Acute otitis media is one of the most common pediatric illnesses; however, there is considerable controversy in its management. While most cases are treated with antibiotics, there is a growing concern regarding antibiotic overuse and subsequent drug resistance. Researchers in the Netherlands have developed a “watchful waiting" (ie, an observation approach) that has been successful in treating acute otitis media, although it has not gained widespread popularity in the United States. This review will summarize the latest research on diagnosing acute otitis media as well as different treatment regimens, including the efficacy of the watchful-waiting approach.
Key words: acute otitis media, AOM, otitis media with effusion, watchful-waiting, observation, wait-and-see, ear pain, otalgia, otorrhea, bulging tympanic membrane, AAP guidelines
A mother has brought her 2 children to the ED on a Saturday evening, with both complaining of ear pain. The first child, a 3-year-old girl, has been complaining of a right-sided earache for the past 2 days. Today, she had a fever of 38.4°C at home. She has been fussier than usual, but she is still active and has been eating normally. She is an otherwise healthy girl and has never been diagnosed with acute otitis media before. On otoscopic exam, the right tympanic membrane is erythematous and bulging, with decreased movement on insufflation.
The second child, the 2-year-old brother of the first patient, has been tugging on his left ear for the past day. Otherwise, he seems fine, although he has a runny nose and has sneezed several times. He has not had a fever and has no medical problems. Although he does not appear to be as sick as his sister, his mother wonders if he has caught the same bug. On his otoscopic exam, there is opacity of the tympanic membranes bilaterally, with retraction and decreased movement of the tympanic membrane with insufflation on the left.
The mother asks you if her children will need antibiotics for an infection. Both children attend daycare, and the mother is worried because other children there have had ear infections. You think:
Acute otitis media (AOM) is one of the most common infections diagnosed in children in the United States. It accounts for 13% of all emergency department (ED) visits and 30 million clinic visits by children, making it the second leading diagnosis in pediatric ED visits (after upper respiratory infection).1 In 2000, $5 billion was spent on the diagnosis and treatment of AOM.2 Traditional management of AOM – particularly in patients diagnosed in the ED – has included antibiotic therapy. Although a 2002 study found a decrease in the overall populationbased antibiotic prescription rate for AOM,3 a 2007 study reported that up to 91% of ED patients received antibiotic prescriptions for AOM.4 Traditional antibiotic treatment for AOM has been called into question in the past several decades based on early studies that suggested a benign natural history of the disease. A meta-analysis of clinical trials from 1966 to 1992 showed that AOM spontaneously resolved without treatment in 80% of cases, and it concluded that antibiotic prescriptions may not be necessary for all patients.5 Although the results of these studies were later called into question based on their less-than-stringent diagnostic criteria for AOM, researchers began to turn to other models for treating AOM.
For more than 20 years, physicians in the Netherlands have been treating AOM in children with initial observation or a “watchful-waiting” approach. Initial studies demonstrated that this approach was safe, effective, and acceptable to parents. 6,7 As a result of this new treatment paradigm, a national survey of Dutch general physicians found that antibiotics for children with AOM were given in 14% to 20% of diagnosed cases from 1987 to 2001;8 however, more-recent data indicate that antibiotic prescription rates for AOM are increasing in the Netherlands. In 2003, 1 study reported prescription rates of up to 64%,9 and another study reported prescription rates of 40% to 50% from 2002 to 200810 (although these numbers are still lower than their United States counterparts). Although the healthcare system in the Netherlands differs greatly from that in the United States in that many of these patients are treated by their family physicians with close follow-up, researchers began to study this treatment model in the hope that the Dutch system would be applicable to United States physicians and their patients.
The interest in a new treatment model for AOM in the United States was also fueled by the growing rate of antibiotic use and the subsequent concern for antibiotic resistance. Early studies found that, as antibiotic overuse increases, the resistance to penicillin of the Streptococcus pneumoniae bacterium has been increasing (27.5% of strains in 1995 were resistant compared to 43.8% in 1997).11 By comparison, in the Netherlands, resistance rates of S pneumoniae strains to penicillin are very low (as low as < 1%, as reported in a small study involving respiratory isolates in 89 patients).12 With the 2010 introduction of the new pneumococcal conjugate vaccine (PCV13), the microbiology of AOM continues to change, but antibiotic resistance remains a concern.13
In an effort to decrease antibiotic prescribing and antibiotic resistance trends, and building on the successes of the watchful-waiting approach in the Netherlands, the American Academy of Family Physicians (AAFP) and the American Academy of Pediatrics (AAP) released a practice guideline in 2004 that suggested observation without antibiotics in certain cases of AOM.7 Although the 2004 guideline recommendations received significant publicity, adherence to them was not widespread, and data show that there was little difference in antibiotic prescribing rates for AOM after publication.14,15
Since 2004, researchers have begun to scrutinize closely the clinical trials from the past several decades. Many older trials have been criticized because they utilized broad inclusion criteria, leading to inaccurate diagnosis on study entry and creating a study population not reflective of the true AOM population. Many studies included children who did not have AOM, children who often had otitis media with effusion (OME), or children who had no middle ear disease at all. They also excluded very young children, children with severe disease, children with recent antibiotic treatment, and children with recent AOM.16 Newer trials have subsequently included a very strict definition of AOM, prompting the AAP to revise their guidelines in 2013.17 These guidelines continue to recommend an observation approach, but they strongly emphasize appropriate diagnostic criteria. The literature will continue to evolve as better-designed clinical trials are conducted using these criteria. This issue of Pediatric Emergency Medicine Practice will present evidence-based recommendations for the diagnosis of AOM and will review the efficacy of different treatment modalities.
A literature search was performed using the PubMed and Ovid MEDLINE® databases. Searches were limited to studies in English involving human subjects. Studies were limited to clinical trials, meta-analyses, practice guidelines, randomized controlled trials (RCTs), review articles, and systematic reviews. Prospective and retrospective cohort studies were used for the epidemiology section. Search terms included: acute otitis media, children, treatment, and emergency department. This search yielded 1208 studies; however, articles related to prevention or prophylaxis of AOM, chronic otitis media (OM), myringotomy/tympanostomy tubes, or upper respiratory infections (in general) were not reviewed. The Cochrane Database of Systematic Reviews was searched for reviews using the same terms as above,7 and relevant reviews were identified. The Database of Abstracts of Reviews of Effectiveness (DARE) was searched using the terms as above and identified 8 relevant reviews. Additionally, the National Guideline Clearinghouse (www.guideline.gov) was explored, and 1 guideline was found.
In 2004, the AAP and the AAFP partnered with the Agency for Healthcare Research and Quality (AHRQ) and the Southern California Evidence-Based Practice Center to develop a set of clinical practice guidelines for the management of AOM.7 These guidelines were based largely on data gathered for the 2001 evidence report of AOM management published by the AHRQ.18 The issues addressed in the AAP/AAFP guidelines were: (1) the definition of AOM; (2) the natural history of AOM without antibacterial treatment; (3) the effectiveness of antibacterial agents in preventing clinical failure; and (4) the relative effectiveness of specific antibacterial regimens. Their search of the literature from 1966 to 1999 uncovered 3461 articles, and 74 studies were reviewed in full. The published clinical practice guidelines were systematic, evidence based, and peer reviewed. Subsequent to the 2004 publication of the guidelines, the AHRQ issued a 2010 update to their 2001 evidence report.19 This resource was also extensively reviewed and provided a critical analysis of the latest research addressing the following: (1) the clinical symptoms and otoscopic findings to diagnose AOM; (2) the impact of the pneumococcal heptavalent immunization (PCV7) on AOM microbial epidemiology; (3) the comparative effectiveness of different treatment options for treating uncomplicated AOM in average-risk children; (4) the comparative effectiveness of different management options for recurrent OM and persistent OM or relapse of AOM; (5) the treatment outcomes based on the following characteristics: laterality, otorrhea or perforation, severity, comorbidities, age groups, race, ethnicity, or daycare attendance; and (6) adverse effects of treatment.
In 2013, the AAP again partnered with the AHRQ and the Southern California Evidence-Based Practice Center to publish an update of the 2004 guidelines.17 The 2013 guidelines address appropriate diagnosis of AOM using a strict definition, pain management, initial observation versus antibiotic treatment, appropriate choices of antibiotics, and preventative measures. These guidelines are based largely on the 2010 AHRQ update as well as continued review of newly published literature. This source represents the most current review of the literature on AOM.
Overall, the diagnosis and treatment of AOM has been a well-studied topic. There are many large RCTs, meta-analyses, and systematic reviews addressing the management of AOM. Differences in study design (particularly diagnostic criteria for inclusion or exclusion of subjects and definitions of clinical success or failure) have made it difficult to compare different studies. The biggest flaw in the AOM literature is the lack of a strict definition of AOM for study participants. Many studies (particularly older studies prior to 2000) included subjects that did not have AOM by the current definition but had either OME or a normal variant. It is difficult to draw conclusions from these studies because a true population of AOM was not studied; however, recent studies have applied strict inclusion criteria to study participants, and this topic has been extensively discussed in the 2013 AAP guidelines as well as throughout this article.
Evidence-based medicine requires a critical appraisal of the literature based upon study methodology and number of subjects. Not all references are equally robust. The findings of a large, prospective, randomized, and blinded trial should carry more weight than a case report.
To help the reader judge the strength of each reference, pertinent information about the study, such as the type of study and the number of patients in the study will be included in bold type following the references, where available. The most informative references cited in this paper, as determined by the author, will be noted by an asterisk (*) next to the number of the reference.
Chadd E. Nesbit, Margaret C. Powers
April 1, 2013