The adoption of more stringent diagnostic criteria for acute otitis media (AOM) support a uniform approach to antibiotic treatment for children aged younger than 2 years who receive the diagnosis, researchers suggest.

The most recent American Academy of Pediatrics guidelines recommend antimicrobial treatment for children aged 6 months to 2 years with AOM, with one exception — clinicians may consider watchful waiting for children in whom the disease is unilateral and unaccompanied by severe signs or symptoms.

However, findings from a new pooled analysis of two previously published trials suggest this distinction may not be necessary, as diagnostic criteria used in studies on which the guidelines were based were less strict than current requirements, and present the possibility that some treated children did not actually have AOM.

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Alejandro Hoberman, MD, of the University of Pittsburgh and colleagues, assessed findings from two previously published trials, one conducted in Pittsburgh and the other in Turku, Finland, both of which had stringent requirements for enrollment that came close to guaranteeing valid diagnoses.

In the Pittsburgh trial, treatment failure was defined as inadequate symptomatic or otoscopic improvement by day four or day five, and incomplete resolution by days 10 to 12.

In the Turku trial, treatment failure was defined as a lack of overall improvement by day three, no improvement in otoscopic findings by day eight and the occurrence at any time of overall clinical deterioration, perforation of the tympanic membrane or treatment discontinuation.

Cases were defined as severe AOM if parents described their child’s pain as moderate or severe or if the child had a temperature of 39 degrees C.

In general, treatment failure rates were similar for severe and nonsevere AOM and for unilateral or bilateral cases, Oberman and colleagues reported in JAMA Pediatrics.

Among patients with unilateral severe disease, treatment failure rates were 14% in the treated group and 47% in the placebo group, with an adjusted relative risk of 0.34 (95% CI: 0.18-0.50) 

Among those with bilateral nonsevere AOM, treatment failure was 22% and 53%, respectively, for the treated and untreated risk, for an aOR of 0.31 (95% CI: 0.14-0.48).

The numbers needed to treat were similar for all forms of AOM, at four and three for unilateral nonsevere and severe cases, and four and three for bilateral nonsevere and severe cases, respectively.

“These findings make a case for a uniform approach to antimicrobial treatment in children younger than 2 years with stringently diagnosed AOM, irrespective of laterality or apparent severity of their illness,” the researchers concluded.


  1. Hoberman A et al. JAMA Pediatr 2013; DOI: 10.1001/jamapediatrics.2013.3068.