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Introduction To EBM

This document provides an introduction to evidence-based medicine. It discusses the goals of treatment decisions, which include making the patient feel better and improving survival while weighing benefits against harms. Off-label drug use is described as exposing patients to unnecessary risks due to limited evidence of safety and efficacy. The need for continuously updating medical knowledge based on new evidence rather than just experience is explained. Formulating answerable clinical questions using the PICO framework can help guide the search for relevant evidence. Critical appraisal of evidence requires assessing the validity of methodology, statistical significance of results, and potential for biases. Safety, efficacy, effectiveness, tolerability and costs must all be considered when evaluating drug treatments.

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34 views28 pages

Introduction To EBM

This document provides an introduction to evidence-based medicine. It discusses the goals of treatment decisions, which include making the patient feel better and improving survival while weighing benefits against harms. Off-label drug use is described as exposing patients to unnecessary risks due to limited evidence of safety and efficacy. The need for continuously updating medical knowledge based on new evidence rather than just experience is explained. Formulating answerable clinical questions using the PICO framework can help guide the search for relevant evidence. Critical appraisal of evidence requires assessing the validity of methodology, statistical significance of results, and potential for biases. Safety, efficacy, effectiveness, tolerability and costs must all be considered when evaluating drug treatments.

Uploaded by

sundaime
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Introduction to Evidence-Based

Medicine
Edy Junaidi

09/08/11

The Goal of Treatment Decision

To make the patient feel better


To reduce the risks of future complications
To improve survival
Economic benefits
Returning to work
Supporting family
Reduce future demand on health care system

It is essential to determine that the benefit


outweight harm on treating the patient
09/08/11

Off-Labeled Use of Drug


Should be Avoided

Regulatory Body only permit Drug


Manufacturers to market drug to health care
provider and public for the approved indication

In contrast, practice of medicine is not regulated


health care professionals can prescribe drugs
for unapproved uses if they believe it is for
the best interest of patients

09/08/11

Study of 160 commonly prescribed drugs used


among office-based physicians revealed that
21% is off-label use.
Limited evidence of safety and efficacy,
including dosing, exposes patients to
unnecessary risks
Direct risk : off-label use of the drug is ineffective,
harmful or both
Indirect risk : proven alternative treatment, should
they exist, could be denied
09/08/11

Why Would We Need to Continously


Update What We've Learned?

Experieced Based vs. Evidence Based

Severity of Disease

INTERVENTION

Natural History of Disease


(with or without intervention)
Time

09/08/11

Might results in different


interpretations

Example

RCT of antibiotic use for sore throat, 716 patients


with sore throat assigned randomly to receive
immediate, delayed, or no antibiotics.
No difference in early return or complications between
antibiotics and other groups Antibiotics use
did not influence the natural history of
sore throat
Reattendace for future episodes 38% in antibiotic
group compare to 27% in other group Giving
antibiotics encourage consultation
behaviour
09/08/11

From : Evaluating Clinical Research,


2007
09/08/11

Causal Relationship

Strength of association
Consistency of the observed association
Specificity
Temporality
Biological gradient/Dose Response Relationship
Biological plausibility
Coherence
Experiment
Analogy

09/08/11

Austin Bradford Hill (18971991)

Hierarchy of Evidence

09/08/11

Appraising Study
determining Causation

Is the study the strongest that could have been


performed ?
Were opportunities for exposure and determinants of
exposure free from bias ?
Was selection of cases and control free from bias ?
Were both statistical & clinical significance considered ?
Temporal sequence
Dose response
Does the association make sense
Consistency
09/08/11

Selection Bias

Performance Bias

Exclusion Bias

Detection Bias

09/08/11

It is easier to a New Drug to


Look Good when Compare
to Nothing

09/08/11

Formulating Clinical Question

One of hardest problem in practicing evidencebased medicine is translation of clinical (patient)


problems into an answerable question

Why would we need one and How ?


Focuses attention to real problem at hand will
ultimately lead to evidence relevant to the problem
Provide guidance to where should we find such
evidences that is relevant to the question
Properly formulated clinical question will suggest the
format of the answer and also suggest the type of
evidence should be sought
09/08/11

How to formulate Answerable


Clinical Question ?

Patient (category) in question


The diagnostic or therapeutic Intervention
Comparison to the intervention
The Outcome expected ?
PICO

09/08/11

It Ain't Easy to Find The Right


Answer if You Don't Know What
You're Looking For

09/08/11

Sources of Information

Hand Searching
Asking Experts
Electronic Databases
Medline
Embase
Web of Science
National research register
Etc
09/08/11

Other Online Resources

Www.hsrc.org.uk/links/arif/arifhome.htm
Www.jr2.ox.ac.uk/Bandolier
Www.cochrane.org/cochrane/ccweb.htm
Www.clinicalevidence.org
Www.doctors.net.uk/
Www.acponline.org/journals/ebm/ebmmenu.htm
Www.hta.nhsweb.nhs.uk/
Www.nhs.uk/nelh
Www.nzgg.org.nz/news/bulletin.htm
Etc...
09/08/11

How Would You Read It ?

09/08/11

Critical Appraisal /
Assessing Evidence

Critical appraisal lies at the heart of evidencebased medicine


Critical appraisal :
Assessing truth, is the conclusion is
substantiated by data ?
Validity, is the methodology sound and
appropiate ?
Probability, is the statistical analysis significant ?

09/08/11

09/08/11

09/08/11

Common statistical
terminology

Statistically significance
Clinically significance/relevance
Relative risk (RR)
Relative Risk Reduction (RRR)
(1 RR) x 100%

Absolute Risk Reduction (ARR)


Attributable Risk
Number Needed to Treat (NNT)
Number Needed to Harm (NNH)
09/08/11

Is it good enough ?

Relative Risk Reduction (RRR) of Treatment


A is ~ 50% ?

09/08/11

Appraising the Evidence

Sources of Biases

Selection Bias
Measurement Bias
Tools
Observers/raters
09/08/11

Reporting Bias
Publication Bias

Etc

What needs to be
considered on using
drugs ?

Safety
Efficacy
Effectiveness
Tolerability - Compliance
Cost
Etc

09/08/11

Drug withdrawn from US


Market

alosetron (2000),
astemizole (1999),

benoxaprofen (1982),
bromfenac (1998),

cerivastatin (2001),
Cisapride (2000),

Dexfenfluramine (1997),
fenfluramine (1998),
Encainide (1991),

Flosequinan (1993),
Grepafloxin (1999),
09/08/11

Phenylpropanolamine (2000),
Rapacuronium (2001),
Rofecoxib (2004),
Suprofen (1987),
Terfenadine (1998),
Temafloxacin (1992),
Ticrynafen (1980),
Troglitazone (2000),

Zomepirac (1983)
Mibefradil (1998),

Nomifensine (1986),

Storm, B.L., Kimmel, S.E., 2006, Textbook of

Is it class effects ?

Canadian Coordinating Office for Health


Technology Assessment (CCOHTA) in its
report for policymaker (1997) stated that
all drug in the class of statins provided
benefit (class effect)
CCOHTA being lawsuit by BMS (Bristol-Myers
Squibb Inc., producer of Atorvastatin)

09/08/11

The money spent by CCOHTA on lawyers to defend


its right to publish amounted to 13% of its annual
budget

Semoga Termotivasi untuk terus


Belajar !!!

Terima kasih atas


perhatiannya

09/08/11

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