Evidence based medicine

Evidence based medicine in health care delivery system and also evidence based medicine in public health,
5 step approach

1. Evidence Based Medicine Presenter : Dr. Suhasini K. Dept. Community Medicine J.N.M.C., Belagavi 23 January 2015 1 Evidence Based Medicine

2. Heading Introduction Definition of Evidence Based Medicine Evidence-based health care practice Importance of EBM Evolution of EBM Decision making in EBM Five-Step Approach to Practicing EBM Benefits of adopting EBM Misconceptions in EBM Evidence-based Public Health Conclusion 23 January 2015 Evidence Based Medicine 2

3. Which doctor do you want? 23 January 2015 3 Evidence Based Medicine

4. Which doctor do you want? 23 January 2015 4 Evidence Based Medicine

5. Bloodletting 3000years ago Egyptians, Greeks then Romans, Arabs and so on. The cure for (hot , moist diseases) several medical conditions. Galen was able to propagate his ideas through the force of personality and the power of the pen 23 January 2015 5 Evidence Based Medicine

6. Pierre Louis (1787-1872) Inventor of the “numeric method” and the “method of observation” French physician who wanted to analyze the efficacy of bloodletting in the treatment of acute pneumonia Examined the clinical course and outcomes of 77 patients 23 January 2015 6 Evidence Based Medicine

7. Overall Results (n=77) “Experimental” oup Comparision Group Absolute Risk Reduction Bled Early Phase Bled Late Phase Difference Mortality 44% 25% - 19% Conclusion: Effect of bloodletting procedure was actually much less helpful than has been commonly believed 23 January 2015 7 Evidence Based Medicine

8. William Osler (1849 -1919) First “attending physician” at Johns Hopkins Author of hugely influential textbook, ' The Principles and Practice of Medicine ' believed that most drugs in his day were useless, but still advocated blood-letting in some cases 23 January 2015 8 Evidence Based Medicine

9. Bloodletting today Today phlebotomy therapy is primarily used in Western medicine for a few conditions such as hemochromatosis , polycythemia vera , and porphyria cutanea tarda . Why did it persist? It resulted from the dynamic interaction of social, economic, and intellectual pressures, a process that continues to determine medical practice 23 January 2015 9 Evidence Based Medicine

10. But… . We practice EBM today 23 January 2015 10 Evidence Based Medicine

11. Patient: Mr. A Mr. A is a 60 year old presenting with 1 hour of retrosternal chest pain. ECG shows lateral ST-elevation consistent with acute MI. QUESTION: In patients with acute MI, does treatment with aspirin reduce mortality? What is the best evidence? 23 January 2015 11 Evidence Based Medicine

12. Evidence: 1988 Reduction of mortality in acute myocardial infarction with streptokinase and aspirin therapy. Results: Patients with acute MI treated with Aspirin vs. placebo had a significant 23% relative risk reduction in five-week cardiovascular mortality, with an absolute risk reduction of 11.8% to 9.4% The combination of SK and Aspirin resulted in a 42% relative risk reduction in cardiovascular mortality after five weeks compared with the placebo 23 January 2015 12 Evidence Based Medicine

13. Application: 1997 How many patients receive ASA following acute myocardial infarction? Aspirin was not given to 55%!!! 78% of patients who did receive aspirin received it more than 30 minutes after arrival to the emergency department . Annals of Intern Medicine. Jul 1997;127(2):126 23 January 2015 13 Evidence Based Medicine

14. But as late as 2000, even in the US, aspirin was being prescribed for at most one third of patients with coronary artery disease (for whom there were no contraindications to its use) R elatively simple, and cheap practices shows that we have a problem in getting providers to apply knowledge gained through research The paradigm for the translation of new information from research bench to bedside has been conceptualized as a “translational highway”. 23 January 2015 14 Evidence Based Medicine

15. What is evidence-based medicine ? “ Evidence-based medicine is the integration of best research evidence with clinical expertise and patient values” - D avid Sackett “Explicit, judicious, and conscientious use of current best evidence from medical care research to make decisions about the medical care of individuals” 23 January 2015 15 Evidence Based Medicine

16. EBM - What is it? Clinical Expertise Research Evidence Patient Preferences 23 January 2015 16 Evidence Based Medicine

17. Evidence-based health-care practice The integration of: individual clinical expertise best available external clinical evidence from systematic research Evidence Based Medicine 17 23 January 2015

18. I - Individual clinical expertise Skills Judgement which individual health care workers acquire through clinical experience and clinical practice Evidence Based Medicine 18 23 January 2015

19. II - Best available clinical evidence Clinically relevant research derived from: basic medical sciences and patient- centred clinical research into the safety and efficacy of therapeutic interventions. Systematic Reviews Evidence Based Medicine 19 23 January 2015

20. Why is EBM important? New types of evidence are being generated which can create changes in the way patients are treated Although evidence is needed on a daily basis, usually physicians don’t get it. How much is actually being applied to patient care? lack of time out-of-date textbooks the disorganization of the up-to-date journals 23 January 2015 20 Evidence Based Medicine

21. Importance of EBM for practicing clinicians? TIME AVAILABLE TO READ : Less than 1 Hour per Week TIME NEEDED TO KEEP CURRENT ON GENERAL MEDICINE : 19 Articles per DAY 365 Days per Year Source: Davidoff F, Haynes B, Sackett D, Smith R. BMJ. 1995;310:1085-1086. 21 Evidence Based Medicine

22. Evidence increasing so rapidly we need better skills to keep up-to-date more efficiently than previous generations of clinicians 23 January 2015 22 Evidence Based Medicine

23. 5,000? per day 2,000 per day 7 5 per day Articles Per Year Why do we need to use evidence efficiently? 23 January 2015 23 Evidence Based Medicine

24. Time-poor clinician suffering from Information Overload 23 January 2015 24 Evidence Based Medicine

25. Gets worse with “duration in practice” 23 January 2015 25 Evidence Based Medicine

26. Evolution of EBM Pre EBM: Passive diffusion (“publish it and they will come”) Early EBM: Pull diffusion (“teach them to read it and they will come”) Current EBM: Push diffusion (“read it for them and send it to them”) Future EBM: Prompt diffusion (“read it for them, connect it to their individual patients”) 23 January 2015 26 Evidence Based Medicine

27. For I once saved one group by it, while I intentionally neglected another group. By doing that, I wished to reach a conclusion . Al- Rhazi 900 AD 1780 1840 1937/48 1967 1970’s Alvan Feinstein publishes his book Clinical Judgement James Lind publishes review & clinical trial in Treatise on Scurvy Pierre Louis Develops his “numerical method” and changes blood letting practice in France Bradford-Hill publishes Principles of Medical Statistics & MRC trial of streptomycin Some milestones in the history of EBM 23 January 2015 27 Evidence Based Medicine

28. An EBM Approach to Education Evidence cart on ward rounds - 1995 Looked up 2-3 questions per patient Took 15-90 seconds to find Change about 1/3 decision David Sackett 23 January 2015 28 Evidence Based Medicine

29. Prof Archibald Cochrane, CBE (1909 - 1988 ) The Cochrane Collaboration is named in honor of Archie Cochrane, a British researcher. In 1979 he wrote, "It is surely a great criticism of our profession that we have not organized a critical summary, by specialty or subspecialty, adapted periodically, of all relevant randomized controlled trials” 23 January 2015 29 Evidence Based Medicine

30. Why the sudden interest in EBM? Increasing realization among clinicians that years of experience unaccompanied by updating of knowledge can result in decline of clinical performance The need for valid information about diagnosis, therapy, prognosis, and prevention in this era of consumer activism 23 January 2015 30 Evidence Based Medicine

31. The common man has access to the very same medical literature as the clinicians through numerous sources Limited time available to the clinician for acquiring information is a major impediment for updating the knowledge from traditional sources 23 January 2015 31 Evidence Based Medicine

32. Assumptions of evidence-based practices Not all evidence is equivalent There is a hierarchy of study design External evidence can inform but can never replace individual clinical expertise ( Sackett et al., 1996) Starting from the best external evidence and work from there. Values always influence decisions 23 January 2015 32 Evidence Based Medicine

33. Where do we go for help with decisions when we are not sure how to proceed? 23 January 2015 Evidence Based Medicine

34. Decision making in clinical practice using evidence Decision-making  is the  cognitive process  resulting in the selection of a course of action among several alternative possibilities 23 January 2015 Evidence Based Medicine

35. The Evidence Pyramid 23 January 2015 35 Evidence Based Medicine

36. Type of Question Suggested best type of Study Therapy RCT>cohort > case control > case series Diagnosis Prospective, blind comparison to a gold standard Etiology/Harm RCT > cohort > case control > case series Prognosis Cohort study > case control > case series Prevention RCT>cohort study > case control > case series Clinical Exam Prospective, blind comparison to gold standard Cost Economic analysis Identifying the Best Study 23 January 2015 36 Evidence Based Medicine

37. 23 January 2015 37 Evidence Based Medicine

38. 23 January 2015 38 Evidence Based Medicine

39. So in clinical practice Disease Treatment options 23 January 2015 39 Evidence Based Medicine

40. Ectopic pregnancy Medical Laparoscopic laparotomy 23 January 2015 40 Evidence Based Medicine

41. Outcome – the only thing that matters 23 January 2015 41 Evidence Based Medicine

42. What EBM additionally provides is Opportunity for change Opportunity for better treatment 23 January 2015 42 Evidence Based Medicine

43. How evidence affects clinicians Happy !!! I am the best !!! Will the patient recover or not?? Will they sue me?? What about my reputation ?? 23 January 2015 43 Evidence Based Medicine

44. Everything thats old is outdated???? 23 January 2015 44 Evidence Based Medicine

45. Think 100 times before refuting an old time tested method of treatment Classic example is vaginal hysterectomy for benign diseases “Give me 2 retractors, 2 scissors , 2 clamps, one tissue holding forceps and one needle holder, I will do a vaginal hysterectomy in any setup” Surgeon 23 January 2015 45 Evidence Based Medicine

46. Laparoscopic hysterectomy setup 23 January 2015 46 Evidence Based Medicine

47. New developments ( unnecessary) in minimally invasive surgery Studies sponsored by pharma companies Use of meshes in different clinical conditions Mesh Erosion in bladder or bowel , infection or rejection of mesh , vaginal pain or painful intercourse, groin infection/abscess, extrusion , obstruction , voiding dysfunction and erosion. 23 January 2015 47 Evidence Based Medicine

48. Changes in clinical practice shouldn’t be like this 23 January 2015 48 Evidence Based Medicine

49. Changes should be like this 23 January 2015 49 Evidence Based Medicine

50. The Five-Step Approach to Practicing EBM Step 1- Framing a Proper, Pertinent, Focused and Answerable Question Step 2 - Searching the Literature Step 3 - Critical Appraisal of the Literature Step 4 –Integrating the Evidence with Clinical Expertise and Patient Values Step 5 – Evaluating the Process 23 January 2015 50 Evidence Based Medicine

51. A cquire the best evidence A ppraise the evidence A pply evidence to patient care A ssess your patient A sk clinical questions EBM Method 23 January 2015 51 Evidence Based Medicine

52. Answerable questions EFFECTIVENESS A description of the populations P An identified intervention I An explicit comparison C Relevant outcomes O 23 January 2015 52 Evidence Based Medicine

53. Ask Clinical Questions Patient/ Population Outcome Intervention/ Exposure Comparison Components of Clinical Questions In patients with acute MI In post- menopausal women In women with suspected coronary disease does early treat- ment with a statin what is the accuracy of exercise ECHO does hormone replacement therapy compared to placebo compared to exercise ECG compared to no HRT decrease cardio- vascular mortality? for diagnosing significant CAD? increase the risk of breast cancer? 23 January 2015 53 Evidence Based Medicine

54. Step-1 Clinical Scenario : 12 years old only male child admitted to ICU history of accidental ingestion of OP compound 4 hours back On admission the patient was comatose but hemodynamically stable 23 January 2015 54 Evidence Based Medicine

55. The anaesthesiologist used his past experience, knowledge, skill & expertise and treated the patient with an infusion of atropine Inspite of that patient developed respiratory paralysis in the next 2 hours The clinician used his expertise puts him on mechanical ventilation 23 January 2015 55 Evidence Based Medicine

56. Now, the consultant understands the gap in his knowledge & he identifies the same. The consultant wanted to administer Inj Pralidoxime . But he was not sure of the dosage and the mode of administration (a single bolus dose or an infusion). 23 January 2015 56 Evidence Based Medicine

57. ‘P’ — Patient Problem: How would I describe a group of patients similar to mine? In this clinical situation it is a male pediatric patient (12 years) who has developed organophosphorous poisoning following its ingestion. ‘ I ’ — Intervention strategy: Which main intervention, prognostic factor or exposure am I considering? Here the intervention is the therapy with Pralidoxime in optimum dosage. 23 January 2015 57 Evidence Based Medicine

58. ‘C’ — Comparison: What is the main alternative to compare with the intervention? In his patient the clinical dilemma pertains to the dosage and mode of administration of Pralidoxime (low dose infusion vs. single large bolus dose) ‘O’ — (Outcome): - What can I hope to accomplish? Recovery from OP poisoning and decrease in morbidity & mortality 23 January 2015 58 Evidence Based Medicine

59. Step-2 Literature Search ‘Traditional’ print resources like textbooks or journals ‘Browse’ online electronic databases 23 January 2015 59 Evidence Based Medicine

60. Step 3 - Critical Appraisal of the Literature 1 . Screening for internal validity and relevance 2. Determining the intent of the article 3.Evaluating the validity based on its intent 23 January 2015 60 Evidence Based Medicine

61. The article that was tracked down is Prospective randomized placebo controlled clinical trial of Pralidoxime in two similar groups of patients. ( Control group-low dose and study group-high dose ) Block randomization was used The investigators were not blinded 23 January 2015 61 Evidence Based Medicine

62. The intent of the article is to evaluate two treatment regimes of PAM in the management of OP poisoning The next thing to determine is the strength of the outcome. How large was the treatment effect ? Low dose group fared better than high dose group 23 January 2015 62 Evidence Based Medicine

63. PAM is a very expensive imported drug requiring considerable amount off foreign exchange and there are difficulties in procuring it. It is imperative for the clinician to find a cost-effective and yet effective treatment. Patient’s father, being a primary school teacher, cannot afford the exuberant cost of the drug . T he out come of this research study is very much relevant and beneficial in solving the clinical dilemma 23 January 2015 63 Evidence Based Medicine

64. Step 4 –Integrating the Evidence with Clinical Expertise and Patient Values The best documented critically appraised research evidence is already with the clinician Take into consideration the patient values for example: The patient is a precious, lone male child of the parents. The economical/financial status of the parents does not permit expensive therapies No contraindications for the drug to be administrated Low dose regime requiring 1/16 of the high dose has better effect 23 January 2015 64 Evidence Based Medicine

65. Step 5 – Evaluating the Process Was he able to formulate a focused question? Was he able to devise a precise search strategy for locating the evidence? Did he use the most appropriate resource? Were more pertinent resources like practice guidelines available to him? Did the ‘evidence’ work in his patient ? The clinician should document the outcomes of the application of the evidence and based on his experiences T hose of his colleagues should be able develop management protocols 23 January 2015 65 Evidence Based Medicine

66. What are the benefits of adopting EBM ? Minimize the errors in patient care R educes the cost of treatment to the patient O ptimizes the quality of patient care Skills learnt in practicing EBM are the very same ones needed for being a lifelong, self-directed learner Habit of accessing literature on a daily basis is the best guarantor of ensuring advancement of knowledge and keeping abreast of scientific progress 23 January 2015 66 Evidence Based Medicine

67. EBM Misconceptions FALLACY FACT EBM is useless when there is no good evidence EBM means appropriately using the best available evidence to care for patients EBM is algorithms that ignore clinical judgment/expertise Clinical judgment must be used in deciding how to apply the evidence EBM is just numbers and statistics EBM is not numbers in a vacuum – the evidence must be individualized to each patient 23 January 2015 67 Evidence Based Medicine

68. Who benefits? Practitioners current knowledge to assist with decision making Researchers reduced duplication identify research gaps Community recipients of evidence-based interventions Funders identify research gaps/priorities Policy maker current knowledge to assist with policy formulation 23 January 2015 68 Evidence Based Medicine

69. 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. 23 January 2015 69 Evidence Based Medicine

70. Clinical vs. Public health interventions Clinical Individuals Single interventions Outcomes only (generally) Often limited consumer input Quantitative approaches to research and evaluation Public health Populations and communities Combinations of strategies Processes as well as outcomes Involve community members in design and evaluation Qualitative and quantitative Health promotion theories and beliefs Evidence Based Medicine 23 January 2015 70

71. Challenges - The research-practice gap Research Evidence Practice Diffusion /Adoption Information overload Application to other populations Lack of consideration of local community groups, agencies and governments role and needs Cultural factors Economic factors Social factors Evidence Based Medicine 23 January 2015 71

72. Research Evidence Policy making Challenges: The research-policy gap Service level National policy level Evidence Based Medicine 23 January 2015 72

73. Evidence Based Medicine 23 January 2015 73

74. 23 January 2015 Evidence Based Medicine 74 Develop statement of the issue Determine what is known through scientific literature Quantify the issue Develop Program or policy options Evaluate the program or Policy Develop an action plan Tools: meta-analysis, risk assessment, expert panel Tools: rates, risks, Surveillance data Implement Re- tool Disseminate widely Or Discontinue Program/Policy

75. Conclusion Medicine is not an exact science, but a science of probability The challenge to physicians is to provide up to-date medical care The ultimate goal for clinicians should be to help patients live long, functional, satisfying, and pain and symptom free life By adopting the principles of Evidence Based Medicine, it will be possible to maximize the benefits of scientific research for patient care 23 January 2015 Evidence Based Medicine 75

76. Medical educators and medical colleges have the singular responsibility of indoctrinating the principles of EBM as a concept, a philosophy, a religion necessary for being efficient, compassionate, caring, and responsible clinician among the future physicians during their formative years of training 23 January 2015 Evidence Based Medicine 76

77. References Evidence-based Medicine Workbook-Finding and applying the better research , Paul Glasziou, Chris Del Mar and Janet Salisbury Sackett, D. L., Straus, S. E., Richardson, W. S., Rosenberg, W., Haynes, R. B.: Evidence- Based Medicine – How to Practice and Teach EBM 2nd Ed., Churchill. Livingstone, 2000. Sackett DL, Rosenberg WMC, Gray JA, Haynes RB Richardson WS. Evidence based medicine: What it is and what it isn’t Br. Med J 1996;312:71-72. Evidence Based Medicine And Its Impact On Medical Education Dr. H. B. Rajashekhar1 Dr. B. S. Kodkany2 Dr. Vijaya A. Naik3 Dr. P. F. Kotur4 Dr. Shivaprasad S. Goudar5: Indian J. Anaesth . 2002; 46 (2) : 96-103 Guyatt GH, Evidence–based Medicine. Ann Intern Med . 1991;114(ACP J Club. Suppl 2): A-16 23 January 2015 Evidence Based Medicine 77

78. 23 January 2015 Evidence Based Medicine 78 We are drowning in information but starved for knowledge

79. 23 January 2015 Evidence Based Medicine 79 Thank you