use of ebm in developing cpg (1)
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Use of EBM in Developing
Clinical Practice GuidelinesKuntjoro HarimurtiDepartment of Internal Medicine
Center for Clinical Epidemiology and Evidence-Based MedicineFaculty of Medicine UI / Cipto Mangunkusumo Hospital
Jakarta
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What is EBM?
Evidence-based medicine is the conscientious,
explicit, and judicious use of current best
evidence in making decisions about the care ofindividual patients.
- David Sackett -
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Patient withproblem
Search theevidence
Criticallyappraise
the evidence
Formulatein answerable
questionApply
the evidence
The EBM Paradigm
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Elements of EBM
- identify relevant best evidence
Define clinical question to be answered
(for a specific clinical situation)
Find best scientific evidence relevant to the specificclinical question (using systematic methods)
Rely on best evidence to guide clinical decision-
making
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Elements of EBM
- identify relevant best evidence
Original evidence
clinical epidemiology (e.g. clinical trials)
descriptive epidemiology outcomes research / economic studies
Literature synthesis / analysis
systematic literature reviews / meta-analyses
clinical practice guidelines
cost-effectiveness studies
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Elements of EBM
- focus on clinical outcomes
Clinical outcomes (things that matter to patients
and families)
survival impairment / disability / disfigurement
symptom severity
quality of life (QOL) cost / convenience
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Elements of EBM
- use standard measures of effect
Evaluate therapies using standard measures:How does it affect rate, degree or timing of:
Physical impairment, disfigurement or death
Return to normal functioning Symptom resolution
Potential harms (from therapy)
Total costs (for patient, employer and society)
Allows comparisons of benefits and harms ofdifferent clinical methods
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Elements of EBM
- assess likely benefits / harms
Evaluate clinical methods on benefits / harms
Beneficial
Likely to be beneficial
Trade off between benefits and harms
Unknown effectiveness
Unlikely to be beneficial
Likely to be ineffective or harmful
Promotes informed decision-making by clinicians andpatients
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Elements of EBM
- base decisions on best evidence
Find best scientific evidence that is
applicable to the specific clinical situation
individual patients clinical situation
program or policy decision
Use evidence to guide decision-making
does the likelihood of benefit outweigh likelihood of harm
enough to justify the cost?
same question applies to individual and society
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What are
clinical practice guidelines?
Clinical practice guidelines are recommendations for
clinicians and consumers about optimal and
appropriate care for specific clinical situations
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Formal or informal guidelines are the basis for
all clinical practice
Basis for most clinical decisions
Foundation of clinical teaching Mental short-cuts and memory aids for
common or complex problems
Primary method to evaluate care patternsand monitor standards of care
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Types of guideline development approaches
Single author - expert opinion
Single author - systematic literature review
Consensus panel using expert opinion only
Consensus panel using evidenced-based approach
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Steps in developing
guideline recommendations
define clinical questions of interest
develop summary of evidence on:
clinical efficacy (potential benefits)
potential harms / projected costs
weigh likelihood of benefit versus
likelihood of harms, and consider costs
develop finding / recommendation statements document all aspects of the process
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Evidence-based guidelines
- need to explicitly document
methodology and assumptions
evidence reviewed
summary of findings
decision-making rules for recommendations
rationale for each conclusion and recommendation
statement
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Types of guideline statements
Based on AHCPR guidelines, the types of guideline
statements are:
Recommendation for use
Option for use
Recommendation against use
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Strength of evidence ratings for guideline
recommendations
A = Strong research based evidence
multiple relevant, high quality studies
B = Moderate research based evidence
one relevant, high quality study
C = Limited research based evidence
one adequate study, somewhat relevant
D = Panel opinion
based on information not meeting criteria for A-C
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1. Formulate clinical problems in answerablequestions
2. Searchthebestevidence: use internet or other
on-line database for current evidence
3. Critically appraise the evidence for Validity (was the study valid?)
Importance (were the results clinicallyimportant?) Applicability (could we apply to our
patient?)
4. Apply the evidence to patient5. Evaluate our erformance
Steps in EBM practice
VIA
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Diagnosis
(Determination of disease or problem)
Treatment
(Intervention necessary to help the patient)
Prognosis(Prediction of the outcome of the disease)
Main area
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Meta-analysis
Clinical guidelinesEconomic analysis
Clinical decision making
Cost-effectiveness analysisQualitative research
Others:
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(I)
Formulating clinical questions
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Four elements of
good clinical question: PICO
The Patient or Problem
The Intervention
Comparative intervention (if relevant)
The Outcome
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Four elements of a well constructed clinical
question: PICO
P I C O
The mainintervention
considered
Thealternative
to compare
with the
intervention
Outcomeexpected
from this
intervention?
Description
of patient
or problem
B e b r i e f a n d s p e c i f i c
http://www.epi.bris.ac.uk/undergrad/compcrit.htmmailto:[email protected] -
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Relevance: Type of Evidence
POE: Patient-oriented evidence
mortality, morbidity, quality of life DOE: Disease-oriented evidence
pathophysiology, pharmacology, etiology
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IISearchingthe evidence
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Online Medical Information Resource
18:24 EBM Searching
Resource Internet address Annual
Cost
Google
Scholar
http://scholar.google.com.br/ Free
Medline-
Pubmed
www.ncbi.nlm.nih.gov/PUBMED Free
emedicine www.emedicine.com Free
Medscape www.medscape.com FreeMedical
Matrix
www.medmatrix.org/index.asp Free
Clinical
practice
guidelines
www.guidelines.gov Free
www.cma.caa/cpgs Free
MD
consult
www.mdconsult.com $200
UpToDate www.Uptodate.com $495
Best
Evidence
www.acponline.org/catalog/electronic/best_evidence.htm $85
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Step Searching in PubMed
1. Formulate a focused PICO question.
2. Define keywords.
3. Identify the type of article that is most likely to answer yourquestion: therapy, diagnosis, harm, etc.
4. Identify the design that is most likely to answer yourquestion: RCT, cohort, cross sectional, case control, etc.
5. Always try to find systematic reviews.
6. Use MeSH or Thesaurus or text words for searching
7. Combine concepts with Boolean operators (AND/OR/NOT).
8. Limiting to age, sex, language, year of publication, etc.
9. Evaluate search results.
10. Use "Related Articles" link option.
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Types of study
Question Best study design
Intervention Randomised controlled trial (RCT)
Etiology and risk factor RCT
Cohort studyCase-control study
Frequency and rate Cohort study
Cross-sectional study
Diagnosis Cross-sectional study with random or
consecutive sample
Prognosis and prediction Cohort/survival study
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Boolean operators
AND
OR
NOT
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Strategy of using Boolean operators:
first increase sensitivity, then specificity
1. One keyword concerning the patient
2. Another keyword concerning the patient
3. #1 OR #24. One keyword concerning the intervention
5. Another keyword concerning the intervention
6. #4 OR #5
7. One keyword concerning the outcome8. Another keyword concerning the outcome
9. #7 OR #8
10. #3 AND #6 AND #9
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Answerable question - PICO
Patient or
Problem
Intervention Comparison
Intervention
Outcome
Description of the
patient or the targetdisorder of interest
questions
Could include:
ExposureDiagnostic test
Prognostic factor
Therapy
Patient perception
etc.
Relevant most often
when looking attherapy
Clinical outcome of
interest to you andyour patient
Centre for Evidence-Based Medicine; http://www.cebm.utoronto.ca
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Effective searchinguse PI(C)O!
Patients Intervention Outcome
Elderly ACE-inhibitors Death
Older people ACE-i Stroke
Geriatric Angiotensin-
convertingenzymes
Myocardial infarction
Senior
OR
OR
OR
AND AND
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Clinical problem
Define important,
searchable question
Select most
likely resource
Design search
strategy
Summarized
the evidence
Apply
the evidence
Design search
strategy
Summarized
the evidence
Select second most
likely resource
Poor
yield
General
searchstrategy
http://d/aRtData/EBM/Ebm-internet%20search/search-strategy.htmhttp://d/aRtData/EBM/Ebm-internet%20search/search-strategy.htmhttp://d/aRtData/EBM/Ebm-internet%20search/search-strategy.htmhttp://d/aRtData/EBM/Ebm-internet%20search/search-strategy.htmhttp://d/aRtData/EBM/Ebm-internet%20search/search-strategy.htmhttp://d/aRtData/EBM/Ebm-internet%20search/search-strategy.htm -
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IIIAppraisingtheevidence:VIA
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Validity: In Methods section: design, sample, sample size, eligibility criteria
(inclusion, exclusion), sampling method,randomization method, intervention,
measurements, methods of analysis, etcImportance: In Results section
characteristics of subjects, drop out, analysis,p value, confidence intervals, etc
Applicability: In Discussionsection + our patientscharacteristics, local setting
V I A
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Were the subjects randomized?
Were all subjects received similar treatment?
Were all relevant outcomes considered? Were all subjects randomized included in the
analysis?
Calculate CER, EER, RRR, ARR, and NNT
Were study subjects similar to our patients interms of prognostic factors?
Example:
Critical appraisal for therapy
l d
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Translating evidence into
a clinical practice guideline
Using and gathering opinion Will be used to interpret evidence and to derive
recommendation in the absence of evidence
To assess issue such as generalisability of evidence
Resource implications and feasibility Different view of implication among clinician and
healthcare providers
Feasibility issues: time, skills, staffs, equipment
Grading recommendation Provide user a confidence that following guideline will
produce the desired health outcome
Strength of recommendation classification: range fromsimple to complex
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Suggestions in developing guidelines
Making the goals of each guideline explicitforexample, effectiveness, cost effectiveness, equity
Providing information on the reasons fordisagreements within a guideline development
groupsuch as, differences in interpretation ofthe research literature, differences in personalexperience, different perceptions of or responsesto costs
Publishing information on the closeness ofagreement about a recommendation as well asthe strength of support for a recommendation.
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Updating clinical guideline
Situations might require clinical guidelines to
be updated:
Changes in evidence on the existing benefits and
harms of interventions
Changes in outcomes considered important
Changes in available interventions
Changes in values placed on outcomes Changes in resources available for health care
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Thank you