Evidence Based Medicine

Presenter : Dr. Suhasini K.

Dept. Community Medicine
J.N.M.C., Belagavi

23 January 2015 Evidence Based Medicine 1

 Heading
• Introduction
• Definition of Evidence Based Medicine
• Evidence-based health care practice
• Importance of EBM
• Evolution of EBM
• Decision making in EBM
• Five-Step Approach to Practicing EBM
• Benefits of adopting EBM
• Misconceptions in EBM
• Evidence-based Public Health
• Conclusion

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 Which doctor do you want?

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 Which doctor do you want?

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 Bloodletting
3000years ago
Egyptians, Greeks then
Romans, Arabs and so
on.
The cure for (hot, moist
diseases) several
medical conditions.
Galen was able to
propagate his ideas
through the force of
personality and the
23 January 2015
power of the pen
Evidence Based Medicine 5
 Pierre Louis (1787-1872)
Inventor of the “numeric method” and the “method of
observation”

French physician who wanted

to analyze the efficacy of
bloodletting in the treatment
of acute pneumonia

Examined the clinical

course and outcomes of 77
patients

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 Overall Results (n=77)

Bled Early Bled Late Difference

“Experimental” Comparision Absolute
Phase Phase
Group Risk Reduction
oup

Mortality 44% 25% - 19%

Conclusion: Effect of bloodletting procedure was actually much

less helpful than has been commonly believed

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 William Osler (1849 -1919)
First “attending physician” at Johns Hopkins

Author of hugely influential textbook, 'The

Principles and Practice of Medicine'
believed that most drugs in his day were
useless, but still advocated blood-letting
in some cases

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 Bloodletting today
Today phlebotomy therapy is primarily used in Western
medicine for a few conditions such as
hemochromatosis, polycythemia vera, and porphyria
cutanea tarda.

Why did it persist?

It resulted from the dynamic interaction of social,
economic, and intellectual pressures, a process that
continues to determine medical practice
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 But….

We practice EBM today

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 Patient: Mr. A
Mr. A is a 60 year old presenting with
1 hour of retrosternal chest pain.
ECG shows lateral ST-elevation consistent with acute
MI.

QUESTION: In patients with acute MI,

does treatment with aspirin reduce mortality?

What is the best evidence?

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 Evidence: 1988
• Reduction of mortality in acute myocardial infarction
with streptokinase and aspirin therapy. Results:
– Patients with acute MI treated with Aspirin vs.
placebo had a significant 23% relative risk
reduction in five-week cardiovascular mortality,
with an absolute risk reduction of 11.8% to 9.4%
– The combination of SK and Aspirin resulted in a
42% relative risk reduction in cardiovascular
mortality after five weeks compared with the
placebo
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 Application: 1997
• How many patients receive ASA following acute
myocardial infarction?
– Aspirin was not given to 55%!!!
– 78% of patients who did receive aspirin received it
more than 30 minutes after arrival to the
emergency department.

23 January 2015 EvidenceAnnals of Intern

Based Medicine Medicine. Jul 1997;127(2):126
13
• But as late as 2000, even in the US, aspirin was being
prescribed for at most one third of patients with
coronary artery disease (for whom there were no
contraindications to its use)

• Relatively simple, and cheap practices shows that we

have a problem in getting providers to apply knowledge
gained through research

• The paradigm for the translation of new information

from research bench to bedside has been conceptualized
as a “translational highway”.

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 What is evidence-based medicine?
“Evidence-based medicine is the integration of best
research evidence with clinical expertise and patient
values”
- David Sackett

• “Explicit, judicious, and conscientious use of current

best evidence from medical care research to make
decisions about the medical care of individuals”

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 EBM - What is it?

Clinical
Expertise

Research Patient
Evidence Preferences

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 Evidence-based health-care practice

• The integration of:

– individual clinical expertise
– best available external clinical evidence from
systematic research

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 I - Individual clinical expertise

• Skills
• Judgement
– which individual health care workers acquire
through
– clinical experience and clinical practice

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 II - Best available clinical evidence

• Clinically relevant research derived from:

– basic medical sciences and
– patient-centred clinical research into the safety
and efficacy of therapeutic interventions.
– Systematic Reviews

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 Why is EBM important?

 New types of evidence are being generated which

can create changes in the way patients are treated

How much is actually being applied to patient

care?
 Although evidence is needed on a daily basis, usually
physicians don’t get it.
lack of time

out-of-date textbooks
the disorganization of the up-to-date journals
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 Importance of EBM for practicing
clinicians?

TIME AVAILABLE TO READ: TIME NEEDED TO KEEP CURRENT

Less than ON GENERAL MEDICINE:
1 Hour per Week
19 Articles per DAY
365 Days per Year
Source: Davidoff F, Haynes B, Sackett D, Smith R. BMJ. 1995;310:1085-1086.

Evidence Based Medicine 21

Evidence increasing so rapidly we need better skills to keep up-
to-date more efficiently than previous generations of clinicians

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 Why do we need to use evidence efficiently?

5,000?
2500000
per day
perYear
Year

2000000
Per

1500000
Articles

2,000
Articles

1000000 per day

Medical

75 per
500000
day
0
Biomedical MEDLINE Trials Diagnostic?

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 Time-poor clinician suffering from
Information Overload

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 Gets worse with “duration in practice”

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 Evolution of EBM
Pre EBM: Passive diffusion (“publish it and they
will come”)

Early EBM: Pull diffusion (“teach them to read it

and they will come”)

Current EBM: Push diffusion (“read it for them

and send it to them”)

Future EBM: Prompt diffusion (“read it for them,

connect it to their individual patients”)
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 Some milestones in the history of EBM

James Lind Bradford-Hill

publishes Principles of
publishes review &
Medical Statistics &
clinical trial in
MRC trial of streptomycin
Treatise on Scurvy
900 AD 1780 1840 1937/48 1967 1970’s

Al-Rhazi
For I once saved one group Alvan
by it, while I intentionally Pierre Louis Feinstein
neglected another group. publishes his book
Develops his “numerical
By doing that, I wished to Clinical Judgement
method” and changes blood
reach a conclusion .
letting practice in France

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 An EBM Approach to Education
• Evidence cart on ward rounds - 1995
• Looked up 2-3 questions per patient
• Took 15-90 seconds to find
• Change about 1/3 decision

David Sackett
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 Prof Archibald Cochrane, CBE
(1909 - 1988)

• The Cochrane Collaboration is

named in honor of Archie
Cochrane, a British researcher.
• In 1979 he wrote, "It is surely a
great criticism of our profession
that we have not organized a
critical summary, by specialty or
subspecialty, adapted
periodically, of all relevant
randomized controlled trials”

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 Why the sudden interest in EBM?
• Increasing realization among clinicians that years of
experience unaccompanied by updating of
knowledge can result in decline of clinical
performance

• The need for valid information about diagnosis,

therapy, prognosis, and prevention in this era of
consumer activism

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• The common man has access to the very same
medical literature as the clinicians through numerous
sources

• Limited time available to the clinician for acquiring

information is a major impediment for updating the
knowledge from traditional sources

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 Assumptions of evidence-based practices

• Not all evidence is equivalent

• There is a hierarchy of study design

• External evidence can inform but can never replace

individual clinical expertise (Sackett et al., 1996)

• Starting from the best external evidence and work

from there.

• Values always influence decisions

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 Where do we go for
help with
decisions when
we are not sure
how to proceed?
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 Decision making in clinical practice
using evidence
Decision-making is the cognitive process resulting in
the selection of a course of action among several
alternative possibilities

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 The Evidence Pyramid

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 Identifying the Best Study

Type of Question Suggested best type of Study

Therapy RCT>cohort > case control > case series

Diagnosis Prospective, blind comparison to a gold standard

Etiology/Harm RCT > cohort > case control > case series

Prognosis Cohort study > case control > case series

Prevention RCT>cohort study > case control > case series

Clinical Exam Prospective, blind comparison to gold standard

Cost Economic analysis

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 So in clinical practice
Treatment
options

Disease

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 Medical
Laparoscopic

laparotomy

Ectopic
pregnancy

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Outcome – the only thing that matters

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 What EBM additionally provides is

Opportunity for change

Opportunity for better treatment
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 How evidence affects clinicians

•Happy !!! •Will the patient recover or

•I am the best !!! not??
•Will they sue me??
•What about my reputation ??
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 Think 100 times before refuting an old
time tested method of treatment

• Classic example is vaginal hysterectomy for benign

diseases

• “Give me 2 retractors, 2 scissors , 2 clamps, one

tissue holding forceps and one needle holder, I will do
a vaginal hysterectomy in any setup”
Surgeon

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 Laparoscopic hysterectomy setup

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• New developments ( unnecessary) in minimally invasive
surgery

• Studies sponsored by pharma companies

• Use of meshes in different clinical conditions

• Mesh Erosion in bladder or bowel, infection or rejection

of mesh, vaginal pain or painful intercourse, groin
infection/abscess, extrusion , obstruction , voiding
dysfunction and erosion.
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 Changes in clinical practice shouldn’t
be like this

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 Changes should be like this

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The Five-Step Approach to Practicing EBM
• Step 1- Framing a Proper, Pertinent, Focused and
Answerable Question

• Step 2 - Searching the Literature

• Step 3 - Critical Appraisal of the Literature

• Step 4 –Integrating the Evidence with Clinical

Expertise and Patient Values

•23 January
Step20155 – Evaluating the Process
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 EBM Method

Assess Ask clinical

your patient questions

Acquire the Appraise

best evidence the evidence

Apply
evidence to
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 Answerable questions
EFFECTIVENESS
A description of the populations P

An identified intervention I

An explicit comparison C

Relevant outcomes O

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 Ask Clinical Questions
Components of Clinical Questions

Patient/ Intervention/
Population Comparison Outcome
Exposure

In patients with does early treat- compared to decrease cardio-

acute MI ment with a statin placebo vascular mortality?

In women with what is the compared to for diagnosing

suspected accuracy of exercise significant
coronary disease exercise ECHO ECG CAD?

In post- does hormone compared to no increase the

menopausal replacement HRT risk of
women therapy breast cancer?
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 Step-1
Clinical Scenario :

• 12 years old only male child

• admitted to ICU
• history of accidental ingestion of OP compound 4
hours back
• On admission the patient was comatose but
hemodynamically stable

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 • The anaesthesiologist used his past experience,
knowledge, skill & expertise and treated the patient
with an infusion of atropine
• Inspite of that patient developed respiratory
paralysis in the next 2 hours
• The clinician used his expertise puts him on
mechanical ventilation

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• Now, the consultant understands the gap in his
knowledge & he identifies the same.
• The consultant wanted to administer Inj Pralidoxime.
• But he was not sure of the dosage and the mode of
administration (a single bolus dose or an infusion).

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• ‘P’ — Patient Problem: How would I describe a group
of patients similar to mine?
In this clinical situation it is a male pediatric patient (12
years) who has developed organophosphorous
poisoning following its ingestion.

• ‘ I ’ — Intervention strategy: Which main intervention,

prognostic factor or exposure am I considering?
Here the intervention is the therapy with Pralidoxime in
optimum dosage.

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 • ‘C’ — Comparison: What is the main alternative to
compare with the intervention?
In his patient the clinical dilemma pertains to the
dosage and mode of administration of Pralidoxime
(low dose infusion vs. single large bolus dose)

• ‘O’ — (Outcome): - What can I hope to accomplish?

Recovery from OP poisoning and decrease in
morbidity & mortality

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 Step-2 Literature Search

• ‘Traditional’ print resources like textbooks or

journals

• ‘Browse’ online electronic databases

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 Step 3 - Critical Appraisal of the Literature

1. Screening for internal validity and relevance

2. Determining the intent of the article

3.Evaluating the validity based on its intent

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• The article that was tracked down is Prospective
randomized placebo controlled clinical trial of
Pralidoxime in two similar groups of patients.
(Control group-low dose and study group-high dose)

• Block randomization was used

• The investigators were not blinded

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• The intent of the article is to evaluate two treatment
regimes of PAM in the management of OP poisoning

• The next thing to determine is the strength of the

outcome. How large was the treatment effect?

• Low dose group fared better than high dose group

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• PAM is a very expensive imported drug requiring
considerable amount off foreign exchange and there
are difficulties in procuring it.
• It is imperative for the clinician to find a cost-
effective
• and yet effective treatment.
• Patient’s father, being a primary school teacher,
cannot afford the exuberant cost of the drug.
• The out come of this research study is very much
relevant and beneficial in solving the clinical dilemma
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 Step 4 –Integrating the Evidence with Clinical
Expertise and Patient Values
• The best documented critically appraised research
evidence is already with the clinician
• Take into consideration the patient values for example:
The patient is a precious, lone male child of the
parents.
The economical/financial status of the parents does not
permit expensive therapies
No contraindications for the drug to be administrated
Low dose regime requiring 1/16 of the high dose has better
effect

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 Step 5 – Evaluating the Process

• Was he able to formulate a focused question?

• Was he able to devise a precise search strategy for
locating the evidence?
• Did he use the most appropriate resource?
• Were more pertinent resources like practice guidelines
available to him?
• Did the ‘evidence’ work in his patient?
• The clinician should document the outcomes of the
application of the evidence and based on his experiences
• Those of his colleagues should be able develop
management protocols
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 What are the benefits of adopting EBM?

• Minimize the errors in patient care

• Reduces the cost of treatment to the patient
• Optimizes the quality of patient care
• Skills learnt in practicing EBM are the very same ones
needed for being a lifelong, self-directed learner
• Habit of accessing literature on a daily basis is the
best guarantor of ensuring advancement of
knowledge and keeping abreast of scientific progress

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 EBM Misconceptions
FALLACY FACT

EBM is useless when EBM means

there is no good appropriately using the
evidence best available evidence
to care for patients
EBM is algorithms that Clinical judgment must be
ignore clinical used in deciding how to
judgment/expertise apply the evidence

EBM is just numbers EBM is not numbers in a

and statistics vacuum – the evidence
must be individualized to
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each patient
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 Who benefits?
 Practitioners current knowledge to assist with
decision making

 Researchers reduced duplication

identify research gaps

 Community recipients of evidence-based interventions

 Funders identify research gaps/priorities

 Policy maker current knowledge to assist with policy

formulation

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 Evidence-based Public Health

• “The development, implementation, and evaluation of

effective programs and policies in public health through
application of principles of scientific reasoning, including
systematic uses of data and information systems, and
appropriate use of behavioral science theory and
program planning models”

Source: Brownson, R.C. et al, Evidence-based public health, Oxford University Press, 2003.

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 Clinical vs. Public health interventions

Clinical
• Individuals
• Single interventions
• Outcomes only (generally)
• Often limited consumer input
• Quantitative approaches to
research and evaluation
Public health
• Populations and
communities
• Combinations of strategies
• Processes as well as
outcomes
• Involve community members
in design and evaluation
• Qualitative and quantitative
• Health promotion theories
and beliefs

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 Challenges - The research-practice gap

Research Evidence Practice

Diffusion
/Adoption
Information overload

Application to other populations

Lack of consideration of local

community groups, agencies and
governments role and needs
Cultural factors
Economic factors
Social factors

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 Challenges: The research-policy gap

Research Evidence Policy making

Service level
National policy level

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 Develop
statement of Disseminate widely
the issue Or Discontinue Program/Policy
Tools: meta-
analysis, risk
Determine what is assessment, expert
known through panel
scientific literature

Tools: rates, Evaluate the

risks, program or
Quantify the Surveillance Policy
issue data

Implement
Re- tool
Develop
Program or Develop an
policy action plan
options

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 Conclusion
• Medicine is not an exact science, but a science of
probability
• The challenge to physicians is to provide up to-date
medical care
• The ultimate goal for clinicians should be to help
patients live long, functional, satisfying, and pain and
symptom free life
• By adopting the principles of Evidence Based
Medicine, it will be possible to maximize the benefits
of scientific research for patient care
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• Medical educators and medical colleges have the
singular responsibility of indoctrinating the principles
of EBM
as a concept,
a philosophy,
a religion necessary for being efficient,
compassionate, caring, and responsible clinician
among the future physicians during their formative
years of training

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 References
1. Evidence-based Medicine Workbook-Finding and applying the better
research , Paul Glasziou, Chris Del Mar and Janet Salisbury
2. Sackett, D. L., Straus, S. E., Richardson, W. S., Rosenberg,W., Haynes,
R. B.: Evidence- Based Medicine – How to Practice and Teach EBM
2nd Ed., Churchill. Livingstone, 2000.
3. Sackett DL, Rosenberg WMC, Gray JA, Haynes RB Richardson WS.
Evidence based medicine: What it is and what it isn’t Br. Med J
1996;312:71-72.
4. Evidence Based Medicine And Its Impact On Medical Education Dr. H.
B. Rajashekhar1 Dr. B. S. Kodkany2 Dr. Vijaya A. Naik3 Dr. P. F. Kotur4
Dr. Shivaprasad S. Goudar5:Indian J. Anaesth. 2002; 46 (2) : 96-103
5. Guyatt GH, Evidence–based Medicine. Ann Intern Med. 1991;114(ACP
J Club. Suppl 2): A-16

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