Clinical practice guidelines for the diagnosis and management of acute otitis media (AOM) in children in Japan
Introduction
Acute otitis media (AOM) is a typical upper respiratory inflammation commonly affecting children and is mainly treated by otolaryngologists. Its exact frequency of occurrence in Japan is unknown, however. According to reports from Europe and the US, 62% of children aged less than one year and 83% of those up to the age of three have suffered from at least one bout of AOM [1]. Faden et al. [2] have reported that it affects 75% of children up to the age of one.
Some authors in Europe and the US do not recommend the use of antimicrobial agents for AOM. In the Netherlands, it has been proposed that antimicrobial agents are unnecessary in at least 90% of cases, and that patients should be observed for 3–4 days without antimicrobial agent administration [3], [4]. Rosenfeld et al. have also reported observation as a management option [5], [6], [7], and more recent studies have also found no significant difference in clinical outcome if antimicrobial agents are not given immediately but rather are prescribed if there is no improvement in symptoms after 48 or 72 h [8], [9]. A Cochrane review that examined randomized controlled trials of antimicrobial agent administration versus placebo also found that antimicrobial agents had little effect on childhood AOM [10]. In addition, a double-blind randomized controlled trial of amoxicillin (AMPC) and a placebo found no significant difference in therapeutic efficacy between the two [11], [12]. Dagan et al. [13], [14] and Toltzis et al. [15], in a review and case-control study, advised that antimicrobial agent use would be reduced because the use of a wide variety of antimicrobial agent increases the survival of resistant Streptococcus pneumonia (S. pneumonia) in the nasopharynx, which can cause additional infections in middle-ear (ME) fluid.
In Japan, regular nationwide surveys are performed of the causative bacteria for AOM, acute sinusitis, acute tonsillitis, and peritonsillar abscess. These surveys have reported that multidrug-resistant bacteria are now being detected more frequently [16], [17], which means that the recommendation to avoid administration of antimicrobial agents proposed in Europe and the US does not apply. In addition, the criteria and assessment levels used in conventional clinical assessment are not necessarily uniform even within Europe and the US [18]. Investigation and unified evaluation of the diagnosis and treatment of childhood AOM are therefore required, based on the actual situation in Japan. Based on this perspective, the Japan Otological Society (JOS), the Japan Society for Infectious Diseases in Otolaryngology (JSIDO), and the Japan Society for Pediatric Otorhinolaryngology (JSPO) produced 2006 clinical practice guidelines consistent with evidence-based medicine (EBM) [19] with the aim of supporting the diagnosis and treatment of childhood AOM [20], [21], [22], [23], which was revised and published in 2009 [24].
This paper introduces extracts of the important parts of our 2009 edition of clinical practice guideline for diagnosis and management of AOM in children.
Section snippets
Users
The main users of these guidelines will be otolaryngologists who perform otological procedures including the accurate evaluation of otoscopic findings and myringotomy.
Subjects
The subjects of these guidelines are AOM patients aged <15 years who were free from AOM or otitis media with effusion (OME) within one month prior to onset, who do not have a tympanostomy tube inserted, who have no craniofacial abnormality, and who do not suffer from immunodeficiency. Patients with the following conditions are excluded as subjects: AOM with complications including facial palsy and inner ear disorder, elevated pinna with acute mastoiditis, and AOM with Gradenigo's syndrome or
Gathering evidence
For the 2006 guidelines, PubMed and Japan Centra Revuo Medicina Web version 3 were used, and for the 2009 guidelines, PubMed, the Cochrane library, and Japan Centra Revuo Medicina Web version 4 were used.
Criteria for deciding recommendation grades
The method proposed by the Japan Stroke Society to indicate the level of evidence was used in the preparation of these guidelines, as shown below.
Pre-release review
Before these guidelines were released for general use, they were reviewed with reference to the Conference on Guideline Standardization (COGS) proposals concerning publication format [27] and the Appraisal of Guidelines for Research & Evaluation (AGREE) appraisal instrument for assessing content [28].
Before publication of the 2006 edition of the guidelines, opinions were solicited from the JOS, JSIDO, and JSPO, and pediatricians, and corrections were made where necessary. Otolaryngologists,
Recommendation
AOM is diagnosed when the following tympanic membrane findings are recognized, and thus, detailed inspection of the tympanic membrane is indispensable for its diagnosis (level of recommendation grade: B; hyperemia, protrusion, diminishment of the light reflex, thickening, bullar formation, cloudiness (turbidity), and perforation of the tympanic membrane, MEE, otorrhea, edema of middle-ear mucosa; references used to assess this recommendation level: Rosenfeld et al. [29] (Level IIb)).
Addendum
Treatment
The outcome of the treatment recommended by the present guidelines is defined by improvement of otoscopic findings such as hyperemia, protrusion, diminishment of the light reflex, thickening, bullar formation, cloudiness (turbidity), and perforation of the tympanic membrane, MEE, otorrhea, and edema of middle-ear mucosa at the time point of 3 weeks after onset. A score of 0 for the tympanic membrane and clinical manifestations except for age factor (under 24 months) is judged as cure of AOM.
A
Definition of ROM
The definition of ROM has yet to be standardized either in Japan or internationally, but in these guidelines it has been defined as three or more occurrences of AOM within the previous six months, or four or more within the previous 12 months, as generally used in comparatively recent studies [43], [44], [45].
Pathophysiology of and risk factors for ROM
The pathophysiology of ROM can be categorized into two types: recurrent simple AOM, and recurrent AOM occurring as an acute exacerbation in patients suffering from OME.
Proposed risk
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Clinical practice guideline consistent with evidence-based medicine manual for development and application
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Corresponding author: Haruo Takahashi
Department of Otolaryngology – Head and Neck Surgery, Nagasaki University Graduate School of Biomedical Sciences, Sakamoto 1-7-1, Nagasaki City, 852-8501, Japan. Tel.: +81 95 819 7349; fax: +81 95 819 7352.
E-mail address: [email protected].