Elsevier

Auris Nasus Larynx

Volume 42, Issue 2, April 2015, Pages 99-106
Auris Nasus Larynx

Clinical Practice Guidelines for the diagnosis and management of acute otitis media (AOM) in children in Japan – 2013 update

https://doi.org/10.1016/j.anl.2014.09.006Get rights and content

Abstract

Objective

To (1) indicate methods of diagnosis and testing for childhood (<15 years) acute otitis media (AOM) and (2) recommend methods of treatment in accordance with the evidence-based consensus reached by the Subcommittee of Clinical Practice Guideline for Diagnosis and Management of AOM in Children (Subcommittee of Clinical Practice Guideline), in light of the causative bacteria and their drug sensitivity of AOM in Japan.

Methods

We investigated the most recently detected bacteria causing childhood AOM in Japan as well as antibacterial sensitivity and the worldwide distinct progress of vaccination, produced Clinical Questions concerning the diagnosis, testing methods, and treatment of AOM, searched literature published during 2000–2004, and issued the 2006 Guidelines [1], [2], [3], [4]. In the 2009 and 2013 Guidelines, we performed the same investigation with the addition of literature, which were not included in the 2006 Guidelines and published during 2005–2008 and during 2009–2012, respectively.

Results

We categorized AOM as mild, moderate, or severe on the basis of tympanic membrane findings and clinical symptoms, and presented recommended treatment for each degree of severity.

Conclusion

Accurate assessment of tympanic membrane findings is important for judging the degree of severity and selecting a method of treatment. Some of new antimicrobial agents and pneumococcal vaccination are recommended as new treatment options.

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 pneumoniae (S. pneumoniae) 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].

According to a local survey using a questionnaire in Ishikawa Prefecture, Japan, 85% of otolaryngologists and 52% of pediatricians acknowledged 2006 Guidelines, and among them, 56% of otolaryngologists and 49% of pediatricians have actually put it to practical use [25]. Other reports indicated that treatment outcome of AOM based on the 2006 Guidelines was good [26], [27]. Therefore, JOS, JSIDO and JSPO issued 2009 Guidelines revised from 2006 Guidelines.

Thereafter, AOM guidelines were published from Canada [28] and from Italy [29]. In Italian Guidelines, it was noted that, as in our guidelines, identification and description of detailed tympanic membrane findings were highly appreciated, and that they also indicated as one of the choices for pediatricians to transfer the patient to otolaryngologist who can examine the tympanic membrane precisely by using microscope and/or endoscope, when pediatricians cannot identify or describe the tympanic membrane findings. That principle seems to agree well with our Guidelines, which appreciate the management of AOM based on the detailed observations of tympanic membrane findings. In 2013 AOM Guidelines published from the United States by revising their 2004 Guidelines, the necessity of detailed observation of the tympanic membrane findings was emphasized [30].

In our present 2013 Guidelines, changes of pathogens and their drug sensitivity and the grading system of AOM including signs and symptoms determining the grade were revised. Also descriptions were added based on new data as for rapid test for the detection of pneumococcal antigen, vaccinations for S. pneumoniae, new antimicrobial agents, and Japanese herbal medicine, and so on. Although no remarkable change has been made on the other parts of the 2009 guidelines, items described in 2006 and 2009 guidelines were included in the 2013 Guidelines.

This paper introduces extracts of the important parts of our 2013 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 and 2009 Guidelines, PubMed, Japan Centra Revuo Medicina Web version 3 and 4, were used, and for the 2013 Guidelines, PubMed, the Cochrane library, and Japan Centra Revuo Medicina Web version 5 were used.

Criteria for deciding recommendation grades

The method proposed by the Japan Stroke Society to indicate the level of evidence, which was established on the basis of National Clinical Guidelines for Stroke (Royal College of Physicians, http://www.ebook3000.com/National-Clinical-Guidelines-for-Stroke_9350.html) modified by the Classification of Oxford Centre for Evidence-based Medicine (http://www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/), was used in the preparation of these Guidelines, as shown below.

Pre-release review

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, regarded as the general users of the Guidelines, were also surveyed regarding the utility of the Guidelines in the clinical setting, and the results were reflected where appropriate.

Before 2006 and 2009 Guidelines were released for general use, they were reviewed with reference to the Conference on

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, ME effusion (MEE), otorrhea, edema of middle-ear mucosa; references used to assess this recommendation level: Rosenfeld et al. [35] (Level

Recommendation

The PCV is effective for the prevention of infant AOM (level of recommendation grade: A; references used to assess the recommendation level: Benninger [45] (level Ia), Dinleyici [46] (level Ia), Boonacker et al. [47] (level Ia), Gisselsson-Solén et al. [48] (level Ib), van Gils et al. [49] (level Ib))

Background

Concerning vaccine against S. pneumoniae in Japan, a 23-valent pneumococcal polysaccharide vaccine was released in the 1980s; however, the usefulness and safety of this vaccine are not necessarily

Treatment

The outcome of the treatment recommended by the present Guidelines is defined by improvement of otoscopic findings such as hyperemia, protrusion, thickening, bullar formation, cloudiness (turbidity), and perforation of the tympanic membrane, MEE, otorrhea, and edema of ME 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 patient who has already received

Recurrent otitis media (ROM)

  • 1.

    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 [59], [60], [61].

  • 2.

    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

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 Clinical Practice Guideline during the production of these Guidelines is provided as follows:

Astellas Pharma Inc.AstraZeneca K.K.
Bayer Yakuhin, Ltd.Chugai Pharmaceutical Co., Ltd.
Daiichi Sankyo Company, LimitedEisai Co.,

Acknowledgements

The present 2013 Guideline was revised by the members of the Subcommittee of Clinical Practice Guideline for Diagnosis and Management of Acute Otitis Media in Children composed by Japan Otological Society, Japan Society for Pediatric Otorhinolaryngology, and Japan Society for Infectious Diseases in Otolaryngology.

References (80)

  • D.W. Teele et al.

    The Greater Boston Otitis Media Study Group. Epidemiology of otitis media during the first seven years of life in children in Greater Boston: a prospective cohort study

    J Infect Dis

    (1989)
  • H. Faden et al.

    Otitis media: back to basics

    Pediatr Infect Dis J

    (1998)
  • F.L. van Buchem et al.

    Acute otitis media: a new treatment strategy

    BMJ

    (1985)
  • R. Damoiseaux et al.

    Primary care based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under 2 years

    BMJ

    (2000)
  • D. Kay

    Natural history of untreated otitis media

  • R.M. Rosenfeld et al.

    Natural history of untreated otitis media

    Laryngoscope

    (2003)
  • D.M. Spiro et al.

    Wait-and-see prescription for the treatment of acute otitis media: a randomized controlled trial

    JAMA

    (2006)
  • P. Little et al.

    Longer term outcomes from a randomized trial of prescribing strategies in otitis media

    Br J Gen Pract

    (2006)
  • P.P. Glasziou et al.

    Antibiotics for acute otitis media in children

    Cochrane Database Syst Rev

    (2004)
  • N. Le Saux et al.

    A randomized, double-blind, placebo-controlled noninferiority trial of amoxicillin for clinically diagnosed acute otitis media in children 6 months to 5 years of age

    CMAJ

    (2005)
  • D.P. McCormick et al.

    Nonsevere acute otitis media: a clinical trial comparing outcomes of watchful waiting versus immediate antibiotic treatment

    Pediatrics

    (2005)
  • R. Dagan et al.

    Antibiotic treatment in acute otitis media promotes superinfection with resistant Streptococcus pneumoniae carried before initiation of treatment

    J Infect Dis

    (2001)
  • P. Toltzis et al.

    Impact of amoxicillin on pneumococcal colonization compared with other therapies for acute otitis media

    Pediatr Infect Dis J

    (2005)
  • K. Suzuki

    The status quo of drug-resistant bacteria in pediatric otolaryngological infectious diseases

    Pediatr Otorhinolaryngol Japan

    (2000)
  • T. Nishimura et al.

    The third nationwide survey of clinical isolates from patients with otolaryngological field infections

    J Jpn Soc Infect Dis Otolaryngol

    (2004)
  • L.S. Chan et al.

    Evidence assessment of management of acute otitis media: II. Research gaps and priorities for future research

    Pediatrics

    (2001)
  • Nakayama T. Clinical Practice Guideline consistent with evidence-based medicine manual for development and application....
  • Clinical Practice Guideline for diagnosis and management of acute otitis media in children (2006)

    Otol Jpn

    (2006)
  • Clinical Practice Guideline for diagnosis and management of acute otitis media in children

    Pediatr Otorhinolaryngol Jpn

    (2006)
  • Japan Council for Quality Healthcare Minds...
  • Clinical Practice Guideline for diagnosis and management of acute otitis media in children. Japan Otological Society,...
  • Clinical Practice Guideline for diagnosis and management of acute otitis media in children – 2009 edition. Japan...
  • M. Ito et al.

    Usefulness of the guideline of diagnosis and management of acute otitis media

    Pediatr Otorhinolaryngol Jpn

    (2008)
  • T. Hayashi et al.

    Treatment outcome of acute otitis media in children treated with the newly released guideline in Japan

    Otol Jpn

    (2007)
  • K. Sugahara et al.

    Treatment based on the guidelines for pediatric acute otitis media

    Pediatr Otorhinolaryngol Jpn

    (2007)
  • S. Forgie et al.

    Management of acute otitis media

    Paediatr Child Health

    (2009)
  • A.S. Lieberthal et al.

    The diagnosis and management of acute otitis media

    Pediatrics

    (2013)
  • T. Fukui et al.

    Guide to the preparation of clinical practice guidelines, 4th ed.

    EBM J

    (2003)
  • D. Atkins et al.

    GRADE Working Group. Grading quality of evidence and strength of recommendations

    BMJ

    (2004)
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