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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/8/10/2019 Evidence-Based Medicine Maman
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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
Annual Meeting 2005
Vannevar Bush
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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
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evidence-base in cancer
research & treatment
The Cochrane Library
http://www.cochrane.org
The Cochrane Cancer Network
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/