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SS/EBM/Intro/2010 E vidence Sudigdo Sastroasmoro Medical School University of Indonesia (”Bringing research evidence into practice”)

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Presentation on theme: "SS/EBM/Intro/2010 E vidence Sudigdo Sastroasmoro Medical School University of Indonesia (”Bringing research evidence into practice”)"— Presentation transcript:

1 SS/EBM/Intro/2010 E vidence Sudigdo Sastroasmoro ( Medical School University of Indonesia (”Bringing research evidence into practice”) (”Bringing research evidence into practice”) B ased M edicine

2 SS/EBM/Intro/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)

3 SS/EBM/Intro/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

4 SS/EBM/Intro/2010 Previous practice: 6 yrs medical education 40-50 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

5 SS/EBM/Intro/2010 Trust me In my experience …. Logically Textbook, handbook, capita selecta

6 SS/EBM/Intro/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

7 SS/EBM/Intro/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, 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)

8 SS/EBM/Intro/2010 (Mark Twain) “Hierarchy of Lies”

9 SS/EBM/Intro/2010 WHY EBM? 1. Information overload 2.Keeping current with literature 3.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

10 SS/EBM/Intro/2010 >25,000 periodical (journals) 6,000,000 articles annually 17,000 biomedical books annually 3000 recognized diseases 1500 therapeutic regimens (+250 annually) The fact……..

11 SS/EBM/Intro/2010 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

12 SS/EBM/Intro/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.

13 SS/EBM/Intro/2010 The inevitable consequence: On average, the clinically-important knowledge of physicians deteriorates rapidly after we complete our training.

14 SS/EBM/Intro/2010 Years after graduation Relative % of remaining knowledge 2 4 6 8 10 12 $ 100% THE SLIPPERY SLOPE

15 SS/EBM/Intro/2010 1. 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

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

17 SS/EBM/Intro/2010 Meta-analysis Clinical guidelines Economic analysis Clinical decision making Cost-effectiveness analysis Qualitative research Others:

18 SS/EBM/Intro/2010 (I) Formulating clinical questions

19 SS/EBM/Intro/2010 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?

20 SS/EBM/Intro/2010 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?

21 SS/EBM/Intro/2010 House officers (Foreground question) In infants with large VSD and CHF, would administration of digoxin or other inotropic agent delay the need for surgery?

22 SS/EBM/Intro/2010 Foreground questions Background questions Experience with condition

23 SS/EBM/Intro/2010 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 example

24 SS/EBM/Intro/2010 In women with history of eclampsia, would administration of low-dose aspirin (compared with no aspirin) during pregnancy prevent eclampsia? Other example

25 SS/EBM/Intro/2010 Examples of clinical questions in practice

26 SS/EBM/Intro/2010 Example: Etiology P I C O “In premature infants … …is mode of delivery… …a risk factor for the developmnt HMD?

27 SS/EBM/Intro/2010 Example: Diagnosis P I C O “In patients with suspected malaria …can rapid test …compared with microscope exam …effectively establish diagnosis?

28 SS/EBM/Intro/2010 Example: Therapy P I C O “For px with Stevens Johnson syndrome will early IV Immuno- globulin (IVIG) …when compared with no IVIG …prevent severe complica- tions?

29 SS/EBM/Intro/2010 Example: Prognosis P I C O “For px with SLE …would history of heart failure …compared with no history of HF …worsen the prognosis?

30 SS/EBM/Intro/2010 Four elements of good clinical question: PICO The Patient or Problem The Intervention Comparative intervention The Outcome Domain Determinants Outcome

31 SS/EBM/Intro/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/Intro/2010 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)

33 SS/EBM/Intro/2010 Remember (2) In the PICO context, Intervention does not necessarily mean TREATMENT or 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?

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

35 SS/EBM/Intro/2010 Comparing DOEs and POEMs Prostate screening PSA screening detects prostate Ca. early ? whether PSA screening  mortality DOE exists, but POEM unknown Antiarrhythmic Therapy Antihypertens. Therapy Drug A  PVC On ECG Drug X  BP Drug X  mortality Drug A > mortality DOE & POEM contradicts POEM agrees With DOE ExampleDOEPOEMComment

36 SS/EBM/Intro/2010 II Searching the evidence

37 SS/EBM/Intro/2010 Examples of on-line Journals / Databases http://adc/ MEDLINE/PubMed EMBASE MDConsult AAP Journal Club Cochrane Library

38 SS/EBM/Intro/2010 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 Use keywords for searching

39 SS/EBM/Intro/2010 III Appraising the evidence: VIA

40 SS/EBM/Intro/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

41 SS/EBM/Intro/2010 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

42 SS/EBM/Intro/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

43 SS/EBM/Intro/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

44 SS/EBM/Intro/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

45 SS/EBM/Intro/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

46 SS/EBM/Intro/2010 Development of EBM practice Passive diffusion model Active dissemination model Coordinated implementation model: Patients & community Health administrators Public policy makers Clinical policy makers

47 SS/EBM/Intro/2010


49 The EBM Cycle Patient With problem Formulate In answerable question Search the evidence Critically Appraise The evidence Apply The evidence

50 SS/EBM/Intro/2010 Accessible population (time, place) Usu. Based on practical purposes Appropriate sampling technique [Non-response, drop outs, withdrawals, loss to follow-up] Target population (Domain) (demographic, clinical) Intended Sample [Subjects selected for study] Actual study subjects Subjects completed the study Your patient is here!

51 SS/EBM/Intro/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

52 SS/EBM/Intro/2010 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

53 SS/EBM/Intro/2010 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

54 SS/EBM/Intro/2010 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

55 SS/EBM/Intro/2010 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

56 SS/EBM/Intro/2010 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

57 SS/EBM/Intro/2010 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

58 SS/EBM/Intro/2010 Barriers to the implementation of Evidence-Based Medicine “It takes too long.” “Possibly a limitation to my clinical freedom.” “It questions my professional autonomy.”

59 SS/EBM/Intro/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

60 SS/EBM/Intro/2010 End result Self directed, life-long learning attitude for high quality patient care

61 SS/EBM/Intro/2010 Conclusion EBM is nothing more than a framework of systematic use of current valid study results relevant to our patient

62 SS/EBM/Intro/2010 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!!!

63 SS/EBM/Intro/2010 In God we trust All others must have evidence

64 SS/EBM/Intro/2010 Remember, however …... Medicine is the science of uncertainty and the art of probabilities

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