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

Toward Answering the Question

Conceptually, the design of a study to address the question seems quite simple. Enrollment would be limited to children younger than 2 or 3 years who have unequivocal otoscopic evidence of middle-ear infection but who are substantially asymptomatic. The children would be randomly assigned to receive a course of either an antimicrobial or placebo and would then be monitored over an extended period to ascertain the extent to which they experience recurrent symptoms, new AOM episodes and persistent middle-ear effusion. Eligible children could comprise not only those completing a course of antimicrobial treatment for AOM but also those in whom an episode of AOM was purposely not treated or in whom the presence of AOM is discovered incidentally in the course of routine well-child care.

Practically, however, mounting and effectively conducting such a study will likely not be so simple. The appearance of potentially eligible children will not be an everyday occurrence in most clinical settings, so that a sustained, multicenter effort will likely be required to enroll sufficient numbers of subjects to enable reaching definitive conclusions. Potentially interested researchers should nonetheless not be deterred; until such a study is successfully carried out, the symptoms-versus-signs debate will almost certainly go on, and decisions about antimicrobial treatment for many young children with AOM will continue to be based on opinion rather than on relevant evidence.

This work was supported, in part, by Grant 3U01AI066007-02S1 from the National Institute of Allergy and Infectious Diseases. The authors have no other funding or conflicts of interest to disclose.