Researchers embarking on clinical trials of antimicrobial treatment for acute otitis media (AOM) must make several key decisions beforehand. They must choose a study age group, stipulate study eligibility, specify criteria for the diagnosis of AOM, decide on the antimicrobial drug to be used and on its dosage, specify analgesic use, and settle on 1 or more endpoints or outcome measures. If more than 1 outcome is to be measured, convention calls preferentially for only 1 of them to be designated as primary. Each of these decisions potentially bears on what the eventual study findings will be, on how they may be interpreted and on the treatment recommendations that logically flow from them.
Pediatr Infect Dis J. 2013;32(7):745-747. © 2013
Lippincott Williams & Wilkins