Clinicians use various criteria to diagnose acute otitis media (AOM). Using American Academy of Pediatrics (AAP) guidelines, we reviewed the consistency of AOM diagnosis in clinical trials (1994-2005). Eighty-one percent of the studies required at least one of the three AAP criteria. Only 20% of the 88 studies met all three AAP criteria for a diagnosis. We found no association between the number of criteria met and study quality or industry sponsorship. Better agreement on the definition of AOM using AAP criteria could facilitate a more accurate clinical diagnosis and provide standardization of research and patient care practices.
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