What is EBM? Introduction to Evidence-Based Medicine. The integration of: Defining EBM: From the Surgeon s Perspective

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1 What is EBM? Introduction to Evidence-Based Medicine Michael Alvarado, MD March 21, 2011 The integration of: Best Research Evidencewith Clinical Expertiseand Patient Values Sackett et al., 2000 Defining EBM: From the Surgeon s Perspective EBM is about integrating individual clinical expertise and the best external evidence derived from research. -BLACK N. EVIDENCE-BASED SURGERY: A PASSING FAD? WORLD J SURG 1999; 23: Research Evidence: clinically relevant research, sometimes from basic sciences, often from clinical research studies examining diagnostic tests, markers of prognosis, safety and efficacy of treatment, rehabilitative or preventive regimens 1

2 Clinical Expertise: using our clinical skills and past experience to identify health states, diagnosis, risks and benefits for individual patients, and integrate Patient Values: the unique concerns, expectations and preferences each patient brings to that particular clinical encounter. We incorporate these into clinical-decision making as part of our collaborative treatment with the patient. Goals of EBP Provide practicing surgeons with evidencebased data Resolve problems in the clinical setting Achieve excellence in care delivery Introduce innovation Reduce variations in surgical care Assists with efficient and effective decisionmaking Starts with Training Programs Understand and recognize the difficulties of conducting randomized controlled trials in surgery Admit that there will never be enough Cochrane reviews to cover allsurgical questions Commit to training residents in the process of answering clinical questions with themost accurate evidence available 2

3 Evidence-Based Practice of Surgery in Resident Training Literature is over-focused on critical appraisal skills (World J Surg May, 2005) Databases lead the user to be overconfident Many practicing surgeons lack access to medical library services Forming searchable patient care questions is a teachable skill EBM arising from Challenges and Opportunities Daily need for valid information in clinical settings (diagnoses, prognoses, treatment and prevention information) Inadequacy of traditional information sources (textbooks, experts, voluminous and variable quality publications) We note an increase in our diagnostic skills and clinical judgment with time and experience, but a decline in up-to-date knowledge Lack of time for in-depth search and evaluation of information pertinent to our clinical work JASPA* (Journal associated score of personal angst) J: Are you ambivalent about renewing your JOURNAL subscriptions? A: Do you feel ANGER towards prolific authors? S: Do you ever use journals to help you SLEEP? P: Are you surrounded by PILES of PERIODICALS? A: Do you feel ANXIOUS when journals arrive? 0 (?liar) 1-3 (normal range) >3 (sick; at risk for polythenia gravis and related conditions) * Modified from: BMJ 1995;311: EBM arising from Challenges and Opportunities Development of strategies to efficiently track down and appraise evidence, evaluate its validity and relevance Development of systematic reviews and concise summaries (e.g., Cochrane Reviews) Creation of Evidence-based Journals of secondary publication (pull together the small fraction of articles that are both valid and of immediate clinical use) Information systems at our fingertips Development of strategies for life-long learning to improve clinical performance 3

4 The Practice of EBM Step 1: Asking an answerable question Step 2: Tracking down the best evidence to answer that question Step 3: Critically appraise the evidence for validity, size of the effect, and utility of the findings Step 4: Incorporate the clinical appraisal into our clinical expertise and patient s individual issues Step 5: Evaluate and improve steps 1-4 with each new opportunity to apply these principles Limitations Shortage of coherent, consistent, valid and information Difficulties in applying evidence to the care of individual patients Other barriers to the practice of high quality medicine EBM does not Deny the importance of clinical experience Ignore patient values and preferences Promote a cookbook approach to medicine or health care 4

5 Good clinical questions Background Questions General knowledge Two components Root (who, what, when, where, why) A disorder or aspect of a disorder E.g., What is the typical age of onset of bipolar disorder? How do I decide to use a typical vs. atypical antipsychotic for agitation? Good clinical questions Foreground Questions These ask for specific information about managing a patient with a disorder They have 3-4 essential components What the EBP Trained Resident Does: The PICO Model Well-framed clinical questions contain the following components: Asking answerable clinical questions (CEBM- Oxford) P The Patient or Problem addressed I The Intervention (or Exposure) being considered C A Comparison intervention or exposure O The clinical Outcome of interest 5

6 Level of Evidence Opinion papers, editorials Case studies, case reports Laboratory Testing Animal Experiments Early Human Experiments-Phase I Trials Case Series-Phase II Trials Clinical Trials-Phase III Trials Asking answerable clinical questions (CEBM- Oxford) 56 year old African-American veteran is noted to be delirious and agitated post-operatively after hernia repair. He has no hx of alcohol abuse/dependence and is otherwise healthy Your attending recommends using haloperidol to manage the agitation; a visiting consultant recommends lorazepam 6

7 Forming the Clinical Question In a 56 year old man with post-op delirium and agitation, does treatment with haloperidol vs. lorazepam result in greater improvement in agitation? Finding the Best Evidence Typically not in textbooks (quickly obsolete) Difficult with traditional journals Use electronic databases, some which explicitly evaluate the evidence Evidence-based Medicine Reviews (EBMR) Cochrane Database of Systematic Reviews Reviews Systematic v. Narrative Reviews Systematic Review: CLEAR CLINICAL QUESTION CONCLUSION BASED ON DATA Search Tools Medline Both PubMed and Ovid are often refered to as Medline. They contain the same information. PubMed Clinical Queries Narrative Review: NO CLEAR QUESTION NO EVIDENCE CITED Ovid Cochrane s Database Best Evidence 7

8 Medsearch EBM Reviews- available on Ovid Cochrane Database of Systematic Review ACP Journal Club Database of Abstracts of Reviews of Effects Cochrane Central Register of Controlled Trial haloperidol and lorazepam references Combine with delirium - 11 references Drug therapy for delirium in terminally ill patients Jackson, KC; Lipman, AG Date of Most Recent Update: 21-October-2004 Date of Most Recent Substantive Update: 18- February-2004 Cochrane Pain, Palliative and Supportive Care Group. Dr. Kenneth Jackson, II, PharmD, Clincal Pharmacist, Pain/Palliative Care Abstract Background: Delirium is a common disorder that often complicates treatment in patients with life-limiting disease. Delirium is described using a variety of terms such as agitation, acute confusionalstates, encephalopathy, organic mental disorders, and terminal restlessness. Delirium may arise from any number of causes, and treatment should be directed at addressing these causes. In cases where this is not possible, or does not prove successful, the use of drug therapy may become necessary. Objectives: The primary objective of this review was to identify and evaluate studies examining medications used to treat patients suffering from delirium during the terminal phases of disease. Search strategy: We searched the following sources: MEDLINE (1966 to July 2003), EMBASE 1980 to July 2003), CINAHL (1982 to July 2003), PSYCH LIT (1974 to July 2003), PSYCHINFO (1990 to July 2003) and the Cochrane Library Volume 2, 2003) for literature pertaining to this topic. Selection criteria: Prospective trials with or without randomization and/or blinding involving the use of pharmacological agents for the treatment of delirium at the end of life were considered. Data collection and analysis: Two reviewers independently assessed trial quality using standardized methods and extracted data for evaluation. Outcomes related to both efficacy and adverse effects were collected. 8

9 Main results: Thirteen potential studies were identified by the search strategy. Of these, only one study met the criteria for inclusion in this review. This study evaluated 30 hospitalized AIDS patients receiving one of three different agents: chlorpromazine, haloperidol, and lorazepam. Analysis of this trial found chlorpromazine and haloperidol to be equally effective. Chlorpromazine was noted to slightly worsen cognitive function over time but this result was not significant. The lorazepam arm of the study was stopped early as a consequence of excessive sedation. Conclusions: The data from one study of 30 patients would perhaps suggest that haloperidol is the most suitable drug therapy for the treatment of patients with delirium near the end of life. Chlorpromazine may be an acceptable alternative if a small risk of slight cognitive impairment is not a concern. However, there is insufficient evidence to draw any conclusions about the role of pharmacotherapy in terminally ill patients with delirium, and further research is essential. Delirium: prevention, treatment, and outcome studies (Structured abstract) [Not stated] Centre for Reviews and Dissemination Date of Most Recent Update: 2000 NHS Centre for Reviews and Dissemination. University of York, York, U.K. Abstract and Commentary for:cole M G, Primeau F J, Elie L M, Delirium: prevention, treatment, and outcome studies. Journal of Geriatric Psychiatry and Neurology, 1998;11(3): Centres for Review and Dissemination Results of the review Treatment studies (13 studies overall; 6 pharmacotherapy, 7 nonpharmacotherapy): Non-pharmacotherapy interventions appeared to have a beneficial effect For pharmacotherapy, results from one RCT suggested that haloperidol and chlorpromazine were more useful than lorazepam in improving delirium in younger AIDS patients, one cohort study reported that haloperidol was more useful than narcotics in controlling delirium in older cardiac patients, and two nonrandomised trials reported that mianserin was as effective as haloperidol in controlling symptoms in older medical-surgical and psychiatric patients. For both prevention and treatment studies, there were frequent flaws in study design, including non-randomised designs, differences between treatment and control groups at baseline, and outcomes not rated blind. Findings from a third literature review of outcome (prognostic) studies suggested that better premorbid function (i.e. admission from home or to a surgical unit) was the most important predictor of better outcomes. Antibiotics for all Laparoscopic procedures? Antibiotics Prophylaxis Laparoscopic 9

10 Systematic Reviews Laparoscopic Perioperative Care Antibiotic prophylaxis DVT prophylaxis Postoperative nausea and vomitting Evidence Based Practice in Laparoscopic Surgery: Perioperative Care Goldfaden et al., Surg Inov, 2005 Systematically review data Include high-level evidence from randomizedcontrolled trials Antibiotic Prophylaxis From current data it may be safe to forego prophylactic antibiotics for clean laparoscopic procedures including diagnostic laparoscopy, antirefluxsurgery, splenectomyand adrenalectomy. Develop conclusions based on this evidence Goldfaden et al., Surg Inov,

11 VTE Prophylaxis Current evidence does not provide clear guidance about the use of VTE prophylaxis in patients undergoing laparoscopic surgery we believe it is reasonable to forego VTE prophylaxis for common, relatively brief laparoscopic procedures, including cholecystecotmyand herniorrhaphy. EBM and Outcomes: more incentive? Goldfaden et al., Surg Inov, 2005 Payers Interest in Quality of Care Implementation of pay-for-performance Based on evidence-based guidelines Wide variation in performance for surgeons and hospitals for surgery Will require different strategies Surgery and Quality Structure- setting of care Process- details of care given Outcomes- results of that care Birkmeyer NEJM Birkmeyer NEJM 11

12 Examples Structure Procedure volume Fellowship trained surgeons Closed ICU Advantages Expedient, inexpensive proxies of outcomes Disadvantages Most variables not actionable Not perfect for outcomes; reflects average results of groups, not individuals Process Examples Periop B-blockers high risk surgical patients Using IMA for CABG Advantages Reflects actual patient care Seems fair to providers Actionable by provider, clear link to quality improvement Disadvantage Little information to decide which process important for specific procedures Outcomes Examples Morbidity and mortality rates Patient satisfaction Cost Advantages Surgeon agreement-reflects bottom-line of what is done Measuring alone may improve outcomes Disadvantage Numbers too small to measure accurately Outcomes measures that aren t procedure specific less useful for QI Centers of Excellence Pay for Performance Pay for Participation Strategies Birkmeyer NEJM 12

13 Birkmeyer NEJM Birkmeyer NEJM Conclusions EBM is not just a collection of statisitics Need for more qualitative research Learn and embrace EBM Current tools for measuring surgical quality are inadequate Need to measure patient-centered outcomes, not just morbidity and mortality Doing the right thing right Birkmeyer NEJM 13

14 Thank you 14