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Assessing Diagnostic Accuracy and Tympanocentesis Skills in the Management of Otitis Media
Michael E. Pichichero, MD;
Michael D. Poole, MD, PhD
Arch Pediatr Adolesc Med. 2001;155:1137-1142.
ABSTRACT
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Background The distinction between acute suppurative otitis media (AOM) and otitis
media with effusion (OME) is important for antibiotic treatment decisions.
Tympanocentesis may be useful in the diagnosis of AOM in selected patients.
Objectives To assess physician accuracy in diagnosing AOM and OME from physical
examination findings and technical competence in performing tympanocentesis.
Design and Subjects Five hundred fourteen pediatricians and 188 otolaryngologists viewed
9 different videotaped pneumatic otoscopic examinations of tympanic membranes
during a continuing medical education course. Diagnostic differentiation of
AOM, OME, and a normal tympanic membrane was ascertained. An infant mannequin
model was used to assess the technical proficiency of performing tympanocentesis
on artificial tympanic membranes.
Results Overall, the average correct diagnosis by pediatricians was 50% (range,
25%-73%) and by otolaryngologists was 73% (range, 48%-88%). Pediatricians
and otolaryngologists correctly recognized the absence of normality 89% to
100% and 93% to 100% of the time, respectively, but overdiagnosed AOM in 7%
to 53% (mean, 27%) and in 3% to 23% (mean, 10%) of examinations. Performance
of tympanocentesis was optimally performed by 89% of otolaryngologists and
by 83% of pediatricians.
Conclusions The use of video-presented examinations to assess diagnostic ability
suggests that AOM and OME may be misdiagnosed often. Interactive continuing
medical education courses with simulation technology may enhance skills and
improve diagnostic accuracy and treatment paradigms.
INTRODUCTION
ANTIBIOTICS are indicated for acute suppurative otitis media (AOM) but
may be appropriately deferred for children with acute otitis media with effusion
(OME) in agreement with recommendations by the US Agency for Healthcare Policy
and Research.1 The distinction is essential
for management decision making. In both AOM and OME, fluid collects in the
middle ear space and the mobility of the tympanic membrane (TM) may be diminished
with pneumatic otoscopy examination. The TMs of patients with AOM are under
positive (full or bulging) pressure while the TMs of patients with OME are
under negative pressure (retracted) or no pressure (neutral position). Patients
with OME are said to have an absence of symptoms (other than reduced hearing)
although some may experience mild otalgia.
In January 1999 a report was issued from the drug-resistant Streptococcus pneumoniae Therapeutic Working Group convened by the
Centers for Disease Control and Prevention (Atlanta, Ga).2
The objective of the group was to provide consensus recommendations for the
management of AOM. The group stated:
. . . diagnostic tympanocentesis with culture and susceptibility
testing of isolates, although difficult to achieve in most practice settings,
may be necessary to guide the choice of therapy in difficult AOM cases . .
. Although logarithmic delineated choices of broad spectrum antibiotics eg
multiple shots of ceftriaxone or high-dose amoxicillin/clavulanate may be
as effective as a culture-directed therapy approach for most patients . .
. obtaining a culture may be particularly important if a child has recently
received several courses of antimicrobial therapy and is therefore more likely
to harbor a multiply resistant strain . . . In an era of increasing antimicrobial
resistance, clinicians treating children with AOM should consider developing
the capacity to perform tympanocentesis themselves or establish a ready referral
mechanism to a clinician with this capacity.2
Other authorities have advocated tympanocentesis for the child who is
highly febrile, toxic-appearing, and in severe pain.3, 4, 5, 6
The procedure can be safely performed in an office practice setting without
general anesthesia.5, 6, 7, 8, 9, 10, 11
With these indications, it is neither necessary nor appropriate for the insertion
of tympanostomy tubes. Otolaryngologists and properly trained and certified
primary care physicians can and should perform the procedure with increasing
frequency in an era of rising antibiotic-resistant otitis media pathogens.
During a series of continuing medical education-accredited courses conducted
in 35 cities across the United States, pediatricians and otolaryngologists
were shown video footage of TMs that were either normal or from patients with
AOM or OME; their diagnostic decisions are described in this report. The physicians
also participated in tympanocentesis skill validation or training. Four artificial
TMs in infant mannequin models were tapped by each participant and successful
performance was assessed.
METHODS
An accredited 3 -hour continuing medical education workshop titled
"Improving Outcomes in Otitis Media," organized by Outcomes Management Educational
Workshops (Boynton Beach, Fla), was conducted in Rochester, NY. The course
consisted of 3 components: improving diagnostic accuracy (1 hour); improving
familiarity with otitis media diagnostic tests, ie, tympanometry, acoustic
reflexometry, audiometry, and tympanocentesis training (1 hours);
and judicious antibiotic selection strategies (1 hour). To improve diagnosis
skills, participants were shown 30-second video clips of TMs projected on
a large screen. Two example examinations were shown first: (1) a normal TM
(translucent, slightly gray, fully mobile on pneumatic otoscopy, no evidence
of middle ear effusion) and (2) a typical TM from a patient with AOM (bulging,
red, opaque, diminished mobility on pneumatic otoscopy, and middle ear effusion).
The distinguishing features of a normal examination compared with AOM and
OME (gray, retracted, or neutral position, diminished mobility, and middle
ear effusion) were reviewed. Then, 9 sequential video clips of TMs were shown.
The video footage included a 10-second interval in still frame, 10 seconds
with pneumatic otoscopy, and 10 seconds in still frame. All cerumen had been
removed from the external auditory canal prior to filming. The participants
were instructed to record the TM findings in a structured format and to diagnose
the patient with 1 of 4 possible conditions: AOM, OME, retracted but otherwise
normal, and normal. (The correct diagnosis had been previously established
by consensus among an expert panel based on reviewing the video plus tympanometry
and tympanocentesis findings.) Participants were afforded as much time as
necessary for each member in the course to reach a conclusion and record his
or her answers on a digitized personal keypad that was electronically linked
to a laptop computer, thereby creating a database. Active instruction and
interaction between instructor and participants occurred as the correct answers
were reviewed for each diagnostic test.
DESCRIPTION OF THE MANNEQUIN
To assess the skill of otolaryngologists in performing tympanocentesis
and to train pediatricians, a mannequin model was developed and validated.
The mannequin consists of a plastic head and shoulders with an external pinnae
and auditory canal. The caliber, length, and angulation of the external auditory
canal are designed to simulate the anatomical specifications of a 2-year-old
child. The ear canal material is slightly spongy, flesh colored, and moderately
resistant to needle puncture.
A cartridge consisting of 4 simulated TMs is inserted into the head
portion of the mannequin model. A sliding mechanism positions the artificial
TM at an anatomically accurate angle. The TM is engineered to simulate the
appearance and feel of a pop when a tympanocentesis needle or myringotomy
knife is used for penetration. Behind the TM, artificial pus is placed in
the inferior portion of the simulated middle ear space—the recommended
target for tympanocentesis. The anterior inferior quadrant is suggested as
the preferred location (out of concern for safety and the provision of increased
depth before the posterior wall of the middle ear space is encountered during
the aspiration procedure). The superior half of the simulated middle ear space
contains a red dye. This is an area of designated avoidance owing to possible
injury to the malleus, incus, or stapes. At a depth of approximately 5 mm,
a second membrane is present, which prevents access to a second chamber containing
a blue dye. The depth between the TM surface and the second chamber is anatomically
correlated with the depth of the middle ear space in a 1- to 2-year-old child.
Thus, the trainee is instructed to insert the tympanocentesis needle in the
inferior half of the simulated TM with preference to the anterior inferior
quadrant. The trainee is further advised to avoid the superior half of the
TM completely. Finally the trainee is advised that if the tympanocentesis
needle is advanced too far, a blue dye will appear.
HAND POSITIONING
Instruction is provided on hand positioning during the procedure. An
operating head on a handheld otoscope is used. For this simulation, a 20-gauge,
3-in spinal needle is attached to either a 1- or 3-mL syringe. The
needle is bent approximately one third from the hub at a 45° to 90°
angle to allow advancement of the needle via the external auditory canal to
the TM without blockage of visualization through the operating scope magnifying
lens. Each TM cartridge contains 4 artificial TM/middle ear effusion disks
to allow 4 attempts during the training session. Each participant is allowed
15 minutes to complete the 4 tympanocentesis procedures. All participants
are evaluated based on their success with each of the 4 test disks. Each trainee
is also assessed for 3 additional parameters: (1) familiarity with the procedure,
(2) familiarity with instruments, and (3) manual dexterity. For these parameters
the trainee is assessed as below average, passing, or above average.
RESULTS
The sequence of TM video projections, descriptions of the findings,
and the correct diagnoses are presented in Table 1.
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Table 1. Tympanic Membrane (TM) and Middle Ear (ME) Findings as Shown
on the Video Presentation of 9 Patients*
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There were 5 video examinations of patients with OME (ears 1, 2, 5,
6, and 8), 3 of patients with retracted TMs but no effusion (ears 3, 7, and
9), and 1 of a patient with classic AOM (ear 4). Ear 5 was a classic glue
ear (thickened TM, completely immobile on pneumatic otoscopy, thick amber
fluid in the middle ear space). Ear 6, from a patient with OME, had a hypermobile
deep retraction pocket in the superior anterior quadrant.
The percentages of correct diagnoses by specialty and overall are presented
in Table 2. There was remarkable
consistency in the percentages of correct diagnoses within a specialty across
cities where the course was conducted (data not shown). Overall the average
correct diagnosis for pediatricians was 50% and for otolaryngologists it was
73%.
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Table 2. Comparison of Diagnostic Accuracy Between Physician Specialties
of Video-Presented Tympanic Membrane (TM) and Middle Ear Findings*
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In Table 3, the diagnosis
made by the pediatricians is presented for all 9 ears. None of the 9 examination
ears was completely normal and pediatricians recognized the absence of normality
accurately 89% to 100% of the time. For the distinction between AOM (antibiotics
appropriate) and OME or a retracted TM but otherwise normal (antibiotics not
necessary), pediatricians overdiagnosed AOM between 7% and 53% of the time
(mean, 27%). In Table 4, the diagnosis
made by otolaryngologists is presented for all 9 ears. Otolaryngologists recognized
the absence of normality accurately 93% to 100% of the time and overdiagnosed
AOM 3% to 23% of the time (mean, 10%).
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Table 3. Diagnoses by Pediatricians of Video-Presented TM and Middle
Ear Findings*
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Table 4. Diagnoses by Otolaryngologists of Video-Presented TM and Middle
Ear Findings*
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Evaluations of the physicians' familiarity with the procedure and instruments
and manual dexterity are presented in Table
5. Evaluations of the actual tympanocentesis procedure are presented
in Table 6.
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Table 5. Tympanocentesis Skills Assessment*
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Table 6. Tympanocentesis Performance Assessment*
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COMMENT
To assess the ability of pediatricians and otolaryngologists to differentiate
the physical findings of AOM and OME, an examination using video images was
developed as a teaching tool. Among pediatricians, the average rate of misdiagnosis
among 9 ear examinations was 50%. Otitis media with effusion was most frequently
misdiagnosed as AOM and a retracted TM without associated middle ear effusion
was often misdiagnosed as OME. Among otolaryngologists, the average rate of
misdiagnosis was 27%.
The participants in this continuing medical education course did not
have the advantage of a history of symptoms relating to the physical examination
findings displayed in the video images. However, symptoms predicting AOM are
neither sensitive nor specific.12, 13
The video provided a 2-dimensional image for the course participants to assess.
One of the ears was particularly difficult to diagnose (ear number 6) as evidenced
by the percentage of incorrect answers among both pediatricians and otolaryngologists.
The lack of a better depth of field may have influenced diagnostic accuracy.
On the other hand, every video image involved patients whose external auditory
canal was completely cleared of cerumen and each image was shown in total
for 30 seconds. Each video examination included pneumatic otoscopy, which
has been recommended as an important tool to assist diagnostic accuracy of
AOM and OME.3, 14, 15, 16, 17, 18
However, not all pediatricians were familiar with pneumatic otoscopy at the
outset of the teaching sessions, although they became familiar with its use
and interpretation as the examinations proceeded through the 9 test ears.
Given the clarity of the videos and the viewing time allowed, it seems likely
that the rate of accuracy in diagnosing real patients, especially infants
and toddlers, would be less than seen in this training scenario. This further
underscores the magnitude of the problem in diagnosing these conditions.
In 1992, Kaleida and Stool19 described
a validation program to assess accuracy regarding the diagnosis of middle
ear effusion, wherein the otoscopist's examination was validated by middle
ear findings with tympanocentesis. Using this approach, the investigators
found that participants became more accurate in diagnosing the presence or
absence of middle ear effusion. The mean sensitivity and specificity for the
group as a whole were 87% and 74%, respectively. This program produced an
improvement in diagnostic skills but was limited by the large amount of time
required.
There is now an increasingly recognized need for both otolaryngologists
and properly trained/certified primary care physicians to perform tympanocentesis
in office-based settings. The mannequin model was designed to validate competency
among otolaryngologists and to facilitate training among pediatricians. Training
is integrated into an overall educational course. During 1999-2000, more than
3000 participants completed tympanocentesis training.
The American Medical Association level 3 certificate awarded to those
successfully completing training in the course indicates readiness to perform
the procedure on patients under supervision by a proctor. As such, the certificate
is not sufficient qualification for a primary care physician trainee to perform
the procedure. Further instruction should be provided by otolaryngologists,
preferably in the operating room suite during a session of tympanostomy tube
insertions. On a typical morning, if a trainee can perform the procedure on
several patients to the satisfaction of the otolaryngologist, then a letter
of competency could be issued to the trainee.
Performance of tympanocentesis in an office setting can be facilitated
by the use of an otomicroscope. This was not used during the mannequin training
session. The dexterity challenge of the syringe evacuation method of middle
ear effusion can be overcome by attachment of a tympanocentesis needle to
an appropriate collection device (eg, Alden-trap; Storz Instruments, Kansas
City, Mo; or Tymp-Tap; Xomed Surgical, Jacksonville, Fla) hooked to suction.9, 10 In the nonanesthetized patient a papoose
board is recommended for immobilization and a nurse assistant should be present
to stabilize the head firmly and pull back on the pinnae if necessary. Sedation
can be helpful. The use of midazolam hydrochloride has been advocated,6 although in some settings its use mandates direct
nurse observation, pulse oximetry monitoring, and postprocedure observation.
The hypothetical problems of tympanocentesis in an office setting20 are all possible consequences of inadequate full
visualization of the TM and/or inadequate immobilization of the child.6, 9, 11
Simulation technology for health care professional skills training and
assessment has been recommended as the most effective in producing acquisition
and retention of knowledge in the continuing medical education arena. Clearly,
simulation technology is superior to traditional lectures.21
Davis et al22 showed that interactive continuing
medical education sessions that enhanced participant activity and provided
the opportunity to practice skills could affect change in professional practice
and, on occasion, health care outcomes. Didactic sessions do not seem to be
effective in changing physician performance.23
The reasons physicians attend traditional continuing medical education programs
have not been studied extensively. Satisfying inner standards of achievement
and a need to validate knowledge and practices seem to be important reasons.
Postprogram application occurs if participants see the "need to do your job
differently."23 Our program most likely attracted
participants who wanted to confirm that what they were doing was correct23 and 85% responded in a postcourse evaluation that
attendance would very likely change their diagnostic approach to this common
malady.
AUTHOR INFORMATION
Accepted for publication April 26, 2001.
The otoendoscopic video clips were generously provided by Alejandro
Hoberman, MD, and Philly Kaleida, Children's Hospital of Pittsburgh, Pittsburgh,
Pa.
What This Study Adds
The overdiagnosis of AOM occurs with unknown frequency, complicated
by problems in differentiating acute OME. To address the rising bacterial
resistance in AOM, the Centers for Disease Control and Prevention advocates
that tympanocentesis be performed on children who fail 2 sequential antibiotic
courses.
Our study suggests that pediatricians correctly distinguish AOM, OME,
and variations of normal TMs about 50% of the time and otolaryngologists,
73% of the time, based on a simulated video examination. Tympanocentesis training
on an infant mannequin model taught the skill successfully to 83% of pediatricians
and was optimally performed by 89% of otolaryngologists.
From the Departments of Microbiology and Immunology, University of
Rochester School of Medicine and Dentistry, and the Elmwood Pediatric Group,
Rochester, NY (Dr Pichichero); and the Department of Otolaryngology, University
of Texas Medical School, Houston (Dr Poole). Drs Pichichero and Poole are
co-chairs and principals in Outcomes Management Educational Workshops.
Corresponding author: Michael E. Pichichero, MD, University of Rochester
Medical Center, 601 Elmwood Ave, Box 672, Rochester, NY 14642 (e-mail: michael_pichichero{at}urmc.rochester.edu).
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