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Sudigdo Sastroasmoro (s\[email protected]) Medical School University of Indonesia. E vidence. B ased . M edicine . (”Bringing research evidence into practice”). Dr. Benjamin Spock: Baby and Child Care.

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e vidence
Sudigdo Sastroasmoro

([email protected])

Medical School University of Indonesia

E vidence

B ased

M edicine

(”Bringing research evidence

into practice”)

dr benjamin spock baby and child care
Dr. Benjamin Spock:Baby and Child Care

“I think it is preferable to accustom a baby to sleeping on his stomach from the start of he is willing. He may change later when he learns to turn over”.

Later evidence indicates that prone position is a

an significant risk factor for SIDS

(sudden infant death syndrome)

slide3
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
Previous practice:

Problems with patients:

Dx, Rx, Px

6 yrs medical

education

40-50 yrs

medical practice

Consultants, colleagues

Textbooks

Handbooks

Lecture notes

Clinical guidelines

CME, seminars, etc

Journals

Usu. see only Resultssection,

or even worse, Abstract section

slide5
Trust me
  • In my experience ….
  • Logically
  • Textbook, handbook, capita selecta
what is evidence based medicine
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) physician’s competence (2) valid evidence from studies (3) patient’spreference
slide7
Pros : “New paradigm in medicine”
  • “Extraordinary innovations, only 2nd to Human Genome Project”
  • Cons : New version of an old song
  • ‘Fair’ : Nothing wrong with EBM, but:
          • Be careful in searching evidence
          • Meta-analyses, clinical trials, etc. should be critically appraised
  • Keyword for EBM:
    • Methodological skill to judge the validity
    • of study reports (Re. Andersen B: Methodological errors in medical research, 1989)
slide8
“Hierarchy of Lies”

Statistics

Damn lies.....

Lies.....

(Mark Twain)

why ebm
WHY EBM?

1. Information overload

  • Keeping current with literature
  • Our clinical performance deteriorates with time (“the slippery slope”)

4. Traditional CME does not improve clinical

performance

5. EBM encourages self directed learning process which should overcome the above shortages

slide10
The fact……..
  • >25,000 periodical (journals)
  • 6,000,000 articles annually
  • 17,000 biomedical books annually
  • 3000 recognized diseases
  • 1500 therapeutic regimens (+250 annually)
the flora and fauna of the medical jungle
Original Research

Academic Reviews

Decision/Cost Analysis

Medical Cookbooks (Practice Guidelines)

Translation Journals

CME

Clinical Experience

Experts

Newsletters and Survey Services

Pharmaceutical Representatives

Computer sources

Audiotapes

Qualitative Research

The Flora and Fauna of the Medical Jungle
our textbooks are out of date
Our textbooks areout-of-date
  • Fail to recommend Rx up to ten years after it’s been shown to be efficacious.
  • Continue to recommend therapy up to ten years after it’s been shown to be useless.
the inevitable consequence
The inevitable consequence:
  • On average, the clinically-important knowledge of physicians deteriorates rapidly after we complete our training.
slide14
100%

$

Relative

% of

remaining

knowledge

2 4 6 8 10 12

Years after graduation

THE SLIPPERY SLOPE

slide15
Steps in EBM practice
  • Formulate clinical problems in answerable questions
  • Searchthebestevidence: use internet or other on-
  • line database for current evidence

3. Critically appraise the evidence for

      • Validity (was the study valid?)
      • Importance (were the results clinically important?)
      • Applicability (could we apply to our patient?)
  • 4. Apply the evidence to patient
  • 5. Evaluate our performance

VIA

slide16
Main area

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

slide17
Others:

Meta-analysisClinical guidelinesEconomic analysis Clinical decision makingCost-effectiveness analysisQualitative research

slide19
A 2-month old infant with large VSD
  • Birth weight 3.1 kg
  • Weight 3.8 kg, HR=132, RR 68
  • Retractions (+)
  • Systolic murmur, gallop rhythm
  • Hepatomegaly
  • Dx: Large VSD, Heart failure, Failure to thrive
  • Definite Rx: early surgery
  • Alternative Rx: Drugs first?
medical students background question
Medical students:(Background question)
  • What is VSD?
  • How to Dx?
  • What are symptoms & signs of CHF in infants with L-R shunt?
  • What is the treatment?
house officers foreground question
House officers(Foreground question)
  • In infants with large VSD and CHF, would administration of digoxin or other inotropic agent delay the need for surgery?
slide22
Foreground

questions

Background

questions

Experience with condition

other example
Other example
  • In neonates born to mothers with history of herpes simplex infection, does the administration of IVIG (intravenous immunoglobulin) reduce the possibility of neonatal herpes?
other example1
In women with history of eclampsia, would administration of low-dose aspirin (compared with no aspirin) during pregnancy prevent eclampsia?Other example
example etiology
Example: Etiology

P I C O

…a risk factor for the developmnt HMD?

“In

premature

infants …

…is mode

of delivery…

example diagnosis
Example: Diagnosis

P I C O

“In patients

with suspected

malaria

…effectively

establish

diagnosis?

…comparedwith microscope

exam

…can

rapid test

example therapy
Example: Therapy

P I C O

will early

IV

Immuno-globulin

(IVIG)

“For px

with Stevens

Johnson

syndrome

…when

compared

with

no IVIG

…prevent

severe

complica-

tions?

example prognosis
Example: Prognosis

P I C O

…worsen

the

prognosis?

“For px

with SLE

…would

history

of

heart failure

…compared

with no

history

of HF

four elements of good clinical question pico
Four elements of good clinical question:PICO

The Patient or Problem

The Intervention

Comparative intervention

The Outcome

Domain

Determinants

Outcome

four elements of a well constructed clinical question pico
Four elements of a well constructed clinical question: PICO

P I C O

The main

intervention

considered

The

alternative

to compare

with the

intervention

Outcome

expected

from this

intervention?

Description

of patient

or problem

B e b r i e f a n d s p e c i f i c

remember 1
Remember (1)
  • Not all clinical questions contain 4 elements, depending on the nature of the condition being asked.
  • Examples:
    • In post-menopausal women on hormone replacement therapy, does addition of vitamin X reduce the likelihood of developing hip fracture? (PIO)
    • In patients with thalassemia HbE disease, what is the prevalence of single gene mutation? (PO)
remember 2
Remember (2)
  • In the PICO context, Intervention does not necessarily mean TREATMENTor PREVENTION, but may be:
    • A diagnostic test (for diagnosis)
      • In a patient with solitary thyroid nodule, does ultrasound exam, compared with needle biopsy, differentiate malignant from benign tumor?
    • A risk factor (for etiology, prognosis)
      • Is poor fiber diet a risk factor for the development of colo-rectal cancer?
    • A condition in the patient himself (for prognosis)
      • In patient with SLE, would the history of cardiac failure, compared with no failure, worsen the long-term prognosis?
relevance type of evidence
Relevance: Type of Evidence

POE: Patient-oriented evidence

mortality, morbidity, quality of life

DOE: Disease-oriented evidence

pathophysiology, pharmacology, etiology

comparing does and poems
Comparing DOEs and POEMs

Example

DOE

POEM

Comment

DOE & POEM

contradicts

Drug A >

mortality

Antiarrhythmic

Therapy

Drug A  PVC

On ECG

Drug X 

mortality

POEM agrees

With DOE

Antihypertens.

Therapy

Drug X  BP

PSA screening

detects prostate

Ca. early

? whether PSA

screening 

mortality

Prostate

screening

DOE exists, but

POEM unknown

examples of on line journals databases
Examples of on-line Journals / Databases
  • http://bmj.com
  • http://adc/bmjjournals.com
  • MEDLINE/PubMed
  • EMBASE
  • MDConsult
  • AAP Journal Club
  • Cochrane Library
slide38
Use keywords for searching

Note:

  • Spelling (American / British), terminology
  • Follow rigidly the instructions of each website

Examples:

  • “Host vs graft reaction” AND management
  • hemosiderosis AND thalassemia OR thalassaemia
  • “breast cancer” OR “Ca mammae” AND immunoglobulin OR IVIG
slide40
VIA

Validity:In Methods section:

  • design, sample, sample size, eligibility criteria (inclusion, exclusion), sampling method, randomization method, intervention, measurements, methods of analysis, etc

Importance:In Results section

  • characteristics of subjects, drop out, analysis, p value, confidence intervals, etc

Applicability:In Discussion section + our patient’s characteristics, local setting

validity other approach rammbo
Validity - other approach: RAMMbo
  • Recruitment: sampling methods, eligibility criteria, sample size
  • Allocation: randomization? concealment?
  • Maintenance: many drop outs?
  • Measurement
    • blinded – RCT, Dx test
    • objective – validity & reliability

Can be applied for all designs with necessary

Adjustment according to nature of the design

slide42
Example:

Critical appraisal for therapy

  • Were the subjects randomized?
  • Were all subjects received similar treatment?
  • Were all relevant outcomes considered?
  • Were all subjects randomized included in the analysis?
  • Calculate CER, EER, RRR, ARR, and NNT
  • Were study subjects similar to our patients in terms of prognostic factors?
hierarchy of evidence
Rec

Weight of

Scientific

Scrutiny

A

Level 1

Level 2

B

Level 3

C

Level 4

Hierarchy of evidence

Meta-analysis of RCT

Large RCT

Small RCT

Non-Randomized trials

Observational studies

Case series / reports

Anecdotes, expert, consensus

implementation of ebm practice how to get started

Implementation of EBM practice:How to get started

1. Teaching EBM in medical schools / PPDS

Easier than to change the already existing attitude

Most important

May be included in formal curricula or integrated in

existing activities: ward rounds, on calls, case

presentations, group discussions, journal clubs, etc

2. Workshop for teaching staff

3. Workshop for practitioners, incl. nurses

resistance to ebm teaching learning

Resistance to EBM teaching & learning

Rudimentary skill in critical appraisal / methodological skill

Limited resources, esp. time factor

Lack of high quality evidence

Skepticism toward evidence-based practice

‘Happy’ with current practice

development of ebm practice

Development of EBM practice

Passive diffusion model

Active dissemination model

Coordinated implementation model:

Patients & community

Health administrators

Public policy makers

Clinical policy makers

slide49
Formulate

In answerable

question

Apply

The evidence

Critically

Appraise

The evidence

Search the

evidence

Patient

With problem

The

EBM

Cycle

slide50
Appropriate

sampling

technique

Actual

study

subjects

Subjects

completed

the study

[Non-response, drop outs,

withdrawals, loss to follow-up]

Usu. Based on practical

purposes

Target population

(Domain)

Accessible

population

(time, place)

(demographic, clinical)

Your patient is here!

Intended

Sample

[Subjects selected

for study]

criticism to ebm
Criticism to EBM
  • EBM makes expensive medical care
  • EBM cannot be implemented in developing countries
  • EBM is costly and time consuming
  • EBM ignore pathophysiology & reasoning
  • EBM ignore experience and clinical judgment
  • EB-guidelines etc interfere with professional autonomy
criticism to ebm1
Criticism to EBM

EBM makes expensive medical care

Cf:

  • Routine antibiotics for ARTI & diarrhea
  • Liberal indication for C-section
  • Unnecessary sophisticated procedures / exams
  • Unnecessary / harmful treatment: steroid for recurrent cough
criticism to ebm2
Criticism to EBM

EBM cannot be implemented in

developing countries

  • By definition EBM is implemented if it is implementable (patient’s preference and local condition) – for the benefit of the patients and the community
criticism to ebm3
Criticism to EBM

EBM is costly and time consuming

  • EBM does requires facilities at the cost of quality medical care!
  • Cost benefit ratio should be assessed in individual and community levels
criticism to ebm4
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 hypothesis and should end-up in empirical evidence
criticism to ebm5
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 ebm6
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 profess-ionalism, valid evidence, and patient’s values
  • Development of clinical guidelines and other standards of care should be seen as a guide and implemented according to clinical setting
barriers to the implementation of evidence based medicine
Barriers to the implementation of Evidence-Based Medicine

“It takes too long.”

“Possibly a limitation to my clinical freedom.”

“It questions my professional autonomy.”

advantages of ebm
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
slide60
End result

Self directed, life-long learning attitude

for high quality patient care

conclusion

Conclusion

EBM is nothing more than a

framework of systematic use of

current valid study results

relevant to our patient

slide62
Evidence-based Cardiology
  • Evidence-based Pediatrics
  • Evidence-based Ob-Gyn
  • Evidence-based Dentistry
  • Evidence-based Nursing
  • Evidence-based Health Policy
  • Evidence-based Health Technology Assessment
  • Evidence-based Decision Making
  • Evidence-based Health Performance Indicators
  • Evidence-based Clinical Audit
  • Evidence-based Risk Management …….
  • Evidence-based Everything!!!
slide63
In God we trust

All others must have evidence

remember however

Remember, however …...

Medicine is the science of uncertainty

and the art of probabilities