Author: Dr. Dainis Berzins
An overview of the journal article titled Wait-and-See Prescription for the Treatment of Acute Otitis Media, a Randomized Controlled Trial (JAMA, Sept. 13, 2006)
While practicing medicine today we are constantly reminded of the importance of antibiotic stewardship while simultaneously feeling the pressure from our patients (and their parents) to unnecessarily write antibiotic prescriptions. This is one of the initial practice-changing studies that equipped clinicians with objective evidence to reduce the amount of antibiotic prescriptions and employ shared decision making to provide better care.
Background:
- AOM is the most common reason antibiotics are prescribed to children.
- AOM accounts for approximately 15 million prescriptions annually in the US.
- Untreated AOM has a high rate of spontaneous resolution, with similar rates of complications whether antibiotics are prescribed or withheld.
- Resistance to antibiotics is a major public health concern worldwide and is associated with the widespread use of antibiotics.
Study Question:
- For the treatment of Acute Otitis Media (AOM), does using a “wait-and-see prescription” (WASP) significantly reduce use of antibiotics compared with a “standard prescription” (SP)?
- How do antibiotics effect clinical symptoms of AOM and what are the adverse outcomes related to antibiotic use?
Design:
- This was a Randomized Controlled Trial carried out at the pediatric ED of Yale-New Haven Hospital looking at children aged 6 months to 12 years who were diagnosed with AOM.
- Computer-assisted randomization assigned patients a unique number corresponding to WASP or SP group.
- WASP group was instructed “not to fill the antibiotic prescription unless your child either is not better or is worse 48 hours (2 days) after today’s visit” while the SP group was told to start taking the antibiotic immediately.
- A research assistant, blinded to group assignment, conducted structured phone interviews to determine outcomes.
Results:
- Sample Size: 283 patients. WASP (n = 138) & SP (n = 145)
- Primary Outcome:
- WASP reduced the use of antibiotics by 56%
- 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.
- Secondary Outcomes:
- No serious adverse events were reported for patients in the study.
- Of those parents who reported otalgia in their children, there were statistically significant but minor differences between the WASP and SP groups in total days of otalgia only at the 4- to 6-day interview (2.4 vs 2.0; P = .02)
- Diarrhea was more frequently reported in the SP group, and this difference was statistically significant (8% vs 23%; P<.001).
Discussion:
- Study Deductions:
- WASP is a successful treatment strategy for AOM when patients may not have an established relationship with the clinician.
- Antibiotics can lead to severe side-effects including GI symptoms, allergic reactions and bacterial resistance which must be weighed against their benefits for an illness that has been shown to be self-limited.
- WASP for AOM will reduce both the costs and adverse effects associated with antibiotic treatment and should reduce selective pressure for organisms resistant to commonly used antimicrobials.
- Strengths:
- Nonresponse bias is negligible as very few parents failed to complete the interviews.
- Group size was large enough to effectively power study.
- Weakness/Limitations:
- Parents were not blinded to group designation since the primary outcome was based on the treatment choice of the parent.
- Results may not be generalizable to all acute-care settings as this was a single-center study performed in an urban emergency department.
Take Away:
- 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 antimicrobials for treatment of such children.
Reference:
- Spiro DM, Tay KY, Arnold DH, Dziura JD, Baker MD, Shapiro ED. Wait-and-see prescription for the treatment of acute otitis media: a randomized controlled trial. JAMA. 2006 Sep 13;296(10):1235-41. doi: 10.1001/jama.296.10.1235. PMID: 16968847.