WASP for AOM

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Spiro DM, Tay KY, Arnold DH, et al. "Wait-and-see prescription for the treatment of acute otitis media: a randomized controlled trial". JAMA. 2006. 296(10):1235-41.
PubMedFull text

Clinical Question

In children aged 6 months to 12 years who present to the Emerg Department, does the "wait-and-see prescription" (WASP) significantly reduce the use of antibiotics compared to standard of care.

Bottom Line

Allowing parents the opportunity to observe their children for 48 hours to determine if symptoms did not resolve and antibiotics should be given led to a dramatic decrease in antibiotic use.

Major Points

Acute Otitis Media (AOM) is a commonly seen self limiting infection commonly associated with either viral or bacteria (Streptococcus pneumoniae, Hemophilus influenzae, or Moraxella catarrhalis most often) etiologies. >50% AOM is seen in children < 5 years. With the often self-limiting nature of the infection, this trial evaluated if a "wait-and-see prescription" (WASP) could decrease the use of antibiotics without putting patients at undo harm. Including 283 children aged 6 months to 12 years at presented to Emerg, in the intervention group parents/care-givers were given the instruction to observe for 48 hours to assess if symptoms improved or if antibiotics would be warranted. In this single urban centre RCT the control group was given a standard prescription.

Overall this led to a dramatic decrease in the filling of antibiotic prescription of 62% not filled in the intervention vs. 13% (P < 0.001). This cannot be applied to all-comers as children with immunocompromise, unclear follow up, perforation, appearing "toxic", tympanostomy tubes, or other indications for antibiotics were excluded. In the intervention group, comparing those that filled the prescription to those that did not, they show more ear pain for longer, fever more often, more vomiting and more diarrhea.

Caution needs to be applied if using this approach as rare outcomes such as mastoiditis may not have been detected. There was some issue with this trial, the diagnosis was not adjudicated, nor was the choice of antibiotic or the duration of therapy. Severity of illness was also not tracked but one could expect the exclusion criteria to remove the patients that were too ill for this to be appropriate.

Guidelines

Canadian Pediatrics Society Position Statement for AOM 2016: (Adapted) [1]

  • If >6 months, generally healthy, acute onset, with or without fever, with or without signs of middle ear infection and suspected Acute Otitis Media
  • with Middle Ear Effusion and bulging tympanic membrane
  • mild illness (alert, responsive, no rigors, able to sleep, temperature <39°C without antipyretics, onset <48 hours)
  • observe for 24-48 hours with follow-up
  • if not improving consider antibiotics
    • <6 months - 2 years: 10 days duration
    • ≥2 years: 5 days duration

American Academy of Pediatrics. Clinical Practice Guidelines for AOM 2013: (Adapted) [2]

  • Key Action Statement 3A: Severe AOM: The clinician should prescribe antibiotic therapy for AOM (bilateral or unilateral) in children 6 months and older with severe signs or symptoms (ie, moderate or severe otalgia or otalgia for at least 48 hours or temperature 39°C [102.2°F] or higher). Evidence Quality: Grade B. Strength: Strong Recommendation.
  • Key Action Statement 3B: Non-severe bilateral AOM in young children: The clinician should prescribe antibiotic therapy for bilateral AOM in children 6 months through 23 months of age without severe signs or symptoms (ie, mild otalgia for less than 48 hours and temperature less than 39°C [102.2°F]). Evidence Quality: Grade B. Strength: Recommendation
  • Key Action Statement 3C: Non-severe unilateral AOM in young children: The clinician should either prescribe antibiotic therapy or offer observation with close follow-up based on joint decision-making with the parent(s)/caregiver for unilateral AOM in children 6 months to 23 months of age without severe signs or symptoms (ie, mild otalgia for less than 48 hours and temperature less than 39°C [102.2°F]). When observation is used, a mechanism must be in place to ensure follow-up and begin antibiotic therapy if the child worsens or fails to improve within 48 to 72 hours of onset of symptoms. Evidence Quality: Grade B. Strength: Recommendation.
  • Key Action Statement 3D: Non-severe AOM in older children: The clinician should either prescribe antibiotic therapy or offer observation with close follow-up based on joint decision-making with the parent(s)/caregiver for AOM (bilateral or uni- lateral) in children 24 months or older without severe signs or symptoms (ie, mild otalgia for less than 48 hours and temperature less than 39°C [102.2°F]). When observation is used, a mechanism must be in place to ensure follow-up and begin antibiotic therapy if the child worsens or fails to improve within 48 to 72 hours of onset of symptoms. Evidence Quality: Grade B. Strength: Recommendation.

Design

  • Single centre, double-blind, randomized, controlled trial
  • N=283
    • Wait-and-see prescription (WASP) (n=138)
    • Standard Prescription (SP) (n=145)
  • Setting: Tertiary facility, USA
  • Enrollment: July 12, 2004 to July 11, 2005
  • Mean follow-up: 40 days
  • Analysis: Intention-to-treat
    • Power calculation based on secondary outcome of otalgia
  • Primary Outcome: antibiotic prescription filling at community pharmacy

Population

Inclusion Criteria

  • Children 6 months to 12 years
  • diagnosed with acute otitis media at clinician's discretion

Exclusion Criteria

  • Intercurrent bacterial infection diagnosed or suspected
  • patient appeared “toxic” as determined by the clinician
  • patient was admitted to hospital
  • immunocompromised
  • treated with antibiotics in the preceding 7 days
  • current myringotomy tubes or a perforated tympanic membrane
  • uncertain access to medical care including no telephone access
  • primary language of the parent or guardian was neither English nor Spanish
  • patient had already enrolled in the study

Baseline Characteristics

WASP Group shown, groups were similar

  • Demographics: Male sex 57%, Median age 3.6 years, 28% <2 years old
  • Race: Black 35%, Hispanic 47%, White 9%, Other 8%
  • Physiologic parameters: temperature 37.1°C, 19% temperature >38°C
  • Symptoms within 5 days of enrollment: Otalgia 82%, Fever 43%, Cough/rhinorrhea 80%, Diarrhea 7%, Vomiting 22%
  • Previous ear infections in past year: 1 57%, 2 19%, ≥3 21%
  • Medicaid insurance: 84%
  • Exposure to second-hand smoke: 33%
  • Day-care/school attendance: 54%

Interventions

  • Wait-and-see prescription (WASP): written and verbal instruction “not to fill the antibiotic prescription unless your child either is not better or is worse 48 hours (2 days) after today's visit.”
  • Standard prescription (SP): written and verbal instruction “fill the antibiotic prescription and give the antibiotic to your child after today's visit.”
  • All antibiotic prescriptions chosen and dosed by clinician
  • All participants received ibuprofen suspension and otic analgesic drops

Outcomes

Comparisons are Wait-and-see Prescription vs. Standard Prescription.

Primary Outcomes

Antibiotic Prescription not filled
62% vs. 13% (P < 0.001)
Worst-case sensitivity analysis: 59% vs. 20% (P < 0.001)
Children <2 years: 47% vs. 5% (P < 0.001)
Days post enrollment prescription filled, d
2.0 vs. 1.2 (P < 0.001)

Secondary Outcomes

Otalgia
4-6 day follow-up: 64% vs. 67% (P = NS)
11-14 day follow-up: 67% vs. 61% (P = NS)
Total days otalgia
4-6 day follow-up: 2.4 vs. 2.0 (P = 0.02)
11-14 day follow-up: 3.0 vs. 2.7 (P = NS)
Use of otic analgesia
4-6 day follow-up: 93% vs. 90% (P = NS)
11-14 day follow-up: 95% vs. 89% (P = NS)
Total days use of otic analgesia
4-6 day follow-up: 2.9 vs. 2.8 (P = NS)
11-14 day follow-up: 3.2 vs. 3.7 (P = NS)
Fever
4-6 day follow-up: 32% vs. 35% (P = NS)
11-14 day follow-up: 32% vs. 31% (P = NS)
Total days of fever
4-6 day follow-up: 2.0 vs. 1.7 (P = NS)
11-14 day follow-up: 2.3 vs. 1.7 (P = 0.03)
Use of ibuprofen or acetaminophen
4-6 day follow-up: 89% vs. 83% (P = NS)
11-14 day follow-up: 85% vs. 85% (P = NS)
Total days use of ibuprofen / acetaminophen
4-6 day follow-up: 2.6vs. 2.4 (P = NS)
11-14 day follow-up: 3.2 v. 2.9 (P = NS)
Diarrhea
4-6 day follow-up: 8% vs. 23% (P <0.001)
11-14 day follow-up: 12% vs. 24% (P = 0.01)
Total days Diarrhea
4-6 day follow-up: 2.3 vs. 2.0 (P = NS)
11-14 day follow-up: 2.6 vs. 2.2 (P = NS)
Vomiting
4-6 day follow-up: 11% vs. 11% (P = NS)
11-14 day follow-up: 9% vs. 10% (P = NS)
Total days Vomiting
4-6 day follow-up: 1.5 vs. 1.2 (P = 0.02)
11-14 day follow-up: 2.1 vs. 2.1 (P = NS)
Unscheduled visits to clinician
4-6 day follow-up: 10% vs. 8% (P = NS)
11-14 day follow-up: 15% vs. 11% (P = NS)
30-40 day follow-up: 22% vs. 21% (P = NS)
Reason for unschedule visit being Acute Otitis Media
61% vs. 60% (P = NS)

Subgroup Analysis

WASP Group, comparisons are filled (n=50) vs. not filled prescription (n=82) at 4-6 days after enrollment

Otalgia
84% vs. 52% (P < 0.001)
Total days otalgia
2.8 vs. 2.1 (P = 0.002)
Use of otic analgesia
96%vs. 91% (P = NS)
Total days use of otic analgesia
3.0 vs. 2.9 (P = NS)
Fever
52% vs. 18% (P < 0.001)
Total days of fever
2.3 vs. 1.5 (P = 0.03)
Use of ibuprofen or acetaminophen
96% vs. 85% (P = 0.05)
Total days use of ibuprofen / acetaminophen
2.8 vs. 2.4 (P = 0.05)
Diarrhea
12% vs. 5% (P = NS)
Total days Diarrhea
2.5 vs. 2.0 (P = NS)
Vomiting
20% vs. 6% (P = 0.01)
Total days Vomiting
1.8 vs. 1.0
Willingness to withhold antibiotics with future cases of AOM
4-6 day follow-up: 63% vs 28% (P < 0.001)
11-14 day follow-up: 65% vs 31% (P < 0.001)
30-40 day follow-up: 66% vs 26% (P < 0.001)

Criticisms

  • Data is missing due to the research assistants being unable to contact with parents
    • Statistically significant for the 30-40 day follow-up
  • Parents were not blinded and clinicians were un-blinded after group designation
  • Generalizability limited with single centre design in urban Emerg
  • Diagnosis was at the discretion of the clinician
  • Did not assess treatment failure vs. re-infection
  • Did not assess short (5-7 day) vs. long (10 day) duration of antibiotics
  • Could have been under-powered to detect rare adverse events like mastoiditis
  • Did not assess severity of AOM

Funding

  • Grant AI01703 from the National Institutes of Health
  • Grant M01-RR00125 from the General Clinical Research Center, Yale University School of Medicine
  • Friends of Yale-New Haven Children's Hospital who provided material support for this research

Further Reading

  1. Canadian Pediatrics Society Position Statement, Management of acute otitis media in children six months of age and older. Paediatr Child Health 2016;21(1):39-44 [1]
  2. American Academy of Pediatrics Clinical Practice Guidelines: The Diagnosis and Management of Acute Otitis Media. Pediatrics 2013;131:e964-e999 [2]