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

Allan S. Lieberthal, MD, FAAP, Aaron E. Carroll, MD, MS, abstract FAAP, Tasnee Chonmaitree, MD, FAAP, Theodore G. Ganiats, This evidence-based clinical practice guideline is a revision of the 2004 MD, Alejandro Hoberman, MD, FAAP, Mary Anne Jackson, 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 fi physicians and experts in the elds 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 — fl 2000. The resulting evidence report and other sources of data were LAIV live-attenuated intranasal in uenza vaccine MEE—middle 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 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 — and benefit-harm relationships. TM tympanic membrane 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 decision-making. It is not intended to replace clinical judgment or es- commercial involvement in the development of the content of 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.

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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)inchildrenwhopresentwith 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 . 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 (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. and temperature less than 39°C child) or intense erythema of Key Action Statement 4C: Clinicians [102.2°F]). When observation is the TM. Evidence Quality: Grade C. should reassess the patient if the used, a mechanism must be in place Strength: Recommendation. 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 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 ). 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 therapy or offer observation with should not prescribe prophylactic assessment of pain. If pain is close follow-up based on joint antibiotics to reduce the frequency present, the clinician should rec- decision-making with the parent(s)/ of episodes of AOM in children with ommend treatment to reduce pain. caregiver for AOM (bilateral or uni- recurrent AOM. Evidence Quality: Evidence Quality: Grade B. Strength: lateral) in children 24 months or Grade B. Strength: Recommendation. Strong Recommendation. older without severe signs or Key Action Statement 5B: Clinicians 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 thepast30daysor 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.

PEDIATRICS Volume 131, Number 3, March 2013 e965 Downloaded from www.aappublications.org/news by guest on September 25, 2021 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 but not limited to the presence of Key Action Statement 6D: Clinicians more attentive to differentiating AOM tympanostomy tubes; anatomic abnor- should encourage avoidance of to- from OM with effusion (OME), resulting malities, including cleft palate; genetic bacco smoke exposure. Evidence in fewer visits coded for AOM and conditions with craniofacial abnormali- Quality: Grade C. Strength: Recom- fewer antibiotic prescriptions written. 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 without AOM are also excluded. INTRODUCTION hesitant to follow the guideline recom- mendations. Vernacchio et al4 surveyed In May 2004, the AAP and AAFP pub- Glossary of Terms lished the “Clinical Practice Guideline: 489 primary care physicians as to their — Diagnosis and Management of Acute management of 4 AOM scenarios AOM the rapid onset of signs and symptoms of inflammation in the Otitis Media”.1 The guideline offered addressed in the 2004 guideline. No 9,10 8 recommendations ranked accord- significant changes in practice were middle ear 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 led to significant discussion, especially 2002 through 2006 to determine the equal to or higher than 39°C9,10 fi frequency of AOM visits without anti- among experts in the eld of otitis me- Nonsevere AOM—AOM with the biotics before and after publication of dia (OM). Also, at the time the guideline presence of mild otalgia and a tem- the 2004 guideline. There was no dif- was written, information regarding the perature below 39°C9,10 heptavalent pneumococcal conjugate ference in prescribing rates. A similar Recurrent AOM—3 or more well- vaccine (PCV7) was not yet published. response to otitis guidelines was found documented and separate AOM epi- Since completion of the guideline in in Italy as in the United States.6,7 sodes in the preceding 6 months or November 2003 and its publication in These findings parallel results of other 4 or more episodes in the preceding May 2004, there has been a significant investigations regarding clinician aware- 12 months with at least 1 episode in body of additional literature on AOM. ness and adherence to guideline the past 6 months11,12 Although OM remains the most common recommendations in all specialties, 8 OME—inflammation of the middle ear condition for which antibacterial agents including pediatrics. Clearly, for clin- with liquid collected in the middle ear; are prescribed for children in the United ical practice guidelines to be effective, the signs and symptoms of acute in- States2,3 clinician visits for OM de- more must be done to improve their fection are absent9 creased from 950 per 1000 children in dissemination and implementation. 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,

e966 FROM THE AMERICAN ACADEMY OF PEDIATRICS Downloaded from www.aappublications.org/news by guest on September 25, 2021 FROM THE AMERICAN ACADEMY OF PEDIATRICS middle ear, mastoid, , 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 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 17–19 immittance (transfer of acoustic en- ment of AOM. 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- Number needed to treat (NNT)—the recurrent OM (uncomplicated) and lished since the 2001 AHRQ report. The number of patients who need to be persistent OM or relapse of AOM? 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- Initial antibiotic therapy—treatment istics of the condition (AOM), patient, dence report, which served as a major of AOM with antibiotics that are pre- environment, and/or health care de- source of data for these practice scribed at the time of diagnosis with the livery system? 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 — outcomes are addressed in Ques- Initial observation initial manage- the new report went beyond the 2001 tions 3 and 4? ment of AOM limited to symptomatic 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- in the 2010 report were as follows: worsens at any time or does not show 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? METHODS considered in the 2001 review (recurrent 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.

PEDIATRICS Volume 131, Number 3, March 2013 e967 Downloaded from www.aappublications.org/news by guest on September 25, 2021 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- fi 20 efficacy, and safety, the search was come measures. Some of the data for lished in the nal evidence report. 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 members reviewed the AAP policy on In total, the reviewers examined 7646 trials could be identified. Studies eligi- conflict of interest and voluntary dis- titles, of which 686 titles were identified ble for analyses of questions pertaining closure and were given an opportu- to treatment efficacy were grouped for for further review. Of those, 72 articles nity to present any potential conflicts comparisons by treatment options. Each that met the predetermined inclusion with the subcommittee’s work. All po- comparison consisted of studies that and exclusion criteria were reviewed in tential conflicts of interest are listed were considered homogeneous across detail. Investigators abstracted data at the end of this document. The project clinical practice. Because some of the into standard evidence tables, with was funded by the AAP. New literature key questions were addressed in the accuracy checked by a second in- on OM is continually being published. 2001 evidence report,17 studies identi- vestigator. Studies were quality-rated Although the systematic review per- fi by 2 investigators by using estab- ed in that report were included with formed by AHRQ could not be repli- fi lished criteria. For randomized con- newly identi ed articles in the 2010 cated with new literature, members 20 trolled trials, the Jadad criteria were evidence report. 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,”

e968 FROM THE AMERICAN ACADEMY OF PEDIATRICS Downloaded from www.aappublications.org/news by guest on September 25, 2021 FROM THE AMERICAN ACADEMY OF PEDIATRICS 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 fi reevaluated for their quality. Con- Key Action Statement Pro le: 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. • ments were generated using BRIDGE-Wiz Promote consistency in diagnosis. 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 software tool that leads guideline de- intervention. 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 recommendation. addressed. Role of patient preferences None After thorough review by the sub- Exclusions None committee for this guideline, a draft Strength Recommendation 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. These recommendations may not Risks, harms, cost Overdiagnosis of AOM. Reduced precision in diagnosis. 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.

PEDIATRICS Volume 131, Number 3, March 2013 e969 Downloaded from www.aappublications.org/news by guest on September 25, 2021 Key Action Statement 1C on 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 childrenwhodonothaveMEE(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 be aware that children with AOM may Aggregate evidence quality Grade B 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. ear pain. However, in young preverbal Intentional vagueness None 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 Accurate diagnosis of AOM is critical to (2) used a clinical diagnosis of AOM less risk of conclusions based on data sound clinical decision-making and based more on symptomatology rather from mixed patients.31,32 high-quality research. The 2004 “Clin- than on tympanocentesis; and (3) in- 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 a children with or without AOM. Karma et al43 is often cited as the best Acute Symptoms and MEE TM Finding in Group I Group II McCormick et al30 used 2 symptom single study of otoscopic findings in Acute Visits (Tampere, (Oulo, scores—a 3-item score (OM-3), con- AOM. However, the study uses only With MEE Finland), % Finland), % a symptom-based diagnosis of AOM sisting of symptoms of physical suffer- 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 diagnosis and daily during the 10-day mobility, and position with the pres- Normal 32.1 22.2 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 (Tampere and Oulu), 2911 children Normal 2.7 4.8 a same group35 also tested a visual scale, Totals are greater than 100%, because each ear may 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 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- 33,42 Shaikh et al 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 fl [AOM-SOS]) for children with AOM, fol- the uid, including culture, were per- moderately red also correlated with fi lowing stringent guidance of the US formed. Pneumatic otoscopic ndings the presence of AOM, and a TM that fi — Food and Drug Administration (FDA) were classi ed 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 ) 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

PEDIATRICS Volume 131, Number 3, March 2013 e971 Downloaded from www.aappublications.org/news by guest on September 25, 2021 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 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 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, Key Action Statement 2 well as simultaneous or sequential 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 fi Risks, harms, cost Potential medication adverse effects. Variable ef cacy of some fi modes of treatment. pain, especially during the rst 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- 56 literature on treating otalgia. direct attention. 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 is, therefore, reproduced here, with the Oil drops in external auditory canal 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. 68 include the new references. Naturopathic agents Comparable to amethocaine/phenazone drops in 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.

PEDIATRICS Volume 131, Number 3, March 2013 e973 Downloaded from www.aappublications.org/news by guest on September 25, 2021 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- The clinician should prescribe an- blind placebo-controlled trial at the agnosis of AOM. In both studies, some tibiotic therapy for bilateral AOM in Australia Children’s Hospital emer- children also received oral analgesics. children younger than 24 months gency department conducted in Three studies compared anesthetic without severe signs or symptoms 2003–2004.65 They used a convenience ear drops with naturopathic herbal (ie, mild otalgia for less than 48 sample of children 3 to 17 years of drops. Naturopathic drops were fa- hours, temperature less than 39°C age diagnosed with AOM in the ED. vored 15 to 30 minutes after [102.2°F]). (Evidence Quality: Grade They excluded children with perfora- installation, and 1 to 3 days after B, Rec. Strength: Recommendation) tion of the TM, pressure-equalizing diagnosis, but the difference was not 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 fi ear drops up to 3 times in 24 hours. natural course of illness, placebo ef- Bene ts Increased likelihood of more fect of receiving treatment, soothing rapidresolutionofsymptoms. They demonstrated a statistically sig- Increasedlikelihoodof 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 ies included in this review were cited cost antibiotics, such as diarrhea, 20 minutes after application of topical diaper dermatitis, and 67–69 lidocaine, compared with normal sa- in the 2004 AAP guideline 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 . Benefits-harms Preponderance of benefit over Key Action Statement 3A A limitation was that some children assessment harm. had received oral acetaminophen be- Severe AOM Value judgments None Role of patient None fore administration of ear drops. The clinician should prescribe an- preference A Cochrane review of topical analgesia tibiotic therapy for AOM (bilateral Intentional None vagueness 66 for AOM 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 AOM in children 6 months to 23 antibiotics leads to increased bacterial resistance. Cost of 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

e974 FROM THE AMERICAN ACADEMY OF PEDIATRICS Downloaded from www.aappublications.org/news by guest on September 25, 2021 FROM THE AMERICAN ACADEMY OF PEDIATRICS follow-up and begin antibiotic ther- onset of symptoms. (Evidence Qual- Purpose of This Section apy if the child worsens or fails to ity:GradeB,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 fi Bene ts Moderately increased likelihood of more rapid resolution of symptoms treatment of AOM with antibiotics with initial antibiotics. Moderately increased likelihood of resolution 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 only if the child’s condition wors- Strength Recommendation 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- observation with close follow-up gies outlined earlier in this guideline. basedonjointdecision-making with apy if the child worsens or fails Another assumption is that a clear the parent(s)/caregiver for AOM toimprovewithin48to72hours 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 signsorsymptoms(ie,mildotalgia 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; fi “ decreased adverse effects of antibiotics; decreased potential for rst 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 implementation of a similar policy in antibiotics leads to increased bacterial resistance. Initial 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

PEDIATRICS Volume 131, Number 3, March 2013 e975 Downloaded from www.aappublications.org/news by guest on September 25, 2021 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. 31,32,75 be in place to ensure follow-up and versus placebo or no therapy, Primary outcome was pain and/or begin antibiotics if the child fails immediate versus delayed antibiotic fever (>38°C) at 3 to 7 days. The ad- 30,76,77 observation. therapy, or delayed antibiotic 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 .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- a TABLE 4 Recommendations for Initial Management for Uncomplicated AOM dren younger than 2 years, the RD was Age Otorrhea Unilateral or Bilateral AOMa Unilateral AOMa 15% (NNT = 7); for those ≥2 years, RD a With Bilateral AOM Without Otorrhea Without Otorrhea was 11% (NNT = 10). For unilateral AOMa With Severe 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 c therapy therapy additional observation additional observation than 2 years, the RD was 5% (NNT = a 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. RD was 7% (NNT = 15). For bilateral c 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 The authors’ conclusions were that than in previous studies that used resolution of symptoms (ie, the time antibiotics produced a small re- less stringent diagnostic criteria. 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 0 or 1), the corresponding values ized, double-blind, placebo-controlled, also concluded that most cases were 20% at day 2, 41% at day 4, and intention-to-treat study of amoxicillin- spontaneously remitted with no com- 67% at day 7 with amoxicillin- clavulanate (40 mg/kg/day) versus plications (NNT = 16). Antibiotics were clavulanate, compared with 14%, placebo. Three hundred nineteen most beneficial in children younger 36%, and 53% with placebo (P = .04 patients from 6 to 35 months of age than 2 years with bilateral AOM and in for the overall comparison). The were studied: 161 in the antibiotic children with otorrhea. symptom burden (ie, mean AOM-SOS group and 158 in the placebo group. 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,

PEDIATRICS Volume 131, Number 3, March 2013 e977 Downloaded from www.aappublications.org/news by guest on September 25, 2021 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 children with AOM is based on a high 16).12,59,62,95 However, randomized tri- amoxicillin-clavulanate group and prevalence of bacteria in the accom- als in these reviews had varying 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 , 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

e978 FROM THE AMERICAN ACADEMY OF PEDIATRICS Downloaded from www.aappublications.org/news by guest on September 25, 2021 FROM THE AMERICAN ACADEMY OF PEDIATRICS 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 finedAOM,ofwhom175completedthe 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 aSNAPwithinstructionstofill 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.

PEDIATRICS Volume 131, Number 3, March 2013 e979 Downloaded from www.aappublications.org/news by guest on September 25, 2021 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, gency department, Spiro et al76 ran- acceptable taste, narrow antimicrobial spectrum. 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. Clinicians were educated on the 2004 Value judgments Better to use a drug that has reasonable cost, has an acceptable 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- fi lled 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. fi lling 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. reduces common adverse effects of Benefits-harms assessment Preponderance of benefit. 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. from middle ear ranging Intentional vagueness “Reassess” is not defined. The clinician may determine the – 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. ria, careful specimen handling, and Strength Recommendation 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 Spneumoniaewas 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, the middle ear cleft. By using com- antibiotic that will have a high likelihood the ordinal frequency of these 3 major prehensive and sensitive microbiologic of being effective against the most likely 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- detected in the middle ear fluid in up siderations of cost, taste, convenience, troduction, Hinfluenzae became the to 96% of AOM cases (eg, 66% bacteria and adverse effects. This section pro- most frequently isolated middle ear and viruses together, 27% bacteria poses first- and second-line antibiotics pathogen, replacing Spneumoniae.122,123 alone, and 4% virus alone).114 Studies that best meet these criteria while Shortly thereafter, a shift to non-PCV7 using less sensitive or less compre- balancing potential benefits and harms. serotypes of S pneumoniae was de- hensive microbiologic assays have scribed.124 Pichichero et al104 later yielded less positive results for bacte- reported that 44% of 212 AOM cases Changes From AAP/AAFP 2004 AOM ria and much less positive results for seen in 2003–2006 were caused by H Guideline viruses.115–117 The 3 most common influenzae, and 28% were caused by S bacterial pathogens in AOM are S Despite new data on the effect of PCV7 pneumoniae, with a high proportion of and updated data on the in vitro pneumoniae, nontypeable Haemophilus highly resistant S pneumoniae.Inthat susceptibility of bacterial pathogens influenzae,andMoraxella 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 treatment failure. A later report125 with remains unchanged from 2004. The for less than 5% of AOM cases. The data from 2007 to 2009, 6 to 8 years current guideline contains revised proportion of AOM cases with patho- after the introduction of PCV7 in the recommendations regarding penicillin genic bacteria isolated from the United States, showed that PCV7 strains allergy based on new data. The in- middle ear fluids varies depending of S pneumoniae virtually disappeared crease of multidrug-resistant strains on bacteriologic techniques, trans- from the middle ear fluid of children of pneumococci is noted. port issues, and stringency of AOM 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 fl Microorganisms detected in the mid- percentage of cases with bacterial fromthemiddleear uid 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 Hinfluenzae 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

PEDIATRICS Volume 131, Number 3, March 2013 e981 Downloaded from www.aappublications.org/news by guest on September 25, 2021 S pneumoniae initially decreased rel- compared with other bacterial and clinical and microbiologic results ative to Hinfluenzae. 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 Hinflu- nontypeable Hinfluenzae, 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 Hinfluenzae 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 Hinfluenzae. 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 Hinfluenzae 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 Hinfluenzae (N = 138), S pneumoniae bacterial pathogens continues to colonization rate among children with (N = 64), and mixed Hinfluenzae 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, Hinfluen- middle ear exudates of 82 cases of cates that approximately 83% and 87% zae wasdetectedin32.4%,andM 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 140 PCV7 increasingly is caused by S causative agent in this condition. 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 fi the patterns of nasopharyngeal colo- possible, but speci c 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- AOM associated with conjunctivitis continue to evolve. quency and importance.104 (otitis-conjunctivitis syndrome) is more Investigators have attempted to pre- likely caused by nontypeable Hinflu- High-dose amoxicillin will yield middle dict the type of AOM pathogenic bac- fl enzae than by other bacteria.141–143 ear uid 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 Hinfluenzae 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 β – (90 mg/kg/day of amoxicillin, with 6.4 moniae (96%) from the middle ear at spiratory tract are -lactamase positive but remain susceptible to amoxicillin- mg/kg/day of clavulanate, a ratio of days 4 to 6 of therapy compared with clavulanate.159 However,thehighrateof amoxicillin to clavulanate of 14:1, given azithromycin. spontaneous clinical resolution occur- in 2 divided doses, which is less likely to 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 Hinfluenzae 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 Hinfluenzae 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.

PEDIATRICS Volume 131, Number 3, March 2013 e983 Downloaded from www.aappublications.org/news by guest on September 25, 2021 cefdinir in recurrent AOM attributable Macrolides, such as erythromycin and the child’s symptoms may worsen to Hinfluenzae showed eradication of azithromycin, have limited efficacy slightly. In the next 24 hours, the the organism in 72% of patients.163 against both Hinfluenzae and S patient’s symptoms should begin to 130,147–149 For penicillin-allergic children, recent pneumoniae. Clindamycin improve. If initially febrile, the tem- fi fl data suggest that cross-reactivity lacks ef cacy against Hinuenzae. 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 may be present, or the causative an overestimate. The rate was based Several of these choices of antibiotic suspensions are barely palatable or bacteria may be resistant to the cho- on data collected and reviewed during frankly offensive and may lead to sen therapy. 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 benefitfromaddingtaste- appropriate antibiotic therapy.109,178,179 have an immunologic reaction to masking products, such as chocolate Literature is conflicting on the corre- 166 penicillin. 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 fi 165,168 ci cagents. 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 fi penicillins and rst-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 174,175 triaxone are highly unlikely to be ment of AOM. Although a single not be required in some children with associated with cross-reactivity with injection of ceftriaxone is approved by mild persistent symptoms. 165 the US FDA for the treatment of AOM, penicillin. Despitethis,theJoint In children with persistent, severe results of a double tympanocentesis Task Force on Practice Parameters; symptoms of AOM and unimproved study (before and 3 days after single American Academy of Allergy, Asthma otologic findings after initial treat- dose ceftriaxone) by Leibovitz et al175 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 recurrence of the middle ear infec- child was initially treated with amoxicillin Immunology169 stated that “cephalo- tion within 5 to 7 days after the initial and failed to improve, amoxicillin- sporin treatment of patients with dose. clavulanate should be used. Patients 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 Tympanocentesis should be consid- physician may choose to reassess 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 should be performed for bacteriologic with severe symptoms or recurrent S pneumoniae, 50% to 71% for non- AOM or when specifically requested by diagnosis and susceptibility testing fl typeable Hinuenzae, and 17% to 19% the child’s parent. when a series of antibiotic drugs have for M catarrhalis. Thenegativepre- Persistent MEE is common and can be failed to improve the clinical condition. dictive value (likelihood that bacteria not detected by pneumatic otoscopy (with or If tympanocentesis is not available, found in the nasopharynx are not AOM without verification by tympanometry) a course of clindamycin may be used, pathogens) ranges from 95% to 99% for after resolution of acute symptoms. Two with or without an antibiotic that cov- all 3 bacteria.188,189 Therefore, if naso- weeks after successful antibiotic treat- ers nontypeable Hinfluenzae and M pharyngeal culture is negative for spe- ment of AOM, 60% to 70% of children catarrhalis, such as cefdinir, cefixime, cific bacteria, that organism is likely not have MEE, decreasing to 40% at 1 month or cefuroxime. 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 eliminate the concern for multidrug- usually multidrug-resistant and may The presence of MEE without clinical 104,149 resistant bacteria and the need for un- not be responsive to clindamycin, symptoms is defined as OME. OME must conventional therapies, such as levo- newer antibiotics that are not ap- be differentiated clinically from AOM floxacin or linezolid. On the other hand, proved by the FDA for treatment of and requires infrequent additional if S pneumoniae is cultured from the AOM, such as levofloxacin or linezolid, monitoring but not antibiotic therapy. nasopharynx, the antimicrobial suscep- may be indicated.185–187 Levofloxacin is Assurance that OME resolves is partic- tibility pattern can help guide treatment. a quinolone antibiotic that is not ap- 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 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 can be found in the evidence-based peated treatment failures, every effort derived from the duration of treatment guideline from the AAP/AAFP/American should be made for bacteriologic di- of streptococcal pharyngotonsillitis. Academy of Otolaryngology-Head and agnosis by tympanocentesis with Several studies favor standard 10-day Neck Surgery published in 2004.84,85 Gram stain, culture, and antibiotic 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)

PEDIATRICS Volume 131, Number 3, March 2013 e985 Downloaded from www.aappublications.org/news by guest on September 25, 2021 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. in the preceding year.12 Risks, harms, cost Small increase in episodes of AOM. 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 Quality:GradeB,Rec.Strength: tubes for recurrent AOM (3 epi- 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, . 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 AOM. Recurrent AOM has been defined as the 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 Long-term, low-dose antibiotic use, re- surgical intervention for OM focus on period that includes at least 1 episode in ferred to as antibiotic prophylaxis or children with persistent MEE with or the preceding 6 months.20 These epi- chemoprophylaxis, has been used to without AOM. The literature on surgery sodes should be well documented and treat children with recurrent AOM to for recurrent AOM as defined here separate acute infections.11 prevent subsequent episodes.85 A2006 is scant. A lack of consensus among 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 recurrentAOMwasreported 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 tionssuchasTMtearsordisplaced AOM but may have benefitwhenper- 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- rophy, , retraction tubes during a 6-month follow-up pe- Prevention of AOM: Key Action 203,204 pockets, and chronic perforation. One riod. One study randomly assigned 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 204,206 alyzed 2 studies 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. fi fi episodes in the 6 months after sur- Bene ts-harms assessment Preponderance of bene t. Value judgments Potential vaccine adverse effects are minimal. 207 gery. Tympanostomy tube insertion Intentional vagueness None. has been shown to improve disease- Role of patient preferences Some parents may choose to refuse the vaccine. specific quality-of-life measures in Exclusions Severe allergic reaction (eg, anaphylaxis) to any component of pneumococcal vaccine or any diphtheria toxoid-containing 208 children with OM. 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. risk. A recent review looking at proto- Intentional vagueness None 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). sorineural hearing loss, vascular injury, Strength Recommendation

PEDIATRICS Volume 131, Number 3, March 2013 e987 Downloaded from www.aappublications.org/news by guest on September 25, 2021 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 fi Key Action Statement Pro le: 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. a 29% reduction in AOM caused by all Intentional vagueness None 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 medical office visits for otitis were Clinicians should encourage C, Rec. Strength: Recommenda- 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 quent AOM and PE tube use after in- Benefits-harms assessment Preponderance of benefit. 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 Hinflu- 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 Hinfluenzae 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 Hinfluenzae.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- Most cases of AOM follow upper re- During infancy and early childhood, feeding was set as the normative spiratory tract infections caused by reducing the incidence of upper re- standard, the recalculated odds ratios viruses, including influenza viruses. As spiratory tract infections by altering (ORs) revealed the risks of any for- many as two-thirds of young children child care-center attendance patterns mula use. For example, any formula with influenza may have AOM.235 can reduce the incidence of recurrent use in the first 6 months of age was 249,269 Investigators have studied the efficacy AOM significantly. significantly associated with in- of trivalent inactivated influenza vac- creased incidence of OM (OR: 1.78; cine (TIV) and live-attenuated in- Xylitol 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 Breastfeeding safely use lozenges or chewing gum. 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 216 and child. 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.

PEDIATRICS Volume 131, Number 3, March 2013 e989 Downloaded from www.aappublications.org/news by guest on September 25, 2021 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 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- The recent studies of Hoberman31 and feeding, would clarify what is now servation arm for patients with non- Tähtinen32 have addressed clinical a more general database. Likewise, severe illness to ensure a clinical and TM appearance by using stringent more focused studies of the effects of benefit over placebo. Studies should diagnostic criteria of AOM. However, lifestyle changes would help clarify also have enough patients to show the outcomes for less stringent di- their effect on AOM. 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 niae or Hinfluenzae in children in can only be inferred from earlier There are no well-designed random- child care settings and with siblings studies that used less stringent cri- ized controlled trials of the usefulness younger than 5 years, studies are still teria but did not specify outcomes for of complementary and alternative needed to determine whether these various grades of findings. Random- medicine in AOM, yet a large number of and other risk factors would indicate ized controlled trials on these less families turn to these methods. Al- a need for different initial treatment certain TM appearances using scales though most alternative therapies are 35 than noted in the guideline. similar to the OS-8 scale could 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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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- Aaron E. Carroll, MD, MS, FAAP (Partnership individuals and healthcare systems rics, Quality Improvement Innovation Network, for Policy Implementation [PPI] Informatician, should be employed by implementers 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- fl little overt change in practice after con icts) gologist, AAP Section on Otolaryngology, Head Alejandro Hoberman, MD, FAAP (general ac- and Neck Surgery, periodic consultant to 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 for AOM had decreased publication. Infectious Disease, no conflicts) (informatician, guideline methodologist, gen- eral academic pediatrician, no conflicts) Studies of educational and dissemi- Mark D. Joffe, MD, FAAP (pediatric emer- gency medicine physician, AAP Committee/ nation methods both at the practic- Section on Pediatric Emergency Medicine, no STAFF ing physician level and especially fl con icts) 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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PEDIATRICS Volume 131, Number 3, March 2013 e997 Downloaded from www.aappublications.org/news by guest on September 25, 2021 conjugated to protein D for prevention of children. Pediatr Infect Dis J. 2009;28(5): 255. Chantry CJ, Howard CR, Auinger P. Full acute otitis media caused by both Strep- 365–371 breastfeeding duration and associated tococcus pneumoniae and non-typable 244. Tam JS, Capeding MR, Lum LC, et al; decrease in respiratory tract infection in Haemophilus influenzae: a randomised Pan-Asian CAIV-T Pediatric Efficacy Trial US children. Pediatrics. 2006;117(2):425– double-blind efficacy study. Lancet. 2006; Network. Efficacy and safety of a live atten- 432 367(9512):740–748 uated, cold-adapted influenza vaccine, tri- 256. Hatakka K, Piirainen L, Pohjavuori S, 233. Prymula R, Schuerman L. 10-valent pneu- valent against culture-confirmed influenza Poussa T, Savilahti E, Korpela R. Factors mococcal nontypeable Haemophilus influ- in young children in Asia. 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PEDIATRICS Volume 131, Number 3, March 2013 e999 Downloaded from www.aappublications.org/news by guest on September 25, 2021 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 DOI: 10.1542/peds.2012-3488 originally published online February 25, 2013;

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Downloaded from www.aappublications.org/news by guest on September 25, 2021 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 DOI: 10.1542/peds.2012-3488 originally published online February 25, 2013;

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