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EBM for the busy Clinician Gil C. Grimes, MD EBM Working Group, Department Family Medicine Scott & White
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Objectives Levels of Evidence DOE vs. POEMs Sources for Evidence Incorporating EBM into Precepting Modeling behavior (dealing with Pharma)
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First a few Questions I am familiar with Evidence Based Medicine? Yes or No I am familiar with or have used the following databases.
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What is EBM? Simply put it is the integration of research evidence with clinical expertise and patient values. EBM will allow us to do more good than harm Patients want to know the following “Will it make me live better” “Will it make me live longer”
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Levels of Evidence This is a method for grading journal articles, guidelines etc. This is not “universal” AAFP uses Level A, B, C Centre for EBM Oxford uses 1,2,3 Focuses on the type of article and quality Therapy/Prevention/Etiology/Harm, Diagnosis, Prognosis Either way is just fine We will begin with the alphabet first…
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Level A Randomized controlled trial/meta-analysis High-quality randomized controlled trial (RCT) that considers all important outcomes. High-quality meta-analysis (quantitative systematic review) using comprehensive search strategies.
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Level B Other study types and some guidelines Well-designed, nonrandomized clinical trial. Nonquantitative systematic review with appropriate search strategies and well-substantiated conclusions. Lower quality RCTs Clinical cohort studies and case-controlled studies with nonbiased selection of study participants and consistent findings. Other evidence, such as high-quality, historical, uncontrolled studies, or well-designed epidemiological studies with compelling findings, is also included.
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Level C Consensus/expert opinion Consensus viewpoint or expert opinion. May represent the only evidence that is out there Use with caution
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Level 1 Therapy/Prevention/Etiology/Harm: 1a: Systematic reviews (with homogeneity ) of randomized controlled trials 1b:Individual randomized controlled trials (with narrow confidence interval) 1c:All or none randomized controlled trials Prognosis: 1a: Systematic review (with homogeneity) of inception cohort studies; or a clinical rule validated on a test set. 1b: Individual inception cohort study with > 80% follow-up 1c:All or none case-series
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Level 2 Therapy/Prevention/Etiology/Harm: 2a: Systematic reviews (with homogeneity) of cohort studies 2b: Individual cohort study or low quality randomized controlled trials <80% follow-up 2c: 'Outcomes' Research Prognosis 2a:Systematic review (with homogeneity) of Level >2 diagnostic studies 2b: Independent blind or objective comparison; study performed in a set of non-consecutive patients, or confined to a narrow spectrum of study individuals (or both) all of whom have undergone both the diagnostic test and the reference standard; a diagnostic clinical rule not validated in a test set.
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Level 3, 4, & 5 Therapy/Prevention/Etiology/Harm: 3a: Systematic review (with homogeneity) of case-control studies 3b: Individual case-control study 4: Case-series (and poor quality cohort and case- control studies) 5: Expert opinion without explicit critical appraisal, or based on physiology, bench research or 'first principles'
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Where’s the beef? Levels of evidence are good…. What I want to know is how this will work for me. Friends the path requires moving from DOE to POE…
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Disease Oriented Evidence Most common type of evidence found in research journals Important to our understanding of disease Responsible for many therapeutic advances Intended for a research audience Pathophysiology Pharmacology Etiology
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Patient Oriented Evidence Uncommon in most journals Outcomes patients care about Mortality Morbidity Quality of Life Cost Harm
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POEMs Patient-Oriented Evidence that Matters Addresses a clinical problem encountered by primary care physicians Uses patient-oriented outcomes Potential to change our practice if valid and applicable
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DOES vs. POEMs The Numbers…. 6 month survey of 90 journals 8,047 articles 213 POEMs 97% DOEs and other material 2.6% POEMs
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A few examples A 72 year old male with COPD and CAD presents with angina. In treating him a Beta blocker is contraindicated. True False Salpeter SS, Ormiston T, Salpeter E, Poole P, Cates C. Cardioselective beta-blockers for chronic obstructive pulmonary disease (Cochrane Review). In: The Cochrane Library, Issue 2, 2003. Oxford: Update Software click hereclick here
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Examples A 23 year old female presents to the ER with RLQ pain and an acute abdomen. The surgeon is 30 minutes away. Pain medication is contraindicated until the surgeon examines the patient. True False Thomas SH, Silen W. Effect on diagnostic efficiency of analgesia for undifferentiated abdominal pain. Br J Surg 2003; 90:5-9.click hereclick here
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Examples When treating mild to moderate alcohol withdrawal (not DT),benzodiazipines are the most effective therapy in helping with detox. True False Malcolm R, Myrick H, Roberts J, Wang W, Anton RF, Ballenger JC. The effects of carbamazepine and lorazepam on single versus multiple previous alcohol withdrawals in an outpatient randomized trial. J Gen Intern Med 2002; 17:349-55.click hereclick here
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Examples Tight glycemic control of gestational diabetics improves outcomes for mother and child. True False Garner P, Okun N, Keely E, et al. A randomized controlled trial of strict glycemic control and tertiary level obstetric care versus routine obstetric care in the management of gestational diabetes: a pilot study. Am J Obstet Gynecol 1997;177:190-5.click hereclick here
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So where do I find this? You could search the literature Yeah like you have that much time! You could ask you colleagues Expert opinion Level C You could familiarize yourself with one or two good sources That sounds pretty good…
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Usefulness equation Usefulness= relevance x validity work Go for sources that have done the work for you
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Systematic Reviews Summarized Evidence- Referenced Resources Research Articles Other Sources
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Cochrane It is an international organization that aims to help people make well informed decisions about health care by preparing, maintaining and ensuring the accessibility of systematic reviews of the effects of health care interventions.
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Cochrane The Collaboration is built on ten principles: collaboration building on the enthusiasm of individuals avoiding duplication minimizing bias keeping up to date striving for relevance promoting access ensuring quality continuity enabling wide participation
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Cochrane Focus is on therapy Excellent resource Solid source Degree of scrutiny limits some applicability Let’s look
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Clinical Evidence Published by BMJ Collects evidence on a wide variety of topics You are eligible for their book, and free access to their web site Let’s look
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InfoRetriever Founded by three Family Physicians, a PharmD and a Psychologist Goal to improve the health and lives of people by providing patient- oriented evidence that matters in a rapid and accessible form I use this database daily Let’s Look
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TRIP Database TRIP was created in 1997 to bring together all the 'evidence-based' healthcare resources available on the Internet. Excellent resource Allows focused PubMed search if all else fails Tracks your usage for educational purposes Let’s Look
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PubMed Clinical Queries PubMed is a Huge database Typical searches are tough Clinical Queries makes that easier Let’s Look
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Journal Sources Journal of Family Practice Journal Watch from NEJM InfoPOEMs ACP-Journal Club Relevance before Validity
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Relevance Slice the bedside stack Is this something that is common to my practice? Is it an outcome my patients would care about? If the outcome is true would I have to change my practice? If relevant then examine for validity
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Mentoring Every Question is a teachable moment If you look up two questions with the student they will learn It should not slow you down
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My Experience New MSIII on his second rotation Lot’s of questions InfoRetriever answered 90% We discussed outcomes No one had discussed outcomes with him to that point It added 15 minutes to my morning and afternoon He reports that he continues to utilize the EBM tools demonstrated
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Pharma Interactions Modeling behavior for students Demonstrating the sales methods being utilized Real life scenarios
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Handhelds This is the key to just in time information InfoRetriever can run off Palm or Microsoft handheld (click here)click here Very functional Gives you decision tools in your hand when you need them
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Handouts List of useful websites Password for InfoRetriever for TAMU Worksheets for reviewing articles Worksheet for pharm reps My contact information
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Questions?
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