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. Nonetheless, to conform with a Food and Drug Administration recommendation at the time, we designated abatement of symptoms as our primary trial outcome and resolution of infection as 1 of several secondary outcomes.
Pediatr Infect Dis J. 2013;32(7):745-747. © 2013
Lippincott Williams & Wilkins