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Marcy M, Takata G, Shekelle P, et al. Management of Acute Otitis Media. Rockville (MD): Agency for Healthcare Research and Quality (US); 2001 May. (Evidence Reports/Technology Assessments, No. 15.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Cover of Management of Acute Otitis Media

Management of Acute Otitis Media.

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1Introduction

Purpose

The purpose of this evidence-based report is to review the evidence on the natural history of acute otitis media (AOM) and the role of antibiotics in the treatment of uncomplicated AOM in children. The evidence compiled in this report is intended to aid the nominating organizations and others to develop clinical practice guidelines or medical review criteria for AOM. The report also will identify areas for future research.

Scope of Work

The nominating organizations to this topic of the evidence report initially proposed five broad areas of inquiry: (1) factors influencing the course of an episode of AOM, (2) variation in definitions of AOM used in studies, (3) the role of antibiotics, (4) followup, and (5) prevention. Based on degree of importance, including level of controversy and feasibility of answering the question, the Technical Expert Panel limited the scope of this evidence report to the natural history of AOM and the role of antibiotics in treatment of children ages 4 weeks to 18 years. The study also evaluated the influence of specific factors apart from antibiotics on the course of AOM.

Definition

Although readily recognized as a clinical condition, AOM appears to be without a standard definition. In 1985, Paparella, Bluestone, Arnold, et al. (1985), reporting on an international effort to define terms related to otitis media, stated "The panel recognizes the impossibility of recommending terms unanimously acceptable to all." The following four sets of references are often cited as sources for authoritative definitions of AOM and demonstrate the lack of uniform specificity:

  • Although not defining acute otitis media, Paparella, Bluestone, Arnold, et al. (1985) defined otitis media as "an inflammation of the middle ear (which may or may not be of infectious origin in contrast to infection, which implies a microbiologic etiology)." An earlier attempt by the same group (Senturia, Paparella, Lowery, et al., 1980) had resulted in 8 categories of otitis media out of 28 that were modified by the term "acute." The group defined "acute process" as the "initial 3 weeks" associated with "onset -- may be short and rapid or signs and symptoms may be subtle and onset slow and insidious."
  • In 1992, the Infectious Diseases Society of America (Chow, Hall, Klein, et al., 1992) offered the following definition of AOM: "inflammation of the middle ear as evidenced by the presence of fluid and accompanied by specific signs or symptoms such as ear pain, ear drainage, hearing loss, or nonspecific findings such as fever, lethargy, irritability, anorexia, vomiting, or diarrhea." Diagnostic criteria were embedded in a definition that emphasized middle ear inflammation.
  • The Agency for Health Care Policy and Research Otitis Media with Effusion in Young Children. Clinical Practice Guideline (Stool, Berg, Berman, et al., 1994a) mentioned two definitions of AOM within the text of their work: "inflammation of the middle ear with signs or symptoms of middle ear infection" and "fluid in the middle ear accompanied by signs or symptoms of ear infection." One emphasized middle ear inflammation, the other middle ear infection.
  • Bluestone and Klein (1996), in a standard text of pediatric otolaryngology, provided two definitions of AOM: "the rapid onset of signs and symptoms of acute infection within the middle ear" and "the rapid and short onset of signs and symptoms of inflammation in the middle ear." The first definition emphasized middle ear infection, the second middle ear inflammation.

In 1985, Paparella, Bluestone, Arnold, et al. (1985) concluded, "It is not the panel's purpose to force usages, but rather to suggest terms to improve clinical and scientific communication. It is appropriate and right and, therefore, incumbent upon every author or speaker to define his/her own terms when communicating with colleagues." For the purpose of systematic review for this evidence-based analysis, a consensus was required among the technical experts on the definition of AOM to evaluate the studies retrieved for analysis of the key questions. A definition would aid in understanding the condition and would describe in codified terms characteristics of the condition that make it unique from other conditions, alluding to etiology and pathophysiology. A well-structured definition also would provide a framework to develop diagnostic criteria to diagnose the presence of AOM in individual patients. This process is detailed in the Methodology section.

Epidemiology

Accurate estimates on the prevalence or incidence of AOM were not found because published population-based estimates are not available on the specific diagnosis of AOM. Data reported from the National Ambulatory Medical Care Survey (NAMCS) provided the best indication of prevalence and incidence of the disease, although nonsuppurative, suppurative, and unspecified otitis media were grouped into the term otitis media, and AOM and OME were not separated in the analyses (Schappert, 1992; Schappert, 1996; Woodwell, 1997a; Woodwell, 1997b; Woodwell and Schappert, 1995). Gates (1996a), commenting on the NAMCS data, stated, "For children, it is probably safe to presume that AOME (AOM with effusion) is the principal disorder noted in these surveys."

Schappert (1992) reported on the 1975-90 NAMCS data. Office visits by patients younger than 15 years of age with the principal diagnosis of otitis media constituted 70.6 percent in 1975; 78.9 percent in 1980; 81.9 in 1985; and 80.5 percent in 1990. From 1975 to 1990, the percentage of office visits with otitis media as the principal diagnosis increased in patients younger than age 15: from 7.3 to 17.4 percent for children younger than age 2; from 10.4 to 18.1 percent for ages 2 to 5; from 6.9 to 10.5 percent for ages 6 to 10; and from 2.6 to 5.2 percent for ages 11 to 14. The number of visits with a principal diagnosis of otitis media per 100 persons per year for the same time period (1975-90) increased from 31.5 to 102.1 for children younger than 2 years of age, 20.8 to 47.8 for those 2 to 5 years of age, 10.2 to 18.2 for those 6 to 10 years of age, and 3.3 to 8.0 for those 11 to 14 years of age.

From 1975 to 1990, the percentage of office visits with a principal diagnosis of otitis media increased from 8.1 to 14.3 percent for pediatricians, from 1.3 to 3.5 percent for general practitioners and family physicians, and 12.8 to 20.2 percent for otolaryngologists. The proportion of office visits for otitis media was higher for pediatricians compared with general practitioners and family physicians or otolaryngologists. In 1990, the number of visits with a principal diagnosis of otitis media per 100 persons per year in children younger than 2 years was 62.9 for pediatricians, 24.0 for general practitioners and family physicians, and 9.1 for otolaryngologists. In 1990, the number of visits with a principal diagnosis of otitis media per 100 persons per year in children 2 to 5 years old was 29.0 for pediatricians, 11.4 for general practitioners and family physicians, and 6.6 for otolaryngologists (Schappert, 1992).

The reports on the NAMCS data for 1993 to 1996 did not stratify by age (Schappert, 1996; Woodwell, 1997a; Woodwell, 1997b; Woodwell and Schappert, 1995). If the 1993-96 data were similar to that in 1975-90, it would be reasonable to conclude that the majority of these patients were younger than 15 years of age. Suppurative and unspecified otitis media was the third most frequently listed principal diagnosis in 1993, the sixth most frequent in 1994, the fourth most frequent in 1995, and the seventh most frequent in 1996 for ambulatory care visits to physician offices, hospital outpatient departments, and emergency departments (Schappert, 1996; Woodwell, 1997a; Woodwell, 1997b; Woodwell and Schappert, 1995). In 1996, visits for a principal diagnosis of otitis media and eustachian tube disorders occurred 82.8 percent of the time in physician offices, 5.3 percent in hospital outpatient departments, and 11.9 percent in emergency departments (Woodwell, 1997a).

Using the published NAMCS data and other published national data such as the National Health Interview Survey, an internal analysis estimated that 5.18 million episodes of AOM and 1.04 million episodes of OME or chronic middle ear infection following AOM occurred in 1995. Each episode of AOM entailed 1.75 visits to the physician, and each episode of OME or chronic middle ear infection entailed 5.1 visits to the physician. The analysis assumed that 20 percent of AOM episodes were followed by OME or chronic middle ear infection. (See Appendix A.)

The NAMCS data also provided information on the duration of office visits for otitis media. The percent of visits for otitis media of 6-15 minutes duration increased between 1975 and 1990 from 64 to 78 percent and was associated with a decrease in visits of less than 6 minutes in duration from 24 to 13 percent (Schappert, 1992). In terms of surgical procedures, the rate of ambulatory surgery visits per 10,000 population for those younger than 15 years of age for otitis media and eustachian tube disorders was 86.9 in 1994 and 83.9 in 1995, based on 498,000 and 484,000 visits respectively (Hall and Lawrence, 1997; Kozak, Hall, Pokras, et al., 1997). In 1995, the number of myringotomy with tympanostomy tube placements reported by NAMCS was 521,000 for a rate of 90.2 procedures per 10,000 children younger than 15 years of age (Hall and Lawrence, 1997).

In general, the NAMCS data demonstrated the importance of otitis media -- and by implication AOM -- based on the prevalence and incidence of the disease and the frequency and duration of visits and surgical interventions.

Risk Factors

Uhari, Mantysaari, and Niemela (1996) conducted a systematic review of studies on the risk factors for development of AOM. This review only searched for studies via MEDLINE and might not have been comprehensive in its scope. Based on the studies included in their study, Uhari, Mantysaari, and Niemela (1996) found the following factors to be associated with increased risk of AOM: family member having AOM, relative risk (RR) 2.63 (95 percent CI, 1.86 and 3.72); day care outside the home, RR 2.45 (95 percent CI, 1.51 and 3.98); family day-care setting vs. care at home, RR 1.59 (95 percent CI, 1.19 and 2.13); parental smoking, RR 1.66 (95 percent CI, 1.33 and 2.06); and pacifier use, RR 1.24 (95 percent CI, 1.06 and 1.46). Having at least one sibling and being in a day-care center also seemed to be associated with increased AOM risk; however, the actual relative risks were not reported. Breast-feeding for at least 3 months was associated with a decreased risk of AOM, RR 0.87 (95 percent CI, 0.79 and 0.95). Breast-feeding in general and breast-feeding for at least 6 months also seemed to be associated with decreased AOM risk; however, the actual relative risks were not reported. Being in a day-care center vs. a family day-care setting did not confer a significant risk for AOM.

Uhari, Mantysaari, and Niemela (1996) also examined the risk factors for recurrent AOM and found the following factors to be associated with an increased risk of recurrent AOM: having at least one sibling, RR 1.92 (95 percent CI, 1.29 and 2.85); child care outside of the home, RR 1.82 (95 percent CI, 1.21 and 2.73); parental smoking, RR 1.76 (95 percent CI, 1.36 and 2.28); and day-care center vs. care at home, RR 1.38 (95 percent CI, 1.19 and 1.61). Breast-feeding in general, RR 0.48 (95 percent CI, 0.32 and 0.72), and breast-feeding for 6 months or longer vs. breast-feeding for less than 6 months, RR 0.69 (95 percent CI, 0.49 and 0.97) were associated with a decreased risk of recurrent AOM. The following factors were not found to be significantly associated with recurrent AOM risk: family day-care setting vs. care at home, day-care center vs. family day-care setting, atopy or allergy, and breast-feeding for 3 months or longer vs. less than 3 months. Rosenfeld (1996) also cited the following factors as mentioned in the literature as risks for recurrence of AOM: young age (younger than 2 years old); multiple previous episodes; bottle feeding; history of ear infections in parents or siblings; and pacifier use.

Risk factors for the outcome of AOM at 2 months were studied by Froom, Culpepper, Bridges-Webb, et al. (1993). Children younger than age 13 months were less likely to be asymptomatic at 2 months than older children. In the study population, several factors had independent risk for poor symptomatic outcome 2 months following diagnosis of AOM. For children age 12 months or younger, the following factors were associated with poor 2-month outcome: history of serous otitis media, odds ratio (OR) 2.3 (95 percent CI, 0.95 and 5.70); episodes of AOM within the past 18 months, OR 1.9 (95 percent CI, 0.82 and 4.51); and male sex, OR 1.7 (95 percent CI, 1.00 and 3.00). For children age 13 months to 15 years, the following factors were associated with poor 2-month outcome: history of ear tubes, OR 2.3 (95 percent CI, 1.46 and 3.58); pus on examination, OR 2.2 (95 percent CI, 1.48 and 3.29); episodes of AOM within the past 18 months, OR 1.8 (95 percent CI, 1.31 and 2.37); and history of serous otitis media, OR 1.4 (95 percent CI, 1.00 and 1.88). Other studies found that bottle feeding, a history of ear infections in parents or siblings, and attendance at a day-care center were factors associated with persistent middle ear effusion after AOM.

Diagnosis

Related to the issue of a uniform definition of AOM is the diagnosis of AOM and the criteria by which the diagnosis is made. Hayden (1980) reviewed 43 full-length articles on AOM that were selected from six journals published from 1955 to 1979. Forty percent of these articles did not describe the criteria by which the diagnosis of AOM was established. In the 26 articles that did describe criteria for the diagnosis of AOM, 18 unique criteria sets were found, and identical criteria sets usually were found in studies performed by the same investigator. These findings, however, are expected considering the lack of a uniform definition.

Rosenfeld (1996) listed the following as possible diagnostic criteria for AOM: acute symptoms either alone, in the presence of middle ear effusion, or without resolution after 24 to 48 hours; purulent otorrhea; bulging tympanic membrane; and middle ear effusion in the presence of acute symptoms. The Otitis Media with Effusion in Young Children. Clinical Practice Guideline (Stool, Berg, Berman, et al., 1994a) stated that pneumatic otoscopy was an appropriate technique to establish the presence of middle ear effusion and that tympanometry could be used as a confirmatory test. Barnett, Klein, Hawkins, et al. (1998) found that acoustic reflectometry was as effective as tympanometry when compared to the gold standard of tympanocentesis.

Froom, Culpepper, Grob, et al. (1990) found that a large proportion of physicians in their study were unsure of the accuracy of their diagnosis of AOM. They reported diagnostic certainty in 58 percent of patients younger than age 12 months, 66 percent of patients age 13 to 30 months, and 73 percent of patients older than age 30 months. Studies from the University of Pittsburgh indicated that practitioners could be trained to diagnose the various forms of otitis media more appropriately (Kaleida and Stool, 1992). The validated otoscopist studies were based on an algorithm which in one study (Mandel, Rockette, Bluestone, et al., 1987) was felt to have potential for systematic bias as judged by the OME Guideline Panel (Culpepper, Long, and Sisk, 1994). As with the issue of the definition, this systematic review required a consensus on the diagnostic criteria for AOM to evaluate the studies retrieved for analysis of the key questions. This process is described in the Methodology section.

Alternatives for Treatment

Various medical and surgical treatments have been used for AOM. For the most part, medical treatment has concentrated on the administration of antibiotics, including penicillins, aminopenicillins, cephalosporins, carbacephems, macrolides, azalides, lincomycins, and combination antibiotics (Rosenfeld, 1996). However, the efficacy of antibiotics in comparison to observation has been in question. The Dutch standard of care is to observe the patient for 48 hours in select children older than age 2 years and for 24 hours in select children age 6 months to 2 years before initiating antibiotics (Froom, Culpepper, Jacobs, et al., 1997). Antibiotics are prescribed if clinical resolution does not occur during the observation period. Other issues pertinent to antibiotics are dose, schedule, and duration of treatment. Antihistamines and decongestants, although shown to be ineffective in the treatment of OME (Cantekin, Mandel, Bluestone, et al., 1983), and analgesics and antipyretics often are used as adjunctive therapies in the treatment of AOM and can be purchased over-the-counter without prescription. One topical analgesic has been shown to be effective in reducing the pain associated with AOM (Hoberman, Paradise, Reynolds, et al., 1997). Alternative medications also have been used and their effectiveness has been subjected to investigation (Barnett, Levatin, Klein, et al., 1999). Myringotomy plus amoxicillin has been shown to be no more effective than antibiotics alone (Kaleida, Casselbrant, Rockette, et al., 1991).

Rosenfeld (1996) suggested that AOM may be prevented through modification of environmental risk factors and through immunizations against both bacteria and viruses associated with AOM. Large doses of xylitol seemed to be effective in reducing the recurrence rate of AOM (Uhari, Kontiokari, and Niemela, 1998). Tympanostomy tubes (Casselbrant, Kaleida, Rockette, et al., 1992; Gebhart, 1981; Gonzalez, Arnold, Woody, et al., 1986) and adenoidectomy (Paradise, Bluestone, Rogers, et al., 1990) appeared effective in preventing recurrent otitis media.

The NAMCS data described practitioner followup patterns for management of AOM. In 1990, compared with 1975, return visits were scheduled to a greater extent (73.2 percent vs. 60.2 percent) for children age 0 to 5 years and to a less extent (46.6 percent vs. 58.3 percent) for those age 15 years or older. As noted above, the NAMCS data did not separate AOM from otitis media effusion (Schappert, 1992).

Outcomes

A wide range of short-term and long-term outcomes must be considered when assessing the effectiveness of treatments for AOM. The following are outcomes often measured in studies: total resolution of signs and symptoms of middle ear inflammation, persistent AOM, chronic OME, suppurative complications, chronic complications, hearing deficits, speech and language problems, behavior problems, and cognitive deficits (Rosenfeld, 1996). Suppurative complications include mastoiditis, petrositis, labyrinthitis, meningitis, subdural empyema, focal otitic encephalitis, brain abscess, and lateral sinus thrombosis (Bluestone and Klein, 1996). Sequelae of the disease include cholesteatoma, tympanosclerosis, chronic tympanic membrane perforation, and ossicular discontinuity and fixation (Bluestone and Klein, 1996; Rosenfeld, 1996).

Adverse effects of the treatments may occur. Antibiotics may lead to diarrhea, rash, anaphylaxis, and symptoms of the hematologic, cardiovascular, central nervous, renal, hepatic, and respiratory systems (Stool, Berg, Berman, et al., 1994b). Antimicrobial drug resistance also may increase with increased use of antibiotics (Dowell, Marcy, Phillips, et al., 1998). Antimicrobial drug resistance appears to be less common in the Netherlands (where antibiotics are not used as frequently for AOM) than in countries that use antibiotics routinely for AOM (Culpepper and Froom, 1997). Antihistamines and decongestants may lead to insomnia, drowsiness, behavior changes, changes in blood pressure, and seizures (Stool, Berg, Berman, et al., 1994). Myringotomy with tympanostomy tube insertion has the following possible adverse effects: external canal laceration, persistent otorrhea, granuloma formation, cholesteatoma, permanent perforation of the tympanic membrane, tympanic membrane flaccidity, retraction, tympanosclerosis, and tube intrusion into the middle ear cleft (Stool, Berg, Berman, et al., 1994).

Cost is another important outcome. Gates (1996b) estimated the cost of AOM for children age 0 to 4 years as $3.15 billion for the year 1994. Stool and Field (1989) estimated the cost of otitis media in general for children age 0 to 6 years as $2.2 to $3.4 billion for the year 1987. Using published NAMCS data, other published national data, and estimates from previously published cost analyses, an internal analysis estimated that the cost of AOM in 1995 was $2.98 billion. The estimated cost of AOM includes the cost of its sequelae. Based on findings by Berman, Roark, and Luckey (1994), it was assumed that OME or chronic middle ear infections followed an episode of AOM in 20 percent of cases. Costs for AOM and OME or chronic middle ear infections were estimated from the existent literature and included direct and indirect costs. The cost per episode for AOM was estimated at $214.19 and included 1.75 visits to a physician. The cost per episode for OME or chronic middle ear infection was estimated at $1,811 and included 5.1 visits to a physician. The estimated number of episodes of AOM and OME or chronic middle ear infection following AOM was described earlier. The $2.98 billion estimate is a minimum estimate because most of the assumptions were conservative. Sensitivity analysis indicated that the estimated national cost for 1995 could be as high as $6 billion. In any case, the national cost of AOM, whether accepting previous estimates or the internally derived estimate, is high. (See Appendix A.)

Ultimately, the importance of these outcomes is dependent on the viewpoint of the evaluator (Russell, Siegel, Daniels, et al., 1996). Furthermore, the perspective of the patient, parent, and physician must be taken into consideration. In general, the societal viewpoint is crucial in terms of balancing health-care costs against the nonhealth-care needs of society; but, the individual patient's condition and circumstances within the societal context also must be taken into account (Gold, Patrick, Torrance, et al., 1996). Quality of life and functional status may be more important than the individual medical outcomes listed above. For otitis media, including AOM, various paradigms for looking at quality of life and functional status are being developed (Alsarraf, Jung, Perkins, et al., 1998; Haggard and Smith, 1999a, 1999b; Rosenfeld, Goldsmith, Tetlus, et al., 1997).

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