PROCEP Teaching and Research Center Rio de Janeiro, Brazil PROCEP Teaching and Research Center Rio de Janeiro, Brazil Scientifically Informed Medical Practice and LEarning (SIMPLE) The Roadmap for Evidence Based Health Care Suzana Alves da Silva, MD, PhD

“The integration of best research evidence with clinical expertise and patient values and circumstances” David Sackett, 1992 Evidence-Based Medicine

2. Acquire 1. Ask 3. Appraise 4. Apply 0. Problem Delineation EBM Skills Cycle

Patients rarely knew to whom they had been talking, either by name or designation Patients knew that something was going wrong but rarely knew what was going wrong. They only knew that it was not a heart attack “But it is something, you know, there is something going on” Johnson et al. Patients ’ opinions of acute chest pain care: a qualitative evaluation of Chest Pain Units. J Adv Nurs 2008 Patient’s Opinion after a Chest Pain Unit Experience Based on ESCAPE Trial, Goodacre et al. BMJ 2007.

Low Patient Satisfaction Overwhelming $$$$$$ Low Patient Satisfaction Overwhelming $$$$$$ + = Low risk patient Follow the algorithm for low risk chest pain in the ER which includes repeated cardiac markers at 3 and 6 hours after admission + echocardiogram + non- invasive test for stratification before discharge Chest Pain Unit Johnson et al. Patients ’ opinions of acute chest pain care: a qualitative evaluation of Chest Pain Units. J Adv Nurs 2008

The SIMPLE Model Values Preferences Priorities Problem delineation “The process of problematization implies a critical return to action. It starts from action and returns to it” Paulo Freire, 1972 Problem delineation “The process of problematization implies a critical return to action. It starts from action and returns to it” Paulo Freire, 1972

P Problem A Action C Choices T Targets Utility Performance Probability Silva, Charon, Wyer. JECP Patient-Practitioner Relationship and Practice Circumstances

P Problem A Action C Choices T Targets Utility Performance Probability P Problem A Action C Choices T Targets Share consideration of the utility alternatives Estimate of impact on patient outcomes Share consideration of the performance alternativesEstimate of effect Share consideration of the probability Estimate of likelihood of possible causes Silva, Charon, Wyer. JECP Patient-Practitioner Relationship and Practice Circumstances

Clinical Scenario ‘I woke up with palpitations and chest pressure this morning. I just want to get it checked out, that’s all.’ This is how a 31-year-old worker, who has come to the emergency department during lunch break, describes his problem. The patient has no significant past medical history but that his father died in his 50’s of a ‘massive heart attack’. The patient lives alone, has an unclear history of similar symptoms. He states that he occasionally takes benzodiazepine ‘for sleep’. However, he stresses that, for now, he just wants his chest symptoms ‘checked out. ’ EKG, vital signs and physical examination and first cardiac enzymes are normal.

Patient Practitioner Am I having a Heart Attack? Diagnosis likelihood If I come back to work what is the probability of something bad happening? Prognosis likelihood Will the algorithm for low risk chest pain help me out excluding ACS for this patient? Diagnosis performance If this patient in fact has ACS what will be the probability of being sued as a result of a bad outcome? Prognosis likelihood Chest Pain Unit Priorities Is it safe to perform an outpatient investigation in this low risk patient? What is the impact on outcomes? Diagnosis utility I would like to perform the tests later. Is that okay? Diagnosis utility

P Problem A Action C Choices T Targets Utility Diagnostic Intervention Utility of out patient investigation within few days To follow the algorithm for low risk chest pain in the ER Estimate of impact on cardiovascular events Performance Diagnosis Performance of negative cardiac markers 6 hours after symptoms Criterion Standard Estimate of accuracy Probability Differential Dx Probability of ACS when chest pain is present Estimate of likelihood of possible causes Silva, Charon, Wyer. JECP Patient-Practitioner Relationship and Practice Circumstances

< 10% < 1% Pre-Test Probability of ACS Probability of a Bad Outcome if the patient has ACS < 1 out of < 1 out of Meyer et al. A Critical Pathway for Patients With Acute Chest Pain and Low Risk for Short-Term Adverse Cardiac Events: Role of Outpatient Stress Testing. Ann Emerg Med Within 1 month Will have a heart attack 100% of patients > 40 y/o 3% with multiple risk factors Low Risk Chest Pain Solving the issues of probability Diagnosis Prognosis Goldman. PREDICTION OF THE NEED FOR INTENSIVE CARE IN PATIENTS WHO COME TO EMERGENCY DEPARTMENTS WITH ACUTE CHEST PAIN. NEJM 1996.

PACT Action Domains Categories of Problems

PACT THERAPYTHERAPY DIAGNOSISDIAGNOSIS PROGNOSISPROGNOSIS HARMHARM Utility Performance Probability Utility Performance Probability Utility Performance Probability Utility Performance Probability Action Domains

The Anatomy of the Question opulation ntervention omparison utcome

Clinical Scenario You are seeing new patients in the “ major care ” area of the ED. You reassess a 45 yo male who had been held in the ED overnight while being treated for renal colic, in the hope he could be discharged. Unfortunately, this patient is not doing so well; he is extremely weak, nauseous and suffering extensive rigors. He has spiked a temp to 39.9 o C and his BP is 90/50, HR 135, and RR 22. His O2 saturation is 98% on room air. You initiate a septic work-up and order aggressive hydration and broad- spectrum antibiotics. Based on tests you diagnose septic shock secondary to UTI, complicated by an obstructing stone.

In patients with septic shock, does Early Goal Directed Therapy affect mortality? Utility Performance Probability

TherapyUtilityTherapyProbabilityP In patients with septic shock IF a pt with septic shock IS submitted to EGDT I Does EGDT During the hospitalization phase C Compared to the usual care O Decrease mortality? What is the expected mortality?

Acquiring the Best Available Evidence

Utility of a Therapeutic Intervention Guidelines Systematic Reviews Randomized trials

Alan E. Jones, MD; Michael D. Brown, MD, MSc; Stephen Trzeciak, MD, MPH. Critical Care Medicine 2008 The effect of a quantitative resuscitation strategy on mortality in patients with sepsis: A meta-analysis*

Guidelines Systematic Reviews Observational Studies Likelihood of outcome if submitted to therapy

In-Hospital mortality in Sepsis Patients submitted to EGDT Lagu et al. Incorporating initial treatments improves performance of a mortality prediction model for patients with sepsis. Pharmacoepidemiology and drug safety 2012; 21(S2): 44–52

Silva and Wyer, Where is the wisdom? II, JECP 2009 Clinical Research Basic Science Clinical Expertise Clinical Knowledge “Problematization” - Constructivism Clinical Knowledge “Problematization” - Constructivism Scientific Knowledge Pos-Positivism - Pragmatism Scientific Knowledge Pos-Positivism - Pragmatism Information Positivism Information Positivism Evidence Hierarchy JAMA 1992 Epistemological Hierarchy Complexity Wisdom Oxford Classification Guidelines Integration of Knowledge

David Eddy. Evidence-Based Medicine: A Unified Approach. Health Affairs Wyer, Silva. Where is the Wisdom I. JECP Sival, Wyer. Where is the Wisdom II. JECP TS Eliot. The Rock. Acknowledgement to Peter Wyer “Where is the wisdom we have lost in knowledge? Where is the knowledge we have lost in information?” Where is the Wisdom?

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