11 pediatric offices of the Cincinnati Pediatric Research Group participated
in the recruitment of study participants. Children, ages 1 to 12 years,
with uncomplicated AOM were eligible. Of the 199 families approached,
5 declined to participate, leaving 194 subjects for study. This allowed
for statistical power of 80% to detect a 5% reduction in antibiotic
Otitis media was a clinic diagnosis defined as: 1) a bulging or pustular
TM on otoscopy or 2) red TM with decreased mobility by pneumatic otoscopy
Children were excluded for "complicated" AOM, e.g. temperature
>101.5, symptoms for >48 hours, toxic appearance, TM perforation
or impending perforation, AOM within the last 3 months, or chronic condition
limiting the child's ability to clear an infection.
Study participants were given written information and samples of ibuprofen,
acetaminophen, and otic drops at no expense. They were provided the
SNAP to be filled if symptoms were worse or not better after 48 hours.
The study nurse conducted a structured phone follow-up interview 5-10
days after enrollment. Main outcome measures were: if the SNAP was filled
compared with antibiotic use for previous AOM and parents' future willingness
to treat AOM with pain medicine alone.
69% of families did not fill the SNAP (95%CI: 61.7%-75.5%). Of those
who did not fill the SNAP, 97% were willing to treat the next AOM with
pain medication alone (95%CI: 94.4-100%). All parents whose child had
previous AOM reported antibiotic use; only 33% of this population used
antibiotics to treat this episode.
Demographic variables did not account for differences in parents' behavior.
Previous episodes of AOM were the only statistically significant variable
associated with increased rate of SNAP use. Parents of children who
had had 2 or more AOM in the past were more likely to fill the SNAP.
Suppurative complications were not reported and the time period for
follow-up was limited.