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Management of Acute Otitis Media after Publication of the 2004 AAP and AAFP Clinical Practice Guideline

Authors:
  • Penn Medicine/Lancaster General Hospital

Abstract and Figures

Observation without initial antibiotic therapy was accepted as an option for acute otitis media (AOM) management in the 2004 American Academy of Pediatrics and American Academy of Family Physicians clinical practice guideline. The guideline also recommended amoxicillin as the first-line treatment for most children, and analgesic treatment to reduce pain if it was present. Our objective was to compare the management of AOM after publication of the 2004 guideline. We analyzed the National Ambulatory Medical Care Survey, 2002-2006 (N = 1114), which occurred in US physicians' offices. The patients were children aged 6 months to 12 years who were diagnosed with AOM. The time comparisons were the 30-month periods before and after the guideline. The main outcome was the encounter rate at which no antibiotic-prescribing was reported. Secondary outcomes were the identification of factors associated with encounters at which no antibiotic-prescribing was reported and antibiotic- and analgesic-prescribing rates. The rate of AOM encounters at which no antibiotic-prescribing was reported did not change after guideline publication (11%-16%; P = .103). Independent predictors of an encounter at which no antibiotic-prescribing was reported were the absence of ear pain, absence of reported fever, and receipt of an analgesic prescription. After guideline publication, the rate of amoxicillin-prescribing increased (40%-49%; P = .039), the rate of amoxicillin/clavulanate-prescribing decreased (23%-16%; P = .043), the rate of cefdinir-prescribing increased (7%-14%; P = .004), and the rate of analgesic-prescribing increased (14%-24%; P = .038). Although management of AOM without antibiotics has not increased after the publication of the 2004 American Academy of Pediatrics and American Academy of Family Physicians clinical practice guideline, children who did not receive antibiotics were more likely to have mild infections. In accordance with the guideline, the prescribing of amoxicillin and analgesics has increased. Contrary to the guideline, the prescribing of amoxicillin/clavulanate has decreased, whereas the prescribing of cefdinir has increased.
Content may be subject to copyright.
DOI: 10.1542/peds.2009-1115
; originally published online January 25, 2010; 2010;125;214Pediatrics
Andrew Coco, Louis Vernacchio, Michael Horst and Angela Anderson
Clinical Practice Guideline
Management of Acute Otitis Media After Publication of the 2004 AAP and AAFP
http://pediatrics.aappublications.org/content/125/2/214.full.html
located on the World Wide Web at:
The online version of this article, along with updated information and services, is
of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.
Boulevard, Elk Grove Village, Illinois, 60007. Copyright © 2010 by the American Academy
published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point
publication, it has been published continuously since 1948. PEDIATRICS is owned,
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Management of Acute Otitis Media After Publication of
the 2004 AAP and AAFP Clinical Practice Guideline
WHAT’S KNOWN ON THIS SUBJECT: The 2004 AAP and AAFP
clinical practice guideline on AOM allowed for observation of the
patient without initial antibiotic therapy, recommended
amoxicillin as the first-line antibiotic treatment, and
recommended treatment to reduce pain if it was present.
WHAT THIS STUDY ADDS: The management of AOM without
antibiotics has not increased after publication of the 2004
guideline. Children who did not receive antibiotics were more
likely to have mild infections. The prescribing of amoxicillin and
analgesic agents has increased after publication of the guideline.
abstract
OBJECTIVES: Observation without initial antibiotic therapy was ac-
cepted as an option for acute otitis media (AOM) management in the
2004 American Academy of Pediatrics and American Academy of Family
Physicians clinical practice guideline. The guideline also recom-
mended amoxicillin as the first-line treatment for most children, and
analgesic treatment to reduce pain if it was present. Our objective was
to compare the management of AOM after publication of the 2004
guideline.
PATIENTS AND METHODS: We analyzed the National Ambulatory Medi-
cal Care Survey, 2002–2006 (N1114), which occurred in US physi-
cians’ offices. The patients were children aged 6 months to 12 years
who were diagnosed with AOM. The time comparisons were the 30-
month periods before and after the guideline. The main outcome was
the encounter rate at which no antibiotic-prescribing was reported.
Secondary outcomes were the identification of factors associated with
encounters at which no antibiotic-prescribing was reported and
antibiotic- and analgesic-prescribing rates.
RESULTS: The rate of AOM encounters at which no antibiotic-
prescribing was reported did not change after guideline publication
(11%–16%; P.103). Independent predictors of an encounter at which
no antibiotic-prescribing was reported were the absence of ear pain,
absence of reported fever, and receipt of an analgesic prescription. Af-
ter guideline publication, the rate of amoxicillin-prescribing increased
(40%– 49%; P.039), the rate of amoxicillin/clavulanate-prescribing
decreased (23%–16%; P.043), the rate of cefdinir-prescribing in-
creased (7%–14%; P.004), and the rate of analgesic-prescribing
increased (14%–24%; P.038).
CONCLUSIONS: Although management of AOM without antibiotics has
not increased after the publication of the 2004 American Academy of
Pediatrics and American Academy of Family Physicians clinical prac-
tice guideline, children who did not receive antibiotics were more likely
to have mild infections. In accordance with the guideline, the prescrib-
ing of amoxicillin and analgesics has increased. Contrary to the guide-
line, the prescribing of amoxicillin/clavulanate has decreased,
whereas the prescribing of cefdinir has increased. Pediatrics 2010;
125:214–220
AUTHORS: Andrew Coco, MD, MS,
a
Louis Vernacchio, MD,
MSc,
b,c
Michael Horst, PhD,
a
and Angela Anderson
a
a
Lancaster General Research Institute, Lancaster, Pennsylvania;
b
Pediatric Physicians’ Organization at Children’s, Brookline,
Massachusetts; and
c
Division of General Pediatrics, Children’s
Hospital Boston, Boston, Massachusetts
KEY WORDS
acute otitis media, antibiotics, practice guidelines
ABBREVIATIONS
AOM—acute otitis media
AAP—American Academy of Pediatrics
AAFP—American Academy of Family Physicians
NAMCS—National Ambulatory Medical Care Survey
NCHS—National Center for Health Statistics
PCV—pneumococcal conjugate vaccine
CDC—Centers for Disease Control and Prevention
ICD-9-CM—International Classification of Diseases, 9th Revision,
Clinical Modification
CI— confidence interval
OR— odd ratio
www.pediatrics.org/cgi/doi/10.1542/peds.2009-1115
doi:10.1542/peds.2009-1115
Accepted for publication Aug 3, 2009
Address correspondence to Andrew Coco, MD, MS, Lancaster
General Hospital, Lancaster General Research Institute, 555 N
Duke St, Lancaster, PA 17604. E-mail:
ascoco@lancastergeneral.org
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
Copyright © 2010 by the American Academy of Pediatrics
FINANCIAL DISCLOSURE: The authors have indicated they have
no financial relationships relevant to this article to disclose.
214 COCO et al by guest on June 11, 2013pediatrics.aappublications.orgDownloaded from
Acute otitis media (AOM) is one of the
most common diseases of childhood,
affecting more than 80% of children by
the age of 5 years. Essentially all diag-
nosed episodes of AOM in the United
States have been historically treated
with antibiotics, making it by far the
most common condition for which an-
tibacterial agents are prescribed for
US children.1However, in other devel-
oped countries, most notably the Neth-
erlands, antibiotics are not routinely
prescribed for uncomplicated AOM,
and this approach has also been gain-
ing interest in the United States.2–4 Fur-
thermore, antibiotic choices are not
always straightforward, because clini-
cians need to be concerned about in-
creased resistance among many of the
pathogens that cause AOM.5–7
In May 2004, the American Academy of
Pediatrics (AAP) and the American
Academy of Family Physicians (AAFP)
jointly issued a well-publicized clinical
practice guideline on the management
of AOM in children aged 6 months
through 12 years.8The guideline en-
dorsed an observation option in se-
lected children with AOM on the basis
of their age, severity of symptoms, and
certainty of diagnosis and made spe-
cific antibiotic recommendations on
the basis of illness severity and treat-
ment response. In addition, the guide-
line also made a strong recommenda-
tion that the management of AOM
should include an assessment of pain
and the appropriate analgesic treat-
ment if pain is present.
A recent survey of physicians in a na-
tional pediatric practice-based re-
search network compared AOM man-
agement before and after publication
of the 2004 guideline.9The responses
indicated that most primary care phy-
sicians agreed with the concept of an
observation option, although they in-
frequently chose it, and the accep-
tance rate decreased slightly 2 years
after the guideline was published. The
survey authors also concluded that an-
tibiotic choices for AOM differed mark-
edly from the guideline’s recommen-
dations, and the difference has
increased since 2004. There are no
data from actual comparisons of
the rate of initial observation and
antibiotic-prescribing choices after
guideline implementation. Data on com-
parative analgesic-prescribing rates are
also lacking.
To measure changes in the rate of
encounters managed without antibi-
otics and changes in patterns of an-
tibiotics and analgesic agents pre-
scribed for AOM after publication of
the 2004 AAP/AAFP clinical practice
guideline, “Diagnosis and Manage-
ment of Acute Otitis Media,” we ana-
lyzed data from the National Ambula-
tory Medical Care Survey (NAMCS)
from 2002 to 2006.
METHODS
Study Design and Administration
The NAMCS is administered by the Na-
tional Center for Health Statistics
(NCHS) for the Centers for Disease
Control and Prevention (CDC). The sur-
vey was designed to meet the need for
objective, reliable information about
ambulatory medical care services in
the United States. The NAMCS collects
information on patient visits to nonfed-
erally employed, office-based physi-
cians in the United States. The survey
sample includes physicians who are
considered to be within the survey
scope and who work in federally qual-
ified health centers and other govern-
ment clinics. The NAMCS has a 3-tiered
design that includes geographic loca-
tion, physician specialty, and individ-
ual patient visits within the practice.
The NCHS weights each visit by taking
into account the location and specialty.
Physicians are randomly selected
from national databases compiled by
the American Medical Association and
the American Osteopathic Association.
Each selected physician is randomly
assigned to a 1-week reporting period.
During this period, the physicians or
the office staff record data for a sys-
tematic random sample of visits on a
standardized encounter form, which is
provided for that purpose and checked
for completeness by the field staff. The
goal is for physicians included in the
sample to complete 30 records per
sampling week.
Study Sample: Episodes of Care for
AOM
Up to 3 diagnoses were recorded for
each visit as free text. The survey
staff then coded the diagnoses by us-
ing the International Classification of
Diseases, 9th Revision, Clinical Mod-
ification (ICD-9-CM).10 Our analysis in-
cluded patient visits with ICD-9-CM
diagnoses of acute suppurative otitis
media (ICD-9-CM 382.0), unspecified
suppurative otitis media (ICD-9-CM
382.4), and unspecified otitis media
(ICD-9-CM 382.9). Patient visits with a
diagnosis of nonsuppurative otitis media
(ICD-9-CM 381–381.4) were not included,
because the AOM clinical practice guide-
line did not address this condition. Pa-
tient visits with an alternative diagnosis
that may have justified an antibiotic pre-
scription were excluded, which included
visits with a diagnosis of acute sinusitis
(ICD-9-CM 461), chronic sinusitis (ICD-
9-CM 473), acute pharyngitis (ICD-9-CM
462), acute tonsillitis (ICD-9-CM 463),
streptococcal sore throat (ICD-9-CM
034.0), or pneumonia (ICD-9-CM 481–
486). In addition, only patient visits that
were recorded as being for an acute or
new problem were included. After the in-
clusion and exclusion criteria were ap-
plied, 1114 records comprised the study
sample.
Covariates
The patients’ age from 6 months to 12
years (collapsed to 2 and 2 years),
gender, race (categories condensed to
white or nonwhite), and insurance sta-
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PEDIATRICS Volume 125, Number 2, February 2010 215
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tus (categories condensed to private,
Medicare/Medicaid, or other) were re-
corded for each visit. The providers’
self-selected specialty was coded as
general pediatrician, family practitio-
ner, or other. The geographic region
was also recorded. Up to 3 complaints,
symptoms, or other reason(s) for the
visit were abstracted as free text and
then coded centrally by using a stan-
dard reason-for-visit classification
(RVC) system. Patient visits that were
coded as presenting with symptoms of
ear pain (RVC code 13551) and fever
(RVC code 10100) were identified.
Preclinical and Postclinical
Guideline Periods
Two 30-month periods were developed
on the basis of the clinical guideline
publication date of May 2004. The
preguideline period ranged from Jan-
uary 2002 through June 2004 and in-
cluded 584 patient visits. The post-
guideline period ranged from July
2004 through December 2006 and in-
cluded 530 patient visits.
Outcome of Prescribed Antibiotics
Up to 6 medications were recorded for
each visit in 2002, and up to 8 medica-
tions were recorded for each visit from
2003 to 2006. All recorded medications
were used in the analysis. From 2002 to
2005, the NAMCS used a 5-digit code that
had been assigned to each official ge-
neric name given to every drug entity by
the US Pharmacopeia.11 Beginning with
the 2006 data release, the generic com-
ponents and therapeutic classifications
of NAMCS drugs were coded by using
Lexicon Plus, a proprietary database of
Cerner Multum, Inc (Denver, CO).12 Ame-
bicides, anthelmintic, antifungal, antima-
larial, antituberculosis, and antiviral
agents, and aminoglycosides were ex-
cluded. Topical agents were also
excluded.
Amoxicillin was defined to include am-
picillin. If more than 1 antibiotic was
used in a single visit (3.1% of sample
records), we counted each antibiotic
prescribed in its respective class, but
the visit only counted once as an epi-
sode of care in which an antibiotic was
prescribed.
Outcome of Prescribed Analgesic
Agents
Analgesic agents were identified by us-
ing a unique classification scheme that
was developed at the NCHS.11 The fol-
lowing drug entries were included:
acetaminophen, Tylenol, Children’s Ty-
lenol, Tylenol Elixir, Advil, ibuprofen,
Motrin, children’s ibuprofen, Chil-
dren’s Advil, and Auralgan. Only those
visits as defined above in “Episodes of
Care for AOM” were included in the
analysis for analgesic-prescribing.
Data Analysis
We used the weights, strata, and pri-
mary sampling-unit design variables
that were provided by the NCHS for all
of the analyses. The main outcomes,
percentage comparison of visits with
and without antibiotic prescriptions
after publication of the 2004 guideline,
were evaluated by using the
2
test. To
control for potential confounding vari-
ables, a multivariate logistic regres-
sion model was developed to deter-
mine the associations with visits in
which no antibiotic prescription was
reported, while controlling for age,
gender, race, preguideline or post-
guideline period, insurance status,
physician specialty, symptoms of ear
pain or fever, and receipt of an analge-
sic prescription. To further explore
temporal changes in the rate of en-
counters during which no antibiotic
was prescribed, the 5-year study pe-
riod was divided into ten 6-month peri-
ods and analyzed by using the linear-
trend test. For all analyses we used
survey weights and took into account
the complex survey design by using the
svy command provided in Stata 10
(Stata Corp, College Station, Texas). All
Pvalues were 2-tailed, and P.05
was considered significant.
RESULTS
The average annual number of visits of
children with AOM was 10.3 million
(95% confidence interval [CI]: 9.0 –11.7
million). Among children with AOM,
53% were male patients and 86% were
white (Table 1). Forty-eight percent of
the patients were 2 years old. Eighty-
two percent of the visits were with pe-
diatricians, 14% with family physi-
cians, and 4% with other physicians.
Fifty-one percent (95% CI: 45%–58%) of
the visits occurred in the preguideline
period. Visits in the preguideline and
postguideline periods were similar in
terms of demographic, insurance, and
symptom variables (Table 1).
Overall, antibiotics were not pre-
scribed in 13% (95% CI: 10%–17%) of
the visits. The percentage of AOM diag-
noses that were managed without an
antibiotic did not change significantly,
ranging from 11% before to 16% after
(P.103) (Fig 1) publication of the
2004 guideline. The proportion of visits
at which amoxicillin was prescribed in-
creased (40%– 49%; P.039),
whereas the prescribing of amoxicil-
lin/clavulanate decreased (23%–16%;
P.043) after guideline publication
(Fig 1). Cefdinir-prescribing increased
(7%–14%; P.004), whereas the pre-
scribing of cephalosporins other than
cefdinir decreased (12%– 6%; P
.025) after publication. Macrolide-
prescribing did not change (14%–13%;
P.82) after the clinical guideline
was issued. The number of visits with
other antibiotic prescriptions was too
small to analyze. The rate of analgesic-
prescribing increased from 14% to
24% (P.038) after the guideline was
published (Fig 1).
Because the AAP/AAFP guideline has
different criteria for the observation
option according to age greater than
or less than 2 years, we also examined
216 COCO et al by guest on June 11, 2013pediatrics.aappublications.orgDownloaded from
whether age was a modifier of the ef-
fect of the proportion of cases in which
an antibiotic was prescribed (Fig 2). In
logistic regression modeling, age (2
vs 2 years) was not an independent
predictor of a visit at which no
antibiotic-prescribing was reported
(odds ratio [OR]: 1.42 [95% CI: 0.86
2.35]).
Over the 5-year study period, there was
a gradual upward trend in the rate of
encounters in which no antibiotic-
prescribing was reported, increasing
from 6% in the first half of 2002 to 24%
in the last half of 2004 and to 14% in the
last half of 2006 (P.01 for the trend)
(Fig 3). The trend was not character-
ized, however, by a sustained positive
inflection after the period of the guide-
line publication in the second half of
2004.
In multivariable logistic regression
modeling, independent predictors of
a patient visit at which antibiotic-
prescribing was not reported were the
absence of ear pain (OR: 3.08 [95% CI:
1.92– 4.96]), absence of fever (OR: 2.70
[95% CI: 1.22– 6.00]), and receipt of an
analgesic prescription (OR: 2.40 [95%
CI: 1.06 –5.46]).
DISCUSSION
In this analysis of data on the ambu-
latory management of AOM in the
United States, our results revealed
that the percentage of pediatric AOM
visits during which an antibiotic was
not prescribed did not increase sig-
nificantly in the 30 months after the
dissemination of a well-publicized
clinical guideline by the AAP/AAFP in
2004, shifting only from 11% to 16%.
Indeed, although the results of our
analysis demonstrate a slightly in-
creased trend in the management of
AOM without antibiotics over the
study period, the absence of an in-
flection point around the time of the
guideline publication argues against
the guideline being a large factor in
what more likely represents a gen-
eral secular trend. It seems that, de-
spite the guideline’s endorsement,
physicians have been reluctant to
frequently use the observation op-
tion, perhaps because of percep-
FIGURE 1
Comparison of prescribing choices in visits for children with a diagnosis of AOM to US physicians’
offices before and after publication of the AAP/AAFP 2004 clinical practice guideline (N1114).
TABLE 1 Visit Characteristics of Children Diagnosed With AOM From 2002 to 2006 in US Physicians’
Offices Before and After Publication of the 2004 AAP/AAFP Clinical Practice Guideline
(N1114)
Characteristic Overall Proportion
of Visits, %
Proportion of Visits
Before Clinical
Guideline, Jan 2002
to Jun 2004
(n584), %
Proportion of Visits
After Clinical
Guideline, Jul 2004
to Dec 2006
(n530), %
P
Gender
Male 53 54 51 .58
Female 47 46 49
Age
2 y 48 47 49 .58
2 y 52 53 51
Race
White 86 87 85 .41
Nonwhite 14 13 15
Health insurance
Private 64 68 58 .06
Medicaid/Medicare 30 27 32
Self-pay and other 7 4 10
Physician specialty
Pediatrics 82 83 81 .69
Family practice 14 14 14
Other 4 3 5
Geographic region
Northeast 21 19 24 .38
Midwest 23 26 19
South 33 34 33
West 23 21 24
Symptoms
Fever 22 24 19 .26
Ear pain 36 34 38 .35
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PEDIATRICS Volume 125, Number 2, February 2010 217
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tions of parental reluctance to ac-
cept this approach and barriers to
follow-up as noted previously.13 Al-
though our results were derived
from a nationally representative
sample of physicians in multiple am-
bulatory settings, the percentage of
visits (16%) without an antibiotic
prescription after guideline avail-
ability is similar to the percentage of
physicians who stated that they used
the observation option in a pair of
sequential surveys that were con-
ducted in 2004 and 2006. The sequen-
tial surveys included 500 physicians
from 42 states who participated in a
pediatric research network.9,13 This
consistency in findings between 2
studies with different methods lends
credibility to our results. It is encour-
aging that children who did not re-
ceive antibiotics were also less likely
to present with symptoms of severe
infection such as fever or ear pain.
Thus, consistent with the guideline, it
seems that the initial observation op-
tion was more likely to be chosen in
children with mild infections.
In terms of the choice of antibiotics for
AOM treatment, it was somewhat unex-
pected that amoxicillin/clavulanate-
prescribing, the recommended guide-
line treatment for children with severe
infection (up to 22% of children with
AOM14) and those with treatment fail-
ure, has decreased after publication of
the guideline. However, our findings
are consistent with the lack of enthusi-
asm that physicians have previously
shown for prescribing amoxicillin/
clavulanate for severe infections.9It
seems that physicians, in the 2006 sur-
vey9and in our study, were choosing
cefdinir (doubling from 7% to 14% of
all antibiotics after publication of the
2004 guideline) as a second-line agent
instead, perhaps because of a more-
convenient dosing schedule, a lower
incidence of diarrhea, or more aggres-
sive marketing.15
A secondary, but important, result of
our analysis was the 71% increase in
analgesic-prescribing in the period
after the guideline was issued. It
seems that pediatric providers have
accepted this strong recommenda-
tion to treat the pain that is often
associated with AOM,16 which is a re-
versal of previous findings showing
that treating otalgia is not prioritized
by clinicians.17 It would seem that
physicians were more willing to
adopt a recommendation from the
guideline to add a treatment (analge-
sic agents) rather than to withhold
one (antibiotics). In addition, our re-
sults demonstrate that children
managed with observation are more
likely to receive a prescription for an
analgesic agent, perhaps as a means
of demonstrating provider willing-
ness to take parental concerns of
FIGURE 2
Effect of age on proportion of visits at which no antibiotic-prescribing was reported for children with
a diagnosis of AOM to US physicians’ offices before and after publication of the AAP/AAFP 2004 clinical
practice guideline (N1114).
FIGURE 3
Trend in the rate of visits at which no antibiotic-prescribing was reported for children with a diagnosis
of AOM to US physicians’ offices before and after publication of the AAP/AAFP 2004 clinical practice
guideline (N1114).
218 COCO et al by guest on June 11, 2013pediatrics.aappublications.orgDownloaded from
ear pain seriously despite not deem-
ing an antibiotic prescription neces-
sary. These findings are limited by a
lack of data on visits in which an an-
algesic agent was recommended but
not prescribed.
In some ways, these results are not en-
tirely surprising, given the limited im-
pact of previous clinical guidelines.
Other research results have demon-
strated that mere familiarity with a
clinical practice guideline is unlikely to
result in the adoption of its specific
recommendations.18 It is possible that
the initial intense publicity that the
AOM guideline received, through con-
ferences and news reports, waned
over the 30-month study period or that
some practitioners were unaware of
the recommendations. Our results
may also reflect clinician overload
with the large number of pediatric
guidelines that have been published in
recent years,19,20 or our findings may
simply indicate a lack of agreement
with the guideline recommendations
themselves.
There were some aspects of the data
that may limit the conclusions that
can be drawn from our results. First,
and most important, because of the
retrospective nature of the data, we
were unable to identify use of the ob-
servation option with a safety-net an-
tibiotic prescription. This approach,
endorsed in the clinical guideline,
has the physician provide a prescrip-
tion for antibiotics, but with instruc-
tions to delay having it filled unless
symptoms persist after 2 to 3 days.
The NAMCS data did not allow us to
determine if an antibiotic prescrip-
tion was meant to be filled immedi-
ately or to be used as a safety net. In
this regard, our analysis may have
underestimated the number of chil-
dren who were initially treated with
observation. Second, inclusion of
data immediately after the release of
the guideline may not have allowed
sufficient time for adaptation to the
guideline recommendations. Third, tele-
phone and e-mail contact information
was not included. Last, the data did not
allow us to distinguish between the
prescribing of high-dose amoxicillin
(recommended in the guidelines) ver-
sus standard-dose amoxicillin.
CONCLUSIONS
We found no compelling evidence
that the 2004 AAP/AAFP guideline
for AOM treatment substantially in-
creased the proportion of the pediat-
ric AOM cases being managed with-
out antibiotics, despite a gradual
secular trend in this direction. How-
ever, our data suggest that children
with AOM who are not prescribed an-
tibiotics are more likely to have mild
infections, consistent with the guide-
line’s recommendations. It is encour-
aging that after the publication of
the guideline, amoxicillin-prescribing
has increased and the pain associated
with AOM is more frequently being
treated.
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Announcement: The National Institute of Allergy and Infectious Diseases to Seek
Public Comment on Food Allergy Clinical Practice Guidelines: The National Institute of
Allergy and Infectious Diseases (NIAID) will seek public comment on draft “Guidelines for the
Diagnosis and Management of Food Allergy.” The period for public comment will open in early
2010 and will last for sixty days. At that time, you are encouraged to examine the guidelines
and participate in the open comment period by visiting the NIAID Food Allergy Clinical Guide-
lines public comment site: http://www3.niaid.nih.gov/topics/foodAllergy/clinical/comments.
htm.
As part of the process of developing the guidelines, NIAID convened a Coordinating Com-
mittee (CC) that includes representatives from 33 professional organizations, advocacy
groups, and federal agencies. The role of the CC is to advise NIAID, review draft(s), approve the
final guidelines, and develop a plan for the dissemination of the final guidelines.
The guidelines will be based on an independent, systematic review of the scientific and
clinical literature. The Rand Corporation was awarded the contract to perform this compre-
hensive literature review and has prepared an evidence-based report.
An Expert Panel (EP) has been convened, composed of 25 members with expertise from a
variety of relevant clinical and scientific areas and chaired by Dr Joshua A. Boyce of Harvard
Medical School. The EP will use both the evidence-based report and consensus expert opinion
as the foundation for developing the draft clinical guidelines. The final guidelines are ex-
pected to be completed and ready for dissemination by the summer of 2010.
More information and updates on this project are available at the NIAID Web site:
www3.niaid.nih.gov/topics/foodAllergy/clinical/.
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DOI: 10.1542/peds.2009-1115
; originally published online January 25, 2010; 2010;125;214Pediatrics
Andrew Coco, Louis Vernacchio, Michael Horst and Angela Anderson
Clinical Practice Guideline
Management of Acute Otitis Media After Publication of the 2004 AAP and AAFP
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... Many of the providers that have access and time to review these guidelines have negative feelings and disagree with these guidelines as they feel the guidelines can lead to a conglomeration of inappropriate patient outcomes. Coco, Vernacchio, Horst, and Anderson (2010) 12 found that physicians are more willing to adopt a recommendation from the guidelines to add a treatment rather than to withhold treatment. Stewart et al. (2001) 8 also found that there is little evidence to predict actual behaviors in practice compared with guideline recommendations due to individual case scenarios. ...
... This routine practice has influenced parents' ideals on AOM treatment and expect antibiotic treatment when their child has AOM symptoms 13 . Coco, Vernacchio, Horst, and Anderson (2010) 12 found that parental reluctance to accepting the guideline recommendations is a major barrier to practitioner implementation. This cycle of parental expectation and provider willingness presents a significant barrier to implementing guidelines. ...
... 4,5 The introduction of guidelines both in the United States and in several European countries have contributed have to more judicious use of antibiotics. [6][7][8][9][10][11][12][13][14][15] Seven European national guidelines were chosen as they are used in the countries where primary care pediatricians answered our survey (Germany, Italy, France, Spain, Czech Republic and Finland) . [8][9][10][11][12][13][14] AOM should be managed on an individualized basis that taking into account of the child's age, the severity of the episode and whether it is unilateral or bilateral. ...
Article
Full-text available
Purpose: To describe the management of Acute Otitis Media in European countries, comparing practices between countries and accordance with the American Academy of Pediatrics guidelines. Methods: The study was completed via an internet survey. A coordinator per country obtained the local ethical approval, distributed the survey and collected responses. 2109 questionnaires were completed in 14 European countries. Results were analyzed by comparing answers within and between each country. Results: Otoscope device used varied, including conventional (89%), fiber-optic (19%) and pneumatic (4.9%) otoscopes. Decision to treat: 78.1% (63.8–90.5%) would immediately initiate antibiotics for a 6-month-old with bilateral Acute Otitis Media; 73.2% (47.6%-82.9%) would use a delayed antibiotic therapy in a 25-month-old with bilateral Acute Otitis Media; 50.2% would immediately initiate antibiotic treatment in a first episode of Acute Otitis Media for a 3-year-old and 31.5% would defer antibiotics. Younger pediatricians tend to prescribe more antibiotics: 87.6% vs 77.2%, OR: 2.08 (1.31–3.29). Amoxicillin as a first-line treatment was nearly unanimous (88.5%). Influenza vaccine was recommended by 35.7% of physician, whereas anti-pneumococcus was recommended by 86.0%. Conclusions: Among surveyed pediatricians, the diagnostic tools used and the decision to treat with antibiotics varied. Common practice guidelines for European pediatricians would unify current practices and reduce unnecessary antibiotic use.
Article
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The influence of the diet and nutritional status of milk donors on the nutritional composition of donor human milk (DHM) is unknown. The present study aimed to determine the nutritional profile of DHM and the associations between donors’ dietary intake and nutritional status and the micronutrient and lipid composition in DHM. For this purpose, 113 donors completed a food frequency questionnaire, provided a five-day weighed dietary record, and collected milk for five consecutive days. Nutrient determinations in donors’ erythrocytes, plasma, urine, and milk were performed. Multiple linear regressions were conducted for the evaluation of the associations. We highlight the following results: DHM docosahexaenoic acid (DHA) was positively associated with donors’ plasma DHA content and donors’ DHA intake (R2 0.45, p < 0.001). For every 1 g/day DHA intake, an increase of 0.38% in DHA content and 0.78% in total omega-3 content was observed in DHM (R2 0.29, p < 0.001). DHM saturated fatty acids were positively associated with erythrocyte dimethyl acetals, plasma stearic acid, trans fatty acids intake, and breastfeeding duration and negatively associated with erythrocyte margaroleic acid (R2 0.34, p < 0.01). DHM cholecalciferol was associated with plasma cholecalciferol levels and dairy intake (R2 0.57, p < 0.01). Other weaker associations were found for free thiamin, free riboflavin, pyridoxal, dehydroascorbic acid, and the lipid profile in DHM. In conclusion, the diet and nutritional status of donors influence the fatty acid profile and micronutrient content of DHM.
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Objectives: Particulate matter (PM) is a risk factor for various diseases. Recent studies have confirmed that otitis media (OM) is associated with PM exposure. To confirm this relationship, a novel exposure model designed to control the concentration of PM was developed, and the effects of PM exposure on the Eustachian tube (ET) and middle ear mucosa of rats were observed. Materials and methods: Forty healthy, 10-week-old, male Sprague Dawley rats were divided into the 3-day, 7-day, 14-day exposure, and control groups (each, n=10). The rats were exposed for 3 hours/day using incense smoke as the PM source. After exposure, bilateral ET and mastoid bullae were harvested, and histopathological findings were compared by microscopy and transmission electron microscopy (TEM). Expression of interleukin (IL)-1β, IL-6, tumor necrosis factor-α, and vascular endothelial growth factor (VEGF) in the middle ear mucosa of each group were compared by real-time polymerase chain reaction (RT-PCR). Results: In the ET mucosa of the exposure group, the goblet cell count increased after PM exposure (p=0.032). In the middle ear mucosa, sub-epithelial space thickening, increased angio-capillary tissue, and inflammatory cell infiltration were observed. Moreover, the thickness of the middle ear mucosa in the exposure groups increased compared to the control group (p<0.01). The TEM findings showed PM particles on the surface of the ET and middle ear mucosa and RT-PCR revealed mRNA expression of IL-1β significantly increased in the 3-day and 7-day exposure groups compared to the control group (p=0.035). VEGF expression significantly increased in the 7-day exposure group compared to the control and 3-day exposure groups (p<0.01). Conclusion: The ET and middle ear mucosa of rats showed histopathologic changes after acute exposure to PM, which reached the ET and middle ear mucosa directly. Therefore, acute exposure to PM may play a role in the development of OM.
Article
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Women of childbearing age in Western societies are increasingly adopting vegetarian diets. These women are sometimes rejected as milk donors, but little about the composition of their milk is known. The present study aimed to compare the intake, nutritional status, and nutritional composition of human milk from omnivore human milk donors (Donors) and vegetarian/vegan lactating mothers (Veg). Milk, blood, and urine samples from 92 Donors and 20 Veg were used to determine their fatty acid profiles, as well as vitamins and minerals. In a representative sample of both groups, we also determined the lipid class profile as a distribution of neutral and polar lipids, the molecular species of triacylglycerols, and the relative composition of phospholipids in their milk. A dietary assessment was conducted with a five-day dietary record (while considering the intake of supplements). We highlight the following results, expressed as the mean (SE), for the Veg vs. Donors: (1) Their docosahexaenoic acid (DHA) intake was 0.11 (0.03) vs. 0.38 (0.03) g/day; the plasma DHA was 0.37 (0.07) vs. 0.83 (0.06)%; and the milk DHA was 0.15 (0.04) vs. 0.33 (0.02)%. (2) Their milk B12 levels were 545.69 (20.49) vs. 482.89 (4.11) pM; 85% of the Veg reported taking B12 supplements (mean dose: 312.1 mcg/day); and the Veg group showed no differences with Donors in terms of total daily intake or plasma B12. (3) Their milk phosphatidylcholine levels were 26.88 (0.67) vs. 30.55 (1.10)%. (4) Their milk iodine levels were 126.42 (13.37) vs. 159.22 (5.13) mcg/L. In conclusion, the Vegs’ milk was shown to be different from the Donors’ milk, mainly due to its low DHA content, which is concerning. However, raising awareness and ensuring proper supplementation could bridge this gap, as has already been achieved for cobalamin.
Chapter
A fully updated version of this popular, clinically oriented, user-friendly text on infectious disease, with even more helpful graphics, tables, algorithms and images. It is packed full of information on diagnosis, differential diagnosis and therapy. In addition to the traditional organization of organ-system and pathogen-related information, this text also includes clinically helpful sections on the susceptible host (with individual chapters, for example, on the diabetic, the elderly, the injection drug user and the neonate), infections related to travel, infections related to surgery and trauma, nosocomial infection and bioterrorism. Positioned between the available encyclopedic tomes and the smaller pocket guides, this is a convenient, comprehensive and highly practical reference for all those practising in infectious diseases as well as internal or general medicine.
Chapter
A fully updated version of this popular, clinically oriented, user-friendly text on infectious disease, with even more helpful graphics, tables, algorithms and images. It is packed full of information on diagnosis, differential diagnosis and therapy. In addition to the traditional organization of organ-system and pathogen-related information, this text also includes clinically helpful sections on the susceptible host (with individual chapters, for example, on the diabetic, the elderly, the injection drug user and the neonate), infections related to travel, infections related to surgery and trauma, nosocomial infection and bioterrorism. Positioned between the available encyclopedic tomes and the smaller pocket guides, this is a convenient, comprehensive and highly practical reference for all those practising in infectious diseases as well as internal or general medicine.
Chapter
A fully updated version of this popular, clinically oriented, user-friendly text on infectious disease, with even more helpful graphics, tables, algorithms and images. It is packed full of information on diagnosis, differential diagnosis and therapy. In addition to the traditional organization of organ-system and pathogen-related information, this text also includes clinically helpful sections on the susceptible host (with individual chapters, for example, on the diabetic, the elderly, the injection drug user and the neonate), infections related to travel, infections related to surgery and trauma, nosocomial infection and bioterrorism. Positioned between the available encyclopedic tomes and the smaller pocket guides, this is a convenient, comprehensive and highly practical reference for all those practising in infectious diseases as well as internal or general medicine.
Chapter
A fully updated version of this popular, clinically oriented, user-friendly text on infectious disease, with even more helpful graphics, tables, algorithms and images. It is packed full of information on diagnosis, differential diagnosis and therapy. In addition to the traditional organization of organ-system and pathogen-related information, this text also includes clinically helpful sections on the susceptible host (with individual chapters, for example, on the diabetic, the elderly, the injection drug user and the neonate), infections related to travel, infections related to surgery and trauma, nosocomial infection and bioterrorism. Positioned between the available encyclopedic tomes and the smaller pocket guides, this is a convenient, comprehensive and highly practical reference for all those practising in infectious diseases as well as internal or general medicine.
Chapter
A fully updated version of this popular, clinically oriented, user-friendly text on infectious disease, with even more helpful graphics, tables, algorithms and images. It is packed full of information on diagnosis, differential diagnosis and therapy. In addition to the traditional organization of organ-system and pathogen-related information, this text also includes clinically helpful sections on the susceptible host (with individual chapters, for example, on the diabetic, the elderly, the injection drug user and the neonate), infections related to travel, infections related to surgery and trauma, nosocomial infection and bioterrorism. Positioned between the available encyclopedic tomes and the smaller pocket guides, this is a convenient, comprehensive and highly practical reference for all those practising in infectious diseases as well as internal or general medicine.
Article
Full-text available
Context: Despite wide promulgation, clinical practice guidelines have had limited effect on changing physician behavior. Little is known about the process and factors involved in changing physician practices in response to guidelines. Objective: To review barriers to physician adherence to clinical practice guidelines. Data sources: We searched the MEDLINE, Educational Resources Information Center (ERIC), and HealthSTAR databases (January 1966 to January 1998); bibliographies; textbooks on health behavior or public health; and references supplied by experts to find English-language article titles that describe barriers to guideline adherence. Study selection: Of 5658 articles initially identified, we selected 76 published studies describing at least 1 barrier to adherence to clinical practice guidelines, practice parameters, clinical policies, or national consensus statements. One investigator screened titles to identify candidate articles, then 2 investigators independently reviewed the texts to exclude articles that did not match the criteria. Differences were resolved by consensus with a third investigator. Data extraction: Two investigators organized barriers to adherence into a framework according to their effect on physician knowledge, attitudes, or behavior. This organization was validated by 3 additional investigators. Data synthesis: The 76 articles included 120 different surveys investigating 293 potential barriers to physician guideline adherence, including awareness (n = 46), familiarity(n = 31), agreement (n = 33), self-efficacy (n = 19), outcome expectancy (n = 8), ability to overcome the inertia of previous practice (n = 14), and absence of external barriers to perform recommendations (n = 34). The majority of surveys (70 [58%] of 120) examined only 1 type of barrier. Conclusions: Studies on improving physician guideline adherence may not be generalizable, since barriers in one setting may not be present in another. Our review offers a differential diagnosis for why physicians do not follow practice guidelines, as well as a rational approach toward improving guideline adherence and a framework for future research.
Article
Full-text available
Despite wide promulgation, clinical practice guidelines have had limited effect on changing physician behavior. Little is known about the process and factors involved in changing physician practices in response to guidelines. To review barriers to physician adherence to clinical practice guidelines. We searched the MEDLINE, Educational Resources Information Center (ERIC), and HealthSTAR databases (January 1966 to January 1998); bibliographies; textbooks on health behavior or public health; and references supplied by experts to find English-language article titles that describe barriers to guideline adherence. Of 5658 articles initially identified, we selected 76 published studies describing at least 1 barrier to adherence to clinical practice guidelines, practice parameters, clinical policies, or national consensus statements. One investigator screened titles to identify candidate articles, then 2 investigators independently reviewed the texts to exclude articles that did not match the criteria. Differences were resolved by consensus with a third investigator. Two investigators organized barriers to adherence into a framework according to their effect on physician knowledge, attitudes, or behavior. This organization was validated by 3 additional investigators. The 76 articles included 120 different surveys investigating 293 potential barriers to physician guideline adherence, including awareness (n = 46), familiarity(n = 31), agreement (n = 33), self-efficacy (n = 19), outcome expectancy (n = 8), ability to overcome the inertia of previous practice (n = 14), and absence of external barriers to perform recommendations (n = 34). The majority of surveys (70 [58%] of 120) examined only 1 type of barrier. Studies on improving physician guideline adherence may not be generalizable, since barriers in one setting may not be present in another. Our review offers a differential diagnosis for why physicians do not follow practice guidelines, as well as a rational approach toward improving guideline adherence and a framework for future research.
Article
Full-text available
Clinical practice guidelines are increasingly being used for a wide variety of medical conditions, but not enough is known about physicians' attitudes and beliefs about guidelines, how often and under what circumstances they are used, and factors associated with their acceptance. To determine practice guideline attitudes, beliefs, practices, and factors associated with use among a representative national sample of general pediatricians. Cross-sectional mail survey. Random sample of general pediatrician members of the American Academy of Pediatrics residing in all 50 states and Puerto Rico. SURVEY INSTRUMENT: Twenty-four multiple-choice, Likert scale, yes-no, and open-ended questions about pediatric clinical practice guidelines. From 1088 respondents, 461 specialists were excluded; the remaining 627 general pediatricians were mostly male (61%), white (81%), and in group practice (62%) in a suburban location (48%). Practice guidelines are used by 35% of pediatricians, in part by 44%, and not at all by 21%. Over 100 different practice guidelines are used, most commonly for asthma (77%), hyperbilirubinemia (27%), and otitis media (19%). Common reasons for use of practice guidelines include standardization of care (17%) and helpfulness (10%). Commonly cited problems with practice guidelines include failure to allow for clinical judgment (54%), use in litigation (16%), and limitation of autonomy (5%). In multivariate analysis, the odds of practice guideline use were greater among pediatricians in health maintenance organization practices (odds ratio [OR]: 9.1; 95% confidence interval [CI]: 1.2-68.0) and those who were nonwhite (OR: 2.3; 95% CI: 1.1-4.8), but lower in those with more weekly patient visits (OR:.7; 95% CI:.5-.9). Features most likely to lead to practice guideline use include simplicity (16%), feasibility (12%), and evidence of improved outcomes (10%). Most pediatricians agree that practice guidelines improve outcomes (89%), are motivated by a desire to improve quality (94%), and should not be used in litigation (82%) or disciplinary actions (77%), nor be motivated by a desire to reduce costs (73%). Most general pediatricians use practice guidelines, but no specific guidelines, except those for asthma, are used by >27% of pediatricians. The results of this study suggest that practice guidelines are most likely to be followed if they are simple, flexible, rigorously tested, not used punitively, and are motivated by desires to improve quality, not reduce costs.
Article
This article introduces a set of principles to define judicious antimicrobial use for five conditions that account for the majority of outpatient antimicrobial use in the United States. Data from the National Center for Health Statistics indicate that in recent years, approximately three fourths of all outpatient antibiotics have been prescribed for otitis media, sinusitis, bronchitis, pharyngitis, or nonspecific upper respiratory tract infection.1Antimicrobial drug use rates are highest for children1; therefore, the pediatric age group represents the focus for the present guidelines. The evidence-based principles presented here are focused on situations in which antimicrobial therapy could be curtailed without compromising patient care. They are not formulated as comprehensive management strategies. For most upper respiratory infections that require antimicrobial treatment, there are several appropriate oral agents from which to choose. Although the general principles of selecting narrow-spectrum agents with the fewest side effects and lowest cost are important, the principles that follow include few specific antibiotic selection recommendations.
Article
Context Annual rates of antimicrobial prescribing for children by office-based physicians increased from 1980 through 1992. The development of antimicrobial resistance, which increased for many organisms during the 1990s, is associated with antimicrobial use. To combat development of antimicrobial resistance, professional and public health organizations undertook efforts to promote appropriate antimicrobial prescribing. Objective To assess changes in antimicrobial prescribing rates overall and for respiratory tract infections for children and adolescents younger than 15 years. Design, Setting, and Participants National Ambulatory Medical Care Survey data provided by 2500 to 3500 office-based physicians for 6500 to 13 600 pediatric visits during 2-year periods from 1989-1990 through 1999-2000. Main Outcome Measures Population- and visit-based antimicrobial prescribing rates overall and for respiratory tract infections (otitis media, pharyngitis, bronchitis, sinusitis, and upper respiratory tract infection) among children and adolescents younger than 15 years. Results The average population-based annual rate of overall antimicrobial prescriptions per 1000 children and adolescents younger than 15 years decreased from 838 (95% confidence interval [CI], 711-966) in 1989-1990 to 503 (95% CI, 419-588) in 1999-2000 (P for slope <.001). The visit-based rate decreased from 330 antimicrobial prescriptions per 1000 office visits (95% CI, 305-355) to 234 (95% CI, 210-257; P for slope <.001). For the 5 respiratory tract infections, the population-based prescribing rate decreased from 674 (95% CI, 568-781) to 379 (95% CI, 311-447; P for slope <.001) and the visit-based prescribing rate decreased from 715 (95% CI, 682-748) to 613 (95% CI, 570-657; P for slope <.001). Both population- and visit-based prescribing rates decreased for pharyngitis and upper respiratory tract infection; however, for otitis media and bronchitis, declines were only observed in the population-based rate. Prescribing rates for sinusitis remained stable. Conclusion The rate of antimicrobial prescribing overall and for respiratory tract infections by office-based physicians for children and adolescents younger than 15 years decreased significantly between 1989-1990 and 1999-2000.
Article
This article introduces a set of principles to define judicious antimicrobial use for five conditions that account for the majority of outpatient antimicrobial use in the United States. Data from the National Center for Health Statistics indicate that in recent years, approx- imately three fourths of all outpatient antibiotics have been prescribed for otitis media, sinusitis, bronchitis, pharyngitis, or nonspecific upper respiratory tract infec- tion.,; therefore, the pediatric age group represents the focus for the present guidelines. The evidence-based principles presented here are focused on situations in which antimicrobial therapy could be curtailed without compromising patient care. They are not formulated as comprehensive management strategies. For most upper respiratory infections that require antimicrobial treat-
Article
A total of 536 infants and children with acute otitis media were randomly assigned to one of six consistent year-long regimens involving the treatment of nonsevere episodes with either amoxicillin or placebo, and severe episodes with either amoxicillin, amoxicillin and myringotomy, or, in children aged 2 years or older, placebo and myringotomy. Nonsevere episodes had more favorable outcomes in subjects assigned to treatment with amoxicillin than with placebo, as measured by the proportions that resulted in initial treatment failure (3.9% vs 7.7%, P = .009) and the proportions in which middle-ear effusion was present at 2 and 6 weeks after onset (46.9% vs 62.5%, P less than .001; and 45.9% vs 51.5%, P = .09, respectively). In subjects whose entry episode was non-severe, those assigned to amoxicillin treatment had less average time with effusion during the succeeding year than those assigned to placebo treatment (36.0% vs 44.4%, P = .004), but recurrence rates of acute otitis media in the two groups were similar. In the 2-year-and-older age group, severe episodes resulted in more initial treatment failures in subjects assigned to receive myringotomy alone than in subjects assigned to receive amoxicillin with, or without, myringotomy (23.5% vs 3.1% vs 4.1%, P = .006). In the study population as a whole, severe episodes in subjects assigned to receive amoxicillin alone, and amoxicillin with myringotomy, had comparable outcomes. It is concluded that children with acute otitis media should routinely be treated with amoxicillin (or an equivalent antimicrobial drug). The data provide no support for the routine use of myringotomy either alone or adjunctively.
Article
• The frequency and correlates of earache were studied prospectively among 335 consecutive episodes of acute otitis media with effusion (AOME) diagnosed in a suburban pediatric practice. Earache was severe in 142 (42%) episodes, mild/moderate in 135 (40%), and absent in 58 (17%). The incidence of apparently painless AOME was higher among children less than 2 years old than among older children (25% v 7%). Redness of the completely bulging tympanic membrane was associated with an increased likelihood of earache. Neither gender nor the extent of involvement (one v both ears) was independently related to earache. Earache is not an invariable component of AOME, especially among infants and young children. Detection of all cases of AOME among young children requires a high index of suspicion, even in the apparent absence of earache. (AJDC 1985;139:721-723)
Article
Penicillin resistance of Streptococcus pneumoniae, one of the most common causes of acute otitis media, has recently increased and is now highly prevalent in many regions. However, its contribution to clinical failure still must be proved. Because the role of antibiotics in acute otitis media is to eradicate the pathogens present in the middle ear fluid, we conducted a randomized controlled study to determine bacterial eradication of pathogens in acute otitis media by two commonly used oral cephalosporins, cefuroxime axetil (30 mg/kg/day) and cefaclor (40 mg/kg/day). Patients 6 to 36 months old with pneumococcal otitis media seen in the Pediatrics Emergency Room were studied. An initial middle ear fluid culture was obtained at enrollment, and a second culture was obtained on Day 4 or 5 during treatment. Follow-up was done also on Days 10, 17 and 42 after initiation of treatment. In cases of clinical relapse a third culture was obtained. In total 78 patients were enrolled, 41 in the cefuroxime axetil group and 37 in the cefaclor group. Of the 78 S. pneumoniae isolates 31 (40%) were intermediately penicillin-resistant (MIC 0.125 to 1.0 microgram/ml). Of the 47 patients with penicillin-susceptible organisms 3 (6%) had bacteriologic failure vs. 4 of 19 (21%) and 7 of 11 (64%) of those with MIC of 0.125 to 0.25 microgram/ml and 0.38 to 1.0 microgram/ml, respectively (P < 0.001). For intermediately resistant pneumococci, in 7 of 12 (58%) of those receiving cefaclor the isolate was not eradicated vs. only 4 of 19 (21%) of those receiving cefuroxime axetil (P = 0.084). MIC to the administered cephalosporin of > 0.5 microgram/ml was associated with bacteriologic failure. Clinical failure was observed in 9 of 14 (64%) patients with bacteriologic failure vs. 10 of 52 (19%) patients with bacteriologic eradication (P = 0.003). Intermediately penicillin-resistant S. pneumoniae is associated with an impaired bacteriologic and clinical response of acute otitis media to cefaclor and cefuroxime axetil. This effect was more pronounced with cefaclor than with cefuroxime axetil.