Clinical practice guidelines for the diagnosis and management of otitis media with effusion (OME) in children in Japan, 2015
Introduction
Otitis media with effusion (OME) is a middle ear disease that affects 90% of children at least once before they reach school age [1] and is the primary cause of pediatric hearing loss. At least 50% of children will experience OME before the age of 1 year, increasing to over 60% by the age of 2 years [2]. While most cases resolve spontaneously within 3 months, some 30%–40% have recurrent OME, and 5%–10% have episodes lasting a year or more [1], [3], [4]. With the potential for sequelae, OME requires long-term medical management.
OME in adults differs from that in children with regard to factors such as background characteristics, major involvement of eustachian tube dysfunction, and the incidence of nasopharyngeal tumors, and thus is outside the scope of this guideline. This treatment guideline provides recommendations for OME in children up to 12 years of age.
The primary symptoms of OME in children are hearing loss and aural fullness. While some cases resolve spontaneously, the absence of acute symptoms of inflammation allows OME to go unnoticed for some time. If OME is left untreated for a long period, patients run the risk of hearing loss that delays language development and interferes with learning, as well as pathological changes in the tympanic membrane and middle ear, such as adhesive otitis media. Surgical intervention, with tympanostomy tube insertion as the preferred initial procedure, is useful for improving hearing loss, but may also cause persistent perforation and tympanosclerosis after insertion.
Many cases (approximately 50%) of OME in children develop with a cold or after acute otitis media (AOM) [5]. Guidance is required regarding the timing and criteria for diagnosing OME in cases of fluid in the middle ear after AOM or previously unnoticed fluid in the middle ear that is discovered by chance. Existing overseas guidelines for managing OME include the US 2004 Clinical Practice Guideline: otitis media with effusion [6] and the UK 2008 National Institute for Health and Care Excellence (NICE) Guidelines for OME in children under 12 years [7]; however, there is an increasing push for OME guidelines to be established in every country worldwide [8]. Treatment guidelines for tympanostomy tube insertion in children have also been developed in the United States, although they target otitis media of any type rather than just OME [9]. The main objective of the American and European guidelines is to establish when patients should be referred to an ear, nose, and throat specialist for tympanostomy tube insertion.
Conversely, in Japan, where an otolaryngologist is primarily responsible for the primary care of OME in children, the OME is viewed and treated in conjunction with related inflammatory lesions of surrounding organs. In other words, clinical management of OME in children in Japan, including follow-up, not only deals with direct OME-related conditions such as fluid collection in the middle ear and pathological changes in the tympanic membrane, but also considers the patient’s overall clinical state and treats any lesions of the surrounding organs. The development of guidelines for the diagnosis and treatment of OME in children in Japan requires comprehensive evaluation of studies taking into consideration the current status of OME. The Japan Otological Society (JOS) and the Japan Society for Pediatric Otorhinolaryngology developed these evidence-based guidelines (2015: 1st edition) to support the diagnosis and treatment of OME in children.
It must be emphasized that recommendations in clinical practice guidelines are not legal grounds for the content of medical treatment that should be practiced in individual clinical situations [10]. The aim is for this guideline to be used to assist clinical decision making in the care of childhood OME, and for it to prove beneficial in the diagnosis and treatment of patients with pediatric OME.
This paper introduces important extracts from the Japanese Clinical Practice Guideline for Diagnosis and Management of OME in Children, 2015.
Section snippets
Users
The target users of this guideline will be any clinician, including otolaryngologists and pediatricians, who engages in the medical management of pediatric OME. The users themselves must determine the difficulty in applying the interventions noted in the guideline according to their specialty area and experience. For health care workers other than doctors (nurses, laboratory technicians, and speech therapists), this guideline is useful for learning more about pediatric OME.
Subjects
The subjects of this guideline are children younger than 12 years of age (of any gender) with a definitive diagnosis of OME. In post-AOM cases, the subjects are children for whom more than 3 weeks have passed after the disappearance of the symptoms of acute inflammation. Patients with OME with immunodeficiency or acute inflammation are excluded.
Collecting evidence
We used the support services of the specified nonprofit corporation, The Japan Medical Library Association, for the development of medical guidelines and retrieved the documents cooperatively. We used PubMed, Ichushi Web (the web site of the Japan Medical Abstracts Society), and The Cochrane Library, and carried out information retrieval from February to April 2014. We conducted retrieval on each theme, namely the definition, the cause of a disease, the disease state, complications, sequelae,
Evaluation of evidence
For each theme in the guideline, a two-person subcommittee excluded documents that deviate from the condition of child patients targeted by the guideline as mentioned in Section 3 and which deviate from the theme, extracted primary information from the remaining documents, evaluated the methodological bias of the research, and developed the evidence tables. In addition, according to the aforementioned policy for selecting documents, they selected documents that we would adopt as evidence.
Reviews before the release
Prior to the release of this guideline, our committee asked otolaryngologists and pediatricians engaged in the remedy of OME in children, as well as experts in guidelines, to carry out an external review on the draft edition of this guideline. We asked two reviewers to conduct their review according to AGREE II (Appraisal of Guidelines for Research & Evaluation II), while the other four reviewers were free to review the guideline as they saw fit.
Definition of otitis media with effusion in children
In this guideline, OME is defined as otitis media with middle ear effusions without eardrum perforation, which causes hearing loss. In addition, OME lacks the signs of acute inflammation of the ear such as otalgia and fever. In the American guideline, “Clinical Practice Guideline: Otitis Media with Effusion” [6], OME is defined as fluid in the middle ear without signs or symptoms of acute ear infection.
OME is classified into three stages: (1) acute phase: within 3 weeks after the onset; (2)
Recommendations
A diagnosis of OME is made when the tympanic membrane findings described below are observed. The nature of the middle ear effusion in this disease varies and is largely classified into three types: serous, viscous, and mucopurulent. Retraction, bulging or opacity of the membrane, diminished or absent light reflex, presence of middle ear effusion (e.g., presence of bubbles and gas or a liquid phase), and/or variously colored middle ear effusion can be observed on examination of the tympanic
Treatment
Fig. 1 shows a clinical management algorithm recommended for standard cases of OME in children not at risk of becoming refractory, and was created by combining the results of a review of the evidence and the expert opinion of the Guideline Committee.
Disclosure statement
Production of these guidelines was funded by JOS operating expenses. The JOS does not receive support from any specific organizations or companies. A list of organizations and companies that posed non-personal financial conflicts of interest to members of the Subcommittee of the Clinical Practice Guideline during the production of these guidelines is provided as follows. Members of the Subcommittee with a conflict of interest (COI) were excluded from the drafting of any part to which the COI is
Financial disclosure statement
The authors have no financial relationships to disclose.
Acknowledgements
The present 2015 Guideline was revised by the members of the Subcommittee of Clinical Practice Guideline for Diagnosis and Management of Otitis Media with Effusion in Children in Japan composed by Japan Otological Society and Japan Society for Pediatric Otorhinolaryngology.
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2022, Auris Nasus LarynxCitation Excerpt :Otitis media with effusion (OME) is defined as an effusion in the middle ear without signs and symptoms of an acute infection [1–3]. It affects 90% of children at least once before school age [1]. At least 50% of children will experience OME before the age of one, increasing to over 60% by two years old [4].