EVIDENCE-BASED PRACTICE & APPLIED NURSING RESEARCH

Competency 724.8.1: Primary Research – The graduate recognizes basic scientific research concepts and techniques, appreciates the ethics of nursing research,
recognizes researchable questions, uses evaluative skills to critique current nursing research, and identifies statistical types.
Competency 724.8.2: Translation of Research Evidence and Evidence Summary –
The graduate applies concepts of nursing research to clinical practice situations, conducts reviews of the literature in relation to therapeutic approaches,
and recognizes the importance of theoretical models in nursing practice or research.
?Objectives:
724.8.1-01: Critique an original research report for a nursing research article to determine how the researcher addresses the five areas of a research
report.
724.8.1-02: Assess the strength of evidence presented in a given literature source on a specified topic.
724.8.1-03: Recognize what ethical issues may arise while conducting a nursing research study.
724.8.1-04: Recommend an appropriate type of research for a given nursing practice purpose.
724.8.1-05: Develop an annotated bibliography of nursing research articles that address a given evidence-based practice issue.
724.8.1-06: Identify types of statistically based tools commonly reported in evidence summaries from nursing research.
724.8.2-01: Use a given preconstructed expert search strategy to locate primary research in a specified major bibliographic database.
724.8.2-02: Identify the key criteria for a well developed evidence summary.
724.8.2-03: Explain why it is important to use a theoretical model for nursing research or practice.
724.8.2-04: Conduct an in-depth review of specified current peer-reviewed research articles to evaluate the efficacy of a specified therapeutic approach to a
given clinical practice problem.
724.8.2-05: Recommend a practical application of a given theoretical model based on a review of current research.
724.8.2-06: Evaluate nursing care or management implications of a specified therapeutic nursing intervention based on a review of relevant literature.
Annoted bib example:
Centers for Disease Control and Prevention. (2007). Overweight and obesity economic consequences. Retrieved May 7, 2009, from
https://www.cdc.gov/nccdphp/dnpa/obesity/economic_consequences.htm
This source is a section of the Centers for Disease Control (CDC) website dedicated to obesity as a public health issue. While this particular section is
about adults, it can still be used in a paper about obesity in children. This article shows the negative economic results of adult obesity in America,
including health costs to individuals, states, and the national government. The economic costs are described in the text of the article and broken down into
useful tables of statistics. The costs are categorized as both direct and indirect, and the indirect costs are much more complicated. Indirect costs include
the loss of income to a family or the economy due to the early death due to obesity. This article is an extremely credible source, as the CDC is the leading
government agency aimed at assessing public health risks. The excellent statistics in this article will be used in the research paper to show the long-term
results of childhood obesity (CDC, 2017).
Okely, A. (2007). Evidence-guided approaches to addressing child obesity: What approaches can dietitians use in their everyday practice? Nutrition and
Dietetics, 64, 140?141. Retrieved May 7, 2016, from the Academic Search Premier database.
In this article, Anthony Okely describes the health consequences of childhood obesity and discusses several programs aimed at helping prevent unhealthy
weight gain in children. He sees parents as the primary source of power over a child?s unhealthy weight gain. This article is an editorial in a peer-reviewed
journal.Although this article is an editorial, it is still a good source of research-based information, as the author uses 16 detailed references from
several countries. The author has a Doctorate in Education and serves as the Director of the Child Obesity Research Centre at Australia?s University of
Wollongong; he is also a Senior Lecturer at the same university. The number of references he provides in the article also boosts the credibility of the
opinions he offers. This article will be used in the research paper for its basic statistics on childhood obesity. Also, the reference list at the end of the
article is a valuable source of credible articles on this topic. The fact that the article is from Australia limits its effectiveness as a major source for
the paper (Okely, 2017).
Primary Research Matrix:
Primary Research Matrix
EBT Task 724.8.1-01-06, 8.2-01-06
1. Create a table using nine columns like the one below, using a spreadsheet or word-processing program.
2. Once you have created these special categorical columns, you can now use them to analyze your data and help organize your review. Simply sort your
spreadsheet or table on a column of interest and you will be able to get a new view or organizing framework for your data. When sorting, select all columns
rather than sorting by one column as this would mix up your data.
Author(s) Source Date (year) Research Type (experimental, quasi-experimental, case series, ethnographic, etc) Population/
sample size Outcome measures Pertinent data from results Suggested Conclusions Comments
3. SUBDOMAIN 724.8 – EVIDENCE-BASED PRACTICE & APPLIED NURSING RESEARCH
Competency 724.8.1: Primary Research – The graduate recognizes basic scientific research concepts and techniques, appreciates the ethics of nursing research,
recognizes researchable questions, uses evaluative skills to critique current nursing research, and identifies statistical types.
Competency 724.8.2: Translation of Research Evidence and Evidence Summary –
The graduate applies concepts of nursing research to clinical practice situations, conducts reviews of the literature in relation to therapeutic approaches,
and recognizes the importance of theoretical models in nursing practice or research.
Objectives: 724.8.1-01: Critique an original research report for a nursing research article to determine how the researcher addresses the five areas of a
research report. 724.8.1-02: Assess the strength of evidence presented in a given literature source on a specified topic. 724.8.1-03: Recognize what ethical
issues may arise while conducting a nursing research study. 724.8.1-04: Recommend an appropriate type of research for a given nursing practice purpose.
724.8.1-05: Develop an annotated bibliography of nursing research articles that address a given evidence-based practice issue. 724.8.1-06: Identify types of
statistically based tools commonly reported in evidence summaries from nursing research. 724.8.2-01: Use a given preconstructed expert search strategy to
locate primary research in a specified major bibliographic database. 724.8.2-02: Identify the key criteria for a well developed evidence summary. 724.8.2-03:
Explain why it is important to use a theoretical model for nursing research or practice. 724.8.2-04: Conduct an in-depth review of specified current peer-
reviewed research articles to evaluate the efficacy of a specified therapeutic approach to a given clinical practice problem. 724.8.2-05: Recommend a
practical application of a given theoretical model based on a review of current research. 724.8.2-06: Evaluate nursing care or management implications of a
specified therapeutic nursing intervention based on a review of relevant literature.
Introduction:
Peer-reviewed research reports are reports reviewed by other credible experts in the field. Nursing, as a profession, uses peer-reviewed primary research
reports to make credible and evidence-based practice implications and recommendations in the clinical area.
In this task, you will collect and analyze 10 research reports (primary research evidence) on one topic of interest to you in nursing practice or healthcare.
Task:
A. Select piece of primary research (original research reports) from a research journal that has nursing implications and critique the article (suggested
length of 2?3 pages) by doing the following:Note: Please notice that you can collect 10 research reports first and then select one of those to complete
aspect A of this task.
1. Identify the article you have chosen in an APA-formatted citation. 2. Design a visual representation (e.g., graph or chart) to show how the researcher
addressed the five areas of a research report (background information or introduction, review of the literature, discussion of methodology, specific data
analysis, and conclusion).
Note: You may use the following table.
3. Based on your analysis of the five areas, assess whether the evidence presented in the research report supports the researcher?s conclusion.
4. Discuss ethical issues that may have arisen for the researcher while conducting the research for the article.
5. Discuss the type of research used for the study. a. Explain whether or not other types of research would have been appropriate in
the same situation.
B. Conduct a literature search to evaluate nursing care or management implications of a nursing intervention by doing the following: 1. Discuss evidence for
a nursing care or management problem. 2. Complete the attached matrix to list 10 primary research sources, in APA format,
from scholarly journal sources you locate in major medical databases (e.g., CINAHL, PubMed, MedLine, or a hard copy journal).
Note: In aspect B you should gather 9 more pieces of similar research on the same topic as in aspect A so you have a total of 10 pieces of primary research
to make a practice implication (a minimum of 8 authors should be used).
Note: You have access to major medical databases within the WGU Library.
Note: You may submit your completed matrix as a separate attachment to the task or you may include the matrix within your paper.
A1 Article: (Indicate primary evidence chosen by way of an APA citation.)
A2 Background or Introduction
A2 Review of the Literature
A2 Discussion of Methodology
A2 Data Analysis
A2 Researcher?s conclusion
Deleted: i
Note: Credible sources may include professional journals, research reports, professional Web sites, governmental reports, and presentations from professional
meetings. Primary research articles must not be more than ten years old.
3. Conduct a review of the 10 peer-reviewed research articles in which you do the following:
a. Develop an annotated bibliography (suggested length of 2?3 pages) of the articles.
Note: An annotated bibliography is one that includes not only a brief summary of content for each book or article reviewed, but also contains other relevant
comments and information that the candidate believes can be of help for future study. See Web Links below for more information on annotated bibliographies.
b. Discuss whether the researchers? evidence collected is adequate to make a recommendation for a practice change.
c. Identify whether the researchers chose tools that were similar or different. d. Discuss whether you believe the tools the researchers chose could have
affected
their results. 4. Develop an evidence summary of the articles, identifying at least two key criteria
that were used to develop it. 5. Recommend a specific nursing strategy based on the researcher?s recommendations
and evidence you found in your review. 6. Explain why you believe it is important to use a theoretical model for nursing
research. C. When you use sources, include all in-text citations and references in APA format. Note: For definitions of terms commonly used in the rubric,
see the attached Rubric Terms.
Note: When using sources to support ideas and elements in a paper or project, the submission MUST include APA formatted in-text citations with a
corresponding reference list for any direct quotes or paraphrasing. It is not necessary to list sources that were consulted if they have not been quoted or
paraphrased in the text of the paper or project.
Note: No more than a combined total of 30% of a submission can be directly quoted or closely paraphrased from sources, even if cited correctly. For tips on
using APA style, please refer to the APA Handout web link included in the General Instructions section.
TASK 2:
SUBDOMAIN 724.8 – EVIDENCE-BASED PRACTICE & APPLIED NURSING RESEARCH
Competency 724.8.3: Research Integration – The graduate recognizes the significance of applying research in evidence-based practice, recognizes sources of
evidence, and applies ethical principles to evidence-based practice research.
Objectives: 724.8.3-01: Recognize appropriate sources of evidence for nursing practice. 724.8.3-02: Describe ethical principles applicable to a given
research task in evidence- based practice. 724.8.3-03: Classify specified clinical knowledge elements as primary research evidence, evidence summary, or
evidence-based guideline. 724.8.3-04: Apply specified evidence-based clinical practice guidelines to determine appropriate care in a given situation.
724.8.3-05: Apply specified research findings to improve nursing practice in a given situation.
Introduction:
Recent clinical guidelines suggest that watchful waiting is better than immediately beginning treatment with antibiotics when a child presents with otitis
media. A group of nurses in the outpatient clinic decide to use evidence-based research for this practice to help them understand whether this is the
appropriate care for the children they see. If they find it is grounded in the research, they will suggest a change in the clinical policy guidelines. They
are aware that this policy may be a concern for parents who are used to getting antibiotics immediately when they bring their children to the clinics.
The nurses brought the following sources of evidence to their first meeting:
Note on retrieving articles for this assessment: ??AAP/AAFP (2014) is retrieved from the web address provided within the citation
below. ??Block (1997), Kelly et al., (in Hay 2017), and McCracken (1998) are all loaded in the
undergraduate Nursing EReserves of the WGU library ready for you to download. ???Interviews? are fictitious evidence that can represent evidence brought by a
nurse in
any format that you want to apply for this assignment, such as anecdotal evidence/clinical experiences shared by the nurse.
? American Academy of Pediatrics and American Academy of Family Physicians. (2004.) Clinical practice guideline: Diagnosis and management of acute otitis
media. Retrieved May 17, 2017, from https://aappolicy.aappublications.org/cgi/content/full/pediatrics;113/5/1451
? Block, S. L. (1997). Causative pathogens, antibiotic resistance and therapeutic
considerations in acute otitis media. Pediatric Infectious Disease Journal, 16, 449?456.
? Kelley, P. E., Friedman, N., Johnson, C. (2015). Ear, nose, and throat. In W. W. Hay, M.
J. Levin, J. M. Sondheimer, & R. R. Deterding (Eds.), Current pediatric diagnosis and
treatment (18th ed., pp. 459?492). New York: Lange Medical Books/McGraw-Hill.
? McCracken, G. H. (1998). Treatment of acute otitis media in an era of increasing
microbial resistance. Pediatric Infectious Disease Journal, 17, 576?579.
? Results from interviews with parents who have brought their children into the clinic for
acute otitis media.Task:
A. Review the sources of evidence listed above and do the following: 1. Classify the type of each source of evidence as either a general information
resource,
a filtered resource, or an unfiltered resource. 2. Discuss whether each source of evidence is appropriate for this nursing practice
situation. 3. Classify each source of evidence as primary research evidence, evidence summary,
evidence-based guideline, or none of these.
B. Review the article (see ?Clinical Practice Guideline? attached below) and do the following:
1. Discuss whether watchful waiting is an appropriate approach for treating children with acute otitis media, based on the evidence presented in the article.
C. Discuss how you would apply the findings in the attached article to improve nursing practice in the clinic.
D. Discuss ethical issues that could arise in researching and changing clinical practice guidelines, based on the evidence-based research. 1. Include issues
of vulnerable populations, confidentiality, and informed consent when
research involves children. E. When you use sources, include all in-text citations and references in APA format. Note: For definitions of terms commonly used
in the rubric, see the attached Rubric Terms.
Note: When using sources to support ideas and elements in a paper or project, the submission MUST include APA formatted in-text citations with a
corresponding reference list for any direct quotes or paraphrasing. It is not necessary to list sources that were consulted if they have not been quoted or
paraphrased in the text of the paper or project.
Note: No more than a combined total of 30% of a submission can be directly quoted or closely paraphrased from sources, even if cited correctly. For tips on
using APA style, please refer to the APA Handout web link included in the General Instructions section.
Article: Otitis Media
AMERICAN ACADEMY OF PEDIATRICS AND AMERICAN ACADEMY OF FAMILY PHYSICIANS
CLINICAL PRACTICE GUIDELINE
Subcommittee on Management of Acute Otitis Media
Diagnosis and Management of Acute Otitis Media
ABSTRACT. This evidence-based clinical practice guideline provides recommendations to primary care cli- nicians for the management of children from 2 months
through 12 years of age with uncomplicated acute otitis media (AOM).
The American Academy of Pediatrics and American Academy of Family Physicians convened a committee composed of primary care physicians and experts in the
fields of otolaryngology, epidemiology, and infectious disease. The subcommittee partnered with the Agency for Healthcare Research and Quality and the
Southern California Evidence-Based Practice Center to develop a comprehensive review of the evidence-based literature related to AOM. The resulting evidence
report and other sources of data were used to formulate the practice guide- line recommendations. The focus of this practice guide- line is the appropriate
diagnosis and initial treatment of a child presenting with AOM.
The guideline provides a specific definition of AOM. It addresses pain management, initial observation versus antibacterial treatment, appropriate choices of
antibacte- rials, and preventive measures. Decisions were made based on a systematic grading of the quality of evidence and strength of recommendations, as
well as expert con- sensus when definitive data were not available. The prac- tice guideline underwent comprehensive peer review be- fore formal approval by
the partnering organizations.
This clinical practice guideline is not intended as a sole source of guidance in the management of children with AOM. Rather, it is intended to assist
primary care clini- cians by providing a framework for clinical decision- making. It is not intended to replace clinical judgment or establish a protocol for
all children with this condition. These recommendations may not provide the only appro- priate approach to the management of this problem.
ABBREVIATIONS. AOM, acute otitis media; OME, otitis media with effusion; AAP, American Academy of Pediatrics; AAFP, American Academy of Family Physicians;
AHRQ, Agency for Healthcare Research and Quality; MEE, middle-ear effusion; CAM, complementary and alternative medicine.
Acute otitis media (AOM) is the most common infection for which antibacterial agents are prescribed for children in the United States. As such, the diagnosis
and management of AOM has
The recommendations in this guideline do not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into
account individual circumstances, may be appropriate. PEDIATRICS (ISSN 0031 4005). Copyright ? 2004 by the American Acad- emy of Pediatrics.
a significant impact on the health of children, cost of providing care, and overall use of antibacterial agents. The illness also generates a significant
social burden and indirect cost due to time lost from school and work. The estimated direct cost of AOM was $1.96 billion in 1995. In addition, the indirect
cost was estimated to be $1.02 billion.1 During 1990 there were almost 25 million visits made to office-based physicians in the United States for otitis
media, with 809 antibacterial prescriptions per 1000 visits, for a total of more than 20 million prescriptions for otitis media?related antibacterials.
Although the total number of office visits for otitis media decreased to 16 million in 2000, the rate of antibacterial prescrib- ing was approximately the
same (802 antibacterial prescriptions per 1000 visits for a total of more than 13 million prescriptions).2?4 An individual course of antibacterial therapy
can range in cost from $10 to more than $100.
There has been much discussion recently as to the necessity for the use of antibacterial agents at the time of diagnosis in children with uncomplicated AOM.
Although in the United States the use of an- tibacterial agents in the management of AOM has been routine, in some countries in Europe it is com- mon
practice to treat the symptoms of AOM initially and only institute antibacterial therapy if clinical im- provement does not occur. For the clinician, the
choice of a specific antibacterial agent has become a key aspect of management. Concerns about the ris- ing rates of antibacterial resistance and the growing
costs of antibacterial prescriptions have focused the attention of the medical community and the general public on the need for judicious use of
antibacterial agents. Greater resistance among many of the patho- gens that cause AOM has fueled an increase in the use of broader-spectrum and generally
more expen- sive antibacterial agents.
It is the intent of this guideline to evaluate the published evidence on the natural history and man- agement of uncomplicated AOM and to make rec-
ommendations based on that evidence to primary care clinicians including pediatricians, family physi- cians, physician assistants, nurse practitioners, and
emergency department physicians as well as otolar- yngologists. The scope of the guideline is the diag- nosis and management of uncomplicated AOM in children
from 2 months through 12 years of age without signs or symptoms of systemic illness unre-
PEDIATRICS Vol. 113 No. 5 May 2004 1451lated to the middle ear. It applies only to the other- wise healthy child without underlying conditions that may alter
the natural course of AOM. These conditions include, but are not limited to, anatomic abnormalities such as cleft palate, genetic conditions such as Down
syndrome, immunodeficiencies, and the presence of cochlear implants. Also excluded are children with a clinical recurrence of AOM within 30 days or AOM with
underlying chronic otitis media with effusion (OME).
METHODS
To develop the clinical practice guideline on the management of AOM, the American Academy of Pediatrics (AAP) and Amer- ican Academy of Family Physicians
(AAFP) convened the Sub- committee on Management of Acute Otitis Media, a working panel composed of primary care and subspecialty physicians. The
subcommittee was cochaired by a primary care pediatrician and a family physician and included experts in the fields of general pediatrics, family medicine,
otolaryngology, epidemiology, infec- tious disease, and medical informatics. All panel members re- viewed the AAP policy on conflict of interest and
voluntary dis- closure and were given an opportunity to present any potential conflicts with the subcommittee?s work.
The AAP and AAFP partnered with the Agency for Healthcare Research and Quality (AHRQ) and the Southern California Evi- dence-Based Practice Center to develop
the evidence report, which served as a major source of data for these practice guideline recommendations.1 Specific clinical issues addressed in the AHRQ
evidence report were the 1) definition of AOM, 2) natural history of AOM without antibacterial treatment, 3) effectiveness of anti- bacterial agents in
preventing clinical failure, and 4) relative ef- fectiveness of specific antibacterial regimens. The AHRQ report focused on children between 4 weeks and 18
years of age with uncomplicated AOM seeking initial treatment. Outcomes in- cluded the presence or absence of signs and symptoms within 48 hours, at 3 to 7
days, 8 to 14 days, 15 days to 3 months, and more than 3 months and the presence of adverse effects from antibac- terial treatment. Southern California
Evidence-Based Practice Cen- ter project staff searched Medline (1966 through March 1999), the Cochrane Library (through March 1999), HealthSTAR (1975
through March 1999), International Pharmaceutical Abstracts (1970 through March 1999), CINAHL (1982 through March 1999), BIOSIS (1970 through March 1999),
and Embase (1980 through March 1999). Additional articles were identified by review of reference lists in proceedings, published articles, reports, and
TABLE 1. Guideline Definitions for Evidence-Based Statements
guidelines. Studies relevant to treatment questions were limited to randomized, controlled trials. For natural history, prospective and retrospective
comparative cohort studies were included also. A total of 3461 titles were identified initially for additional review. Of these, 2701 were excluded, and 760
required article review. Finally, 72 English-language and 2 foreign-language articles were reviewed fully. Results of the literature review were presented in
evidence tables and published in the final evidence report.
New literature about otitis media is being published constantly. Although the systematic review done by the AHRQ could not be replicated with new literature,
members of the Subcommittee on Management of Acute Otitis Media reviewed additional articles published through September 2003. Articles were nonsystemati-
cally evaluated for quality of methodology and importance of results. Articles used in the AHRQ review also were reevaluated for their quality. Conclusions
were based on the consensus of the subcommittee after the review of newer literature and reevalua- tion of the AHRQ evidence. Of significance is that the
literature includes relatively few cases of uncomplicated AOM in children older than 12 years. The subcommittee therefore limited this guideline to children
from 2 months through 12 years of age.
The evidence-based approach to guideline development re- quires that the evidence in support of a policy be identified, appraised, and summarized and that an
explicit link between evidence and recommendations be defined. Evidence-based rec- ommendations reflect the quality of evidence and the balance of benefit
and harm that is anticipated when the recommendation is followed. The AAP definitions of evidence-based recommenda- tions are shown in Table 1.
A draft version of this practice guideline underwent extensive peer review by committees and sections within the AAP, review- ers appointed by the AAFP,
outside organizations, and other individuals identified by the subcommittee as experts in the field. Members of the subcommittee were invited to distribute
the draft to other representatives and committees within their specialty organizations. The resulting comments were reviewed by the sub- committee and, when
appropriate, incorporated into the guide- line.
RECOMMENDATION 1
To diagnose AOM the clinician should confirm a his- tory of acute onset, identify signs of middle-ear effusion (MEE), and evaluate for the presence of signs
and symp- toms of middle-ear inflammation. (This recommendation is based on observational studies and a preponderance of benefit over risk; see Table 2.)
Statement
Strong recommendation
Recommendation
Option
No recommendation
Definition
A strong recommendation in favor of a particular action is made when the anticipated benefits of the recommended intervention clearly exceed the harms (as a
strong recommendation against an action is made when the anticipated harms clearly exceed the benefits) and the quality of the supporting evidence is
excellent. In some clearly identified circumstances, strong recommendations may be made when high-quality evidence is impossible to obtain and the
anticipated benefits strongly outweigh the harms.
A recommendation in favor of a particular action is made when the anticipated benefits exceed the harms, but the quality of evidence is not as strong. Again,
in some clearly identified circumstances, recommendations may be made when high-quality evidence is impossible to obtain but the anticipated benefits
outweigh the harms.
Options define courses that may be taken when either the quality of evidence is suspect or carefully performed studies have shown little clear advantage to
one approach over another.
No recommendation indicates that there is a lack of pertinent published evidence and that the anticipated balance of benefits and harms is unclear.
Implication
Clinicians should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present.
Clinicians would be prudent to follow a recommendation but should remain alert to new information and sensitive to patient preferences.
Clinicians should consider the option in their decision- making, and patient preference may play a substantial role.
Clinicians should be alert to new published evidence that clarifies the balance of benefit versus harm.
1452 DIAGNOSIS AND MANAGEMENT OF ACUTE OTITIS MEDIA
TABLE 2. Definition of AOM
A diagnosis of AOM requires 1) a history of acute onset of signs and symptoms, 2) the presence of MEE, and 3) signs and symptoms of middle-ear inflammation.
Elements of the definition of AOM are all of the following: 1. Recent, usually abrupt, onset of signs and symptoms of
middle-ear inflammation and MEE 2. The presence of MEE that is indicated by any of the
following: a. Bulging of the tympanic membrane b. Limited or absent mobility of the tympanic membrane c. Air-fluid level behind the tympanic membrane d.
Otorrhea
3. Signs or symptoms of middle-ear inflammation as indicated by either a. Distinct erythema of the tympanic membrane or b. Distinct otalgia (discomfort
clearly referable to the ear[s]
that results in interference with or precludes normal activity or sleep)
Children with AOM usually present with a history of rapid onset of signs and symptoms such as otalgia (or pulling of the ear in an infant), irritability in
an infant or toddler, otorrhea, and/or fever. These find- ings, other than otorrhea, are nonspecific and fre- quently overlap those of an uncomplicated viral
up- per respiratory infection.5,6 In a prospective survey among 354 children who visited a physician for acute respiratory illness, fever, earache, and
excessive cry- ing were present frequently (90%) in those with AOM. However, these symptoms also were promi- nent among children without AOM (72%). Other
symptoms of a viral upper respiratory infection, such as cough and nasal discharge or stuffiness, often precede or accompany AOM and are nonspecific also.
Accordingly, clinical history alone is poorly predictive of the presence of AOM, especially in younger children.5
The presence of MEE is commonly confirmed with the use of pneumatic otoscopy7 but can be supple- mented by tympanometry8 and/or acoustic reflec- tometry.9?12
MEE also can be demonstrated directly by tympanocentesis or the presence of fluid in the external auditory canal as a result of tympanic mem- brane
perforation.
Visualization of the tympanic membrane with identification of an MEE and inflammatory changes is necessary to establish the diagnosis with certainty. To
visualize the tympanic membrane adequately it is essential that cerumen obscuring the tympanic mem- brane be removed and that lighting is adequate. For
pneumatic otoscopy, a speculum of proper shape and diameter must be selected to permit a seal in the external auditory canal. Appropriate restraint of the
child to permit adequate examination may be neces- sary also.
The findings on otoscopy indicating the presence of MEE and inflammation associated with AOM have been well defined. Fullness or bulging of the tympanic
membrane is often present and has the highest predictive value for the presence of MEE. When combined with color and mobility, bulging is also the best
predictor of AOM.7,13,14 Reduced or absent mobility of the tympanic membrane during performance of pneumatic otoscopy is additional ev- idence of fluid in
the middle ear. Opacification or
cloudiness, other than that caused by scarring, is also a consistent finding and is caused by edema of the tympanic membrane. Redness of the tympanic mem-
brane caused by inflammation may be present and must be distinguished from the pink erythematous flush evoked by crying or high fever, which is usu- ally
less intense and remits as the child quiets down. In bullous myringitis, blisters may be seen on the tympanic membrane.15 When the presence of mid- dle-ear
fluid is difficult to determine, the use of tym- panometry or acoustic reflectometry16 can be helpful in establishing a diagnosis.
A major challenge for the practitioner is to discrim- inate between OME and AOM.17,18 OME is more common than AOM. OME may accompany viral upper respiratory
infections, be a prelude to AOM, or be a sequela of AOM.19 When OME is identified mistakenly as AOM, antibacterial agents may be pre- scribed
unnecessarily.20,21 Clinicians should strive to avoid a false-positive diagnosis in children with mid- dle-ear discomfort caused by eustachian tube dys-
function and retraction of the tympanic membrane or when acute viral respiratory infection is superim- posed on chronic preexisting MEE.
The diagnosis of AOM, particularly in infants and young children, is often made with a degree of un- certainty. Common factors that may increase uncer-
tainty include the inability to sufficiently clear the external auditory canal of cerumen, a narrow ear canal, or inability to maintain an adequate seal for
successful pneumatic otoscopy or tympanometry. An uncertain diagnosis of AOM is caused most often by inability to confirm the presence of MEE.22 Acous- tic
reflectometry can be helpful, because it requires no seal of the canal and can determine the presence of middle-ear fluid through only a small opening in the
cerumen.10,11 When the presence of middle-ear fluid is questionable or uncertain, a diagnosis of AOM may be considered but cannot be confirmed. Although
every effort should be made by the clini- cian to differentiate AOM from OME or a normal ear, it must be acknowledged that, using all available tools,
uncertainty will remain in some cases. Efforts to improve clinician education must be increased to improve diagnostic skills and thereby decrease the
frequency of an uncertain diagnosis. Ideally, instruc- tion in the proper examination of the child?s ear should begin with the first pediatric rotation in
med- ical school and continue throughout postgraduate training.18 Continuing medical education should re- inforce the importance of and retrain the clinician
in the use of pneumatic otoscopy. By including the degree of certainty into the formation of a manage- ment plan, the everyday challenge of pediatric exam-
inations is incorporated into decision-making.
A certain diagnosis of AOM meets all 3 of the criteria: rapid onset, presence of MEE, and signs and symptoms of middle-ear inflammation. The clinician should
maximize diagnostic strategies, particularly to establish the presence of MEE, and should con- sider the certainty of diagnosis in determining man- agement.
Clinicians may wish to discuss the degree of diagnostic certainty with parents/caregivers at the time of initial AOM management.
AMERICAN ACADEMY OF PEDIATRICS 1453
TABLE 3. Treatments for Otalgia in AOM
Modality
Acetaminophen, ibuprofen26
Home remedies (no controlled studies that directly address effectiveness)
Distraction External application of heat or cold Oil
Topical agents Benzocaine (Auralgan, Americaine Otic)27
Naturopathic agents (Otikon Otic Solution)28
Homeopathic agents29,30 Narcotic analgesia with codeine or analogs
Tympanostomy/myringotomy31
RECOMMENDATION 2
The management of AOM should include an as- sessment of pain. If pain is present, the clinician should recommend treatment to reduce pain. (This is a strong
recommendation based on randomized, clinical trials with limitations and a preponderance of benefit over risk.)
Many episodes of AOM are associated with pain.23 Although pain is an integral part of the illness, clini- cians often see otalgia as a peripheral concern not
requiring direct attention.24 The AAP published the policy statement ?The Assessment and Management of Acute Pain in Infants, Children, and Adoles- cents?25
to assist the clinician in addressing pain in the context of illness. The management of pain, es- pecially during the first 24 hours of an episode of AOM,
should be addressed regardless of the use of antibacterial agents.
Various treatments of otalgia have been used, but none has been well studied. The clinician should select a treatment based on a consideration of bene- fits
and risks and, wherever possible, incorporate parent/caregiver and patient preference (Table 3).
RECOMMENDATION 3A
Observation without use of antibacterial agents in a child with uncomplicated AOM is an option for selected children based on diagnostic certainty, age,
illness sever- ity, and assurance of follow-up. (This option is based on randomized, controlled trials with limitations and a rela- tive balance of benefit
and risk.)
The ?observation option? for AOM refers to defer- ring antibacterial treatment of selected children for 48 to 72 hours and limiting management to symp-
tomatic relief. The decision to observe or treat is based on the child?s age, diagnostic certainty, and illness severity. To observe a child without initial
antibacterial therapy, it is important that the parent/ caregiver has a ready means of communicating with the clinician. There also must be a system in place
that permits reevaluation of the child. If necessary, the parent/caregiver also must be able to obtain medication conveniently.
This option should be limited to otherwise healthy
Comments
Effective analgesia for mild to moderate pain, readily available, mainstay of pain management for AOM
May have limited effectiveness
Additional but brief benefit over acetaminophen in patients ????5 y
Comparable with ametocaine/phenazone drops (Anaesthetic) in patients ????6 y
No controlled studies that directly address pain Effective for moderate or severe pain; requires
prescription; risk of respiratory depression, altered mental status, gastrointestinal upset, and constipation
Requires skill and entails potential risk
children 6 months to 2 years of age with nonsevere illness at presentation and an uncertain diagnosis and to children 2 years of age and older without severe
symptoms at presentation or with an uncertain diag- nosis. In these situations, observation provides an opportunity for the patient to improve without anti-
bacterial treatment. The association of age younger than 2 years with increased risk of failure of watchful waiting and the concern for serious infection
among children younger than 6 months influence the deci- sion for immediate antibacterial therapy. Conse- quently, the panel recommends an age-stratified ap-
proach that incorporates these clinical considerations along with the certainty of diagnosis (Table 4).
Placebo-controlled trials of AOM over the past 30 years have shown consistently that most children do well, without adverse sequelae, even without anti-
bacterial therapy. Between 7 and 20 children must be treated with antibacterial agents for 1 child to derive benefit.34?36 By 24 hours, 61% of children have
de- creased symptoms whether they receive placebo or
TABLE 4. Criteria for Initial Antibacterial-Agent Treatment or Observation in Children With AOM
1454 DIAGNOSIS AND MANAGEMENT OF ACUTE OTITIS MEDIA
Age
????6 mo 6 mo to 2 y
????2 y
Certain Diagnosis
Antibacterial therapy Antibacterial therapy
Antibacterial therapy if severe illness; observation option* if nonsevere illness
Uncertain Diagnosis
Antibacterial therapy Antibacterial therapy if severe illness;
observation option* if nonsevere illness
Observation option*
This table was modified with permission from the New York State Department of Health and the New York Region Otitis Project Committee.32,33 * Observation is
an appropriate option only when follow-up can be ensured and antibacterial agents started if symptoms persist or worsen. Nonsevere illness is mild otalgia
and fever ????39?C in the past 24 hours. Severe illness is moderate to severe otalgia or fever ????39?C. A certain diagnosis of AOM meets all 3 criteria: 1)
rapid onset, 2) signs of MEE, and 3) signs and symptoms of middle-ear inflammation.
antibacterial agents. By 7 days, approximately 75% of children have resolution of symptoms.37 The AHRQ evidence-report meta-analysis showed a 12.3% re-
duction in the clinical failure rate within 2 to 7 days of diagnosis when ampicillin or amoxicillin was pre- scribed, compared with initial use of placebo or
ob- servation (number needed to treat: 8).1
In 1990 the Dutch College of General Practitioners adopted a guideline for the management of AOM that recommended treating symptoms without anti- bacterial
agents for 24 hours (for those 6?24 months old) or 72 hours (for those more than 24 months) and adding antibacterial agents if no improvement is ev- ident at
reassessment. A 1999 revision to this early guideline does not distinguish the younger age group for special consideration.38 Although this guideline has
been widely adopted in The Nether- lands, its use in other countries requires consider- ation of the availability of access to care for follow-up and the
presence of an adult who can adequately monitor the child?s course. Although there are no controlled studies that address the question of whether the Dutch
guideline has resulted in more complications after AOM, van Buchem et al39,136 found that only 2.7% of 4860 Dutch children older than 2 years given only
symptomatic treatment de- veloped severe illness, defined by persistent fever, pain, or discharge after 3 to 4 days. Only 2 children developed mastoiditis.
One case of mastoiditis was present at initial assessment, and the other devel- oped within the first week and resolved promptly with oral antibacterial
agents.
Randomized trials of observation with symptom- atic treatment have been few. A recent randomized trial in general practice in the United Kingdom com- pared
providing immediate antibacterial therapy with delaying antibacterial agents for 72 hours in children aged 6 months to 10 years.40 Seventy-six percent of
children in the delayed-treatment group never required antibacterial agents. Seventy percent of the delayed-antibacterial group were symptomat- ically better
at 3 days, whereas 86% of the immedi- ate-treatment group were better. Immediate use of antibacterial agents was associated with approxi- mately 1-day-
shorter illness and one-half teaspoon a day less acetaminophen consumption but no differ- ence in school absence, pain, or distress scores. Among children
with fever or vomiting on day 1, those receiving immediate antibacterial agents were 21% less likely to have distress on day 3. In children without fever or
vomiting, immediate antibacterial agents decreased distress on day 3 by only 4%.41 This study, however, was limited because of the use of imprecise criteria
for the diagnosis of AOM and the use of low doses of amoxicillin (125 mg, 3 times a day, for 7 days for all patients regardless of weight) in the treatment
group.
The likelihood of recovery without antibacterial therapy differs depending on the severity of signs and symptoms at initial examination. Kaleida et al42
divided patients into severe and nonsevere groups based on degree of fever, a scoring system based on duration and severity of pain or apparent discom- fort,
and estimated parental anxiety. In the nonse-
vere group, initial treatment failure occurred in 3.8% more children who received placebo rather than amoxicillin. In the severe group of children, the ini-
tial failure rate on placebo plus myringotomy was 23.5% versus an initial failure rate of 9.6% on amoxi- cillin alone (a difference of 13.9%).
Several investigators report poorer outcomes in younger children. A greater number of penicillin- resistant strains of pneumococci are isolated in those
younger than 18 months, compared with older chil- dren,43 and are associated with an increased bacteri- ologic failure rate in children younger than 2
years.44?47 The study by Kaleida et al42 also shows a greater initial clinical failure rate (9.8%) in children younger than 2 years than in those older than
2 years (5.5%) who were in the placebo group.
Routine antibacterial therapy for AOM is often cited as the main reason for the decrease in the incidence of mastoiditis in the antibacterial era.48,49 By
the 1950s, mastoiditis (frequent in the pre?anti- bacterial-agent era48) had decreased dramatically. Although some have expressed concern about a pos- sible
resurgence,50,51 such concern is not supported by published data.
The AHRQ evidence report on AOM concluded that mastoiditis is not increased with initial observa- tion, provided that children are followed closely and
antibacterial therapy is initiated in those who do not improve. Pooled data from 6 randomized trials and 2 cohort studies showed comparable rates of mastoid-
itis in children (0.59%) who received initial antibac- terial therapy and children (0.17%) who received placebo or observation (P ???? .212). External
validity might be limited, however, because some trials ex- cluded very young children or those with severe illness.1
Recently published case series of pediatric mas-
toiditis show that acute mastoiditis is most common
in infants and young children and can be the pre-
senting sign of AOM in a patient with no prior
middle-ear disease.50?60 Routine antibacterial ther-
apy of AOM is not an absolute safeguard against
mastoiditis and other complications, because most
cases (36%? 87%) have received prior antibacterial- agent therapy.50,53,57?59,61?63
Van Zuijlen et al64 compared national differences in acute mastoiditis rates from 1991 to 1998 for chil- dren 14 years of age or younger. Incidence rates
were higher in The Netherlands, Norway, and Denmark (in which antibacterial agents are not necessarily given on initial diagnosis of AOM) than in the United
Kingdom, Canada, Australia, and the United States (in which antibacterial agents are prescribed in more than 96% of cases). However, despite initial use of
antibacterial agents more than twice as often in Norway and Denmark than in The Netherlands, mastoiditis rates in all 3 countries were comparable.
Thus current evidence does not suggest a clinically important increased risk of mastoiditis in children when AOM is managed only with initial symptom- atic
treatment without antibacterial agents. Clini- cians should remain aware that antibacterial-agent treatment might mask mastoiditis signs and symp-
AMERICAN ACADEMY OF PEDIATRICS 1455
toms, producing a subtle presentation that can delay diagnosis.56,59,61
Although bacteremia may accompany AOM, par- ticularly in children with a temperature higher than 39?C,65 there is little evidence that routine antibacte-
rial treatment for otitis media prevents bacterial meningitis. In a study of 4860 children with AOM who did not receive antibacterial therapy, no cases of
bacterial meningitis were observed.39 However, in a study involving 240 children between 6 and 24 months of age, 1 child in the placebo group was
subsequently diagnosed as having meningitis.66 In another report, positive blood cultures were equally common in children with bacterial meningitis re-
gardless of whether they received preadmission treatment with antibacterials for AOM (77% and 78%).67 Thus, as with mastoiditis, the incidence of meningitis
in those with AOM is unlikely to be in- fluenced by initial treatment of AOM with antibac- terial agents.
The incidence of invasive pneumococcal disease has decreased since the introduction of the protein- polysaccharide conjugate vaccine (PPV7). There has been a
69% decline in children younger than 2 years between 1998 ?1999 and 2001. The decline in this age group for invasive disease caused by vaccine sero- types
during that period was 78%.68 How this will affect the risk of AOM-associated invasive pneumo- coccal disease is not known yet.
As noted by Dagan and McCracken,69 studies comparing efficacy of different antibacterial agents or placebo compared with antibacterial therapy often have
significant design flaws that may influence the outcome of the studies. Methodologic considerations include enrollment criteria, sample size, diagnostic
criteria, dosing regimens, definition and timing of outcome criteria, age, severity of symptoms, race, immune system, compliance, virulence and resis- tance
of the infecting organism, duration of antibac- terial therapy, and the presence of an underlying respiratory infection. One of the most important is- sues
among the design characteristics of the studies of otitis media is the definition of AOM used in the individual investigations. If studies that evaluate the
impact of antibacterial therapy on the clinical course of children with AOM have weak definitions of AOM (that allow the inclusion of children who are more
likely to have OME than AOM), recipients of placebo will not respond significantly differently from those who receive antibacterial therapy.
Given the sum of the available evidence, clinicians may consider observation with symptomatic treat- ment as an option for initial management of selected
children with AOM. If the ?observation option? is used, the clinician should share with parents/care- givers the degree of diagnostic certainty and con-
sider their preference. The potential of antibacterial therapy at the initial visit to shorten symptoms by 1 day in 5% to 14% of children can be compared
with the avoidance of common antibacterial side effects in 5% to 10% of children, infrequent serious side effects, and the adverse effects of antibacterial
resistance. When considering this option, the clinician should verify the presence of an adult who will reliably
observe the child, recognize signs of serious illness, and be able to provide prompt access to medical care if improvement does not occur. If there is
worsening of illness or if there is no improvement in 48 to 72 hours while a child is under observation, institution of antibacterial therapy should be
considered. Reex- amination may be warranted if discussion with the parents raises concern as to the degree of illness.
Strategies for following children being managed with initial observation include a parent-initiated visit and/or phone contact for worsening condition or no
improvement at 48 to 72 hours, a scheduled follow-up appointment in 48 to 72 hours, routine follow-up phone contact, or use of a safety-net anti- biotic
prescription to be filled if illness does not improve in 48 to 72 hours.70,71 Clinicians should determine the most appropriate strategy for their practice
setting, taking into account the availability and reliability of the reporting parent/caregiver, available office resources, cost to the health care sys- tem
and the family, and the convenience of the fam- ily. An assessment of the potential risk of inappro- priate use of an antibacterial agent in a patient who
may be worsening or may have a condition other than AOM must also be made. Table 5 summarizes the data on initial observation versus initial antibac-
terial-agent treatment of AOM.
RECOMMENDATION 3B
If a decision is made to treat with an antibacterial agent, the clinician should prescribe amoxicillin for most chil- dren. (This recommendation is based on
randomized, clin- ical trials with limitations and a preponderance of benefit over risk.)
When amoxicillin is used, the dose should be 80 to 90 mg/kg per day. (This option is based on extrapolation from microbiologic studies and expert opinion,
with a prepon- derance of benefit over risk.)
If a decision is made to treat with antibacterial agents, there are numerous medications that are clin- ically effective. The choice of first-line treatment
should be based on the anticipated clinical response as well as the microbiologic flora likely to be present. The justification to use amoxicillin as first-
line ther- apy in most patients with AOM relates to its general effectiveness when used in sufficient doses against susceptible and intermediate resistant
pneumococci as well as its safety, low cost, acceptable taste, and narrow microbiologic spectrum.75
In patients who have severe illness (moderate to severe otalgia or fever of 39?C or higher42) and in those for whom additional coverage for ????-lactamase?
positive Haemophilus influenzae and Moraxella ca- tarrhalis is desired, therapy should be initiated with high-dose amoxicillin-clavulanate (90 mg/kg per day
of amoxicillin component, with 6.4 mg/kg per day of clavulanate in 2 divided doses).76 This dose has sufficient potassium clavulanate to inhibit all ????-
lactamase?producing H influenzae and M ca- tarrhalis.
Many clinical studies comparing the effectiveness of various antibacterial agents in the treatment of AOM do not carefully define standard criteria for
diagnosis of AOM at entry or for improvement or
1456 DIAGNOSIS AND MANAGEMENT OF ACUTE OTITIS MEDIA
TABLE 5. Comparative AOM Outcomes for Initial Observation Versus Antibacterial Agent*
AOM Outcome
Symptomatic relief at 24 hours37,72 Symptomatic relief at 2?3 days72 Symptomatic relief at 4?7 days72 Clinical resolution at 7?14 days72 Pain duration, mean
days73 Crying duration, mean days73 Analgesic use, mean doses66
Fever duration, median days66 Incidence of mastoiditis or suppurative
complications1 Persistent MEE at 4?6 weeks72 Persistent MEE at 3 months72 Antibacterial-agent?induced diarrhea or
vomiting74 Antibacterial-agent?induced skin rash74
* NS indicates not significant.
cure at follow-up.69 Another way to measure the outcome of treatment of AOM with various antibac- terial agents is to assess bacteriologic efficacy. Al-
though this does not provide a one-to-one correlation with clinical effectiveness, there is a definite concor- dance between the two.77?79 Children who
experi- ence a bacteriologic cure improve more rapidly and more often than children who experience bacterio- logic failure. Carlin et al79 showed an 86%
agreement between clinical and bacteriologic response. Dagan et al77 showed that 91% of clinical failures at or before day 10 were culture-positive at days 4
to 5. If we use bacteriologic cure as a surrogate for clinical efficacy, there is strong evidence that drugs that achieve antibacterial concentrations that
are able to eradicate pathogens from the middle-ear fluid are the preferred selection.80,81
Numerous studies have shown that the common
pathogens in AOM are Streptococcus pneumoniae,
nontypeable H influenzae, and M catarrhalis.82,83 S
pneumoniae has been recovered from the middle-ear
fluid of approximately 25% to 50% of children with
AOM, H influenzae from 15% to 30%, and M catarrha-
lis from approximately 3% to 20%.83 There is some
evidence that the microbiology of AOM may be
changing as a result of routine use of the heptavalent
pneumococcal vaccine. Block et al84 showed an in-
crease in H Influenzae from 39% to 52% of isolates in
children 7 to 24 months of age with AOM and a
decrease in S pneumoniae from 49% to 34% between
1992?1998 and 2000 ?2003. Viruses, including respi-
ratory syncytial virus, rhinovirus, coronavirus, para-
influenza, adenovirus, and enterovirus, have been
found in respiratory secretions and/or MEE in 40%
to 75% of AOM cases and in MEE without bacteria in
5% to 22% of cases and may be responsible for many
cases of apparent antibacterial agent ?failure.? In
approximately 16% to 25% of cases of AOM, no
bacterial or viral pathogen can be detected in MEE.19,85,86
Currently approximately 50% of isolates of H in- fluenzae and 100% of M catarrhalis derived from the upper respiratory tract are likely to be ????-lactamase?
positive nationwide.87 Between 15% and 50% (aver-
Initial Initial Antibacterial Observation
Therapy
60% 59% 91% 87% 79% 71% 82% 72%
2.8 3.3 0.5 1.4 2.3 4.1 2.0 3.0 0.59% 0.17%
P Value
NS NS NS NS NS ????.001
.004 .004
NS
45% 48% NS 21% 26% NS 16% ??
2% ??
age: 30%) of upper respiratory tract isolates of S pneumoniae are also not susceptible to penicillin; approximately 50% of these are highly resistant to
penicillin (minimum inhibitory concentration: 2.0 ????g/mL or higher), and the remaining 50% are inter- mediate in resistance (minimum inhibitory concen-
tration: between 0.1 and 1.0 ????g/mL).88?91 The mech- anism of penicillin resistance among isolates of S pneumoniae is not associated with ????-lactamase
pro- duction but rather an alteration of penicillin-binding proteins. This phenomenon, which varies consider- ably according to geographic location, results
in re- sistance to penicillins and cephalosporins.
Data from early studies of patients with AOM show that 19% of children with S pneumoniae and 48% with H influenzae cultured on initial tympano- centesis who
were not treated with antibacterial agents cleared the bacteria at the time of a second tympanocentesis 2 to 7 days later.92 Estimates are that approximately
75% of children infected with M catarrhalis also experience bacteriologic cure, based on resolution after treatment with an antibacterial agent to which it
is not susceptible (amoxicillin).93,94 Only S pneumoniae that are highly resistant to peni- cillin will not respond to conventional doses of amoxicillin.95
Accordingly, approximately 80% of children with AOM will respond to treatment with high-dose amoxicillin, including many caused by re- sistant pneumococci.
The higher dose will yield mid- dle-ear fluid levels that exceed the minimum inhibi- tory concentration of all S pneumoniae that are intermediate in
resistance to penicillin and many, but not all, highly resistant S pneumoniae.76 Risk factors for the presence of bacterial species likely to be re- sistant
to amoxicillin include attendance at child care, recent receipt (less than 30 days) of antibacterial treatment, and age younger than 2 years.96,97
If the patient is allergic to amoxicillin and the allergic reaction was not a type I hypersensitivity reaction (urticaria or anaphylaxis), cefdinir (14 mg/kg
per day in 1 or 2 doses), cefpodoxime (10 mg/kg per day, once daily), or cefuroxime (30 mg/kg per day in 2 divided doses) can be used. In cases of type I
reactions, azithromycin (10 mg/kg per
AMERICAN ACADEMY OF PEDIATRICS 1457
day on day 1 followed by 5 mg/kg per day for 4 days as a single daily dose) or clarithromycin (15 mg/kg per day in 2 divided doses) can be used in an effort
to select an antibacterial agent of an entirely different class. Other possibilities include erythromycin-sul- fisoxazole (50 mg/kg per day of erythromycin)
or sulfamethoxazole-trimethoprim (6 ?10 mg/kg per day of trimethoprim). Alternative therapy in the pen- icillin-allergic patient who is being treated for
infec- tion that is known or presumed to be caused by penicillin-resistant S pneumoniae is clindamycin at 30 to 40 mg/kg per day in 3 divided doses. In the
patient who is vomiting or cannot otherwise tolerate oral medication, a single dose of parenteral ceftriax- one (50 mg/kg) has been shown to be effective for
the initial treatment of AOM.98,99
The optimal duration of therapy for patients with AOM is uncertain. Studies comparing standard du- ration of treatment (10 days) to short-duration treat-
ment (1?7 days) were often characterized by limita- tions including inadequate sample size (therefore having low or limited statistical power), few or no
children younger than 2 years, exclusion of otitis- prone children, lack of standardized or stringent cri- teria for the diagnosis of AOM or for improvement
or cure, use of an antibacterial medication that had less than optimal efficacy against common middle- ear pathogens, use of lower than recommended dos- age
of a medication, and lack of analysis of outcome by age.100 Not surprisingly, the results of these stud- ies were variable. Several more recent studies have
been reported that addressed the issue of duration of therapy.101?105 The results favoring standard 10-day therapy have been most significant in children
younger than 2 years and suggestive of increased efficacy in those 2 to 5 years of age. Thus, for younger children and for children with severe disease, a
stan- dard 10-day course is recommended.106 For children 6 years of age and older with mild to moderate disease, a 5- to 7-day course is appropriate.
RECOMMENDATION 4
If the patient fails to respond to the initial management option within 48 to 72 hours, the clinician must reassess the patient to confirm AOM and exclude
other causes of illness. If AOM is confirmed in the patient initially man- aged with observation, the clinician should begin antibac- terial therapy. If the
patient was initially managed with an antibacterial agent, the clinician should change the anti- bacterial agent. (This recommendation is based on obser-
vational studies and a preponderance of benefit over risk.)
When antibacterial agents are prescribed for AOM, the time course of clinical response should be 48 to 72 hours. With few exceptions, the first 24 hours of
therapy are characterized by a stabilization of the clinical condition. Early during this period the pa- tient may actually worsen slightly. In the second 24
hours, the patient should begin to improve. If ini- tially febrile, the patient is expected to defervesce within 48 to 72 hours. Irritability should improve,
and sleeping and eating patterns should begin to normalize.37 If the patient is not improved by 48 to 72 hours, either another disease is present or the
ther- apy that has been chosen was not adequate. When
observation has been the chosen management and spontaneous improvement has not been noted by 48 to 72 hours, antibacterial therapy is indicated to limit the
duration of further illness.
The patient should be given clear instructions at the initial visit as to when and how to communicate continuation or worsening of signs and symptoms to the
clinician to expedite a change in treatment.
Antibacterial-agent choice after initial failure of observation or first-line antibacterial therapy should be based on the likely pathogen(s) present and on
clinical experience. If the patient was treated with initial observation, amoxicillin should be started at a dose of 80 to 90 mg/kg per day. For patients who
have severe illness (moderate to severe otalgia or temperature of 39?C or higher42), in those for whom additional coverage for ????-lactamase?positive H
influ- enzae and M catarrhalis is desired, and for those who had been treated initially with amoxicillin and did not improve, high-dose amoxicillin-
clavulanate (90 mg/kg per day of amoxicillin component, with 6.4 mg/kg per day of clavulanate in 2 divided doses)76 should be used. Alternatives in patients
with a his- tory of a non?type I allergic reaction to penicillins are cefdinir, cefpodoxime, or cefuroxime.88 In cases of type I reactions, alternatives are
azithromycin, clar- ithromycin, erythromycin-sulfisoxazole, or sulfame- thoxazole-trimethoprim. Ceftriaxone (50 mg/kg per day), given for 3 consecutive days
either intrave- nously or intramuscularly, can be used in children with vomiting or in other situations that preclude administration of oral antibacterial
agents. In the treatment of AOM unresponsive to initial antibacte- rial therapy, a 3-day course of ceftriaxone has been shown to be better than a 1-day
regimen.99 Although trimethoprim-sulfamethoxazole and erythromycin- sulfisoxazole have traditionally been useful as first- and second-line therapy for
patients with AOM, re- cent pneumococcal surveillance studies indicate that resistance to these 2 combination agents is substan- tial.90,95 Therefore, when
patients fail to improve while receiving amoxicillin, neither trimethoprim- sulfamethoxazole107 nor erythromycin-sulfisoxazole is optimal for antibacterial
therapy.
A patient who fails amoxicillin-potassium clavu- lanate should be treated with a 3-day course of par- enteral ceftriaxone because of its superior efficacy
against S pneumoniae, compared with alternative oral antibacterials.91,99 If AOM persists, tympanocentesis should be recommended to make a bacteriologic di-
agnosis. If tympanocentesis is not available, a course of clindamycin may be considered for the rare case of penicillin-resistant pneumococcal infection not
re- sponding to the previous regimens. If the patient still does not improve, tympanocentesis with Gram-stain, culture, and antibacterial-agent sensitivity
studies of the fluid is essential to guide additional therapy. Table 6 summarizes antibacterial options.
Once the patient has shown clinical improvement, follow-up is based on the usual clinical course of AOM. Persistent MEE after resolution of acute symp- toms
is common and should not be viewed as a need for active therapy. Two weeks after an episode of AOM, 60% to 70% of children have MEE, decreasing
1458 DIAGNOSIS AND MANAGEMENT OF ACUTE OTITIS MEDIA
to 40% at 1 month and 10% to 25% after 3 months.37(161?162) OME must be differentiated clini- cally from AOM and requires additional monitoring but not
antibacterial therapy. Assurance that OME resolves is particularly important for children with cognitive or developmental delays that may be im- pacted
adversely by transient hearing loss associated with MEE.
RECOMMENDATION 5
Clinicians should encourage the prevention of AOM through reduction of risk factors. (This recommendation is based on strong observational studies and a
preponderance of benefits over risks.)
A number of factors associated with early or re- current AOM are not amenable to change, for exam- ple, genetic predisposition, premature birth, male gender,
Native American/Inuit ethnicity, family his- tory of recurrent otitis media, presence of siblings in the household, and low socioeconomic status.108?113
During infancy and early childhood, reducing the
incidence of respiratory tract infections by altering
child care center attendance patterns can reduce the
incidence of recurrent AOM significantly.108,114 The
implementation of breastfeeding for at least the first
6 months also seems to be helpful against the devel-
opment of early episodes of AOM.108,109 Avoiding
supine bottle feeding (?bottle propping?),115 reduc-
ing or eliminating pacifier use in the second 6
months of life,116 and eliminating exposure to pas-
sive tobacco smoke117,118 have been postulated to
reduce the incidence of AOM in infancy; how-
ever, the utility of these interventions is un- clear.108,109,114,119,120
Immunoprophylaxis with killed121 and live-atten- uated intranasal122 influenza vaccines has demon- strated more than 30% efficacy in prevention of AOM during
the respiratory illness season. Most of the children in these studies were older than 2 years. A controlled study among infants and toddlers 6 to 23 months
of age failed to demonstrate any efficacy of killed vaccine in preventing AOM.123 Pneumococ- cal conjugate vaccines have proven effective in pre- venting
vaccine-serotype pneumococcal otitis media, but their overall benefit is small, with only a 6% reduction in the incidence of AOM.124?126 Medical office
visits for otitis were reduced by 7.8% and antibiotic prescriptions by 5.7% in a large clinical practice after introduction of the pneumococcal con- jugate
vaccine.127 Respiratory syncytial virus, para- influenza virus, and adenovirus vaccines currently under development hold additional promise for pre- vention
of ear infections.
RECOMMENDATION 6
No recommendations for complementary and alterna- tive medicine (CAM) for treatment of AOM are made based on limited and controversial data.
Increasing numbers of parents/caregivers are us- ing various forms of nonconventional treatment for their children.128,129 The types of treatments used can
differ depending on the ethnic background and be- lief system of the family and the availability of alter- native medicine in a particular community. Treat-
AMERICAN ACADEMY OF PEDIATRICS 1459
TABLE 6. Recommended Antibacterial Agents for Patients Who Are Being Treated Initially With Antibacterial Agents or Have Failed 48 to 72 Hours of Observation
or Initial Management With Antibacterial Agents
Temperature ???? 39?C and/or Severe Otalgia
No
Yes
At Diagnosis for Patients Being Treated Initially With Antibacterial Agents
Clinically Defined Treatment Failure at 48?72 Hours After Initial Management With Observation Option
Clinically Defined Treatment Failure at 48?72 Hours After Initial Management With Antibacterial Agents
Recommended
Amoxicillin, 80?90 mg/ kg per day
Amoxicillin-clavulanate, 90 mg/kg per day of amoxicillin, with 6.4 mg/kg per day of clavulanate
Alternative for Penicillin Allergy
Non-type I: cefdinir, cefuroxime, cefpodoxime; type I: azithromycin, clarithromycin
Ceftriaxone, 1 or 3 days
Recommended
Amoxicillin, 80?90 mg/kg per day
Amoxicillin, clavulanate, 90 mg/kg per day of amoxicillin, with 6.4 mg/kg per day of clavulanate
Alternative for Penicillin Allergy
Non-type I: cefdinir, cefuroxime, cefpodoxime; type I: azithromycin, clarithromycin
Ceftriaxone, 1 or 3 days
Recommended
Amoxicillin-clavulanate, 90 mg/kg per day of amoxicillin component, with 6.4 mg/kg per day of clavulanate
Ceftriaxone, 3 days
Alternative for Penicillin Allergy
Non-type I: ceftriaxone, 3 days; type I: clindamycin
Tympanocentesis, clindamycin
Fig 1. Management of AOM.
ments that have been used for AOM include homeopathy, acupuncture, herbal remedies, chiro- practic treatments, and nutritional supplements.130 Many
physicians ask parents, caregivers, or older
children if they are using medicines, supplements, or other means to maintain health or treat specific con- ditions;131 however, parents/caregivers are often
re- luctant to tell their physicians that they are using
1460 DIAGNOSIS AND MANAGEMENT OF ACUTE OTITIS MEDIA
complementary or alternative treatments.132 Al- though most treatments are harmless, some are not. Some treatments can have a direct and dangerous effect,
whereas others may interfere with the effects of conventional treatments.30 Clinicians should be- come more informed about CAM, ask whether they are being
used, and be ready to discuss potential benefits or risks.133
To date there are no studies that conclusively show a beneficial effect of alternative therapies used for AOM. Recent interest in the use of CAM has led to
research efforts to investigate its efficacy.134 It is dif- ficult to design and conduct studies on certain forms of CAM because of the unique nature of the
treat- ment.135 Any study conducted will need to show proof of effectiveness of a specific therapy when compared with the natural history of AOM. Conclu-
sions regarding CAM cannot be made until research evidence is available.
FUTURE RESEARCH
Despite the voluminous literature about AOM, there still are many opportunities for future research to continue to clarify the accurate diagnosis and most
effective management of this common condition. Most important is that future studies address con- cerns regarding the quality and applicability of many
studies in AOM.21,69,78,100 Future studies should use standardized criteria for diagnosis, outcome, and se- verity of illness; increase sample size, which in
gen- eral has been too limited to identify small but signif- icant differences in clinical outcome; include children younger than 2 years and older than 12
years; use
doses of medication shown to achieve adequate lev- els in the middle ear to treat the target organisms successfully; and stratify outcomes by age and sever-
ity of illness. In addition, studies done in limited geographic areas must be replicated in other areas to ensure generalizability.
Some of the studies that should be considered include:
? Additional validation of standard definitions of AOM
? New or improved technologies for objective diag- nosis of MEE
? Efficacy of education programs to improve clini- cian diagnostic skills
? Additionalstudiesonpainmanagementincluding topical agents, CAM, and role of tympanocente- sis/myringotomy in pain management
? Large population-based studies on the benefits and risks of the ?observation option? looking at antibacterial use; bacterial resistance; incidence of
adverse events; long-term effects on hearing; per- sistence of MEE; and parent, patient, and clinician satisfaction
? Continued development of new antibacterial agents to address potential changes in resistance patterns of organisms responsible for AOM (stud- ies on new
agents must be appropriately designed and have adequate sample size to show clinical efficacy equal to or better than current agents)
? Randomized, controlled trials on duration of treat- ment in all age groups
Fig 1. Continued.
AMERICAN ACADEMY OF PEDIATRICS 1461
? Vaccine research directed at more of the causative organisms of AOM
? Additional studies on potential measures to pre- vent AOM
SUMMARY
This clinical practice guideline provides evidence- based recommendations for the definition and man- agement of AOM in children from 2 months through 12
years of age without signs or symptoms of sys- temic illness unrelated to the middle ear. It empha- sizes accurate diagnosis and adherence to a consis- tent
definition of AOM. Management of the pain associated with AOM is identified as an essential aspect of care. An option to observe a select group of children
with AOM with symptomatic therapy for 48 to 72 hours is supported by evidence and may po- tentially lead to decreased use of antibacterial agents. If a
decision is made to treat with an antibacterial agent, amoxicillin at a dose of 80 to 90 mg/kg per day is recommended as the initial antibacterial agent of
choice for most children. Additional guidance is given for choosing an antibacterial agent when an alternative to amoxicillin is indicated. Also ad- dressed
is evidence related to the prevention of AOM and the role of CAM in the treatment of AOM. The recommendations are summarized in Fig. 1.
CONCLUSIONS
1. Recommendation: To diagnose AOM the clinician should confirm a history of acute onset, identify signs of MEE, and evaluate for the presence of signs and
symptoms of middle-ear inflammation.
2. Strong recommendation: The management of AOM should include an assessment of pain. If pain is present, the clinician should recommend treatment to reduce
pain.
3A. Option: Observation without use of antibacterial agents in a child with uncomplicated AOM is an option for selected children based on diagnostic
certainty, age, illness severity, and assurance of follow-up.
3B. Recommendation: If a decision is made to treat with an antibacterial agent, the clinician should prescribe amoxicillin for most children.
Option: When amoxicillin is used, the dose should be 80 to 90 mg/kg per day.
4. Recommendation: If the patient fails to respond to the initial management option within 48 to 72 hours, the clinician must reassess the patient to confirm
AOM and exclude other causes of illness. If AOM is confirmed in the patient initially man- aged with observation, the clinician should begin antibacterial
therapy. If the patient was initially managed with an antibacterial agent, the clinician should change the antibacterial agent.
5. Recommendation: Clinicians should encourage the prevention of AOM through reduction of risk factors.
6. No recommendation: There is insufficient evi- dence to make a recommendation regarding the use of CAM for AOM.
Subcommittee on Management of Acute Otitis Media
Allan S. Lieberthal, MD, Cochairperson Theodore G. Ganiats, MD, Cochairperson Edward O. Cox, MD Larry Culpepper, MD, MPH
Martin Mahoney, MD, PhD Donald Miller, MD, MPH Desmond K. Runyan, MD, DrPH Nina Lisbeth Shapiro, MD
Ellen Wald, MD*
Liaisons
Richard Besser, MD Centers for Disease Control and Prevention
Ellen Friedman, MD American Academy of Otolaryngology-Head and Neck Surgery
Norman Wendell Todd, MD American Academy of Otolaryngology-Head and Neck Surgery
Consultants
S. Michael Marcy, MD Richard M. Rosenfeld, MD, MPH Richard Shiffman, MD
Staff
Maureen Hannley, PhD Carla Herrerias, MPH Bellinda Schoof, MHA, CPHQ
*Dr Ellen Wald withdrew from the Subcommittee on Management of Acute Otitis Media before publication of this guideline.
1462 DIAGNOSIS AND MANAGEMENT OF ACUTE OTITIS
MEDIA
1.
2. 3. 4. 5.
6. 7. 8. 9.
10.
11. 12. 13.
14.
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AMERICAN ACADEMY OF PEDIATRICS 1465
TASK 3:
SUBDOMAIN 724.8 – EVIDENCE-BASED PRACTICE & APPLIED NURSING RESEARCH
Competency 724.8.3: Research Integration – The graduate recognizes the significance of applying research in evidence-based practice, recognizes sources of
evidence, and applies ethical principles to evidence-based practice research. Competency 724.8.4: Outcome Evaluation – The graduate recognizes barriers to
evidence-based practice and applies an evidence-based framework to promote safe and reliable healthcare.
Objectives: 724.8.3-06: Identify strategies for overcoming barriers to adopting an evidence-based practice for a given nursing situation. 724.8.4-01: Apply
evidence-based research to guide implementation of a given quality improvement process. 724.8.4-02: Identify barriers to evidence-based practice in a given
process or situation. 724.8.4-03: Recognize why a systematic review can provide a strong evidential foundation for clinical decision making in a given
situation. 724.8.4-04: Discuss the difficulties of translating from research to practice. 724.8.4-05: Determine how to involve key stakeholders in obtaining
staff compliance with an evidence-based practice change in a given situation.
Introduction:
As a nurse in a leadership role, you and some of your colleagues have begun to question one of the routine nursing admission/assessment or patient
care/preparation procedures that are conducted. You wonder whether the procedure has a basis in research. In order to improve quality of care, you decide to
undertake an evidence-based project to determine the basis for the procedure, any suggested changes, and possible barriers to implementation of a revised
clinical practice guideline.
Task:
A. Select a nursing admission/assessment or patient care/preparation procedure (e.g., routine shaving of the surgical site) that you would commonly find in
your practice setting. 1. Describe the process or procedure, and then, include reasons/supporting evidence
why this needs to be changed. 2. Based on your initial investigation of the situation, do the following:
Note: You will need to ask workplace personnel. Also note it is not sufficient to say there was not a process in place before your change. You must have a
process to change.
a. Explain who determined the basis for the practice. b. Explain the decision makers? rationale for instituting or supporting the current
procedure or practice. c. Explain why the decision makers decided to implement the practice or procedure.
3a. Gather and list five relevant and credible sources (less than five years old) to support your suggested practice change for the procedure you have chosen
Note: Credible sources are less than five years old and may include professionaljournals, research reports, professional Web sites, governmental reports,
current texts less than five years old, and presentations from professional meetings.
4. Explain the clinical implications your suggested change might have on patients, based on the relevant and credible sources you identified in part A3a.
5. Explain the implications your suggested change might have on the practice setting, based on the relevant and credible sources you identified in part A3a.
6. Discuss how you would involve key stakeholders in the decision to change the procedure or comply with a proposed change.
B. Write an essay in which you do the following: 1. Discuss specific difficulties you may encounter in applying the research to practices
and procedures in your practice setting.
Note: You should distinguish between difficulties you would have interpreting what the research says and synthesizing it into a practice guideline or
procedure, rather than just the outside barriers to change.
2. Discuss the specific barriers you could encounter in attempting to institute a change in procedure in your practice setting.
3. Identify at least two strategies that you and your team could use to overcome these barriers you identified.
4. Explain how you would implement your new process or procedure based on the research findings.
C. When you use sources, include all in-text citations and references in APA format.
Note: For definitions of terms commonly used in the rubric, see the attached Rubric Terms.
Note: When using sources to support ideas and elements in a paper or project, the submission MUST include APA formatted in-text citations with a
corresponding reference list for any direct quotes or paraphrasing. It is not necessary to list sources that were consulted if they have not been quoted or
paraphrased in the text of the paper or project.
Note: No more than a combined total of 30% of a submission can be directly quoted or closely paraphrased from sources, even if cited correctly. For tips on
using APA style, please refer to the APA Handout web link included in the General Instructions section.

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