EVIDENCE-BASED MEDICINE

Therapy

Evidence
1. Validity
2. Importance
or
1. Importance
2. Validity

Clinical Scenario
A 75-year-old man is seen in our office after
being discharged from hospital 2 weeks
previously. During this admission he underwent a
carotid endarterectomy after suffering a transient
ischemic attack (TIA), and being diagnosed with
significant carotid stenosis. His hospital stay was
uncomplicated and his discharge medications
included metoprolol 50 mg twice daily for
hypertension and aspirin 81 mg daily.

Clinical Scenario
Today, he has brought us an article from the
Internet describing the benefits of statins for
stroke prevention and he wonders what this
medication is and if he should take it. Our
note from his last visit showed that his total
cholesterol was 5mmol/L, HDL-cholesterol
was 2.0mmol/L, and LDL-cholesterol was
2mmol/L. His examination was unremarkable.

Steps in Practicing EBM

1. Convert the need for information into an
answerable question.
2. Track down the best evidence with which to
answer that question.
3. Critically appraise the evidence for its
validity, impact, and applicability.
4. Integrate the evidence with our clinical
expertise and our patients characteristics
and values.
5. Evaluating our effectiveness and efficiency in
executing steps 14 and seeking ways to improve
them both for next time.

Clinical Question
Components of foreground question (PICO):
Patient and the
problem:
Patient with
history of TIA,
carotid
endarterectomy,
hypertension,
and normal lipid
profile

Intervention:

Comparison:

Outcome of
interest:

Statin

None

Stroke

Clinical Question
In a patient with history of TIA, carotid
endarterectomy, hypertension, and normal
lipid profile, does therapy with a statin
decrease risk of stroke?

Steps in Practicing EBM

1. Convert the need for information into an
answerable question.
2. Track down the best evidence with which to
answer that question.
3. Critically appraise the evidence for its
validity, impact, and applicability.
4. Integrate the evidence with our clinical
expertise and our patients characteristics
and values.
5. Evaluating our effectiveness and efficiency in
executing steps 14 and seeking ways to improve
them both for next time.

TYPES OF THERAPEUTIC REPORTS

Individual trials
Systematic review
Clinical decision analysis
Economic analysis
Clinical practice guidelines
Qualitative studies
N-of-1 study

Search Strategy
Medline database:
http://www.ncbi.nlm.nih.gov/pubmed/

The Evidence
Heart Protection Study Collaborative Group.
MRC/BHF Heart Protection Study of
cholesterol lowering with simvastatin in
20,536 high-risk individuals: a randomisedplacebo controlled trial. Lancet 2002; 360: 7
22.
MRC-BHF Heart Protection Study.pdf

Steps in Practicing EBM

1. Convert the need for information into an
answerable question.
2. Track down the best evidence with which to
answer that question.
3. Critically appraise the evidence for its
validity, impact, and applicability.
4. Integrate the evidence with our clinical
expertise and our patients characteristics
and values.
5. Evaluating our effectiveness and efficiency in
executing steps 14 and seeking ways to improve
them both for next time.

ARE THE RESULTS OF THIS

INDIVIDUAL STUDY VALID?

ARE THE RESULTS OF THIS

INDIVIDUAL STUDY VALID?
1.Wastheassignmentofpatientstotreatment
randomized?
In the MRC trial that we found to answer our question
about the effectiveness of statin therapy, the title states
that it is a randomized trial, and a quick scan of the
methods refers us to another article for complete details:
Patients and methods
Detailsofthestudyobjectives,design,andmethodshave
beenreportedpreviously12,23(includingtheprotocolon
thestudywebsite:www.hpsinfo.org),..

ARE THE RESULTS OF THIS

INDIVIDUAL STUDY VALID?
2.Wastherandomizationconcealed? (apakah
pengacakan nya tersembunyi)
Design
Randomised (allocation concealed), blinded
(participants, clinicians, data collectors, and outcome
assessors), placebo controlled trial with mean follow
up of 5 years.
Evid Based Med 2003;8:10

ARE THE RESULTS OF THIS

INDIVIDUAL STUDY VALID?
3.Werethegroupssimilaratthestartofthetrial?
In the statin study, there were no significant differences
between patients receiving placebo and those receiving
statin.
Thelargesizeofthestudy(andtheuseofminimisation)
producedgoodbalancebetweenthetreatmentgroupsfor
themainprerandomisationprognosticfeaturesthatwere
measured,andshouldhavedonelikewiseforthosethat
werenot.

ARE THE RESULTS OF THIS

INDIVIDUAL STUDY VALID?
4.Wasfollow-upofpatientssufficientlylong
andcomplete?
In our statin study, follow-up was 99% at a mean
of 5 years.

ARE THE RESULTS OF THIS

INDIVIDUAL STUDY VALID?
5.Wereallpatientsanalyzedinthegroupstowhich
theywererandomized?
The statin study used an intention-to-treat analysis and we
can feel confident that it has passed all major validity
criteria.
Asaconsequence,theintention-to-treatcomparisonsin
thisreportassesstheeffectsofabouttwo-thirdsof
simvastatin-allocatedparticipantsactuallytaking40mg
simvastatindaily.

ARE THE RESULTS OF THIS

INDIVIDUAL STUDY VALID?
6.Werepatients,clinicians,andstudy
personnelkeptblindtotreatment?
TheMRCtrialstatesthatitwasadouble-blind
placebo-controlledtrial.
Blinded:participants,clinicians,datacollectors,
andoutcomeassessors.

ARE THE RESULTS OF THIS

INDIVIDUAL STUDY VALID?
7.Weregroupstreatedequally,apartfromthe
experimentaltherapy?
Thisisarandomisedplacebo-controlledtrial.

ARE THE VALID RESULTS OF THIS

INDIVIDUAL STUDY IMPORTANT?

ARE THE VALID RESULTS OF THIS

INDIVIDUAL STUDY IMPORTANT?
1.Whatisthemagnitudeofthetreatmenteffect?

ARE THE VALID RESULTS OF THIS

INDIVIDUAL STUDY IMPORTANT?
1.Whatisthemagnitudeofthetreatment
effect?

ARE THE VALID RESULTS OF THIS

INDIVIDUAL STUDY IMPORTANT?
2.Howpreciseisthisestimateofthetreatment
effect?

ARE THE VALID, IMPORTANT RESULTS OF THIS

INDIVIDUAL STUDY APPLICABLE TO OUR PATIENT?

ARE THE VALID, IMPORTANT RESULTS OF THIS

INDIVIDUAL STUDY APPLICABLE TO OUR PATIENT?

1.Isourpatientsodifferentfromthoseinthe
studythatitsresultscannotapply?
No.Ourpatientfulfilstheinclusioncriteriaofthe
study.

ARE THE VALID, IMPORTANT RESULTS OF THIS

INDIVIDUAL STUDY APPLICABLE TO OUR PATIENT?

2.Isthetreatmentfeasibleinoursetting?
Yes. The drug is widely available in Indonesia.
Simvastatin OGB Dexa capsule costs only Rp
13,991 (10 mg x 30's)
(http://www.mims.com/Indonesia/drug/info/)

ARE THE VALID, IMPORTANT RESULTS OF THIS

INDIVIDUAL STUDY APPLICABLE TO OUR PATIENT?

3.Whatareourpatientspotentialbenefitsandharms
fromthetherapy?
In our statin example, the study reported an NNT of 72, so
wed need to treat 72 patients like those in the trial with a
statin for a mean of 5 years to prevent one more of them
from experiencing a stroke.
If, however, we judge that our patient is at three times the
risk of stroke without treatment as the patients in the
control group, ft = 3 and NNT/ft = 72/3 = 24. This means
that we would only need to treat 24 higher-risk patients
like ours for 5 years to prevent an additional stroke.

ARE THE VALID, IMPORTANT RESULTS OF THIS

INDIVIDUAL STUDY APPLICABLE TO OUR PATIENT?

4.Whatareourpatientsvaluesand
expectationsforboththeoutcomeweare
tryingtopreventandthetreatmentweare
offering?
The clinical bottom line is that in patients with a
high 5 year risk of death, simvastatin safely
reduced all cause mortality, vascular mortality,
and vascular events.

Steps in Practicing EBM

1. Convert the need for information into an
answerable question.
2. Track down the best evidence with which to
answer that question.
3. Critically appraise the evidence for its
validity, impact, and applicability.
4. Integrate the evidence with our clinical
expertise and our patients characteristics
and values.
5. Evaluating our effectiveness and efficiency in
executing steps 14 and seeking ways to improve
them both for next time.

Resolution of The Case Scenario

The patient should take simvastatin to
prevent stroke.

Steps in Practicing EBM

1. Convert the need for information into an
answerable question.
2. Track down the best evidence with which to
answer that question.
3. Critically appraise the evidence for its
validity, impact, and applicability.
4. Integrate the evidence with our clinical
expertise and our patients characteristics
and values.
5. Evaluating our effectiveness and efficiency in
executing steps 14 and seeking ways to improve
them both for next time.