Scientifically Informed Medical Practice and Learning

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.

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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.

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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.

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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.

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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

10

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

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?

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

10

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

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

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

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

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.

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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.

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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.

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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?

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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?

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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?

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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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Wednesday, August 8, 12

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Thank You! Gracias!

Danke!

Merci!

Obrigada!

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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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