Use of EBM in Developing CPG (1)

7/27/2019 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

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Use of EBM in Developing CPG (1)

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