Lets shake & Break Ice• STEP – 1, Introductions & Opinions• Those FOR EBM• Those AGAINST EBM• No NEUTRALS Allowed
Program TodayTime Slot Activity10:30 – 11:00 Introductions, Ice-Breaking, Review of Objectives & Expectations, Code of Conduct, Basic Definitions Review11:00 – 12:00 Role Play Activity – EBM or NOT12:00 – 12:30 The New Hierarchy of Medical Education & Profession12:30 – 2:00 Break for Jumm’a Prayer2:00 – 3:00 Real Life EBM in Abbottabad3:00 – 4:00 EBM or NOT – Future Implications
Best teachers do not make new knowledgeThey let you realize what you already know and do not know
OBJECTIVES Participants will achieve:• A midlevel understanding about their own beliefs in applying EBM in medical education• Graduate level confidence when discussing EBM in national international medical circles• Faculty level competence when teaching pros and cons of EBM to their students• An appreciation for the “Method of EBM” already existing in their practices
EBM - ORIGINS• In 1996 David Sackett wrote that "Evidence- based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients”• Adopted by major organizations, including the Cochrane Collaboration and the Centre for Evidence Based Medicine
EBM - BASICS• Trisha Greenhalgh and Anna Donald define it more specifically as• “The use of mathematical estimates of the risk of benefit and harm, derived from high-quality research on population samples, to inform clinical decision-making in the diagnosis, investigation or management of individual patients."
References• Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS (January 1996). "Evidence based medicine: what it is and what it isnt". BMJ 312 (7023): 71–2.PMC2349778. PMID 8555924.• Timmermans S, Mauck A (2005). "The promises and pitfalls of evidence-based medicine". Health Aff (Millwood)24 (1): 18-28. doi: 10.1377/hlthaff.24.1.18.PMID15647212.• Greenhalgh, Trisha. How To Read a Paper: The Basics of Evidence-Based Medicine. Wiley-Blackwell, fourth edition, 2010, p. 1
First, Do No Harm!• EBM seeks to assess the strength of the evidence of risks and benefits of treatments (including lack of treatment) and diagnostic tests. This helps clinicians predict whether a treatment will do more good than harm• Elstein AS (2004). "On the origins and development of evidence-based medicine and medical decision making". Inflamm. Res. 53 (Suppl 2): S184–9. doi:10.1007/s00011-004-0357-2. PMID 15338074.• Atkins D, Best D, Briss PA, et al. (2004). "Grading quality of evidence and strength of recommendations". BMJ 328(7454): 1490
QUALITY OF EVIDENCE• Evidence quality can be assessed based on the source type• From meta-analyses and systematic reviews of triple-blind randomized clinical trials with concealment of allocation and no attrition at the top end, down to conventional wisdom at the bottom
QUALITY OF EVIDENCE• Statistical validity, clinical relevance, currency, and peer-review acceptance• EBM recognizes that many aspects of health care depend on individual factors such as quality- and value-of-life judgments, which are only partially subject to quantitative scientific methods.
CASE - 1• You are seeing an 18 year old female patient in your private clinic. She is recently diagnosed with acute cholecystitis. This is the third time she has had this problem.• How will you proceed with her investigations?• What relevant screenings will you perform at this point?• What is the best treatment option?
CASE-2• You are seeing a 28 year old female patient in your private clinic. She is recently diagnosed with acute cholecystitis. This is the third time she has had this problem.• During the history she tells you that her mother, maternal grand mother and a maternal aunt died of breast cancer.• She mentions her fear of developing this disease as well
CASE – 2 (cont.)• How will you proceed with her investigations?• What other screenings will you perform at this point?• What is the best treatment option?• Self breast exam teaching• Annual mammography after age 40 years• BRCA GENE STATUS
CASE - 3• You are seeing a 38 year old female patient in your private clinic. She is recently diagnosed with acute cholecystitis. This is the third time she has had this problem.• During the history she tells you that her mother, maternal grand mother and a maternal aunt died of breast cancer.• She has recently had a breast lump biopsied. She is very anxious about her future.
CASE – 3, (cont.)• How will you proceed with her investigations?• What other screenings will you perform at this point?• What is the best treatment option?• Self breast exam teaching• Annual mammography after age 40 years• BRCA GENE STATUS• ER/PR Status of Breast biopsy
FIVE STEPS OF EBM1. Translation of uncertainty to an answerable question and includes critical questioning, study design and levels of evidence2. Systematic retrieval of best evidence available3. Critical appraisal of evidence for internal validity that can be broken down into aspects regarding: Systematic errors as a result of selection bias, information bias and confounding Quantitative aspects of diagnosis and treatment effect Size and aspects regarding its precision Clinical importance of results External validity or generalizability4. Application of results in practice5. Evaluation of performance
COCHRANE COLLABORATION• The systematic review of published research studies is a major method used for evaluating particular treatments. The XXX is one of the best-known, respected examples of systematic reviews. Like other collections of systematic reviews, it requires authors to provide a detailed and repeatable plan of their literature search and evaluations of the evidence.• Once all the best evidence is assessed, treatment is categorized as "likely to be beneficial", "likely to be harmful", or "evidence did not support either benefit or harm".
REFERENCES• Cook DJ, Jaeschke R, Guyatt GH (1992). "Critical appraisal of therapeutic interventions in the intensive care unit: human monoclonal antibody treatment in sepsis. Journal Club of the Hamilton Regional Critical Care Group".J Intensive Care Med 7 (6): 275–82. PMID 10147956• Dawes M, Summerskill W, Glasziou P, et al. (January 2005). "Sicily statement on evidence-based practice".BMC Med Educ 5 (1): 1. doi:10.1186/1472-6920-5- 1.PMC 544887. PMID 15634359. Archivedfrom the original on 2011-02-17.• Richardson WS, Wilson MC, Nishikawa J, Hayward RS (1995). "The well-built clinical question: a key to evidence-based decisions". ACP J. Club 123 (3): A12–3.PMID 7582737• Rosenberg WM, Deeks J, Lusher A, Snowball R, Dooley G, Sackett D (1998). "Improving searching skills and evidence retrieval". J R Coll Physicians Lond 32 (6): 557–63.PMID9881313• Parkes J, Hyde C, Deeks J, Milne R (2001). "Teaching critical appraisal skills in health care settings". Cochrane Database Syst Rev (3): CD001270.doi:10.1002/14651858.CD001270 PMID 11686986.• Epling J, Smucny J, Patil A, Tudiver F (October 2002). "Teaching evidence-based medicine skills through a residency-developed guideline". Fam Med 34 (9): 646– 8.PMID 12455246• Jamtvedt G, Young JM, Kristoffersen DT, Thomson OBrien MA, Oxman AD (2003). "Audit and feedback: effects on professional practice and health care outcomes". Cochrane Database Syst Rev (3): CD000259
“Levels of Evidence” CEBM• Level A: Consistent Randomised Controlled Clinical Trial, cohort study, all or none, clinical decision rule validated in different populations.• Level B: Consistent Retrospective Cohort, Exploratory Cohort, Ecological Study, Outcomes Research, case- control study; or extrapolations from level A studies.• Level C: Case-series study or extrapolations from level B studies.• Level D: Expert opinion without explicit critical appraisal, or based on physiology, bench research or first principles
U.S. Preventive Services Task Force (August 1989). Guide to clinical preventive services: report of the U.S. Preventive Services Task Force• Level I: Evidence obtained from at least one properly designed randomized controlled trial.• Level II-1: Evidence obtained from well-designed controlled trials without randomization.• Level II-2: Evidence obtained from well- designed cohort or case-control analytic studies, preferably from more than one center or research group.• Level II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence.• Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees
Balshem H, Helfand M, Schünemann HJ, et al. (April 2011). "GRADE guidelines: 3. Rating the quality of evidence". J Clin Epidemiol 64 (4): 401–6.• The GRADE working group defines quality of evidence and strength of recommendations based on the quality as two different concepts which are commonly confused with each other.
Risk of bias• Is a judgement made on the basis of the chance that bias in included studies have influenced the estimate of effect.
Imprecision• Is a judgement made on the basis of the chance that the observed estimate of effect could change completely.
Indirectness• : Is a judgement made on the basis of the differences in characteristics of how the study was conducted and how the results are actually going to be applied.
Inconsistency:• Is a judgement made on the basis of the variability of results across the included studies.
Publication bias• Is a judgement made on the basis of the question whether all the research evidence has been taken to account
Schünemann H, Brożek J, Oxman A,, ed. (2009). [Availablefrom http://www.cc-ims.net/gradepro GRADE handbook for grading quality of evidence and strength of recommendation] (Version 3.2 ed.)• Large effect: This is when methodologically strong studies show that the observed effect is so large that the probability of it changing completely is less likely.• Plausible confounding would change the effect: This is when despite the presence of a possible confounding factor which is expected to reduce the observed effect, the effect estimate still shows significant effect.• Dose response gradient: This is when the intervention used becomes more effective with increasing dose. This suggests that a further increase will likely bring about more effect.
Quality of evidence as per GRADE• High Quality Evidence: The authors are very confident that the estimate that is presented lies very close to the true value. One could interpret it as: there is very low probability of further research completely changing the presented conclusions.• Moderate Quality Evidence: The authors are confident that the presented estimate lies close to the true value, but it is also possible that it may be substantially different. One could also interpret it as: further research may completely change the conclusions.
Quality of evidence as per GRADE• Low Quality Evidence: The authors are not confident in the effect estimate and the true value may be substantially different. One could interpret it as: further research is likely to change the presented conclusions completely.• Very low quality Evidence: The authors do not have any confidence in the estimate and it is likely that the true value is substantially different from it. One could interpret it as: New research will most probably change the presented conclusions completely.