CRITICAL APPRAISAL

EBM THERAPY I
KELOMPOK A13
GENITOURINARY SYSTEM
2012

Optimal Duration of Antibiotic

Therapy for Uncomplicated Urinary
Tract Infection in Older Women : A
Double-Blind Randomized Controlled
Trial
Thomas Vogel, Rene Verreault, Marie Gourdeau,
Michele Morin, Lisa Grenier-Gosselin, Louis
Rochette

ABSTRACT
Background
The optimal duration of antibiotic therapy in older
patients with uncomplicated urinary tract infection (UTI)
is still a matter of debate. The aim of this randomized
controlled double-blind non-inferiority trial was to
compare that efficacy and safety of 3-day and 7-day
courses of oral ciprofloxacin for uncomplicated
symptomatic UTI in older women.

Methods
A total of 183 women at least 65 years old of age with
acute uncomplicated UTI were recruited from
ambulatory clinics and hospital acute care units. Patients
with pyelonephritis, contraindications to
fluoroquinolones, recent use of antibiotics, urinary tract
abnormalities, and diabetes mellitus were excluded.
Double-blind procedures were maintained throughout

ABSTRACT
Results
The proportion of patients with bacterial eradication
at 2 days after treatment was 98% in the 3-day
group and 93% in the 7-day group. The frequency
of adverse events, including drowsiness, headache,
nausea or vomiting, and loss of appetite, was
significantly lower in the 3-day group.

Interpretation
These results suggest that 3-day course of
antibiotic therapy is not inferior to a 7-day course
for treatment of uncomplicated symptomatic UTI in
older women, and that the shorter course is better
tolerated.

EBM THERAPY
WORKSHEET
Validity Importance Applicability

EBM Therapy Worksheet - Validity

ARE THE RESULTS OF THIS SINGLE

PREVENTIVE OR THERAPEUTIC TRIAL
VALID ?

Was the assignment of patients

to treatments randomized ?

Yes. The trial was using a

computer-generated
randomization.

Was the randomization list

concealed ?
Yes. The subjects codes were sealed
in individual envelopes, which were
kept by the study statistician and
revealed to the researchers only after
recruitment, data collection and
laboratory analyses were complete.
No envelope had to be opened for
safety reasons during data collection.

Was follow-up of patients

sufficiently long and complete?

Yes. There is a follow-up

protocol that was held 2 days
after completion of treatment.

Were all patients analyzed in

the groups to which they were
randomized ?
Yes. The trial is using an
intention-to-treat analysis,
even there was 1 subject being
excluded soon after
randomization because of
immunosuppression.

Were patients, clinicians, and

study personnel kept blind to
treatment ?

No. In Methods, it was written

that the study design of the
trial was double-blinded,
randomized controlled trial.

Were the groups treated

equally, apart from the
experimental treatment ?
Yes. To evaluate the long-term risk of
relapse, subjects were visited 6 weeks
after randomization. This visit
included collection of urine for
urinalysis and culture, as well as as
short interview about presence of
urinary symptoms and history of UTI
and antibiotic use in the preceding
weeks.

Were the groups similar at the

start of the trial apart from the
experimental therapy ?

Yes. There are baseline

characteristics for subjects to
be included into the trial.

EBM Therapy Worksheet - Importance

ARE THE VALID RESULTS

OF THIS RANDOMIZED
TRIAL IMPORTANT ?

YES

NO

TOTAL

EXPERIMENTA
L
SUBJECTS

88

93

CONTROL
SUBJECTS

81

89

What is the magnitude of the

treatment effect ?
Most often results are
presented as dichotomous
outcomes.
RR = 0.054/0.089 = 0.61
The treatment decreases the
risk of death.

How precise is the estimate of

the treatment effect ?
The true risk of the outcome in the
population is not known and the best
we can do is to estimate the true risk
based on the sample of the patients in
the trial, which is called the point
estimate, by looking through the
confidence interval. If the confidence
interval is fairly narrow then we can be
confident that our point estimate is a
precise reflection of the population
value.

Calculations
Relative Risk Reduction (RRR)
Risk of the outcome in the treatment group / risk of
the outcome in the control group.
The RRR is the complement of the RR and is
probably the most commonly reported measure of
treatment effects. It tells us the reduction in the
rate of the outcome in the treatment group relative
to that in the control group.
Absolute Risk Reduction (ARR)
Risk of the outcome in the control group risk the
outcome in the treatment group. Also known as
Absolute Risk Differences. The ARR tells us the
absolute difference in the rates of events between
the two groups and gives an indication of the
baseline risk and treatment effects. An ARR of 0
means that there is no difference between the two
group thus, the treatment had no effect.

Calculations
Number Needed to Treat
Inverse of the ARR and is calculated as 1/ARR.
The NNT represents the number of patients we need
to treat with the experimental therapy in order to
prevent 1 bad outcome and incorporates the duration
of treatment.

CALCULATIONS

CER

EER

0,089 = 0,054 =
8,9%
5,4%

RRR

ARR

NNT

CER
EER
CER

CER EER

1/ARR

40%

0.036

28

95% CI

INTERPRETATION
RRR = 0.40 = 40%
The treatment reduced the risk of
death by 40% relative to that
occurring in the control group.
ARR = 0,036 = 3,6%
The absolute benefit of the
treatment is 3,6% reduction in the
death rate.
NNT = 28
We would need to treat 28 people
in order to prevent 1 death.

EBM THERAPY WORKSHEET - APPLICABILITY

CAN YOU APPLY THIS VALID,

IMPORTANT EVIDENCE ABOUT THERAPY
IN CARING FOR YOUR PATIENT ?

Do these results apply to our

patients ?
Yes.
Is our patient so different from
those in the study that its
results cannot apply ?
No.

Is the treatment feasible in our

setting ?

Yes.

What are our patients potential

benefits and harms from the
therapy ?
Method I = f
Risk of the outcome in our
patient, relative to patients in
the trial.
Expressed as a decimal = 1
NNT / f = 28/1 = 28

What are our patients potential

benefits and harms from the
therapy ?
Method II = 1/(PEER x RRR)
Our patients expected event
rate if they received the control
treatment (PEER) = 0,054
1/(PEER x RRR) = 1/(0.054 X
0.4) = 46
(NNT for patients like ours)

Are our patients values and

preferences satisfied by the
regimen and its consequences ?
Yes.
Do we and our patient have a
clear assessment of their values
and preferences ?
Yes.

Are they met by this regimen

and its consequences ?
Yes.

THANK YOU!