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The Diagnosis and Management of Acute Otitis Media

Allan S. Lieberthal, Aaron E. Carroll, Tasnee Chonmaitree, Theodore G. Ganiats,


Alejandro Hoberman, Mary Anne Jackson, Mark D. Joffe, Donald T. Miller, Richard
M. Rosenfeld, Xavier D. Sevilla, Richard H. Schwartz, Pauline A. Thomas and David
E. Tunkel
Pediatrics 2013;131;e964; originally published online February 25, 2013;
DOI: 10.1542/peds.2012-3488

The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://pediatrics.aappublications.org/content/131/3/e964.full.html

PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly


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Organizational Principles to Guide and Define the Child
Health Care System and/or Improve the Health of all Children

CLINICAL PRACTICE GUIDELINE

The Diagnosis and Management of Acute Otitis Media

abstract Allan S. Lieberthal, MD, FAAP, Aaron E. Carroll, MD, MS,


FAAP, Tasnee Chonmaitree, MD, FAAP, Theodore G. Ganiats,
MD, Alejandro Hoberman, MD, FAAP, Mary Anne Jackson,
This evidence-based clinical practice guideline is a revision of the 2004
MD, FAAP, Mark D. Joffe, MD, FAAP, Donald T. Miller, MD,
acute otitis media (AOM) guideline from the American Academy of Pe- MPH, FAAP, Richard M. Rosenfeld, MD, MPH, FAAP, Xavier D.
diatrics (AAP) and American Academy of Family Physicians. It provides Sevilla, MD, FAAP, Richard H. Schwartz, MD, FAAP, Pauline A.
recommendations to primary care clinicians for the management of Thomas, MD, FAAP, and David E. Tunkel, MD, FAAP, FACS
children from 6 months through 12 years of age with uncomplicated KEY WORDS
AOM. acute otitis media, otitis media, otoscopy, otitis media with
effusion, watchful waiting, antibiotics, antibiotic prophylaxis,
In 2009, the AAP convened a committee composed of primary care tympanostomy tube insertion, immunization, breastfeeding
physicians and experts in the fields of pediatrics, family practice, oto- ABBREVIATIONS
laryngology, epidemiology, infectious disease, emergency medicine, AAFP—American Academy of Family Physicians
and guideline methodology. The subcommittee partnered with the AAP—American Academy of Pediatrics
AHRQ—Agency for Healthcare Research and Quality
Agency for Healthcare Research and Quality and the Southern Califor- AOM—acute otitis media
nia Evidence-Based Practice Center to develop a comprehensive review CI—confidence interval
of the new literature related to AOM since the initial evidence report of FDA—US Food and Drug Administration
LAIV—live-attenuated intranasal influenza vaccine
2000. The resulting evidence report and other sources of data were MEE—middle ear effusion
used to formulate the practice guideline recommendations. MIC—minimum inhibitory concentration
The focus of this practice guideline is the appropriate diagnosis and NNT—number needed to treat
OM—otitis media
initial treatment of a child presenting with AOM. The guideline provides OME—otitis media with effusion
a specific, stringent definition of AOM. It addresses pain management, OR—odds ratio
initial observation versus antibiotic treatment, appropriate choices of PCV7—heptavalent pneumococcal conjugate vaccine
PCV13—13-valent pneumococcal conjugate vaccine
antibiotic agents, and preventive measures. It also addresses recur- RD—rate difference
rent AOM, which was not included in the 2004 guideline. Decisions were SNAP—safety-net antibiotic prescription
made on the basis of a systematic grading of the quality of evidence TIV—trivalent inactivated influenza vaccine
TM—tympanic membrane
and benefit-harm relationships. WASP—wait-and-see prescription
The practice guideline underwent comprehensive peer review before This document is copyrighted and is property of the American
formal approval by the AAP. Academy of Pediatrics and its Board of Directors. All authors
have filed conflict of interest statements with the American
This clinical practice guideline is not intended as a sole source of guid- Academy of Pediatrics. Any conflicts have been resolved through
ance in the management of children with AOM. Rather, it is intended to a process approved by the Board of Directors. The American
assist primary care clinicians by providing a framework for clinical Academy of Pediatrics has neither solicited nor accepted any
commercial involvement in the development of the content of
decision-making. It is not intended to replace clinical judgment or es- this publication.
tablish a protocol for all children with this condition. These recommend-
The recommendations in this report do not indicate an exclusive
ations may not provide the only appropriate approach to the course of treatment or serve as a standard of medical care.
management of this problem. Pediatrics 2013;131:e964–e999 Variations, taking into account individual circumstances, may be
appropriate.

(Continued on last page)

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FROM THE AMERICAN ACADEMY OF PEDIATRICS

Key Action Statement 1A: Clinicians temperature less than 39°C [102.2°F]). to penicillin. Evidence Quality: Grade
should diagnose acute otitis media Evidence Quality: Grade B. Strength: B. Strength: Recommendation.
(AOM) in children who present with Recommendation. Key Action Statement 4B: Clinicians
moderate to severe bulging of the Key Action Statement 3C: Non- should prescribe an antibiotic with
tympanic membrane (TM) or new severe unilateral AOM in young additional β-lactamase coverage
onset of otorrhea not due to acute children: The clinician should ei- for AOM when a decision to treat
otitis externa. Evidence Quality: ther prescribe antibiotic therapy with antibiotics has been made,
Grade B. Strength: Recommendation. or offer observation with close and the child has received amoxi-
Key Action Statement 1B: Clinicians follow-up based on joint decision- cillin in the last 30 days or has
should diagnose AOM in children making with the parent(s)/caregiver concurrent purulent conjunctivitis,
who present with mild bulging of the for unilateral AOM in children 6 or has a history of recurrent AOM
TM and recent (less than 48 hours) months to 23 months of age without unresponsive to amoxicillin. Evi-
onset of ear pain (holding, tugging, severe signs or symptoms (ie, mild dence Quality: Grade C. Strength:
rubbing of the ear in a nonverbal otalgia for less than 48 hours Recommendation.
child) or intense erythema of and temperature less than 39°C
Key Action Statement 4C: Clinicians
the TM. Evidence Quality: Grade C. [102.2°F]). When observation is
should reassess the patient if the
Strength: Recommendation. used, a mechanism must be in place
caregiver reports that the child’s
to ensure follow-up and begin anti-
Key Action Statement 1C: Clinicians symptoms have worsened or failed
biotic therapy if the child worsens
should not diagnose AOM in chil- to respond to the initial antibiotic
or fails to improve within 48 to
dren who do not have middle ear treatment within 48 to 72 hours
72 hours of onset of symptoms.
effusion (MEE) (based on pneu- and determine whether a change
Evidence Quality: Grade B. Strength:
matic otoscopy and/or tympanometry). in therapy is needed. Evidence
Recommendation.
Evidence Quality: Grade B. Strength: Quality: Grade B. Strength: Recom-
Recommendation. Key Action Statement 3D: Nonsevere mendation.
AOM in older children: The clinician
Key Action Statement 2: The man- Key Action Statement 5A: Clinicians
should either prescribe antibiotic
agement of AOM should include an should not prescribe prophylactic
therapy or offer observation with
assessment of pain. If pain is antibiotics to reduce the frequency
close follow-up based on joint
present, the clinician should rec- of episodes of AOM in children with
decision-making with the parent(s)/
ommend treatment to reduce pain. recurrent AOM. Evidence Quality:
caregiver for AOM (bilateral or uni-
Evidence Quality: Grade B. Strength: Grade B. Strength: Recommendation.
lateral) in children 24 months or
Strong Recommendation. Key Action Statement 5B: Clinicians
older without severe signs or
Key Action Statement 3A: Severe symptoms (ie, mild otalgia for less may offer tympanostomy tubes for
AOM: The clinician should prescribe than 48 hours and temperature less recurrent AOM (3 episodes in 6
antibiotic therapy for AOM (bilateral than 39°C [102.2°F]). When obser- months or 4 episodes in 1 year
or unilateral) in children 6 months vation is used, a mechanism must with 1 episode in the preceding
and older with severe signs or be in place to ensure follow-up and 6 months). Evidence Quality: Grade
symptoms (ie, moderate or severe begin antibiotic therapy if the child B. Strength: Option.
otalgia or otalgia for at least 48 worsens or fails to improve within Key Action Statement 6A: Clinicians
hours or temperature 39°C [102.2°F] 48 to 72 hours of onset of symptoms. should recommend pneumococcal
or higher). Evidence Quality: Grade B. Evidence Quality: Grade B. Strength: conjugate vaccine to all children
Strength: Strong Recommendation. Recommendation. according to the schedule of the
Key Action Statement 3B: Non- Key Action Statement 4A: Clinicians Advisory Committee on Immuniza-
severe bilateral AOM in young should prescribe amoxicillin for tion Practices of the Centers for
children: The clinician should pre- AOM when a decision to treat with Disease Control and Prevention,
scribe antibiotic therapy for bi- antibiotics has been made and the American Academy of Pediatrics
lateral AOM in children 6 months child has not received amoxicillin in (AAP), and American Academy of
through 23 months of age without the past 30 days or the child does Family Physicians (AAFP). Evidence
severe signs or symptoms (ie, mild not have concurrent purulent con- Quality: Grade B. Strength: Strong
otalgia for less than 48 hours and junctivitis or the child is not allergic Recommendation.

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Key Action Statement 6B: Clinicians resulting in antibiotic prescriptions for primary care clinicians including
should recommend annual influenza remained relatively stable (80% in 1995– pediatricians and family physicians,
vaccine to all children according to 1996; 76% in 2005–2006).2 Many factors emergency department physicians,
the schedule of the Advisory Com- may have contributed to the decrease otolaryngologists, physician assistants,
mittee on Immunization Practices, in visits for OM, including financial and nurse practitioners. The scope
AAP, and AAFP. Evidence Quality: issues relating to insurance, such as of the guideline is the diagnosis
Grade B. Strength: Recommendation. copayments, that may limit doctor visits, and management of AOM, including
2Key Action Statement 6C: Clinicians public education campaigns regarding recurrent AOM, in children 6 months
should encourage exclusive breast- the viral nature of most infectious dis- through 12 years of age. It applies only
feeding for at least 6 months. Evi- eases, use of the PCV7 pneumococcal to an otherwise healthy child without
dence Quality: Grade B. Strength: vaccine, and increased use of the underlying conditions that may alter
Recommendation. influenza vaccine. Clinicians may also be the natural course of AOM, including
more attentive to differentiating AOM but not limited to the presence of
Key Action Statement 6D: Clinicians
from OM with effusion (OME), resulting tympanostomy tubes; anatomic abnor-
should encourage avoidance of to-
in fewer visits coded for AOM and malities, including cleft palate; genetic
bacco smoke exposure. Evidence
fewer antibiotic prescriptions written. conditions with craniofacial abnormali-
Quality: Grade C. Strength: Recom-
ties, such as Down syndrome; immune
mendation. Despite significant publicity and
deficiencies; and the presence of co-
awareness of the 2004 AOM guideline,
chlear implants. Children with OME
evidence shows that clinicians are
INTRODUCTION without AOM are also excluded.
hesitant to follow the guideline recom-
In May 2004, the AAP and AAFP pub- mendations. Vernacchio et al4 surveyed
489 primary care physicians as to their Glossary of Terms
lished the “Clinical Practice Guideline:
Diagnosis and Management of Acute management of 4 AOM scenarios AOM—the rapid onset of signs and
Otitis Media”.1 The guideline offered addressed in the 2004 guideline. No symptoms of inflammation in the
8 recommendations ranked accord- significant changes in practice were middle ear9,10
ing to level of evidence and benefit- noted on this survey, compared with Uncomplicated AOM—AOM without
harm relationship. Three of the a survey administered before the 2004 otorrhea1
recommendations—diagnostic criteria, AOM guideline. Coco5 used the National Severe AOM—AOM with the presence
observation, and choice of antibiotics— Ambulatory Medical Care Survey from of moderate to severe otalgia or fever
led to significant discussion, especially 2002 through 2006 to determine the equal to or higher than 39°C9,10
among experts in the field of otitis me- frequency of AOM visits without anti-
Nonsevere AOM—AOM with the
dia (OM). Also, at the time the guideline biotics before and after publication of
presence of mild otalgia and a tem-
was written, information regarding the the 2004 guideline. There was no dif-
perature below 39°C9,10
heptavalent pneumococcal conjugate ference in prescribing rates. A similar
response to otitis guidelines was found Recurrent AOM—3 or more well-
vaccine (PCV7) was not yet published.
in Italy as in the United States.6,7 documented and separate AOM epi-
Since completion of the guideline in
These findings parallel results of other sodes in the preceding 6 months or
November 2003 and its publication in
investigations regarding clinician aware- 4 or more episodes in the preceding
May 2004, there has been a significant
ness and adherence to guideline 12 months with at least 1 episode in
body of additional literature on AOM.
recommendations in all specialties, the past 6 months11,12
Although OM remains the most common
including pediatrics.8 Clearly, for clin- OME—inflammation of the middle ear
condition for which antibacterial agents
ical practice guidelines to be effective, with liquid collected in the middle ear;
are prescribed for children in the United
more must be done to improve their the signs and symptoms of acute in-
States2,3 clinician visits for OM de-
dissemination and implementation. fection are absent9
creased from 950 per 1000 children in
1995–1996 to 634 per 1000 children in This revision and update of the AAP/AAFP MEE—liquid in the middle ear without
2005–2006. There has been a pro- 2004 AOM guideline1 will evaluate pub- reference to etiology, pathogenesis,
portional decrease in antibiotic pre- lished evidence on the diagnosis and pathology, or duration9
scriptions for OM from 760 per 1000 management of uncomplicated AOM Otorrhea—discharge from the ear,
in 1995–1996 to 484 per 1000 in and make recommendations based on originating at 1 or more of the follow-
2005–2006. The percentage of OM visits that evidence. The guideline is intended ing sites: the external auditory canal,

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middle ear, mastoid, inner ear, or in- In preparing for the 2004 AAP guide- of antimicrobial resistance in AOM
tracranial cavity lines, the Agency for Healthcare Re- since the introduction of PCV7?
Otitis externa—an infection of the search and Quality (AHRQ) funded and 3. What is the comparative effective-
external auditory canal conducted an exhaustive review of the ness of various treatment options
Tympanometry—measuring acoustic literature on diagnosis and manage- for treating uncomplicated AOM in
immittance (transfer of acoustic en- ment of AOM.17–19 In 2008, the AHRQ and average risk children?
ergy) of the ear as a function of ear the Southern California Evidence-Based 4. What is the comparative effectiveness
canal air pressure13,14 Practice Center began a similar pro- of different management options for
cess of reviewing the literature pub- recurrent OM (uncomplicated) and
Number needed to treat (NNT)—the
lished since the 2001 AHRQ report. The persistent OM or relapse of AOM?
number of patients who need to be
AAP again partnered with AHRQ and
treated to prevent 1 additional bad 5. Do treatment outcomes in Ques-
the Southern California Evidence-Based
outcome15 tions 3 and 4 differ by character-
Practice Center to develop the evi- istics of the condition (AOM), patient,
Initial antibiotic therapy—treatment
dence report, which served as a major environment, and/or health care de-
of AOM with antibiotics that are pre-
source of data for these practice livery system?
scribed at the time of diagnosis with the
guideline recommendations.20,21 New
intent of starting antibiotic therapy as 6. What adverse effects have been ob-
key questions were determined by
soon as possible after the encounter served for treatments for which
a technical expert panel. The scope of
Initial observation—initial manage- outcomes are addressed in Ques-
the new report went beyond the 2001
ment of AOM limited to symptomatic tions 3 and 4?
AHRQ report to include recurrent AOM.
relief, with commencement of antibiotic For the 2010 review, searches of PubMed
The key questions addressed by AHRQ
therapy only if the child’s condition and the Cochrane Database of System-
worsens at any time or does not show in the 2010 report were as follows:
atic Reviews, Cochrane Central Register
clinical improvement within 48 to 72 1. Diagnosis of AOM: What are the op- of Controlled Trials, and Education
hours of diagnosis; a mechanism must erating characteristics (sensitivity, Resources Information Center were
be in place to ensure follow-up and specificity, and likelihood ratios) of conducted by using the same search
initiation of antibiotics if the child fails clinical symptoms and otoscopic strategies used for the 2001 report for
observation findings (such as bulging TM) to publications from 1998 through June
diagnose uncomplicated AOM and 2010. Additional terms or conditions not
to distinguish it from OME? considered in the 2001 review (recurrent
METHODS
2. What has been the effect of the use OM, new drugs, and heptavalent pneu-
Guideline development using an of heptavalent PCV7 on AOM micro- mococcal vaccine) were also included.
evidence-based approach requires bial epidemiology, what organisms The Web of Science was also used to
that all evidence related to the (bacterial and viral) are associated search for citations of the 2001 report
guideline is gathered in a systematic with AOM since the introduction of and its peer-reviewed publications. Titles
fashion, objectively assessed, and then PCV7, and what are the patterns were screened independently by 2
described so readers can easily see
the links between the evidence and
recommendations made. An evidence-
based approach leads to recom-
mendations that are guided by both
the quality of the available evidence
and the benefit-to-harm ratio that
results from following the recom-
mendation. Figure 1 shows the re-
lationship of evidence quality and
benefit-harm balance in determining
the level of recommendation. Table 1
presents the AAP definitions and
FIGURE 1
implications of different levels of Relationship of evidence quality and benefit-harm balance in determining the level of recommen-
evidence-based recommendations.16 dation. RCT, randomized controlled trial.

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TABLE 1 Guideline Definitions for Evidence-Based Statements
Statement Definition Implication
Strong Recommendation A strong recommendation in favor of a particular action is made Clinicians should follow a strong recommendation unless
when the anticipated benefits of the recommended a clear and compelling rationale for an alternative approach
intervention clearly exceed the harms (as a strong is present.
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.
Recommendation A recommendation in favor of a particular action is made when Clinicians would be prudent to follow a recommendation but
the anticipated benefits exceed the harms, but the quality of should remain alert to new information and sensitive to
evidence is not as strong. Again, in some clearly identified patient preferences.
circumstances, recommendations may be made when high-
quality evidence is impossible to obtain but the anticipated
benefits outweigh the harms.
Option Options define courses that may be taken when either the Clinicians should consider the option in their decision-making,
quality of evidence is suspect or carefully performed studies and patient preference may have a substantial role.
have shown little clear advantage to 1 approach over another.
No Recommendation No recommendation indicates that there is a lack of pertinent Clinicians should be alert to new published evidence that
published evidence and that the anticipated balance of clarifies the balance of benefit versus harm.
benefits and harms is presently unclear.

pediatricians with experience in con- included parameters necessary to de- definitive data were not available.
ducting systematic reviews. fine study groups, inclusion/exclusion Results of the literature review were
For the question pertaining to diagnosis, criteria, influencing factors, and out- presented in evidence tables and pub-
efficacy, and safety, the search was come measures. Some of the data for lished in the final evidence report.20
primarily for clinical trials. For the analysis were abstracted by a bio- In June 2009, the AAP convened a new
question pertaining to the effect of PCV7 statistician and checked by a physician subcommittee to review and revise the
on epidemiology and microbiology, the reviewer. A sequential resolution strat- May 2004 AOM guideline.1 The sub-
group searched for trials that compared egy was used to match and resolve the committee comprised primary care
microbiology in the same populations screening and review results of the physicians and experts in the fields of
before and after introduction of the 2 pediatrician reviewers. pediatrics, family practice, otolaryn-
vaccine or observational studies that For the assessment of treatment effi- gology, epidemiology, infectious dis-
compared microbiology across vacci- cacy, pooled analyses were performed ease, emergency medicine, and
nated and unvaccinated populations. for comparisons for which 3 or more guideline methodology. All panel
trials could be identified. Studies eligi- members reviewed the AAP policy on
In total, the reviewers examined 7646
ble for analyses of questions pertaining conflict of interest and voluntary dis-
titles, of which 686 titles were identified
closure and were given an opportu-
for further review. Of those, 72 articles to treatment efficacy were grouped for
nity to present any potential conflicts
that met the predetermined inclusion comparisons by treatment options. Each
with the subcommittee’s work. All po-
and exclusion criteria were reviewed in comparison consisted of studies that
tential conflicts of interest are listed
detail. Investigators abstracted data were considered homogeneous across
at the end of this document. The project
into standard evidence tables, with clinical practice. Because some of the
was funded by the AAP. New literature
accuracy checked by a second in- key questions were addressed in the
on OM is continually being published.
vestigator. Studies were quality-rated 2001 evidence report,17 studies identi-
Although the systematic review per-
by 2 investigators by using estab- fied in that report were included with formed by AHRQ could not be repli-
lished criteria. For randomized con- newly identified articles in the 2010 cated with new literature, members
trolled trials, the Jadad criteria were evidence report.20 of the Subcommittee on Diagnosis
used.22 QUADAS criteria23 were used to Decisions were made on the basis of and Management of Acute Otitis Media
evaluate the studies that pertained to a systematic grading of the quality of ev- reviewed additional articles. PubMed
diagnosis. GRADE criteria were applied idence and strength of recommendations was searched by using the single
to pooled analyses.24 Data abstracted as well as expert consensus when search term “acute otitis media,”

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approximately every 6 months from KEY ACTION STATEMENTS to severe bulging of the TM or new
June 2009 through October 2011 to Key Action Statement 1A onset of otorrhea not due to acute
obtain new articles. Subcommittee Clinicians should diagnose AOM in otitis externa. (Evidence Quality: Grade
members evaluated pertinent articles children who present with moderate B, Rec. Strength: Recommendation)
for quality of methodology and im-
portance of results. Selected articles
used in the AHRQ review were also
reevaluated for their quality. Con- Key Action Statement Profile: KAS 1A
Aggregate evidence quality Grade B
clusions were based on the consensus
Benefits • Identify a population of children most likely to benefit from
of the subcommittee after the review intervention.
of newer literature and reevaluation of • Avoid unnecessary treatment of those without highly certain
the AHRQ evidence. Key action state- AOM.
• Promote consistency in diagnosis.
ments were generated using BRIDGE-Wiz Risks, harms, cost May miss AOM that presents with a combination of mild bulging,
(Building Recommendations in a Devel- intense erythema, or otalgia that may not necessarily
opers Guideline Editor), an interactive represent less severe disease and may also benefit from
intervention.
software tool that leads guideline de-
Benefits-harms assessment Preponderance of benefit.
velopment through a series of questions Value judgments Identification of a population of children with highly certain AOM
that are intended to create a more ac- is beneficial. Accurate, specific diagnosis is helpful to the
tionable set of key action statements.25 individual patient. Modification of current behavior of
overdiagnosis is a goal. Increased specificity is preferred
BRIDGE-Wiz also incorporates the quality even as sensitivity is lowered.
of available evidence into the final de- Intentional vagueness By using stringent diagnostic criteria, the TM appearance of less
termination of the strength of each severe illness that might be early AOM has not been
addressed.
recommendation. Role of patient preferences None
After thorough review by the sub- Exclusions None
Strength Recommendation
committee for this guideline, a draft
Notes Tympanocentesis studies confirm that using these diagnostic
was reviewed by other AAP committees findings leads to high levels of isolation of pathogenic
and sections, selected outside organ- bacteria. Evidence is extrapolated from treatment studies
izations, and individuals identified that included tympanocentesis.

by the subcommittee as experts in


the field. Additionally, members of
the subcommittee were encouraged to
distribute the draft to interested par-
ties in their respective specialties. All
comments were reviewed by the writ- Key Action Statement 1B (holding, tugging, rubbing of the
ing group and incorporated into the Clinicians should diagnose AOM in ear in a nonverbal child) or intense
final guideline when appropriate. children who present with mild erythema of the TM. (Evidence
This clinical practice guideline is not bulging of the TM and recent (less Quality: Grade C, Rec. Strength:
intended as a sole source of guidance than 48 hours) onset of ear pain Recommendation)
in the management of children with
AOM. Rather, it is intended to assist
clinicians in decision-making. It is not Key Action Statement Profile: KAS 1B
intended to replace clinical judgment Aggregate evidence quality Grade C
or establish a protocol for the care Benefits Identify AOM in children when the diagnosis is not highly
of all children with this condition. certain.
Risks, harms, cost Overdiagnosis of AOM. Reduced precision in diagnosis.
These recommendations may not Benefits-harms assessment Benefits greater than harms.
provide the only appropriate approach Value judgments None.
to the management of children with Intentional vagueness Criteria may be more subjective.
AOM. Role of patient preferences None
Exclusions None
It is AAP policy to review and update Strength Recommendation
evidence-based guidelines every 5 years. Notes Recent onset of ear pain means within the past 48 hours.

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Key Action Statement 1C on pneumatic otoscopy and/or tym- purposes of the studies.31,32 The current
Clinicians should not diagnose AOM in panometry). (Evidence Quality: Grade guideline endorses stringent otoscopic
children who do not have MEE (based B, Rec. Strength: Recommendation) diagnostic criteria as a basis for man-
agement decisions (described later). As
clinicians use the proposed stringent
criteria to diagnose AOM, they should
Key Action Statement Profile: KAS 1C
Aggregate evidence quality Grade B
be aware that children with AOM may
also present with recent onset of ear
Benefits Reduces overdiagnosis and unnecessary treatment. Increases
correct diagnosis of other conditions with symptoms that pain and intense erythema of the TM
otherwise might be attributed to AOM. Promotes the use of as the only otoscopic finding.
pneumatic otoscopy and tympanometry to improve
diagnostic accuracy.
Risks, harms, cost Cost of tympanometry. Need to acquire or reacquire skills in
pneumatic otoscopy and tympanometry for some clinicians. Symptoms
Benefits-harms assessment Preponderance of benefit.
Value judgments AOM is overdiagnosed, often without adequate visualization of Older children with AOM usually
the TM. Early AOM without effusion occurs, but the risk of present with a history of rapid onset of
overdiagnosis supersedes that concern.
Intentional vagueness None
ear pain. However, in young preverbal
Role of patient preferences None children, otalgia as suggested by
Exclusions Early AOM evidenced by intense erythema of the TM. tugging/rubbing/holding of the ear,
Strength Recommendation excessive crying, fever, or changes in
the child’s sleep or behavior pattern
as noted by the parent are often rel-
Purpose of This Section could be made in children with acute atively nonspecific symptoms. A num-
There is no gold standard for the di- onset of symptoms, including severe ber of studies have attempted to
agnosis of AOM. In fact, AOM has otalgia and MEE, without other otoscopic correlate symptom scores with di-
a spectrum of signs as the disease findings of inflammation.27 Further- agnoses of AOM.
develops.26 Therefore, the purpose of more, the use of “uncertain dia- A systematic review36 identified 4
this section is to provide clinicians gnosis” in the 2004 AOM guideline may articles that evaluated the accuracy
and researchers with a working clin- have permitted diagnoses of AOM of symptoms.37–40 Ear pain appeared
ical definition of AOM and to differ- without clear visualization of the TM. useful in diagnosing AOM (combined
entiate AOM from OME. The criteria Earlier studies may have enrolled positive likelihood ratio 3.0–7.3, nega-
were chosen to achieve high specific- children who had OME rather than tive likelihood ratio 0.4–0.6); however,
ity recognizing that the resulting de- AOM, resulting in the possible classi- it was only present in 50% to 60% of
creased sensitivity may exclude less fication of such children as improved children with AOM. Conclusions from
severe presentations of AOM. because their nonspecific symptoms these studies may be limited, because
would have abated regardless of they (1) enrolled children seen by
Changes From AAP/AAFP 2004 AOM therapy.28–30 Two studies, published in specialists, not likely to represent the
Guideline 2011, used stringent diagnostic crite- whole spectrum of severity of illness;
ria for diagnosing AOM with much (2) used a clinical diagnosis of AOM
Accurate diagnosis of AOM is critical to
less risk of conclusions based on data based more on symptomatology rather
sound clinical decision-making and
from mixed patients.31,32 than on tympanocentesis; and (3) in-
high-quality research. The 2004 “Clin-
ical Practice Guideline: Diagnosis and Since publication of the 2004 AOM cluded relatively older children.37,40
Management of AOM”1 used a 3-part guideline, a number of studies have Laine et al34 used a questionnaire
definition for AOM: (1) acute onset of been conducted evaluating scales for administered to 469 parents who
symptoms, (2) presence of MEE, and the presence of symptoms. These suspected their children, aged 6 to 35
(3) signs of acute middle ear in- studies did not show a consistent months, had AOM. Of the children, 237
flammation. This definition generated correlation of symptoms with the ini- had AOM using strict otoscopic crite-
extensive discussion and reanalysis of tial diagnosis of AOM, especially in ria, and 232 had upper respiratory
the AOM diagnostic evidence. The 2004 preverbal children.33–35 tract infection without AOM. Restless
definition lacked precision to exclude Recent research has used precisely sleep, ear rubbing, fever, and non-
cases of OME, and diagnoses of AOM stated stringent criteria of AOM for specific respiratory or gastrointestinal

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tract symptoms did not differentiate and tympanocentesis. A study by TABLE 2 Otoscopic Findings in Children With
Acute Symptoms and MEEa
children with or without AOM. Karma et al43 is often cited as the best
McCormick et al30 used 2 symptom single study of otoscopic findings in TM Finding in Group I Group II
Acute Visits (Tampere, (Oulo,
scores—a 3-item score (OM-3), con- AOM. However, the study uses only With MEE Finland), % Finland), %
sisting of symptoms of physical suffer- a symptom-based diagnosis of AOM
Color
ing such as ear pain or fever, emotional plus the presence of MEE. Thus, chil- Distinctly red 69.8 65.6
distress (irritability, poor appetite), and dren with acute upper respiratory Hemorrhagic 81.3 62.9
tract infection symptoms and OME Strongly red 87.7 68.1
limitation in activity; and a 5-item score Moderately red 59.8 66.0
(Ear Treatment Group Symptom Ques- would have been considered to have Slightly red 39.4 16.7
tionnaire, 5 Items [ETG-5]), including AOM. There also were significant dif- Cloudy 95.7 80.0
fever, earache, irritability, decreased ferences in findings at the 2 centers Normal 1.7 4.9
Position
appetite, and sleep disturbance—to that participated in the study. Bulging 96.0 89
assess AOM symptoms at the time of The investigators correlated TM color, Retracted 46.8 48.6
Normal 32.1 22.2
diagnosis and daily during the 10-day mobility, and position with the pres- Mobility
treatment or observation period. They ence of middle ear fluid obtained by Distinctly impaired 94.0 78.5
found both to be a responsive measure tympanocentesis. At 2 sites in Finland Slightly impaired 59.7 32.8
of changes in clinical symptoms. The Normal 2.7 4.8
(Tampere and Oulu), 2911 children a
Totals are greater than 100%, because each ear may
same group35 also tested a visual scale, were followed from 6 months to 2.5 have had different findings.43
Acute Otitis Media-Faces Scale (AOM-FS), years of age. A single otolaryngologist
with faces similar to the Wong-Baker at Tampere and a single pediatrician at
pain scale.41 None of the scales were Oulu examined subjects. Color, posi- best predictor of AOM using the
adequately sensitive for making the di- tion, and mobility were recorded. symptom-based diagnosis in this study.
agnosis of AOM based on symptoms. The Myringotomy and aspiration were Impaired mobility had the highest sen-
AOM-FS combined with an otoscopy score, performed if MEE was suspected. sitivity and specificity (approximately
OS-8,30 were presented as a double-sided AOM was diagnosed if MEE was found 95% and 85%, respectively). Cloudi-
pocket card. The combination of AOM-FS and the child had fever, earache, irri- ness had the next best combination of
and OS-8 was more responsive to change tability, ear rubbing or tugging, si- high sensitivity (∼74%) and high
than either instrument alone. multaneous other acute respiratory specificity (∼93%) in this study. Bulg-
Shaikh et al33,42 validated a 7-item tract symptoms, vomiting, or di- ing had high specificity (∼97%) but
parent-reported symptom score (Acute arrhea. The presence or absence of lower sensitivity (∼51%). A TM that
Otitis Media Severity of Symptom Scale MEE was noted, but no analyses of was hemorrhagic, strongly red, or
[AOM-SOS]) for children with AOM, fol- the fluid, including culture, were per- moderately red also correlated with
lowing stringent guidance of the US formed. Pneumatic otoscopic findings the presence of AOM, and a TM that
Food and Drug Administration (FDA) were classified as follows: color— was only “slightly red” was not helpful
on the development of patient-reported hemorrhagic, strongly red, moderately diagnostically.
outcome scales. Symptoms included red, cloudy or dull, slightly red, or nor-
McCormick et al reported that a bulg-
ear tugging/rubbing/holding, excessive mal; position—bulging, retracted, or
ing TM was highly associated with the
crying, irritability, difficulty sleeping, normal; and mobility—distinctly im-
presence of a bacterial pathogen, with
decreased activity or appetite, and paired, slightly impaired, or normal.
or without a concomitant viral patho-
fever. AOM-SOS was correlated with For this analysis, 11 804 visits were gen.44 In a small study, 31 children
otoscopic diagnoses (AOM, OME, and available. For visits with acute symp- (40 ears) underwent myringotomy.45
normal middle ear status). AOM-SOS toms, MEE was found in 84.9% and Bulging TMs had positive bacterial
changed appropriately in response to 81.8% at the 2 sites at which the study cultures 75% of the time. The
clinical change. Its day-to-day re- was performed. There were signifi- percentage of positive cultures for
sponsiveness supports its usefulness in cant differences among the results at a pathogen increased to 80% if the
following AOM symptoms over time. the 2 centers involved in the study. color of the TM was yellow. The con-
Table 2 shows specific data for each clusion is that moderate to severe
Signs of AOM finding. bulging of the TM represents the most
Few studies have evaluated the re- The combination of a “cloudy,” bulging important characteristic in the di-
lationship of otoscopic findings in AOM TM with impaired mobility was the agnosis of AOM—a finding that has

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implications for clinical care, re- Symptoms may be mild or overlap with semiopaque, opaque), and its mobility
search, and education. those of an upper respiratory tract (normal, increased, decreased, ab-
The committee recognized that there is illness. The TM may be obscured by sent). The normal TM is translucent,
a progression from the presence of cerumen, and subtle changes in the TM pearly gray, and has a ground-glass
MEE to the bulging of the TM, and it may be difficult to discern. Additional appearance (Fig 2A). Specific land-
is often difficult to differentiate this factors complicating diagnosis may marks can be visualized. They include
equivocal appearance from the highly include lack of cooperation from the the short process and the manubrium
certain AOM criteria advocated in this child; less than optimal diagnostic of the malleus and the pars flaccida,
guideline.26 As such, there is a role for equipment, including lack of a pneu- located superiorly. These are easily
individualized diagnosis and manage- matic bulb; inadequate instruments observed and help to identify the po-
ment decisions. Examples of normal, for clearing cerumen from the external sition of the TM. Inward movement of
mild bulging, moderate bulging, and auditory canal; inadequate assistance the TM on positive pressure in the
severe bulging can be seen in Fig 2. for restraining the child; and lack of external canal and outward move-
experience in removing cerumen and ment on negative pressure should
Distinguishing AOM From OME performing pneumatic otoscopy. occur, especially in the superior pos-
OME may occur either as the aftermath The pneumatic otoscope is the stan- terior quadrant. When the TM is
of an episode of AOM or as a conse- dard tool used in diagnosing OM. retracted, the short process of the
quence of eustachian tube dysfunction Valuable also is a surgical head, which malleus becomes more prominent,
attributable to an upper respiratory greatly facilitates cleaning cerumen and the manubrium appears short-
tract infection.46 However, OME may from an infant’s external auditory ened because of its change in position
also precede and predispose to the canal. Cerumen may be removed by within the middle ear. Inward motion
development of AOM. These 2 forms of using a curette, gentle suction, or ir- occurring with positive pressure is
OM may be considered segments of rigation.48 The pneumatic otoscope restricted or absent, because the
a disease continuum.47 However, be- should have a light source of suffi- TM is frequently as far inward as
cause OME does not represent an cient brightness and an air-tight seal its range of motion allows. However,
acute infectious process that benefits that permits application of positive outward mobility can be visualized
from antibiotics, it is of utmost im- and negative pressure. In general, when negative pressure is applied. If
portance for clinicians to become nondisposable specula achieve a bet- the TM does not move perceptibly with
proficient in distinguishing normal ter seal with less pain because of applications of gentle positive or
middle ear status from OME or AOM. a thicker, smoother edge and better negative pressure, MEE is likely.
Doing so will avoid unnecessary use light transmission properties. The Sometimes, the application of pres-
of antibiotics, which leads to in- speculum size should be chosen to sure will make an air-fluid interface
creased adverse effects of medication gently seal at the outer portion of the behind the TM (which is diagnostic of
and facilitates the development of external auditory canal. MEE) more evident.49
antimicrobial resistance. Pneumatic otoscopy permits assess- Instruction in the proper evaluation of
ment of the contour of the TM (normal, the child’s middle ear status should
Examination of the TM retracted, full, bulging), its color begin with the first pediatric rotation
Accurate diagnosis of AOM in infants (gray, yellow, pink, amber, white, red, in medical school and continue
and young children may be difficult. blue), its translucency (translucent, throughout postgraduate training.50

FIGURE 2
A, Normal TM. B, TM with mild bulging. C, TM with moderate bulging. D, TM with severe bulging. Courtesy of Alejandro Hoberman, MD.

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Continuing medical education should Hopkins Nursing,53 also available at with AOM can be substantial in the
reinforce the importance of, and re- http://www2.aap.org/sections/infectdis/ first few days of illness and often
train the clinician in, the use of video.cfm,54 and through a Web-based persists longer in young children.57
pneumatic otoscopy.51 Training tools program, ePROM: Enhancing Proficiency Antibiotic therapy of AOM does not
include the use of a video-otoscope in in Otitis Media.52 provide symptomatic relief in the first
residency programs, the use of Web- 24 hours58–61 and even after 3 to 7
based educational resources,49,52 as days, there may be persistent pain,
well as simultaneous or sequential Key Action Statement 2
fever, or both in 30% of children
examination of TMs with an expert The management of AOM should younger than 2 years.62 In contrast,
otoscopist to validate findings by using include an assessment of pain. If analgesics do relieve pain associated
a double headed or video otoscope. pain is present, the clinician with AOM within 24 hours63 and
Tools for learning the ear examination should recommend treatment to should be used whether antibiotic
can be found in a CD distributed by the reduce pain. (Evidence Quality: therapy is or is not prescribed; they
Johns Hopkins University School of Grade B, Rec. Strength: Strong should be continued as long as
Medicine and the Institute for Johns Recommendation)
needed. The AAP published the policy
statement “The Assessment and
Management of Acute Pain in Infants,
Key Action Statement Profile: KAS 2 Children, and Adolescents”64 to assist
Aggregate evidence quality Grade B
the clinician in addressing pain in the
Benefits Relieves the major symptom of AOM. context of illness. The management of
Risks, harms, cost Potential medication adverse effects. Variable efficacy of some
modes of treatment. pain, especially during the first 24
Benefits-harms assessment Preponderance of benefit. hours of an episode of AOM, should be
Value judgments Treating pain is essential whether or not antibiotics are addressed regardless of the use of
prescribed.
Intentional vagueness Choice of analgesic is not specified. antibiotics.
Role of patient preferences Parents may assist in the decision as to what means of pain Various treatments of otalgia have
relief they prefer.
Exclusions Topical analgesics in the presence of a perforated TM. been used, but none has been well
Strength Strong Recommendation studied. The clinician should select
a treatment on the basis of a consid-
Purpose of This Section a common symptom in these ill- eration of benefits and risks and,
Pain is the major symptom of AOM. This nesses, clinicians often see otalgia as wherever possible, incorporate
section addresses and updates the a peripheral concern not requiring parent/caregiver and patient prefer-
literature on treating otalgia. direct attention.56 Pain associated ence (Table 3).
TABLE 3 Treatments for Otalgia in AOM
Changes From AAP/AAFP 2004 AOM Treatment Modality Comments
Guideline
Acetaminophen, ibuprofen63 Effective analgesia for mild to moderate pain.
Only 2 new articles directly address Readily available. Mainstay of pain management
the treatment of otalgia. Both address for AOM.
Home remedies (no controlled studies May have limited effectiveness.
topical treatment. The 2 new articles that directly address effectiveness)
are consistent with the 2004 guideline Distraction
statement. The text of the 2004 guideline External application of heat or cold
Oil drops in external auditory canal
is, therefore, reproduced here, with the Topical agents
addition of discussion of the 2 new Benzocaine, procaine, lidocaine65,67,70 Additional, but brief, benefit over acetaminophen
articles. Table 3 has been updated to in patients older than 5 y.
Naturopathic agents68 Comparable to amethocaine/phenazone drops in
include the new references.
patients older than 6 y.
Homeopathic agents71,72 No controlled studies that directly address pain.
Treatment of Otalgia Narcotic analgesia with codeine Effective for moderate or severe pain. Requires
or analogs prescription; risk of respiratory depression, altered
Many episodes of AOM are associated mental status, gastrointestinal tract upset, and
with pain.55 Some children with OME constipation.
also have ear pain. Although pain is Tympanostomy/myringotomy73 Requires skill and entails potential risk.

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Since the 2004 guideline was pub- It identified 5 trials in children 3 to Key Action Statement 3B
lished, there have been only 2 signifi- 18 years of age. Two (including Bolt
Nonsevere Bilateral AOM in Young
cant new articles. et al,65 discussed above) compared
Children
Bolt et al reported in 2008 on a double- anesthetic drops and placebo at di-
agnosis of AOM. In both studies, some The clinician should prescribe an-
blind placebo-controlled trial at the
children also received oral analgesics. tibiotic therapy for bilateral AOM in
Australia Children’s Hospital emer-
Three studies compared anesthetic children younger than 24 months
gency department conducted in
ear drops with naturopathic herbal without severe signs or symptoms
2003–2004.65 They used a convenience
drops. Naturopathic drops were fa- (ie, mild otalgia for less than 48
sample of children 3 to 17 years of
vored 15 to 30 minutes after hours, temperature less than 39°C
age diagnosed with AOM in the ED.
installation, and 1 to 3 days after [102.2°F]). (Evidence Quality: Grade
They excluded children with perfora-
diagnosis, but the difference was not B, Rec. Strength: Recommendation)
tion of the TM, pressure-equalizing
tube, allergy to local anesthetic or statistically significant. The Cochrane
paracetamol, epilepsy, or liver, renal, group concluded that there is limited Key Action Statement Profile: KAS
or cardiac disease. Sixty-three eligible evidence that ear drops are effective 3B
children were randomized to receive at 30 minutes and unclear if results Aggregate evidence Grade B
quality
aqueous lidocaine or normal saline from these studies are a result of the
natural course of illness, placebo ef- Benefits Increased likelihood of more
ear drops up to 3 times in 24 hours. rapid resolution of symptoms.
They demonstrated a statistically sig- fect of receiving treatment, soothing Increased likelihood of
nificant 50% reduction in reported effect of any liquid in the ear, or the resolution of AOM.
pain at 10 and 30 minutes but not at drops themselves. Three of the stud- Risks, harms, Adverse events attributable to
cost antibiotics, such as diarrhea,
20 minutes after application of topical ies included in this review were cited
diaper dermatitis, and
lidocaine, compared with normal sa- in the 2004 AAP guideline67–69 and the allergic reactions. Overuse
line. Complications were minimal: 3 1 new paper by Bolt et al.65 of antibiotics leads to
increased bacterial resistance.
children reported some dizziness the Cost of antibiotics.
next day, and none reported tinnitus. Benefits-harms Preponderance of benefit over
Key Action Statement 3A assessment harm.
A limitation was that some children
Value judgments None
had received oral acetaminophen be- Severe AOM Role of patient None
fore administration of ear drops. The clinician should prescribe an- preference
Intentional None
A Cochrane review of topical analgesia tibiotic therapy for AOM (bilateral
vagueness
for AOM66 searched the Cochrane or unilateral) in children 6 months Exclusions None
register of controlled trials, random- and older with severe signs or Strength Recommendation
ized controlled trials, or quasi- symptoms (ie, moderate or severe
randomized controlled trials that otalgia or otalgia for at least 48
compared otic preparations to pla- hours, or temperature 39°C
cebo or that compared 2 otic prepa- [102.2°F] or higher). (Evidence Key Action Statement 3C
rations. It included studies of adults Quality: Grade B, Rec. Strength: Nonsevere Unilateral AOM in Young
and children, without TM perforation. Strong Recommendation) Children
The clinician should either prescribe
Key Action Statement Profile: KAS 3A
Aggregate evidence quality Grade B antibiotic therapy or offer obser-
Benefits Increased likelihood of more rapid resolution of symptoms. vation with close follow-up based
Increased likelihood of resolution of AOM. on joint decision-making with the
Risks, harms, cost Adverse events attributable to antibiotics, such as diarrhea, parent(s)/caregiver for unilateral
diaper dermatitis, and allergic reactions. Overuse of
antibiotics leads to increased bacterial resistance. Cost of
AOM in children 6 months to 23
antibiotics. months of age without severe
Benefits-harms assessment Preponderance of benefit over harm. signs or symptoms (ie, mild otalgia
Value judgments None
for less than 48 hours, tempera-
Role of patient preference None
Intentional vagueness None ture less than 39°C [102.2°F]).
Exclusions None When observation is used, a mech-
Strength Strong Recommendation anism must be in place to ensure

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follow-up and begin antibiotic ther- onset of symptoms. (Evidence Qual- Purpose of This Section
apy if the child worsens or fails to ity: Grade B, Rec. Strength: Recom- The purpose of this section is to offer
improve within 48 to 72 hours of mendation) guidance on the initial management of
AOM by helping clinicians choose be-
Key Action Statement Profile: KAS 3C tween the following 2 strategies:
Aggregate evidence quality Grade B
1. Initial antibiotic therapy, defined as
Benefits Moderately increased likelihood of more rapid resolution of symptoms
with initial antibiotics. Moderately increased likelihood of resolution
treatment of AOM with antibiotics
of AOM with initial antibiotics. that are prescribed at the time of
Risks, harms, cost Adverse events attributable to antibiotics, such as diarrhea, diaper diagnosis with the intent of start-
dermatitis, and allergic reactions. Overuse of antibiotics leads to ing antibiotic therapy as soon as
increased bacterial resistance. Cost of antibiotics.
Benefits-harms assessment Moderate degree of benefit over harm. possible after the encounter.
Value judgments Observation becomes an alternative as the benefits and harms 2. Initial observation, defined as ini-
approach balance.
Role of patient preference Joint decision-making with the family is essential before choosing
tial management of AOM limited
observation. to symptomatic relief, with com-
Intentional vagueness Joint decision-making is highly variable from family to family mencement of antibiotic therapy
Exclusions None
Strength Recommendation
only if the child’s condition wors-
Note In the judgment of 1 Subcommittee member (AH), antimicrobial ens at any time or does not show
treatment of these children is preferred because of a preponderance clinical improvement within 48 to
of benefit over harm. AH did not endorse Key Action Statement 3C 72 hours of diagnosis. A mecha-
nism must be in place to ensure
follow-up and initiation of antibiot-
Key Action Statement 3D for less than 48 hours, tempera- ics if the child fails observation.
ture less than 39°C [102.2°F]).
Nonsevere AOM in Older Children This section assumes that the clinician
When observation is used, a mecha-
The clinician should either pre- has made an accurate diagnosis of
nism must be in place to ensure
scribe antibiotic therapy or offer AOM by using the criteria and strate-
follow-up and begin antibiotic ther- gies outlined earlier in this guideline.
observation with close follow-up
based on joint decision-making with apy if the child worsens or fails Another assumption is that a clear
the parent(s)/caregiver for AOM to improve within 48 to 72 hours distinction is made between the role of
(bilateral or unilateral) in children of onset of symptoms. (Evidence analgesics and antibiotics in providing
24 months or older without severe Quality: Grade B, Rec Strength: symptomatic relief for children with
signs or symptoms (ie, mild otalgia Recommendation) AOM.

Key Action Statement Profile: KAS 3D Changes From Previous AOM


Aggregate evidence quality Grade B Guideline
Benefits Initial antibiotic treatment: Slightly increased likelihood of more The AOM guideline published by the
rapid resolution of symptoms; slightly increased likelihood of AAP and AAFP in 2004 proposed, for the
resolution of AOM. Initial observation: Decreased use of antibiotics;
decreased adverse effects of antibiotics; decreased potential for first time in North America, an “ob-
development of bacterial resistance. servation option” for selected children
Risks, harms, cost Initial antibiotic treatment: Adverse events attributable to antibiotics with AOM, building on successful
such as diarrhea, rashes, and allergic reactions. Overuse of
antibiotics leads to increased bacterial resistance. Initial
implementation of a similar policy in
observation: Possibility of needing to start antibiotics in 48 to 72 h the state of New York74 and the use of
if the patient continues to have symptoms. Minimal risk of adverse a similar paradigm in many countries
consequences of delayed antibiotic treatment. Potential increased
in Europe. A common feature of both
phone calls and doctor visits.
Benefits-harms assessment Slight degree of benefit of initial antibiotics over harm. approaches was to prioritize initial
Value judgments Observation is an option as the benefits and harms approach balance. antibiotic therapy according to di-
Role of patient preference Joint decision-making with the family is essential before choosing agnostic certainty, with greater
observation.
Intentional vagueness Joint decision-making is highly variable from family to family. reliance on observation when the di-
Exclusions None agnosis was uncertain. In response to
Strength Recommendation. criticism that allowing an “uncertain

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diagnosis” might condone incomplete the current guideline indicates Age, Severity of Symptoms,
visualization of the TM or allow in- a choice between initial antibiotic Otorrhea, and Laterality
appropriate antibiotic use, this cate- therapy or initial observation in this Rovers et al62 performed a systematic
gory has been eliminated with greater age group for children with unilat- search for AOM trials that (1) used
emphasis now placed on maximizing eral AOM and mild symptoms but random allocation of children, (2) in-
diagnostic accuracy for AOM. only after joint decision-making with cluded children 0 to 12 years of age
Since the earlier AOM guideline was the parent(s)/caregiver (Table 4). with AOM, (3) compared antibiotics
published, there has been substantial This change is supported by evidence with placebo or no treatment, and (4)
new research on initial management on the safety of observation or had pain or fever as an outcome. The
of AOM, including randomized con- delayed prescribing in young chil- original investigators were asked for
trolled trials of antibiotic therapy dren.30,31,32,75,76,81 A mechanism must their original data.
versus placebo or no therapy,31,32,75 be in place to ensure follow-up and
Primary outcome was pain and/or
immediate versus delayed antibiotic begin antibiotics if the child fails
fever (>38°C) at 3 to 7 days. The ad-
therapy,30,76,77 or delayed antibiotic observation.
verse effects of antibiotics were also
with or without a concurrent pre- analyzed. Baseline predictors were
scription.78 The Hoberman and Tähtinen age <2 years versus ≥2 years, bi-
articles are especially important as Importance of Accurate Diagnosis lateral AOM versus unilateral AOM,
they used stringent criteria for di- The recommendations for manage- and the presence versus absence of
agnosing AOM.31,32 Systematic reviews ment of AOM assume an accurate otorrhea. Statistical methods were
have been published on delayed anti- diagnosis on the basis of criteria used to assess heterogeneity and to
biotic therapy,79 the natural history of outlined in the diagnosis section of this analyze the data.
AOM in untreated children,57 pre- guideline. Many of the studies since Of the 10 eligible studies, the inves-
dictive factors for antibiotic benefits,62 the 2004 AAP/AAFP AOM guideline1 tigators of 6 studies30,75,86–89 provided
and the effect of antibiotics on used more stringent and well-defined the original data requested, and 4 did
asymptomatic MEE after therapy.80 AOM diagnostic definitions than were not. A total of 1642 patients were in-
Observational studies provide addi- previously used. Bulging of the TM cluded in the 6 studies from which
tional data on outcomes of initial ob- was required for diagnosis of AOM for data were obtained. Of the cases
servation with delayed antibiotic most of the children enrolled in the submitted, the average age was 3 to 4
therapy, if needed,81 and on the re- most recent studies.31,32 By using the years, with 35% of children younger
lationship of previous antibiotic ther- criteria in this guideline, clinicians than 2 years. Bilateral AOM was
apy for AOM to subsequent acute will more accurately distinguish AOM present in 34% of children, and 42% of
mastoiditis.82,83 from OME. The management of OME children had a bulging TM. Otorrhea
In contrast to the earlier AOM guide- can be found in guidelines written by was present in 21% of children. The
line,1 which recommended antibiotic the AAP, AAFP, and American Academy antibiotic and control groups were
therapy for all children 6 months to 2 of Otolaryngology-Head and Neck comparable for all characteristics.
years of age with a certain diagnosis, Surgery.84,85
The rate difference (RD) for pain, fever,
or both between antibiotic and control
groups was 13% (NNT = 8). For chil-
TABLE 4 Recommendations for Initial Management for Uncomplicated AOMa dren younger than 2 years, the RD was
Age Otorrhea Unilateral or Bilateral AOMa Unilateral AOMa 15% (NNT = 7); for those ≥2 years, RD
With Bilateral AOMa Without Otorrhea Without Otorrhea
AOMa With Severe
was 11% (NNT = 10). For unilateral
Symptomsb AOM, the RD was 6% (NNT = 17); for
6 mo to 2 y Antibiotic Antibiotic Antibiotic therapy Antibiotic therapy or bilateral AOM, the RD was 20% (NNT =
therapy therapy additional observation 5). When unilateral AOM was broken
≥2 y Antibiotic Antibiotic Antibiotic therapy or Antibiotic therapy or into age groups, among those younger
therapy therapy additional observation additional observationc
a
than 2 years, the RD was 5% (NNT =
Applies only to children with well-documented AOM with high certainty of diagnosis (see Diagnosis section).
b
A toxic-appearing child, persistent otalgia more than 48 h, temperature ≥39°C (102.2°F) in the past 48 h, or if there is 20), and among those ≥2 years, the
uncertain access to follow-up after the visit.
c
RD was 7% (NNT = 15). For bilateral
This plan of initial management provides an opportunity for shared decision-making with the child’s family for those
categories appropriate for additional observation. If observation is offered, a mechanism must be in place to ensure
AOM in children younger than 2 years,
follow-up and begin antibiotics if the child worsens or fails to improve within 48 to 72 h of AOM onset. the RD was 25% (NNT = 4); for

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bilateral AOM in children ≥2 years, a validated symptom scale33,92; MEE; effusion.” Treatment failure occurred by
the RD was 12% (NNT = 9). For and moderate or marked bulging of day 4 to 5 in 4% of the antimicrobial
otorrhea, the RD was 36% (NNT = 3). the TM or slight bulging accompanied treatment group versus 23% in the
One child in the control group who by either otalgia or marked erythema placebo group (P < .001) and at day
developed meningitis had received of the TM. They chose to use high- 10 to 12 in 16% of the antimicrobial
antibiotics beginning on day 2 be- dose amoxicillin-clavulanate (90 mg/kg/ treatment group versus 51% in the
cause of worsening status. There day) as active treatment, because it placebo group (NNT = 2.9, P < .001). In
were no cases of mastoiditis. has the best oral antibiotic coverage a comparison of outcome in unilateral
In a Cochrane Review, Sanders et al59 for organisms causing AOM. Included versus bilateral AOM, clinical failure
identified 10 studies that met the fol- in the study were 291 patients 6 to 23 rates by day 10 to 12 in children with
lowing criteria: (1) randomized con- months of age: 144 in the antibiotic unilateral AOM were 9% in those
trolled trial, (2) compared antibiotic group and 147 in the placebo group. treated with amoxicillin-clavulanate
versus placebo or antibiotic versus The primary outcome measures were versus 41% in those treated with
observation, (3) age 1 month to 15 the time to resolution of symptoms placebo (RD, 32%; NNT = 3) and 23%
years, (4) reported severity and dura- and the symptom burden over time. vs 60% (RD, 37%; NNT = 3) in those
tion of pain, (5) reported adverse The initial resolution of symptoms (ie, with bilateral AOM. Most common ad-
events, and (6) reported serious com- the first recording of an AOM-SOS verse events were diarrhea (25% vs
plications of AOM, recurrent attacks, score of 0 or 1) was recorded 15% in the treatment versus placebo
and hearing problems. Studies were among the children who received groups, respectively; P = .05) and di-
analyzed for risk of bias and assess- amoxicillin-clavulanate in 35% by day aper dermatitis (51% vs 35% in the
ment of heterogeneity. The studies 2, 61% by day 4, and 80% by day 7. treatment versus placebo groups,
were the same as analyzed by Rovers Among children who received placebo, respectively; P = .008). One placebo
et al62 but included the 4 studies for an AOM-SOS score of 0 or 1 was recipient developed mastoiditis. Ac-
which primary data were not available recorded in 28% by day 2, 54% by day cording to these results, antimicrobial
to Rovers.60,61,90,91 4, and 74% by day 7 (P = .14 for the treatment of AOM was more beneficial
overall comparison). For sustained than in previous studies that used
The authors’ conclusions were that
resolution of symptoms (ie, the time less stringent diagnostic criteria.
antibiotics produced a small re-
to the second of 2 successive
duction in the number of children with Tähtinen et al32 conducted a random-
recordings of an AOM-SOS score of
pain 2 to 7 days after diagnosis. They ized, double-blind, placebo-controlled,
0 or 1), the corresponding values
also concluded that most cases intention-to-treat study of amoxicillin-
were 20% at day 2, 41% at day 4, and
spontaneously remitted with no com- clavulanate (40 mg/kg/day) versus
67% at day 7 with amoxicillin-
plications (NNT = 16). Antibiotics were placebo. Three hundred nineteen
clavulanate, compared with 14%,
most beneficial in children younger patients from 6 to 35 months of age
36%, and 53% with placebo (P = .04
than 2 years with bilateral AOM and in were studied: 161 in the antibiotic
for the overall comparison). The
children with otorrhea. group and 158 in the placebo group.
symptom burden (ie, mean AOM-SOS
Two recent studies only included scores) over the first 7 days were AOM definition was the presence of
children younger than 3 years32 or lower for the children treated with MEE, distinct erythema over a bulging
younger than 2 years.31 Both included amoxicillin-clavulanate than for those or yellow TM, and acute symptoms
only subjects in whom the diagnosis who received placebo (P = .02). Clini- such as ear pain, fever, or respiratory
of AOM was certain. Both studies used cal failure at or before the 4- to 5-day symptoms. Compliance was measured
improvement of symptoms and im- visit was defined as “either a lack of by using daily patient diaries and
provement in the appearance of the substantial improvement in symp- number of capsules remaining at the
TM in their definitions of clinical suc- toms, a worsening of signs on oto- end of the study. Primary outcome
cess or failure. scopic examination, or both,” and was time to treatment failure de-
Hoberman et al31 conducted a random- clinical failure at the 10- to 12-day visit fined as a composite of 6 indepen-
ized, double-blind, placebo-controlled was defined as “the failure to achieve dent components: no improvement in
study of the efficacy of antimicrobial complete or nearly complete resolu- overall condition by day 3, worsening
treatment on AOM. The criteria for tion of symptoms and of otoscopic of the child’s condition at any time, no
AOM were acute symptoms with signs, without regard to the persis- improvement in otoscopic signs by
a score of at least 3 on the AOM-SOS, tence or resolution of middle ear day 8, perforation of the TM,

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development of severe infection (eg, developed a severe infection; 1 de- school absence and parent days
pneumonia, mastoiditis), and any other veloped pneumococcal bacteremia, and missed from work.
reason for stopping the study drug/ 1 developed radiographically confirmed Children younger than 2 years with
placebo. pneumonia. AOM may take longer to improve
Groups were comparable on multiple Most studies have excluded children clinically than older children,57 and
parameters. In the treatment group, with severe illness and all exclude although they are more likely to ben-
135 of 161 patients (84%) were youn- those with bacterial disease other efit from antibiotics,31,32 AOM in many
ger than 24 months, and in the placebo than AOM (pneumonia, mastoiditis, children will resolve without anti-
group, 124 of 158 patients (78%) were meningitis, streptococcal pharyngitis). biotics.62 A clinically significant benefit
younger than 24 months. Treatment Kaleida et al91 compared myringotomy of immediate antibiotic therapy is
failure occurred in 18.6% of the alone with myringotomy plus anti- observed for bilateral AOM,62,96 Strep-
treatment group and 44.9% in the biotics. Severe AOM was defined as tococcus pneumoniae infection, or
placebo group (NNT = 3.8, P < .001). temperature >39°C (102.2°F) or the AOM associated with otorrhea.62
Rescue treatment was needed in 6.8% presence of severe otalgia. Patients
of the treatment group and 33.5% of with severe AOM in the group that
placebo patients (P < .001). Contra- received only myringotomy (without Initial Observation for AOM
lateral AOM developed in 8.2% and initial antibiotics) had much worse
In systematic reviews of studies that
18.6% of treatment and placebo outcomes.
compare antibiotic therapy for AOM
groups, respectively (P = .007). There
with placebo, a consistent finding has
was no significant difference in use of Initial Antibiotic Therapy been the overall favorable natural
analgesic or antipyretic medicine,
The rationale for antibiotic therapy in history in control groups (NNT = 8–
which was used in 84.2% of the 16).12,59,62,95 However, randomized tri-
children with AOM is based on a high
amoxicillin-clavulanate group and als in these reviews had varying
prevalence of bacteria in the accom-
85.9% of the placebo group. panying MEE.93 Bacterial and viral diagnostic criteria that would have
Parents of child care attendees on cultures of middle ear fluid collected permitted inclusion of some children
placebo missed more days of work by tympanocentesis from children with OME, viral upper respiratory
(P = .005). Clinical failure rates with AOM showed 55% with bacteria infections, or myringitis, thereby
in children with unilateral AOM only and 15% with bacteria and viru- limiting the ability to apply these
were 17.2% in those treated with ses. A beneficial effect of antibiotics findings to children with a highly
amoxicillin-clavulanate versus 42.7% on AOM was first demonstrated in certain AOM diagnosis. In more re-
in those treated with placebo; for bi- 1968,94 followed by additional ran- cent AOM studies31,32 using stringent
lateral AOM, clinical failure rates domized trials and a meta-analysis95 diagnostic criteria, approximately
were 21.7% for those treated with showing a 14% increase in absolute half of young children (younger than
amoxicillin-clavulanate versus 46.3% rates of clinical improvement. Sys- 2–3 years) experienced clinical suc-
in the placebo group. Reported rates tematic reviews of the literature pub- cess when given placebo, but the
of treatment failure by day 8 were lished before 201121,59,62 revealed effect of antibiotic therapy was sub-
17.2% in the amoxicillin-clavulanate increases of clinical improvement stantially greater than suggested by
group versus 42.7% in the placebo with initial antibiotics of 6% to 12%. studies without precise diagnosis
group in children with unilateral AOM Randomized clinical trials using (NNT = 3–4).
and 21.7% vs 46.3% among those with stringent diagnostic criteria for AOM in Observation as initial management for
bilateral disease. young children31,32 show differences in AOM in properly selected children
Adverse events, primarily diarrhea clinical improvement of 26% to 35% does not increase suppurative com-
and/or rash, occurred in 52.8% of the favoring initial antibiotic treatment as plications, provided that follow-up is
treatment group and 36.1% of the compared with placebo. Greater ben- ensured and a rescue antibiotic is
placebo group (P = .003). Overall efit of immediate antibiotic therapy given for persistent or worsening
condition as evaluated by the parents was observed for bilateral AOM62,96 or symptoms.17 In contrast, withholding
and otoscopic appearance of the TM AOM associated with otorrhea.62 In of antibiotics in all children with
showed a benefit of antibiotics over most randomized trials,30,75,77,88,89 an- AOM, regardless of clinical course,
placebo at the end of treatment visit tibiotic therapy also decreased the would risk a return to the suppu-
(P < .001). Two placebo recipients duration of pain, analgesic use, or rative complications observed in the

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preantibiotic era. At the population based on a 3-item symptom score a joint decision of the clinician and the
level, antibiotics halve the risk of (OM-3) and TM appearance based on parents. In such cases, a system for
mastoiditis after AOM, but the high an 8-item scale (OS-8). Primary out- close follow-up and a means of be-
NNT of approximately 4800 patients to comes were parent satisfaction with ginning antibiotics must be in place if
prevent 1 case of mastoiditis pre- AOM care, resolution of AOM symptoms symptoms worsen or no improvement
cludes a strategy of universal antibiotic after initial treatment, AOM failure and is seen in 48 to 72 hours.
therapy as a means to prevent mas- recurrence, and nasopharyngeal car- Initial observation of AOM should be
toiditis.83 riage of S pneumoniae strains resistant part of a larger management strategy
The favorable natural history of AOM to antibiotics after treatment. The study that includes analgesics, parent in-
makes it difficult to demonstrate sig- was confounded by including patients formation, and provisions for a rescue
nificant differences in efficacy between who had received antibiotics in the antibiotic. Education of parents should
antibiotic and placebo when a suc- previous 30 days. include an explanation about the self-
cessful outcome is defined by relief or In the watchful waiting group, 66% of limited nature of most episodes of
improvement of presenting signs and children completed the study without AOM, especially in children 2 years and
symptoms. In contrast, when otoscopic antibiotics. There was no difference in older; the importance of pain man-
improvement (resolution of TM bulg- parent satisfaction scores at day 12. agement early in the course; and the
ing, intense erythema, or both) is also A 5-item symptom score (ETG-5) was potential adverse effects of antibiotics.
required for a positive outcome,31,32 assessed at days 0 to 10 by using Such an approach can substantially
the NNT is 3 to 4, compared with 8 to patient diaries. Subjects receiving reduce prescription fill rates for res-
16 for symptom improvement alone in immediate antibiotics resolved their cue antibiotics.103
older studies that used less precise symptoms faster than did subjects A critical component of any strategy
diagnostic criteria. MEE, however, may who underwent watchful waiting (P = involving initial observation for AOM is
persist for weeks or months after an .004). For children younger than 2 the ability to provide a rescue antibi-
AOM episode and is not a criterion for years, the difference was greater (P = otic if needed. This is often done by
otoscopic failure. .008). Otoscopic and tympanogram using a “safety net” or a “wait-and-see
National guidelines for initial obser- scores were also lower in the antibi- prescription,”76,102 in which the
vation of AOM in select children were otic group as opposed to the watchful parent/caregiver is given an antibiotic
first implemented in the Netherlands97 waiting group (P = .02 for otoscopic prescription during the clinical en-
and subsequently in Sweden,98 Scot- score, P = .004 for tympanogram). counter but is instructed to fill the
land,99 the United States,1 the United Combining all ages, failure and re- prescription only if the child fails to
Kingdom,100 and Italy.101 All included currence rates were lower for the improve within 2 to 3 days or if
observation as an initial treatment antibiotic group (5%) than for the symptoms worsen at any time. An al-
option under specified circumstances. watchful waiting group (21%) at 12 ternative approach is not to provide
In numerous studies, only approximately days. By day 30, there was no differ- a written prescription but to instruct
one-third of children initially observed ence in failure or recurrence for the the parent/caregiver to call or return
received a rescue antibiotic for persis- antibiotic and watchful waiting groups if the child fails to improve within 2 to
tent or worsening AOM,30,32,76,81,89,102 (23% and 24%, respectively). The as- 3 days or if symptoms worsen.
suggesting that antibiotic use could sociation between clinical outcome In one of the first major studies of ob-
potentially be reduced by 65% in eligible and intervention group was not signifi- servation with a safety-net antibiotic
children. Given the high incidence of cantly different between age groups. prescription (SNAP), Siegel et al102 en-
AOM, this reduction could help sub- Immediate antibiotics resulted in erad- rolled 194 patients with protocol de-
stantially in curtailing antibiotic-related ication of S pneumoniae carriage in the fined AOM, of whom 175 completed the
adverse events. majority of children, but S pneumoniae study. Eligible patients were given
McCormick et al30 reported on 233 strains cultured from children in the a SNAP with instructions to fill the
patients randomly assigned to receive antibiotic group at day 12 were more prescription only if symptoms wors-
immediate antibiotics (amoxicillin, 90 likely to be multidrug resistant than ened or did not improve in 48 hours.
mg/kg/day) or to undergo watchful were strains cultured from children in The SNAP was valid for 5 days. Pain
waiting. Criteria for inclusion were the watchful waiting group. medicine was recommended to be
symptoms of ear infection, otoscopic The decision not to give initial antibi- taken as needed. A phone interview was
evidence of AOM, and nonsevere AOM otic treatment and observe should be conducted 5 to 10 days after diagnosis.

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One hundred twenty of 175 families did children in the United States with to treat with antibiotics has been
not fill the prescription. Reasons for heptavalent pneumococcal conjugate made and the child has not re-
filling the prescription (more than 1 vaccine.104,105 In contrast, countries ceived amoxicillin in the past 30
reason per patient was acceptable) with low antibiotic use for AOM have days or the child does not have
were as follows: continued pain, 23%; a low prevalence of resistant naso- concurrent purulent conjunctivitis
continued fever, 11%; sleep disruption, pharyngeal pathogens in children.106
or the child is not allergic to
6%; missed days of work, 3%; missed
Key Action Statement 4A penicillin. (Evidence Quality:
days of child care, 3%; and no reason
given, 5%. One 16-month-old boy com- Clinicians should prescribe amoxi- Grade B, Rec. Strength: Recom-
pleted observation successfully but 6 cillin for AOM when a decision mendation)
weeks later developed AOM in the op-
posite ear, was treated with antibiotics,
and developed postauricular cellulitis. Key Action Statement Profile: KAS 4A
In a similar study of a “wait-and-see Aggregate evidence quality Grade B

prescription” (WASP) in the emer- Benefits Effective antibiotic for most children with AOM. Inexpensive, safe,
acceptable taste, narrow antimicrobial spectrum.
gency department, Spiro et al76 ran- Risks, harms, cost Ineffective against β-lactamase–producing organisms. Adverse
domly assigned 283 patients to either effects of amoxicillin.
a WASP or standard prescription. Benefits-harms assessment Preponderance of benefit.
Value judgments Better to use a drug that has reasonable cost, has an acceptable
Clinicians were educated on the 2004
taste, and has a narrow antibacterial spectrum.
AAP diagnostic criteria and initial Intentional vagueness The clinician must determine whether the patient is truly
treatment options for AOM; however, penicillin allergic.
diagnosis was made at the discretion Role of patient preferences Should be considered if previous bad experience with
amoxicillin.
of the clinician. Patients were ex- Exclusions Patients with known penicillin allergy.
cluded if they did not qualify for ob- Strength Recommendation.
servation per the 2004 guidelines. The
primary outcome was whether the
prescription was filled within 3 days Key Action Statement 4B amoxicillin in the past 30 days or
of diagnosis. Prescriptions were not Clinicians should prescribe an an- has concurrent purulent conjunc-
filled for 62% and 13% of the WASP tibiotic with additional β-lactamase tivitis or has a history of recurrent
and standard prescription patients, coverage for AOM when a decision AOM unresponsive to amoxicillin.
respectively (P < .001). Reasons for to treat with antibiotics has been (Evidence Quality: Grade C, Rec.
filling the prescription in the WASP made and the child has received Strength: Recommendation)
group were fever (60%), ear pain
(34%), or fussy behavior (6%). No se-
rious adverse events were reported.
Key Action Statement Profile: KAS 4B
Strategies to observe children with AOM Aggregate evidence quality Grade C
who are likely to improve on their own Benefits Successful treatment of β-lactamase–producing organisms.
without initial antibiotic therapy Risks, harms, cost Cost of antibiotic. Increased adverse effects.
Benefits-harms assessment Preponderance of benefit.
reduces common adverse effects of
Value judgments Efficacy is more important than taste.
antibiotics, such as diarrhea and di- Intentional vagueness None.
aper dermatitis. In 2 trials, antibiotic Role of patient preferences Concern regarding side effects and taste.
therapy significantly increased the ab- Exclusions Patients with known penicillin allergy.
Strength Recommendation
solute rates of diarrhea by 10% to 20%
and of diaper rash or dermatitis by 6%
to 16%.31,32 Reduced antibiotic use may
also reduce the prevalence of resis- Key Action Statement 4C initial antibiotic treatment within
tant bacterial pathogens. Multidrug- Clinicians should reassess the pa- 48 to 72 hours and determine
resistant S pneumoniae continues to tient if the caregiver reports that whether a change in therapy is
be a significant concern for AOM, the child’s symptoms have wors- needed. (Evidence Quality: Grade B,
despite universal immunization of ened or failed to respond to the Rec. Strength: Recommendation)

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Key Action Statement Profile: KAS 4C from 2807 cases of AOM.118 Studies that
Aggregate evidence quality Grade B
applied more stringent otoscopic cri-
Benefits Identify children who may have AOM caused by pathogens teria and/or use of bedside specimen
resistant to previous antibiotics.
Risks, harms, cost Cost. Time for patient and clinician to make change. Potential
plating on solid agar in addition to
need for parenteral medication. liquid transport media have a reported
Benefit-harm assessment Preponderance of benefit. rate of recovery of pathogenic bacteria
Value judgments None.
Intentional vagueness “Reassess” is not defined. The clinician may determine the
from middle ear exudates ranging
method of assessment. from 85% to 90%.119–121 When using
Role of patient preferences Limited. appropriate stringent diagnostic crite-
Exclusions Appearance of TM improved.
Strength Recommendation
ria, careful specimen handling, and
sensitive microbiologic techniques, the
vast majority of cases of AOM will in-
volve pathogenic bacteria either alone
Purpose of This Section dysfunction, negative middle ear pres- or in concert with viral pathogens.
If an antibiotic will be used for treatment sure, and movement of secretions Among AOM bacterial pathogens,
of a child with AOM, whether as initial containing the upper respiratory tract S pneumoniae was the most frequently
management or after a period of ob- infection causative virus and patho- cultured in earlier reports. Since the
servation, the clinician must choose an genic bacteria in the nasopharynx into debut and routine use of PCV7 in 2000,
antibiotic that will have a high likelihood the middle ear cleft. By using com-
the ordinal frequency of these 3 major
of being effective against the most likely prehensive and sensitive microbiologic
middle ear pathogens has evolved.105
testing, bacteria and/or viruses can be
etiologic bacterial pathogens with con- In the first few years after PCV7 in-
siderations of cost, taste, convenience, detected in the middle ear fluid in up
troduction, H influenzae became the
and adverse effects. This section pro- to 96% of AOM cases (eg, 66% bacteria
most frequently isolated middle ear
poses first- and second-line antibiotics and viruses together, 27% bacteria
pathogen, replacing S pneumoniae.122,123
that best meet these criteria while alone, and 4% virus alone).114 Studies
Shortly thereafter, a shift to non-PCV7
balancing potential benefits and harms. using less sensitive or less compre-
serotypes of S pneumoniae was de-
hensive microbiologic assays have
scribed.124 Pichichero et al104 later
yielded less positive results for bacte-
Changes From AAP/AAFP 2004 AOM reported that 44% of 212 AOM cases
ria and much less positive results for
Guideline seen in 2003–2006 were caused by H
viruses.115–117 The 3 most common
influenzae, and 28% were caused by S
Despite new data on the effect of PCV7 bacterial pathogens in AOM are S
pneumoniae, with a high proportion of
and updated data on the in vitro pneumoniae, nontypeable Haemophilus
highly resistant S pneumoniae. In that
susceptibility of bacterial pathogens influenzae, and Moraxella catarrhalis.111
study, a majority (77%) of cases in-
most likely to cause AOM, the recom- Streptococcus pyogenes (group A
volved recurrent disease or initial
mendations for the first-line antibiotic β-hemolytic streptococci) accounts
for less than 5% of AOM cases. The treatment failure. A later report125 with
remains unchanged from 2004. The
proportion of AOM cases with patho- data from 2007 to 2009, 6 to 8 years
current guideline contains revised
genic bacteria isolated from the after the introduction of PCV7 in the
recommendations regarding penicillin
middle ear fluids varies depending United States, showed that PCV7 strains
allergy based on new data. The in-
on bacteriologic techniques, trans- of S pneumoniae virtually disappeared
crease of multidrug-resistant strains
port issues, and stringency of AOM from the middle ear fluid of children
of pneumococci is noted.
definition. In series of reports from with AOM who had been vaccinated.
the United States and Europe from However, the frequency of isolation of
Microbiology 1952–1981 and 1985–1992, the mean non-PCV7 serotypes of S pneumoniae
Microorganisms detected in the mid- percentage of cases with bacterial from the middle ear fluid overall was
dle ear during AOM include pathogenic pathogens isolated from the middle increased; this has made isolation of S
bacteria, as well as respiratory viru- ear fluids was 69% and 72%, respec- pneumoniae and H influenzae of chil-
ses.107–110 AOM occurs most frequently tively.118 A large series from the Uni- dren with AOM nearly equal.
as a consequence of viral upper re- versity of Pittsburgh Otitis Media In a study of tympanocentesis over 4
spiratory tract infection,111–113 which Study Group reported bacterial path- respiratory tract illness seasons in
leads to eustachian tube inflammation/ ogens in 84% of the middle ear fluids a private practice, the percentage of

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S pneumoniae initially decreased rel- compared with other bacterial and clinical and microbiologic results
ative to H influenzae. In 2005–2006 pathogens.134–136 As for clinical find- and predicted compliance with the
(N = 33), 48% of bacteria were S ings in cases with S pneumoniae and drug are also taken into account. Early
pneumoniae, and 42% were H influ- nontypeable H influenzae, some stud- studies of AOM patients show that 19%
enzae. For 2006–2007 (N = 37), the ies suggest that signs and symptoms of children with S pneumoniae and
percentages were equal at 41%. In of AOM caused by S pneumoniae may 48% with H influenzae cultured on
2007–2008 (N = 34), 35% were S pneu- be more severe (fever, severe ear- initial tympanocentesis who were not
moniae, and 59% were H influenzae. In ache, bulging TM) than those caused treated with antibiotic cleared the
2008–2009 (N = 24), the percentages by other pathogens.44,121,137 These bacteria at the time of a second tym-
were 54% and 38%, respectively, with findings were refuted by results of the panocentesis 2 to 7 days later.144 Ap-
an increase in intermediate and non- studies that found AOM caused by proximately 75% of children infected
susceptible S pneumoniae.126 Data on nontypeable H influenzae to be asso- with M catarrhalis experienced bac-
nasopharyngeal colonization from ciated with bilateral AOM and more teriologic cure even after treatment
PCV7-immunized children with AOM severe inflammation of the TM.96,138 with amoxicillin, an antibiotic to which
have shown continued presence of S Leibovitz et al139 concluded, in a study it is not susceptible.145,146
pneumoniae colonization. Revai et al127 of 372 children with AOM caused by Antibiotic susceptibility of major AOM
showed no difference in S pneumoniae H influenzae (N = 138), S pneumoniae bacterial pathogens continues to
colonization rate among children with (N = 64), and mixed H influenzae and change, but data on middle ear
AOM who have been unimmunized, S pneumoniae (N = 64), that clinical/ pathogens have become scanty be-
underimmunized, or fully immunized otologic scores could not discriminate cause tympanocentesis is not gener-
with PCV7. In a study during a viral among various bacterial etiologies of ally performed in studies of children
upper respiratory tract infection, in- AOM. However, there were significantly with uncomplicated AOM. Most avail-
cluding mostly PCV7-immunized chil- different clinical/otologic scores be- able data come from cases of per-
dren (6 months to 3 years of age), S tween bacterial culture negative and sistent or recurrent AOM. Current US
pneumoniae was detected in 45.5% of culture positive cases. A study of data from a number of centers indi-
968 nasopharyngeal swabs, H influen- middle ear exudates of 82 cases of cates that approximately 83% and 87%
zae was detected in 32.4%, and M bullous myringitis has shown a 97% of isolates of S pneumoniae from all
catarrhalis was detected in 63.1%.128 bacteria positive rate, primarily S age groups are susceptible to regular
Data show that nasopharyngeal colo- pneumoniae. In contrast to the pre- (40 mg/kg/day) and high-dose amoxi-
nization of children vaccinated with vious belief, mycoplasma is rarely the cillin (80–90 mg/kg/day divided twice
PCV7 increasingly is caused by S causative agent in this condition.140 daily), respectively.130,147–150 Pediatric
pneumoniae serotypes not contained Accurate prediction of the bacterial isolates are smaller in number and
in the vaccine.129–132 With the use of the cause of AOM on the basis of clinical include mostly ear isolates collec-
recently licensed 13-valent pneumo- presentation, without bacterial cul- ted from recurrent and persistent
coccal conjugate vaccine (PCV13),133 ture of the middle ear exudates, is not AOM cases with a high percentage of
the patterns of nasopharyngeal colo- possible, but specific etiologies may multidrug-resistant S pneumoniae,
nization and infection with these com- be predicted in some situations. Pub- most frequently nonvaccine serotypes
mon AOM bacterial pathogens will lished evidence has suggested that that have recently increased in fre-
continue to evolve. AOM associated with conjunctivitis quency and importance.104
(otitis-conjunctivitis syndrome) is more
Investigators have attempted to pre- High-dose amoxicillin will yield middle
likely caused by nontypeable H influ-
dict the type of AOM pathogenic bac-
enzae than by other bacteria.141–143 ear fluid levels that exceed the mini-
teria on the basis of clinical severity, mum inhibitory concentration (MIC) of
but results have not been promising. all S pneumoniae serotypes that are
S pyogenes has been shown to occur intermediately resistant to penicillin
more commonly in older children134 Bacterial Susceptibility to (penicillin MICs, 0.12–1.0 μg/mL), and
and to cause a greater degree of in- Antibiotics many but not all highly resistant
flammation of the middle ear and TM, Selection of antibiotic to treat AOM is serotypes (penicillin MICs, ≥2 μg/mL)
a greater frequency of spontaneous based on the suspected type of bac- for a longer period of the dosing in-
rupture of the TM, and more frequent teria and antibiotic susceptibility pat- terval and has been shown to improve
progression to acute mastoiditis tern, although clinical pharmacology bacteriologic and clinical efficacy

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compared with the regular dose.151–153 influenzae, compared with data repor- for whom coverage for β-lactamase–
Hoberman et al154 reported superior ted in the 2004 AOM guideline. positive H influenzae and M catarrhalis
efficacy of high-dose amoxicillin- Nationwide data suggest that 100% of M is desired, therapy should be initiated
clavulanate in eradication of S pneu- catarrhalis derived from the upper re- with high-dose amoxicillin-clavulanate
moniae (96%) from the middle ear at spiratory tract are β-lactamase–positive (90 mg/kg/day of amoxicillin, with 6.4
but remain susceptible to amoxicillin- mg/kg/day of clavulanate, a ratio of
days 4 to 6 of therapy compared with
clavulanate.159 However, the high rate of amoxicillin to clavulanate of 14:1, given
azithromycin. in 2 divided doses, which is less likely to
spontaneous clinical resolution occur-
The antibiotic susceptibility pattern for ring in children with AOM attributable cause diarrhea than other amoxicillin-
S pneumoniae is expected to continue to M catarrhalis treated with amoxicil- clavulanate preparations).162
to evolve with the use of PCV13, lin reduces the concern for the first-line Alternative initial antibiotics include
a conjugate vaccine containing 13 coverage for this microorganism.145,146 cefdinir (14 mg/kg per day in 1 or 2
serotypes of S pneumoniae.133,155,156 AOM attributable to M catarrhalis rarely doses), cefuroxime (30 mg/kg per day
Widespread use of PCV13 could po- progresses to acute mastoiditis or in- in 2 divided doses), cefpodoxime (10
tentially reduce diseases caused by tracranial infections.102,160,161 mg/kg per day in 2 divided doses), or
multidrug-resistant pneumococcal ceftriaxone (50 mg/kg, administered
serotypes and diminish the need for Antibiotic Therapy intramuscularly). It is important to
the use of higher dose of amoxicillin High-dose amoxicillin is recommended note that alternative antibiotics vary in
or amoxicillin-clavulanate for AOM. as the first-line treatment in most their efficacy against AOM pathogens.
Some H influenzae isolates produce patients, although there are a number For example, recent US data on in vitro
β-lactamase enzyme, causing the iso- of medications that are clinically ef- susceptibility of S pneumoniae to cef-
late to become resistant to penicillins. fective (Table 5). The justification for dinir and cefuroxime are 70% to 80%,
Current data from different studies the use of amoxicillin relates to its compared with 84% to 92% amoxicillin
with non-AOM sources and geographic effectiveness against common AOM efficacy.130,147–149 In vitro efficacy of
locations that may not be comparable bacterial pathogens as well as its cefdinir and cefuroxime against H
show that 58% to 82% of H influenzae safety, low cost, acceptable taste, and influenzae is approximately 98%, com-
isolates are susceptible to regular- narrow microbiologic spectrum.145,151 pared with 58% efficacy of amoxicillin
and high-dose amoxicillin.130,147,148,157,158 In children who have taken amoxicillin and nearly 100% efficacy of amoxicillin-
These data represented a significant in the previous 30 days, those with clavulanate.158 A multicenter double
decrease in β-lactamase–producing H concurrent conjunctivitis, or those tympanocentesis open-label study of

TABLE 5 Recommended Antibiotics for (Initial or Delayed) Treatment and for Patients Who Have Failed Initial Antibiotic Treatment
Initial Immediate or Delayed Antibiotic Treatment Antibiotic Treatment After 48–72 h of Failure of Initial Antibiotic Treatment

Recommended First-line Alternative Treatment Recommended Alternative


Treatment (if Penicillin Allergy) First-line Treatment Treatment
Amoxicillin (80–90 mg/ kg per Cefdinir (14 mg/kg per day Amoxicillin-clavulanatea (90 mg/kg per Ceftriaxone, 3 d Clindamycin
day in 2 divided doses) in 1 or 2 doses) day of amoxicillin, with 6.4 mg/kg (30–40 mg/kg per day in 3
per day of clavulanate in 2 divided doses), with or without
divided doses) third-generation cephalosporin
or Cefuroxime (30 mg/kg per or Failure of second antibiotic
day in 2 divided doses)
Amoxicillin-clavulanatea (90 mg/kg Cefpodoxime (10 mg/kg per Ceftriaxone (50 mg IM or IV for 3 d) Clindamycin (30–40 mg/kg per day
per day of amoxicillin, with 6.4 mg/kg day in 2 divided doses) in 3 divided doses) plus
per day of clavulanate [amoxicillin to third-generation cephalosporin
clavulanate ratio, 14:1] in 2 Tympanocentesisb
divided doses) Ceftriaxone (50 mg IM or IV Consult specialistb
per day for 1 or 3 d)
IM, intramuscular; IV, intravenous.
a
May be considered in patients who have received amoxicillin in the previous 30 d or who have the otitis-conjunctivitis syndrome.
b
Perform tympanocentesis/drainage if skilled in the procedure, or seek a consultation from an otolaryngologist for tympanocentesis/drainage. If the tympanocentesis reveals
multidrug-resistant bacteria, seek an infectious disease specialist consultation.
c
Cefdinir, cefuroxime, cefpodoxime, and ceftriaxone are highly unlikely to be associated with cross-reactivity with penicillin allergy on the basis of their distinct chemical structures.
See text for more information.

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cefdinir in recurrent AOM attributable Macrolides, such as erythromycin and the child’s symptoms may worsen
to H influenzae showed eradication of azithromycin, have limited efficacy slightly. In the next 24 hours, the
the organism in 72% of patients.163 against both H influenzae and S patient’s symptoms should begin to
For penicillin-allergic children, recent pneumoniae.130,147–149 Clindamycin improve. If initially febrile, the tem-
data suggest that cross-reactivity lacks efficacy against H influenzae. perature should decline within 48 to
among penicillins and cephalo- Clindamycin alone (30–40 mg/kg per 72 hours. Irritability and fussiness
day in 3 divided doses) may be used should lessen or disappear, and
sporins is lower than historically
for suspected penicillin-resistant S sleeping and drinking patterns should
reported.164–167 The previously cited
pneumoniae; however, the drug normalize.176,177 If the patient is not
rate of cross-sensitivity to cepha-
will likely not be effective for the improved by 48 to 72 hours, another
losporins among penicillin-allergic
multidrug-resistant serotypes.130,158,166 disease or concomitant viral infection
patients (approximately 10%) is likely
Several of these choices of antibiotic may be present, or the causative
an overestimate. The rate was based
suspensions are barely palatable or bacteria may be resistant to the cho-
on data collected and reviewed during sen therapy.
frankly offensive and may lead to
the 1960s and 1970s. A study analyzing
avoidance behaviors or active rejection Some children with AOM and persis-
pooled data of 23 studies, including
by spitting out the suspension. Palat- tent symptoms after 48 to 72 hours of
2400 patients with reported history of
ability of antibiotic suspensions has initial antibacterial treatment may
penicillin allergy and 39 000 with no
been compared in many studies.170–172 have combined bacterial and viral in-
penicillin allergic history concluded Specific antibiotic suspensions such as fection, which would explain the per-
that many patients who present with cefuroxime, cefpodoxime, and clinda- sistence of ongoing symptoms despite
a history of penicillin allergy do not mycin may benefit from adding taste- appropriate antibiotic therapy.109,178,179
have an immunologic reaction to masking products, such as chocolate Literature is conflicting on the corre-
penicillin.166 The chemical structure or strawberry flavoring agents, to ob- lation between clinical and bacterio-
of the cephalosporin determines the scure the initial bitter taste and the logic outcomes. Some studies report
risk of cross-reactivity between spe- unpleasant aftertaste.172,173 In the pa- good correlation ranging from 86% to
cific agents.165,168 The degree of tient who is persistently vomiting or 91%,180,181 suggesting continued pres-
cross-reactivity is higher between cannot otherwise tolerate oral medi- ence of bacteria in the middle ear in
penicillins and first-generation ceph- cation, even when the taste is masked, a high proportion of cases with per-
alosporins but is negligible with the ceftriaxone (50 mg/kg, administered sistent symptoms. Others report that
second- and third-generation cepha- intramuscularly in 1 or 2 sites in the middle ear fluid from children with
losporins. Because of the differences anterior thigh, or intravenously) has AOM in whom symptoms are persis-
in the chemical structures, cefdinir, been demonstrated to be effective for tent is sterile in 42% to 49% of
cefuroxime, cefpodoxime, and cef- the initial or repeat antibiotic treat- cases.123,182 A change in antibiotic may
triaxone are highly unlikely to be ment of AOM.174,175 Although a single not be required in some children with
associated with cross-reactivity with injection of ceftriaxone is approved by mild persistent symptoms.
penicillin.165 Despite this, the Joint the US FDA for the treatment of AOM,
In children with persistent, severe
Task Force on Practice Parameters; results of a double tympanocentesis
symptoms of AOM and unimproved
American Academy of Allergy, Asthma study (before and 3 days after single
dose ceftriaxone) by Leibovitz et al175 otologic findings after initial treat-
and Immunology; American College of ment, the clinician may consider
Allergy, Asthma and Immunology; and suggest that more than 1 ceftriaxone
dose may be required to prevent changing the antibiotic (Table 5). If the
Joint Council of Allergy, Asthma and child was initially treated with amoxicillin
recurrence of the middle ear infec-
Immunology169 stated that “cephalo- and failed to improve, amoxicillin-
tion within 5 to 7 days after the initial
sporin treatment of patients with clavulanate should be used. Patients
dose.
a history of penicillin allergy, selecting who were given amoxicillin-clavulanate
out those with severe reaction histo- or oral third-generation cephalosporins
ries, show a reaction rate of 0.1%.” Initial Antibiotic Treatment Failure may receive intramuscular ceftriaxone
They recommend a cephalosporin in When antibiotics are prescribed for (50 mg/kg). In the treatment of AOM
cases without severe and/or recent AOM, clinical improvement should be unresponsive to initial antibiotics, a 3-day
penicillin allergy reaction history noted within 48 to 72 hours. During the course of ceftriaxone has been shown to
when skin test is not available. 24 hours after the diagnosis of AOM, be better than a 1-day regimen.175

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Although trimethoprim-sulfamethoxazole When tympanocentesis is not available, 1 symptoms, a 5- to 7-day course is ad-
and erythromycin-sulfisoxazole had possible way to obtain information on equate treatment.
been useful as therapy for patients the middle ear pathogens and their
with AOM, pneumococcal surveillance antimicrobial susceptibility is to obtain
studies have indicated that resis- a nasopharyngeal specimen for bacterial Follow-up of the Patient With AOM
tance to these 2 combination agents culture. Almost all middle ear pathogens Once the child has shown clinical im-
is substantial.130,149,183 Therefore, when derive from the pathogens colonizing the provement, follow-up is based on the
patients fail to improve while receiv- nasopharynx, but not all nasopharyngeal usual clinical course of AOM. There is
ing amoxicillin, neither trimethoprim- pathogens enter the middle ear to cause little scientific evidence for a routine
sulfamethoxazole184 nor erythromycin- AOM. The positive predictive value of 10- to 14-day reevaluation visit for all
sulfisoxazole is appropriate therapy. nasopharyngeal culture during AOM children with an episode of AOM. The
(likelihood that bacteria cultured from physician may choose to reassess
Tympanocentesis should be consid-
the nasopharynx is the middle ear
ered, and culture of middle ear fluid some children, such as young children
pathogen) ranges from 22% to 44% for with severe symptoms or recurrent
should be performed for bacteriologic S pneumoniae, 50% to 71% for non-
diagnosis and susceptibility testing AOM or when specifically requested by
typeable H influenzae, and 17% to 19% the child’s parent.
when a series of antibiotic drugs have for M catarrhalis. The negative pre-
failed to improve the clinical condition. Persistent MEE is common and can be
dictive value (likelihood that bacteria not
If tympanocentesis is not available, detected by pneumatic otoscopy (with or
found in the nasopharynx are not AOM
a course of clindamycin may be used, without verification by tympanometry)
pathogens) ranges from 95% to 99% for
with or without an antibiotic that cov- after resolution of acute symptoms. Two
all 3 bacteria.188,189 Therefore, if naso-
ers nontypeable H influenzae and M weeks after successful antibiotic treat-
pharyngeal culture is negative for spe-
catarrhalis, such as cefdinir, cefixime, ment of AOM, 60% to 70% of children
cific bacteria, that organism is likely not
or cefuroxime. have MEE, decreasing to 40% at 1 month
the AOM pathogen. A negative culture
and 10% to 25% at 3 months after
Because S pneumoniae serotype 19A is for S pneumoniae, for example, will help
successful antibiotic treatment.177,195
usually multidrug-resistant and may eliminate the concern for multidrug-
The presence of MEE without clinical
not be responsive to clindamycin,104,149 resistant bacteria and the need for un-
symptoms is defined as OME. OME must
newer antibiotics that are not ap- conventional therapies, such as levo-
be differentiated clinically from AOM
proved by the FDA for treatment of floxacin or linezolid. On the other hand,
and requires infrequent additional
AOM, such as levofloxacin or linezolid, if S pneumoniae is cultured from the
monitoring but not antibiotic therapy.
may be indicated.185–187 Levofloxacin is nasopharynx, the antimicrobial suscep-
Assurance that OME resolves is partic-
a quinolone antibiotic that is not ap- tibility pattern can help guide treatment.
ularly important for parents of children
proved by the FDA for use in children. with cognitive or developmental delays
Linezolid is effective against resistant Duration of Therapy that may be affected adversely by
Gram-positive bacteria. It is not ap- transient hearing loss associated with
The optimal duration of therapy for
proved by the FDA for AOM treatment MEE. Detailed recommendations for the
patients with AOM is uncertain; the
and is expensive. In children with re- management of the child with OME
usual 10-day course of therapy was
peated treatment failures, every effort can be found in the evidence-based
derived from the duration of treatment
should be made for bacteriologic di- guideline from the AAP/AAFP/American
of streptococcal pharyngotonsillitis.
agnosis by tympanocentesis with Academy of Otolaryngology-Head and
Several studies favor standard 10-day
Gram stain, culture, and antibiotic Neck Surgery published in 2004.84,85
therapy over shorter courses for chil-
susceptibility testing of the organism dren younger than 2 years.162,190–194
(s) present. The clinician may con- Thus, for children younger than 2
sider consulting with pediatric medi- years and children with severe symp- Key Action Statement 5A
cal subspecialists, such as an toms, a standard 10-day course is Clinicians should NOT prescribe
otolaryngologist for possible tympano- recommended. A 7-day course of oral prophylactic antibiotics to reduce
centesis, drainage, and culture and an antibiotic appears to be equally effec- the frequency of episodes of AOM
infectious disease expert, before use of tive in children 2 to 5 years of age with in children with recurrent AOM.
unconventional drugs such as levo- mild or moderate AOM. For children 6 (Evidence Quality: Grade B, Rec.
floxacin or linezolid. years and older with mild to moderate Strength: Recommendation)

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Key Action Statement Profile: KAS 5A year to prevent 1 episode of OM. The
Aggregate evidence quality Grade B
effect may be more substantial for
Benefits No adverse effects from antibiotic. Reduces potential for development children with 6 or more AOM episodes
of bacterial resistance. Reduced costs.
Risks, harms, cost Small increase in episodes of AOM.
in the preceding year.12
Benefit-harm assessment Preponderance of benefit. This decrease in episodes of AOM oc-
Value judgments Potential harm outweighs the potential benefit.
curred only while the prophylactic an-
Intentional vagueness None.
Role of patient preferences Limited. tibiotic was being given. The modest
Exclusions Young children whose only alternative would be tympanostomy tubes. benefit afforded by a 6-month course of
Strength Recommendation antibiotic prophylaxis does not have
longer-lasting benefit after cessation of
Key Action Statement 5B 1 year, with 1 episode in the therapy. Teele showed no differences
preceding 6 months). (Evidence between children who received pro-
Clinicians may offer tympanostomy phylactic antibiotics compared with
tubes for recurrent AOM (3 epi- Quality: Grade B, Rec. Strength:
those who received placebo in AOM
sodes in 6 months or 4 episodes in Option) recurrences or persistence of OME.198
Antibiotic prophylaxis is not appropriate
Key Action Statement Profile: KAS 5B for children with long-term MEE or for
Aggregate evidence quality Grade B children with infrequent episodes of AOM.
Benefits Decreased frequency of AOM. Ability to treat AOM with topical The small reduction in frequency of AOM
antibiotic therapy.
with long-term antibiotic prophylaxis
Risks, harms, cost Risks of anesthesia or surgery. Cost. Scarring of TM, chronic
perforation, cholesteatoma. Otorrhea. must be weighed against the cost of such
Benefits-harms assessment Equilibrium of benefit and harm. therapy; the potential adverse effects of
Value judgments None. antibiotics, principally allergic reaction
Intentional vagueness Option based on limited evidence.
Role of patient preferences Joint decision of parent and clinician. and gastrointestinal tract consequences,
Exclusions Any contraindication to anesthesia and surgery. such as diarrhea; and their contribution
Strength Option to the emergence of bacterial resistance.

Surgery for Recurrent AOM


Purpose of This Section addresses the literature on recurrent
The use of tympanostomy tubes for
Recurrent AOM has been defined as the AOM.
treatment of ear disease in general, and
occurrence of 3 or more episodes of AOM for AOM in particular, has been con-
in a 6-month period or the occurrence of Antibiotic Prophylaxis troversial.199 Most published studies of
4 or more episodes of AOM in a 12-month surgical intervention for OM focus on
Long-term, low-dose antibiotic use, re-
period that includes at least 1 episode in children with persistent MEE with or
ferred to as antibiotic prophylaxis or
the preceding 6 months.20 These epi- without AOM. The literature on surgery
chemoprophylaxis, has been used to
sodes should be well documented and for recurrent AOM as defined here
treat children with recurrent AOM to
separate acute infections.11 is scant. A lack of consensus among
prevent subsequent episodes.85 A 2006
Winter season, male gender, and pas- Cochrane review analyzed 16 studies of otolaryngologists regarding the role of
sive exposure to smoking have been long-term antibiotic use for AOM and surgery for recurrent AOM was reported
associated with an increased likelihood found such use prevented 1.5 episodes in a survey of Canadian otolaryngolo-
of recurrence. Half of children younger of AOM per year, reducing in half the gists in which 40% reported they would
than 2 years treated for AOM will ex- number of AOM episodes during the “never,” 30% reported they would
perience a recurrence within 6 months. period of treatment.197 Randomized “sometimes,” and 30% reported they
Symptoms that last more than 10 days placebo-controlled trials of prophylaxis would “often or always” place tympa-
may also predict recurrence.196 reported a decrease of 0.09 episodes nostomy tubes for a hypothetical 2-year-
per month in the frequency of AOM old child with frequent OM without per-
Changes From AAP/AAFP 2004 AOM attributable to therapy (approximately sistent MEE or hearing loss.200
Guideline 0.5 to 1.5 AOM episodes per year for Tympanostomy tubes, however, remain
Recurrent AOM was not addressed in 95% of children). An estimated 5 chil- widely used in clinical practice for both
the 2004 AOM guideline. This section dren would need to be treated for 1 OME and recurrent OM.201 Recurrent

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AOM remains a common indication for or ossicular chain disruption, in 10 000 when compared with chemoprophylaxis
referral to an otolaryngologist. tube insertions performed primarily by or placebo.212 Adenoidectomy alone
Three randomized controlled trials have residents, although minor complica- should not be used for prevention of
compared the number of episodes of tions such as TM tears or displaced AOM but may have benefit when per-
AOM after tympanostomy tube place- tubes in the middle ear were seen in formed with placement of tympanos-
ment or no surgery.202 Two found sig- 0.016% of ears.210 Long-term sequelae tomy tubes or in children with previous
nificant improvement in mean number of tympanostomy tubes include TM tympanostomy tube placement in OME.213
of AOM episodes after tympanostomy structural changes including focal at-
tubes during a 6-month follow-up pe- rophy, tympanosclerosis, retraction
Prevention of AOM: Key Action
riod.203,204 One study randomly assigned pockets, and chronic perforation. One
Statement 6A
children with recurrent AOM to groups meta-analysis found tympanosclerosis
receiving placebo, amoxicillin pro- in 32% of patients after placement of Pneumococcal Vaccine
phylaxis, or tympanostomy tubes and tympanostomy tubes and chronic per- Clinicians should recommend pneu-
followed them for 2 years.205 Although forations in 2.2% of patients who had mococcal conjugate vaccine to all
prophylactic antibiotics reduced the short-term tubes and 16.6% of patients children according to the schedule
rate of AOM, no difference in number with long-term tubes.211 of the Advisory Committee on Im-
of episodes of AOM was noted be- Adenoidectomy, without myringotomy munization Practices, AAP, and AAFP.
tween the tympanostomy tube group and/or tympanostomy tubes, did not (Evidence Quality: Grade B, Rec.
and the placebo group over 2 years. A reduce the number of episodes of AOM Strength: Strong Recommendation)
Cochrane review of studies of tympa-
nostomy tubes for recurrent AOM an-
Key Action Statement Profile: KAS 6A
alyzed 2 studies204,206 that met Aggregate evidence quality Grade B
inclusion criteria and found that Benefits Reduced frequency of AOM attributable to vaccine serotypes.
tympanostomy tubes reduced the Reduced risk of serious pneumococcal systemic disease.
number of episodes of AOM by 1.5 Risks, harms, cost Potential vaccine side effects. Cost of vaccine.
Benefits-harms assessment Preponderance of benefit.
episodes in the 6 months after sur- Value judgments Potential vaccine adverse effects are minimal.
gery.207 Tympanostomy tube insertion Intentional vagueness None.
has been shown to improve disease- Role of patient preferences Some parents may choose to refuse the vaccine.
Exclusions Severe allergic reaction (eg, anaphylaxis) to any component of
specific quality-of-life measures in
pneumococcal vaccine or any diphtheria toxoid-containing
children with OM.208 One multicenter, vaccine.
nonrandomized observational study Strength Strong Recommendation
showed large improvements in a
disease-specific quality-of-life instru-
ment that measured psychosocial Key Action Statement 6B the Advisory Committee on Im-
domains of physical suffering, hearing Influenza Vaccine: Clinicians munization Practices, AAP, and
loss, speech impairment, emotional should recommend annual in- AAFP. (Evidence Quality: Grade B,
distress, activity limitations, and care- fluenza vaccine to all children Rec. Strength: Recommenda-
giver concerns that are associated with according to the schedule of tion)
ear infections.209 These benefits of
tympanostomy tubes have been dem- Key Action Statement Profile: KAS 6B
onstrated in mixed populations of chil- Aggregate evidence quality Grade B
dren that include children with OME as Benefits Reduced risk of influenza infection. Reduction in frequency of AOM
well as recurrent AOM. associated with influenza.
Risks, harms, cost Potential vaccine adverse effects. Cost of vaccine. Requires annual
Beyond the cost, insertion of tympa- immunization.
nostomy tubes is associated with Benefits-harms assessment Preponderance of benefit.
a small but finite surgical and anesthetic Value judgments Potential vaccine adverse effects are minimal.
Intentional vagueness None
risk. A recent review looking at proto- Role of patient preferences Some parents may choose to refuse the vaccine.
cols to minimize operative risk reported Exclusions See CDC guideline on contraindications (http://www.cdc.gov/flu/
no major complications, such as sen- professionals/acip/shouldnot.htm).
Strength Recommendation
sorineural hearing loss, vascular injury,

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Key Action Statement 6C for at least 6 months. (Evidence xylitol, a possible adjunct to AOM
Breastfeeding: Clinicians should Quality: Grade B, Rec. Strength: prevention, is discussed; however, no
encourage exclusive breastfeeding Recommendation) recommendations are made.

Pneumococcal Vaccine
Pneumococcal conjugate vaccines
Key Action Statement Profile: KAS 6C have proven effective in preventing OM
Aggregate evidence quality Grade B
caused by pneumococcal serotypes
Benefits May reduce the risk of early AOM. Multiple benefits of breastfeeding
unrelated to AOM. contained in the vaccines. A meta-
Risk, harm, cost None analysis of 5 studies with AOM as an
Benefit-harm assessment Preponderance of benefit. outcome determined that there is
Value judgments The intervention has value unrelated to AOM prevention.
Intentional vagueness None
a 29% reduction in AOM caused by all
Role of patient preferences Some parents choose to feed formula. pneumococcal serotypes among chil-
Exclusions None dren who received PCV7 before 24
Strength Recommendation
months of age.217 Although the overall
benefit seen in clinical trials for all
causes of AOM is small (6%–7%),218–221
Key Action Statement 6D posure. (Evidence Quality: Grade observational studies have shown that
C, Rec. Strength: Recommenda- medical office visits for otitis were
Clinicians should encourage
reduced by up to 40% comparing
avoidance of tobacco smoke ex- tion)
years before and after introduction of
PCV7.222–224 Grijvala223 reported no
Key Action Statement Profile: KAS 6D effect, however, among children first
Aggregate evidence quality Grade C
vaccinated at older ages. Poehling
Benefits May reduce the risk of AOM. et al225 reported reductions of fre-
Risks, harms, cost None
Benefits-harms assessment Preponderance of benefit.
quent AOM and PE tube use after in-
Value judgments Avoidance of tobacco exposure has inherent value unrelated troduction of PCV7. The observations
to AOM. by some of greater benefit observed
Intentional vagueness None
in the community than in clinical tri-
Role of patient preferences Many parents/caregivers choose not to stop smoking. Some
also remain addicted, and are unable to quit smoking. als is not fully understood but may be
Exclusions None related to effects of herd immunity or
Strength Recommendation may be attributed to secular trends or
changes in AOM diagnosis patterns
over time.223,226–229 In a 2009 Cochrane
review,221 Jansen et al found that the
Purpose of This Section prevention of diseases attributable to overall reduction in AOM incidence
The 2004 AOM guideline noted data on S pneumoniae and nontypeable H influ- may only be 6% to 7% but noted that
immunizations, breastfeeding, and enzae. Annual influenza immunization is even that small rate may have public
lifestyle changes that would reduce the now recommended for all children 6 health relevance. O’Brien et al con-
risk of acquiring AOM. This section months of age and older in the United curred and noted in addition the po-
addresses new data published since States.214,215 Updated information re- tential for cost savings.230 There is
2004. garding these vaccines and their effect evidence that serotype replacement
on the incidence of AOM is reviewed. may reduce the long-term efficacy of
Changes From AAP/AAFP 2004 AOM The AAP issued a new breastfeeding pneumococcal conjugate vaccines
Guideline policy statement in February 2012.216 against AOM,231 but it is possible that
PCV7 has been in use in the United This guideline also includes a recom- new pneumococcal conjugate vac-
States since 2000. PCV13 was introduced mendation regarding tobacco smoke cines may demonstrate an increased
in the United States in 2010. The 10- exposure. Bottle propping, pacifier effect on reduction in AOM.232–234 Data
valent pneumococcal nontypeable H use, and child care are discussed, but on AOM reduction secondary to the
influenzae protein D-conjugate vaccine no recommendations are made be- PCV13 licensed in the United States in
was recently licensed in Europe for cause of limited evidence. The use of 2010 are not yet available.

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The H influenzae protein D-conjugate through 6 months of age with no Avoiding supine bottle feeding (“bottle
vaccine recently licensed in Europe breastfeeding or breastfeeding less propping”) and reducing or eliminat-
has potential benefit of protection than 4 months. In a prospective co- ing pacifier use in the second 6
against 10 serotypes of S pneumoniae hort, Scariatti253 found a significant months of life may reduce AOM in-
and nontypeable H influenzae.221,234 dose-response effect. In this study, OM cidence.265–267 In a recent cohort
was self-reported by parents. In a study, pacifier use was associated
Influenza Vaccine systematic review, McNiel et al254 with AOM recurrence.268
found that when exclusive breast- During infancy and early childhood,
Most cases of AOM follow upper re-
feeding was set as the normative reducing the incidence of upper re-
spiratory tract infections caused by
standard, the recalculated odds ratios spiratory tract infections by altering
viruses, including influenza viruses. As
(ORs) revealed the risks of any for- child care-center attendance patterns
many as two-thirds of young children
mula use. For example, any formula can reduce the incidence of recurrent
with influenza may have AOM.235
use in the first 6 months of age was AOM significantly.249,269
Investigators have studied the efficacy
significantly associated with in-
of trivalent inactivated influenza vac-
creased incidence of OM (OR: 1.78; Xylitol
cine (TIV) and live-attenuated in-
95% CI: 1.19–2.70; OR: 4.55; 95% CI:
tranasal influenza vaccine (LAIV) in Xylitol, or birch sugar, is chemically
1.64–12.50 in the available studies;
preventing AOM. Many studies have a pentitol or 5-carbon polyol sugar
pooled OR for any formula in the first
demonstrated 30% to 55% efficacy of alcohol. It is available as chewing gum,
3 months of age, 2.00; 95% CI: 1.40–
influenza vaccine in prevention of syrup, or lozenges. A 2011 Cochrane
2.78). A number of studies255–259
AOM during the respiratory illness review270 examined the evidence for
addressed the association of AOM and
season.6,235–239 One study reported no the use of xylitol in preventing re-
other infectious illness in infants with
benefit of TIV in reducing AOM burden; current AOM. A statistically significant
duration and exclusivity of breast-
however, 1 of the 2 respiratory illness 25% reduction in the risk of occur-
feeding, but all had limitations and
seasons during which this study was rence of AOM among healthy children
none had a randomized controlled
conducted had a relatively low in- at child care centers in the xylitol
design. However, taken together, they
fluenza activity. A pooled analysis240 of group compared with the control
continue to show a protective effect of
8 studies comparing LAIV versus TIV group (relative risk: 0.75; 95% CI: 0.65
exclusive breastfeeding. In all studies,
or placebo241–248 showed a higher ef- to 0.88; RD: –0.07; 95% CI: –0.12 to
there has been a predominance of
ficacy of LAIV compared with both –0.03) in the 4 studies met criteria for
white subjects, and child care atten-
placebo and with TIV. Influenza vacci- analysis.271–274 Chewing gum and loz-
dance and smoking exposure may not
nation is now recommended for all enges containing xylitol appeared to
have been completely controlled. Also,
children 6 months of age and older in be more effective than syrup. Children
feeding methods were self-reported.
the United States.214,215 younger than 2 years, those at the
The consistent finding of a lower in- greatest risk of having AOM, cannot
cidence of AOM and recurrent AOM safely use lozenges or chewing gum.
Breastfeeding
with increased breastfeeding supports Also, xylitol needs to be given 3 to 5
Multiple studies provide evidence that the AAP recommendation to encourage times a day to be effective. It is not
breastfeeding for at least 4 to 6 exclusive breastfeeding for the first 6 effective for treating AOM and it must
months reduces episodes of AOM and months of life and to continue for at be taken daily throughout the re-
recurrent AOM.249–253 Two cohort least the first year and beyond for as spiratory illness season to have an
studies, 1 retrospective study250 and 1 long as mutually desired by mother effect. Sporadic or as-needed use is
prospective study,253 suggest a dose and child.216 not effective.
response, with some protection from
partial breastfeeding and the greatest
protection from exclusive breastfeed- Lifestyle Changes Future Research
ing through 6 months of age. In mul- In addition to its many other bene- Despite advances in research partially
tivariate analysis controlling for fits,260 eliminating exposure to passive stimulated by the 2004 AOM guideline,
exposure to child care settings, the tobacco smoke has been postulated there are still many unanswered
risk of nonrecurrent otitis is 0.61 to reduce the incidence of AOM in in- clinical questions in the field. Following
(95% confidence interval [CI]: 0.4–0.92) fancy.252,261–264 Bottles and pacifiers are possible clinical research ques-
comparing exclusive breastfeeding have been associated with AOM. tions that still need to be resolved.

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Diagnosis persistent MEE. Such a study would of decreasing duration of antibiotic
There will probably never be a gold require randomization of patients use. These would need to be per-
standard for diagnosis of AOM because with unimproved TM appearance to formed initially with amoxicillin and
of the continuum from OME to AOM. continued observation and antibiotic amoxicillin-clavulanate but should also
Conceivably, new techniques that could groups. be performed for any antibiotic used in
be used on the small amount of fluid The most efficient and acceptable AOM. Again, an observation arm should
obtained during tympanocentesis methods of initial observation should be included in nonsevere illness.
could identify inflammatory markers continue to be studied balancing the
in addition to the presence of bacteria convenience and benefits with the Recurrent AOM
or viruses. However, performing tym- potential risks to the patient. There have been adequate studies
panocentesis studies on children with regarding prophylactic antibiotic use
uncomplicated otitis is likely not fea- in recurrent AOM. More and better
sible because of ethical and other Antibiotics controlled studies of tympanostomy
considerations. Amoxicillin-clavulanate has a broader tube placement would help determine
Devices that more accurately identify spectrum than amoxicillin and may be its benefit versus harm.
the presence of MEE and bulging that a better initial antibiotic. However,
are easier to use than tympanometry because of cost and adverse effects, Prevention
during office visits would be welcome, the subcommittee has chosen amoxi- There should be additional de-
especially in the difficult-to-examine cillin as first-line AOM treatment. velopment of vaccines targeted at
infant. Additional development of in- Randomized controlled trials com- common organisms associated with
expensive, easy-to-use video pneu- paring the 2 with adequate power to AOM.275 Focused epidemiologic studies
matic otoscopes is still a goal. differentiate clinical efficacy would on the benefit of breastfeeding, spe-
clarify this choice. Stringent diagnostic cifically addressing AOM prevention,
criteria should be the standard for including duration of breastfeeding
Initial Treatment these studies. Antibiotic comparisons and partial versus exclusive breast-
for AOM should now include an ob- feeding, would clarify what is now
The recent studies of Hoberman31 and
servation arm for patients with non- a more general database. Likewise,
Tähtinen32 have addressed clinical
severe illness to ensure a clinical more focused studies of the effects of
and TM appearance by using stringent
benefit over placebo. Studies should lifestyle changes would help clarify
diagnostic criteria of AOM. However,
also have enough patients to show their effect on AOM.
the outcomes for less stringent di-
small but meaningful differences.
agnostic criteria, a combination of
symptoms, MEE, and TM appearance Although there have been studies on Complementary and Alternative
not completely consistent with OME the likelihood of resistant S pneumo- Medicine
can only be inferred from earlier niae or H influenzae in children in
There are no well-designed random-
studies that used less stringent cri- child care settings and with siblings
ized controlled trials of the usefulness
teria but did not specify outcomes for younger than 5 years, studies are still
of complementary and alternative
various grades of findings. Random- needed to determine whether these
medicine in AOM, yet a large number of
ized controlled trials on these less and other risk factors would indicate
families turn to these methods. Al-
certain TM appearances using scales a need for different initial treatment
though most alternative therapies are
similar to the OS-8 scale35 could than noted in the guideline.
relatively inexpensive, some may be
clarify the benefit of initial antibiotics New antibiotics that are safe and costly. Such studies should compare
and initial observation for these less effective are needed for use in the alternative therapy to observation
certain diagnoses. Such studies must AOM because of the development of rather than antibiotics and only use an
also specify severity of illness, later- multidrug-resistant organisms. Such antibiotic arm if the alternative ther-
ality, and otorrhea. new antibiotics must be tested against apy is shown to be better than ob-
Appropriate end points must be the currently available medications. servation. Such studies should focus
established. Specifically is the ap- Randomized controlled trials using on children with less stringent criteria
pearance of the TM in patients without different durations of antibiotic ther- of AOM but using the same descriptive
clinical symptoms at the end of a study apy in different age groups are needed criteria for the patients as noted
significant for relapse, recurrence, or to optimize therapy with the possibility above.

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FROM THE AMERICAN ACADEMY OF PEDIATRICS

DISSEMINATION OF GUIDELINES SUBCOMMITTEE ON DIAGNOSIS AND Richard M. Rosenfeld, MD, MPH, FAAP (oto-
MANAGEMENT OF ACUTE OTITIS laryngologist, AAP Section on Otolaryngology,
An Institute of Medicine Report notes MEDIA Head and Neck Surgery, American Academy of
that “Effective multifaceted imple- Allan S. Lieberthal, MD, FAAP (Chair, general Otolaryngology-Head and Neck Surgery, no finan-
mentation strategies targeting both pediatrician, no conflicts) cial conflicts; published research related to AOM)
Xavier D. Sevilla, MD, FAAP (general pediat-
individuals and healthcare systems Aaron E. Carroll, MD, MS, FAAP (Partnership
rics, Quality Improvement Innovation Network,
should be employed by implementers for Policy Implementation [PPI] Informatician,
no conflicts)
general academic pediatrician, no conflicts)
to promote adherence to trustworthy Richard H. Schwartz, MD, FAAP (general pe-
[clinical practice guidelines].”230 Tasnee Chonmaitree, MD, FAAP (pediatric diatrician, no financial conflicts; published re-
infectious disease physician, no financial con- search related to AOM)
Many studies of the effect of clinical flicts; published research related to AOM) Pauline A. Thomas, MD, FAAP (epidemiologist,
practice guidelines have been per- Theodore G. Ganiats, MD (family physician, general pediatrician, no conflicts)
formed. In general, the studies show American Academy of Family Physicians, no David E. Tunkel, MD, FAAP, FACS (otolaryn-
conflicts) gologist, AAP Section on Otolaryngology, Head
little overt change in practice after and Neck Surgery, periodic consultant to
Alejandro Hoberman, MD, FAAP (general ac-
a guideline is published. However, as ademic pediatrician, no financial conflicts; Medtronic ENT)
was seen after the 2004 AOM guideline, published research related to AOM)
the number of visits for AOM and the Mary Anne Jackson, MD, FAAP (pediatric in- CONSULTANT
number of prescriptions for antibiotics fectious disease physician, AAP Committee on Richard N. Shiffman, MD, FAAP, FACMI
Infectious Disease, no conflicts) (informatician, guideline methodologist, gen-
for AOM had decreased publication.
Mark D. Joffe, MD, FAAP (pediatric emer- eral academic pediatrician, no conflicts)
Studies of educational and dissemi-
gency medicine physician, AAP Committee/
nation methods both at the practic- Section on Pediatric Emergency Medicine, no STAFF
ing physician level and especially conflicts) Caryn Davidson, MA
at the resident level need to be Donald T. Miller, MD, MPH, FAAP (general Oversight by the Steering Committee on Quality
examined. pediatrician, no conflicts) Improvement and Management, 2009–2012

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(Continued from first page)


All clinical practice guidelines from the American Academy of Pediatrics automatically expire 5 years after publication unless reaffirmed, revised, or retired at or
before that time.

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doi:10.1542/peds.2012-3488
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Bell et al. Adolescent and Young Adult Male Health: A Review. Pediatrics. E R R ATA
2013;132(3):535–546
A production error occurred in the article by Bell et al, titled “Adolescent and
Young Adult Male Health: A Review” published in the September 2013 issue of
Pediatrics (2013;132[3]:535–546; originally published online August 12, 2013; doi:
10.1542/peds.2012-3414). On page 535, the series note read “This is the 10th
article in our series, ‘Transitions to Adult Care.’” This should have read “This is
the first article in our series on Adolescent Health.” It has been corrected online.
doi:10.1542/peds.2013-3063

Chen et al. Cost-effectiveness of Augmenting Universal Hepatitis B Vaccination


with Immunoglobin Treatment. Pediatrics. 2013;131(4):e1135–e1143
An error occurred in the article by Chen et al, titled “Cost-effectiveness of Augmenting
Universal Hepatitis B Vaccination with Immunoglobin Treatment” published in the
April 2013 issue of Pediatrics (2013;131[4]:e1135–e1143; originally published online
March 25, 2013; doi:10.1542/peds.2012-1262). On page e1142, under Acknowledg-
ments, this reads: “This project was conducted while Drs Chen and Toy were fellows
of the Takemi Program in International Health at Harvard School of Public Health.”
This should have read: “This project was conducted when Drs Chen and Toy were
fellows of the Takemi Program in International Health at Harvard School of Public
Health. Dr Yeh was supported by the National Institutes of Health’s National Cancer
Institute (K07-CA143044).”
doi:10.1542/peds.2013-3728

Eng et al. Bisphenol A and Chronic Disease Risk Factors in US Children.


Pediatrics. 2013;132(3):e637–e645
An error occurred in the article by Eng et al, titled “Bisphenol A and Chronic Disease
Risk Factors in US Children” published in the September 2013 issue of Pediatrics
(2013;132[3]:e637–e645; originally published online August 19, 2013; doi:10.1542/
peds.2013-0106). On page e637, the author order for this publication was in-
correctly listed as follows: “Donna S. Eng, MD,a Achamyeleh Gebremariam, MS,b
John D. Meeker, ScD,c Karen Peterson, DSc, MD, MPH,c Vasantha Padmanabhan,
PhD,a,c and Joyce M. Lee, MD, MPH.a,b” This should have read: “Donna S. Eng,
MD,a Joyce M. Lee, MD, MPH,a,b Achamyeleh Gebremariam, MS,b John D. Meeker,
ScD,c Karen Peterson, DSc, MD, MPH,c and Vasantha Padmanabhan, PhD.a,c”
doi:10.1542/peds.2013-3758

Lieberthal AS, Carroll AE, Chonmaitree T, et al. Clinical Practice Guideline: The
Diagnosis and Management of Acute Otitis Media. Pediatrics. 2013;131(3):
e964–e999
An error occurred in the following publication: Lieberthal AS, Carroll AE,
Chonmaitree T, et al. Clinical Practice Guideline: The Diagnosis and Management of
Acute Otitis Media. Pediatrics. 2013;131(3):e964–e999. The dosing for ceftriaxone
in Table 5 was incorrect. The corrected Table 5 follows.
doi:10.1542/peds.2013-3791

346 ERRATA
ERRATA

TABLE 5 Recommended Antibiotics for (Initial or Delayed) Treatment and for Patients Who Have Failed Initial Antibiotic Treatment
Initial Antibiotic Treatment at AOM Diagnosis or After Observation Antibiotic Treatment After 48–72 Hours of Initial Antibiotic Treatment Failure

Recommended First-Line Treatment Alternative Treatment Recommended Alternative Treatment


First-Line Treatment
Amoxicillin (80–90 mg/kg per day) Cefdinir (14 mg/kg per day in Amoxicillin–clavulanate (90 mg/kg per Ceftriaxone, 3 d, or Clindamycin
1 or 2 doses), day of amoxicillin, with 6.4 mg/kg per (30–40 mg/kg per day in 3 divided
Cefuroxime (30 mg/kg per day of clavulanate) doses), with or without second- or
day in 2 divided doses), third-generation cephalosporin
OR OR
Cefpodoxime (10 mg/kg per
day in 2 divided doses), or
Amoxicillin–clavulanatea (90 mg/kg per Ceftriaxone (50 mg/kg per Ceftriaxone (50 mg/kg per Clindamycin plus second- or
day of amoxicillin, with 6.4 mg/kg per day IM or IV for 1 to 3 d) day IM or IV for 3 d) third-generation cephalosporin
day of clavulanate) Tympanocentesisb
Consult specialistb
a
May be considered in patients who have received amoxicillin in the previous 30 d or who have the otitis–conjunctivitis syndrome.
b
Perform tympanocentesis/drainage if skilled in the procedure or seek a consult from an otolaryngologist for tympanocentesis/drainage. If the tympanocentesis reveals multidrug-
resistant bacteria, then seek an infectious disease specialist consultation.

PEDIATRICS Volume 133, Number 2, February 2014 347


The Diagnosis and Management of Acute Otitis Media
Allan S. Lieberthal, Aaron E. Carroll, Tasnee Chonmaitree, Theodore G. Ganiats,
Alejandro Hoberman, Mary Anne Jackson, Mark D. Joffe, Donald T. Miller, Richard
M. Rosenfeld, Xavier D. Sevilla, Richard H. Schwartz, Pauline A. Thomas and David
E. Tunkel
Pediatrics 2013;131;e964; originally published online February 25, 2013;
DOI: 10.1542/peds.2012-3488
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