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Shekelle PG, Takata G, Newberry SJ, et al. Management of Acute Otitis Media: Update. Rockville (MD): Agency for Healthcare Research and Quality (US); 2010 Nov. (Evidence Reports/Technology Assessments, No. 198.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Cover of Management of Acute Otitis Media: Update

Management of Acute Otitis Media: Update.

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Acute Otitis Media (AOM) is a viral or bacterial infection of the middle ear and represents the most common childhood infection for which antibiotics are prescribed in the United States (US).9–11 A 2009 analysis estimated the annual medical expenditures for treating OM in US children (including AOM and OM with effusion) to be approximately $2 billion.12 Timely and accurate diagnosis and management of AOM can have significant individual and public health consequences. The 2001 AHRQ evidence report on the management of AOM analyzed the evidence on the initial management of uncomplicated AOM in children, focusing on the natural history of the disease and the use of antibiotics in management. The report concluded that among children not treated with antimicrobials, the clinical failure rate was highly variable.13 Antibiotic treatment with either ampicillin or amoxicillin did reduce clinical failure rates, and among the antibiotic regimens assessed, there were no differences in clinical failure rates; however some antibiotic regimens were associated with more adverse events than others.

Although the 2001 report provided valuable analysis of the literature on the management of uncomplicated AOM in children, it did not address issues related to diagnostic accuracy and precision, management of AOM in specific subgroups of children, or the impact of immunization with Heptavalent Pneumococcal Conjugate Vaccine (PCV7), recommended for widespread use in 2000, on the microbiology of AOM. Additionally, new trials of treatment continue to be published. The purpose of this current AHRQ evidence report is to examine and analyze the evidence on three broad areas of inquiry: 1) the diagnosis of AOM, 2) the impact of PCV7 on AOM microbial epidemiology, and 3) the comparative effectiveness and safety of different treatment options for uncomplicated AOM in average risk children, and in children with recurrent or persistent AOM.

Diagnostic Accuracy

Otitis media with effusion (OME) is defined as fluid in the middle ear without signs or symptoms of acute infection. Distinguishing AOM from OME often poses a diagnostic challenge.14, 15 Key elements of the diagnosis of AOM include the acute onset of symptoms, presence of middle ear effusion (MEE), and signs of middle ear inflammation.16–18 Errors often occur when the clinician makes a diagnosis of AOM in the absence of MEE.14 At least at the time of the first systematic review on management of AOM, diagnostic certainty appeared to be linked to patients‘ age: Older children (>30 months) were more likely to have a certain diagnosis of AOM than children ≤ 12 months of age.19 Given the uncertainty associated with diagnosis, particularly in young children, it is important to continually assess the validity of the clinical signs and symptoms used to diagnose AOM.


Traditional management approaches have centered on the use of antimicrobials; a 2009 study found that prescription of broad-spectrum antibiotics for AOM increased from 34% of doctor visits in 1998 to 45% of visits in 2004.20 However, debate is increasing over their benefits. Concerns regarding increased antimicrobial resistance and uncertainty about the benefits of antibiotic treatments (e.g., AOM may be either bacterial or viral) have resulted in a number of clinical guidelines proposing more judicious use of antimicrobials.16, 21 The 2004 guidelines released by the American Academy of Pediatrics (AAP) and American Academy of Family Practice (AAFP) recommend antibiotics for all children under 6 months and an observation approach for otherwise healthy children ages 6 months to less than 2 years who have BOTH an uncertain diagnosis and non-severe disease. Observation is also an option for otherwise healthy children 2 years of age or older with either non-severe disease or uncertain diagnosis.16 However, the benefits of a watchful waiting approach in young patients with a certain diagnosis of AOM are unclear.

Amoxicillin is often recommended as the first-line antibiotic for children.16, 21 Although empiric therapy recommendations vary depending on the local antimicrobial resistance patterns, evidence of recent microbiologic shifts and changing resistance patterns associated with PCV7 warrant determining the effectiveness and safety of the current recommendations and evaluating additional antimicrobial agents and other management strategies.

Recurrent otitis media (ROM), defined as three or more episodes in six months or four or more episodes within 12 months, occurs in 20% of children under six months of age.9 Antibiotic resistant Streptococcus pneumoniae (SP) is commonly associated with ROM and presents a significant therapeutic challenge.22, 23 The choice of antimicrobial is not always clear, and the role of prophylactic antibiotics remains uncertain.

Pneumococcal Conjugate Vaccine

SP is a common bacterial isolate from the middle ear fluid of children with otitis media.24 In February 2000, a heptavalent pneumococcal polysaccharide protein conjugate vaccine (PCV7) was recommended for use in children aged 2–23 months and for children aged 24–59 months at increased risk for pneumococcal disease.25 These recommendations were expanded in 2007 to include all healthy, previously unvaccinated children 24–59 months of age. A question that needs to be addressed is whether PCV7 vaccination is associated with a microbiologic shift among pathogens commonly responsible for otitis media.


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