EVIDENCE BASED MEDICINE A new approach to clinical care and research

1. EVIDENCE BASED MEDICINEA new approach to clinical care and research Developed and presented by Judy Tarselli, RN Dubai, UAE Karachi, Pakistan October 2003 Organized by NKF cyberNephrology University of Alberta, Canada www.cyberNephrology.org Special thanks to our sponsors Janssen-Cilag

2. PROGRAM OUTLINE Definition of EBM Basic Steps Trials, Studies and Reports Pros, Cons and Limitations EBM in Developing Countries EBM Library Advanced EBM

3. But first, a test…

4. 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

5. 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

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 BUT… Past knowledge and practice might be outdated or inadequate Up to date Knowledge Clinical skills and Experience Graduate Medical School Practiced Physician

7. 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

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 BUT… This evidence may be biased, outdated, incorrect, or not applicable to your patient JOURNALS (1987 to present) ARTICLES ADVERTISEMENTS

9. 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

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

11. 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!

12. 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!

13. 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!

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

15. 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

16. 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.

17. But… A practice based exclusively on science and math is effective only if your patients are robots or clones! • Don’t forget to allow for individual human differences • and personal preferences!

18. WHAT IS THE BASIS OF YOUR MEDICAL PRACTICE? • If you checked all 4 items… • 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

19. CONGRATULATIONS! You are practicing EVIDENCE BASED MEDICINE! • 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

20. EVIDENCE BASED MEDICINEA new approach to clinical care and research Definition of EBM Basic Steps Trials, Studies and Reports Pros, Cons and Limitations EBM in Developing Countries EBM Library Advanced EBM

21. “What is Evidence Based Medicine?” “And where did it come from?”

22. 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.”

23. Evidence Based Medicine It is a change in the way physicians practice medicine, teach and learn, and handle research. Clinical practice: Based on the best current evidence (not necessarily on how it’s always been done) Patient Care: Compassionate, patient-oriented (less authoritarian) Learning & Teaching: Problem-based, problem-solving more investigative, less know-it-all-by-yesterday Research: More stringent approach, better proof criteria (more demanding of proof, less room for error)

24. THREE MAJOR COMPONENTS of EBM PATIENT Question or Problem PHYSICIAN INFORMATION

25. THE ADDED DETAILS PATIENT Values, Concerns Preferences, Expectations Life predicament EBM PHYSICIAN Training & Experience Current Expertise Continued learning Demand for proof INFORMATION Clinically relevant Proven by research Best up-to-date evidence

26. OPTIONAL COMPONENTSTO BE ADDED BY THE PHYSICIAN PATIENT Values, Preferences Concerns, Expectations Life predicament HUMILITY Non-authoritarian practice CHARITY EBM is not a required practice (yet) EBM PHYSICIAN Training Expertise Continued Learning Demand for proof INFORMATION Clinically relevant Proven by research Current, up to date ENTHUSIASM Challenge, Variety, Change

27. “Isn’t this the way we have always practiced medicine?” “Aren’t these just the same old ingredients tossed into a new recipe?” When am I supposed to find the time to do that?

28. The basic steps of EBM

29. THE FIVE BASIC STEPS OF EBM Clinical Question Patient-focused, problem-oriented 2. Find Best Evidence Literary Search 3. Critical Appraisal Evaluate evidence for quality and usefulness 4. Apply the Evidence Implement useful findings in clinical practice 5. Evaluate The information, intervention, and EBM process

30. THE FIVE BASIC STEPS OF EBM Clinical Question Patient-focused, problem-oriented 2. Find Best Evidence Literary Search 3. Critical Appraisal Evaluate evidence for quality and usefulness 4. Apply the Evidence Implement useful findings in clinical practice 5. Evaluate The information, intervention, and EBM process

31. THE FIVE BASIC STEPS OF EBM Clinical Question Patient-focused, problem-oriented 2. Find Best Evidence Literary Search 3. Critical Appraisal Evaluate evidence for quality and usefulness 4. Apply the Evidence Implement useful findings in clinical practice 5. Evaluate The information, intervention, and EBM process

32. THE FIVE BASIC STEPS OF EBM Clinical Question Patient-focused, problem-oriented 2. Find Best Evidence Literary Search 3. Critical Appraisal Evaluate evidence for quality and usefulness 4. Apply the Evidence Implement useful findings in clinical practice 5. Evaluate The information, intervention, and EBM process

33. THE FIVE BASIC STEPS OF EBM Clinical Question Patient-focused, problem-oriented 2. Find Best Evidence Literary Search 3. Critical Appraisal Evaluate evidence for quality and usefulness 4. Apply the Evidence Implement useful findings in clinical practice 5. Evaluate The information, intervention, and EBM process

34. THE FIVE BASIC STEPS OF EBM Clinical Question Patient-focused, problem-oriented 2. Find Best Evidence Literary Search 3. Critical Appraisal Evaluate evidence for quality and usefulness 4. Apply the Evidence Implement useful findings in clinical practice 5. Evaluate The information, intervention, and EBM process

35. The Clinical Question The FIRST step The HARDEST step The MOST IMPORTANT step!

36. FACT: We all have informational needs! That is not a problem!

37. Problems arise • if we fail to recognize those needs • if we fail to bridge the information gap • if we fail to ask the right questions

38. Asking good questions is a skill to be learned. Hmmm… Is he about to give me a BONUS? Or is he about to FIRE me? Lee, exactly how much time did you spend on that big project? It will make life easier for you... And also for others around you!

39. Lee, can you give me an accounting of the extra time you spent on that project so that I can charge it back to the client? Oh sure! I’ll have it on your desk by tomorrow! • A GOOD QUESTION… • Is focused and relevant • Provides clear communication • Clarifies your goal or need • Will reduce the amount of time needed to obtain the answer

40. WHEN PRACTICING EBM, a good question must also: ACTUAL CASE SCENARIO Large cauc male, age 40 2mo ago: Presented with classic nephrotic syndrome, significant symptoms. Bx showed IgAN. Cr 1.4, incr to 2 range, now 1.6 Tried prednisone 60mg qd - tolerated poorly w/tremors and depression. Needs new regimen, but others are aimed more at nephritic IgA rather than nephrotic syndrome. Suggestions? • Be specific Identify the problem, clarifiy the clinical issue • Be answerable through the literature • Contain multiple aspects (patient, options, comparisons, etc) It should NOT involve a question of Personal Preference or Local Concern.

41. THE EVIDENCE BASED RESPONSE Posted on Nephrol 4/13/03 Respondant recommends cyclophosphamide and prednisolone (assuming secondary causes excluded) - a combination that allows for lower dose prednisolone… “In the study below, proteinuria and renal function improved on this combination: Ballardie FW, Roberts IS. Controlled prospective trial of prednisolone and cytotoxics in progressive IgAN. J Am Soc Nephrol 2002 Jan….” “I have patients on this regime who have benefitted.” Regards, Dr. Paulose P. Thomas Nephrologist - Belhoul Apollo Hospital, Dubai, UAE

42. BACKGROUND and FOREGROUND QUESTIONS (all part of EBM) FOREGROUND QUESTIONS NEW POSSIBILITIES INDEFINITE ANSWERS “Where do we want to go, and how else might we get there?” “Where are we now? And which way are we headed?” BASIC & CONCRETE BACKGROUND QUESTIONS STUDENT GRAD EXPERT

43. BACKGROUND QUESTIONS BASIC & CONCRETE • 1. QUESTION • Who, What, Where, When, Why, How 2. VERB • is, causes, does, treats, reduces, cures, prevents, affects • 3. GENERAL KNOWLEDGE ABOUT DISORDER • clinical manifestations of disease, patient findings, differential diagnosis, etiology, patient experience, comorbid condition, screening and diagnostic tests, prognosis, therapy, risk factors, etc. STUDENT GRAD EXPERT

44. FOREGROUND QUESTIONS NEW POSSIBILITIES INDEFINITE ANSWERS PT AND/OR PROBLEMDifferential dx, Unusual presentation, uncertain etiology, pt’s prior experience, comorbid conditions INTERVENTIONExposure, test. Prognostic factor, treatment, pt perception, etc. COMPARISON INTERVENTION OUTCOMES STUDENT GRAD EXPERT

45. EBM QUESTION: Should include multiple factors • (Examples) • P PATIENT type of patient or population • Ex: 47 yr male w/DM2 and cellulitis toe, 25 yr female w/DVT and chest pain • E EXPOSUREenvironmental, personal, biological • Ex: TB, tobacco, drug, diet, pregnancy or menopause, MRSA, allergy • I INTERVENTIONclinical intervention • Ex: medication, procedure, test, surgery, radiation, drug, vaccine • C COMPARISONcompare alternative treatment • Ex: other prior, new or existing therapy • O OUTCOME clinical outcome of interest • Ex: Reduced death rate in 5 yrs, decreased infections, fewer hospitalizations

46. FRAMING THE QUESTION (Example: PICO) ELEMENTPROMPTS THE QUESTION: Patient How would I describe a group of patients similar to mine? InterventionWhat main action am I considering? ComparisonWhat is/are the other options? OutcomeWhat do I (or the patient) want to happen (or not happen)? Example: P: In kids under age 12 with poorly controlled asthma on metered dose inhaled steroids… I: would the addition of salmetrol to the current therapy C: compared to increasing the dose of current steroid O: lead to better control of symptoms without increasing side effects?

47. CATEGORY OF QUESTION • MAJOR CATEGORIES • Diagnosis • Prognosis • Therapy/ Treatment PICO • Harm (iatrogenic, other)PEO MISCELLANEOUS • Quality of care • Health economics • Office Management • Etc.

48. THE PATIENT’S QUESTIONS Must be considered! Often QUALITATIVE (not based on measureable outcomes) Feelings, ideas, experiences, preferences, concerns, fears, beliefs, ethnicity Usually based on LIMITED BACKGROUND Perception of problem Self-diagnosis Treatment wanted or needed Alternatives (read, heard, considered, tried) What is the patient hoping to avoid? What benefits does the patient want or need most? Etc.

49. QUANTITATIVE vs QUALITATIVE QUESTIONS • QUANTITATIVE: “Solid Evidence” • Measurable answer or response • Necessary for scientific study • Necessary for the practice of EBM • QUALITATIVE: “Quality of Life” • “Fuzzy” data - Impact on daily life, work, family, etc. • May be very important and influential to decisions – especially for the patient • Creates added challenge or twist to practice of EBM

50. QUALY: QUALITY ADJUSTED LIFE YEAR