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3	What Is the Definition of Evidence-Based Medicine? ‘…the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients…’ ‘…integration of best research evidence with clinical expertise and patient values…’
4	What Are Sources of Evidence-Based Medicine? New England Journal of Medicine AMA Guidelines Clinicaltrials.gov Wall Street Journal TV or radio shows Web sites
5	What Are Sources of Evidence-Based Medicine? Review articles Medical textbooks Clinical data published in a scientific journal Clinical data presented at national meeting
6	What Are Sources of Evidence-Based Medicine? Large clinical trial conducted by a pharmaceutical company Small clinical trial conducted by independent clinicians
7	Where, When Did Evidence-Based Medicine (EBM) Begin? Term coined by clinicians and epidemiologists at McMaster University, Ontario, Canada, in early 1990s Evidence Based Medicine: What It Is and What It Isn’t. Sackett D, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. BMJ. 1996;312:71-72.
8	Where, When Did EBM Begin? Original model: JAMA, 1992 Clinician conducts research when clinical question arises Select best research, evaluate evidence, determine validity, plan clinical actions Not practical in daily practice Evidence-based medicine. A new approach to teaching the practice of medicine. Evidence-Based Medicine Working Group. JAMA. 1992 Nov 4;268:2420-2425.
9	Why the Need for EBM? Too much evidence for clinicians to process. Medical myths from training are carried forward to new trainees. Assist clinicians with decision-making process. Improve quality of medical care.
10	Why the Need for EBM? Traditional medicine does not demand ‘better evidence’ In 2005, PubMed reports 19,905 articles published 2500 articles published with term ‘evidence based medicine’
11	What the Stakeholders Say: AMA CME providers must ensure that the content of educational activities they designate for AMA PRA category 1 credit is Scientifically based Accurate Current Objectively presented
12	What the Stakeholders Say: ACCME 1. All recommendations involving clinical medicine in a CME activity must be based on evidence that is accepted within the profession of medicine as adequate justification of their indications and contraindications in the care of patients.
13	What the Stakeholders Say: ACCME 2. All scientific research referred to, reported, or used in CME in support or justification of a patient care recommendation must conform to the generally accepted standards for experimental design, data collection, and analysis.
14	What the Stakeholders Say: ACCME 3. Providers are not eligible for ACCME accreditation or reaccreditation if they present activities that promote recommendations, treatments, or manners of practicing medicine that are not within the definition of CME, or known to have risks or dangers that outweigh the benefits, or are known to be ineffective in the treatment of patients.
15	What the Stakeholders Say: ACCME 4. An offer by a commercial entity to provide a presentation reporting the results of scientific research shall be accompanied by a detailed outline of the presentation which shall be used by the accredited provider to confirm the scientific objectivity of the presentation. Such information must conform to the generally accepted standards of experimental design, data collection, and analysis.
16	Defining EBM Basing patient-care recommendations on the best evidence available Consider evidence from multiple sources Systematic reviews (SR), meta-analyses Clinical trial data: randomized, cohort, or case studies Clinical practice guidelines Consensus statements, expert opinions Journal articles Textbooks
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18	Hierarchy of Evidence Meta-analysis Randomized clinical trials (RCT) Cohort studies Case-control studies Expert opinions
19	AAFP: Levels of Evidence on ABC Scale Level A: High-quality RCT or meta-analysis using comprehensive search strategies Level B: Well-designed, nonrandomized clinical trial, epidemiologic studies, historical studies, or nonquantitative SR with appropriate search strategies and well-substantiated conclusions Level C: Consensus viewpoint or expert opinion
20	Why Clinical Study Data? Institutional Review Board reviews protocol to ensure proper care of patients, consistent treatment, appropriate assessment of data, study design Alternative: historical review of records searching for specific qualifying characteristics of patient or treatment
21	Elements of Clinical Study Data Design Size Demographics Reference standard Blinding Statistical power Intent-to-treat analysis
22	AAFP: SORT Strength of Recommendation Taxomony A: Consistent, good quality, patient-oriented evidence B: Inconsistent or limited quality C: Consensus, usual practice, disease-oriented evidence or case series for studies of diagnosis, treatment, prevention, or screening
23	How Do You Evaluate Program Content? Robbins Pathology opening quote “When you hear hooves, think horses, not zebras”
24	How Do You Evaluate Program Content? “Critical Appraisal” evaluates Validity and relevance of information Study design Randomized, blinded, ITT, follow up Treatment effect How large? How precise? Application to patients
25	How Do You Evaluate Program Content? AAFP Study Quality Level 1: Good quality, patient-oriented evidence Diagnosis: validated clinical decision rule, SR, meta-analysis, high quality diagnostic cohort study Treatment/prevention/screening: SR or meta-analysis of RCTs Prognosis: SR or meta-analysis of good quality cohort studies
26	How Do You Evaluate Program Content? Patient-Oriented Evidence Measures Outcomes relevant to patients Morbidity Mortality Symptom improvement Cost reduction
27	How Do You Evaluate Program Content? Disease-Oriented Evidence Measures Outcomes relevant to disease state Physiologic Intermediate Surrogate end points: may or may not reflect patient outcomes Blood pressure Blood chemistry Physiologic function Pathologic findings
28	POEMs Patient-Oriented Evidence that Matters Developed for primary-care practitioners in 1994 by David Slawson, MD, and Allen Shaughnessy, PharmD Concept: expert searches literature, filters information, validates information, and summarizes information into a point of care “Information Mastery” http://www.poems.msu.edu/infomastery/ An Introduction to Information Mastery Department of Family Practice College of Human Medicine Michigan State University
29	How Do You Evaluate Program Content? Content presents a case report of a rare infection in a pediatric setting What is the program goal? What are the learning objectives? Who is the audience? What is the setting?
30	How Do You Evaluate Program Content? Content presents a case report of a rare infection in a pediatric setting Grand rounds for hospitalists focusing on an ID topic of rare, hospital-acquired infections and treatment Web-based program for PCPs on ID topic of best practices for common childhood infections
31	How Do You Evaluate Program Content? Content presents clinical trial data for a novel treatment for breast cancer Learning objectives Evaluate current treatments for breast cancer Develop effective treatment regimens for newly diagnosed patients and relapsing patients Setting: 90-minute Web-based activity targeted to oncologists and Ob/Gyns
32	How Do You Evaluate Program Content? Content presents clinical trial data for a novel treatment for breast cancer Clinical trial data 1 Regional studies, 5 to 10 patients per study No combined analysis of data Results compared with standard of care at each setting Clinical trial data 2 Large, multicentered trial; 800 patients total Integrated safety and efficacy data Compared with gold standard
33	How Do You Evaluate Program Content? Regional meeting to discuss treatment protocols for patients with anemia Key clinical data briefly discussed Application to daily clinical practice made by regional thought leader
34	How Do You Evaluate Program Content? Regional meeting to discuss treatment protocols for patients with anemia Translating clinical trial results into suggestions for daily clinical practice activities improves standard of care and dispels medical myths or outdated clinical practices
35	Outcomes of EBM Balance in presentation Improved care for patients Dispel ‘medical myths’
36	Controversies Surrounding EBM Clinicians currently challenging need for EBM for clinicians to make clinical decision Recent publications support case studies as valid and important information to be communicated to health-care providers
37	What Are Sources of Evidence-Based Medicine? New England Journal of Medicine AMA Guidelines Clinicaltrials.gov Wall Street Journal TV or radio show Websites
38	What Are Sources of Evidence-Based Medicine? Review articles Medical textbooks Clinical data published in a scientific journal Clinical data presented at national meeting
39	What Are Sources of Evidence-Based Medicine? Large clinical trial conducted by a pharmaceutical company Small clinical trial conducted by independent clinicians
40	The following resource information is available at our Web site www.iche.edu
41	Resources: Free Online Articles Evidence-Based Medicine Working Group. Evidence-Based Medicine: A new approach to teaching the practice of medicine. JAMA. 1992;268:2420-2425. Becoming a medical information master: Feeling good about knowing everything. Slawson DC, Shaughnessy AF, Bennett JH. J Fam Pract. 1994;38:505-513. Evidence based medicine: An approach to clinical problem solving. Rosenberg W, Donald A. BMJ. 1995;310:1122-26. Evidence based medicine: What it is and what it isn’t. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. BMJ. 1996;312:71-72. Evidence-based medicine: How to practice and teach EBM. Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Second Edition. Churchill Livingstone: Edinburgh, 2000. Evidence-based medicine: How to practice and teach EBM. Straus SE, Richardson WS, Glasziou P, Haynes RB. Third Edition. Churchill Livingstone: Edinburgh, 2005. Making evidence-based medicine doable in everyday practice. White B. Family Practice Management. 2004;11. What’s next for evidence-based medicine? Pencheon D. Evidence-based Healthcare & Public Health. 2005;9:319-321. Strength of Recommendation Taxonomy (SORT). www.aafp.org/afp
42	Resources: EBM ACP Journal Club http://www.acpjc.org/?hp Bimonthly clinical review journal with EBM components ($78/year) Today's Featured Articles: 20 Jan 06 A sequential 10-day regimen was better than standard triple therapy for eradicating Helicobacter pylori in older patients Atorvastatin did not prevent cardiovascular events or death in patients with type 2 diabetes receiving hemodialysis Low-dose aspirin did not prevent cancer in healthy women Vitamin E did not prevent cardiovascular disease and cancer in healthy women Review: Vitamin D plus calcium, but not vitamin D alone, prevents osteoporotic fractures in older persons Review: Evidence of benefit for perioperative β-blockers in noncardiac surgery is unreliable A simple risk score predicted 7-day stroke risk after transient ischemic attack
43	Resources: EBM American Family Physician http://www.aafp.org/afp Twice-monthly clinical review journal with EBM components POEMs, Cochrane for Clinicians Evidence Based Medicine Defined http://fmignet.aafp/org/x57.xml Bandolier http://www.jr2.ox.ac.uk/bandolier Free online access Monthly journal providing summaries of searches of PubMed and Cochrane library for systematic reviews and meta-analyses The Journal of Family Practice http://www.jfponline.org Monthly journal with EBM components Evidence-Based Medicine Tool Kil http://www.cebm/net/toolbox.asp Provided by the Center for Evidence-Based Medicine
44	Resources: EBM Summaries Clinical Evidence http://www.clinicalevidence.com Clinical reviewed, updated semi-annually Assembled by: http://www.unitedhealthfoundation Cochrane Database of Systematic Reviews http://www.cochrane.org/cochrane/revabstr/mainindex.htm Collection of systematic reviews Free online York Database of Abstracts and Reviews of Effects (DARE) http://www.york.ac.uk/inst/crd/dare.htm Abstracts of systematic reviews Free online access Dynamed http://www.dynamedical.com Database of summaries of evidence from Clinical Evidence and Cochrane database $200/y online access First Consult http://firstconsult.com Database of summaries of evidence from Clinical Evidence, Cochrane databases and National Clearinghouse guidelines $149/y online, CD, hard copy
45	Resources: EBM Summaries InfoRetriever http://www.infopoems.com Search engine with access to EBM resources – POEMs (including daily POEM via e-mail), Cochrane, diagnostic test database $249/year online, CD, or hard copy SUM Search http://sumsearch.uthscsa.edu Search engine gathering EBM information from Medline, DARE, and National Guidelines Clearinghouse Free online TRIP Database (Turning Research Into Practice) http://www.tripdatabase.com Search engine gathering EBM information from Medline, DARE, and National Guidelines Clearinghouse Free online access PubMed Systemic Reviews http://www.ncbi.nlm.nih.gov PubMed Services, Clinical Queries, Systematic Reviews Citations of systematic reviews, reviews of clinical trials, consensus development, conferences, and guidelines Free online access
46	Resources: Guidelines Institute for Clinical Systems Improvement (ICSI) http://www.ICSI.org Guidelines for preventive services and disease management ICSI is a non-profit collaboration of health-care organizations, including the Mayo Clinic Free online National Guideline Clearinghouse http://www.guideline.gov Initiative of the Agency for Healthcare Research and Quality, Department of Health and Human Services Free online US Preventive Services Task Force (USPSTF) Recommendations http://www.arhq.gov/clinic/uspstfix.htm Recommendations for clinical preventive services based on reviews by USPSTF Free online access
47	Resources: Guidelines CDC Wonder http://wonder.cdc.gov/ Online public health information system Provides numbers and rates of sexually transmitted diseases, cancer cases, or deaths in the United States Demographic data (population, Data2010, Healthy People 2010), deaths (overall, occupational, fatal accidents), morbidity, disease, health promotion, sexually transmitted diseases, tuberculosis surveillance, babies, immunization, reports and recommendations, occupational safety Users request data for any disease and demographic group by submitting ad hoc queries against available datasets
48	Resources: Guidelines NIH Consensus Development Program (CDP) http://consensus.nih.gov/ Unbiased, independent, evidence-based assessment of complex medical issues Conferences are jointly sponsored and administered by one or more Institutes or Centers (ICs) of NIH and by the Office of Medical Applications of Research (OMAR) in the Office of the Director of NIH Agency for Healthcare Research and Quality (AHRQ) provides a systematic review of literature on the conference topic through one of its Evidence-Based Practice Centers Purpose of a CDP conference: evaluate the available scientific information on a biomedical issue and develop a statement that advances understanding of the issue under consideration and will be useful to health professionals and the public.
49	Resources: Clinical Trials and Alerts Center Watch Clinical Trials Listing Service http://www.centerwatch.com/patient/trials.htm Service to help patients find clinical trials ClinicalTrials.gov http://www.clinicaltrials.gov Federally and privately sponsored clinical research in humans Free online Clinical Alerts http://www.nlm.nih.gov/databases/alerts/clinical_alerts.html Expedited release of findings of NIH-funded clinical trials when data impacts morbidity and mortality Free online access PubMed Clinical Queries http://www.ncbi.nlm.nih.gov PubMed Services, Clinical Queries Identifies citations corresponding to specific clinical study categories
50	For more information, consult our Web site www.iche.edu
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