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Educational Objectives:
After evaluating this article participants will be able to:
-Incorporate the current evidence into practice to more accurately diagnose otitis media
-Modify their practice to include an option for observation of otitis media patients to reduce antibiotic prescribing
-Recognize the necessary elements for appropriate observation of patients with suspected otitis media

 
Elements of the definition of acute otitis media (AOM) are all of the following:
  • Recent, usually abrupt, onset of signs and symptoms of middle-ear inflammation and MEE
  • The presence of a middle ear effusion that is indicated by any of the following:
  • Bulging of the tympanic membrane
  • Limited or absent mobility of the tympanic membrane
  • Air-fluid level behind the tympanic membrane Otorrhea

Signs or symptoms of middle-ear inflammation as indicated by either:
  • Distinct erythema of the tympanic membrane or
  • Distinct otalgia (discomfort clearly referable to the ear[s] that results in interference
 
It is important to note that the AAP uses limited or absent mobility of the tympanic membrane in the criteria for diagnosis. Therefore it is imperative for us to use an insufflator when performing and documenting the ear examination. The presence of a red ear alone, is not enough to confirm the diagnosis. It is also important to be aware of the criteria for Initial Antibacterial-Agent Treatment or Observation in Children With AOM (Diagnosis and Management of Acute Otitis Media AMERICAN ACADEMY OF PEDIATRICS: Subcommittee on Management of Acute Otitis Media. Pediatrics, May 2004; 113: 1451 - 1465.)

Study #1:
Siegel RM, Kiely M, Bien JP etal Treatment of otitis media with observation and a safety-net antibiotic prescription. Pediatrics. 2003 Sep;112(3 Pt 1):527-31.

Objective: To determine whether antibiotic usage for AOM could be decreased by prescribing a safety-net antibiotic prescription (SNAP) to be filled if symptoms do not resolve.
 
Methods: A pediatric practice-based research network in a midwestern community of 1.8 million was the setting for this study. The Cincinnati Pediatric Research Group (CPRG) includes practices in Ohio, Kentucky, and Indiana. Children who were between 1 and 12 years of age and presented to the offices of the CPRG with uncomplicated AOM were eligible for the study. Children were excluded when they had temperature >101.5 degrees F, had an ear infection in the past 3 months, showed signs of another bacterial infection, or were toxic appearing. Families were given acetaminophen, ibuprofen, or topical otic anesthetic drops for pain control. They were also given a prescription for an antibiotic and instructed not to fill it unless symptoms either increased or did not resolve after 48 hours. The data were entered directly by investigators via an Internet site.
 
Results: A total of 194 children were enrolled in 11 offices over 12 months; 175 (90%) completed the follow-up interview. The average child’s age was 5.0 years. Only 55 (31%) of the 175 who were contacted for follow-up had filled their antibiotic prescription. Compared with their previous experience, parents were overwhelmingly willing to treat AOM with pain medication alone (chi(2) = 111). Seventy-eight percent (95% confidence interval: 71%-84%) of parents reported that the pain medication was effective. Sixty-three percent (95% confidence interval: 55%-70%) of parents reported that they would be willing to treat future AOM episodes without antibiotics and with pain medication alone.

Conclusion: A subset of parents find a safety-net prescription and pain control acceptable in the treatment of AOM, and antibiotic usage can be lowered with this strategy.
**********

Study #2:

Spiro DM, Tay KY, Arnold DH, etal. Wait-and-see prescription for the treatment of acute otitis media: a randomized controlled trial. JAMA. 2006 Sep 13;296(10):1235-41.

Context: 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.
 
Objectives: To determine whether 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.

Method: A randomized controlled trial conducted between July 12, 2004, and July 11, 2005. Children with AOM aged 6 months to 12 years seen in an emergency department 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, blinded to group assignment, conducted structured phone interviews 4 to 6, 11 to 14, and 30 to 40 days after enrollment to determine outcomes.

Main Outcome Measures: Filling of the antibiotic prescription and clinical course.

Results: Overall, 283 patients were randomized either to the WASP group (n = 138) or the SP group (n = 145). 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 [RR], 2.95; 95% confidence interval [CI], 1.75 - 4.99; P<.001) and otalgia (RR, 1.62; 95% CI, 1.26 - 2.03; P<.001) were associated with filling the prescription.

Conclusion: 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
**********

Study #3:
Chao JH, Kunkov S, Reyes LB, etal. Comparison of two approaches to observation therapy for acute otitis media in the emergency department.Pediatrics. 2008 May;121(5):e1352-6.

Objective: This study compared parental adherence to delayed antibiotic therapy for acute otitis media with and without a written prescription in a pediatric emergency department.

Patients and Methods: Children aged 2 to 12 years who met criteria for delayed antibiotic treatment were randomly assigned to observation therapy with or without a prescription. Patients randomly assigned to observation therapy without prescription were instructed to seek follow-up care if symptoms persisted for 2 to 3 days. Patients assigned to observation therapy with a prescription were discharged with an antibiotic prescription, and instructed to fill it if their child’s symptoms persisted 2 to 3 days. A research assistant who was blinded to group assignment called parents 7 to 10 days after the visit to assess adherence to observation therapy.

Results: Of 117 children assigned to the observation therapy group, 100 completed follow-up; of 115 assigned to the observation therapy with a prescription group, 106 completed follow-up. In the observation therapy group, 87 parents reported no antibiotic use within the 3-day observation period compared with 66 parents in the prescription group. During the entire study period, 81% of the observation therapy group reported no use of antibiotics compared with 53% in the prescription group. These groups did not differ in satisfaction with the visit; 91% and 95% were very or extremely satisfied, respectively. No complications were reported.
 
Conclusions: Observation therapy with and without a prescription were both well accepted by parents of children diagnosed with acute otitis media in an urban pediatric emergency department. Adherence to delayed antibiotic therapy was better for those not offered a prescription. These data suggest that, in the pediatric emergency department setting, observation therapy reduces antibiotic use without compromising satisfaction with the visit.

AOM Final analysis
Observation is an appropriate option only when follow-up can be ensured and antibacterial agents started if symptoms persist or worsen. Mobility of the tympanic membrane should be documented when diagnosing or ruling out an acute otitis media. There are some occasions when this may not be necessary and this includes a bulging or ruptured tympanic membrane. However, documenting a “red” ear is not adequate and if the chart is reviewed for medicolegal purposes, the diagnosis will no doubt be questioned.

Patients who should typically not follow the watch and wait approach are those at increased risk for otitis media. These risk factors include: <2 years old, day care exposure, history of prior AOM, recent ABX for AOM, lack of full heptavalent pneumococcal immunization, low rate of breastfeeding, and exposure to tobacco smoke. For the non-high risk group, a watch and wait approach, may be warranted. Chao’s study confirmed that requiring an ear recheck and not giving a prescription actually decreased antibiotic use more than the wait and see prescription approach. Depending on the ease of scheduling follow up and whether the 48-72 hour follow-up window falls on a weekend or holiday, the decision to write the prescription is an individual one. The advantage is that it saves the family another trip to the ED or PMD but there is also higher risk of the family filling the prescription even if it may not have been warranted.
 


     

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