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1 (”Bringing research evidence
B ased M edicine (”Bringing research evidence into practice”) Sudigdo Sastroasmoro Medical School University of Indonesia

2 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) 2

3 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

4 Previous practice: 6 yrs medical education Problems with patients:
Dx, Rx, Px 40-50 yrs medical practice Consultants, colleagues Textbooks Handbooks Lecture notes Clinical guidelines CME, seminars, etc Journals Usu. see only Results section, or even worse, Abstract section

5 Trust me In my experience …. Logically Textbook, handbook, capita selecta

6 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 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 “Hierarchy of Lies” Statistics Damn lies..... Lies..... (Mark Twain)

9 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

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

11 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 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. Antman EM, Lau J, Kupelnick B, Mosteller F, Chalmers TC: A comparison of results of meta-analyses of randomised control trials and recommendations of clinical experts. JAMA 1992;268:240-8. Then I show two slides from their article, showing the lag in recommending thrombolytics and the lag in de-recommending lidocaine for myocardial infarction.

13 The inevitable consequence:
On average, the clinically-important knowledge of physicians deteriorates rapidly after we complete our training. We have a nice slide from the late Ted Evans, but also include a jazzier version of it from Brian Haynes, and it follows here. Evans CE, Haynes RB, Birkett NJ et al: Does a mailed continuing education program improve clinician performance? Results of a randomised trial in antihypertensive care. JAMA 1986:255:501-4.

14 $ THE SLIPPERY SLOPE 100% Relative % of remaining knowledge
Years after graduation THE SLIPPERY SLOPE

15 Steps in EBM practice VIA
Formulate clinical problems in answerable questions 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 VIA

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

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

18 (I) Formulating clinical questions

19 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 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 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 Foreground questions Background Experience with condition

23 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?

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

25 Examples of clinical questions in practice

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

27 …comparedwith microscope
Example: Diagnosis P I C O “In patients with suspected malaria …can rapid test …comparedwith microscope exam …effectively establish diagnosis?

28 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 Example: Prognosis P I C O “For px with SLE …worsen the prognosis?
…would history of heart failure …compared with no history of HF

30 Four elements of good clinical question: PICO
The Patient or Problem The Intervention Comparative intervention The Outcome Domain Determinants Outcome

31 Four elements of a well constructed clinical question: PICO
The main intervention considered The alternative to compare with the 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 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 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 Relevance: Type of Evidence
POE: Patient-oriented evidence mortality, morbidity, quality of life DOE: Disease-oriented evidence pathophysiology, pharmacology, etiology

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

36 II Searching the evidence

37 Examples of on-line Journals / Databases
MEDLINE/PubMed EMBASE MDConsult AAP Journal Club Cochrane Library

38 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

39 III Appraising the evidence: VIA

40 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

41 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 Critical appraisal for therapy
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?

43 Hierarchy of evidence Rec Meta-analysis of RCT Level 1 Large RCT A
B C Rec Weight of Scientific 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

44 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 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 Development of EBM practice
Passive diffusion model Active dissemination model Coordinated implementation model: Patients & community Health administrators Public policy makers Clinical policy makers

47 Summing up ....


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

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

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

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

62 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 All others must have evidence
In God we trust All others must have evidence

64 Medicine is the science of uncertainty and the art of probabilities
Remember, however …... Medicine is the science of uncertainty and the art of probabilities

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