Introduction to Evidence-based Medicine EBM

Scenario of a crime : Ten men in the dock

Ten men are awaiting for trial for murder Only three of them actually committed a murder, the seven others are innocent of any crime the juries hear each case and find six of the men guilty of murder Two of the convicted are true murderers Four men are wrongly imprisoned One murder walks free

They NEED Evidence-based trial?

The case can be expressed into a two by two table for evidence
TRUTH Juries Guilty 3 No guilty Total
p >0.01-CI 0,02

Killers

Non-Killers Total

1
3

3
7

4
10

That is WHY they NEED Evidence ?

Medical Mistakes
The National Institute of Medicine found that medical mistakes kill somewhere between 44,000 and 98,000 people (average: 71,000) in hospitals in the U.S. each year On average, one out of every 500 people admitted to a hospital in the U.S. is killed by mistake The chance of being killed in a commercial airline accident is one per 8 million flights

WHY DO WE NEED EBM ?

CARING FOR PATIENTS CREATES THE NEED FOR CLINICALLY IMPORTANT INFORMATION DIAGNOSIS.THERAPY.PROGNOSIS KNOWLEDGE DETERIORATES WITH TIME: PRACTITIONERS PRACTICE WHAT THEY LEARNED DURING RESIDENCY TRAINING (THE SLIPPERY SLOPE) IMPOSSIBLE TO PROSPECTIVELY ACQUIRE ALL INFORMATION NECESSARY TO TREAT ALL FUTURE PATIENTS NEW EVIDENCE OFTEN CHANGES CLINICAL PRACTICE PROSPECTIVE LEARNING FROM READING TEXTBOOKS, JOURNALS AND GOING TO CONFERENCES / CME IS IMPORTANT, BUT NOT SUFFICIENT

EBM
Started in early 90s by clinical epidemiologists 1992 : only few articles on EBM 2000 : >1000 articles Indonesia : started in 1997 Group discussion on EBM / mailing list:
<ebm-f2000@yahoogroups.com>

EBM & Clinical Epidemiology

Fletcher & Fletcher: CE = The application of epidemiologic principles in problems encountered in clinical medicine Sackett et al: CE = The basic science for clinical medicine Much resistance by experts EBM: In principle no one disagree All major medical journals have adopted EBM Centers for EBM all over the world

Previous practice:
6 yrs medical education Problems with patients: Dx, Rx, Px

40-50 yrs medical practice

Usu. see only Results section, or even worse, Abstract section

Consultant, colleagues Textbooks Handbooks Lecture notes Clinical guidelines CME, seminars, etc Journals

Contrast: Traditional Mode vs. Evidence-Based Medicine

TRADITIONAL Identify the problem Use your experience Ask a colleague Consult a textbook Read a review EBM Formulate a question Search of literature Select key articles Appraise the articles Apply result to patient

Former paradigm
Was based on the following assumptions:
Unsystematic observations from clinical experience is a valid way of building knowledge about a patient Understanding of basic mechanisms of disease is a sufficient guide Traditional medical training and common sense is sufficient Content expertise and clinical experience are sufficient

The new paradigm:

Puts a much lower value on authority Does not imply rejection of what can be learned from colleagues and teachers

Scientific investigation alone is not sufficient

What is Evidence-based Medicine?

The conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients Pemanfaatan bukti mutakhir yang sahih dalam tata laksana pasien Integration of (1) physicians competence (2) valid evidence from studies (3) patients preference

WHY EBM?
1. Information overload 2. Keeping current with literature
Our textbooks are out-of-date Journals are disorganized

3. Consequently our knowledge deteriorates with time (the slippery slope) 4. CME does not improve clinical performance 5. EBM encourages self directed learning process which should overcome the above shortages

100%
Relative % of remaining knowledge

10

12

Years after graduation

THE SLIPPERY SLOPE

SS/EBM/KPPIK-FKUI/02-05

Dean, Harvard Medical School to students:

We believe that 50% of what we are teaching to you now will prove to be false 5 years later; the problem is that we do not know which 50%

The balance of clinical medicine

Premised-based medicine
Physiologic

Evidence-based medicine
Population

Deductive reasoning

Inductive reasoning

Deductive reasoning
Major premise: Minor premise: Conclusion: All cats have four legs Si Manis is my cat Si Manis has four legs

If the premises are correct Then the conclusion must be correct

Inductive reasoning
Resident A is clever Resident B is clever Resident C is clever
Conclusion: All residents are clever
The conclusion is based on individual observations Never absolute, but in terms of probability depending on the quality of observations

What can we do?

Accept that there is a problem Take steps to fix it
Review of practice (Audit) Review of clinical decisions (EBM) Review of outcomes (Quality assurance)

Main area
Diagnosis (Determination of disease or problem) Treatment (Intervention necessary to help the patient) Prognosis (Prediction of the outcome of the disease)

Others:
Meta-analysis Clinical guidelines Economic analysis Clinical decision making Cost-effectiveness analysis Qualitative research

Original Research is at the center of our information jungle

Hierarchy of evidence
Weight of Scientific Scrutiny

Rec A

Meta-analysis of RCT

Level 1

Large RCT
Small RCT

Level 2

Non-Randomized trials
Observational studies Case series / reports Anecdotes, expert, consensus Level 4

Level 3
C

Criticism to EBM
EBM cannot be implemented in developing countries
By definition evidence is implemented if it is implementable (patients preference and local condition) for the benefit of the patients and the community

Criticism to EBM
EBM is costly and time consuming
EBM does require facilities at the cost of quality medical care! EBM discourage lazy thinking Cost benefit ratio should be assessed in individual and community levels

Criticism to EBM
EBM ignores pathophysiology & reasoning
EBM encourages clinical reasoning in the light of valid and important evidence Pathophysiology and reasoning should be seen as hypotheses and should end-up in (whenever possible) empirical evidence

Criticism to EBM
EBM ignore experience and clinical judgment
Personal experience and clinical judgment are by no means can be eliminated EBM encourage detailed and systematic documentation of experience and judgment Subjective experience should be, whenever possible, translated into more objective measures

Criticism to EBM
EB-guidelines etc interfere with professional autonomy
Professional conduct (competence, altruism, openness, collegiality, ethics) is encouraged in EBM Every physician should develop their own practice attitude based on his/her professionalism, valid evidence, and patients values Development of clinical guidelines and other standards of care should be seen as a guide and should be implemented according to clinical setting

What about clinical freedom?

Freedom to do harm is not available Freedom to do good is
Patients

are unique We must individualize care We must care, as well as diagnose and cure

We must be responsible or else lose our freedom

Advantages of EBM
Encourages reading habit Improves methodological skill (and willingness to do research?!) Encourages rational & up to date management of patients Reduces intuition & judgment in clinical practice, but not eliminates them Consistent with ethical and medico-legal aspects of patient management

End result Self directed, life-long learning attitude for high quality patient care

Conclusion
EBM is nothing more than a framework of systematic use of current valid study results relevant to our patient