Wait-and-See Prescription for the Treatment of Acute Otitis Media: A Randomized Controlled Trial

Abstract

Spiro DM, Tay KY, Arnold DH, Dziura JD, Baker MD, Shapiro ED. JAMA. 2006;296:1235–1241 PURPOSE OF THE STUDY. Acute otitis media (AOM) is the most common diagnosis for which antibiotics are prescribed for children. Previous trials that have evaluated a “wait-and-see prescription” (WASP) for antibiotics, with which parents are asked not to fill the prescription unless the child either is not better or is worse in 48 hours, have excluded children with severe AOM. None of these trials were conducted in an emergency department. The purpose of this study was to determine if treatment of AOM using a WASP significantly reduces use of antibiotics compared with a standard prescription (SP) and to evaluate the effects of this intervention on clinical symptoms and adverse outcomes related to antibiotic use. STUDY POPULATION. Children with AOM aged 6 months to 12 years seen in an emergency department in 1 year. METHODS. A randomized, controlled trial was conducted; patients were randomly assigned to receive either a WASP or an SP. All patients received ibuprofen and otic analgesic drops for use at home. A research assistant who was blinded to group assignment conducted structured telephone interviews 4 to 6, 11 to 14, and 30 to 40 days after enrollment to determine outcomes and monitor filling of the antibiotic prescription and clinical course. RESULTS. Overall, 283 patients were randomly assigned to either the WASP (n = 138) or SP (n = 145) group. Substantially more parents in the WASP group did not fill the antibiotic prescription (62% vs 13%; P < .001). There was no statistically significant difference between the groups in the frequency of subsequent fever, otalgia, or unscheduled visits for medical care. Within the WASP group, both fever (relative risk: 2.95; 95% confidence interval: 1.75–4.99; P < .001) and otalgia (relative risk: 1.62; 95% confidence interval: 1.26–2.03; P < .001) were associated with filling the prescription. CONCLUSIONS. The WASP approach substantially reduced unnecessary use of antibiotics in children with AOM seen in an emergency department and may be an alternative to routine use of antimicrobial agents for treatment of such children. REVIEWER COMMENTS. This study added a few new twists to 2 previous, similar studies: (1) the patients had no previous relationship with the prescribing physician; (2) the patients, overall, were sicker, being seen in an ED; and (3) otic analgesics and ibuprofen were allowed. The use of antibiotics by those in the WASP group was 56% less than those in the SP group. We try in our practice to use a similar approach in our patients who also present with symptoms of acute sinusitis. Still, I wonder how many patients who do not use their prescription just save it for their next episode.