Evidence Based Medicine in the office and hospital

1. Evidence Based Medicine in the office and hospital • Daniel J. Van Durme, MD • Professor and Chair • Dept. of Family Medicine and Rural Health Evidence Based Medicine D.J. Van Durme, MD

2. Who is this guy and what does he know? • Private practice in semi-rural Pasco county (north of Tampa) 1991-1996 • Faculty at University of South Florida College of Medicine 1989-1991 and 1996-2004 • Still seeing patients at Madison County Health Department • Creator, Course Director, and lecturer for “Evidence Based Medicine” course at USF COM • 40 hours of lecture and small group for Med 2’s Evidence Based Medicine D.J. Van Durme, MD

3. I am NOT an EBM expert • Expert – from Latin • “ex” – has been • “spurt” – a drip under pressure • I struggle with stats • I am often overwhelmed with the volume of medical information and the need to critically review the important stuff • BUT – I can still provide high quality Evidence Based Care Evidence Based Medicine D.J. Van Durme, MD

4. Learning Objectives for today • At the conclusion of today’s session, the learner should be able to: • Define evidence based medicine • Demonstrate an ability to formulate a patient-oriented clinical question from a clinical scenario • Discuss appropriate search strategies for finding answer(s) to clinical questions • Demonstrate the use of PDA and computer resources for finding high quality evidence based answers • Discuss how evidence based findings would be applied to the care of a patient Evidence Based Medicine D.J. Van Durme, MD

5. EBM: Original “Official” Definition The explicit, conscientious, and judicious use of the current best evidence in making decisions about the care of individual patients (and populations) Evidence-Based Medicine Working Group Sackett et al circa 1996 Evidence Based Medicine D.J. Van Durme, MD

6. Problems with EBM definition • EBM has been accused of being . . . • Cookbook medicine • “It takes away the art of medicine or the clinical judgment” • WRONG – the research results may not be applicable or appropriate for a given patient • Cost-Cutting medicine • “It is all a plot by managed care companies to cut cost of care and increase their profit share” • WRONG - When you find what is best for a given patient it may cost more OR it may save money Evidence Based Medicine D.J. Van Durme, MD

7. Problems with EBM (cont.) … • EBM has been accused of being . . . • Impossible or impractical • “There is no way I can spend hours looking for and critically reviewing medical articles for each of the patients that I see.” • WRONG – there are many tools available at the point of care (PDA’s and computers and texts) that can help you find answers in a matter of 1-2 minutes. Evidence Based Medicine D.J. Van Durme, MD

8. Better – EBM definition • The integration of best research evidence with clinical expertise and patient values • Sackett et al 2000 Evidence Based Medicine D.J. Van Durme, MD

9. Evidence Based Medicine D.J. Van Durme, MD

10. Two Fundamental Principles of true Evidence Based Practice • Clinical Decision Making: • Evidence is Never Enough a. Treatment of Pneumococcal pneumonia SHOULD be different for: Terminal Cancer Patient Elderly, Severely Demented Patient Young, mother of 2 children b. Importance of Values/Preferences Evidence Based Medicine D.J. Van Durme, MD

11. Two Fundamental Principles of EBM • A hierarchy of evidence a. There is a hierarchy of possible information b. Look for the highest level of evidence available BE ready to change your approach or management when a higher level of evidence contradicts your experience “Experience Based Medicine” – doing the wrong thing with increasing confidence for an impressive number of years. Evidence Based Medicine D.J. Van Durme, MD

12. Best research evidence • Clinically relevant – not just “well-done research” • Ideally patient-centered clinical research • What matters to patients? • Morbidity, mortality, quality of life • POEM • Patient Oriented Evidence that Matters • Matters to my practice and my patients • Sometimes disease-oriented evidence (DOE) • How many irregular heartbeats per hour? • Can be misleading (sometimes dangerously so) • Occasionally basic science • What is the level of C-reactive protein (CRP) in the serum? • Can be VERY misleading Evidence Based Medicine D.J. Van Durme, MD

13. Clinical Expertise • Use of clinical skills and past experience • Identification of individual patient’s . . . • Health status and health risks • Personal values and expectations • (Probable) diagnosis • Knowledge of disease prevalence, access to medical or test availability, etc. in your community • Did you ask the correct clinical question(s)? Evidence Based Medicine D.J. Van Durme, MD

14. Patient values • Patient preferences and concerns • Cultural influences • Religious/spiritual influences • Psychosocial issues • May include . . . • Reimbursement or insurance status • Access to care • Societal factors • Other influences Evidence Based Medicine D.J. Van Durme, MD

15. Why do we need EBM? • Stay up to date • Medical information changes constantly • Unlike bread – our knowledge does not become visibly moldy or stale – we just keep using it Evidence Based Medicine D.J. Van Durme, MD

16. Why do we need EBM? • Save LIVES! • Encainide and flecainide for ventricular arrhythmia • Well proven to decrease the number of premature ventricular beats – became widely used 1980’s • BUT • Further studies showed significant INCREASE in MORTALITY – died from other cardiac complications and dysrhythmias ( a dangerous “DOE”) • Thrombolytics for acute MI • CLEAR evidence of benefit in the 1970’s • Not widely recommended until 1988 – almost 13 yrs later • How many thousands of people died unnecessarily in the years in between? Evidence Based Medicine D.J. Van Durme, MD

17. Why do we need EBM? • We want to do the “right thing” – what is “best” for our patients • Practice variations that do not make sense . . . • Not to doctors • Not to patients • Not to payors • Not to policy makers Evidence Based Medicine D.J. Van Durme, MD

18. Assessment of Radical Prostatectomy: Time Trends, Geographic Variation, and Outcomes Lu-Yao: JAMA, Volume 269(20). May 26, 1993. Evidence Based Medicine D.J. Van Durme, MD

19. So why not get info from textbooks and review articles? • Texts and review articles? • Dated – perhaps by several years • Often heavily biased • Author chooses article that he/she agrees with (or has written) • May help more with background knowledge (help me learn about disease) not foreground (help me answer the specific clinical question for this patient) Evidence Based Medicine D.J. Van Durme, MD

20. Foreground questions Background questions Experienced clinician Medical student Evidence Based Medicine D.J. Van Durme, MD

21. But how does EBM REALLY work? • Step 1: Translate clinical scenarios into an answerable clinical questions • TRUE STORY – • My 54 yr old patient was just diagnosed with prostate cancer • I received pathology report and he is coming in to see me tomorrow Evidence Based Medicine D.J. Van Durme, MD

22. What are my questions? • What do I know about prostate cancer? • How common is it? • Is it usually aggressive and rapidly fatal? • How can it be treated – surgery, chemotherapy, radiation? • What about family history – what should I tell him about his son’s risk? • Etc. • These are called “background” questions Evidence Based Medicine D.J. Van Durme, MD

23. Foreground questions apply to that specific patient (or population) • After meeting with patient and spouse we find that he has seen the urologist who recommended surgery but the patient is reluctant • 54 year old male patient was diagnosed with intermediate grade prostate cancer and wants to know whether to get a radical prostatectomy or radiation treatment. He is concerned about death from prostate CA and also risks of impotence and incontinence. Evidence Based Medicine D.J. Van Durme, MD

24. Question? • Population: • For middle aged males with intermediate stage prostate cancer, • Intervention: • Treated with radical prostatectomy • Comparison: • Compared to radiation treatment • Outcome: • What are the rates of incontinence, impotence and cancer-related mortality? Evidence Based Medicine D.J. Van Durme, MD

25. Developing the question requires: • Some background knowledge of the condition • Understanding of the patient and what are the outcomes that matter in this patient • Death? • Disability? • Quality of life? – Anxiety, Impotence, etc. • Cost? Evidence Based Medicine D.J. Van Durme, MD

26. Hands on – Part 1 • Think in your practice THIS week – what was a clinical question you had? • Think of a foreground question (not just a drug dose or drug interaction) • What diagnostic test would have been best for that pt with abdominal pain? • What treatment would have been best for the pt with Parkinsons? • What about the patient who was asking about acupuncture for osteoarthritis? Evidence Based Medicine D.J. Van Durme, MD

27. How does EBM REALLY work? • Step 2: Translate question into effective searches for the best evidence • Requires knowledge of medical informatics • How to search – what terms to use, what types of studies, etc. • Where to search – utility of varied sources of information • Evidence based sources, Texts, Medline, Evidence Based Medicine D.J. Van Durme, MD

28. Purpose-specific resources • CDC Travel • Drug information resources • Patient Education handouts • Medical Search engines • Textbooks • Journals Evidence Based Medicine D.J. Van Durme, MD

29. EBM sources • EBM sources – Cochrane, USPSTF, Clinical Evidence • + Ideally best information source – hard to argue with, will explicitly state the level of evidence (weak to strong) • - There may not be any “good” evidence Evidence Based Medicine D.J. Van Durme, MD

30. How does EBM REALLY work? • Step 3: Critically appraise the evidence • Validity of the evidence • Internal – study design, blinding, randomized, sample size, appropriate statistics, etc. • Relevance of the evidence • Did they measure something pts care about? • Is population similar (enough) to mine? • Is the intervention feasible? • Importance of the evidence • Magnitude of effect or clinical significance? • P values, confidence intervals, relative risk or absolute risk reduction Evidence Based Medicine D.J. Van Durme, MD

31. Step 3: Critically appraise the evidence (cont.) • Requires some knowledge of basic epidemiology and biostatistics • Sensitivity, specificity, prevalence, likelihood ratios • Absolute risk reduction, relative risk reduction, odds ratios, number needed to treat • Requires knowledge of study types • ASSUMING THAT IT IS A WELL DESIGNED STUDY • Appropriate sample size, randomization, stats, treatment allocation, etc., etc. • Meta-analysis of RCT’s > RCT > Cohort > Case Control > Case Series > Case Report Evidence Based Medicine D.J. Van Durme, MD

32. Hierarchy of studies Evidence Based Medicine D.J. Van Durme, MD

33. Step 3 – Critical appraisal of medical literature • This is often confused with EBM • they are not the same thing • This is often the toughest part of EBM • Skipped by many doctors suffering from photonumerophobia • The fear that one’s fear of numbers and statistics will come to light • This is where most attempts come to a halt • Not enough time and expertise Evidence Based Medicine D.J. Van Durme, MD

34. EBM Databases Systematic Literature Searches • Cochrane Library (OVID) • Clinical Evidence Systematic Literature Surveillance • ACP Journal Club (OVID) • DARE • DynaMed • Medical InfoRetriever • Journal of Family Practice POEMS EMB Search Engine • TRIP Database Evidence Based Medicine D.J. Van Durme, MD

35. Cochrane Library Clinical Evidence Clinical Inquiries Specialty-specific POEMs ACP Journal Club Textbooks, Up-to-Date, 5-Minute Clinical Consult Usefulness Journals/ Medline PubMed Drilling for the Best Information Evidence Based Medicine D.J. Van Durme, MD

36. Cochrane Library • The current resource with the highest methodological standards • For each clinical question, all of the English literature meticulously searched for randomized trials • Large systematic reviews with valid methods + collaborative effort • Conclusions are based on all the evidence from valid randomized trials Evidence Based Medicine D.J. Van Durme, MD

37. Cochrane Library • Included in OVID subscription • Limitations • limited to English • only addresses questions amenable to randomized trials • most of medicine has not been studied enough to allow for conclusions • $235/year or abstracts only Evidence Based Medicine D.J. Van Durme, MD

38. InfoRetriever • 104 journals surveyed for Evidence-Based Practice Newsletter • Over 1300 article synopses/ POEMS • Cochrane abstracts • Selected evidence-based guidelines (USPSTF, CDC, others) • Basic drug info • ICD-9 codes • Clinical calculators/prediction rules Evidence Based Medicine D.J. Van Durme, MD

39. InfoRetriever Symbols Evidence Based Medicine D.J. Van Durme, MD

40. InfoRetriever • Comes in web, desktop and PDA versions • Explicitly states Levels of Evidence • Limitations • individual article summaries may not account for the “big picture” • may have to read multiple items • $249/year • Optimized for use with Internet Explorer 5.x or Netscape 6.x Evidence Based Medicine D.J. Van Durme, MD

41. Hands on with InfoRetriever • 1. Look up “migraine” • 5 min clinical consult – level 5 evidence • Background info • Overview: practice guidelines • ACEP – guidelines for ED • Tx: Drug treatment – anticonvulsants? • Note symbols for Cochrane database or InfoPOEM • Info available on CAM, screening, Pt ed, etc Evidence Based Medicine D.J. Van Durme, MD

42. Levels of Evidence • Level 1: Randomized Clinical Trials • Level 2: Head to Head Trial or Systematic Review of Cohort Studies • Level 3: Case-Control Studies • Level 4: Case-series • Level 5: Expert Opinion Evidence Based Medicine D.J. Van Durme, MD

43. Guidelines • What is a guideline? • Guidelines may be • Explicitly evidence-based • Evidence-based • Research-based (highly referenced) • Opinion-based • “expert consensus” Evidence Based Medicine D.J. Van Durme, MD

44. Guidelines • National Guideline Clearinghouse • Primary Care Clinical Practice Guidelines • Agency/Association sites • AAFP • AAP • ACS Evidence Based Medicine D.J. Van Durme, MD

45. Clinical Evidence • BMJ • Summaries of Evidence • Specific clinical questions: treatment • Makes specific recommendations • States when there is a lack of evidence • Free from United Health Foundation Evidence Based Medicine D.J. Van Durme, MD

46. Clinical Evidence Evidence Based Medicine D.J. Van Durme, MD

47. Hands On with Clinical Evidence • Look up Stroke Prevention in Clinical Evidence • Beneficial – control BP and cholesterol and give aspirin • Unknown – other antiplatelet agents showed no benefit over aspirin • Ineffective or harmful – anticoagulant for those in sinus rhythm & carotid endarterectomy for those with <30% symptomatic stenosis Evidence Based Medicine D.J. Van Durme, MD

48. Hands on (POSSIBLE example or use your own!) • Patient wants to know if Gingko biloba will help her mom’s Alzheimer’s • See InfoRetriever – dementia • Treatment – Complementary and alternative medicine • Mixed results in InfoPOEMS – some say maybe yes, some say no • Cochrane says – it seems safe, but studies are weak, we really do not know – more study is needed • See Clinical Evidence - dementia Evidence Based Medicine D.J. Van Durme, MD

49. ACP Journal Club • About 100 journals systematically surveyed • Highest-validity articles abstracted • Structured abstracts to guide critical appraisal • Clinical commentary • Included in our OVID subscription Evidence Based Medicine D.J. Van Durme, MD

50. ACP Journal Club • Limitations • individual article summaries may not account for the “big picture” • may have to read multiple items • No “control” over what is covered • $78/year ? Evidence Based Medicine D.J. Van Durme, MD