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AMERICAN ACADEMY OF PEDIATRICS AND AMERICAN ACADEMY OF FAMILY PHYSICIANS

CLINICAL PRACTICE GUIDELINE

Subcommittee on Management of Acute Otitis Media

Diagnosis and Management of Acute Otitis Media

ABSTRACT. This evidence-based clinical practice guideline provides recommendations to primary care clinicians for the management of children from 2 months through 12 years of age with uncomplicated acute otitis media (AOM).

The American Academy of Pediatrics and American Academy of Family Physicians convened a committee composed of primary care physicians and experts in the fields of otolaryngology, epidemiology, and infectious disease. The subcommittee partnered with the Agency for Healthcare Research and Quality and the Southern California Evidence-Based Practice Center to develop a comprehensive review of the evidence-based literature related to AOM. The resulting evidence report and other sources of data were used to formulate the practice guideline recommendations. The focus of this practice guideline is the appropriate diagnosis and initial treatment of a child presenting with AOM.

The guideline provides a specific definition of AOM. It addresses pain management, initial observation versus antibacterial treatment, appropriate choices of antibacterials, and preventive measures. Decisions were made based on a systematic grading of the quality of evidence and strength of recommendations, as well as expert consensus when definitive data were not available. The practice guideline underwent comprehensive peer review before formal approval by the partnering organizations.

This clinical practice guideline is not intended as a sole source of guidance in the management of children with AOM. Rather, it is intended to assist primary care clinicians by providing a framework for clinical decisionmaking. It is not intended to replace clinical judgment or establish a protocol for all children with this condition. These recommendations may not provide the only appropriate approach to the management of this problem.

ABBREVIATIONS. AOM, acute otitis media; OME, otitis media with effusion; AAP, American Academy of Pediatrics; AAFP, American Academy of Family Physicians; AHRQ, Agency for Healthcare Research and Quality; MEE, middle-ear effusion; CAM, complementary and alternative medicine.

Acute otitis media (AOM) is the most common infection for which antibacterial agents are prescribed for children in the United States. As such, the diagnosis and management of AOM has

The recommendations in this guideline do not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate. PEDIATRICS (ISSN 0031 4005). Copyright ? 2004 by the American Academy of Pediatrics.

a significant impact on the health of children, cost of providing care, and overall use of antibacterial agents. The illness also generates a significant social burden and indirect cost due to time lost from school and work. The estimated direct cost of AOM was $1.96 billion in 1995. In addition, the indirect cost was estimated to be $1.02 billion.1 During 1990 there were almost 25 million visits made to office-based physicians in the United States for otitis media, with 809 antibacterial prescriptions per 1000 visits, for a total of more than 20 million prescriptions for otitis media?related antibacterials. Although the total number of office visits for otitis media decreased to 16 million in 2000, the rate of antibacterial prescribing was approximately the same (802 antibacterial prescriptions per 1000 visits for a total of more than 13 million prescriptions).2?4 An individual course of antibacterial therapy can range in cost from $10 to more than $100.

There has been much discussion recently as to the necessity for the use of antibacterial agents at the time of diagnosis in children with uncomplicated AOM. Although in the United States the use of antibacterial agents in the management of AOM has been routine, in some countries in Europe it is common practice to treat the symptoms of AOM initially and only institute antibacterial therapy if clinical improvement does not occur. For the clinician, the choice of a specific antibacterial agent has become a key aspect of management. Concerns about the rising rates of antibacterial resistance and the growing costs of antibacterial prescriptions have focused the attention of the medical community and the general public on the need for judicious use of antibacterial agents. Greater resistance among many of the pathogens that cause AOM has fueled an increase in the use of broader-spectrum and generally more expensive antibacterial agents.

It is the intent of this guideline to evaluate the published evidence on the natural history and management of uncomplicated AOM and to make recommendations based on that evidence to primary care clinicians including pediatricians, family physicians, physician assistants, nurse practitioners, and emergency department physicians as well as otolaryngologists. The scope of the guideline is the diagnosis and management of uncomplicated AOM in children from 2 months through 12 years of age without signs or symptoms of systemic illness unre-

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lated to the middle ear. It applies only to the otherwise healthy child without underlying conditions that may alter the natural course of AOM. These conditions include, but are not limited to, anatomic abnormalities such as cleft palate, genetic conditions such as Down syndrome, immunodeficiencies, and the presence of cochlear implants. Also excluded are children with a clinical recurrence of AOM within 30 days or AOM with underlying chronic otitis media with effusion (OME).

METHODS

To develop the clinical practice guideline on the management of AOM, the American Academy of Pediatrics (AAP) and American Academy of Family Physicians (AAFP) convened the Subcommittee on Management of Acute Otitis Media, a working panel composed of primary care and subspecialty physicians. The subcommittee was cochaired by a primary care pediatrician and a family physician and included experts in the fields of general pediatrics, family medicine, otolaryngology, epidemiology, infectious disease, and medical informatics. All panel members reviewed the AAP policy on conflict of interest and voluntary disclosure and were given an opportunity to present any potential conflicts with the subcommittee's work.

The AAP and AAFP partnered with the Agency for Healthcare Research and Quality (AHRQ) and the Southern California Evidence-Based Practice Center to develop the evidence report, which served as a major source of data for these practice guideline recommendations.1 Specific clinical issues addressed in the AHRQ evidence report were the 1) definition of AOM, 2) natural history of AOM without antibacterial treatment, 3) effectiveness of antibacterial agents in preventing clinical failure, and 4) relative effectiveness of specific antibacterial regimens. The AHRQ report focused on children between 4 weeks and 18 years of age with uncomplicated AOM seeking initial treatment. Outcomes included the presence or absence of signs and symptoms within 48 hours, at 3 to 7 days, 8 to 14 days, 15 days to 3 months, and more than 3 months and the presence of adverse effects from antibacterial treatment. Southern California Evidence-Based Practice Center project staff searched Medline (1966 through March 1999), the Cochrane Library (through March 1999), HealthSTAR (1975 through March 1999), International Pharmaceutical Abstracts (1970 through March 1999), CINAHL (1982 through March 1999), BIOSIS (1970 through March 1999), and Embase (1980 through March 1999). Additional articles were identified by review of reference lists in proceedings, published articles, reports, and

guidelines. Studies relevant to treatment questions were limited to randomized, controlled trials. For natural history, prospective and retrospective comparative cohort studies were included also. A total of 3461 titles were identified initially for additional review. Of these, 2701 were excluded, and 760 required article review. Finally, 72 English-language and 2 foreign-language articles were reviewed fully. Results of the literature review were presented in evidence tables and published in the final evidence report.

New literature about otitis media is being published constantly. Although the systematic review done by the AHRQ could not be replicated with new literature, members of the Subcommittee on Management of Acute Otitis Media reviewed additional articles published through September 2003. Articles were nonsystematically evaluated for quality of methodology and importance of results. Articles used in the AHRQ review also were reevaluated for their quality. Conclusions were based on the consensus of the subcommittee after the review of newer literature and reevaluation of the AHRQ evidence. Of significance is that the literature includes relatively few cases of uncomplicated AOM in children older than 12 years. The subcommittee therefore limited this guideline to children from 2 months through 12 years of age.

The evidence-based approach to guideline development requires that the evidence in support of a policy be identified, appraised, and summarized and that an explicit link between evidence and recommendations be defined. Evidence-based recommendations reflect the quality of evidence and the balance of benefit and harm that is anticipated when the recommendation is followed. The AAP definitions of evidence-based recommendations are shown in Table 1.

A draft version of this practice guideline underwent extensive peer review by committees and sections within the AAP, reviewers appointed by the AAFP, outside organizations, and other individuals identified by the subcommittee as experts in the field. Members of the subcommittee were invited to distribute the draft to other representatives and committees within their specialty organizations. The resulting comments were reviewed by the subcommittee and, when appropriate, incorporated into the guideline.

RECOMMENDATION 1

To diagnose AOM the clinician should confirm a history of acute onset, identify signs of middle-ear effusion (MEE), and evaluate for the presence of signs and symptoms of middle-ear inflammation. (This recommendation is based on observational studies and a preponderance of benefit over risk; see Table 2.)

TABLE 1. Guideline Definitions for Evidence-Based Statements

Statement

Definition

Strong recommendation

Recommendation Option No 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.

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.

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.

No recommendation indicates that there is a lack of pertinent published evidence and that the anticipated balance of benefits and harms is unclear.

Implication

Clinicians should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present.

Clinicians would be prudent to follow a recommendation but should remain alert to new information and sensitive to patient preferences.

Clinicians should consider the option in their decisionmaking, and patient preference may play a substantial role.

Clinicians should be alert to new published evidence that clarifies the balance of benefit versus harm.

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TABLE 2. Definition of AOM

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: 1. Recent, usually abrupt, onset of signs and symptoms of middle-ear inflammation and MEE 2. The presence of MEE that is indicated by any of the following: a. Bulging of the tympanic membrane b. Limited or absent mobility of the tympanic membrane c. Air-fluid level behind the tympanic membrane d. Otorrhea 3. Signs or symptoms of middle-ear inflammation as indicated by either a. Distinct erythema of the tympanic membrane or b. Distinct otalgia (discomfort clearly referable to the ear[s] that results in interference with or precludes normal activity or sleep)

Children with AOM usually present with a history of rapid onset of signs and symptoms such as otalgia (or pulling of the ear in an infant), irritability in an infant or toddler, otorrhea, and/or fever. These findings, other than otorrhea, are nonspecific and frequently overlap those of an uncomplicated viral upper respiratory infection.5,6 In a prospective survey among 354 children who visited a physician for acute respiratory illness, fever, earache, and excessive crying were present frequently (90%) in those with AOM. However, these symptoms also were prominent among children without AOM (72%). Other symptoms of a viral upper respiratory infection, such as cough and nasal discharge or stuffiness, often precede or accompany AOM and are nonspecific also. Accordingly, clinical history alone is poorly predictive of the presence of AOM, especially in younger children.5

The presence of MEE is commonly confirmed with the use of pneumatic otoscopy7 but can be supplemented by tympanometry8 and/or acoustic reflectometry.9?12 MEE also can be demonstrated directly by tympanocentesis or the presence of fluid in the external auditory canal as a result of tympanic membrane perforation.

Visualization of the tympanic membrane with identification of an MEE and inflammatory changes is necessary to establish the diagnosis with certainty. To visualize the tympanic membrane adequately it is essential that cerumen obscuring the tympanic membrane be removed and that lighting is adequate. For pneumatic otoscopy, a speculum of proper shape and diameter must be selected to permit a seal in the external auditory canal. Appropriate restraint of the child to permit adequate examination may be necessary also.

The findings on otoscopy indicating the presence of MEE and inflammation associated with AOM have been well defined. Fullness or bulging of the tympanic membrane is often present and has the highest predictive value for the presence of MEE. When combined with color and mobility, bulging is also the best predictor of AOM.7,13,14 Reduced or absent mobility of the tympanic membrane during performance of pneumatic otoscopy is additional evidence of fluid in the middle ear. Opacification or

cloudiness, other than that caused by scarring, is also a consistent finding and is caused by edema of the tympanic membrane. Redness of the tympanic membrane caused by inflammation may be present and must be distinguished from the pink erythematous flush evoked by crying or high fever, which is usually less intense and remits as the child quiets down. In bullous myringitis, blisters may be seen on the tympanic membrane.15 When the presence of middle-ear fluid is difficult to determine, the use of tympanometry or acoustic reflectometry16 can be helpful in establishing a diagnosis.

A major challenge for the practitioner is to discriminate between OME and AOM.17,18 OME is more common than AOM. OME may accompany viral upper respiratory infections, be a prelude to AOM, or be a sequela of AOM.19 When OME is identified mistakenly as AOM, antibacterial agents may be prescribed unnecessarily.20,21 Clinicians should strive to avoid a false-positive diagnosis in children with middle-ear discomfort caused by eustachian tube dysfunction and retraction of the tympanic membrane or when acute viral respiratory infection is superimposed on chronic preexisting MEE.

The diagnosis of AOM, particularly in infants and young children, is often made with a degree of uncertainty. Common factors that may increase uncertainty include the inability to sufficiently clear the external auditory canal of cerumen, a narrow ear canal, or inability to maintain an adequate seal for successful pneumatic otoscopy or tympanometry. An uncertain diagnosis of AOM is caused most often by inability to confirm the presence of MEE.22 Acoustic reflectometry can be helpful, because it requires no seal of the canal and can determine the presence of middle-ear fluid through only a small opening in the cerumen.10,11 When the presence of middle-ear fluid is questionable or uncertain, a diagnosis of AOM may be considered but cannot be confirmed. Although every effort should be made by the clinician to differentiate AOM from OME or a normal ear, it must be acknowledged that, using all available tools, uncertainty will remain in some cases. Efforts to improve clinician education must be increased to improve diagnostic skills and thereby decrease the frequency of an uncertain diagnosis. Ideally, instruction in the proper examination of the child's ear should begin with the first pediatric rotation in medical school and continue throughout postgraduate training.18 Continuing medical education should reinforce the importance of and retrain the clinician in the use of pneumatic otoscopy. By including the degree of certainty into the formation of a management plan, the everyday challenge of pediatric examinations is incorporated into decision-making.

A certain diagnosis of AOM meets all 3 of the criteria: rapid onset, presence of MEE, and signs and symptoms of middle-ear inflammation. The clinician should maximize diagnostic strategies, particularly to establish the presence of MEE, and should consider the certainty of diagnosis in determining management. Clinicians may wish to discuss the degree of diagnostic certainty with parents/caregivers at the time of initial AOM management.

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TABLE 3. Treatments for Otalgia in AOM Modality

Acetaminophen, ibuprofen26

Home remedies (no controlled studies that directly address effectiveness)

Distraction External application of heat or cold Oil Topical agents Benzocaine (Auralgan, Americaine Otic)27

Naturopathic agents (Otikon Otic Solution)28

Homeopathic agents29,30 Narcotic analgesia with codeine or analogs

Tympanostomy/myringotomy31

Comments

Effective analgesia for mild to moderate pain, readily available, mainstay of pain management for AOM

May have limited effectiveness

Additional but brief benefit over acetaminophen in patients 5 y

Comparable with ametocaine/phenazone drops (Anaesthetic) in patients 6 y

No controlled studies that directly address pain Effective for moderate or severe pain; requires

prescription; risk of respiratory depression, altered mental status, gastrointestinal upset, and constipation Requires skill and entails potential risk

RECOMMENDATION 2

The management of AOM should include an assessment of pain. If pain is present, the clinician should recommend treatment to reduce pain. (This is a strong recommendation based on randomized, clinical trials with limitations and a preponderance of benefit over risk.)

Many episodes of AOM are associated with pain.23 Although pain is an integral part of the illness, clinicians often see otalgia as a peripheral concern not requiring direct attention.24 The AAP published the policy statement "The Assessment and Management of Acute Pain in Infants, Children, and Adolescents"25 to assist the clinician in addressing pain in the context of illness. The management of pain, especially during the first 24 hours of an episode of AOM, should be addressed regardless of the use of antibacterial agents.

Various treatments of otalgia have been used, but none has been well studied. The clinician should select a treatment based on a consideration of benefits and risks and, wherever possible, incorporate parent/caregiver and patient preference (Table 3).

RECOMMENDATION 3A

Observation without use of antibacterial agents in a child with uncomplicated AOM is an option for selected children based on diagnostic certainty, age, illness severity, and assurance of follow-up. (This option is based on randomized, controlled trials with limitations and a relative balance of benefit and risk.)

The "observation option" for AOM refers to deferring antibacterial treatment of selected children for 48 to 72 hours and limiting management to symptomatic relief. The decision to observe or treat is based on the child's age, diagnostic certainty, and illness severity. To observe a child without initial antibacterial therapy, it is important that the parent/ caregiver has a ready means of communicating with the clinician. There also must be a system in place that permits reevaluation of the child. If necessary, the parent/caregiver also must be able to obtain medication conveniently.

This option should be limited to otherwise healthy

children 6 months to 2 years of age with nonsevere illness at presentation and an uncertain diagnosis and to children 2 years of age and older without severe symptoms at presentation or with an uncertain diagnosis. In these situations, observation provides an opportunity for the patient to improve without antibacterial treatment. The association of age younger than 2 years with increased risk of failure of watchful waiting and the concern for serious infection among children younger than 6 months influence the decision for immediate antibacterial therapy. Consequently, the panel recommends an age-stratified approach that incorporates these clinical considerations along with the certainty of diagnosis (Table 4).

Placebo-controlled trials of AOM over the past 30 years have shown consistently that most children do well, without adverse sequelae, even without antibacterial therapy. Between 7 and 20 children must be treated with antibacterial agents for 1 child to derive benefit.34?36 By 24 hours, 61% of children have decreased symptoms whether they receive placebo or

TABLE 4. Criteria for Initial Antibacterial-Agent Treatment or Observation in Children With AOM

Age

Certain Diagnosis

Uncertain Diagnosis

6 mo 6 mo to 2 y

2 y

Antibacterial therapy Antibacterial therapy

Antibacterial therapy if severe illness; observation option* if nonsevere illness

Antibacterial therapy Antibacterial therapy

if severe illness; observation option* if nonsevere illness Observation option*

This table was modified with permission from the New York State Department of Health and the New York Region Otitis Project Committee.32,33 * Observation is an appropriate option only when follow-up can be ensured and antibacterial agents started if symptoms persist or worsen. Nonsevere illness is mild otalgia and fever 39?C in the past 24 hours. Severe illness is moderate to severe otalgia or fever 39?C. A certain diagnosis of AOM meets all 3 criteria: 1) rapid onset, 2) signs of MEE, and 3) signs and symptoms of middle-ear inflammation.

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antibacterial agents. By 7 days, approximately 75% of children have resolution of symptoms.37 The AHRQ evidence-report meta-analysis showed a 12.3% reduction in the clinical failure rate within 2 to 7 days of diagnosis when ampicillin or amoxicillin was prescribed, compared with initial use of placebo or observation (number needed to treat: 8).1

In 1990 the Dutch College of General Practitioners adopted a guideline for the management of AOM that recommended treating symptoms without antibacterial agents for 24 hours (for those 6 ?24 months old) or 72 hours (for those more than 24 months) and adding antibacterial agents if no improvement is evident at reassessment. A 1999 revision to this early guideline does not distinguish the younger age group for special consideration.38 Although this guideline has been widely adopted in The Netherlands, its use in other countries requires consideration of the availability of access to care for follow-up and the presence of an adult who can adequately monitor the child's course. Although there are no controlled studies that address the question of whether the Dutch guideline has resulted in more complications after AOM, van Buchem et al39,136 found that only 2.7% of 4860 Dutch children older than 2 years given only symptomatic treatment developed severe illness, defined by persistent fever, pain, or discharge after 3 to 4 days. Only 2 children developed mastoiditis. One case of mastoiditis was present at initial assessment, and the other developed within the first week and resolved promptly with oral antibacterial agents.

Randomized trials of observation with symptomatic treatment have been few. A recent randomized trial in general practice in the United Kingdom compared providing immediate antibacterial therapy with delaying antibacterial agents for 72 hours in children aged 6 months to 10 years.40 Seventy-six percent of children in the delayed-treatment group never required antibacterial agents. Seventy percent of the delayed-antibacterial group were symptomatically better at 3 days, whereas 86% of the immediate-treatment group were better. Immediate use of antibacterial agents was associated with approximately 1-day-shorter illness and one-half teaspoon a day less acetaminophen consumption but no difference in school absence, pain, or distress scores. Among children with fever or vomiting on day 1, those receiving immediate antibacterial agents were 21% less likely to have distress on day 3. In children without fever or vomiting, immediate antibacterial agents decreased distress on day 3 by only 4%.41 This study, however, was limited because of the use of imprecise criteria for the diagnosis of AOM and the use of low doses of amoxicillin (125 mg, 3 times a day, for 7 days for all patients regardless of weight) in the treatment group.

The likelihood of recovery without antibacterial therapy differs depending on the severity of signs and symptoms at initial examination. Kaleida et al42 divided patients into severe and nonsevere groups based on degree of fever, a scoring system based on duration and severity of pain or apparent discomfort, and estimated parental anxiety. In the nonse-

vere group, initial treatment failure occurred in 3.8% more children who received placebo rather than amoxicillin. In the severe group of children, the initial failure rate on placebo plus myringotomy was 23.5% versus an initial failure rate of 9.6% on amoxicillin alone (a difference of 13.9%).

Several investigators report poorer outcomes in younger children. A greater number of penicillinresistant strains of pneumococci are isolated in those younger than 18 months, compared with older children,43 and are associated with an increased bacteriologic failure rate in children younger than 2 years.44?47 The study by Kaleida et al42 also shows a greater initial clinical failure rate (9.8%) in children younger than 2 years than in those older than 2 years (5.5%) who were in the placebo group.

Routine antibacterial therapy for AOM is often cited as the main reason for the decrease in the incidence of mastoiditis in the antibacterial era.48,49 By the 1950s, mastoiditis (frequent in the pre?antibacterial-agent era48) had decreased dramatically. Although some have expressed concern about a possible resurgence,50,51 such concern is not supported by published data.

The AHRQ evidence report on AOM concluded that mastoiditis is not increased with initial observation, provided that children are followed closely and antibacterial therapy is initiated in those who do not improve. Pooled data from 6 randomized trials and 2 cohort studies showed comparable rates of mastoiditis in children (0.59%) who received initial antibacterial therapy and children (0.17%) who received placebo or observation (P .212). External validity might be limited, however, because some trials excluded very young children or those with severe illness.1

Recently published case series of pediatric mastoiditis show that acute mastoiditis is most common in infants and young children and can be the presenting sign of AOM in a patient with no prior middle-ear disease.50?60 Routine antibacterial therapy of AOM is not an absolute safeguard against mastoiditis and other complications, because most cases (36%? 87%) have received prior antibacterialagent therapy.50,53,57?59,61?63

Van Zuijlen et al64 compared national differences in acute mastoiditis rates from 1991 to 1998 for children 14 years of age or younger. Incidence rates were higher in The Netherlands, Norway, and Denmark (in which antibacterial agents are not necessarily given on initial diagnosis of AOM) than in the United Kingdom, Canada, Australia, and the United States (in which antibacterial agents are prescribed in more than 96% of cases). However, despite initial use of antibacterial agents more than twice as often in Norway and Denmark than in The Netherlands, mastoiditis rates in all 3 countries were comparable.

Thus current evidence does not suggest a clinically important increased risk of mastoiditis in children when AOM is managed only with initial symptomatic treatment without antibacterial agents. Clinicians should remain aware that antibacterial-agent treatment might mask mastoiditis signs and symp-

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toms, producing a subtle presentation that can delay diagnosis.56,59,61

Although bacteremia may accompany AOM, particularly in children with a temperature higher than 39?C,65 there is little evidence that routine antibacterial treatment for otitis media prevents bacterial meningitis. In a study of 4860 children with AOM who did not receive antibacterial therapy, no cases of bacterial meningitis were observed.39 However, in a study involving 240 children between 6 and 24 months of age, 1 child in the placebo group was subsequently diagnosed as having meningitis.66 In another report, positive blood cultures were equally common in children with bacterial meningitis regardless of whether they received preadmission treatment with antibacterials for AOM (77% and 78%).67 Thus, as with mastoiditis, the incidence of meningitis in those with AOM is unlikely to be influenced by initial treatment of AOM with antibacterial agents.

The incidence of invasive pneumococcal disease has decreased since the introduction of the proteinpolysaccharide conjugate vaccine (PPV7). There has been a 69% decline in children younger than 2 years between 1998 ?1999 and 2001. The decline in this age group for invasive disease caused by vaccine serotypes during that period was 78%.68 How this will affect the risk of AOM-associated invasive pneumococcal disease is not known yet.

As noted by Dagan and McCracken,69 studies comparing efficacy of different antibacterial agents or placebo compared with antibacterial therapy often have significant design flaws that may influence the outcome of the studies. Methodologic considerations include enrollment criteria, sample size, diagnostic criteria, dosing regimens, definition and timing of outcome criteria, age, severity of symptoms, race, immune system, compliance, virulence and resistance of the infecting organism, duration of antibacterial therapy, and the presence of an underlying respiratory infection. One of the most important issues among the design characteristics of the studies of otitis media is the definition of AOM used in the individual investigations. If studies that evaluate the impact of antibacterial therapy on the clinical course of children with AOM have weak definitions of AOM (that allow the inclusion of children who are more likely to have OME than AOM), recipients of placebo will not respond significantly differently from those who receive antibacterial therapy.

Given the sum of the available evidence, clinicians may consider observation with symptomatic treatment as an option for initial management of selected children with AOM. If the "observation option" is used, the clinician should share with parents/caregivers the degree of diagnostic certainty and consider their preference. The potential of antibacterial therapy at the initial visit to shorten symptoms by 1 day in 5% to 14% of children can be compared with the avoidance of common antibacterial side effects in 5% to 10% of children, infrequent serious side effects, and the adverse effects of antibacterial resistance. When considering this option, the clinician should verify the presence of an adult who will reliably

observe the child, recognize signs of serious illness, and be able to provide prompt access to medical care if improvement does not occur. If there is worsening of illness or if there is no improvement in 48 to 72 hours while a child is under observation, institution of antibacterial therapy should be considered. Reexamination may be warranted if discussion with the parents raises concern as to the degree of illness.

Strategies for following children being managed with initial observation include a parent-initiated visit and/or phone contact for worsening condition or no improvement at 48 to 72 hours, a scheduled follow-up appointment in 48 to 72 hours, routine follow-up phone contact, or use of a safety-net antibiotic prescription to be filled if illness does not improve in 48 to 72 hours.70,71 Clinicians should determine the most appropriate strategy for their practice setting, taking into account the availability and reliability of the reporting parent/caregiver, available office resources, cost to the health care system and the family, and the convenience of the family. An assessment of the potential risk of inappropriate use of an antibacterial agent in a patient who may be worsening or may have a condition other than AOM must also be made. Table 5 summarizes the data on initial observation versus initial antibacterial-agent treatment of AOM.

RECOMMENDATION 3B

If a decision is made to treat with an antibacterial agent, the clinician should prescribe amoxicillin for most children. (This recommendation is based on randomized, clinical trials with limitations and a preponderance of benefit over risk.)

When amoxicillin is used, the dose should be 80 to 90 mg/kg per day. (This option is based on extrapolation from microbiologic studies and expert opinion, with a preponderance of benefit over risk.)

If a decision is made to treat with antibacterial agents, there are numerous medications that are clinically effective. The choice of first-line treatment should be based on the anticipated clinical response as well as the microbiologic flora likely to be present. The justification to use amoxicillin as first-line therapy in most patients with AOM relates to its general effectiveness when used in sufficient doses against susceptible and intermediate resistant pneumococci as well as its safety, low cost, acceptable taste, and narrow microbiologic spectrum.75

In patients who have severe illness (moderate to severe otalgia or fever of 39?C or higher42) and in those for whom additional coverage for -lactamase? positive Haemophilus influenzae and Moraxella catarrhalis is desired, therapy should be initiated with high-dose amoxicillin-clavulanate (90 mg/kg per day of amoxicillin component, with 6.4 mg/kg per day of clavulanate in 2 divided doses).76 This dose has sufficient potassium clavulanate to inhibit all -lactamase?producing H influenzae and M catarrhalis.

Many clinical studies comparing the effectiveness of various antibacterial agents in the treatment of AOM do not carefully define standard criteria for diagnosis of AOM at entry or for improvement or

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