An evidence-based clinical practice guideline¹ to inform physicians on the management of uncomplicated acute otitis media (AOM) among children ages two months through 12 years is now available. It was developed by the multidisciplinary Subcommittee on Management of Acute Otitis Media, which was composed of representatives from the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), and other relevant professional organizations. A summary of this clinical practice guideline appears in this issue of American Family Physician.²

Using a methodology similar to that used for the recent guideline on the management of otitis media with effusion,³ this AOM guideline is based on the best available published data as summarized in the Agency for Healthcare Research and Quality report on AOM⁴ and literature subsequently published through September 2003. Evidence-based statements contained in the AOM guideline¹ follow AAP definitions, reflecting both the quality of evidence and the balance of benefit and harm.⁵

To highlight the key points, the guideline¹ offers recommendations for accurate diagnosis, assessment, and treatment of pain, and the use of an observation option among selected patients, with interval reassessment.

• The diagnosis of AOM requires that the clinician confirm a history of acute onset, identify signs of middle ear effusion, and evaluate for the presence of signs and symptoms of middle ear inflammation. [Recommendation] The degree of diagnostic certainty, which should be discussed with the child's caregiver, is important because of its impact on management strategies.

• The management of AOM should include an assessment of pain. If pain is present, the clinician should recommend treatment to reduce pain. [Strong recommendation] Because episodes of AOM commonly are associated with varying levels of discomfort, management of pain should be addressed.

• Observation without the use of antibacterial agents in a child with uncomplicated AOM is an option for selected children based on diagnostic certainty, age, illness severity, and assurance of follow-up. [Option] This “observation option” should be limited to otherwise healthy children six months to two years of age with nonsevere illness at presentationand an uncertain diagnosis,and to children two years of age and older without severe symptoms at presentation or with an uncertain diagnosis; access to follow-up care also should be ensured.

This observation option relies on clinical judgment and provides an opportunity for the patient to improve without antibacterial treatment. Most cases of AOM resolve, with 61 percent of children having decreased symptoms after 24 hours whether they receive placebo or antibacterial agents; by seven days, about 75 percent of children have resolution of symptoms.⁶ A meta-analysis⁴ showed that there was a 12 percent reduction in the clinical failure rate within two to seven days of diagnosis when ampicillin or amoxicillin was prescribed, compared with an initial use of placebo or observation (number needed to treat, 8).

In 1990, observation was successfully implemented in the Netherlands and has been jointly promoted since 2002 by the New York State Department of Health and the New York Region Otitis Project Committee.^7,8

• If a decision is made to treat with an antibacterial agent, the clinician should prescribe amoxicillin for most children. [Recommendation] The justification to use amoxicillin as first-line therapy in most patients with AOM relates to its general effectiveness when used in sufficient dosages (80 to 90 mg per kg per day). The optimal duration of therapy is uncertain, and clinical judgment is advised.

• Patients who fail to respond to the initial management option within 48 to 72 hours warrant reassessment to confirm AOM and exclude other causes of illness. If AOM is confirmed in the patient initially managed with observation, the clinician should begin anti-bacterial therapy. If the patient initially was managed with an antibacterial agent(s), the clinician should change the antibacterial agent(s). [Recommendation]

• Clinicians should encourage the prevention of AOM through reduction of risk factors. [Recommendation] Risk factor reduction includes promoting the use of pneumococcal conjugate and influenza vaccines.

The guideline made no recommendation regarding the use of complementary and alternative medicine in the management of AOM because of the lack of evidence documenting efficacy. In addition, the guideline identifies multiple research issues for primary care researchers relating to the diagnosis and management of AOM.

Care providers represent an important ally to engage regarding monitoring and follow-up of children managed with the observation option. It should be noted, however, that these guidelines are not appropriate for all practice settings, and some may view these guidelines as controversial. These joint AOM guidelines provide valuable support for efforts to integrate evidence into clinical practice while potentially decreasing the unnecessary use of antibiotics.

The complete AOM guideline, along with a set of questions and answers related to the guideline, can be found at the AAFP Web site athttps://www.aafp.org/x26481.xml.