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THERAPY WORKSHEET

Optimal duration of antibiotic therapy for uncomplicated


Citation:
urinary tract infection in older women: a double-blind randomized
controlled trial

Are the results of this single preventive or therapeutic trial valid?

Was the assignment of patients to Yes, (method)


treatments randomized?
Was the randomization list concealed? Yes, page 470, second paragraph
(method)
Was follow-up of patients sufficiently long Yes, follow up to the patient until 6 weeks
and complete? after treatment, no more loss to follow up
20%(to evaluate the long term risk of
relaps and reinfection at 6 weeks after
completion of treatment)
Were all patients analyzed in the groups to Yes, intention to treat (result)
which they were randomized?

Were patients, clinicians, and study Yes, double blind


personnel kept “blind” to treatment?
Were the groups treated equally, apart from Yes, the group were treated equally, a
the experimental treatment? part from the experimental treatment, for
3 day and 7 day
Were the groups similar at the start of the Yes, criteria inclusion and eclusion of the
trial apart from the experimental therapy? study

Are the valid results of this randomized trial important?

What is the magnitude of the treatment CEER, EER, RRR, ARR, NNT
effect?
How precise is the estimate of the treatment CI
effect?

SAMPLE CALCULATIONS

Occurrence of diabetic Relative risk Absolute risk Number


neuropathy at 5 years among reduction (RRR) reduction (ARR) needed to
insulin-dependent diabetics in treat (NNT)
the DCCT trial
Usual insulin Intensive insulin CER − EER CER − EER 1/ARR
regimen regimen
control event experimental event CER
rate (CER) rate (EER)
9.6% 2.8% 9.6% − 2.8% 9.6% − 2.8% 1/6.8%

9.6% =6.8% =15 patients

=71%
95% CI a 4.4% to 9.2% 11 to 23
a
95% confidence interval (CI) on an NNT
=1/(limits on the CI of its ARR)
Bacterial Eradicasi
Yes No Total
Eksperimen (3day) 91 2 93
Control ( 7 day) 83 6 89

YOUR CALCULATIONS

Relative risk Absolute risk Number


reduction (RRR) reduction needed to
(ARR) treat (NNT)
CER EER CER − EER CER − EER 1/ARR

CER
6/89=0,067 2/93=0,022 0,067-0,022/0,067 0,067-0,022 22
= 0,67
=0,045
=67%

95% CI -0,012 – 0,105 10 to inf

-22 – 100%
Can you apply this valid, important evidence about therapy in caring for
your patient?

Do these results apply to our patient?


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

Is the treatment feasible in our setting? Yes


What are our patient’s potential benefits and harms from the therapy?

Method I : f =1 Risk of the outcome in our patient, relative to


patients in the trial.

Expressed as a decimal:______

NNT/f=____72__/____1__=______ 72

(NNT for patients like ours)


Method II : 1/(PEER × RRR) Our patient’s expected event rate if they
received the control treatment (PEER)
=______

1/(PEER × RRR)=1/________=______

(NNT for patients like ours)


Are our patient’s values and preferences satisfied by the regimen and its consequences?

Yes
Do we and our patient have a clear Yes
assessment of their values and
preferences?

Are they met by this regimen and its Yes


consequences?

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