Evidence-Based Medicine Maman

8/10/2019 Evidence-Based Medicine Maman

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Maman Abdurahman

Dept. of Surgery Hasan Sadikin Hospital

Faculty of Medicine Universitas Padjadjaran


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Evidence Based-Medicine is the conscientious, explicitand judicious use of the best current evidence inmaking decisiobs about the care of individual patientsSackett et. al. 2000

Change your thought and you change your worldNorman Vincent Peale


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Five-step Process of EBMAsking answerable clinical questions

Searching for the best evidence

Critically appraising the evidence for its validity andrelevance

Appliying the evidence groups and individuals

Evaluating your own self-education performance.

Sackett, et al. 2000


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The EBM process

Evaluate Your

Performance

Application

Critical appraisal

Literature searching

Question formulation

Information need


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Surgical decision making

Evidence Inference

Experience

OptimalJudgement

ClinicalObservation

BiologicUnderstanding

Patient Preferences & Surgeon Capabilities


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Lowvaluecare

Highvaluecare

1.Investment ofResources

3. Application ofKnowledge

2. SystemsDevelopment

1. ProfessionalDevelopment

4. Patient and PublicInvolvement


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R/EDUCATIONAL PRESCRIPTIONTHE PATIENT PROBLEM

The intervention(therapeutic, diagnosis, prognosis, causal)

Vs. alternative

The Target Outcome/s

(a change in the risk or likelihood of):

The learner:

Presentation will cover:1. HOW you found what you found, i.e. Search

Strategies;2. WHAT you found (the bottom line)3. The VALIDITY and APPLICABILITY of what you

found (the critical appraisal)4. How what you found will ALTER your

MANAGEMENT of such patients5. How WELL you think you DID in filling this Rx


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P

E C

O

GATE: Graphic Appraisal Tool for Epidemiology

T

GATE Frame: PECOT Picture: a frameworkfor thinking about epidemiological evidence

ParticipantsExposure (intervention)Comparison (control)Outcomes

Time


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STEP 1: Translate information needsinto focussed questions: 5-part

PECOT tool

1. Participants (patient/population group)2. Exposure (intervention if about therapy)3. Comparison (there is always an alternative!)

4. Outcome5. Timeframe


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Useful links Centre for Evidence-Based Medicine, Mount Sinai, Toronto:

www.cebm.utoronto.ca

Centre for Health Evidence, University of Alberta:

www.cche.net/che/home/asp Clinical Evidence: www.clinicalevidence.com

The Cochrane library: www.cochrane.org

Oxford Centre for Evidence-Based Medicine:

www.cebm.net/downloads.asp Public Health Resource Unit:

www.phru.nhs.uk/casp/appraisa.htm

PubMed: www.ncbi.nih.gov/entry/query.fcgi
http://www.cebm.utoronto.ca/http://www.cche.net/che/home/asphttp://www.clinicalevidence.com/http://www.cochrane.org/http://www.cebm.net/downloads.asphttp://www.phru.nhs.uk/casp/appraisa.htmhttp://www.ncbi.nih.gov/entry/query.fcgihttp://www.ncbi.nih.gov/entry/query.fcgihttp://www.phru.nhs.uk/casp/appraisa.htmhttp://www.cebm.net/downloads.asphttp://www.cochrane.org/http://www.clinicalevidence.com/http://www.cche.net/che/home/asphttp://www.cebm.utoronto.ca/


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Aware Accepted Applicable Able Acted on Agreed Adhered to

Unsound

Research

SoundResearch

Systems(bottomline +/- ref)

Synopses(user summary of research)

Systematic Reviews and CATs(search; appraise; synthesis)

(1)

(2)

(3)

(4) Quality

Improvement Skills Systems

Evidence-BasedMedicine

Questioning Skills in EBM Evidence Resources Time (substitution)

Patient Choice Decision Aids Education Compliance

aids(5)


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The rapid progress in the medical knowledgelead to several changes in the medical practice

Numerous ineffective & sometimes harmful

therapies have been abandoned and replaced bybetter ones

It was realized that anecdotes, common sense

personal biases, clinical experience can not

justify clinical decision or therapeutic modalities

anymore

Introduction


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Smarter Doctors Are Not the Answer

Trials of interventions to improve physician behaviorhave shown disappointing results

Education leads to modest, transient effects

Computerized and paper patient-specific remindershave shown little or no effect

Financial incentives lead to modest, sustained

improvement Emerging focus: getting patient engaged in care


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EBM - What is it?

Clinical

Expertise

ResearchEvidence

Patient

Preferences


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What is EBM

EBM is the integration of

- best research evidence- clinical expertise- patient value

Bybest research evidence :clinically relevant research : from basic sciences of

medicine, especially from patients centered clinicalresearch - accuracy and precision of D/ test

- power of prognostic marker- efficacy and safety of therapeutic,rehabilitative and preventive regimen

By clinical expertise : the ability to use our clinicalskills and past experienceto rapidly identify

-patient unique health state- diagnosis- individual risks and benefit of potential interventions- their personal values and expectation


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What is EBM ( cont )Bypatients values :

unique preference concerns and

expectations each patients brings to aclinical encounter and which must be

integrated into clinical decisionsto

serve the patients


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Why the Sudden interest in EBM ?

Our daily need for valid information about diagnosis,

prognosis, therapy and prevention ( 5x for in patients &3x for out patients )

Inadequacy of traditional sources for this informationbecause they out of date ( textbooks ) frequently wrong

( experts ), ineffective ( didactic CME ) too much intheir volume and too variable in their validity for

practical clinical use

DisparityD/ skills and clinical judgment

increase with experience,up to date knowledge, clinical performancedecline

No time sufficient for finding and assimilating this

evidence


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5 situation developed to overcome this

problem Development of strategies for efficiently tracking

down and appraising evidence ( the validity andrelevance)

Creation of Systematic Review

Creation of EBM journals, EBM summary servicessuch Clinical Evidence

Creation of information system Identification and information of effective strategies

for lifelong learning and improving our clinicalperformance


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How do we actually - Practice EBM ? Step 1 : converting the need for information

( about prevention, diagnosis, prognosis, therapy, causation,etc) into an answerable question

Step 2: tracking down the best evidence with which to answerthat question

Step 3 : critically appraising that evidence for its validity( closeness to the truth ), impact ( size of the effect ) andapplicability ( usefulness in our clinical practice)

Step 4 : integrating the critical appraisal with our clinicalexpertise and with our patients unique biology, values, and

circumstances Step 5 : evaluating our effectiveness and efficiency in

executing steps 1 to 4 and seeking ways to improve them bothfor next time


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What are the limitation of EBM ? Criticism usually focus on misunderstanding and

misperceptions of EBM

EBM will be hijacked by managers to promote cost

cutting, EBM is not an effective cost cutting toolEBM

care directed toward maximizing patients quality of life

often increase the cost


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Clinical performance can keep up to date:

1 by learning how to practice EBM ourselves.

2 by seeking and applying EBM summaries generated by

others.

3 by applying EBM strategies for changing our clinical

behavior.


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Rules of Evidence

All evidence is not created equal.

Evidence alone never makes clinical decisions.

Values always influence decisions.


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cquirethe

best evidence

ppraise

the evidence

pply

evidence to

patient care

ssess

your patient

skclinical

questions

EBM Method5A


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Summary of EBM Method

cquirethebest evidence

ppraise

the evidence

pply

evidence to

patient care

ssess

patient

sk

clinical

questions

With history and physical, assessed the risk of stroke.

In patients with nonvalvular AF, does warfarin compared to

aspirin or no treatment reduce the risk of stroke?

Easily found answers using UpToDate or Best Evidence

Pre-appraised evidence indicated that high quality, unbiased

studies found that treatment with warfarin results in important

reductions in stroke in patients with nonvalvular AF.Our patient had similar characteristics to the patients studied,

the adverse effects of treatment were minimal, the cost was

reasonable, and the benefits were important. Our patient

agreed that warfarin was the optimal treatment for her.


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TodayNational Guidelines Clearinghouse (AHRQ)

Clinical Trials.gov

Cochrane

ACP Journal Club

Dynamed

InfoRetriever PDxMD


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Does providing EBM care improve patients

outcome ?

No evidence is available


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S.R.

Types of clinical research

General Overview

Diagnostic test

cost-effective

Harm

Therapeutic or

Interventionprognosis


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The measurement methods= Diagnostic

Is it Valid = absence of systematic deviation from thetruth.

Is reliable/reproducible.

Is it standardized?

ReproducibleValid and

ReproducibleValidity


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Sensitivity and Specificity When a test has a very high sensitivity, a negative

result effectively rules out the diagnosis.

When a test has a very high Specificity, a Positiveresult effectively rules in the diagnosis.

However we can be misled by the old sensitivityspecificity approach that restricts us to just twolevels (positive and negative) of the test result.


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Therapeutic Worksheet

Can We Apply it to our Pts?

Will the results help me in caring for my patients?

Can the results be applied to my patients?

Rx/intervention AVAILABLE in our setting.

Were all clinically relevant outcomes considered?

Are the benefits worth the harm and cost?


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Tools Used in Rx Worksheet

Relative Risk (RR)

ARRRRRRR

150-100

=50 Kg

150-100/150

=33 %

100%/150%

=66%

Patient was 150 kg weight

He lost 50 Kg form his weight.

If we say that 1 kg = 1 risk


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Control event rate (CER) = 10 / 100 =10%

Experimental event rate (EER) = 3 / 100 =3%

RR = EER/CER =3% / 10% =33 %

RRR = CER

EER / CER =10% - 3% / 10% = 70 %ARR = CER EER = 10% - 3% = 7 %

NNT = 1/ARR =1 / 7 x100 =14

Hypertension

No

Stroke

Stroke

973Rx +

9010Rx -

Tools Used in Rx WorksheetRelative Risk (RR)


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Tools Used in Rx Worksheet

Confidence Interval

Is the result of the study true for the whole population?

It specifies how far above or below a sample-based valuethepopulation value lies.

The smaller the size of the study = the wider confidenceinterval.


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How to find the

Best Available Evidence

1. Burn your (traditional) textbooks !!!

2. Invest in evidence data bases

3. Trade in evidence-based journals and online services

3. Look into computerized clinical decision support systems

4. Get trained about search strategies


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EBM Databases

Systematic Literature Searches

Cochrane Library (OVID)

Clinical Evidence

Systematic Literature Surveillance

ACP Journal Club (OVID)

DynaMed *

Medical InfoRetrieverEBM Search Engine

TRIP Database


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Common EBM Misperceptions

You must be well versed in statistics to practice EBM

EBM ignores patients values and preferences

be conducted only from ivory towers

is a "cook-book" medicine is a cost-cutting medicine

restricted to RCT and meta-analyses


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EBM Misconceptions

FALLACY FACT

EBM is useless when there

is no good evidence

EBM means appropriately

using the best availableevidence to care for patients

EBM is algorithms that

ignore clinicaljudgment/expertise

Clinical judgment must be used

in deciding how to apply theevidence

EBM is just numbers and

statistics

EBM is not numbers in a

vacuumthe evidence must be

individualized to each patient

Old world EBM world


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Old world EBM world

Source of knowledge Expert opinion analysis of the evidence

Essential skills Clinical Clinical plus ability to appraise

evidence

Essential information sources Experts

Textbooks

Selected

journals

Electronic access to all research

evidence

Cochrane Library

Importance of statisticians,epidemiologist, economists, etc

Low High

Importance of gathering new

evidence on patients

Low High

Consultant to Juniors Dictatorship Democratic

Importance of keeping up to date Optional Essential

Importance of access to research

evidence

Low High

Relationship to patients Expert to pupil Potentially much more equal


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The Evidence Base for theTreatment of Breast Cancer - The

Cochrane Network

Mark Lodge,

Cochrane Cancer Network,

Wolfson College,University of Oxford, Oxford UK

[email protected]

Annual Meeting 2005

Vannevar Bush
mailto:[email protected]:[email protected]


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Vannevar Bush

US Director, Office of

Scientific R & D. 1945

A record if it is to be useful to Science, must be

continuously extended, it must be stored, and above

all it must be consulted.

Bush V As We May Think Atlantic MonthlyJuly 1945

Archie Cochrane


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Archie Cochrane

UK epidemiologist, 1979

"It is surely a great criticism of our profession that we

have not organised a critical summary, by specialty or

subspecialty, adapted periodically, of all relevantrandomised controlled trials." Cochrane AL. 1931-1971: a critical review, with particular reference to the medical profession. In:

Medicines for the year 2000. London: Office of Health Economics, 1979, 1-11.

The Evidence Base


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for the Treatment of

Breast Cancer

Who prepared the evidence?

Is the evidence from a reliable source?

What level of evidence is it?

What does it say?

Is the evidence relevant?

Who prepared the


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Who prepared the

evidence?

The Cochrane Collaboration is aninternational not-for-profit organization thataims to help people make well-informed

decisions about health care by preparing,maintaining, and promoting theaccessibility of systematic reviews of theeffects of healthcare interventions.

Definition:


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Definition:

Systematic Review

A review of a clearly formulated question that usessystematic and explicit methods to identify, select,and critically appraise relevant research, and tocollect and analyse data from the studies that are

included in the review. Statistical methods (meta-analysis) may or may not

be used to analyse and summarise the results of theincluded studies.

(Source: Cochrane Reviewers' Handbook 2005)

The Cochrane


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The Cochrane

Collaboration

90 independently financed bases worldwide 11,000 + contributors 50 Cochrane Review Groups (CRGs) Multi-national, multi-disciplinary editorial

teams Developing country involvement

encouraged

Cochrane Breast Cancer Review Group(Sydney, Australia)

What use can be


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made of systematic

reviews?

Categories

There is evidence of effectiveness

Insufficient or no evidence of effectiveness (Moreresearch?)

Evidence of no effectiveness

Harmful to patients

What use can be


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made of systematic

reviews?

Clinical practice

determine the effects & effectiveness of health

care interventions

Used by individual clinicians

very useful to guideline developers.

What use can be


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made systematic

reviews? Clinical research

Establish baseline of knowledge

Identify gaps in research

Prevent wasteful duplication of effort

Identify adverse effects of interventions

Identify methodological difficulties

Protect patients from unnecessary orinappropriate research

Is the evidence


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Is the evidence

from a reliable

source? Cochrane systematic reviews designed tominimise bias

Transparent methodology

Explicit inclusion/exclusion criteria Extensive literature searches

Peer reviewed protocols and reviews

Published protocols on Cochrane Library

What level of


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What level of

evidence is it?

Breast cancer treatment: 14 systematic

reviews

Primarily based on evidence from randomized

controlled trials (RCTs)

4,898 reports of RCTs in breast cancer (SR-

BREASTCA)in CENTRAL database on The

Cochrane Library

Evidence of


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Evidence of

effectiveness

Polychemotherapy can reduce the number of deathsfrom breast cancer, as well as recurrences, especiallyin women under 50 Early Breast Cancer Trialists' Collaborative Group. Multi-agent chemotherapy for early breast cancer.

The Cochrane Database of Systematic Reviews 2001, Issue 4

Hormone therapy and chemotherapy improvesurvival of women with metastatic breast cancer, buthormone therapy may have fewer side-effects Wilcken N, Hornbuckle J, Ghersi D. Chemotherapy alone versus endocrine therapy alone for

metastatic breast cancer. The Cochrane Database of Systematic Reviews 2003, Issue 2.

Evidence of


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Evidence of

effectiveness

Tamoxifen can increase 10-year survival rates for

women with ER-positive breast cancers Early Breast Cancer Trialists' Collaborative Group. Tamoxifen for early breast cancer. The

Cochrane Database of Systematic Reviews 2001, Issue 1.

Decision making in breast cancer: Making the

best of the evidence

25 October 2005 Melbourne Australia

Insufficient or no


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evidence of

effectiveness Chemotherapy including taxane could improve survival and

disease progression in women with advanced breast cancer,but more research is needed on which regimens help most.

Ghersi D, Wilcken N, Simes J, Donoghue E. Taxane containing regimens for metastatic breast cancer. The Cochrane Database of SystematicReviews 2005, Issue 2.

There is insufficient evidence to support the routine use ofhigh dose chemotherapy with autograft for women with earlypoor prognosis breast cancer.

Farquhar C, Marjoribanks J, Basser R, Lethaby A. High dose chemotherapy and autologous bone marrow or stem cell transplantation versusconventional chemotherapy for women with early poor prognosis breast cancer. The Cochrane Database of Systematic Reviews 2005, Issue 3

There is currently insufficient evidence to show that womenwith metastatic breast cancer live longer if they undergo highdose chemotherapy with bone marrow or peripheral stem cell

transplantation Farquhar C, Marjoribanks J, Basser R, Hetrick S, Lethaby A. High dose chemotherapy and autologous bone marrow or

stem cell transplantation versus conventional chemotherapy for women with metastatic breast cancer.

Insufficient or no


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evidence of

effectiveness There is insufficient evidence to determine the relative

efficacy of non-anthracycline anti-tumour antibiotic regimenscompared to non-antitumour antibiotics.

Lord S, Ghersi D, Gattellari M, Wortley S, Wilcken N, Simes J. Antitumour antibiotic containing regimens for metastatic breast cancer. TheCochrane Database of Systematic Reviews 2004, Issue 4.

Systemic therapy for treating locoregional recurrence inwomen with breast cancer insufficient evidence to do other

than conclude that the most appropriate form of practicemight be participation in RCTs of systemic treatment versusobservation.

Rauschecker H, Clarke M, Gatzemeier W, Recht A. Systemic therapy for treating locoregional recurrence in womenwith breast cancer. The Cochrane Database of Systematic Reviews2001, Issue 4

Evidence of no


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Evidence of no

effectiveness

Regimens that contain antitumour antibiotics do notoffer any additional benefit in overall survival overregimens that do not contain these agents in thefirst-line management of metastatic breast cancer.

Lord S, Ghersi D, Gattellari M, Wortley S, Wilcken N, Simes J. Antitumour antibiotic containing regimens for metastatic breastcancer. The Cochrane Database of Systematic Reviews 2004, Issue 4.

No strong evidence has been found that supportgroups can increase survival from advanced breastcancer, or that this and other psychological

interventions can improve psychological wellbeing Edwards AGK, Hailey S, Maxwell M. Psychological interventions for women with metastatic breast cancer. The

Cochrane Database of Systematic Reviews 2004, Issue 2.

Forthcoming


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Forthcoming

Cochrane reviews

Pre-operative care Sequencing

Chemotherapy for locally advanced breast cancer

Single agent chemotherapy for advanced breast cancer

Multi-agent chemotherapy for advanced breast cancer (3) Endocrine therapy (2)

Radiotherapy (2)

Surgery (2)

Control of treatment side effects (2)

Is the evidence


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Is the evidence

relevant?

Relevance to current treatment options

Appropriate to Developing Country setting?

Reflect the priorities?

Reflect the realities?

Wh i th id


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Where is the evidencecoming from?

Review Authors AUSTRALIA: 14

DENMARK:3

GERMANY: 2

ITALY: 11

NEW ZEALAND: 6

SPAIN 5

UK: 9

USA: 5

Protocol Authors AUSTRALIA: 18

CANADA 9

CHILE: 7

CHINA: 14

GERMANY: 3

ITALY2

NEW ZEALAND: 6

NETHERLANDS: 3

SINGAPORE: 3

SPAIN: 6 SWITZERLAND1

UK: 15

USA: 13

Cochrane Developing


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Cochrane Developing

Countries Initiative

Human Reproduction Library (WHO)

Evidence Aid

South Asia Cochrane Network

Base: Christian Medical College, Vellore TN, India

Cancer hub: Tata Memorial Hospital, Mumbai,

India

Cochrane Developing


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Cochrane Developing

Countries Initiative

Cochrane Branch Centre in Bahrain Cancer meeting in 2006?

Cochrane bases: Argentina, Brazil, Chile, Colombia, CostaRica, Cuba, Ecuador, Mexico, Peru, Venezuela, China ,

Russia, South Africa, Thailand,

Cochrane/INCTR


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Cochrane/INCTR

collboration

Draw up a short list of three questionsrelevant to the effectiveness of health careinterventions in breast cancer

Send shortlists to [email protected] Referred to Cochrane Breast cancer Group

Invitation to prepare & maintain a Cochrane

systematic review

Contributing to the
mailto:[email protected]:[email protected]


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evidence-base in cancer

research & treatment

The Cochrane Library

http://www.cochrane.org

The Cochrane Cancer Network

[email protected]

Cochrane Breast Cancer Review Group

http://www.ctc.usyd.edu.au/cochrane

Breast Cancer Forum (25 Oct. 2005) http://www.ctc.usyd.edu.au/cochrane/index.html
http://www.cochrane/mailto:[email protected]://www.ctc.usyd.edu.au/cochranehttp://www.ctc.usyd.edu.au/cochrane/index.htmlhttp://www.ctc.usyd.edu.au/cochrane/index.htmlhttp://www.ctc.usyd.edu.au/cochranemailto:[email protected]://www.cochrane/

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Evidence-Based Medicine Maman