~$EBM Prof Darwin 1. Introduction_Prof Sudigdo
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Transcript of ~$EBM Prof Darwin 1. Introduction_Prof Sudigdo
Evidence-based Medicine• Opinion-based medicine• Experience-based medicine• Power-based medicine• Hope-based medicine• Logic-based medicine• Erratic-based medicine• Obat berbasis Opini
Obat berbasis pengalaman Obat berbasis-Power Kedokteran berbasis Harapan Obat berbasis logika Obat menentu berbasis
• Medicine-based evidence• Pragmatic research• Outcome research
Evidence-based Medicine
Related with morbidity, mortality, & quality of life
Diagnosis• Patient with complaint• History• Physical• Simple test• Specific test
Yes or no answerPredictive value is the most important
The spectrum of the presentations must resemble that in practice
Treatment
• Patient with certain diagnosis• Does drug X more effective than Y?• Focus on the outcome, rather than its
explanation (biomolecular markers)• Yes or no outcome most useful
Prognosis• Usually in cohort studies• To inform the patient about the fate of the
patient • Absolute risk is more important than relative
risk– Absolute: Your risk of having second stroke in 1 year is 30%– Relative: Your risk of having second stroke in 1 year is 2 times
than in non-smokers (RR = 2)
EBM• Started in early 90’s by clinical epidemiologists• 1992 : only few articles on EBM• 2000 : >1000 articles• Indonesia : started in 1997• Workshops : Yogya (2000)
IKA FKUI (2000, 2001, etc)• Group discussion on EBM / mailing list:
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 Practice6 yrs medical
education
40-50 yrsmedical practice
Problems with patients:Dx, Rx, Px
Consultants, colleaguesTextbooks
HandbooksLecture notes
Clinical guidelinesCME, seminars, etc
JournalsUsu. see only Results section,
or even worse, Abstract section
The results….“Opinion-based medicine”• Steroid inj. in prematures to prevent RDS• Routine episiotomy• Routine circumcision• Antibitotics for flu-like syndrome• Use of immunomodulators• “Skin test” before antibiotic injection• Routine chest X-ray for pre-op preparation• CT scan after minor head trauma• etc ……
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’s preference
• 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, and all study
results should be critically appraised• Keyword for EBM:
Methodological skill to judge the validity of study reports (Re. Andersen B: Methodo-logical errors in medical research, 1989)
WHY EBM?1. Information overload 2. Keeping current with literature3. Our clinical performance deteriorates with time
(“the slippery slope”)4. Traditional CME does not improve clinical
performance5. EBM encourages self directed learning process
which should overcome the above shortages
Our textbooks are out-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
• On average, the clinically-important knowledge of physicians deteriorates rapidly after we complete our training.
Steps in EBM practice1. Formulate clinical problems in answerable questions2. Search the best evidence: 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 patient5. Evaluate our performance
VIA
Main AreaDiagnosis
(Determination of disease or problem)
Treatment(Intervention necessary to help the patient)
Prognosis(Prediction of the outcome of the disease)
• A 2-year old boy diagnosed presented with 6-day high fever, conjunctival injection without secretion, skin rash> blood test shows leukocytosis, high ESR, CRP +++. He was suspected to have Kawasaki disease. The pediatrician is aware of the use of immunoglobulin to prevent coronary involvement, but uncertain about the dosage.
Medical students:(Background question)
• What is Kawasaki disease? • What is the etiology?• How it is diagnosed?• What is the treatment of choice?• Complications?
House Officers(Foreground Question)
• In a child with KD, would immuno -globulin treatment, compared with no immunoglobulin, reduce the chance to develop coronary complication?
Other Examples• In women with history of eclampsia, would
administration of low-dose aspirin during pregnancy prevent eclampsia? (Prevention)
• In young women with solitary thyroid nodule, can USG, compared with biopsy, differentiate between benign from malignant? (Diagnosis)
• In women systemic lupus erythematosus, is history of congestive heart failure, compared with no heart failure, worsen the prognosis? (Prognosis)
1Four elements of good clinical question: P I
C O• The Patient or Problem• The Intervention / Index• Comparative intervention (if relevant)• The Outcome
Four elements of a well constructed clinical question: PICO
P I C O
The maininterventionconsidered
The alternativeto compare
with theintervention
Outcomeexpected from this
intervention?
Descriptionof patient
or problem
B e b r i e f a n d s p e c i f i c
Relevance: Type of Evidence
• POE: Patient-oriented evidence –mortality, morbidity, quality of life
• DOE: Disease-oriented evidence–pathophysiology, pharmacology,
etiology
E
Comparing DOES and POEMs
Example DOE POEM Comment
AntiarrhythmicTherapy
Prostatescreening
PSA screeningdetects prostate
Ca. early
? whether PSAscreening mortality
Antihypertens.Therapy
Drug A PVCOn ECG
Drug X BP Drug X mortality
Drug A > mortality
DOE & POEMcontradicts
POEM agreesWith DOE
VIAValidity: 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, etcApplicability: In Discussion section + our patient’s
characteristics, local setting
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
Weight ofScientific Scrutiny
Meta-analysis of RCT
Large RCT
Small RCT
Non-Randomized trials
Observational studies
Case series / reports
Anecdotes, expert, consensus
Level 1
Level 2
Level 3
Level 4
A
B
C
Rec
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 • 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
FormulateIn answerable
question
Search theevidence
Critically Appraise
The evidence
ApplyThe evidence
PatientWith problem
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 EBM
EBM makes expensive medical careCf:
– Routine antibiotics for ARTI & diarrhea– Liberal indication for C-section– Unnecessary sophisticated procedures /
exams– Unnecessary / harmful treatment:
steroid for recurrent cough
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 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 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 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 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
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
Conclusion
• EBM is nothing more than a
• framework of systematic use of
• current valid study results
• relevant to our patient