Treating Acute Otitis Media in Young Children

What Constitutes Success?

Jack L. Paradise, MD; Alejandro Hoberman, MD; Howard E. Rockette, PhD; Nader Shaikh, MD, MPH


Pediatr Infect Dis J. 2013;32(7):745-747. 

In This Article

Choice of Primary Outcome

Our original predilection was to designate resolution of infection as our primary outcome, reflecting our belief that the assessment of TM status by a validated otoscopist better reflects middle-ear status than do symptoms, which, in infants and young children with AOM, are mostly nonspecific, variable and not infrequently absent.[5] Nonetheless, to conform with a Food and Drug Administration recommendation at the time,[6] we designated abatement of symptoms as our primary trial outcome and resolution of infection as 1 of several secondary outcomes.