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The Impact of Empirical Management of Acute Cystitis on Unnecessary Antibiotic Use
Warren J. McIsaac, MD, MSc;
Donald E. Low, MD;
Anne Biringer, MD;
Nicholas Pimlott, MD, PhD;
Michael Evans, MD;
Richard Glazier, MD, MPH
Arch Intern Med. 2002;162:600-605.
ABSTRACT
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Background Guidelines for the management of acute cystitis support empirical antibiotic
treatment; however, up to half of symptomatic women have negative urine cultures.
Objective To determine whether empirical treatment leads to unnecessary antibiotic
prescriptions in women with symptoms of acute cystitis.
Methods A cohort of 231 women (defined as females aged 16 years and older) presenting
to family physicians' offices with symptoms of cystitis underwent a standardized
clinical assessment, urine dip testing, and culture. Recommendations for urine
testing and antibiotic treatment under 3 empirical strategies were compared
with observed physician management and a logistic regression model for the
outcomes of antibiotic prescriptions, urine culture testing, and unnecessary
antibiotics, defined as a prescription where the subsequent urine culture
was negative.
Results There were 123 positive urine cultures (53.3%). Physicians prescribed
antibiotics to 186 women (80.9%), of whom 74 (39.8%) were culture negative.
Unnecessary antibiotic use was similar for 2 guidelines recommending empirical
antibiotic treatment without testing for pyuria (41.4% and 40.6%). Treating
women with classic cystitis symptoms and pyuria would have decreased unnecessary
antibiotic use (26.2%; P = .02) but resulted in fewer
women with confirmed urinary tract infection receiving immediate antibiotics
(66.4% vs 91.8% usual care; P<.001). A derived
prediction model incorporating testing for pyuria and nitrites would also
have reduced unnecessary antibiotic use (27.5%; P
= .03), but more women with confirmed urinary tract infection would have received
immediate antibiotics (81.3%; P = .01).
Conclusions Empirical antibiotic treatment of acute cystitis in women without testing
for pyuria promotes unnecessary antibiotic use. A simple decision rule provides
for prompt treatment of infected women while reducing antibiotic overuse and
unnecessary urine testing.
INTRODUCTION
URINARY TRACT infections (UTIs) account for 0.9% to 2.1%1-2
of an estimated 700 million office visits each year in the United States.3 An antibiotic is prescribed in 58% of encounters,
representing 5% of all antibiotic prescriptions to adults.4
In recent years, antibiotic resistance among common uropathogens has been
increasing.5 At the same time, physicians have
been advised that empirical antibiotic treatment without culture is appropriate
in cases of uncomplicated UTI.6-8
The majority of these occur in women; however, up to half of women with symptoms
suggestive of UTI do not demonstrate significant bacteriuria on culture.9-12 As
a result, empirical treatment may promote unnecessary antibiotic use, which
has been associated with increased levels of antimicrobial resistance.13-17
To assess the impact of empirical management of uncomplicated UTI on
antibiotic use, a cohort of women presenting to family physicians with symptoms
suggesting a UTI were assessed. Recommendations from 3 empirical strategies6-7,18 were applied retrospectively
to the cohort to determine what would have been the rates of antibiotic prescribing
and unnecessary antibiotic use had physicians followed these recommendations.
The latter was defined as prescriptions of antibiotics to women with negative
urine cultures. The empirical management strategies were then compared with
the actual care provided by the study physicians. In addition, we sought to
determine whether any other combination of clinical findings and urine testing
were more helpful in guiding initial prescribing decisions.
SUBJECTS AND METHODS
The study took place in 4 urban academic family medicine clinics affiliated
with the Department of Family and Community Medicine of the University of
Toronto, Toronto, Ontario. These clinics have more than 70 full- and part-time
physician staff, 52 residents, and in excess of 150 000 patient visits
per year. The cohort of women was prospectively enrolled between January 1,
1998, and January 7, 2000. Women (defined as females aged 16 years and older)
presenting with urinary tract symptoms for which the treating physician considered
UTI a possible diagnosis were eligible for the study. No attempt was made
to further define an eligible case, to encourage physicians to enroll cases
representative of their usual practice.19 The
study was explained to eligible women by a research assistant or a nontreating
physician, and consent was obtained. Ethics approval for the study was obtained
from the University of Toronto research ethics board.
Physicians completed a standardized clinical assessment to determine
symptoms, risk factors for UTI,20-21
and physical findings. Patients were excluded if they had been taking antibiotics
in the previous 7 days, were immunocompromised, were pregnant, or were following
up a previously diagnosed UTI. A urine sample was obtained for dipstick testing
with leukocyte esterase and nitrite test strips (Multistix 5; Bayer, Inc,
Etobicoke, Ontario) and submitted for culture. Urine cultures were processed
at the usual laboratory to which the clinics referred their samples. These
included 3 tertiary care academic teaching hospitals and 1 commercial laboratory.
The gold standard for a diagnosis of a UTI was a positive culture with more
than 100 000 colonies of a single organism per milliliter, or 102 to 105 colonies of coliform organisms per milliliter.6 At the time of the initial visit, and before culture
results were available, physicians recorded their diagnosis and treatment
decisions. The physicians were free to treat patients in their usual fashion.
For each woman, the recommendations from 3 strategies recommending empirical
antibiotic treatment were applied retrospectively on the basis of the presenting
clinical findings and the results of the urine dip testing, where relevant.6-7,18 Stamm and Hooton6 recommended empirical treatment without the need for
urine cultures in patients with typical symptoms (defined as dysuria, frequency,
and urgency) and pyuria, either microscopically or on leukocyte esterase testing.
The Group Health Cooperative of Puget Sound introduced a clinical guideline
in their health maintenance organization that offered telephone treatment
without urine testing, or an office visit, to women with symptoms of dysuria
or urgency.7 Those accepting telephone management
were offered antibiotic treatment, while those requesting an office visit
were treated at the discretion of the health care provider.
The Protocol Steering Committee of the British Columbia Medical Association
recommended no testing for patients with classic symptoms of a UTI (not defined)
where the physician planned to prescribe an antibiotic.18
If a suspected UTI was not initially treated, a culture was recommended if
there was either pyuria or nitrites. For all 3 strategies, it was assumed
that a urine culture would be ordered where an antibiotic was not prescribed
or dip testing was positive, as appropriate to the particular approach. The
culture results from groups of women with similar symptoms or dipstick findings
in the cohort were used to determine what culture results would have been
under these strategies.
We also assessed whether any other combination of clinical and urine
dip test findings was more predictive of a positive urine culture. The association
of individual clinical findings and dipstick results with culture results
was assessed by means of a  2 or Fisher exact test as appropriate.
Variables associated with a positive urine culture (P<.25)
were retained for multivariate modeling by means of backward stepwise multiple
logistic regression.22-23 The
final model retained only variables that were independently associated with
the outcome of a positive urine culture (P<.05).
Recommendations for empirical antibiotic use and urine culture testing were
developed on the basis of the probability of a positive urine culture and
compared with the other strategies.
The sensitivity and specificity of each strategy and of observed physician
management was determined in relation to the decision to initiate antibiotics.
If a strategy recommended immediate antibiotic therapy and the culture result
was positive, then the prescribing decision was considered appropriate (sensitivity
of the prescribing decision). If an antibiotic was not recommended and the
urine culture was negative, then this was considered appropriate for a negative
case (specificity). An antibiotic prescription was classed as unnecessary
if the subsequent urine culture result was negative.
The outcomes assessed, therefore, were antibiotic prescriptions, unnecessary
antibiotics, urine culture use, and the sensitivity and specificity of each
strategy. These outcomes were determined for the 3 empirical treatment strategies
(classic symptoms and pyuria,6 Puget Sound
guideline,7 and British Columbia Protocol Steering
Committee guideline18) and the derived management
approach (logistic model), and compared with actual treatment of the cohort
of women by the physicians (usual care) by means of a 2 test.
The sample size calculation determined that 108 persons with infection
were needed to detect whether any combination of dipstick testing and clinical
findings had a sensitivity for identifying a positive urine culture of at
least 90%, with the lower 95% confidence interval (CI) being no less than
75% and 90% power.24 A pilot study found a
prevalence of infection of 46% in this setting, so that the sample size was
estimated to be 235.
RESULTS
A total of 231 women were assessed. The average age of these women was
43.9 years (range, 20-92 years). More than half were married or in common-law
relationships and had had a previous history of a UTI (Table 1). Thirty-six women (17.5%) came to the office after 1 day
of symptoms, approximately one third (72/206) presented within 2 days, and
one third (72/206) waited more than 5 days. More than 80% of women asked (119/143)
thought they had a UTI, and almost three quarters thought they needed an antibiotic.
The most frequent symptoms were frequency (85.7%), dysuria (78.4%), and urgency
(77.5%). The physicians' diagnosis was UTI in 92.3% of cases. This was somewhat
higher (>95%) if there was dysuria, with or without other symptoms. An antibiotic
was prescribed to 186 women (80.9%) (including 6 cases of a delayed prescription
pending culture results). The prevalence of UTI in this population was 53.3%.
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Table 1. Risk Factors for and Symptoms of Acute Cystitis in 231 Women:
Association With a Positive Urine Culture*
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A positive urine culture was more likely if symptoms had been present
for only 1 day, there was dysuria, the patient reported hematuria or intercourse
within the previous week, the patient thought she had a UTI, or the physician
diagnosed a UTI (all P<.05). A negative culture
result was somewhat more likely if the woman reported vaginal discharge (P = .07). All urine dip test results were associated with
being more likely to have a positive culture. Variables associated with a
positive urine culture (P<.25) were entered into
a backward stepwise multiple logistic regression model. Patients' views as
to whether a UTI was present were not included because of missing data.
Factors independently associated with a positive culture were symptoms
for only 1 day (odds ratio [OR], 2.83; 95% CI, 1.07-7.45), burning or discomfort
on urination (OR, 3.97; 95% CI, 1.66-9.50), postvoid urgency (OR, 0.45; 95%
CI, 0.21-0.98), a positive leukocyte test (>trace) (OR, 2.38; 95% CI, 1.16-4.85),
a positive nitrite test (OR, 5.49; 95% CI, 1.89-15.99), and blood on dip testing
(>trace) (OR, 2.35; 95% CI, 1.14-4.84). Postvoid urgency was dropped from
the model, as the direction of the association lacked clinical sensibility
and the univariate association was weak. Blood on dip testing was also dropped,
as the reduced model without this factor was found to perform as well. The
area under the receiver operating characteristic curve for the 4 remaining
variables was 0.79.
Table 2 shows the rate of
positive urine cultures in relationship to the number of these 4 clinical
characteristics present. Fewer than 2 findings were associated with a relatively
low rate of positive cultures (15.8%-27.9%), whereas 2 or more characteristics
were associated with a high positive culture rate (62.9%-100.0%; P<.001). Therefore, a management algorithm was devised suggesting
that a urine culture be obtained where fewer than 2 of the 4 characteristics
were present and antibiotic treatment without culture be given for those with
2 or more findings (UTI rule).
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Table 2. Number of Clinical Findings Derived From Multiple Logistic
Regression (Symptoms for 1 Day, Dysuria, Positive Leukocyte* or Positive Nitrite
Test) and Rate of Positive Urine Cultures
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Figure 1 illustrates how prescribing
rates were estimated for each empirical strategy, using the Puget Sound algorithm
as an example. Three women with a final diagnosis of pyelonephritis were excluded
and 39 who reported a vaginal discharge were not considered eligible for telephone
management, as per the algorithm.7 In a previous
report,7 40% of women accepted telephone management
and were considered to have been prescribed antibiotics. Applying this percentage
would result in 69 women in the current cohort receiving telephone treatment
and 104 requesting an office visit. Physicians in the current study prescribed
antibiotics to 85.5% of women presenting with dysuria or urgency. Applying
this to the estimated 60% of women who would be seen by physicians at an office
visit under the Puget Sound guideline would mean 88.9 women would receive
antibiotics. The positive culture rate was 60.5% for women with similar symptoms
in the cohort (estimate of 53.8 of 88.9 persons) compared with 32.0% where
physicians did not immediately prescribe antibiotics (or 4.8 of 15 persons).
Those latter women were assumed to have undergone urine culture testing. The
estimated numbers of persons in each category of Figure 1 have been rounded to the nearest whole number for convenience.
This approach was also followed for women without dysuria or urgency, or reporting
vaginal discharge. The other empirical management strategies were similarly
evaluated.
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Culture results and antibiotic prescription rates from the cohort
of women subjected to the Puget Sound guideline for managing uncomplicated
urinary tract infection in women.7 Three women
with pyelonephritis were excluded from the eligible group.
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Table 3 summarizes the antibiotic
use, unnecessary antibiotic prescriptions, culture use, and the sensitivity
for identifying UTI of all strategies compared with observed physician management
(usual care). All strategies would have reduced urine culture testing compared
with usual physician care (P<.01). Both treating
classic symptoms with pyuria and the UTI rule would have reduced unnecessary
antibiotic use compared with usual care (34% and 31% reductions, respectively; P<.05). The Puget Sound and British Columbia Protocol
Steering Committee guidelines were the most sensitive for treatment of UTI
at initial presentation before culture results, but were the least specific,
resulting in high levels of unnecessary antibiotic use similar to that observed
for usual care. Following the classic approach or the derived management algorithm
would have reduced initial antibiotic prescriptions by 40% and 26%, respectively
(P<.001), and urine culture testing by 40% and
54%, respectively (P<.001). The UTI rule had a
significantly higher sensitivity for treating subsequently confirmed UTI cases
at initial presentation (81.3%) than did the classic approach (66.4%; P = .01).
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Table 3. Impact of Various Empirical Strategies for Managing Acute
Cystitis in Women on Urine Testing and Antibiotic Use Compared With Usual
Physician Care (N = 231)*
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COMMENT
There is wide variation in how physicians manage acute uncomplicated
cystitis. In one study, physicians proposed 82 different treatment regimens.25 Half reported they would treat typical UTI symptoms
over the telephone, whereas the other half would not. Another study comparing
microbiologists, urologists, and general practitioners found similar variations
in management and concluded, "there is a need for evidenced-based rather than
consensus-directed guidelines."26
Empirical antibiotic treatment of acute, uncomplicated cystitis has
been advocated on the basis of the predictable set of pathogens that are found6 and the high rate of negative, and therefore unnecessary,
urine cultures that are submitted.18 Empirical
treatment can help to decrease unnecessary urine testing.7
However, guidelines and treatment recommendations need to be evaluated for
their impact on a variety of clinical outcomes.27
We found that, although empirical management can reduce the number of unnecessary
urine cultures substantially, some strategies are associated with high levels
of unnecessary antibiotic use. Given the accumulating evidence of a causal
relationship between antibiotic resistance and antibiotic overuse,13-17
the impact of empirical management on unnecessary antibiotic use is an important
consideration.
Antibiotic resistance is a growing problem in urinary tract infections.5, 28 Escherichia coli, which accounts for up to 80% of uncomplicated cystitis in young women,6 demonstrates resistance to trimethoprim-sulfamethoxazole
in up to 18% of isolates, and 38% are resistant to ampicillin.5
Sulfamethoxasole-trimethoprim is frequently recommended as first-line therapy.6-7,29 A Welsh study compared
rates of antibiotic resistance in urinary tract isolates from different community-based
groups of general practitioners and found a direct correlation between rates
of antibiotic resistance and community rates of antibiotic prescribing.30 If further resistance among uropathogens is to be
limited, treatment strategies that reduce unnecessary antibiotic use need
to be encouraged.
It is also relevant that women with uncomfortable symptoms due to UTI
receive timely antibiotic treatment. Although usual physician management and
2 empirical strategies7, 18 resulted
in the greatest number of women receiving immediate antibiotic treatment,
the severity of their symptoms and willingness to wait for culture results
was not directly assessed. We observed that 35% of women waited more than
5 days before visiting their physician, suggesting that some were perhaps
less bothered by their symptoms and may have been willing to wait for culture
results. The use of classic symptoms and pyuria proposed by Stamm and Hooton6 resulted in the fewest women with UTI receiving antibiotics
immediately. However, the original description of this approach also included
abrupt onset and severe symptoms as being relevant to the diagnosis of cystitis.6 We were not able to model these factors with this
cohort and so may have underestimated the sensitivity of this approach.
The management algorithm derived by means of logistic regression modeling
(UTI rule) would have reduced urine culture testing compared with usual care
and the classic approach. It would also have reduced unnecessary antibiotic
use compared with usual care and the Puget Sound and British Columbia protocols
and resulted in more women with positive urine cultures being treated immediately
with antibiotics than would the classic approach. The UTI rule also allows
for telephone treatment if women have symptoms for 1 day and dysuria. Komaroff
et al31 were among the first to propose that
explicit clinical strategies could help improve the cost and quality of medical
care with the use of UTI as the model. However, their algorithm and another
decision rule32 are somewhat more complex,
which may be less appealing to busy practitioners.
Prediction rules have been proposed as a method for incorporating research
evidence into practice.33 However, validation
in independent patient populations is a prerequisite,34
as they may not perform well if the disease prevalence in the new setting
differs from that in the population in which the prediction rule was originally
derived.35-36 We found that the
prevalence of positive cultures in this study was similar to reports in other
general practice settings.9-12
Antibiotic prescribing by these family physicians was also similar to the
82% to 86% reported in other studies.37-38
A Canadian study had a somewhat lower prescribing rate (63%) but also included
children.39 Although such observations suggest
that the algorithm will likely perform similarly in other general and family
practice clinics, the validity of the algorithm still requires independent
confirmation.
Guidelines recommending empirical treatment of women presenting to family
physicians with symptoms suggestive of an uncomplicated UTI without urine
testing result in high rates of unnecessary antibiotic use. In the face of
emerging antibiotic resistance among uropathogens,5, 28
these strategies require reevaluation. The use of classic symptoms combined
with testing for pyuria limits unnecessary antibiotic use but may leave symptomatic
women untreated until urine culture results are available. The simple UTI
decision rule described in this article results in prompt treatment of most
infected women and, at the same time, limits unnecessary urine culture testing
and antibiotic prescriptions. The rule requires validation in an independent
population, and its acceptability to patients needs to be assessed, as some
women will be advised to delay antibiotic treatment until culture results
are available.
AUTHOR INFORMATION
Accepted for publication July 17, 2001.
This study was supported by the physicians of the province of Ontario
through grant 98-051 from the Physicians' Services Inc Foundation, Toronto.
We thank Joanne Permaul for assistance with data collection and entry.
Corresponding author: Warren J. McIsaac, MD, MSc, Mt Sinai Family
Medicine Centre, 600 University Ave, Room 413, Toronto, Ontario, Canada M5G
1X5 (e-mail: mcisaac{at}mtsinai.on.ca).
From the Mt Sinai Family Medicine Centre (Drs McIsaac and Biringer)
and Department of Microbiology (Dr Low), Mt Sinai Hospital, Family Healthcare
Research Unit, Department of Family and Community Medicine (Drs McIsaac, Pimlott,
Evans, and Glazier) and Department of Laboratory Medicine and Pathobiology
(Dr Low), University of Toronto, Department of Microbiology, The Toronto Hospital
(Dr Low), Family Medicine Unit, Women's College Hospital (Dr Pimlott), Family
Medicine Unit, University Health Network–Toronto Western Division, Toronto
(Dr Evans), and Department of Family and Community Medicine and Inner City
Health Research Unit, St Michael's Hospital (Dr Glazier), Toronto, Ontario.
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