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Learn the conscientious, explicit, and judicious use of current best evidence in clinical decisions for individual patients, using research information effectively. Explore EBM processes, clinical questions, study types, and critical appraisal methods. Discover the strengths of evidence hierarchies and categories of recommendations for clinical practice guidelines. Examine limitations and biases in EBM implementation.
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EBM Introduction to Evidence Based Medicine ThewarugWerawatganon, MD Anesthesiology, Chulalongkorn University
EBM • Evidence Based Medicine • Use of research information in clinical decision: David Eddy • Experience Based Medicine • Experience, Explanation
Evidence-Based Medicine:Definition Conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. (Sackett, DL et al Evidence-based medicine: what it is and what it isn’t, BMJ 1996)
Clinical problem • High cholesterol • Aspirin
EBM process • 1. Translation of uncertainty to a question • 2. Systematic retrieval of the best evidence • 3. Critical appraisal of evidence for validity • 4. Application in practice • 5. Evaluation of performance
Clinical Question • Diagnosis • Therapy • Prognosis • Etiology
Hierarchy of Study Design Meta-Analysis Systematic Review Randomized Controlled Trial Cohort study Case Control study Case Report Animal study
Question • P Patient • I Intervention • C Comparison • O Outcome
Clinical trial Phase I healthy volunteers for dose-ranging Phase II efficacy and safety Phase III efficacy, effectiveness and safety Phase IV postmarketing surveillance
Systematic retrieval • Pubmed • Embase • Cochrane
EBM • Create • Use
Use EBM for patient management Critical Appraisal Valid Result Application
EBM • Application • Clinical decision • Clinical practice guideline • Policy – technology assessment
EBM • Randomized Controlled Trial (RCT) • Systematic Review • Clinical Practice Guideline (CPG) • Health Policy
EBM • Randomized Controlled Trial (RCT) • Systematic Review: Cochrane • Clinical Practice Guideline (CPG) • Health Policy • Agency for Healthcare Research and Quality's (AHRQ) • National Institute for Clinical Excellence (NICE)
Strength of Evidence Clinical Practice Guideline (CPG) Evidence level Ia - Evidence from Meta-analysis of RCTs Ib - Evidence from at least one RCT IIa - Evidence from at least one well designed controlled trial which is not randomized IIb - Evidence from at least one well designed experimental trial III - Evidence from case, correlation, and comparative studies. IV - Evidence from a panel of experts
Categories of recommendations Level A: Good evidence suggests that the benefits substantially outweigh the risks. Should discuss the service with eligible patients. Level B: At least fair evidence suggests that the benefits outweighs the risks. Clinicians should discuss the service with eligible patients. Level C: At least fair evidence suggests that there are benefits, but the balance between benefits and risks are too close for making general recommendations. Clinicians need not offer it unless there are individual considerations. Level D: At least fair evidence suggests that the risks outweighs potential benefits. Not routinely offer the service to asymptomatic patients. Level I: Scientific evidence is lacking, of poor quality, or conflicting, such that the risk versus benefit balance cannot be assessed. Clinicians should help patients understand the uncertainty
Limitation • Bias • Sponsor's interests. • Lag • Population segments under-researched • Published and unpublished • EBM from groups of people but applies to treat each patient
Clinical problem • Aspirin 39,876 initially healthy women 45+ yrs Receive aspirin 100 mg or placebo monitored 10 years for major cardiovascular events
Nonfatal 198 244 0.81 (0.67–0.97) 0.02 198 193 1.02 (0.84–1.25) Fatal 14 12 1.16 (0.54–2.51) 0.70 Nonfatal 184 181 1.01 (0.83–1.24) 0.90 Death from cardiovascular causes 120 126 0.95 (0.74–1.22) 0.68
Objective Good Research Interim Analysis
Formulation of Research Question ThewarugWerawatganon, MD Anesthesiology, Chulalongkorn University
Previous knowledge Test hypothesis Reject / accept New knowledge What is research?
ประโยชน์ • Position • Honor • Promotion • Money • Skill • Knowledge • Graduate • Improvement
Research>>>…. Development>>>…. Outcome Improvement
Example Nasotracheal intubation in ICU • Oral hygeine care • Less misplacement • Comfortable
Nosocomial maxillary sinusitis during mechanical ventilation: a prospective comparison of orotracheal versus the nasotracheal route Intensive Care Med. 1990;16(6):390-3. Salord F, Gaussorgues P, Marti-Flich J, Sirodot M, Allimant C, Lyonnet D, Robert D.
A randomized study assessing the systematic search for maxillary sinusitis in nasotracheally mechanically ventilated patients. Influence of nosocomial maxillary sinusitis on the occurrence of ventilator-associated pneumonia. Am J RespirCrit Care Med. 1999 Mar;159(3):695-701. Holzapfel L, Chastang C, Demingeon G, Bohe J, Piralla B, Coupry A.
Starting Point? Problem
Problem …Data DataQuestion
Starting Point? Problem >> Research Question
Research Question • Work • Read • Think
Research Question See Look Intelligence
Scope of Anesthesia • General & Regional anesthesia • Critical care • Respiratory care • Pain service • Cardiopulmonary resuscitation
Aspect • Basic science • Clinical • Health Service System • Economic Analysis
Finding • Advisor • Friend • Previous Study • Pondering
Finding • Topic of interest • Explore Textbook & Journal • The most specific thought
Write Down The Research Question • Define research boundary clearly • Suitable method to do
Evaluate The Research Question • Exist • No clear answer • Innovate • Narrow focus • Feasible • Benefit • Creating Not Destroying anyone • Answerable by research
Example: Ventilator Associated Pneumonia • What is the incidence of VAP?
Example: Ventilator Associated Pneumonia • What is the incidence of VAP? • What are the significant Risk factors for VAP?
Example: Ventilator Associated Pneumonia • What is the incidence of VAP? • What are the significant Risk factors for VAP? • Is orotracheal is better than nasotracheal tube?
Example: Ventilator Associated Pneumonia • What is the incidence of VAP? • What are the significant Risk factors for VAP? • Is orotracheal is better than nasotracheal tube? • Can new mode ventilation prevent VAP?