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SS/EBM/IKA-UDIP-2010 (”Bringing research evidence into practice”) Evidence-Based Medicine Sudigdo Sastroasmoro Clinical Epidemiology and Evidence-based.

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Presentation on theme: "SS/EBM/IKA-UDIP-2010 (”Bringing research evidence into practice”) Evidence-Based Medicine Sudigdo Sastroasmoro Clinical Epidemiology and Evidence-based."— Presentation transcript:

1 SS/EBM/IKA-UDIP-2010 (”Bringing research evidence into practice”) Evidence-Based Medicine Sudigdo Sastroasmoro Clinical Epidemiology and Evidence-based Medicine Unit FMUI – CMH, Jakarta

2 SS/EBM/IKA-UDIP day workshop 3-day workshop 2-day workshop

3 SS/EBM/IKA-UDIP-2010 Evidence-based Medicine Opinion-based medicine Experience-based medicine Power-based medicine Hope-based medicine Logic-based medicine Erratic-based medicine versus

4 SS/EBM/IKA-UDIP-2010 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)

5 SS/EBM/IKA-UDIP-2010 Evidence-based Medicine Medicine-based evidence Pragmatic research Outcome research Related with morbidity, mortality, quality of life

6 SS/EBM/IKA-UDIP-2010 Value = Quality Cost Morbidity Mortality QoL Patient Satisfaction Health Status

7 SS/EBM/IKA-UDIP-2010 Diagnosis Patient with complaint History Physical Simple test Specific test: If the test (+) what is the probability that the patient has the disease? Yes or no answer Predictive value is the most important The spectrum of the presentations must resemble that in practice

8 SS/EBM/IKA-UDIP-2010 Treatment Patient with certain diagnosis: best treatment? Is drug X more effective than Y? Focus on the clinical outcome, rather than its explanation (biomolecular markers, etc) Yes or no outcome most useful Not in studies with “idealized” subjects Px with DM are frequently have hypercholesterolemia, obese, hypertension, etc

9 SS/EBM/IKA-UDIP-2010 Prognosis Usually in cohort studies To inform 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)

10 SS/EBM/IKA-UDIP-2010 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 EBM & Clinical Epidemiology

11 SS/EBM/IKA-UDIP-2010 Previous practice: 6 yrs medical education yrs medical practice Problems with patients: Dx, Rx, Px Consultants, colleagues Textbooks Handbooks Lecture notes Clinical guidelines CME, seminars, etc Journals Usu. see only Results section, or even worse, Abstract section

12 SS/EBM/IKA-UDIP-2010 Trust me In my experience …. Logically Textbook, handbook, capita selecta

13 SS/EBM/IKA-UDIP-2010 The results…. “Opinion-based medicine” Steroid inj. in prematures to prevent RDS Routine episiotomy Routine circumcision Antibiotics 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 ……

14 SS/EBM/IKA-UDIP-2010 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

15 SS/EBM/IKA-UDIP-2010 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)

16 SS/EBM/IKA-UDIP-2010 Y= a + b 1 x 1 + b 2 X 2 + b 3 X 3 + ……. + b i x i   $ 6,000 Yesss!!!


18 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%”

19 SS/EBM/IKA-UDIP-2010 WHY EBM? 1Information overload 2Keeping current with literature 3Our clinical performance deteriorates with time (“the slippery slope”) 4Traditional CME does not improve clinical performance 5EBM encourages self directed learning process which should overcome the above shortages

20 SS/EBM/IKA-UDIP-2010 Years after graduation Relative % of remaining knowledge $ 100% THE SLIPPERY SLOPE

21 SS/EBM/IKA-UDIP-2010 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.

22 SS/EBM/IKA-UDIP Formulate clinical problems in answerable questions 2.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 patient 5. Evaluate our performance Steps in EBM practice VIA

23 SS/EBM/IKA-UDIP-2010 Diagnosis (Determination of disease or problem) Treatment (Intervention necessary to help the patient) Prognosis (Prediction of the outcome of the disease) Main area

24 SS/EBM/IKA-UDIP-2010 (I) Formulating clinical questions

25 SS/EBM/IKA-UDIP-2010 A 2-year old boy 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 or recent developments.

26 SS/EBM/IKA-UDIP-2010 Medical students: (Background question) What is Kawasaki disease? What is the etiology? How it is diagnosed? What is the treatment of choice? Complications?

27 SS/EBM/IKA-UDIP-2010 House officers (Foreground question) In a child with KD, would immunoglobulin treatment, compared with no immunoglobulin, reduce the chance to develop coronary complication?

28 SS/EBM/IKA-UDIP-2010 Foreground questions Background questions Experience with condition

29 SS/EBM/IKA-UDIP-2010 In women with history of eclampsia, would administration of low-dose aspirin during pregnancy prevent eclampsia? (Prevention) Other examples 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)

30 SS/EBM/IKA-UDIP-2010 Four elements of good clinical question: PICO The Patient or Problem The Intervention / Index Comparative intervention (if relevant) The Outcome

31 SS/EBM/IKA-UDIP-2010 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

32 SS/EBM/IKA-UDIP-2010 Do all clinical questions contain 4 elements of PICO? No The C implies in the question - PIO Does temulawak increase appetite in undernourished children? Asking prevalence – PO What is the prevalence of abnormal gene XYZ in patients with  -thalassemia?

33 SS/EBM/IKA-UDIP-2010 Relevance: Type of Evidence POE: Patient-oriented evidence mortality, morbidity, quality of life DOE: Disease-oriented evidence pathophysiology, pharmacology, etiology

34 SS/EBM/IKA-UDIP-2010 POEM Patient-Oriented Evidence

35 SS/EBM/IKA-UDIP-2010 Comparing DOES and POEMs

36 SS/EBM/IKA-UDIP-2010 II Searching the evidence

37 SS/EBM/IKA-UDIP-2010 III Appraising the evidence: VIA

38 SS/EBM/IKA-UDIP-2010 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 VIA

39 SS/EBM/IKA-UDIP-2010 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? Example: Critical appraisal for therapy

40 SS/EBM/IKA-UDIP-2010 Hierarchy of evidence 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 Weight of Scientific Scrutiny For complete description see

41 SS/EBM/IKA-UDIP-2010 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

42 SS/EBM/IKA-UDIP-2010 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

43 SS/EBM/IKA-UDIP-2010 Patient’s values Physician’s competence Valid evidence

44 SS/EBM/IKA-UDIP-2010 The EBM Cycle Patient With problem Formulate In answerable question Search the evidence Appraise The evidence Apply The evidence

45 SS/EBM/IKA-UDIP-2010 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

46 SS/EBM/IKA-UDIP-2010 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

47 SS/EBM/IKA-UDIP-2010 End result Self directed, life-long learning attitude for high quality patient care

48 SS/EBM/IKA-UDIP-2010 Conclusion EBM is nothing more than a framework of systematic use of current valid study results relevant to our patient

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