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DEPARTMENT OF FAMILY AND COMMUNITY MEDICINE
UP-PHILIPPINE GENERAL HOSPITAL
INTRODUCTION TO
EVIDENCE-BASED MEDICINE
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OBJECTIVES
1. To define Evidence Based-Medicine Family and Community Practice (EBMFCP)
2. To discuss the uses (importance) of EBMFCP
3. To discuss the foundations of a clinical dilemma (clinical question) based on a patient’s case scenario
4. To discuss the different strategies in searching for answers
5. To discuss the steps regarding the critical appraisal of a journal
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Introduction
Medicine is not an exact science. Medicine is a dynamic field of knowledge.
Problems arise
New information regarding therapeutics and diagnostics
Affect patient management
Quality of care changes
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In our day to day encounter with patients we often find ourselves facing a dilemma or questions in regard to:
Therapeutics
Diagnostics
Differential diagnoses
Prognosis
Harm
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Diagnosis How to select and interpret the appropriate diagnostic tests
Therapy How to select treatments to offer patients that do more good than harm and that are worth the efforts and costs of using them
Prognosis How to estimate the patient’s likely clinical course over time and anticipate likely complications of disease
Harm/Etiology How to identify causes for the disease (including iatrogenic forms)
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Patients usually serve as the starting point
Good questions are the backbone of EBM
Searching for the right answers is usually the hardest step.
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RESOLUTION OF THE CLINICAL DILEMMA
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Looking for answers
The usual thing…………
When asked or in doubt, > we get it from books and journals > ask other: friends, colleagues, mentors,
subspecialty experts
However,
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OUR INFORMATION NEEDS ARE NOT MET!!!
our textbooks are out of date by the day they are published
our journals are disorganized and inaccessible to us
our colleagues may not have the answers that we seek
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Evidence Based Medicine
New Paradigm
Search for the CURRENT BEST EVIDENCEAppraise Decide and ApplyEvaluate
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WHAT IS EBM?
“The conscientious, explicit and judicious use of current best evidence in making decisions about the care of the individual patient. It
means integrating individual clinical expertise with the best available external clinical
evidence from systematic research."Dr. David Sackett, 1996
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EBM is a systematic approach ACQUISITION APPRAISAL APPLICATION of Research
to guide decisions in health care
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ADVANTAGES OF EBFCP
TO DOCTORS:
Lifelong learning Continuing professional development Keeping up to date
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Better quality of careCost-effective careBetter outcomes
TO PATIENTS:
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TO THE HEALTH CARE SYSTEM:
Better utilization of healthcare resources
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The Evidence-Based Family and Community Practitioner
Clinical Experience
Patient Values
Evidence
DECISION
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Ask
Acquire
Appraise
Apply
Act & Assess
Patient dilemma
Principles of evidence-based
practice
Evidence alone does not decide – combine with otherknowledge and values
Hierarchy of evidence
Process of EBP
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Steps in the EBM Process
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CLINICAL SCENARIO
Maria, 50/FHistory of CHF 2o to several Myocardial
InfarctionsHospitalized 2x w/n the last 6 months due to
worsening of heart failure
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Normal sinus rhythm presentlyEnalapril, aspirin and simvastatinWants desperately to stay out of the hospitalDigoxin (?)
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CLINICAL SCENARIO
You think she should also be taking digoxin but you arent certain if this will help keep her out of the hospital.
You decide to research this question before her next visit.
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Background Questions:
Ask for general knowledge about a disease or disease process, tests, treatments, etc. 2 components:
a. root* + verb “What causes….” b. condition …. SARS?”
* Who, What, Where, When, How, Why
Usually asked because of the need for basic information.Answering the background question. textbooks,
handbooks and databases
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Foreground Question:
About patient care decisions and actions
4 (or 3) components: a. Patient, problem or population b. intervention, exposure, or manuever c. comparison (if relevant) d. clinical outcomes (including time horizon)
e.g: in young children with acute otitis media, is short-term antibiotic therapy as effective as long term antibiotic therapy?
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Formulating a Focused Question
Population (P) – general characteristics of the group of subjects in question
Intervention(I) – drug or treatment, diagnostic test, risk factor or anything that is being tested
Outcome (O) – endpoint against which a certain intervention is measured
Methodology (M) – study design
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Translate dilemmas into questionsKeep the questions simple, relevant, and manageableComplex questions: FRUSTRATION!!
Patient/problem Congestive heart failure, elderly
Intervention Digoxin
Comparison, if any None, placebo
Outcome Primary:reduce need for hospitalizationSecondary: reduce mortality
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The question:
In elderly patients with congestive heart failure, is digoxin effective in reducing the need for rehospitalization?
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THE SEARCH
Identify key termsUse the boolean principle (Venn diagram) in
combining termsUse OR to broaden searchUse AND to narrow down searchUse of “Quotation Marks”Use of the MeSH Use of limitsUse of truncations
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The Key Terms
Population – elderly hypertensives with CHFIntervention – digoxinOutcome – rate of hospitalizationMethodology – RCT
In elderly patients with congestive heart failure, is digoxin effective in reducing the need for rehospitalization?
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The Boolean Principle
Congestive Heart
FailureDigoxin
Hospitalization
OR to broaden search
AND to narrow down search
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The Evidence Pyramid
Meta-Analysis
Systematic Review
Randomized Controlled Trial
Cohort Studies
Case-Control Studies
Case Series/Case Report
Animal Research/Laboratory Studies
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Type of Question
Suggested Best Type of Study
Therapy RCT > Cohort > Case-Control > Case Series
Diagnostic Prospective, blind comparison to a gold standard
Etiology/Harm RCT > Cohort > Case-Control > Case Series
Prognosis Cohort > Case Control > Case Series
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WHAT TO ACCESS?
www.nlm.nih.govwww.nejm.com www.bmj.com www.freemedicaljournals.com www.medscape.com www.pubmed.com
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What do we do with our output?
When you have the article, appraise it using the Evidence-Based Family and Community Practice and Quality Improvement in Health Care Manual (FMRG, 2003)
Weigh the evidence afforded by the article
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EVIDENCE-BASED FAMILY AND COMMUNITY PRACTICE
I. Is it relevant?II. Is it valid?III. What are the results?IV. Is it applicable to my patient?
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JOURNAL REPORT FORMAT
Case ScenarioResearch QuestionSearchTitleSourceAuthorsAppraisal
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CRITICAL APPRAISAL OF AN ARTICLE ON
THERAPEUTICS
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CRITICAL APPRAISAL OF AN ARTICLE ON THERAPEUTICS
I. Is it relevant?Is the objective of the study similar to your
clinical dilemma? population of the study intervention and comparative interventions outcome of the study
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2. Was follow-up complete?
Methodology and Result Section
Look at the number of patients enrolled at the outset and compare this with the number of patients reported in the results table
A drop-out rate of 20% or more is usually declared substantial, if otherwise, check whether an intention to treat analysis was done.
What is the drop-out rate?
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Secondary Guides:
1. Was the study blinded?
What is the definition and importance of blinding?
Look at the methodology and results section.
Single Blinding?
Double Blinding?
Triple Blinding?
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2. Were the outcome measurements clearly described and determined in the same way between interventions?
whether the outcome measures are those which you and your patient are interested in
Surrogate outcome?
Clinical outcomes?
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Overall, is the study valid?
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III. What are the results?
A. How large was the treatment effect? Risk in Control (Rc):
Risk in Treatment (Rt):
No. pxs who did not get well in the control
Total no. of pxs in the control group
No. who did not get well in the txt group
Total no. pxs in the treatment group
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Absolute Risk Reduction (ARR) = Rc - Rt
Relative Risk (RR) = Rt/RcRR of 1 : No difference between Treatment and ControlRR of >1: Treatment is more harmfulRR of <1: Treatment is more effective
Relative Risk Reduction (RRR) = 1 – RR
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B. Are the results reliable?
What is the confidence interval?What is the p-value?
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IV. Are the Results Applicable to My Patient?
Are the medical, social and economic resources needed to administer the treatment available in your setting?
In your perception, were the treatment and its outcome as measured in the article preferred by the patient and his family?
Do you think that the patient, family, and/or community will be willing to accept and pay for the treatment in question?
Number Needed to Treat = 1/ARRCost-Effectiveness Formula: NNT x price/unit x dose x duration
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RESOLUTION OF THE THERAPEUTIC DILEMMA
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CRITICAL APPRAISAL OF AN ARTICLE ON
DIAGNOSTICS
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The Decision Analysis
- Establish Diagnostic and therapeutic thresholdsDiagnostic Threshold (DT): arbitrary point at which you rule out the diseaseTherapeutic Threshold (TT): arbitrary point at which you decide to treat
- Determine other parametersPre-test Probability: probability that the patient has the diseasePost-test Probability: probability that the patient has the disease after doing the diagnostic exam
DT TT.50 1
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30 80.50 1
30 80.50 1
30 50.50 1
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30 50.50 1
Search
Appraise
DETERMINE THE POST-TEST PROBABILITY
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CRITICAL APPRAISAL OF AN ARTICLE ON DIAGNOSTICS
I. Is it relevant?Is the objective of the study similar to your clinical
dilemma? - population of the study - intervention and comparative interventions - outcome of the study
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Primary Validity Guides:
II. Is it valid?
Was there a comparison with a reference standard? Whether the reference standard was done regardless
of the results of the diagnostic test Meaning of reference standard? Precision? Accuracy?
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CRITICAL APPRAISAL OF AN ARTICLE ON DIAGNOSTICS
II. Is it valid?
2. Did the patient sample include an appropriate spectrum of patients on whom the test will be used?
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Representativeness includes subjects with the whole spectrum of the disease.
-Exclusion and Inclusion Criteria
The accuracy of a diagnostic test among patients with low risk for the disease is different from patients with high risk for the disease.
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2. 3. Was the reading or interpretation of the diagnostic test and reference standard done independently?
Presence of blinding
Evaluates the performance of the diagnostic test independently
Avoids bias
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2. 4. Was the diagnostic test and reference standard described in detail to permit replication?
Clear procedures including preparation of subjects
Diet, Drugs to avoid, precautions
Step by step descriptions
Be able to duplicate the test and get the same outcome.
Look at the “results and methodology” section
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III. What are the results?
What are the likelihood ratios for the different testresults?
- Sensitivity and Specificity- Likelihood Ratios- Pre and Post Test Probabilities
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Recall: Sensitivity and Specificity
Present Absent
Positive TP FP
Negative FN TN
Disease
Test
Sensitivity: probability/likelihood that the diseased patient will test positive
Specificity: probability/likelihood that those without the disease will test negative
TP/TP+FN
TN/TN+FP
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Presumptions:
Pre-test probabilities will have a profound effect on the post-test probability
Diagnostic tests provide more information when the diagnosis is truly uncertain than when the diagnosis is either unlikely or truly certain.
- if results of the test could shift the probability of the disease across the treatment threshold
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- Using likelihood ratios
- Using likelihood ratios and a nomogram
Post-test Probability
Estimates make quick assessment of the usefulness of a contemplated diagnostic test.
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Likelihood ratios- Uses sensitivity and specificity values
- utilizes the 2 x 2 contingency table
Probability of result in diseased persons
Probability of result in non-diseased persons
Every test has two likelihood ratios: LR (+) and LR (-)
LR (+) :
Probability that test is + among diseased persons
Probability that test is + among non-diseased persons
Sensitivity
1- Specificity
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LR (-) :
Probability that test is - among diseased persons
Probability that test is - among non-diseased persons
1-Sensitivity
Specificity
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Using likelihood ratios and a nomogram
Establish pre-test probabilities
Calculate the LR
Plot
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30 50.50 1
Search
Appraise
DETERMINE THE POST-TEST PROBABILITY
The Decision Making Line
DT TT
TREAT!!!Don’t start treatment!
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IV. Can the Results Help Me in Caring for My Patient?
1. Will the reproducibility of the test result and the interpretation be satisfactory in my setting?
2. Are the results applicable to my patient?
3. Will the result change my management?
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RESOLUTION OF THE DIAGNOSTIC DILEMMA
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Sources:
http://www.hsl.unc.edu/Services/Tutorials/EBM/welcome.htm EBM ’08 edition UP-PGH DFCM http://www.cebm.net/index.aspx?o=1001 http://www.med.yale.edu/library/nursing/education/
clinquest.html
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THANK YoU!The doctor of the future will give no medicine, but will interest her or his patients in the care of the human frame, in a proper diet, and in the cause and prevention of disease.
Thomas A. EdisonUS inventor (1847 - 1931)