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A direct comparison of American Academy of Pediatrics, American Academy of Family Physicians (AAP/AAFP), Cincinnati Children's Hospital Medical Center (CCHMC), Scottish Intercollegiate Guidelines Network (SIGN) and University of Michigan Health System (UMHS) recommendations for diagnosing and managing acute otitis media (AOM) in pediatric patients is provided in the tables, below.
The comparison focuses on the appropriate diagnosis and initial treatment of a child presenting with AOM; however, the scope of the guidelines and the populations they consider vary. For example, the AAP/AAFP and CCHMC guidelines address AOM only, while SIGN and UMHS also address otitis media with effusion (OME). The topic of OME is addressed in separate guidelines by AAP/AAFP and CCHMC, and in another synthesis available on the National Guideline Clearinghouse (NGC) Web site.
All four guidelines included in this synthesis focus on the pediatric population. The AAP/AAFP, CCHMC guidelines apply to children age 2 months and older, while SIGN does not specify an age range, targeting children in general. The UMHS guideline targets children age 2 months and older as well as adults with suspected or confirmed otitis media. AAP/AAFP, CCHMC and SIGN note that recommendations concerning children with underlying conditions that increase the risk for AOM or alter its natural course (such as cleft palate, Down syndrome, and immunodeficiencies) are beyond the guidelines' scope. Two guidelines also explicitly exclude from consideration additional patient subgroups: AAP/AAFP excludes children with a clinical recurrence of AOM within 30 days, while CCHMC excludes children with pressure equalization (PE) tubes in place. The UMHS guideline addresses special populations including infants 0 to 8 weeks old, children with chronic illnesses and adults. These recommendations, however, are beyond the scope of this guideline. In developing their recommendations, CCHMC and UMHS considered the conclusions of AAP/AAFP.
A summary discussion of the areas of agreement and areas of differences among the guidelines is presented following the content comparison.
Abbreviations used in the text and table:
TABLE 2: COMPARISON OF GUIDELINE SCOPE | |
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Objectives | |
AAP/AAFP (2004) |
To provide recommendations to primary care clinicians for the management of children from 2 months through 12 years of age with uncomplicated AOM |
CCHMC (2004) |
|
SIGN (2003) |
Notes:
|
UMHS (2007) |
|
Target Population | |
AAP/AAFP (2004) |
|
CCHMC (2004) |
Note: Children with comorbid conditions increasing the risk or severity of otitis media, including immunodeficiencies, craniofacial or neurologic abnormalities, or sensory deficits, are excluded. Children with pressure equalization (PE) tubes in place are also excluded. |
SIGN (2003) |
Note: The needs of children with genetic or facial abnormalities are not considered. |
UMHS (2007) |
|
Intended Users | |
AAP/AAFP (2004) |
Advanced Practice Nurses Allied Health Personnel Nurses Physician Assistants Physicians |
CCHMC (2004) |
Advanced Practice Nurses Allied Health Personnel Health Care Providers Nurses Patients Physician Assistants Physicians |
SIGN (2003) |
Advanced Practice Nurses Nurses Patients Physician Assistants Physicians Public Health Departments Social Workers Speech-Language Pathologists |
UMHS (2007) |
Advanced Practice Nurses Nurses Pharmacists Physician Assistants Physicians |
TABLE 3: COMPARISON OF RECOMMENDATIONS FOR THE DIAGNOSIS, MANAGEMENT, AND PREVENTION OF AOM IN PEDIATRIC PATIENTS | |
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Definition of AOM | |
AAP/AAFP |
A diagnosis of AOM requires 1) a history of acute onset of signs and symptoms, 2) the presence of MEE, and 3) signs and symptoms of middle-ear inflammation. Elements of the definition of AOM are all of the following:
|
CCHMC |
Definitions used in this guideline:
Requirements for diagnosis of AOM:
|
SIGN |
The working definition of AOM in this Guideline is inflammation of the middle ear of rapid onset presenting most often with local symptoms (the two most common being earache and rubbing or tugging of the affected ear) and systemic signs (fever, irritability, and poor sleep, for example). There may be a preceding history of upper respiratory symptoms including cough and rhinorrhea. |
UMHS |
Diagnostic Definitions Acute Otitis Media (AOM)
|
Diagnosis of AOM | |
AAP/AAFP |
|
CCHMC |
General
History and Physical Examination
|
SIGN |
|
UMHS |
Diagnosis
Rationale for Recommendations Diagnosis Distinguishing AOM and OME. The distinction between AOM and OME does not refer to etiology or depend on whether pathogenic bacteria are present in the middle ear. No "gold standard" exists for the diagnosis of AOM. The National AOM-guideline defines AOM as a combination of (see Table 1 in the original guideline document):
OME is defined as MEE in the absence of acute symptoms. Techniques for identifying MEE The basic question facing a clinician evaluating a patient's ears is whether or not MEE is present. If the presence or absence of MEE is not clear, all available techniques should be used. Techniques include otoscopy, pneumatic otoscopy, and tympanometry. Pneumatic otoscopy. In the national guidelines, pneumatic otoscopy is recommended as an essential hands with appropriate equipment this technique is 70 to 90% sensitive and specific for determining the presence of middle ear effusion. This can be compared to 60 to 70% accuracy with simple otoscopy. Pneumatic otoscopy is most helpful when cerumen is removed from the external auditory canal and the otoscopist uses equipment such as hard plastic reusable ear tips with rounded edges rather than disposable tips. Having a well-maintained, fully-charged otoscope is also important. Pneumatic otoscopy is also helpful in identifying middle ear pathology such as retraction pockets and tympanic membrane adhesion to the ossicles even in the absence on MEE. Tympanometry/acoustic reflectometry. Tympanometry and acoustic reflectometry can be valuable adjuncts to, but not a substitute for, otoscopy and pneumatic otoscopy. Tympanometry provides an important confirmation of middle ear fluid and is helpful for physicians honing their otoscopy skills. Tympanometry can also measure middle ear pressures and easily demonstrate the patency of myringotomy tubes by measuring increased external canal volumes. Tympanometry has a sensitivity and specificity of 70 to 90% for the detection of middle ear fluid, but depends on patient cooperation. Technical factors such as cerumen and probe position can lead to artifactual flattening of the tympanogram. The presence of a "normal" curve does not rule out the presence of air-fluid levels and effusion in the middle ear. However, together with normal otoscopy, a normal tympanogram is predictive of the lack of middle ear fluid. A "flat" tympanogram should be confirmed through repeated measurements, recording appropriate external canal volumes, and through correlation with pneumatic otoscopy. Acoustic reflectometry is also an appropriate approach for evaluating the presence of middle ear fluid, but, like tympanometry, it has imperfect sensitivity and specificity and must be correlated with the clinical exam. For most clinical purposes, a tympanic membrane bulging with an apparent purulent effusion is a more useful sign of bacterial infection than isolated immobility on pneumatic otoscopy, and it is probably sufficient to make the diagnosis of AOM in association with typical symptoms. The clinician should feel comfortable diagnosing AOM based on the clinical history, even if a cerumen impaction prevents pneumatic otoscopy and adequate visualization of the tympanic membrane, if the clinician feels that AOM is likely. Conversely, the clinician should not diagnose AOM without the presence of symptoms no matter what physical findings are observed. |
Observation Without Treatment In Patients With AOM | |
AAP/AAFP |
|
CCHMC |
AOM is a disease with a high spontaneous resolution rate (78 to 80% resolve within 7 to 14 days), and routine antibiotic therapy of all children with suspected AOM results in the treatment of many children in whom there may be either modest benefit and/or modest adverse outcomes from antibiotic therapy (Glasziou et al., 2003 [M]; Marcy et al., 2001 [M]; Rosenfeld et al., 1994 [M]; Dowell et al., "Otitis media," 1998 [S]). Moreover, the decision to use antibiotics and the specific choice of antibiotics must take into account the increasing emergence of bacterial resistance (Doern et al., 1998 [C]; Jacobs et al., 2003 [O]; Mason et al., 2003 [O]). Note: While it is suggested in general that children under two years of age with AOM be treated with antibiotics, it is recognized that in certain situations observation without antibiotics or with a safety-net antibiotic prescription (SNAP) may be reasonable. (See Table 5 in original guideline.) If observation or SNAP is utilized, both the clinician and the parents are advised to be aware of the higher relapse/recurrence rate in this age group, and close follow-up must be assured (Siegel et al., 2003 [C]).
|
SIGN |
|
UMHS |
Therapy of Acute Otitis Media
Observation vs. Initiating Antibiotic Therapy Amoxicillin therapy provides a small increase in the likelihood of short term resolution of AOM symptoms. A strategy for improving the care of AOM is to identify the subset of patients least likely to benefit from antibiotic therapy and consider deferring antibiotic therapy for those patients. This category would likely include children over 2 years of age or children without fever or with relatively minor symptoms. The rate of antibiotic therapy can be significantly reduced through the provision of adequate parental education about the natural history of AOM. Specifically, parents should be informed at the outset that on average, only one in ten children benefit from antibiotic therapy, that approximately 10% of children receiving antibiotics will have an untoward outcome such as diarrhea or rash, and that occasionally children on antibiotics acquire more aggressive and antibiotic resistant bacteria leading to invasive bacterial infections requiring hospital admission and IV antibiotics. In addition, parents need to know that at least a third of cases of AOM are caused by viruses, not bacteria, that no oral antibiotic eliminates more than 80% of the bacteria found in cases of AOM, and that oral analgesics, such as ibuprofen, are much more likely to speed resolution of symptoms than oral antibiotics. Finally, they need to know that 10 to 20% of children will continue to have symptoms no matter what therapy is given, and that apparent failure with the observation option does not mean that antibiotics will necessarily be needed in the future. These points are summarized in the patient education materials provided with this guideline. "Back-up" options for prescriptions. In order for the observation to be acceptable for patients, clinicians must facilitate the subsequent access to antibiotics for patients whose symptoms worsen. One option is to provide parents with "back-up" prescriptions to be filled in the event of symptomatic persistence. Such prescriptions should be dated as needing to be filled within 3 to 4 days of diagnosis, to prevent parents from inappropriately treating future illnesses. Alternatively, a system by which parents can call to request antibiotic prescriptions without excessive inconvenience could be established. In one study, the use of a safety net prescription system reduced the number of courses of antibiotics given by 70%. |
Use of Analgesics in Patients with AOM | |
AAP/AAFP |
|
CCHMC |
|
SIGN |
|
UMHS |
Therapy of acute otitis media
Analgesics. Analgesics are recommended for symptoms of ear pain, fever, and irritability. Analgesics are particularly important at bed time, since disrupted sleep is one of the most common symptoms motivating parents to seek care. Ibuprofen is preferred over acetaminophen, given its longer duration of action and its lower toxicity in the event of overdose. Topical analgesics can also be helpful. |
Antimicrobial Therapy In Patients With AOM | |
AAP/AAFP |
See Table 6 in the original guideline document for recommended antibacterial agents for patients who are being treated initially with antimicrobial agents or have failed 48 to 72 hours of observation or initial management with antimicrobial agents. |
CCHMC |
|
SIGN |
With Streptococcus pneumoniae and Haemophilus influenzae, broad spectrum antibiotics such as amoxicillin, or amoxicillin with clavulanic acid, are the drugs of choice if an antibiotic is to be used. Cefaclor, cotrimoxazole, trimethoprim and erythromycin can be effective, but are less safe than amoxicillin. |
UMHS |
Therapy of AOM
Basic management recommendations are:
Antibiotic choice. The choice of antibiotic should almost always be high dose amoxicillin. The advantages of amoxicillin include cost, tolerability, safety, and efficacy. No antibiotic has been demonstrated to be superior to amoxicillin in clinical trials involving tympanocentesis before and after therapy. Oral cephalosporins are uniformly inferior to high-dose amoxicillin for pneumococcus, especially penicillin-resistant pneumococcus. Unless the patient is allergic to amoxicillin, in which case high-dose azithromycin would be the first-line agent, no empirical oxicillin in some studies. However, excessive use of azithromycin is associated with increasing rates of erythromycin resistance, particularly involving group A beta-hemolytic streptococci, and therefore its routine use should be discouraged. Cefdinir can also be used, although it is clinically inferior to amoxicillin and carries with it an excessive risk of selection of resistant bacteria. The use of ceftriaxone should be reserved for episodes of clinical failure (see below) or for clinical situations in which the clinician suspects a serious bacterial infection as a comorbidity of the AOM. Consideration should be given to obtaining appropriate laboratory studies such as blood or urine cultures before administering ceftriaxone, and it is reasonable to obtain a white count with differential or C reactive protein in order to confirm the severity of the illness. Follow up should be ensured, and alternative diagnoses, such as a viral illness or Kawasaki disease, should be considered in the event of clinical failure. Although some children will likely benefit from IM ceftriaxone, the decision to prescribe this agent should not be made lightly, since the overuse of this agent is likely to significantly increase high level penicillin resistance in this population. Ceftriaxone can be administered for up to three days, but a single dose is often sufficient. Ceftriaxone might also be appropriate in situations where antibiotics are indicated but oral antibiotics are not tolerated, such as vomiting or medication refusal. Bicillin CR might also be an option in that situation. Amoxicillin dosing and duration. Given the risk of penicillin resistant pneumococcus, for children under 4 years amoxicillin should be dosed at 80 mg/kg per day divided twice a day for 5 to 10 days. Children 4 years and older are at lower risk of resistant pneumococcus and therefore can probably receive 40 to 60 mg/kg/day. Since the major impact of antibiotic therapy is to reduce symptoms at 48 to 72 hours, 5 days of therapy are usually sufficient. Since it is unclear how many parents continue to give amoxicillin consistently once the symptoms are resolved, and since inconsistent antibiotic dosing would be predicted to select more effectively for antibiotic resistant bacteria, it is possible that the increased cost and inconvenience of giving a ten day course might not be outweighed by the improvement in symptomatic outcome at 10 days. This would be particularly true in older children. Furthermore, illnesses, rashes, and diarrhea occur in all children at some time, and they will be more likely to occur while on antibiotics. Thus, we recommend reserving the use of a ten day course of antibiotics for children most likely to benefit, e.g., young children with significant early URI symptoms, children with possible sinusitis, and children with possible strep throats. In most other cases, one would expect the major symptoms to resolve in five days, even without treatment. If desired, a prescription could be given for ten days of amoxicillin with instructions to discontinue and discard the medication 2 to 3 days after resolution of symptoms. Diarrhea and candidal infections are among the most common complications of antibiotic therapy. Therefore parents should be warned about this in advance. It is also appropriate to provide recommendations about diaper care and the application of clotrimazole cream in the event of diaper rash. Giving yogurt with active cultures might also be helpful. |
Education and Preventive Counseling | |
AAP/AAFP |
During infancy and early childhood, reducing the incidence of respiratory tract infections by altering child care center attendance patterns can reduce the incidence of recurrent AOM significantly. The implementation of breastfeeding for at least the first 6 months also seems to be helpful against the development of early episodes of AOM. Avoiding supine bottle feeding ("bottle propping"), reducing or eliminating pacifier use in the second 6 months of life, and eliminating exposure to passive tobacco smoke have been postulated to reduce the incidence of AOM in infancy; however, the utility of these interventions is unclear. |
CCHMC |
|
SIGN |
No specific recommendations are given for patient education or preventive counseling for AOM. |
UMHS |
Risk Factors for AOM Age. Age is a significant predictor of AOM frequency, severity, and responsiveness to treatment. Infants and toddlers are more severely affected, and appear to be less responsive to therapy than older children. Consequently, clinicians should be cautious in extrapolating results from clinical trials involving older children to younger age groups. Additional risk factors. Several specific risk factors for recurrent AOM and OME have been identified or are likely:
Observation vs. Initiating Antibiotic Therapy The rate of antibiotic therapy can be significantly reduced through the provision of adequate parental education about the natural history of AOM. Specifically, parents should be informed at the outset that on average, only one in ten children benefit from antibiotic therapy, that approximately 10% of children receiving antibiotics will have an untoward outcome such as diarrhea or rash, and that occasionally children on antibiotics acquire more aggressive and antibiotic resistant bacteria leading to invasive bacterial infections requiring hospital admission and intravenous (IV) antibiotics. In addition, parents need to know that at least a third of cases of AOM are caused by viruses, not bacteria, that no oral antibiotic eliminates more than 80% of the bacteria found in cases of AOM, and that oral analgesics, such as ibuprofen, are much more likely to speed resolution of symptoms than oral antibiotics. Finally, they need to know that 10 to 20% of children will continue to have symptoms no matter what therapy is given, and that apparent failure with the observation option does not mean that antibiotics will necessarily be needed in the future. These points are summarized in the patient education materials provided with this guideline. Recurrent AOM For children with genuine recurrent AOM (3 or more episodes in 6 months), several strategies are likely to be helpful. Immunization with the pneumococcal conjugate vaccine and annual influenza vaccination have both been shown to have a small but statistically significant impact on the frequency of AOM, although the major benefit of each of these vaccines is in the prevention of systemic disease. Reduction in exposure to passive smoke and elimination of bottle propping and pacifiers are probably helpful. Gastroesophageal reflux also appears to contribute to AOM, and it is possible that appropriate treatment of this condition could reduce middle ear disease. In some cases, undiagnosed food allergies probably contribute to gastrointestinal (GI) disturbances, chronic rhinorrhea, and eczema. The chronic nasal congestion in turn contributes to AOM. A trial of a soy formula might be helpful. For children in day care, recurrent rhinorrhea is the norm, and parents can be reassured that it will eventually resolve, particularly with the onset of summer. In the event that recurrent AOM leads to intolerable symptoms, or is associated with significant complications or multiple, clinically significant antibiotic sensitivities, ventilation tube placement is a good option. In most cases, however, AOM is a benign, easily treatable condition that responds well to a combination of amoxicillin and analgesics. Furthermore, recurrent AOM has a favorable natural history, and in the only RCT of tympanostomy tubes vs. watchful waiting, tubes reduced the incidence of AOM and/or otorrhea by only one episode per year. On a positive note, ventilation tubes will turn what would otherwise be an episode of AOM into an episode of purulent ear drainage. Such drainage is likely to be less painful than the comparable episode of AOM and is effectively treated with ear irrigation ("otic toilet") and fluoroquinolone drops. Unfortunately, placement of ventilation tubes is also associated with an increased risk of long-term tympanic membrane abnormalities and reduced hearing compared to medical therapy. Thus, it is reasonable to reserve ventilation tube placement for those children with a more problematic clinical history. Although it is tempting to place children on long term antibiotic therapy for the prophylaxis of recurrent AOM, long term therapy is not recommended in this era of increasing antibiotic resistance. |
Recommendations For Referral | |
AAP/AAFP |
No recommendations offered |
CCHMC |
|
SIGN |
|
UMHS |
Referral process. Otolaryngology evaluation plays an important role in the management of recurrent AOM and persistent OME. However, the ability of the surgeon to reach the most appropriate decision for the management of a given patient may be limited by a lack of historical information including previous antibiotic therapy and an accurate time course of middle ear disease. Special Situations Primary care follow-up and management of tympanostomy tubes. Be familiar with the preferences of the surgeon to whom you refer patients, since he/she will likely be handling any complications of tube placement. Patients with tubes should follow up with otolaryngology every six months and should be referred back to otolaryngology in the event of suspicion for ongoing middle ear disease. Tubes should be removed if they remain in place longer than 3 years. Cerumen Removal Children with cerumen impaction and tympanostomy tubes should be referred to otolaryngology for further management. It is also reasonable to refer young children with cerumen impactions to otolaryngology, since removal of such impactions is probably facilitated by access to an operating microscope and suction. |
Use of Complementary and Alternative Medicine For AOM | |
AAP/AAFP |
There is insufficient evidence to make a recommendation regarding the use of complementary and alternative medicine for AOM. (No Recommendation) |
CCHMC |
It is not recommended that other therapies be used in the treatment of AOM (AAP 2004 [S]). Note: Steroids, antihistamines, decongestants, and complementary or alternative treatments have not been documented to be efficacious in the treatment of AOM (Butler & Van Der Voort, 2002 [M]; Flynn, Griffin, & Tudiver, 2002 [M]; Barnett et al., 2000 [C]; AAP Subcommittee, 2004 [S]. Antihistamines may prolong the duration of MEE. Note: It is recognized that use of complementary and alternative medicine (CAM) is common and its use is often not reported to the primary care physician (PCP) (Eisenberg et al., 1998 [O], Spigelblatt et al., 1994 [O]). The PCP may take the AOM visit as an opportunity to begin a respectful discussion regarding the safety and efficacy of CAM with families who report its use. |
SIGN |
While homeopathy was considered, due to lack of evidence, no recommendation can be made at this time. |
UMHS |
No recommendations offered. |
TABLE 4: BENEFITS AND HARMS | |
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Benefits | |
AAP/AAFP (2004) |
|
CCHMC (2004) |
|
SIGN (2003) |
|
UMHS (2007) |
Accurate diagnosis and effective treatment and management of otitis media |
Harms | |
AAP/AAFP (2004) |
General Antibiotic Therapy
Analgesic Therapy
|
CCHMC (2004) |
None stated |
SIGN (2003) |
Analgesic Therapy
|
UMHS (2007) |
|
TABLE 5: EVIDENCE RATING SCHEMES | |
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AAP/AAFP (2004) |
Recommendations Rating Scheme: Strong Recommendation - A strong recommendation in favor of a particular action is made when the anticipated benefits of the recommended intervention clearly exceed the harms (as a strong recommendation against an action is made when the anticipated harms clearly exceed the benefits) and the quality of the supporting evidence is excellent. In some clearly identified circumstances, strong recommendations may be made when high-quality evidence is impossible to obtain and the anticipated benefits strongly outweigh the harms. Clinicians should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present. Recommendation - A recommendation in favor of a particular action is made when the anticipated benefits exceed the harms, but the quality of evidence is not as strong. Again, in some clearly identified circumstances, recommendations may be made when high-quality evidence is impossible to obtain but the anticipated benefits outweigh the harms. Clinicians would be prudent to follow a recommendation, but should remain alert to new information and sensitive to patient preferences. Option - Options define courses that may be taken when either the quality of evidence is suspect or carefully performed studies have shown little clear advantage to one approach over another. Clinicians should consider the option in their decision making, and patient preference may have a substantial role. No Recommendation - No recommendation indicates that there is a lack of pertinent published evidence and that the anticipated balance of benefits and harms is presently unclear. Clinicians should be alert to new published evidence that clarifies the balance of benefit versus harm. |
CCHMC (2004) |
The type of evidence is identified and classified for each recommendation using the following scheme: Evidence Based Grading Scale A: Randomized controlled trial: large sample References Supporting the Recommendations
|
SIGN (2003) |
Grades of Recommendations A - At least one meta-analysis, systematic review of randomised controlled trials (RCTs), or randomised controlled trial rated as 1++ and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B - A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C - A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D - Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ Levels of Evidence 1++ - High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias 1+ - Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1- - Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2++ - High quality systematic reviews of case control or cohort studies. High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+ - Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2- - Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3 - Non-analytic studies, e.g., case reports, case series 4 - Expert opinion |
UMHS (2007) |
Levels of Evidence
|
The American Academy of Pediatrics/American Academy of Family Physicians (AAP/AAFP), Cincinnati Children's Hospital Medical Center (CCHMC), Scottish Intercollegiate Guidelines Network (SIGN), and University of Michigan Health System (UMHS) present recommendations for the diagnosis and management of acute otitis media (AOM) in pediatric patients based on evidence available at the time of each report and provide explicit reasoning behind their judgments, ranking the level of evidence for each major recommendation. CCHMC also offers literature citations to support its major recommendations.
Each guideline develops a working definition for AOM, but the focus of the guidelines and their respective target populations vary. For example, the AAP/AAFP and CCHMC guidelines are limited to a discussion of recommendations for the diagnosis and treatment of uncomplicated AOM, with both groups presenting recommendations for OME in separate guidelines. The SIGN and UMHS guidelines consider the diagnosis and treatment of both AOM and OME.
There is overall general agreement regarding the definition and requirements for diagnosing AOM. All of the groups agree that the diagnosis of AOM should be based on an acute onset of signs and symptoms (e.g., earache, tugging of the ears, irritability, fever), evidence of middle ear effusion (MEE) (e.g., bulging of the tympanic membrane, limited or absent mobility of the tympanic membrane), and evidence of acute inflammation (e.g., bulging tympanic membrane with loss of normal landmarks, change in color, and poor mobility). Furthermore, both AAP/AAFP and SIGN agree that systemic signs of illness with a MEE or clinical history alone are not sufficient to make a diagnosis of AOM.
All four groups recommend analgesic use in AOM, particularly acetaminophen and ibuprofen. UMHS notes that ibuprofen is preferred over acetaminophen, given its longer duration of action and its lower toxicity in the event of overdose. The SIGN guideline warns that although NSAIDs are frequently used by parents, caution should be used because of their side effect profile. AAP/AAFP notes that topical agents such as benzocaine and naturopathic agents may provide additional, but brief, benefit over acetaminophen in patients older than 5 years. They add that narcotic analgesia with codeine or analogs is effective for moderate or severe pain. In addition to acetaminophen and ibuprofen, CCHMC also recommends topical ear drops (anesthetic or naturopathic herbal extract), but cautions against their use in patients with a perforated eardrum and/or discharge from the ear, as their use will likely result in severe dizziness and vomiting. UMHS also notes that topical analgesics can be helpful.
Amoxicillin as First-Line Therapy. All four guidelines recommend amoxicillin for first-line therapy (when the use of antibiotics is warranted). SIGN also recommends amoxicillin/clavulanate for first-line therapy.
Duration of Therapy. In spite of uncertainty concerning the optimal duration of therapy, the guidelines are in general agreement that a course ranging from 5 to 10 days is appropriate. In addition, AAP/AAFP and CCHMC are in agreement that children younger than 2 years should receive a 10-day course of therapy. See "Areas of Differences" below, for a discussion of differences in the recommendations concerning duration of therapy.
Amoxicillin Alternatives. Three guidelines, AAP/AAFP, CCHMC and UMHS, address alternative antimicrobials in the event of clinical failure (see below paragraph) or intolerance/allergy to amoxicillin. In the event of allergy to amoxicillin, UMHS recommends azithromycin as the appropriate first line therapy. In this instance AAP/AAFP and CCHMC recommend cephalosporins (e.g., cefdinir, cefuroxime, ceftriaxone) and macrolides/azalides (azithromycin, clarithromycin) as alternatives. SIGN does not specifically address the issue of allergy to amoxicillin, but states that cefaclor, cotrimoxazole, trimethoprim, and erythromycin can be effective, but are less safe than amoxicillin.
Clinical Failure. For patients initially treated with amoxicillin as first-line therapy who have not improved within 72 hours, AAP/AAFP and CCHMC agree that amoxicillin/clavulanate is the preferred second-line therapy. UMHS recommends that clinical unresponsiveness to amoxicillin should be treated with either amoxicillin clavulanate or azithromycin. AAP/AAFP and CCHMC also agree that patients with beta-lactamase producing organisms should be treated with high-dose amoxicillin-clavulanate. SIGN does not specifically address the issue of treatment failure.
The SIGN guideline makes recommendations concerning prevention of OME, but not of AOM. In contrast, the AAP/AAFP. CCHMC and UMHS guidelines encourage clinicians to counsel parents concerning preventable risk factors for AOM.
AAP/AAFP, CCHMC and UMHS agree that day care attendance, pacifier use, and exposure to tobacco smoke significantly increase the risk of AOM. AAP/AAFP states that, during infancy and early childhood, reducing the incidence of respiratory tract infections by altering child care center attendance patterns can significantly reduce the incidence of AOM. AAP/AAFP, CCHMC and UMHS include short duration of breastfeeding and bottlefeeding with the child on his/her back as additional preventable risk factors.
AAP/AAFP, CCHMC and UMHS agree that administration of the pneumococcal conjugate vaccines reduces the risk of ear infections slightly (UMHS reserves this option for children with recurrent AOM [3 or more episodes in 6 months]). AAP/AAFP and UMHS also suggest the influenza vaccine may be useful for the prevention of AOM. AAP/AAFP states that pneumococcal conjugate vaccines have proven effective in preventing vaccine-serotype pneumococcal otitis media, but their overall benefit is small, with only a 6% reduction in the incidence of AOM. CCHMC agrees that the effectiveness of influenza vaccination in preventing AOM remains unclear. UMHS notes that the pneumococcal conjugate vaccine and annual influenza vaccination have both been shown to have a small but statistically significant impact on the frequency of AOM, although the major benefit of each of these vaccines is in the prevention of systemic disease.
Concerning referral to an audiologist, CCHMC recommends that the practitioner have a low threshold for referral for an audiologic evaluation if concerns around hearing, speech, or language are raised by parents, clinicians, or other caregivers because of recurrent AOM. SIGN recommends referral to an audiologist when audiometry is required for assessment of hearing thresholds and middle ear function. AAP/AAFP makes no recommendation concerning the need for an audiology referral for AOM patients.
CCHMC and SIGN recommend referral to an otolaryngologist in cases of complicated or persistent AOM. CCHMC recommends referral for recurrent AOM, persistent otorrhea, concerns about mastoiditis or other complications, evaluation for surgery, and an abnormal audiologic evaluation. SIGN identified no studies concerning when AOM patients should be referred and therefore adopts the recommendation of the National Institute for Clinical Excellence (NICE) that children with frequent episodes of AOM (more than four in six months) should be referred to an otolaryngologist. SIGN also recommends referral for complications of AOM such as mastoiditis or facial nerve paresis.
UMHS makes more recommendations for referral for OME than for AOM patients. They acknowledge that otolaryngology evaluation plays an important role in the management of recurrent AOM and persistent OME. They add, however, the ability of the surgeon to reach the most appropriate decision for the management of a given patient may be limited by a lack of historical information including previous antibiotic therapy and an accurate time course of middle ear disease. UMHS also provides referral recommendations for special circumstances, including management of tympanostomy tubes and cerumen removal. AAP/AAFP makes no recommendations concerning referrals to an otolaryngologist.
Both AAP/AAFP and SIGN agree that no recommendations can be made due to an absence of evidence of effectiveness in the literature. CCHMC specifically recommends against CAM and certain other therapies to treat AOM. Recognizing that use of CAM is common, however, CCHMC encourages providers to respectfully discuss its safety and efficacy with families who report its use. UMHS does not address this topic.
Although all four guidelines provide a delayed treatment option in which antibacterial treatment of selected children is deferred for 48 to 72 hours, they differ concerning the patient groups to which this option applies. AAP/AAFP, CCHMC and UMHS use age and/or symptom criteria to determine if observation without treatment is appropriate, while SIGN does not limit the option based on either age or symptoms.
AAP/AAFP recommends that deferred treatment should be limited to otherwise healthy children aged 6 months to 2 years with non-severe illness at presentation and an uncertain diagnosis, as well as to children age 2 years and older without severe symptoms at presentation or with or an uncertain diagnosis.
While CCHMC generally recommends that children under two years of age be treated with antibiotics, they do note that in certain situations observation without antibiotics or with a SNAP may be reasonable. For children over age 2 years who are well-appearing, CCHMC recommend that treatment options be discussed with the family. These options include SNAP or a 5-day course of antibiotics.
UMHS notes that deferring antibiotic therapy for lower risk children should be considered. They add that this category would likely include children over 2 years of age or children without fever or with relatively minor symptoms. Should symptoms worsen, UMHS recommends that patient access to antibiotics should be facilitated, e.g. a "back-up" prescription given at the visit or a convenient system for subsequent call-in.
SIGN recommends that in general antibiotics should not be prescribed for the initial management of AOM. Delayed antibiotic treatment (antibiotic to be collected at parents' discretion after 72 hours if child has not improved) is recommended as an alternative approach.
Amoxicillin Dose. Recommendations concerning amoxicillin dosing differ slightly among the guideline groups. AAP/AAFP and CCHMC recommend 80 to 90 mg/kg/day. UMHS similarly recommends 80 mg/kg/day for children under 4 years of age, but for children 4 years of age or older, however, they note that this population can probably be treated at 40 to 60 mg/kg/day. The SIGN guidelines do not provide amoxicillin doses, but refer the reader to the British National Formulary.
Duration of Therapy. Recommendations differ regarding the recommended duration of initial amoxicillin therapy. As noted above under "Areas of Agreement," AAP/AAFP and CCHMC generally agree that an initial 10 day course of antibiotics is preferred in children under 2 years of age. For children 2 years of age and older, however, CCHMC recommends they receive a 5-day course of therapy, while AAP/AAFP recommends that only children age 6 years and older with mild to moderate disease receive a 5- to 7-day course of therapy; younger children and/or those with severe disease are recommended to receive the standard 10-day course. In contrast to both AAP/AAFP and CCHMC, UMHS recommends that children under 4 years of age should receive a 5 to 10 day course of therapy, and that in children 4 years of age or older 5 days of therapy are usually sufficient. They add that they recommend reserving the use of a ten day course of antibiotics for children most likely to benefit, e.g., young children with significant early URI symptoms, children with possible sinusitis, and children with possible strep throats. SIGN differs from the three other groups in recommending the conventional five day course, regardless of patient age.
This Synthesis was prepared by ECRI on November 4, 2005. The information was verified by AAP on April 6, 2006; by CCHMC on May 1, 2006; by SIGN on April 5, 2006; and by UMHS on April 28, 2006. This synthesis was revised on December 6, 2007 to remove recommendations from UMHS and on April 14, 2008 to update UMHS recommendations.
Internet citation: National Guideline Clearinghouse (NGC). Guideline synthesis: Acute otitis media. In: National Guideline Clearinghouse (NGC) [website]. Rockville (MD): 2006 May (revised 2008 Jun). [cited YYYY Mon DD]. Available: http://www.guideline.gov.