|Acute Otitis Media: Improving
Published in American Family Practice, 2000, Vol. 61, Pgs. 2051-2416
Michael E. Pichichero, MD
University of Rochester Medical Center
Elmwood Pediatric Group
Department of Microbiology/Immunology
601 Elmwood Avenue, Box 672
Rochester, NY 14642
Word Count: 2,325
Acute otitis media (AOM) is over-diagnosed. Symptoms predicting
AOM are neither sensitive nor specific. Undue reliance on tympanic
membrane (TM) redness and failure to assess TM mobility with
pneumatic otoscopy contribute to inaccurate assessment of physical
findings. The features distinguishing AOM (for which antibiotics
are appropriate) and otitis media with effusion(OME; for which
antibiotics are infrequently indicated) are often not accurately
appreciated. Tympanometry and acoustic reflectometry can be
useful adjunctive tools to aid diagnosis and follow-up. Selective
use of tympanocentesis may improve diagnostic accuracy because
it validates or refutes the physicians' clinical impression.
Most family physicians are confident that they can make the
diagnosis of acute otitis media (AOM) with relative ease in
the pediatric patient. Yet, in one study, 75 children judged
by family physicians to have AOM were sent to otolaryngologists
for tympanocentesis. Only 11 (15%) of these children actually
had AOM according to the specialists based on examinations
with otomicroscopy, of whom 7 (9% of the total) actually had
a middle ear pathogen isolated by tympanocentesis (1). Consider
the consequences of over-diagnosis - a prescription of antibiotics
almost always follows. If the patient did not actually have
AOM then the patient is placed at risk for the adverse consequences
of antibiotic therapy unnecessarily. If the patient is declared
to not have responded satisfactorily, use of broader spectrum
antibiotics is advocated at a follow-up examination. Repeated
episodes of AOM and particularly repeated episodes of AOM which
appear to have not responded to antibiotics often leads to
referral for tympanostomy tube surgery, sometimes with concurrent
Over-diagnosis of AOM also has an impact in clinical research
trials because it produces an over estimation of efficacy for
all treatments and a blurring of any actual differences in
efficacy between treatments. We lack standardized and stringent
criteria for the clinical diagnosis of AOM and for the characterization
of improvement or cure. In a review of the literature, Hayden
found 19 different sets of criteria for making the diagnosis
of AOM were used in 26 different clinical trials (2). Some
proportion of children did not actually have AOM but either
had otitis media with effusion (OME), or no disease at all.
After enrollment in an antibiotic study, these children probably
would be classified as cured or improved even though they did
not have AOM in the first place.
The classic findings of AOM, such as fever and earache are
sometimes absent even in cases confirmed by tympanocentesis.
A bulging, red, immobile tympanic membrane is highly associated
with AOM. However, many physicians rely on redness of the ear
drum as their main diagnostic clue. Crying (and most children
cry when their ears are examined), removal of cerumen with
associated irritation of the auditory canal, and fever can
cause redness of the ear drum in the absence of any middle
ear infection whatsoever. Most of all, when a parent brings
a child to the physician with a report of sleeplessness, irritability,
rhinorrhea and perhaps fever, the temptation is great to see
at least a little bit of redness or fluid behind the ear drum
as justification for an antibiotic prescription (3).
Distinguishing episodes of otitis media as acute suppurative
otitis media (AOM) versus otitis media with effusion (OME)
is critical (4). The distinction between these entities should
be clear. AOM is defined by the presence of symptoms of acute
illness and a tympanic membrane (TM) under positive pressure
(full or bulging). OME is defined by the absence of symptoms
and signs of acute infection (other than reduced hearing) and
a TM under negative pressure (retracted) or no pressure (neutral
position) with the presence of fluid in the middle ear space.
This distinction is essential for management decision making.
Antibiotics are indicated for AOM but may be appropriately
deferred for children with OME, in agreement with recommendations
by the US Agency for Healthcare Policy and Research (4).
Symptoms and Signs of AOM
Niemela et al (5) carried out a prospective survey collecting
information on 354 consecutive children visiting a pediatrician,
otolaryngologist or family physician because of any kind of
acute respiratory illness to compare their symptoms with children
who had AOM. The symptoms and signs observed at home were recorded
by the parents before the visit and the findings upon physical
examination were recorded later by the physician. AOM was diagnosed
in 191 patients (54%). The most important symptoms increasing
the likelihood of AOM were ear-related symptoms, such as earache,
rubbing of the ear or report of the ear feeling blocked. However,
only two-thirds of the children younger than two years of age
with AOM had any ear-related symptoms. Fever, earache or crying/irritability
were present in 90% of patients with AOM but also in 72% of
patients without it. Many of the symptoms thought to be related
to AOM, such as fever, cough, loss of appetite, diarrhea or
vomiting were not more common in children with AOM than in
children with other acute illnesses. Further, the duration
of the symptoms was not markedly different in children with
AOM in comparison to children with other diagnoses. Heikkinen
and Ruuskanen (6) prospectively examined of 302 children younger
than four years of age attending day care centers during episodes
of upper respiratory infections. Forty percent of the children
with AOM never complained or had symptoms of an earache, 31%
had no fever, and half slept soundly. Kontiokari et al (7)
prospectively examined 857 healthy day care children during
upper respiratory infections. The parents were able to predict
the presence of AOM in their own child with a sensitivity and
specificity of 71% and 80%, respectively (positive predictive
value 51%, negative predictive value 90%).
In a study of 85 infants and children, Schwartz et al (8)
made a diagnosis of AOM based on pneumatic otoscopy findings
of diminished mobility of the TM, bulging contour and color.
The diagnosis was validated by tympanocentesis and positive
culture of middle ear fluid. A poorly mobile, bulging, yellow,
and opacified TM were the most predictive of finding AOM; unfortunately,
they were all seen in only 19% of the studied patients. The
color of the TM did not correlate at all with pathogen isolation
from the middle ear exudate. Seventy-seven percent of children
with AOM had no fever and 28% had no ear pain or irritable
et al (9) used a multi-variable analysis of TM findings to
the strongest associations with the presence of AOM.
Their report was tabulated by Pelton (10). Combining the TM
position (normal, retracted or bulging), color (normal, red
or opaque = "cloudy") and mobility (normal or impaired
= reduced) could result in 99% predictive value (Table 1) when
compared with the findings at tympanocentesis. The presence
of a normal or retracted position of the TM with slightly impaired
or normal mobility was unlikely to be associated with AOM unless
the fluid behind the membrane was cloudy. A slightly red TM
with normal TM position and mobility had a predictive value
of 7% for AOM. A distinctly red TM in normal position and normal
mobility had a 15% predictive value.
In 1992, Kaleida and Stool (11) described an otoscope validation
program to assess accuracy regarding the diagnosis of middle
ear effusion. Children were examined by the investigators concurrently
with the physician in training. The children had a history
of recurrent or chronic otitis media or both and had been scheduled
for elective myringotomy (with or without tympanostomy tube
placement). The children underwent general anesthesia after
the examinations and a tympanocentesis was performed. The otoscopists
examination was therefore validated by the middle ear findings.
Using this approach, the investigators found that physicians
became more accurate in diagnosing the presence than the absence
of middle ear effusion. The mean sensitivity and mean specificity
for the group as a whole were 87% and 74%, respectively. The
chief benefit of the program was an improvement in diagnostic
skills; the chief limitation was the large amount of time required.
et al (12) compared tympanometry and pneumatic otoscopy with
findings of myringotomy in 86 children (163 ears). Seventy
percent of the ears had an effusion as revealed by myringotomy.
Abnormal tympanograms consistent with middle ear effusion were
flat. The sensitivity and specificity for tympanometry were
90% and 86%, respectively; for pneumatic otoscopy, it was 93%
and 58%, respectively. In 40% of the examined children, family
physicians over-diagnosed the presence of middle ear effusion.
Barnett et al (13) compared acoustic reflectometry and other
diagnostic techniques for detection of middle ear effusion
in children with middle ear disease in their study of 299 ears.
When the spectral gradient angle of the acoustic reflectometry
instrument was < 49, 88% of children were found to have
middle ear effusion with tympanocentesis. In contrast, when
the spectral gradient angle was > 95, 17% of children had
middle ear effusion. Sensitivity, specificity, positive predictive
value and negative predictive value of acoustic reflectometry
and tympanometry compared favorably in predicting the presence
or absence of middle ear effusion at surgery. Lampe and Schwartz
(14) summarized the value of acoustic reflectometry in children
with AOM. Six studies evaluating 12,333 ears were described.
The gold standard of tympanocentesis was available for comparison
in several studies whereas in others, pneumatic otoscopy findings
represented the gold standard. Acoustic reflectometer sensitivity
varied from 54% to 94% and specificity from 59% to 83%.
How can we improve diagnostic accuracy in AOM?
Adequate illumination is critical. Barriga et al (15) examined
otoscopes located at the private offices of 96 physicians.
The light output of each unit was measured and then remeasured
with a new bulb, and when possible, a new battery was placed
in the unit. Approximately 1/3 of the otoscopes had a sub-optimal
output of light. Replacement of the bulb restored adequate
illumination for 80% of these otoscopes. One-third of the physicians
reported changing otoscope bulbs less often than every two
years (as is recommended) and almost half of the rechargeable
batteries inspected were outdated.
The TM cannot be adequately seen while partially occluded
by cerumen. (8, 11, 16) Some type of cerumen removal curette
is essential and should be regularly used. If the wax is dry
or deep in the auditory canal then cerumenolytics and/or warm
water irrigation may be necessary. Parents should be taught
how to restrain an uncooperative child for wax removal and
proper examination of the TM. Disposable specula are too short
to allow optimal TM visualization; the widest caliber,
re-usable specula should be used to maximize illumination of
Pneumatic otoscopy has been advocated as an important adjunct
to assist in diagnostic accuracy of AOM (Table 1) (3, 8-11,
16-19) yet most physicians find it inconvenient or remain unconvinced.
The ear speculum must create an air seal against the external
auditory canal to successfully cause movement of the TM; a
rubber sleeve over the speculum may reduce the discomfort of
the process. Four characteristics of the TM should be evaluated
and described in every examination (position, mobility, color,
degree of translucency). The normal TM is in the neutral position
(neither retracted nor bulging), pearly gray, translucent and
responds briskly to positive and negative pressure, indicating
an air filled space. The abnormal TM may be retracted or bulging,
and immobile or poorly mobile to positive and/or negative air
pressure. The color of the eardrum is of minor importance although
patients with AOM more often have a red TM. The key differentiating
features of AOM compared to OME on physical exam relate to
TM position. In AOM the TM almost always is bulging and in
OME it is usually retracted or, occasionally, it is in neutral
position. The TM is thickened in both AOM and OME, thereby
reducing visibility through it. Sometimes a yellow or grayish
middle ear effusion can be seen behind the TM in either condition.
Tympanometry and acoustic reflectometry each have attributes
which make them of value in providing information about the
possible presence of a middle ear effusion (13, 14, 20). The
sensitivity, specificity, positive predictive value and negative
predictive value of the two instruments has been assessed in
comparison with pneumatic otoscopy, audiometry and tympanocentesis
findings (13). A comparison of the two instruments in office
practice has also been made (21); neither is a perfect instrument
and both have some limitations. Both instruments have portable
models which allow them to be carried from one examination
room to another. Acoustic reflectometry has the advantage of
not requiring a seal within the canal which improves it's usefulness
in the crying child because a reading can be obtained when
a child stops crying to take a breath. Tympanometry provides
additional information about actual pressures within the middle
ear space (20). Both instruments can be connected to printers,
thereby providing a permanent record of the readings for comparison
at subsequent examinations and for documentation to health
Family physicians who see young children with AOM may be called
upon to perform tympanocentesis in selected patients in their
office as recommended by the CDC (22). The gold standard in
clinical trials for the diagnosis of AOM has always been tympanocentesis
determination for the presence of middle ear fluid with subsequent
culture for identification of causative pathogens (17-19, 22,
23). Selective use of tympanocentesis may improve diagnostic
accuracy because it validates or refutes the physicians' impression
after visual examination. Few experiences are more self-educating
than to diagnose AOM and then find no fluid with tympanocentesis.
Why are so few family physicians utilizing this procedure in
their office practices? Some fear complications and yet, after
proper training, the procedure has a very satisfactory safety
record (Table 2). Certainly proper restraint of the patient
and excellent visualization of the TM are essential; mild sedation
may also be helpful in some cases (24) (Table 3). Table 4 outlines
when tympanocentesis should be performed and it's benefits.
It would appear we need post-graduate training through continuing
medical education courses to allow more physicians to learn
and practice the use of tympanocentesis (22, 23) and this is
now available (Outcomes Management Educational Workshops: 1-877-EAR-OMEW
The average physician examines the ears of more than 30 patients
each working day (60 ears), 5 days per week for about 40 weeks
per year for a total of more than 14,000 ears per year. Nevertheless,
published literature suggests that AOM is very frequently over-diagnosed.
We need to make an effort to improve the accuracy of this diagnosis.
The Centers for Disease Control has initiated a campaign to
promote the judicious use of antibiotics, especially by differentiation
of AOM from OME (Table 5)(25).
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Predictive Value of Middle Ear Effusion in Children
Modified from Pelton SI. Pediatr Infect Dis J 1998;17:540-543;
adapted from Karma et al. In: Lim et al, eds. Recent advances
in otitis media: proceedings of the Fifth International Symposium.
Burlington, Ontario, Canada: Decker 1993;41-45.