The Roadmap by Suzana Silva

The Roadmap for Evidence-Based Clinical Practice Suzana Alves da Silva Teaching and Research Center of Pr贸-Card铆aco Rio de Janeiro, Brasil

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Center for Education Research and Evaluation

CLARITY Group

Teaching and Research Center of Pr贸-Card铆aco

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â&#x20AC;&#x153;The integration of best research evidence with clinical expertise and patient values and circumstancesâ&#x20AC;? David Sackett domingo, 16 de maio de 2010

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â&#x20AC;&#x153;To learn how to transform

information into knowledge.â&#x20AC;?

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â&#x20AC;&#x153;To learn how to transform

information into knowledge.â&#x20AC;?

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â&#x20AC;&#x153;To develop critical consciousness for social transformation both in the classroom and in the world.â&#x20AC;?

domingo, 16 de maio de 2010

â&#x20AC;&#x153;To develop critical consciousness for social transformation both in the classroom and in the world.â&#x20AC;?

domingo, 16 de maio de 2010

â&#x20AC;&#x153;To develop critical consciousness for social transformation both in the classroom and in the world.â&#x20AC;?

domingo, 16 de maio de 2010

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

“Knowledge is not extended from those who consider that they know to those who consider that they do not know.” Paulo Freire

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Circumstances

Practitioner 

“Knowledge is not extended from those who consider that they know to those who consider that they do not know.”

Patients

Evidence Haynes. ACP J Club 2002.

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Scientific Informed Medical Practice and Learning Model

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Scientific Informed Medical Practice and Learning Model



Knowledge is built up in the relations between human beings [...], and perfects itself in the critical problematization of these relations.”

 9

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The School of Athens domingo, 16 de maio de 2010

Theory

Knowledge

The School of Athens domingo, 16 de maio de 2010

Theory

Knowledge Practice Wisdom

The School of Athens domingo, 16 de maio de 2010

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“Where is the wisdom we lost in Knowledge? Where is the Knowledge we lost in Information?” TS Eliot. The Rock. Acknowledgment to Peter Wyer

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Skill Category

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Study Design 14

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Study Design 14

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Study Design 14

“The process of problematization implies a critical return to action. It starts from action and returns to it” •

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Paulo Freire. Pedagogy of the Oppressed. 1974

The Action Domains

ACTION DOMAIN THERAPY

DIAGNOSIS

Ask

Acquire

Appraise

Apply

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PROGNOSIS

HARM

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Therapy

Diagnosis

Prognosis

Harm

Patient or population

Therapeutic Intervention

Diagnostic Assessment

Destiny

Intervention or exposure

Choices

Different Dx Performance

Likelihood Performance

Utility

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Therapy

P A C T

Diagnosis

Prognosis

Harm

Patient or population

Therapeutic Therapeutic

Intervention Intervention

Diagnostic Diagnostic Assessment Assessment

Destiny Destiny

Intervention Intervention or exposure or Exposure

Choices

Different Different Dx Dx Utility Utility

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Likelihood Likelihood Performance Performance Utility Performance Performance Utility Utility Utility

Utility Utility

Clinical Scenario

You are seeing new patients in the â&#x20AC;&#x153;major careâ&#x20AC;? 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 broad-spectrum antibiotics. Based on tests you diagnose septic shock secondary to UTI, complicated by an obstructing stone.

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Clinical Action 

Should this septic patient be referred to immediate operation of obstructive stone?



What is his probability of death within the hospital staying period?



Should fluid resuscitation be guided by Central Venous Saturation monitoring?



What are his choices for treatment?

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THE ANATOMY

HEAD

ARMS

LEGS

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THE ANATOMY

opulation

ntervention

omparison

utcome

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In patients with septic shock, does Early Goal Directed Therapy affect mortality? •! Therapy •! Diagnosis •! Prognosis •! Harm domingo, 16 de maio de 2010

Therapy

P I C

Diagnosis

Patient or population

Symptomatic Asymptomatic

Patient or population

Surgical, Preventive or Medical Treatment

-Set of signals and symptoms

-Time of observation

-Test or Rule

-Predictor(s) or Prediction Rule

Control

Standard assessment Differential Dx

Prognosis

Clinical Outcome

Possible Dx Performance

Accuracy Utility

Clinic Outc domingo, 16 de maio de 2010

Harm Patient or population

Intervention or Exposure

Control

Likelihood

Probab cond Performance

Association

Clinical outcome

Utility

Clinic Outc 26

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

â&#x20AC;&#x201C; In patients with septic shock, does Early Goal Directed Therapy affect mortality?

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

Therapy

P I

Prognosis In patients with septic shock,

In patients with septic shock

that WERE submitted to early goal direct therapy

Does early goal direct therapy

Compared to the usual care

Decrease Mortality?

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During the hospitalization phase

What is the Mortality?

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

Therapy

P I

Prognosis In patients with septic shock,

In patients with septic shock

that WERE submitted to early goal direct therapy

Does early goal direct therapy

Compared to the usual care

Decrease Mortality?

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During the hospitalization phase

What is the Mortality?

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

P I C O

s s Therapy Prognosis s s s In patients with septic shock, s In patients with septic shock sthat WERE submitted to early sgoal direct therapy s s During the hospitalization s Does early goal direct therapy sphase s s s Compared to the usual care s s s Effect on s Outcome sWhat is the Mortality? Decrease Mortality? s s

domingo, 16 de maio de 2010

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

Therapy

P I C O

Prognosis In patients with septic shock,

In patients with septic shock

that WERE submitted to early goal direct therapy

Does early goal direct therapy

During the hospitalization phase

Compared to the usual care

Decrease Mortality?

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Effect on Outcome

What is the Mortality?

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

Therapy

P I C O

Prognosis In patients with septic shock,

In patients with septic shock

Does early goal direct therapy

that WERE submitted to Time early of Observation goal direct therapy During the hospitalization phase

Compared to the usual care

Decrease Mortality?

domingo, 16 de maio de 2010

Effect on Outcome

What is the Mortality?

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

Therapy

P I C O

Prognosis In patients with septic shock,

In patients with septic shock

Does early goal direct therapy

that WERE submitted to Time early of Observation goal direct therapy During the hospitalization phase

Compared to the usual care

Decrease Mortality?

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Effect on Outcome

Comparison is not applicable

What is the Mortality?

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

Therapy

P I C O

Prognosis In patients with septic shock,

In patients with septic shock

Does early goal direct therapy

that WERE submitted to Time early of Observation goal direct therapy During the hospitalization phase

Compared to the usual care

Decrease Mortality?

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Effect on Outcome

What is the Mortality?

Comparison is not applicable

Likelihood of the Outcome

Disclosure of APOE Genotype for Risk of Alzheimer’s Disease Robert C. Green, M.D., M.P.H., J. Scott Roberts, Ph.D., L. Adrienne Cupples, Ph.D., Norman R. Relkin, M.D., Ph.D., Peter J. Whitehouse, M.D., Ph.D., Tamsen Brown, M.S., Susan LaRusse Eckert, M.S., Melissa Butson, Sc.M., A. Dessa Sadovnick, Ph.D., Kimberly A. Quaid, Ph.D., Clara Chen, M.H.S., Robert Cook-Deegan, M.D., and Lindsay A. Farrer, Ph.D., for the REVEAL Study Group*

An Example of PROGNOSIS UTILITY

A bs t r ac t Background

The apolipoprotein E (APOE) genotype provides information on the risk of Alzheimer’s disease, but the genotyping of patients and their family members has been discouraged. We examined the effect of genotype disclosure in a prospective, randomized, controlled trial. Methods

We randomly assigned 162 asymptomatic adults who had a parent with Alzheimer’s disease to receive the results of their own APOE genotyping (disclosure group) or not to receive such results (nondisclosure group). We measured symptoms of anxiety, depression, and test-related distress 6 weeks, 6 months, and 1 year after disclosure or nondisclosure. Results

There were no significant differences between the two groups in changes in timeaveraged measures of anxiety (4.5 in the disclosure group and 4.4 in the nondisclosure group, = 0.84), depression (8.8 and 8.7, respectively; P = 0.98), or test-related domingo, 16 dePmaio de 2010

From Boston University School of Medicine (R.C.G., T.B., L.A.F.), Boston University School of Public Health (R.C.G., L.A.C., C.C., L.A.F.), and Harvard Medical School Genetics Training Program (R.C.G.) — all in Boston; the University of Michigan School of Public Health, Ann Arbor (J.S.R.); Weill Cornell Medical College, New York (N.R.R.); Case Western Reserve University School of Medicine, Cleveland (P.J.W., M.B.); Columbia University School of Medicine, New York (S.L.E.); the University of British Columbia, Vancouver Hospital and Health Sciences Centre, Vancouver, BC, Canada (A.D.S.); Indiana University School of Medicine, Indianapolis (K.A.Q.); and Duke University, Durham, NC (R.C.-D.). Address reprint requests to Dr. Green at Boston University School of Medicine, 715 Albany St., L-320, Boston, MA 02118, or at 28

An Example of Diagnosis Utility

In this study, CTPA was not inferior to V/Q scanning in ruling out pulmonary embolism. However, significantly more patients were diagnosed with pulmonary embolism using the CTPA approach. Further research is required to determine whether all pulmonary emboli detected by CTPA should be managed with anticoagulant therapy.

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Therapy

Harm

In patients with dislipidemia

In patients with

The use of statin

Compared to placebo

Reduce...?

Cause...?

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dislipidemia

Therapy

Harm

In patients with dislipidemia

In patients with

The use of statin

Compared to placebo

Reduce...?

Cause...?

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dislipidemia

Therapy

Harm

In patients with dislipidemia

In patients with

The use of statin

Compared to placebo

Reduce...?

Cause...?

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dislipidemia

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Phases of the Development and Incorporation of a New Technology

Efficiency Effectiveness Efficacy

Basic Research

Applied Research

Translational Research

Surrogate Endpoints

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Clinical Research

Clinical Endpoints

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Phases of the Development and Incorporation of a New Technology

Efficiency Effectiveness Efficacy

Basic Research

Applied Research

Translational Research

Surrogate Endpoints Cholesterol Level

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Clinical Research

Clinical Endpoints

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Phases of the Development and Incorporation of a New Technology

Efficiency Effectiveness Clinical Research

Efficacy

Surrogate Endpoints Cholesterol Level

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Clinical Research

Basic Research

Applied Research

Translational Research

Clinical Research

Clinical Endpoints

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Phases of the Development and Incorporation of a New Technology

Efficiency Effectiveness Clinical Research

Efficacy

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M I Ra or ta te lity Ra te

Surrogate Endpoints Cholesterol Level

Clinical Research

Basic Research

Applied Research

Translational Research

Clinical Research

Clinical Endpoints

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Phases of the Development and Incorporation of a New Technology

Efficiency Effectiveness Clinical Research

Efficacy

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Ra te M I Ra or t Re tal e va ity sc Ra ul te ar iza tio n

Surrogate Endpoints Cholesterol Level

Clinical Research

Basic Research

Applied Research

Translational Research

Clinical Research

Clinical Endpoints

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Phases of the Development and Incorporation of a New Technology

Efficiency Effectiveness Clinical Research

Efficacy

domingo, 16 de maio de 2010

Ra te M I Ra or t Re tal e va ity sc Ra ul te ar iza tio n

Surrogate Endpoints Cholesterol Level

Clinical Research

Basic Research

Applied Research

Translational Research

Clinical Research

Clinical Endpoints

Costs

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Phases of the Development and Incorporation of a New Technology

Efficiency Effectiveness Clinical Research

Efficacy

domingo, 16 de maio de 2010

Ra te M I Ra or t Re tal e va ity sc Ra ul te ar iza tio n

Surrogate Endpoints Cholesterol Level

Clinical Research

Basic Research

Applied Research

Translational Research

Clinical Research

Clinical Endpoints

Costs

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Phases of the Development and Incorporation of a New Technology

Efficiency Effectiveness Clinical Research

Efficacy

domingo, 16 de maio de 2010

Ra te M I Ra or t Re tal e va ity sc Ra ul te ar iza tio n

Surrogate Endpoints Cholesterol Level

Clinical Research

Basic Research

Applied Research

Translational Research

Clinical Research

Clinical Endpoints

Costs

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Phases of the Development and Incorporation of a New Technology

Efficiency Effectiveness Clinical Research

Efficacy

domingo, 16 de maio de 2010

Ra te M I Ra or t Re tal e va ity sc Ra ul te ar iza tio n

Surrogate Endpoints Cholesterol Level

Clinical Research

Basic Research

Applied Research

Translational Research

Clinical Research

Clinical Endpoints

Costs

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Phases of the Development and Incorporation of a New Technology

Efficiency Effectiveness Clinical Research

Efficacy

domingo, 16 de maio de 2010

Ra te M I Ra or t Re tal e va ity sc Ra ul te ar iza tio n

Surrogate Endpoints Cholesterol Level

Clinical Research

Basic Research

Applied Research

Translational Research

Clinical Research

Clinical Endpoints

Costs

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Guidelines

Economic Analyses Decision Analyses Systematic Review

Randomized Trials

Single Studies

Health Technology Assessment

SUMMARIES

Syntheses

Non Randomized Trials

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Guidelines

Economic Analyses Decision Analyses Systematic Review

Randomized Trials

Single Studies

Health Technology Assessment

SUMMARIES

Syntheses

Non Randomized Trials

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Guidelines

Syntheses Economic Analyses Decision Analyses Systematic Review

Randomized Trials

Single Studies

Health Technology Assessment

SUMMARIES

SYNOPSES

Non Randomized Trials

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Precedent: Haynes, ACP J Club 2005

UR CE S

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S N SIG

Precedent: Haynes, ACP J Club 2005

UR CE S

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S N SIG

Precedent: Haynes, ACP J Club 2005

UR CE S

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S N SIG

Precedent: Haynes, ACP J Club 2005

UR CE S

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S N SIG

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Randomized Trials

Cross-Sectional Studies

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Cohort Studies

Case-Control Studies

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How to link the study design to the specific question?

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Linking Study Designs to Question

Appendix of the roadmap

Diagnosis on Symptomatic Patients

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The methodology

Precedent: Jackson “Gate” Model – ACP J Club 2006

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to bili sce pti

End

Middle Su

se a Ph

e h t f o s

bia s

y d u st

Beginning

Study Designs that Matter

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Beginning

Middle

End

Randomization

Extent of Blinding

Intention to treat

Concealment

Co-Intervention

Adequacy of follow up

Adequacy of assessment (frequency of follow up and outcome measures)

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Trial stopped early for benefit

Beginning

Applicab ility

Middle

End

Randomization

Extent of Blinding

Intention to treat

Concealment

Co-Intervention

Adequacy of follow up

Adequacy of assessment (frequency of follow up and outcome measures)

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Trial stopped early for benefit

Beginning

Middle

End

Appropriate source and spectrum of patients

Independence of study test and criterion standard

Blinded comparison to criterion standard

Appropriate Standard

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Beginning

Middle

End

Appropriate source and spectrum of patients

Independence of study test and criterion standard

Blinded comparison to criterion standard

Appropriate Standard

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Beginning

Middle

End

Similar prognostic factors

Adequacy of assessment.

Adequacy of follow up

-Frequency

Adjustment

-Objective outcome measure

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Beginning

Middle

End

Similar prognostic factors

Adequacy of assessment.

Adequacy of follow up

-Frequency

Adjustment

-Objective outcome measure

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Beginning

Middle

End

Matching

Objective outcome measures

Adjustment

-Prognostically similar groups -Equal opportunity of exposure

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Beginning

Middle

End

Matching

Objective outcome measures

Adjustment

-Prognostically similar groups -Equal opportunity of exposure

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Beginning

Plausible hypothesis referring to a sensible clinical question: - common (P)atient populations; - common (I)ntervention and (C)omparison if appropriate; - common (O)utcome measures; - common (S)tudy designs.

Middle

Exhaustive search; Reproducible selection and assessment of studies; Selection of studies of high methodological quality.

End

Results similar across studies; Precision of results that meet accepted evidence criteria (statistical significance, confidence bands and magnitude of effect).

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What are the most important results?

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Appendix of the roadmap

Diagnosis on Symptomatic Patients

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The importance of the results

Domains

Therapy

Diagnosis Performance

Measures Frequency HR RR, OR

Impact

RD, NNT, NNH

Post-test Prob

Precision

Harm

Utility

Pre-Test Prob

Effects

Prognosis AR

HR RR, OR RD, NNT, NNH, NNS CI

HR RR, OR

RD, NNT, NNH, NNS

RD, NNH

RD = Risk Difference

CI = Confidence Interval

HR = Hazard Ratio

LR = Likelihood Ratio

RR = Relative Risk

NNT, NNH and NNS = Number Needed to Treat, to Harm and to Screen

OR = Odds Ratio domingo, 16 de maio de 2010

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First Level of Applicability



Similarity of researcher and practitioner question (PICO)



Integration with relevant scientific knowledge from other sources



Feasibility within patient and practice circumstances

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A Second Level of Applicability

Enabling Skills

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Knowledge Translation

Enabling Skills

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Knowledge Translation

Research Q = Your Q

Enabling Skills

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Knowledge Translation

Research Q = Integrate Your Q Knowledge

Enabling Skills

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Knowledge Translation

Research Q = Integrate Your Q Knowledge Feasibility

Enabling Skills

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Knowledge Translation

Enabling Skills

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suzana.silva@procardiaco.com.br

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Thank You! suzana.silva@procardiaco.com.br

domingo, 16 de maio de 2010