Abstract

At least 1 episode of acute otitis media is seen in 94% of children before age 2. Attendance in a day-care setting is among the major risk factors. Middle ear fluid may be sterile or may grow viruses and/or bacteria. Accurate diagnosis and distinction from otitis media with effusion is essential for proper management, but physicians often have difficulty in making the correct diagnosis. Since overuse of antibacterial agents contributes to an increase in bacterial resistance, physicians should consider delaying treatment for 2 to 3 days, during which therapy is aimed at controlling pain. High-dose amoxicillin is the preferred antibacterial agent in a young child with a purulent middle ear effusion, but amoxicillin-clavulanate, cefuroxime axetil, and ceftriaxone are options when resistant bacteria are encountered.

Introduction

Acute otitis media (AOM) is a common clinical problem facing all providers who care for children. Ear infections account for $3 billion in health care expenditures annually.^[1] In the United States, about 24 million prescriptions for antibacterial agents are written annually for AOM. The number of cases of diagnosed AOM continues to rise. In 1975, AOM was diagnosed during 9.9 million health care visits, and in 1990, it was diagnosed at 24.5 million visits.^[2] Increased bacterial resistance to antibacterial agents combined with increased use of these drugs to treat AOM has generated discussions in the pediatric community focused on determining the best way to manage this common condition that plagues children, parents, and physicians. In this article, we present 20 pearls we have found helpful in understanding, diagnosing, treating, and preventing this disorder.

Fluid Accumulation Breeds Bacteria

The pathophysiology of AOM is impaired mucociliary clearance of fluid from the middle ear resulting from eustachian tube dysfunction. The middle ear becomes a fluid-filled closed space that provides a wonderful medium for growth of bacteria that may be present. When bacteria are isolated from middle ear effusions, the question becomes, "Is the middle ear infected or are bacteria merely proliferating in the trapped fluid?" Children are at higher risk for eustachian tube dysfunction because their eustachian tubes are shorter, more horizontal, and more prone to obstruction by adenoid tissue than those in adults.^[3]

Otitis Media is Seasonal and is Often Associated with Viral URIs

Children average 3 to 8 viral upper respiratory tract infections (URIs) each year, predominantly in the winter months. URIs can cause inflammatory edema of the eustachian tubes with resultant dysfunction leading to AOM.^[3] Aspirated middle ear fluid (MEF) from children with viral URIs may contain bacteria alone, virus alone, or bacteria and viruses, or it may be sterile.

AOM is Almost Universal

Before the age of 2 years, 94% of children will have had at least 1 episode of otitis media. The peak age for otitis media is between 6 and 13 months.^[4] The occurrence of AOM decreases with age, and by 6 years of age, AOM is relatively uncommon in healthy children.^[5]

Age, Day Care Top List of Risk Factors

Risk factors for AOM include attendance at day care, exposure to secondhand smoke, not being breast-fed, craniofacial abnormalities, and having biologic siblings or parents with a history of problems with AOM. However, the greatest risk factors are being younger than 2 years and attending day care.^[6]

Viral, Bacterial, or Both?

In a study that looked for both bacterial and viral causes of AOM, Chonmaitree et al^[6] found 93 (34%) of 271 children to have bacterial pathogens in their MEF and no evidence of a viral infection. Forty-three children (16%) had bacteria in their MEF and evidence of viral infection (virus isolated from a nasal wash or serologic evidence). Fifty children (18%) had both bacteria and viruses isolated from their MEF, and 16 children (6%) had only virus isolated from their MEF. Sixty-nine children (25%) had no pathogens in their MEF, but 15 of these children had other evidence of a viral infection.^[6] When bacteria are isolated from the MEF, the usual pathogens are Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. The most common viruses found in the middle ear include respiratory syncytial virus, influenza virus, parainfluenza virus, rhinovirus, and adenovirus.^[7]

Accurate Diagnosis is Imperative

It is important to distinguish between AOM and otitis media with effusion (OME). Essential tools for the physical diagnosis of otitis media are otoscopy and pneumatic insufflation. Position, color, translucency, and mobility of the eardrum are 4 components that should be adequately assessed in each patient (Figures 1, 2, and 3). Tympanometry and acoustic reflectometry are additional resources that can help assess whether an effusion is present in the middle ear, but they do not provide information about whether the fluid is infected.

Figure 1. Normal appearance of the tympanic membrane. (Figures 1, 2, and 3 courtesy of Janet Griffin, MD, Children's Hospital Medical Center of Akron, Ohio.)

Figure 2. Acute otitis media with effusion. The tympanic membrane is injected but landmarks are still clearly visualized.

Figure 3. Acute otitis media. The tympanic membrane is bulging and hyperemic, and yellow purulent fluid is seen in the middle ear space.

Diagnosis Can be Challenging

General pediatricians surveyed indicated that 30% of the time they are uncertain about their diagnosis. Evaluating the tympanic membrane of a fighting child with cerumen in the external auditory canal is always a challenge. Pichichero and Poole8 examined the accuracy of the diagnosis of AOM by pediatricians compared with otolaryngologists. They found that pediatricians correctly diagnosed AOM 50% of the time and otolaryngologists were correct 73% of the time. Although both groups were able to recognize abnormal tympanic membranes, pediatricians called OME or a retracted tympanic membrane AOM 27% of the time on average.^[8]

Effusions are Common after AOM

Fifty percent of children will have an effusion that persists for a month after an episode of AOM, but 90% of the effusions will resolve without treatment within 3 months.^[9,10]

Resistance, Resistance, Resistance!

Bacterial resistance to antibacterial agents is increasing, and concern about this problem is impacting the treatment of AOM. A major cause of increased resistance is the ongoing inappropriate use of antibacterial agents. In some regions, the rate of penicillin resistance exceeded 50% for S pneumoniae (Figure 4) and 30% for H influenzae.^[11,12] It is imperative that physicians improve their ability to diagnose AOM and thereby increase their confidence in not using antimicrobial agents when they are not called for. By using antibacterial agents more judiciously and appropriately, we should see a decrease in resistance.

Figure 4. Penicillin-resistant pneumococcal infections in the United States, 1979 - 1999.

Earache: Bacteria Do Not Cause Pain

The inability to effectively drain the eustachian tube results in increased pressure in the middle ear. Pressure in the middle ear causes the pain. Pain control for any type of AOM is imperative and includes analgesics, topical analgesic eardrops, cold or hot packs, and positioning the child to keep the head propped up.^[13,14]

OME: No Treatment Needed

OME usually resolves spontaneously. Treatment with myringotomy and tympanostomy tube placement may be necessary if the effusion is present for more than 3 months, if OME is chronic (present 6 months out of the previous 12 months), or if OME is associated with hearing loss.^[10]

Delaying Treatment is an Option

Meta-analysis of studies comparing antibacterial therapy with placebo consistently finds that about 80% of episodes of AOM will resolve in 2 to 7 days without antibacterial therapy, compared with slightly more than 90% if antibacterial agents are used.^[15,16] Furthermore, no antibacterial agent has been shown to be superior to amoxicillin.^[16] Initial treatment of a patient with fluid in the middle ear, but not pus, who has symptoms and signs such as ear pain, erythema of the tympanic membrane, and fever, and accompanying symptoms of URI should be pain control for 2 to 3 days with a contingency plan. The plan may include office recheck in 48 to 72 hours or a prescription to use if symptoms persist for more than 2 to 3 days (Table).^[11] Children younger than 2 years should be rechecked in 24 hours. This approach has been used in the Netherlands since 1990.

Delaying Treatment Does Not Substantially Increase Complications

In the United States, where 96% of patients with AOM are treated with antibacterial agents, the incidence of mastoiditis is 2 per 100,000. In the Netherlands, Norway, and Denmark, where the rates of treatment with antibacterial agents are 31%, 67%, and 76%, respectively, the incidence of mastoiditis is 4 per 100,000.^[17]

Start with Amoxicillin

For the young child with a purulent middle ear effusion, treatment is high-dose amoxicillin (80 to 100 mg/kg/d) for 7 days. If a child fails to respond to this treatment within 3 days, alternative therapy for resistant bacteria should be started with high-dose amoxicillin-clavulanate (80 to 100 mg/kg/d of the amoxicillin component) for 7 days. Treatment with cefuroxime axetil (30 mg/kg twice a day) for 7 days or ceftriaxone (50 mg/kg IM once a day) for 3 days is the next step.^[11,18]

Patients, Parents, and Antibacterial Agents

Recent studies have shown that contrary to popular belief, patient and parental satisfaction is not dependent on the prescription of antibacterial agents.^[19,20] Studies have shown that parents and patients want reliable information and good communication, not antibacterial agents. Patients and parents were satisfied with caregivers who explained the illness, gave reasons for a specific treatment, suggested symptomatic control measures and, most important, provided a contingency plan should the patient's condition worsen. Providing parents with literature that explains the increasing bacterial resistance and inappropriate use of antibacterial drugs was also found to be beneficial in decreasing the expectations of the parents to receive antibacterial agents.^[20] Information for parents, patients, and physicians is available at the CDC Web site (www.cdc. gov/drugresistance/community/tools.htm).

Vaccination May Help

Prevention of infections with respiratory pathogens, such as influenza virus, lowers the incidence of AOM.^[21] Clements and associates^[22] suggest that giving influenza vaccine to children older than 6 months should significantly cut down on winter respiratory disease, thus decreasing the likelihood of otitis media. The 7-valent conjugate pneumococcal vaccine has been successful in decreasing the incidence of AOM in Finland.^[23]

Hand Washing and other Factors

Hand washing remains one of the most important methods of decreasing person-to-person transmission of bacteria and viruses. Other factors that may potentially decrease the risk of AOM include breast-feeding for at least 3 months, limiting day-care exposure, and eliminating secondhand smoke exposure.^[5]

New Guidelines

The American Academy of Pediatrics (AAP) Committee on Infectious Diseases is likely to review current recommendations for the management of children with AOM with an eye toward decreasing antibacterial therapy for this diagnosis. Stay tuned to the AAP news.

Continuing Education

Education for physicians, residents, patients, and parents is an ongoing process and is essential. In a survey of accredited pediatric residency program directors, only 59% of the respondents had some formal otitis media curriculum.^[24] Instructional videos, seminars with interactive simulation to teach otoscopy, and formal lecture series for residency programs are examples of ways to help retrain physicians and teach residents the importance of accuracy in the diagnosis of AOM.

Principles to Keep in Mind

Accuracy in the diagnosis of AOM is paramount. Observation and symptomatic treatment is an option for some patients, but the recognition and treatment of pain is essential for all patients. Amoxicillin is the drug of choice to treat AOM. If the patient does not respond to the initial treatment in 48 to 72 hours, be prepared with a backup plan. Emphasize preventive measures for the child who has recurrent episodes of AOM.

Condition	Treatment
Otitis media with bulging tympanic membrane	Immediate treatment with high-dose amoxicillin (80 to 100 mg/kg/d orally) for 7 days
Otitis media without bulging tympanic membrane	Delayed-treatment option (see pearls on Delaying treatment)
Recurrent acute otitis media	Delayed-treatment option (see pearls on Delaying treatment); immunization with influenza vaccine

Modified from Hendley JO. N Engl J Med. 2002.[11]

1. Bondy J, Berman S, Glazner J, Lezotte D. Direct expenditures related to otitis media diagnoses: extrapolations from a pediatric medicaid cohort. Pediatrics. 2000;105:E72.
2. Schappert SM. Office visits for otitis media: United States, 1975-2000. Hyattsville, Md: National Center for Health Statistics. Data From Vital and Health Statistics of the Centers for Disease Control; 1992;214:1-18.
3. Kenna M. Otitis media and its complications. In: Behrman RE, Kliegman RM, Jenson HB, eds. Nelson Textbook of Pediatrics. Philadelphia: WB Saunders Co; 2000:1950-1959.
4. Block SL, Harrison CJ, Hedrick J, et al. Restricted use of antibiotic prophylaxis for recurrent acute otitis media in the era of penicillin non-susceptible Streptococcus pneumoniae. Int J Pediatr Otorhinolaryngol. 2001;61:47-60.
5. Duffy LC, Faden H, Wasielewski R, et al. Exclusive breastfeeding protects against bacterial colonization and day care exposure to otitis media. Pediatrics. 1997;100:E7. Available at: http://www.pediatrics.org/cgi/content/full/100/4/e7. Accessed March 31, 2003.
6. Chonmaitree T, Owen MJ, Patel JA, et al. Effect of viral respiratory tract infection on outcome of acute otitis media. J Pediatr. 1992;120:856-862.
7. Heikkinen T. Role of viruses in pathogenesis of acute otitis media. Pediatr Infect Dis J. 2000;19:S17-S23.
8. Pichichero ME, Poole MD. Assessing diagnostic accuracy and tympanocentesis skills in the management of otitis media. Arch Pediatr Adolesc Med. 2001;155:1137-1142.
9. Dowell SF, Marcy SM, Phillips WR, et al. Otitis media -- principles of judicious use of antimicrobial agents. Pediatrics. 1998;101:S165-S171.
10. DeRosa J, Grundfast KM. Surgical management of otitis media. Pediatr Ann. 2002;31:814-820.
11. Hendley JO. Otitis media. N Engl J Med. 2002;347:1169-1174.
12. Froom J, Culpapeer L, Jacobs M, et al. Antimicrobials for acute otitis media? A review from the International Primary Care Network. BMJ. 1997;315:98-102.
13. Kemper KJ. Otitis media: when parents don't want antibiotics or tubes. Contemp Pediatr. 2002;19:47-58.
14. Hoberman A, Paradise JL, Reynolds EA, Urkin J. Efficacy of Auralgan for treating ear pain in children with acute otitis media. Arch Pediatr Adolesc Med. 1997;151:675-678.
15. Takata GS, Chan LS, Shekelle P, et al. Evidence assessment of management of acute otitis media: I. The role of antibiotics in treatment of uncomplicated acute otitis media. Pediatrics. 2001;108:239-247.
16. Rosenfeld RM, Vertrees JE, Carr J, et al. Clinical efficacy of antimicrobial drugs for acute otitis media: metaanalysis of 5400 children from thirty-three randomized trials. J Pediatr. 1994;124:355-365.
17. Van Zuijlen DA, Schilder AG, Van Balen FA, Hoes AW. National differences in incidence of acute mastoiditis: relationship to prescribing patterns of antibiotics for acute otitis media? Pediatr Infect Dis J. 2001;20:140-144.
18. Dowell SF, Butler JC, Giebink GS, et al. Acute otitis media: management and surveillance in an era of pneumococcal resistants -- a report from the Drug-resistant Streptococcus pneumoniae Therapeutic Working Group. Pediatr Infect Dis J. 1999;18:1-9.
19. Hamm RM, Hicks RJ, Bemben DA. Antibiotics and respiratory infections: are patients more satisfied when expectations are met? J Fam Pract. 1996;43:56-62.
20. Mangione-Smith R. Parent expectation for antibiotics, physician-parent communication, and satisfaction. Arch Pediatr Adolesc Med. 2001;155:800-806.
21. Belshe RB, Mendelman PM, Treanor J, et al. The efficacy of live attenuated, cold-adapted, trivalent, intransal influenza virus vaccine in children. N Engl J Med. 1998;338:1459-1461.
22. Clements DA, Langdon L, Bland C, Walter E. Influenza A vaccine decreases the risk of developing acute otitis media (AOM) in 6- to 30-month-old children in day care. Arch Pediatr Adolesc Med. 1995;149:1113-1117.
23. Eskola J, Kilpi T, Palmu A, et al. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med. 2001;344:403-409.
24. Steinbach WJ, Sectish TC. Pediatric resident training in the diagnosis and treatment of acute otitis media. Pediatrics. 2002;109:404-408.

Drs Scott and Powell have written a wonderful article providing 20 clinical pearls on acute otitis media (AOM). One particular area that deserves comment relates to the delayed-treatment, or "observation," option instead of antibiotics. The proponents of the observation option point to concerns about rising bacterial resistance, injudicious antibiotic use, the occurrence of viruses as a cause of AOM, a high spontaneous resolution rate (often cited to be 80% to 90%) for AOM, and the lack of a substantial increase in complications when such a strategy is applied (as occurs in the Netherlands). The opponents of the observation option point out that AOM is caused by bacterial pathogens in more than 70% of cases; that antibiotic treatment improves symptom resolution and shortens the duration of middle ear effusion; that planning a follow-up visit within 24 hours in children younger than 2 years and within 48 to 72 hours in children older than 2 years is impractical; that the risk of complications, even if small, is a high price to pay; and that exposure to malpractice litigation is a real concern. In my view, the center of the controversy is the issue of accurate diagnosis.

As Scott and Powell state, "Accurate diagnosis and distinction [between acute otitis media and] otitis media with effusion is essential for proper management, but physicians often have difficulty in making the correct diagnosis." We recently examined the accuracy of the diagnosis of AOM by pediatricians attending a continuing medical education (CME) course (Outcomes Management Education Workshops; www.OMEW.com). The pediatricians were shown video of 9 pneumatic otoscopy examinations. All cerumen had been removed from the external auditory canal. The pediatricians were comfortably seated in a classroom setting and were afforded as much time as they needed to reach their best diagnosis based on the visual findings. The pediatricians made the correct diagnosis 50% of the time, while otolaryngologists were correct 73% of the time.^[1]

In other publications, we have reported that nurse practitioners achieve the correct diagnosis 42% of the time^[2] and pediatric residents in training 41% of the time.^[3] Is this representative? Thousands of pediatricians and hundreds of otolaryngologists, nurse practitioners, and pediatric residents were included in the database. Clinicians who attend CME courses generally are motivated to learn, to keep up, and to acquire new skills. One wonders how the practitioner too busy to find the time for CME and too confident to consider the possibility that his or her diagnostic acumen may be lacking would perform on this CME test.

If pediatricians incorrectly diagnose AOM 50% of the time and otolaryngologists about 25% of the time, then how often do the general practitioners in the Netherlands misdiagnose AOM? One study suggests the misdiagnosis rate may be as high as 85%.^[4] How often did the investigators who generated the data for the clinical trials included in the meta-analysis that yielded a spontaneous cure rate of 80% for AOM^[5] actually misdiagnose AOM? How many of these patients really had otitis media with effusion (and not AOM), which indeed will improve as well with observation as with antibiotic therapy?

We are moving toward a new definition of AOM that requires that the patient have a bulging tympanic membrane. When the tympanic membrane is bulging, bacteria are isolated more than 90% of the time^[6] and antibiotics are recommended by all authorities and all guidelines. How many of the investigations without tympanocentesis that evaluated amoxicillin versus the more potent broader-spectrum agents included bulging as a required sign for the diagnosis of AOM?

Based on these concerns, I and others^[7] believe that the data are so fundamentally flawed for non-tympanocentesis trials of nonantibiotic treatment and comparative trials of amoxicillin versus broader-spectrum antibiotic treatment that we are left with more questions than answers. While we are waiting for those answers, I favor continued use of antibiotics for appropriately and accurately diagnosed AOM. If the patient has a bulging tympanic membrane, then a prescription of an appropriately selected antibiotic should follow.

Michael E. Pichichero, MD
Professor of Microbiology and Immunology, Pediatrics and Medicine
University of Rochester School of Medicine and Dentistry
Rochester, NY

References

1. Pichichero ME, Poole MD. Assessing diagnostic accuracy and tympanocentesis skills in the management of otitis media. Arch Pediatr Adolesc Med. 2001;155:1137-1142.
2. Sorrento A, Pichichero ME. Assessing diagnostic accuracy and tympanocentesis skills by nurse practitioners in management of otitis media. J Am Acad Nurse Pract. 2001;13:524-529.
3. Pichichero ME. Diagnostic accuracy, tympanocentesis training performance, and antibiotic selection by pediatric residents in management of otitis media. Pediatrics. 2002;110:1064-1070.
4. Laurin L, Prellner K, Kamme C. Phenoxymethylpenicillin and therapeutic failure in acute otitis media. Scand J Infect Dis. 1985;17:367-370.
5. Rosenfeld RM, Vertrees JE, Carr J, et al. Clinical efficacy of antimicrobial drugs for acute otitis media: metaanalysis of 5400 children from thirty-three randomized trials. J Pediatr. 1994;124:355-367.
6. Leibovitz E, Greenberg D, Piglansky L, et al. Recurrent acute otitis media occurring within one month from completion of antibiotic therapy: relationship to the original pathogen. Pediatr Infect Dis J. 2003;22:209-216.
7. Wald E. Acute otitis media: more trouble with the evidence. Pediatr Infect Dis J. 2003;22:103-104.