Impact of the Rapid Diagnosis of Influenza on Physician Decision-
Making and Patient Management in the Pediatric Emergency Department:
Results of a Randomized, Prospective, Controlled Trial
Aleta B. Bonner, DVM, MD*; Kathy W. Monroe, MD*; Lynya I. Talley, PhD§; Ann E. Klasner, MD, MPH*;
and David W. Kimberlin, MD‡
ABSTRACT. Objective. To determine the impact of
the rapid diagnosis of influenza on physician decision-
making and patient management, including laboratory
tests and radiographs ordered, patient charges associated
with these tests, antibiotics/antivirals prescribed, and
length of time to patient discharge from the emergency
department.
Methods. Patients aged 2 months to 21 years present-
ing to an urban children’s teaching hospital emergency
department were screened for fever and cough, coryza,
myalgias, headache, and/or malaise. After obtaining in-
formed consent, patients were randomized to 1 of 2
groups: 1) physician receives (physician aware of) the
rapid influenza test result; or 2) physician does not re-
ceive (physician unaware of) the result. For patients in
the physician aware group, nasopharyngeal swabs were
obtained, immediately tested with the FluOIA test for
influenza A and B, and the result was placed on the chart
before patient evaluation by the attending physician. For
the physician unaware group, nasopharyngeal swabs
were obtained, stored according to manufacturer’s direc-
tions, and tested within 24 hours. Results for the physi-
cian unaware group were not disclosed to the treating
physicians at any time. The 2 resultant influenza-positive
groups (aware and unaware) were compared for labora-
tory and radiograph studies and their associated patient
charges, antibiotic/antiviral prescriptions, and length of
stay in the emergency department.
Results. A total of 418 patients were enrolled, and 391
completed the study. Of these, 202 tested positive for
influenza. Comparison of the 96 influenza-positive pa-
tients whose physician was aware of the result with the
106 influenza-positive patients whose physician was un-
aware of the result revealed significant reductions among
the former group in: 1) numbers of complete blood
counts, blood cultures, urinalyses, urine cultures, and
chest radiographs performed; 2) charges associated with
these tests; 3) antibiotics prescribed; and 4) length of stay
in the emergency department. The number of influenza-
positive patients who received prescriptions for antiviral
drugs was significantly higher among those whose phy-
sician was aware of the result.
From the Divisions of *Pediatric Emergency Medicine, and ‡Pediatric In-
fectious Disease, Department of Pediatrics, and §Medical Statistics Section,
Department of Medicine, University of Alabama at Birmingham, Birming-
ham, Alabama.
Received for publication Dec 20, 2002; accepted May 15, 2003.
Reprint requests to (A.B.B.) Department of Emergency Medicine, Scott &
White Hospital, Texas A&M University Health Science Center, 2401 S 31st
St, Temple, TX 76508. E-mail: abonner@swmail.sw.org
PEDIATRICS (ISSN 0031 4005). Copyright © 2003 by the American Acad-
emy of Pediatrics.
Downloaded from www.aappublications.org/news by guest on September 30, 2018
Conclusions. Physician awareness of a rapid diagno-
sis of influenza in the pediatric emergency department
significantly reduced the number of laboratory tests and
radiographs ordered and their associated charges, de-
creased antibiotic use, increased antiviral use, and de-
creased length of time to discharge. Pediatrics 2003;112:
363–367; pediatric, influenza, physician decision-making,
patient management.
I
nfluenza virus types A and B are common respi-
ratory pathogens in the pediatric population. De-
pending on age, attack rates may be 1.5 to 3 times
higher than for adults, with school-aged children
having the highest attack rates.1,2 A retrospective
cohort study of children under 15 years of age dem-
onstrated outpatient visits attributable to influenza
ranging from 6 to 15 per 100 children.3 Infection with
influenza virus leads to a significant increase in pri-
mary care visits, and also increases in emergency
department utilization during wintertime epidem-
ics.2
Rapid diagnostic test kits for influenza types A
and B are currently available for outpatient use and
have proven to be both sensitive and specific.4 –7 Few
studies have been performed which analyze the im-
pact of rapid diagnostic testing for influenza and
subsequent effect on patient management.8 –11 To
date, there are no prospective, randomized studies
analyzing use of rapid influenza testing and effect on
patient management in the pediatric emergency de-
partment. Rapid diagnostic tests are not currently
routinely incorporated in the work-up of infants and
children with fever and vague symptoms, or with
fever and no documented source.12 Use of rapid tests
in the pediatric emergency department which are
sensitive and specific for influenza could potentially
decrease performance of other more invasive tests,
thereby reducing associated patient charges, reduc-
ing patient length of stay in the emergency depart-
ment, avoiding unnecessary antibiotic usage, and
increasing appropriate antiviral use.
The aim of this randomized, prospective study
was to evaluate the effect of knowledge of a positive
rapid influenza test on physician decision-making
and patient management in the pediatric emergency
department. The hypothesis was that physicians
would alter their decision-making and subsequent
patient management when they were aware of a
positive rapid influenza test before patient evalua-
PEDIATRICS Vol. 112 No. 2 August 2003
363
tion. Analysis of all study participants and the 2- to
36-month aged subgroup was planned as part of the
study design.
METHODS
Study Population
All children who presented to the Children’s Hospital of Ala-
bama emergency department were eligible if they: 1) were be-
tween the ages of 2 months and 21 years; 2) had a temperature of
100.4°F or greater in the emergency department; 3) had cough,
coryza, malaise, headache, and/or myalgias; and 4) had symptom
duration of 72 hours or less. Children with immunosuppression
secondary to drugs, malignancy, or HIV infection, as well as all
transplant recipients, were excluded from enrollment. Addition-
ally, children who had already been evaluated for this illness or
were on antibiotics at the time of evaluation in the emergency
department were ineligible for enrollment.
Following approval by the University of Alabama at Birming-
ham Institutional Review Board, research team members were
stationed at the emergency department triage area and screened
patients for eligibility criteria. If eligibility was met, the study was
described to the patient and parent or legal guardian, and in-
formed consent for participation was obtained.
Study Design
Overview
Rapid diagnostic testing for influenza virus infection is not the
standard of care in our emergency department for evaluation of
patients with fever and flu-like symptoms.
The only option for influenza diagnosis in our institution before
this study was by a viral respiratory panel that is only available
Monday through Friday mornings before 11:30 am. Several weeks
into this study, rapid influenza testing was made available
through our main laboratory; however, lack of physician familiar-
ity with the test and a 1- to 2-hour turnaround time precluded its
routine use in our emergency department patients.
This study was undertaken to determine the impact of the rapid
diagnosis of influenza on physician decision-making and patient
management. Study endpoints included: 1) reduction of antibiotic
prescriptions of 40%; 2) reduction of laboratory and radiograph
charges of 50%; 3) decrease length of time to discharge by 1 hour;
and 4) increase antiviral use by 25%. Sample size calculations were
based on a 40% reduction of antibiotic prescriptions written for
known influenza-positive children. A total of 340 study patients
would be required to meet these objectives.
This randomized, prospective, controlled trial evaluated 2
groups of pediatric patients: group 1, patients whose rapid influ-
enza test results were known by the treating physician; and group
2, patients whose results were not known by the treating physi-
cian. The principal investigator did not provide care for any
patients enrolled in the study in an effort to reduce potential study
bias. All physicians (emergency department and fast track area)
participating in this study are board-certified in pediatrics. All of
the emergency department attending physicians are also sub-
board-certified in pediatric emergency medicine or are engaged in
pediatric emergency medicine fellowship training.
For patients randomized to group 1, nasopharyngeal swabs
were obtained and immediately tested by study personnel using
rapid diagnostic testing for influenza A and B. Test results for this
group were available within 20 to 25 minutes and were placed on
the patient’s chart before evaluation by the attending physician.
Specimens obtained from patients in group 2 were stored accord-
ing to manufacturer’s recommendations and the tests were run
within 24 hours following collection. All study patients received
care in the usual manner by attending physicians in the emer-
gency department, the only difference between groups being
whether or not the physician was given the influenza test result.
Study Period
Influenza virus determination on viral respiratory panels run
by the Children’s Hospital virology laboratory was monitored for
the seasonal appearance of influenza virus in the pediatric com-
munity. Once influenza was documented to be in the community,
patient screening and enrollment was begun. Enrollment began on
364 INFLUENZA DIAGNOSIS AND PHYSICIAN DECISION-MAKING
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January 19, 2002, and ended on March 5, 2002, after conclusion of
the peak influenza season.
Influenza Virus Determination
The FluOIA test by Biostar was used to determine infection
with influenza virus types A or B. The nasopharyngeal swab
method was chosen for the highest combination of sensitivity
(83%–96%) and specificity (64%–76%).7 Each patient had a naso-
pharyngeal swab specimen obtained and tested according to the
manufacturer’s recommendations. Positive and negative test re-
sults were determined by use of the visual key provided within
the test kits. The rapid influenza test results were not confirmed by
other methods. The FluOIA test kits were provided by Biostar, but
all other funding for the study was obtained from the Research
Institute of the Children’s Hospital of Alabama.
Data Collection
Demographic information, including age, gender, and race,
was collected for each patient on enrollment into the study. Indi-
vidual influenza test results were recorded as positive or negative
on the data collection forms. Randomization status was also re-
corded on each individual patient data form. Combination of the
influenza result and randomization status ultimately yielded 4
groups of patients: 1) physician aware of result, influenza-posi-
tive; 2) physician unaware of result, influenza-positive; 3) physi-
cian aware of result, influenza-negative; and 4) physician unaware
of result, influenza-negative. Patient records were obtained after
discharge from the emergency department, and information re-
garding patient disposition, laboratory tests and radiographs or-
dered, antibiotic or antiviral use, and length of stay in the emer-
gency department was recorded on a standardized form for
subsequent data entry.
Telephone follow-up was performed for all patients who were
enrolled and completed the entire study. At least 1 attempt was
made to call the parent or legal guardian approximately 2 weeks
after discharge, and the following patient data were collected: 1)
number of return visits to primary physician or emergency de-
partment for this illness; 2) new prescriptions for this illness; 3)
length of time patient missed school or day care; and 4) length of
time parent or primary caregiver missed work.
Statistical Analysis
Randomization was performed using a computerized random-
ization program, Rancode, in blocks of 4 patients with 2 patients
allocated to each Group, 1 and 2. The computer-generated ran-
domization list was produced for the entire study before study
enrollment, eliminating the ability to maneuver patients into one
group or the other. This block randomization technique was also
used to more equally distribute patients into the 2 groups during
the attending physicians’ shifts, thereby reducing potential for
individual physician treatment bias.
Demographic information was categorized for each of the 4
groups using descriptive methods. The study was designed to
evaluate only infants and children positive for influenza; however,
influenza-negative patients were also analyzed for comparison of
the study endpoints. Comparisons within the groups of influenza-
positive patients and influenza-negative patients were made
based on the randomization status (physician aware vs unaware
of the influenza test result). The Student t test was used to com-
pare means between the groups. For nonparametric methods,
statistical comparisons were made using the Wilcoxon 2-sample
test. All tests of significance were 2-sided using an ␣ of 0.05. All
analyses were performed using SAS Version 8.1 for Windows
(SAS Inc, Cary, NC).
RESULTS
During the 46-day study period, 418 patients were
enrolled into the study. Of these, 22 left before ob-
taining evaluation and treatment, and 5 additional
patients were subsequently found to have exclusion
criteria and thus were excluded from analysis. A
total of 391 patients met enrollment criteria and com-
pleted the entire study. Information regarding pa-
tient demographics, influenza test result, and ran-
domization status is located in Table 1. These 4
groups of patients did not differ significantly for age,
gender, ethnicity, or temperature and respiratory
rate at triage.
There were a total of 202 patients who were influ-
enza positive and completed the emergency depart-
ment visit. Randomization status subdivided these
patients into 2 groups: physician aware of the result
(n ⫽ 96), and physician unaware of the result (n ⫽
106), during the visit. Comparison of these groups
for laboratory tests and radiographs ordered and
their associated charges billed to the patient are
shown in Table 2. Effect of the test result on physi-
cian decision-making and patient treatment with re-
gard to length of time to discharge and type of pre-
scription given is also shown in Table 2. Analysis of
the 189 influenza-negative patients is included in this
table as well.
Within the 391 study patients, there were a total of
241 patients ages 2 to 36 months. Subgroup analysis
of these patients for tests ordered, associated
charges, type of prescription given, and time to dis-
charge is shown in Table 3.
Follow-up of all laboratory tests and chest radio-
graphs was performed to assure that serious bacte-
rial illness was not missed in patients who had pos-
itive influenza test results. There were no influenza-
positive patients in either group who had positive
blood, urine, or cerebrospinal fluid bacterial cultures.
Chest radiographic findings in all of the influenza-
positive patients were read as either1 normal or2
consistent with viral lower respiratory tract disease.
There were no cases of lobar pneumonia.
Telephone follow-up revealed no differences be-
tween the 2 influenza-positive groups for 1) number
of return visits to primary physician or emergency
department for this illness; 2) new prescriptions for
this illness; 3) length of time patient missed school or
day care; and 4) length of time parent or primary
caregiver missed work.
DISCUSSION
This study evaluated the effect of knowledge of an
influenza-positive rapid diagnostic test result on
physician management and treatment of patients
with influenza. It demonstrated that physician
knowledge of rapid diagnostic test results for influ-
enza-positive pediatric patients resulted in signifi-
cant alteration of physician decision-making and
TABLE 1. Patient Demographic Information
MD Aware
FluOIA-Positive
(N ⫽ 96)
Mean age in mo (SD)* 54.0 (50.2)
Median age in mo 35.3
Age range in mo 3.1–220.1
Male/females* 55/41
Ethnicity*
Black 67 (69.8%)
White 26 (27.1%)
Hispanic 3 (3.1%)
SD indicates standard deviation.
* P ⬎ .05 for each parameter in comparing across all 4 groups.
Downloaded from www.aappublications.org/news by guest on September 30, 2018
management of the patient’s illness. Rapid diagnosis
of influenza and physician knowledge of the result
produced significant reductions in tests performed
and their associated charges, decreased antibiotic
use, increased antiviral use, and decreased length of
stay in the emergency department.
The ethics of withholding the test results from
treating physicians for half of the study patients was
considered during the study design. Because rapid
diagnostic testing for influenza was not available in
our institution until several weeks into the study, it
was not standard of care in our emergency depart-
ment. When the rapid influenza test became avail-
able, physicians were able to order it if they chose to
do so, although it was ordered in fewer than 10 study
patients. All study patients received usual and cus-
tomary treatment by the attending physicians.
For patients randomized to physician does not get
the result, specimens were stored and the influenza
test was run within 24 hours. This precluded having
information that was being withheld from treating
physicians that could potentially alter patient care.
Physicians were not aware of patients’ enrollment
into the physician does not receive results study arm
during the patient visit and never received influenza
test results for these patients. There was no coercion
of physicians to alter treatment plans for study pa-
tients in the aware arm.
Physicians knew before initiation of the study that
we would be evaluating differences in treatment be-
tween the aware and unaware groups of patients.
There were no physicians who refused to participate
in the study. The study hypothesis and specific aims
were not discussed with the physicians in an effort to
reduce introduction of management and treatment
bias between the groups of patients.
Traditional diagnosis of influenza by viral culture
or polymerase chain reaction is too lengthy to be
useful in generating treatment options. Recent ad-
vances in technology have led to development of
rapid diagnostic tests that are both sensitive and
specific for diagnosis of influenza types A and B.4 –7
To date, rapid diagnostic testing has not been incor-
porated into guidelines for the evaluation of febrile
infants and young children.12 Factors such as lack of
physician familiarity with rapid diagnostic test tech-
nology, cost of the test, reimbursement issues, and
performance of tests in non-Clinical Laboratory Im-
MD Unaware MD Aware MD Unaware
FluOIA-Positive FluOIA-Negative FluOIA-Negative
(N ⫽ 106) (N ⫽ 97) (N ⫽ 92)
42.1 (47.2) 46.4 (51.9) 51.4 (52.6)
26.9 25.3 30.4
2.5–221.3 2.7–202.9 2.3–212.7
58/48 54/43 43/49
86 (81.1%) 72 (74.2%) 67 (72.8%)
17 (16.0%) 22 (22.7%) 22 (23.9%)
3 (2.8%) 3 (3.1%) 3 (3.3%)
ARTICLES 365
TABLE 2. Tests Performed, Associated Charges, Prescriptions, and Time to Discharge for All Participants
MD Aware MD Unaware P Value MD Aware MD Unaware P Value
FluOIA-Positive FluOIA-Positive FluOIA-Negative FluOIA-Negative
(N ⫽ 96) (N ⫽ 106) (N ⫽ 97) (N ⫽ 92)
Complete blood count 0 13 ⬍.001 13 7 .196
Blood culture 0 11 ⬍.001 12 6 .172
Urine dipstick 4 7 .543 7 7 .918
Urinalysis 2 12 .011 10 8 .706
Urine culture 3 14 .011 12 5 .096
Cerebrospinal fluid studies/culture 0 2 .499 3 2 .695
Chest radiograph 7 26 .001 22 23 .708
Mean charge/patient (laboratory and $15.65 $92.37 ⬍.001 $93.07 $68.91 .871
radiograph)
Antibiotic prescriptions 7 26 ⬍.001 27 27 .818
Antiviral prescriptions 18 7 .02 0 2 .236
Mean time in minutes: (from patient 25 49 ⬍.001 45 42 .549
examined by attending to discharge)

TABLE 3. Tests Performed, Associated Charges, Prescriptions, and Time to Discharge for Patients Ages 2 to 36 Months
MD Aware MD Unaware P Value MD Aware MD Unaware P Value
FluOIA-Positive FluOIA-Positive FluOIA-Negative FluOIA-Negative
(N ⫽ 52) (N ⫽ 74) (N ⫽ 62) (N ⫽ 53)
Complete blood count 0 10 .005 11 7 .505
Blood culture 0 9 .010 10 6 .458
Urine dipstick 3 4 1.000 3 4 .702
Urinalysis 1 11 .015 6 5 .965
Urine culture 2 11 .072 8 5 .558
Cerebrospinal fluid studies/culture 0 2 .511 3 1 .623
Chest radiograph 5 21 .010 20 17 .983
Mean charge/patient (laboratory and $16.86 $107.04 .003 $121.23 $94.79 .791
radiograph)
Antibiotic prescriptions 4 23 .002 23 21 .781
Antiviral prescriptions 5 3 .273 0 0 N/A
Mean time in minutes: (from patient 24 47 ⬍.001 46 44 .220
examined by attending to discharge)

provement Amendments settings are possible rea-
sons for lack of use of these tests.
Morbidity associated with influenza is primarily in
the form of upper and lower respiratory tract dis-
ease. Otitis media is a common finding with influ-
enza infection and occurs in 20% to 42% of chil-
dren.13,14 Children with influenza often appear quite
ill and present with a variety of symptoms. In the
setting of the emergency department, ill-appearing
infants and children with fever and vague symptoms
often have extensive testing performed to rule out
serious bacterial illnesses such as bacteremia, pneu-
monia, meningitis, and urinary tract infection. Com-
plete blood counts, urinalyses, blood cultures, lum-
bar punctures, and radiographs are frequently
performed to diagnose these illnesses, especially in
infants and younger children.12 These tests have the
potential to significantly add to total patient charges
and length of stay in the emergency department. One
retrospective study demonstrated that fewer com-
plete blood counts and urinalyses were ordered
when patients were known to be influenza-positive
before discharge from the emergency department.11
Our study confirms that there was a significant re-
duction in tests ordered and their associated charges
when the physician had knowledge of the influenza-
positive result. This was true for all study partici-
pants as well as the subgroup of patients 2 to 36
months of age.
Obtaining laboratory tests and radiographs in any
age group would be expected to increase length of
stay in the emergency department. In a teaching
institution where both a resident and attending phy-
sician sees the patient, it is difficult to measure over-
all length of stay in the emergency department be-
cause of the numerous factors that influence patient
flow. In our institution, it is customary for a resident
to see the patient and then check out to an attending
physician, who is ultimately responsible for patient
management and disposition. For these reasons, we
chose to measure the length of time from when the
patient was first seen by the attending until dis-
charge from the emergency department. We demon-
strated a significant decrease in the length of time
from when initially seen by an attending physician
until discharge from the emergency department in
the patients with influenza for whom the physician
received the result.
Several studies have shown that patients with doc-
umented influenza infection have fewer antibiotics
administered, thus reducing indiscriminant antibi-
otic use in proven viral illness.10,11 Decreased side
effects and reduction in emergence of antibiotic re-
sistance would naturally follow. Other investigators
have demonstrated even further reduction in antibi-
otic use with appropriate diagnosis of influenza and
use of antiviral agents early in the disease course.15
We observed statistically significant differences not
only in tests ordered and their associated charges,
but also demonstrated a significant decrease in anti-

366 INFLUENZA DIAGNOSIS AND PHYSICIAN DECISION-MAKING

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biotic prescriptions between the influenza-positive
groups where the differentiating variable between
them was physician knowledge of the test result.
Subgroup analysis of the 2 to 36 month age influen-
za-positive groups for antibiotic prescriptions also
reached statistical significance. With substantial lit-
erature on antibiotic resistance and because of in-
creasing pressure to utilize antibiotics only for
proven bacterial disease, diagnosis of viral illness
becomes more paramount to decrease inappropriate
antibiotic usage.
Increased appropriate use of antiviral agents
should also occur in patients with known influenza
infection. Currently available antiviral agents for use
in children include oseltamivir, zanamivir, amanta-
dine, and rimantadine.16 Use of these agents has
been proven to hasten resolution of illness, but effec-
tive utilization requires that the child be started on
appropriate therapy within 48 hours of symptom
onset.15,17
The older antiviral agents, amantadine and riman-
tadine, are synthetic cyclic amines with activity
against influenza A and have the advantage of being
relatively inexpensive. Disadvantages to these drugs
include rapid development of viral resistance, inef-
fectiveness against influenza B virus, and adverse
effects such as nervousness, jitteriness, and confu-
sion. Newer agents are the neuraminidase inhibitors
zanamivir and oseltamivir, which inhibit replication
of both influenza A and B viruses. Zanamivir comes
as an inhalational powder and is approved for use in
patients 7 years and older. Oseltamivir is formulated
as both a capsule and a suspension and is licensed for
use down to 1 year of age.
Our study demonstrated a significant increase in
antiviral use in known influenza positive patients.
However, oseltamivir suspension was not produced
for use in the 2001–2002 influenza season, which
possibly resulted in fewer overall prescriptions being
written for antiviral agents. Attending physicians
who cared for known influenza-positive patients
cited the side effect profiles and antiviral resistance
as 2 major reasons for reluctance in prescribing
amantadine and rimantadine.
The major limitation of this study was the rela-
tively small number of influenza positive patients in
the 2 to 36 month age group. Because this age group
is most frequently targeted for testing for serious
bacterial illness, one would suspect that differences
in physician management of these patients could be
altered by having knowledge of the test result. Even
with smaller numbers of patients within these
groups, significant differences were noted between
the influenza-positive groups for many of the out-
Downloaded from www.aappublications.org/news by guest on September 30, 2018
come variables. This suggests that further study of
this subpopulation is warranted to determine the
potential for use of rapid diagnostic testing in
younger febrile children.
Our study demonstrates that rapid diagnostic test-
ing for influenza has a basis for use in the point of
care environment to reduce numbers of tests ordered
and their associated charges, decrease antibiotic use
for proven viral illness, decrease length of stay in the
emergency department, and increase appropriate an-
tiviral use in the pediatric population.
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ARTICLES 367
Impact of the Rapid Diagnosis of Influenza on Physician Decision-Making and
Patient Management in the Pediatric Emergency Department: Results of a
Randomized, Prospective, Controlled Trial
Aleta B. Bonner, Kathy W. Monroe, Lynya I. Talley, Ann E. Klasner and David W.
Kimberlin
Pediatrics 2003;112;363
DOI: 10.1542/peds.112.2.363

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Impact of the Rapid Diagnosis of Influenza on Physician Decision-Making and
Patient Management in the Pediatric Emergency Department: Results of a
Randomized, Prospective, Controlled Trial
Aleta B. Bonner, Kathy W. Monroe, Lynya I. Talley, Ann E. Klasner and David W.
Kimberlin
Pediatrics 2003;112;363
DOI: 10.1542/peds.112.2.363

The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://pediatrics.aappublications.org/content/112/2/363

Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it
has been published continuously since 1948. Pediatrics is owned, published, and trademarked by
the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois,
60007. Copyright © 2003 by the American Academy of Pediatrics. All rights reserved. Print ISSN:
1073-0397.

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