PEDIATRICS Vol. 115 No. 5 May 2005, pp. 1443-1444 (doi:10.1542/peds.2005-0064)
Thoughts on the American Academy of Pediatrics/American Academy of Family Physicians Clinical Practice Guideline on Acute Otitis Media: A Different Perspective
Harry Pellman, MDEdinger Medical Group and Research Center
Fountain Valley, CA 92708
To the Editor.—
In the May 2004 issue of Pediatrics, the Subcommittee on Management of Acute Otitis Media published its long-awaited clinical practice guideline,1 updating our understanding of this complex process.
The guideline is very helpful in pointing out the importance of pain management and reviewing strategies for more effective pain relief. Adopting preventive strategies to reduce the frequency of acute otitis media (AOM) is another important contribution. The most difficult and contentious recommendations made by the subcommittee involve criteria necessary for the accurate diagnosis and treatment of AOM.
An important stated mission of the diagnostic component of the guideline is to reduce overdiagnosis of AOM. The first guideline recommendation concerns the elements of the history and physical examination needed to diagnose AOM accurately. The guideline co-chair, Allan S. Lieberthal, MD, is quoted in the September 2004 issue of Infectious Diseases in Children as stating: "The most important aspect of managing acute otitis media (AOM) is diagnosing the disease...You must make an accurate diagnosis."2 As the authors correctly state, otitis media with effusion (OME) is often misdiagnosed as AOM.3 The guideline states: "Clinicians should strive to avoid a false-positive diagnosis in children with middle-ear discomfort...A major challenge for the practitioner is to discriminate between OME and AOM." In other words, the authors want the diagnostic component of the guideline to stress specificity over sensitivity. "Specificity" means that it would be okay to miss a few cases of AOM as long as almost every ear diagnosed as AOM really had AOM. "Sensitivity" means that no case of AOM would be missed at the expense of mislabeling many ears with OME or other diagnoses as AOM.
However, evidence has shown that many of the elements listed in the complex diagnostic table in the guideline are nonspecific and of limited value in separating AOM from OME. Guideline element 2 suggests that decreased mobility of the tympanic membrane (TM) and the presence of an air-fluid level behind the TM are as important in differentiating AOM from OME as are bulging of the tympanic membrane and otorrhea. Element 3 lists distinct erythema as a key finding in AOM.
In fact, well-conducted studies support different (and simplified) diagnostic criteria for a more specific diagnosis of AOM. Of 15 patients that had distinct redness without bulging of the TM, none had fluid or bacteria when tympanocentesis was performed by Halsted et al.4 In contrast, 61 of 67 patients with bulging and opaque eardrums yielded pus and pathogenic bacteria when tapped regardless of TM color. In fact, their summary states that "[w]ith few exceptions, the drums that showed definite bulging and total absence of landmarks yielded pus when aspirated and bacteria when cultured, while the diffusely red but not bulging membranes yielded no fluid and negative cultures."
Harrison5 states: "Contrary to what many clinicians are taught during training, erythema of the TM is the least specific finding for AOM." Pelton's review,6 referenced in the guideline, showed that TM bulging and opacification had a high predictive value (83–99%) of AOM, whereas distinct TM redness alone had a very low predictive value (7–15%) of AOM.
Schwartz,7 in a well-conducted tympanocentesis study, was able to demonstrate that "a diffusely red, nonbulging, dull tympanic membrane, mobile to negative and positive pressure, must be considered nonpathologic. A completely bulging yellow, opacified tympanic membrane...was the most frequently observed sign of acute otitis media." In addition, Schwartz found that fever was only present in 61% of patients with confirmed AOM. Symptoms of pain, including tugging of the ear, were absent in 20% of young patients. Finally, "segmental AOM should be considered as representing AOM with effusion" and "all three major effusion types, namely purulent, serous, and mucoid, can occur acutely." The above-mentioned findings are all in conflict with the complex criteria listed in the American Academy of Pediatrics/American Academy of Family Physicians diagnostic table. Continuing to promote a red TM as one of the important findings of AOM is incorrect and misleading.
Listing the diagnostic criteria as a bulging, opaque TM, confirmed by pneumatic otoscopy or otomicroscopy, would both simplify the diagnostic criteria in the guideline and confer the greater diagnostic specificity needed to reduce the problem of overdiagnosis of AOM. A small number of evolving or resolving AOM infections would not fit into this diagnostic guideline. Clinical decisions should be made by the practitioner in patients with atypical findings.
Guideline recommendation 3A deals with "the observation option." For studies to reflect the role of antimicrobial therapy accurately, only patients with proven AOM should be enrolled (enrolling patients without proven AOM biases the results toward a nontreatment option), and the antibiotic used must be the best one available and dosed optimally (using a less effective antibiotic also biases the results toward the nontreatment option).
The studies selected by the guideline authors had very nonspecific diagnostic criteria for AOM and therefore included a significant number of enrollees without AOM. This was confirmed by the low rates of positive tympanocentesis cultures on those studies that used myringotomies. A study by Kaleida et al8 only confirmed AOM in 71.4% of "severe" and 64.8% of "nonsevere" AOM-diagnosed children when myringotomies were performed. Despite this bias toward the nontreatment arm, antibiotic treatment still reduced failures, children with middle-ear effusion (MEE), and the length of time with MEE.
Two important goals of therapy that should be considered are improving quality of life and preventing suppurative complications. Other studies cited by the guideline authors that had similar shortcomings still confirmed more rapid pain relief, less crying, shorter fever duration, and less analgesic use. It is reasonable to infer that the results would have been even better with a more accurately diagnosed AOM study population and the use of highly effective antibiotics.
It has been shown that children with a definite diagnosis of AOM (confirmed by tympanocentesis) who are treated with an appropriate antibiotic will sterilize their middle-ear fluid rapidly, whereas children treated with placebo will continue to harbor pathogens9,10 (eg, Howie and Ploussard's9 pooled data for streptococcus pneumonia, Haemophilus influenza, and Moraxella: a 2- to 4-day sterilization rate with antibiotics of 97% and with placebo 17.5%).
In addition, the use of the arbitrary categories of "severe" and "nonsevere" AOM in decision-making does not seem to be helpful and is not based on evidence. The designations made by Kaleida et al8 were based on height of fever and severity of pain. However, fever is frequently absent in AOM,7 and high fever is frequently present in the viral infections that are so common in children. In fact, the positive tympanocentesis rates between the 2 Kaleida et al categories (71.4% for the "severe" groups and 64.8% for the "nonsevere" groups) were so similar that this designation should not be part of the decision-making process.
Although the guideline has provided an important tool for pediatricians, an open forum on some of the guideline recommendations is necessary to clarify some of the discrepancies with the available evidence.
REFERENCES
1. American Academy of Pediatrics, Subcommittee on Management of Acute Otitis Media. Diagnosis and management of acute otitis media.
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2. Rosenthal M. Guideline for AOM: controversy where there shouldn't be? Infect Dis Child. 2004:35
3. Pichichero ME, Poole MD. Assessing diagnostic accuracy and tympanocentesis skills in the management of otitis media.
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4. Halsted C, Lepow ML, Balassanian N, Emmerich J, Wolinsky E. Otitis media. Clinical observations, microbiology, and evaluation of therapy.
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5. Harrison CJ. The laws of acute otitis media. Prim Care. 2003;30 :109 –135[Web of Science][Medline]
6. Pelton SI. Otoscopy for the diagnosis of otitis media. Pediatr Infect Dis J. 1998;17 :540 –543[CrossRef][Web of Science][Medline]
7. Schwartz RH, Stool SE, Rodriguez WJ, Grundfast KM. Acute otitis media: toward a more precise definition. Clin Pediatr (Phila). 1981;20 :549 –554
8. Kaleida PH, Casselbrant ML, Rockette HE, et al. Amoxicillin or myringotomy or both for acute otitis media: results of a randomized clinical trial.
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9. Howie VM, Ploussard JH. Efficacy of fixed combination antibiotics versus separate components in otitis media. Effectiveness of erythromycin estrolate, triple sulfonamide, ampicillin, erythromycin estolate-triple sulfonamide, and placebo in 280 patients with acute otitis media under two and one-half years of age. Clin Pediatr (Phila). 1972;11 :205 –214
10. Ruohola A, Heikkinen T, Meurman O, Puhakka T, Lindblad N, Ruuskanen O. Antibiotic Treatment of acute otorrhea through tympanostomy tube: randomized double-blind placebo-controlled study with daily follow-up.
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PEDIATRICS (ISSN 1098-4275). ©2005 by the American Academy of Pediatrics
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