Acute Otitis Media (AOM) is one of the most common diagnoses of childhood and is responsible for significant morbidity and use of health care services. Nevertheless, management of AOM varies widely. This report was commissioned to produce a systematic review of the literature on diagnosis, primary and secondary prevention, treatment, follow-up and monitoring, and outcomes. METHODOLOGY: A panel of experts that included health care professionals, a consumer, and a representative from a managed care organization was convened to advise with prioritizing proposed questions and guide the development of the scope, search strategy, and analysis plan. According to the panel, the key questions to answer with a literature review were the natural history of AOM without antibiotic treatment, the general effectiveness of antibiotics, and the effectiveness of specific antibiotic regimens. The review focused on children from 4 weeks to 18 years with uncomplicated AOM, seeking initial treatment. Outcomes included presence or absence of signs and symptoms after specific followup intervals, adverse effects from antibiotic treatment, and presence or absence of bacteria. The scientific literature was searched for the period from 1966 through 1999, and research reports were evaluated for study design and quality and were reviewed according to methods developed by the Center. Formal meta-analysis was performed to assess the effectiveness of antibiotics vs. placebo or observational treatment and the effectiveness of various antibiotic regimens. OUTCOMES: Clinical resolution of AOM without treatment appears fairly high, and complication rates tend to be low. Meta-analysis of the effects of antibiotic treatment showed minimal to modest benefits of antibiotics compared with observation only. Several outcomes were unaffected by antibiotic treatment; these outcomes included recurrence and tympanic membrane perforation. Meta-analyses revealed few differences in outcome among the various antibiotic treatment regimens. The literature also was shown to have a number of important limitations that made analysis difficult. These limitations included varying diagnostic criteria for AOM, poor study quality, varying definition or inclusion of outcomes, insufficient statistical power in some cases, failure to report age or risk factors. Recommendations included designing randomized controlled trials without the aforementioned limitations to address the key questions more adequately.
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