Scientifically Informed Medical Practice and LEarning (SIMPLE) The Roadmap for Evidence Based Health Care Suzana Alves da Silva, MD, PhD
PROCEP Teaching and Research Center Rio de Janeiro, Brazil
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Evidence-Based Medicine “The integration of best research evidence with clinical expertise and patient values and circumstances� David Sackett, 1992
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EBM Skills Cycle
4. Apply
3. Appraise
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1. Ask
2. Acquire
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EBM Skills Cycle 0. Problem Delineation
4. Apply
3. Appraise
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1. Ask
2. Acquire
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Patient’s Opinion after a Chest Pain Unit Experience Based on ESCAPE Trial, Goodacre et al. BMJ 2007.
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 Wednesday, August 8, 12
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Chest Pain Unit • 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
Johnson et al. Patients’ opinions of acute chest pain care: a qualitative evaluation of Chest Pain Units. J Adv Nurs 2008 Wednesday, August 8, 12
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Chest Pain Unit • 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
Johnson et al. Patients’ opinions of acute chest pain care: a qualitative evaluation of Chest Pain Units. J Adv Nurs 2008 Wednesday, August 8, 12
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Chest Pain Unit • 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
= •
Low Patient Satisfaction Overwhelming $$$$$$
• •
Johnson et al. Patients’ opinions of acute chest pain care: a qualitative evaluation of Chest Pain Units. J Adv Nurs 2008 Wednesday, August 8, 12
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The SIMPLE Model
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The SIMPLE Model Values
Priorities Preferences
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The SIMPLE Model
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The SIMPLE Model Problem delineation “The process of problematization implies a critical return to action. It starts from action and returns to it� Paulo Freire, 1972
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P A Utility
Performance
Probability
Action
T
Choices
Targets
Patient-Practitioner Relationship and Practice Circumstances
Problem
C
Silva, Charon, Wyer. JECP 2010. Wednesday, August 8, 12
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P A Utility
Performance
Probability
Action
T
Choices
Targets
Patient-Practitioner Relationship and Practice Circumstances
Problem
C
Silva, Charon, Wyer. JECP 2010. Wednesday, August 8, 12
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P A Utility
Performance
Probability
Action
T
Choices
Targets
Patient-Practitioner Relationship and Practice Circumstances
Problem
C
Silva, Charon, Wyer. JECP 2010. Wednesday, August 8, 12
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P A Utility
Performance
Probability
Action
T
Choices
Targets
Patient-Practitioner Relationship and Practice Circumstances
Problem
C
Silva, Charon, Wyer. JECP 2010. Wednesday, August 8, 12
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P A Utility
Performance
Probability
Patient-Practitioner Relationship and Practice Circumstances
Problem
C
T
Choices
Targets
Share consideration of the utility
alternatives
Estimate of impact on patient outcomes
Share consideration of the performance
alternatives
Estimate of effect
Action
Share consideration of the probability
Estimate of likelihood of possible causes Silva, Charon, Wyer. JECP 2010.
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P A Utility
Performance
Probability
Patient-Practitioner Relationship and Practice Circumstances
Problem
C
T
Choices
Targets
Share consideration of the utility
alternatives
Estimate of impact on patient outcomes
Share consideration of the performance
alternatives
Estimate of effect
Action
Share consideration of the probability
Estimate of likelihood of possible causes Silva, Charon, Wyer. JECP 2010.
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P A Utility
Performance
Probability
Patient-Practitioner Relationship and Practice Circumstances
Problem
C
T
Choices
Targets
Share consideration of the utility
alternatives
Estimate of impact on patient outcomes
Share consideration of the performance
alternatives
Estimate of effect
Action
Share consideration of the probability
Estimate of likelihood of possible causes Silva, Charon, Wyer. JECP 2010.
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P A Utility
Performance
Probability
Patient-Practitioner Relationship and Practice Circumstances
Problem
C
T
Choices
Targets
Share consideration of the utility
alternatives
Estimate of impact on patient outcomes
Share consideration of the performance
alternatives
Estimate of effect
Action
Share consideration of the probability
Estimate of likelihood of possible causes Silva, Charon, Wyer. JECP 2010.
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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.
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Chest Pain Unit Priorities
Patient
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Practitioner
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Chest Pain Unit Priorities
Patient
Practitioner
Am I having a Heart Attack?
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Chest Pain Unit Priorities
Patient
Practitioner
Am I having a Heart Attack? Diagnosis likelihood
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Chest Pain Unit Priorities
Patient Am I having a Heart Attack? Diagnosis likelihood
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Practitioner Will the algorithm for low risk chest pain help me out excluding ACS for this patient?
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Chest Pain Unit Priorities
Patient Am I having a Heart Attack? Diagnosis likelihood
Practitioner Will the algorithm for low risk chest pain help me out excluding ACS for this patient? Diagnosis performance
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Chest Pain Unit Priorities
Patient Am I having a Heart Attack? Diagnosis likelihood
Practitioner Will the algorithm for low risk chest pain help me out excluding ACS for this patient? Diagnosis performance
If I come back to work what is the probability of something bad happening? Wednesday, August 8, 12
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Chest Pain Unit Priorities
Patient Am I having a Heart Attack? Diagnosis likelihood
Practitioner Will the algorithm for low risk chest pain help me out excluding ACS for this patient? Diagnosis performance
If I come back to work what is the probability of something bad happening? Prognosis likelihood Wednesday, August 8, 12
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Chest Pain Unit Priorities
Patient Am I having a Heart Attack? Diagnosis likelihood
Practitioner Will the algorithm for low risk chest pain help me out excluding ACS for this patient? Diagnosis performance
If I come back to work what is the probability of something bad happening?
If this patient in fact has ACS what will be the probability of being sued as a result of a bad outcome?
Prognosis likelihood Wednesday, August 8, 12
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Chest Pain Unit Priorities
Patient Am I having a Heart Attack? Diagnosis likelihood
Practitioner Will the algorithm for low risk chest pain help me out excluding ACS for this patient? Diagnosis performance
If I come back to work what is the probability of something bad happening?
If this patient in fact has ACS what will be the probability of being sued as a result of a bad outcome?
Prognosis likelihood
Prognosis likelihood
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Chest Pain Unit Priorities
Patient Am I having a Heart Attack? Diagnosis likelihood
Practitioner Will the algorithm for low risk chest pain help me out excluding ACS for this patient? Diagnosis performance
Is it safe to perform an outpatient investigation in this low risk patient? What is the impact on outcomes? If I come back to work what is the probability of something bad happening?
If this patient in fact has ACS what will be the probability of being sued as a result of a bad outcome?
Prognosis likelihood
Prognosis likelihood
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Chest Pain Unit Priorities
Patient Am I having a Heart Attack? Diagnosis likelihood
Practitioner Will the algorithm for low risk chest pain help me out excluding ACS for this patient? Diagnosis performance
Is it safe to perform an outpatient investigation in this low risk patient? What is the impact on outcomes? Diagnosis utility
If I come back to work what is the probability of something bad happening?
If this patient in fact has ACS what will be the probability of being sued as a result of a bad outcome?
Prognosis likelihood
Prognosis likelihood
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Chest Pain Unit Priorities
Patient Am I having a Heart Attack? Diagnosis likelihood
Practitioner Will the algorithm for low risk chest pain help me out excluding ACS for this patient? Diagnosis performance
I would like to perform the tests later. Is that okay?
Is it safe to perform an outpatient investigation in this low risk patient? What is the impact on outcomes? Diagnosis utility
If I come back to work what is the probability of something bad happening?
If this patient in fact has ACS what will be the probability of being sued as a result of a bad outcome?
Prognosis likelihood
Prognosis likelihood
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Chest Pain Unit Priorities
Patient Am I having a Heart Attack? Diagnosis likelihood
Practitioner Will the algorithm for low risk chest pain help me out excluding ACS for this patient? Diagnosis performance
I would like to perform the tests later. Is that okay? Diagnosis utility
Is it safe to perform an outpatient investigation in this low risk patient? What is the impact on outcomes? Diagnosis utility
If I come back to work what is the probability of something bad happening?
If this patient in fact has ACS what will be the probability of being sued as a result of a bad outcome?
Prognosis likelihood
Prognosis likelihood
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Utility Diagnostic Intervention
Performance Diagnosis
Probability Differential Dx
C
T
Problem
Action
Choices
Targets
Patient-Practitioner Relationship and Practice Circumstances
P A 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 of negative cardiac markers 6 hours after symptoms
Criterion Standard
Estimate of accuracy
Probability of ACS when chest pain is present
Estimate of likelihood of possible causes Silva, Charon, Wyer. JECP 2010.
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Utility Diagnostic Intervention
Performance Diagnosis
Probability Differential Dx
C
T
Problem
Action
Choices
Targets
Patient-Practitioner Relationship and Practice Circumstances
P A 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 of negative cardiac markers 6 hours after symptoms
Criterion Standard
Estimate of accuracy
Probability of ACS when chest pain is present
Estimate of likelihood of possible causes Silva, Charon, Wyer. JECP 2010.
Wednesday, August 8, 12
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Utility Diagnostic Intervention
Performance Diagnosis
Probability Differential Dx
C
T
Problem
Action
Choices
Targets
Patient-Practitioner Relationship and Practice Circumstances
P A 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 of negative cardiac markers 6 hours after symptoms
Criterion Standard
Estimate of accuracy
Probability of ACS when chest pain is present
Estimate of likelihood of possible causes Silva, Charon, Wyer. JECP 2010.
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Low Risk Chest Pain Solving the issues of probability
Pre-Test Probability of ACS
Diagnosis
10%
Probability of a Bad Outcome if the patient has ACS
Prognosis
1%
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 2006. Goldman. PREDICTION OF THE NEED FOR INTENSIVE CARE IN PATIENTS WHO COME TO EMERGENCY DEPARTMENTS WITH ACUTE CHEST PAIN. NEJM 1996. Wednesday, August 8, 12
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Low Risk Chest Pain Solving the issues of probability
Pre-Test Probability of ACS
Diagnosis
10%
Probability of a Bad Outcome if the patient has ACS
Prognosis
Within 1 month
1 out of 1.000 Will have a heart attack
1%
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 2006. Goldman. PREDICTION OF THE NEED FOR INTENSIVE CARE IN PATIENTS WHO COME TO EMERGENCY DEPARTMENTS WITH ACUTE CHEST PAIN. NEJM 1996. Wednesday, August 8, 12
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Low Risk Chest Pain Solving the issues of probability
Diagnosis
10%
Probability of a Bad Outcome if the patient has ACS
Prognosis
1%
Within 1 month
1 out of 1.000 Will have a heart attack
100% of patients > 40 y/o 3% with multiple risk factors
Pre-Test Probability of ACS
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 2006. Goldman. PREDICTION OF THE NEED FOR INTENSIVE CARE IN PATIENTS WHO COME TO EMERGENCY DEPARTMENTS WITH ACUTE CHEST PAIN. NEJM 1996. Wednesday, August 8, 12
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PACT
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PACT Action Domains
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PACT Action Domains Categories of Problems
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PACT Action Domains THERAPY
DIAGNOSIS
PROGNOSIS
HARM
Utility
Utility
Utility
Utility
Performance
Performance
Performance
Performance
Probability
Probability
Probability
Probability
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PACT Action Domains THERAPY
DIAGNOSIS
PROGNOSIS
HARM
Utility
Utility
Utility
Utility
Performance
Performance
Performance
Performance
Probability
Probability
Probability
Probability
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PACT Action Domains THERAPY
DIAGNOSIS
PROGNOSIS
HARM
Utility
Utility
Utility
Utility
Performance
Performance
Performance
Performance
Probability
Probability
Probability
Probability
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PACT Action Domains THERAPY
DIAGNOSIS
PROGNOSIS
HARM
Utility
Utility
Utility
Utility
Performance
Performance
Performance
Performance
Probability
Probability
Probability
Probability
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The Anatomy of the Question opulation
ntervention omparison
utcome Wednesday, August 8, 12
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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 oC 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 broadspectrum antibiotics. Based on tests you diagnose septic shock secondary to UTI, complicated by an obstructing stone.
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In patients with septic shock, does Early Goal Directed Therapy affect mortality?
Utility Performance Probability
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Therapy Utility
Therapy Probability
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
P
O Wednesday, August 8, 12
Decrease mortality?
What is the expected mortality? 18
Therapy Utility
Therapy Probability
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
P
O Wednesday, August 8, 12
Decrease mortality?
What is the expected mortality? 18
Therapy Utility
Therapy Probability
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
P
O Wednesday, August 8, 12
Decrease mortality?
What is the expected mortality? 18
Acquiring the Best Available Evidence
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Utility of a Therapeutic Intervention
Guidelines Systematic Reviews Randomized trials
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The effect of a quantitative resuscitation strategy on mortality in patients with sepsis: A meta-analysis* Alan E. Jones, MD; Michael D. Brown, MD, MSc; Stephen Trzeciak, MD, MPH. Critical Care Medicine 2008
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The effect of a quantitative resuscitation strategy on mortality in patients with sepsis: A meta-analysis* Alan E. Jones, MD; Michael D. Brown, MD, MSc; Stephen Trzeciak, MD, MPH. Critical Care Medicine 2008
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Likelihood of outcome if submitted to therapy
Guidelines Systematic Reviews Observational Studies
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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 Wednesday, August 8, 12
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en JA ce M H A ie 19 ra 92 rch y
id Ev
Basic Science
n tio ca sifi s as ne Cl li d de or Gui
Clinical Research
xf
O
Wisdom
Integration of Knowledge
Clinical Expertise
Silva and Wyer, Where is the wisdom? II, JECP 2009 Wednesday, August 8, 12
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en JA ce M H A ie 19 ra 92 rch y
id Ev
Basic Science
Clinical Expertise y h c r a r e
Clinical Knowledge
Ep
m e si t
Information Positivism
ty xi pl e
Pos-Positivism - Pragmatism
o
c i g o l
Scientific Knowledge
Co m
i
“Problematization” - Constructivism
H l a Wednesday, August 8, 12
n tio ca sifi s as ne Cl li d de or Gui
Clinical Research
xf
O
Wisdom
Integration of Knowledge
Silva and Wyer, Where is the wisdom? II, JECP 2009 24
Where is the Wisdom? “Where is the wisdom we have lost in knowledge? Where is the knowledge we have lost in information?” TS Eliot. The Rock. Acknowledgement to Peter Wyer
David Eddy. Evidence-Based Medicine: A Unified Approach. Health Affairs 2005. Wyer, Silva. Where is the Wisdom I. JECP 2009. Sival, Wyer. Where is the Wisdom II. JECP 2009.
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Thank You! Gracias! Danke! Merci! Obrigada! Wednesday, August 8, 12
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Research and Practice
Av ail
> 80%
Inf
c e D
All the rest
orm ati on
Observational Studies
n o isi Wednesday, August 8, 12
< 20%
ab
le
Randomized Controlled Trials
e N g n i k a M
s d e
David Eddy. Evidence-Based Medicine: A Unified Approach. Health Affairs 2005.
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