faster resolution of MEE following AOM than standard treatment alone. ( number NCT00520039.)

Background The prevalence of otitis media in Greenlandic children is one of the highest in the world. International studies have shown that otitis-prone children may benefit from tubulation of the tympanic membrane. However, it is unknown whether these results can be applied to Greenlandic children and trials on the effects of ventilation tubes in high-risk populations have, to our knowledge, never been conducted. Methods The trial is an investigator-initiated, multicentre, randomized, blinded superiority trial of bilateral ventilation tube insertion versus treatment as usual (no tube) in Greenlandic children aged 9–36 months with chronic otitis media with effusion or recurrent acute otitis media. With randomization stratified by otitis media subtype and trial site, a type 1 error of 5% and a power of 80%, a total of 230 participants are needed to detect a decrease of two visits to a health clinic during 2 years, which is considered the minimal clinical relevant difference. The primary outcome measure will be assessed blindly by investigating medical records. Secondary outcome measures are number of episodes of acute otitis media, quality of life, number of episodes of antibiotics administration and proportion of children with tympanic membrane perforations. Discussion This trial will provide evidence-based knowledge of the effects of ventilation tubes in children with middle ear infections from the high-risk Greenlandic population. Furthermore, this trial will improve the understanding of conducting randomized clinical trials in remote areas, where management of logistical aspects is particularly challenging. Trial registration ClinicalTrials.gov, NCT02490332 . Registered on 14 February 2016.

Otitis media, a common disease marked by the presence of fluid within the middle ear space, imparts a significant global health and economic burden. Identifying an effusion through the tympanic membrane is critical to diagnostic success but remains challenging due to the inherent limitations of visible light otoscopy and user interpretation. Here we describe a powerful diagnostic approach to otitis media utilizing advancements in otoscopy and machine learning. We developed an otoscope that visualizes middle ear structures and fluid in the shortwave infrared region, holding several advantages over traditional approaches. Images were captured in vivo and then processed by a novel machine learning based algorithm. The model predicts the presence of effusions with greater accuracy than current techniques, offering specificity and sensitivity over 90%. This platform has the potential to reduce costs and resources associated with otitis media, especially as improvements are made in shortwave imaging and machine learning.

ObjectiveThis study aimed to evaluate the natural history of otitis media with effusion (OME) without hearing loss in children under 12 years.MethodsWe performed a systematic search in Embase, CINAHL, MEDLINE, INAHTA database, CENTRAL, CDSR, Epistemonikos and PsycINFO to identify observational single group studies and comparative studies with untreated control arms published in English up to June 2022, reporting natural history of OME without hearing loss. The JBI (Joanna Briggs Institute) checklist and Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology were used to assess risk of bias and overall quality of evidence, respectively.ResultsNineteen studies with samples ranging from 16 to 816 children met the inclusion criteria. The quality of evidence ranged from low to very low. Resolution of current episode of OME without hearing loss was 10–66% by 1 month, 3–93% by 3 months, 10–98% by 6 months, 20–92% by 9 months and 78–99% by 12 months, depending on populations and how resolution was defined across studies. Resolution of OME (defined as change from type B to non-B tympanogram) was only 10% by 6 months in Aboriginal infants. Recurrence of OME was 7% by 3 months, 8–18% by 6 months, 10–28% by 9 months and 8–35% by 12 months.ConclusionsThere was a trend towards greater resolution of OME without hearing loss and recurrence of OME over longer follow-up periods; however, they did not seem to follow a linear pattern, potentially due to differences in populations and definitions of resolution across studies.

Acute otitis media is diagnosed in patients with acute onset, presence of middle ear effusion, physical evidence of middle ear inflammation, and symptoms such as pain, irritability, or fever. Acute otitis media is usually a complication of eustachian tube dysfunction that occurs during a viral upper respiratory tract infection. Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis are the most common organisms isolated from middle ear fluid. Management of acute otitis media should begin with adequate analgesia. Antibiotic therapy can be deferred in children two years or older with mild symptoms. High-dose amoxicillin (80 to 90 mg per kg per day) is the antibiotic of choice for treating acute otitis media in patients who are not allergic to penicillin. Children with persistent symptoms despite 48 to 72 hours of antibiotic therapy should be reexamined, and a second-line agent, such as amoxicillin/clavulanate, should be used if appropriate. Otitis media with effusion is defined as middle ear effusion in the absence of acute symptoms. Antibiotics, decongestants, or nasal steroids do not hasten the clearance of middle ear fluid and are not recommended. Children with evidence of anatomic damage, hearing loss, or language delay should be referred to an otolaryngologist.

Objective To characterize middle ear (ME) effusion still present 2 months after repair surgery for spontaneous cerebrospinal fluid (CSF) leak via the temporal bone (TB). Study design A retrospective chart review (2011–2022). Setting Tertiary referral academic center. Subjects and methods All patients with persistent ME effusion at 2 months after surgery were included in this study. The indication for surgery for spontaneous TB CSF leak was an active CSF leak with tegmen dehiscence. The presence of effusion was established by findings on microscopic otoscopy aided by tympanocentesis.ME with effusion were sampled for the presence of 𝛽2transferrin. Those negative for 𝛽2transferrin had a ventilation tube placed for ME aeration of serous otitis media (SOM). Data on persistent fluid leakage from tympanostomy tubes, presence or absence of 𝛽2transferrin in the ME, and residual air-bone gap on the postoperative audiogram were recorded. Results Fifty-three ears underwent surgery to repair a CSF leak, 42 via a middle fossa craniotomy and 11 via transmastoid approaches. Fourteen ears (26%) still had ME effusion 2 months after surgery and it was sampled for 𝛽2transferrin. Seven were negative (SOM or mucoid OM) and the patients received a tympanostomy tube with resultant ME aeration and air-bone gap closure. The other seven underwent revision surgery. Conclusions Postoperative ME fluid after surgery for TB CSF leak may often represent effusion by SOM rather than an ongoing or recurrent CSF leak. ME effusion by SOM is likely caused by mucosal irritation from long-standing stagnant CSF or an underlying eustachian tube dysfunction.