Gs Ts Bs Lê Hoàng Ninh ( tài liệu lưu hành nội bộ )

1. Bài 1. Đại cương về y học chứng cứ (EBM), y tế công cộng chứng cứ ( EBPH) và thực hành y học chứng cứ ( EBP) Gs Ts Bs Lê Hoàng Ninh ( tài liệu lưu hành nội bộ )

2. Mục tiêu bài học • Hiểu được vị trí của y học chứng cứ trong thực hành chăm sóc bệnh nhân và trong nghiên cứu khoa học sức khỏe • Phân tích những lý do cần học và thực hành y học chứng cứ • Hiểu được y hoc chứng cứ ( EBM) và y tế công cộng chứng cứ ( EBPH)

3. “…If we did not respect the evidence, we would have very little leverage in our quest for the truth.” Carl Sagan

4. Tại sao phải đọc y văn và tầm quan trọng của y văn Things that • Have patient oriented outcomes • Answer a patient-care question • Might change your practice • Are on a topic you have been following • People are talking about and you want to know more • You find interesting POEM or DOE • Patient-oriented evidence that matters vs disease-oriented evidence

5. Getting Evidence in to PracticeHow do you “do” EBP? What Evidence based practice do you do/help with? What other EBP do you know of?

6. JASPA*(Journal associated score of personal angst) 0 (?liar) 1-3 (normal range) >3 (sick; at risk for polythenia gravis and related conditions) * Modified from: BMJ 1995;311:1666-1668 J: Are you ambivalent about renewing your JOURNALsubscriptions? A:Do you feel ANGER towards prolific authors? S:Do you ever use journals to help you SLEEP? P:Are you surrounded by PILES of PERIODICALS? A:Do you feel ANXIOUSwhen journals arrive?YOUR SCORE? (0 TO 5)

7. Median minutes/week spent reading about my patients: Self-reports at 17 Grand Rounds: Medical Students: 90 minutes House Officers (PGY1): 0 (up to 70%=none) SHOs (PGY2-4): 20 (up to 15%=none) Registrars: 45 (up to 40%=none) Sr. Registrars 30 (up to 15%=none) Consultants: Grad. Post 1975: 45 (up to 30%=none) Grad. Pre 1975: 30 (up to 40%=none)

8. Size of Medical Knowledge 1 disease per day for 30 years To cover the vast field of medicine in four years is an impossible task. - William Olser • NLM MetaThesaurus • 875,255 concepts • 2.14 million concept names • Diagnosis Pro • 11,000 diseases • 30,000 abnormalities (symptoms, signs, lab, X-ray,) • 3,200 drugs (cf FDAs 18,283 products)

9. How many randomized trials are published each year

10. But we are (currently) poorly equipped to tell good from bad research Schroter S et al, accepted for Clinical Trials • BMJ study of 607 reviewers • 14 deliberate errors inserted • Detection rates • On average <3 of 9 major errors detected • Poor Randomisation (by name or day) - 47% • Not intention-to-treat analysis - 22% • Poor response rate - 41%

11. Managing Information“Push” and “Pull”methods • “Push” - alerts us to new information • “Just in Case” learning • Use ONLY for important, new, valid research • “Pull” – access information when needed • “Just in Time” learning • Use whenever questions arise • EBM Steps: Question; search; appraise; apply

12. Quality of the Medical Literature Journal High Quality Articles N Eng J Med 17% Ann Intern Med 13% JAMA 12% BMJ 9% Lancet 8%

13. “Good education teaches us to become both producers of knowledge & discerning consumers of what other people claim to know.”

14. Thực hành y học theo truyền thống • Pathophysiology and pharmacology • Foundation of medical practice • Do what “makes sense” • Expert opinion • In training: learning at the bedside from the master clinician • In practice: lectures and seminars with thought leaders • Clinical experience • Successes, outcomes, and adverse events in our own practice

15. Problems With the Traditional Approach • Physiology may not predict clinical response • Beta-adrenergic blockade in heart failure • Encainide for post-MI arrhythmia • Estrogen replacement for cardioprotection • Expert opinion • Only as good as the expert • May be affected by biases and conflicts of interest • Clinical experience • Dramatic clinical experiences may unduly influence our practice patterns • May not take account of recent medical literature Guyatt et al. Users' Guides to the Medical Literature: A Manual for Evidence-BasedClinical Practice. Chicago, IL: American Medical Association; 2001.

16. Paradigms of Medicine

17. Cần có sự lồng ghép chứng cứ • Clinical expertise • Experience • Judgment • Patient values and preferences • Quality of life • Costs • Other important factors

18. A BRIEF HISTORY 1980’s: McMasters University in Ontario, Canada Dr. David Sackett and colleagues proposed Evidence Based Medicine (EBM) as a new way of teaching, learning and practicing medicine. Dr. Sackett defines EBM as: “…The conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.”

19. Y học dựa vào chứng cứ là gì? “y học chứng cứ ( evidence based medicine – EBM ) là sự lồng ghép , tích hợp các bằng chứng nghiên cứu trốt nhất với kinh nghiệm lâm sàng và các giá trị của bệnh nhân “ Sackett DL, Evidence based medicine : what it is and what isn’t. BMJ 1996; 312: 71-72

20. Thực hành dựa vào chứng cứ là gì ? Evidence-based Practice (EBP) “Thực hành dựa vào chứng cứ yêu cầu các quyết định về chăm sóc sức khỏe phải dựa vào các chứng cứ khoa học tương thích, hiện có , có giá trị , tin cậy, và tốt nhất.Những quyết định nầy phải được xây dựng bởi người được chăm sóc ( bệnh nhân ), họ được thông tin bởi người chăm sóc ( thầy thuốc) với kiến thức , hiểu biết rõ ràng minh bạch trong bối cảnh nguồn tài nguyên sẳn có." Sicily statement on evidence-based practice. BMC Medical Education, 2005 Jan 5;5(1):1

21. Vậy EBP? • The integration of best evidence* from current research, patient preferences and values, and clinical expertise to clinical questions (Sackett, 2000) in a timely fashion. EBP *Best available evidence is: consistent research evidence with high quality and quantity

22. Định nghĩa y tế công cộng chứng cứ (EBPH) The conscientious, explicit, judicious use of the current best evidence in making decisions in routine PH practice, and in developing PH policies and programs. (Ref: Sackett et al, 1996)

23. Định nghĩa YTCC chứng cứ (EBPH) (cont.) EBPH practice requires integrating practitioner expertise, accumulated PH and basic science knowledge, and regulatory requirements, with best evidence from systematic research.

24. Definition: Evidence-based Public Health • “the development, implementation, and evaluation of effective programs and policies in public health through application of principles of scientific reasoning, including systematic uses of data and information systems, and appropriate use of behavioral science theory and program planning models” Source: Brownson, R.C. et al, Evidence-based public health, Oxford University Press, 2003.

25. Community Needs & Values Scientific Evidence Resources EBPH (adapted and modified from Muir Gray)

26. Key Differences between EBM and EBPH

27. Why is EBPH important? • Provides assurance that decision making is based on scientific evidence and effective practices • Helps ensure the retrieval of up-to-date and reliable information about what works and doesn’t work for a particular public health question • Provides assurance that one’s time is being used most efficiently and productively in reviewing the “best of the best” information available on the particular public health question

28. Why is EBPH important? • During the past century, average life expectancy increased by approximately 30 years in industrialized countries • Only about 5 years of that improvement is attributable to preventive services and medical care - Bunker et. al. 1994

29. Some Key Characteristics of EBPH • Intervention approaches developed based on the best possible scientific information • Theory and systematic planning approaches are followed • Problem solving is multi-disciplinary • Sound evaluation principles are followed • Results are disseminated to others who need to know and take action

30. Advantages to Using EBPH • Higher likelihood of success • A move away from decision-making that relies too heavily on: • History • Anecdotes • Pressure from policy makers • Identify common indicators • Defend/expand an existing program • Advocate for new programs • New knowledge is generated to help others

31. When is EBPH used? • when it’s important to have scientific evidence to support decision making • when evaluating the effectiveness and cost benefits of health programs • when establishing new health programs • when policies are being implemented • when conducting literature reviews for grant projects.

32. Tại sao chúng ta cần y học dựa vào chứng cứ

35. Why do we need RANDOMIZED CONTROLLED TRIALS ? www.cebm.net In the early 1980s newly introduced antiarrhythmics were found to be highly successful at suppressing arrhythmias. Not until a RCT was performed was it realized that, although these drugs suppressed arrhythmias, they actually increased mortality. The CAST trial revealed Excess mortality of 56/1000. By the time the results of this trial were published, at least 100,000 such patients had been taking these drugs.

36. Why EBP? • Cải thiện sự chăm sóc: • Cầu nối 2 bờ nghiên cứu và thực hành • “Kill as few patients as possible” (O. London) • Thuốc mới, điều trị mới phải ít / thật ít tác dụng ngioài ý . • Điều trị mới cần rẽ hợn và ít xâm lấn hơn • Điều trị mới là cần cho người đã kháng với các điều trị hiện hành ... • Để có kiến thức và kỹ năng được cập nhật (continuing education) • Tiết kiệm thời gian tìm kiếm thông tin tốt nhất

37. why ebp ?

38. WHAT IS THE BASIS OF YOUR MEDICAL PRACTICE? (Check all that apply) • Training, clinical experience and consultation with other professionals • Convincing evidence (non-experimental) from articles, case reports, product literature, etc. • Preferences of the patient • Active search of Randomized Controlled Trials, Systematic Reviews, Meta-Analysis Reports

39. WHAT IS THE BASIS OF YOUR MEDICAL PRACTICE? • EXCELLLENT! • Training, clinical experience and consultation with other professionals • Convincing evidence (non-experimental) from articles, case reports, product literature, etc. • Preferences of the patient • Active search of Randomized Controlled Trials, Systematic Reviews, Meta-Analysis Reports

40. BUT… Past knowledge and practice might be outdated or inadequate Up to date Knowledge Clinical skills and Experience Graduate Medical School Practiced Physician

41. WHAT IS THE BASIS OF YOUR MEDICAL PRACTICE? • FANTASTIC! • Training, clinical experience and consultation with other professionals • Convincing evidence (non-experimental) from articles, case reports, product literature, etc. • Preferences of the patient • Active search of Randomized Controlled Trials, Systematic Reviews, Meta-Analysis reports

42. BUT… This evidence may be biased, outdated, incorrect, or not applicable to your patient JOURNALS (1987 to present) ARTICLES ADVERTISEMENTS

43. WHAT IS THE BASIS OF YOUR MEDICAL PRACTICE? • WONDERFUL! • Training, clinical experience and consultation with other professionals • Convincing evidence (non-experimental) from articles, case reports, product literature, etc. • Preferences of the patient • Active search of Randomized Controlled Trials, Systematic Reviews, Meta-Analysis reports Mutual Respect + Shared Goals = Better Cooperation and Compliance

44. The patient should be involved in • all important decisions • But this is NOT always an easy task! • And conflicts WILL occur!

45. No salt? Lose weight? Forget it! Just give me a pill! I WON’T take that medicine… The side effects are INTOLERABLE! But doctor, I DO want to have children! • And conflicts WILL occur!

46. No salt? Lose weight? Forget it! Just give me a pill! I WON’T take that medicine… The side effects are INTOLERABLE! But doctor, I DO want to have children! Education about current alternatives and risks is often needed… for both the Patient and the Doctor!

47. Wow… I never knew that high blood pressure could be so dangerous at my age! Yes, I’d like to try that new medication! I’ll discuss those risks with my husband. Education about current alternatives and risks is often needed… for both the Patient and the Doctor!

48. An important rule in Evidence Based Medicine… It STARTS with the patient and ENDS with the patient. The patient’s preferences MUST be considered!

49. WHAT IS THE BASIS OF YOUR MEDICAL PRACTICE? WOW!!! SUPERB!!! • Training, clinical experience and consultation with other professionals • Convincing evidence (non-experimental) from articles, case reports, product literature, etc. • Preferences of the patient • Active search of Randomized Controlled Trials, Systematic Reviews, Meta-Analysis reports

50. In the practice of Evidence Based Medicine, it is the physician’s duty to find the best and most current information and apply it judiciously for the benefit of the patient.