Physician and Evidence Based medicine

1. Physician and Evidence Based medicine Ken N. Kuo, MD National Health Research Institutes Wan Fan Hospital, Taipei May 7, 2004

2. 醫 師 與 實 証 醫 學 國家衛生研究院 論壇執行長 郭耿南 教授 台北市萬芳醫院 2004年 5月 7日

3. 1966 2004

4. My life time National Taiwan University University of Michigan University of Illinois London University University of Edinburgh Rush University National Health Research Institute

5. My life time Rush is the one I stayed the longest, Rush is the place where; I developed my professional career, I matured in my think process, I nurtured my relationship But, Taiwan is always in my mind

6. A Good Life-Then • A stable job • A great dowry-cash, house, motorcycle • A red envelop (紅包) • An easy life---esp. for family • A lot of money • A good social statue

7. A Bad Life-Now? • Decrease income-fight NHI • No more red envelop (紅包) • Decreased social statue • Fight legal dispute • Change of life style- Quality of life issue • No more drug money for wine and dine

8. The population/doctor ratio • 1960: 1890 people per doctor • 2002: 750 people per dotcor • At present time, there are 1300 medical graduate each year, the limit set by DOE • The projection at Health Policy Division, NHRI, it will reach 400 in 20 years

9. So, what left for a physician?

10. WHAT CAN WE DO? Awareness Advocate Education Excellence Medical policy

11. “We are what we repeatedly do. Excellence, then, is not an act, but a habit.” ---Aristotle

12. The Oath of Hippocrates I swear by Apollo Physician, by Asclepius, by Health, by Panacea and by all the Gods and Goddess, making them my witness, that I will carry out, according to my ability and judgment, this oath and this indenture. -------------I will use treatment to help the sick according to my ability and judgment, but never with a view to injury and wrongdoing. Neither will I administer a poison to anybody when asked to do so,-- --------------

13. 我 的 老 師 George C. Lloyd-Roberts (1918-1986) Hospital for Sick Children Great Ormand Street London

14. Think & Ask Questions

15. Six Competencies of Residency by ACGME (2003) • Patient care • Medical knowledge • Professionalism • Practice based learning and improvement • Interpersonal and communication skills • System based practice

16. IOM Core Competencies Health Professions Education: A bridge to Quality (2003) • Provide patient-centered care • Work in interdisciplinary teams • Employ evidence-based practice • Apply quality improvement • Utilize informatics

17. What is it, EBM? • The best available evidence is applied to improve the quality of clinical judgments and facilitate cost-effective medical care. • Three approaches • Best research evidence • Clinical expertise • Patients Value

18. Physician’s Self-Directed Learning • Stage 0: Scanning for problems and other interesting things • Stage 1: Evaluating the problems • Stage 2: Learning the skills and knowledge • Stage 3: Gaining experience using what has been learned

19. Evidence Based Practice Guidelines • Clinical practice guidelines: • Systematically developed statements to assist practitioners and consumer decisions about appropriate health care for specific clinical circumstances. (IOM, 1990) • Organizations: • National Guideline Clearinghouse (NGC) • Cochrane Collaboration

20. Objections • Too restricted, no room for freedom • Become lazy, physicians will spend less time in searching the literature • What happen if there is variation of condition • Medical practice is an art, not a strict rule • Most importantly, there is lack of intellectual stimulation

21. Correct medical practiced distorted By NHI Establish NHI reimbursement guidelines Save time for physicians Improve physician’s skill of learning NHI Physician Contain the cost by having institute a more efficient and less wasteful system Resolve medical dispute in a scientific and state-of-art way Improve the quality of medical care Break the tradition of medical practice which not been critically reviewed Problem based education Cost & Quality Why does Taiwan need EBG?

22. Problems • Not accepted into mainstream practice • Lack authority to make practitioner to value EBG highly • EBG developed has not been put into real test and adopt into practice • Not establish demonstrable value • Done locally and individually

23. Other Problem Scientifically unsupported information used in drug advertising has greater influence on physician decision than the scientific literature, such as: hypertension URI hypercholesterolemia prophylactic antibiotics in elective surgery etc.

24. The Objectives • To develop and implement practice guidelines in Taiwan based on scientific evidence To document the process and critical success factors used in implementing the guidelines in Taiwan To document the process in evaluating the effectiveness of the developed guidelines Establishing the critical indicators

25. Three Stages of The Project Development of Practice Guidelines Implementation of Practice Guidelines Evaluation of the Effectiveness

26. Development of Practice Guidelines • Identification of topic areas • Organizational intervention • Review and identify quality research papers • Formation of a blue-ribbon expert panel • Focus group of practicing physicians

27. Unless a guideline accurately reflects the routine working practices of most doctors, it will act only as a gold standard to be admired. (Farmer, 1993)

28. Implementation of Practice Guidelines • Collaboration of professional organizations • Incorporating into the education curriculum • NHI system implementation • Identify the barriers and solutions

29. Implement Revise Evaluate Evaluation of The Efficacy • Test the feasibility and acceptability • Evaluate the impact • Evaluate the proficiency among medical students and residents

30. 證據等級與建議強度 • 證據的整合 • 審慎的判斷（considered judgment） • 證據等級與建議強度評等

31. 發展臨床診療指引之參與對象 • 發展指引之參與者應含括： • 該專科醫師/專家 • 指引發展小組成員(guideline development group) • 統計學家 • 醫療倫理學專家 • 其他相關醫事人員

32. Types of Studies Therapeutic Studies— Investigating the Results of Treatment Prognostic Studies— Investigating the Outcome of Disease Diagnostic Studies— Investigating a Diagnostic Test Economic and Decision Analyses—Developing an Economic or Decision Model Level I 1. Randomized controlled triala. Significant differenceb. No significant difference but narrow confidence intervals2. Systematic review2 of Level-I randomized controlled trials (studies were homogeneous) 1. Prospective study12. Systematic review2 of Level-I studies 1. Testing of previously developed diagnostic criteria in series of consecutive patients (with universally applied reference "gold" standard)2. Systematic review2 of Level-I studies 1. Clinically sensible costs and alternatives; values obtained from many studies; multiway sensitivity analyses2. Systematic review2 of Level-I studies Level of Evidence for Primary Research Question(I) 1. All patients were enrolled at the same point in their disease course (inception cohort) with greater than or equal to 80% follow-up of enrolled patients.2. A study of results from two or more previous studies.

33. Types of Studies Therapeutic Studies— Investigating the Results of Treatment Prognostic Studies— Investigating the Outcome of Disease Diagnostic Studies— Investigating a Diagnostic Test Economic and Decision Analyses—Developing an Economic or Decision Model Level II 1. Prospective cohort study32. Poor-quality randomized controlled trial (e.g., <80% follow-up)3. Systematic review2a. Level-II studiesb. Nonhomogeneous Level-I studies 1. Retrospective study42. Study of untreated controls from a previous randomized controlled trial3. Systematic review2 of Level-II studies 1. Development of diagnostic criteria on basis of consecutive patients(with universally applied reference "gold" standard)2. Systematic review2 of Level-II studies 1. Clinically sensible costs and alternatives; values obtained from limited studies; multiway sensitivity analyses2. Systematic review2 of Level-II studies Level of Evidence for Primary Research Question(II) 2. A study of results from two or more previous studies.3. Patients were compared with a control group of patients treated at the same time and institution.4. The study was initiated after treatment was performed.

34. Types of Studies Therapeutic Studies— Investigating the Results of Treatment Prognostic Studies— Investigating the Outcome of Disease Diagnostic Studies— Investigating a Diagnostic Test Economic and Decision Analyses—Developing an Economic or Decision Model Level III 1. Case-control study52. Retrospective cohort study43. Systematic review2 of Level-III studies 1. Study of nonconsecutive patients (no consistently applied reference "gold" standard)2. Systematic review2 of Level-III studies 1. Limited alternatives and costs; poor estimates2. Systematic review2 of Level-III studies Level of Evidence for Primary Research Question(III) 2. A study of results from two or more previous studies. 4. The study was initiated after treatment was performed.5. Patients with a particular outcome ("cases" with, for example, a failed total arthroplasty) were compared with those who did not have the outcome ("controls" with, for example, a total hip arthroplasty that did not fail).

35. Types of Studies Therapeutic Studies— Investigating the Results of Treatment Prognostic Studies— Investigating the Outcome of Disease Diagnostic Studies— Investigating a Diagnostic Test Economic and Decision Analyses—Developing an Economic or Decision Model Level IV Case series (no, or historical, control group) Case series 1. Case-control study2. Poor reference standard No sensitivity analyses Level V Expert opinion Expert opinion Expert opinion Expert opinion Level of Evidence for Primary Research Question(IV)

36. 等級 實證類別 1++ 高品質之整合分析(meta analysis)，系統性文獻回顧(systematic reviews)之隨機控制試驗(RCTs)，或該隨機控制試驗之設計誤差(bias)極低。 1+ 執行良好之整合分析(meta analysis)，系統性文獻回顧(systematic reviews)之隨機對照試驗（RCTs），或該隨機對照試驗之設計誤差(bias)極低。 1- 整合分析(meta analysis) 系統性文獻回顧(systematic reviews)之隨機對照試驗（RCTs），或該隨機對照試驗之設計誤差(bias)偏高。 • 證據等級(Levels of Evidence)-I 證據等級的分類：1++-最高等級，4-最低等級 資料來源：Scottish Intercollegiate Guidelines Network, May 2002

37. 等級 實證類別 2++ 1.經過病例對照研究(case-control study)或世代研究(cohort study)之高品質系統性文獻回顧。 2.高品質的病例對照研究法及世代研究法可降低干擾、誤差及機率，並且具有高度的因果相關。 2+ 經過病例對照研究(case-control study)或世代研究(cohort study)之設計良好的系統性文獻回顧。 2- 研究設計誤差（bias）較高之病例對照研究或世代研究 • 證據等級(Levels of Evidence)-II 證據等級的分類：1++-最高等級，4-最低等級 資料來源：Scottish Intercollegiate Guidelines Network, May 2002

38. 等級 實證類別 3 非分析性之研究，例如：個案報告 4 專家意見 • 證據等級(Levels of Evidence)-III 證據等級的分類：1++-最高等級，4-最低等級 資料來源：Scottish Intercollegiate Guidelines Network, May 2002

39. 評等 內容 A 1.至少有一項整合分析、系統性文獻回顧或隨機對照試驗之實證等級為1++，且該研究可直接應用於目標群體(target population)；或 2.系統性文獻回顧(systematic reviews)之隨機對照試驗(RCTs)或大部分的證據主體由實證等級為1+之研究構成，可直接應用於目標群體，或所有的證據都有一致性的結果。 • 建議強度之評等(Grades of Recommendation)-I 建議強度：A>B>C>D 資料來源：Scottish Intercollegiate Guidelines Network, May 2002

40. 評等 內容 B 1.證據主體由實證等級為2++之研究構成，可直接應用於目標群體，或所有的證據都有一致性的結果；或 2.從研究所推算的證據等級為1++或1+。 • 建議強度之評等(Grades of Recommendation)-II 建議強度：A>B>C>D 資料來源：Scottish Intercollegiate Guidelines Network, May 2002

41. 評等 內容 C 1.證據主體由實證等級為2+之研究構成，可直接應用於目標群體，或所有的證據都有一致性的結果；或 2.從研究所推算的證據等級為2++。 D 1.證據等級為3或4；或 2.從研究所推算的證據等級為2+。 • 建議強度之評等(Grades of Recommendation)-III 建議強度：A>B>C>D 資料來源：Scottish Intercollegiate Guidelines Network, May 2002

42. 只有具有科學證據的措施才會受到建議，沒有科學證據支持的做法則不會受到建議。只有具有科學證據的措施才會受到建議，沒有科學證據支持的做法則不會受到建議。

43. 但是一個未受建議的措施，除了可能是證據不支持之外，也可能是因為缺乏證據，或是相關的研究有限，無法明確說明介入與所帶來的益處或害處間的關係，例如：已被大家廣泛接受的臨床概念(在台灣，全髖關節置換術不一定要伴隨抗凝血劑的給予)。但是一個未受建議的措施，除了可能是證據不支持之外，也可能是因為缺乏證據，或是相關的研究有限，無法明確說明介入與所帶來的益處或害處間的關係，例如：已被大家廣泛接受的臨床概念(在台灣，全髖關節置換術不一定要伴隨抗凝血劑的給予)。 • 正確的解讀應該是－該建議措施目前還沒有足夠強的客觀證據支持，而不是該措施不當或是不重要。

44. In addition to the scientific evidence in medical practice, what can a physician do to improve the relation to patient? Hence, improve the outcome of the practice.

45. Qualities of a Physician • Patient welfare paramount • Honest but not yes man • Reliable • Stability from day to day • Good interpersonal skill

46. Qualities of a Physician • Responsible • Pride and Humility • Recognizes own limitation • Interested in people • Has interests other than medicine

47. DIONYSUS---The God of Wine • Dionysus is the son of Zeus and Semele in Greek Mythology. His tutor, Silenus, taught him that wine in excess may lead to weakness and brutality, while in moderation it promotes freedom and and buoyancy. • Bacchus--Bacchae by Euripides (5th century, B,C.) dramatized the event, Bacchanalia.

48. Some bad features of a physician • Stubborn • Inhumane • Rigid • Not considerate • “God” like

49. LOVE

50. A GOOD DOCTOR The Product of Brain x Heart x Hands