saudi center eb
TRANSCRIPT
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Dr Yaser Adi MD, MPH, MSc HTA
Scientific Advisor for the Saudi Centrefor Evidence Based Health Care (EBHC)
Madeenah 31st
Mar 2015
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Aim
To introduce you to the
EBM/EBHC concept and & its applications
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Objectives
• How to be successful in you career
• Explain the components of EBM
•Benefits of EBM• Hierarchy of evidence
• An example to illustrate the EBHC use
•Clinical practice guidelines
•Mobile App at EBHC
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Two words that describe two things...
What are they?
To be successful in your job
you do need …
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Competence
Is the ability to perform a specific
task successfully.
Incompetence is the (opposite)
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Confidence
A belief in yourself that you
can do this job and do it well
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Competence & Confidence
DESPERATELYDELUDED
YOU’RE
DESTINED
FOR SUCCESS
YOU NEEDHELP!
YOU’RE NOT
ACHIEVINGYOUR
POTENTIAL
High
LowHigh
C o n f i d e n c e
Competence
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EBM/EBHC
What is Evidence Based Medicine?
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Evidence: A thing or things helpful in forming a conclusion or judgment
Medicine:The art and science of the diagnosis, treatment, and
prevention of disease and the maintenance of goodhealth
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EBM/EBHC
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Non evidence based medicine
Any examples that you may think of?
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Babies to sleep on … their tummies?
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Rosiglitazone 1999-2010
In Europe, the European Medicines Agency
(EMA) recommended in September 2010 that
the drug be suspended from the Europeanmarket because the benefits of rosiglitazone no
longer outweighed the risks.
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HRT
In observational studies show positive
effect on heart for postmenopausal ladies
Later on, after a large RCT, it was proved
the opposite!
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Benefits of EBHC
• Daily need for up-to-date reliable information
• Inadequacy of traditional sources of
information
•Develop skills for life long learning
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Benefits of EBHC
•Patient satisfaction
• Clinician’s fulfillment
• Healthier nation
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Benefit of EBHC
• Textbooks - out of date
• Experts - frequently wrong• Didactic CME - ineffective
•
Medical journals –
Overwhelming in volume
Variable in validity
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EBHC is then simple
But…
how do we do it ?
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EBHC is simple! The 5 “A”s
1. Asking an
answerable question
P
I/E
C
O
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1. Asking an answerable question
Population (P)
Intervention /exposure (I)
Comparator (C)
Outcome (O)Using the paper that you have, what is
the question you want to answer?
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1. Asking an answerable question
In people aged 66 years or older,
who are receiving ACE inhibitors,would exposure to co-trimoxazolcompared with other antibiotics
cause sudden death?
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EBHC is simple! The 5 “A”s
1. Asking
answerable question
P
I/E
C
O
2. Accessing
the best evidence
Secondary source
Primary source
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Sources of medical info.2. Searching for evidence
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Sources of information
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2. Searching for evidence in pubmed
Search Item Identified
inhibitors of renin-angiotensin 8894
inhibitors of renin angiotensin 11349
Cotrimoxazole 8178
Co-trimozazole 8008
Sudden death 47621
((inhibitors of renin angiotensin) OR (inhibitors of renin-
angiotensin)) AND (Cotrimoxazole OR Co-trimozazole)
AND (Sudden death)
1
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Tips for searching
http://www.google.co.uk/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://www.atmarkit.co.jp/ait/articles/1201/13/news140.html&ei=zz8YVYrxGcPtUq-rgdAD&bvm=bv.89381419,d.d24&psig=AFQjCNF4U92lwk70BuJqAzIMXqQBlVQDPA&ust=1427738909154962
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Results in Pubmed
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EBHC is simple! The 5 “A”s
1. Asking
answerable question
P
I
C
O
2. Accessing
the best evidence
Secondary source
Primary source
3. Appraising
the evidence
Valid?
Important?
Can it help?
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http://www.casp-uk.net/#!casp-tools-checklists/c18f8
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3. Appraising the evidence
Please have a look at the paper
& the CASP questions
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1. Asking
answerable question
P
I
C
O
2. Accessing
the best evidence
Secondary source
Primary source
3. Appraising
the evidence
Valid?
Important?
Can it help?
4. Applying the evidence How much will it help?Patient’s value
Cost-effective
EBHC is simple! The 5 “A”s
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1. Asking
answerable question
P
I
C
O
2. Accessing
the best evidence
Secondary source
Primary source
3. Appraising
the evidence
Valid?
Important?
Can it help?
4. Applying the evidence How much will it help?Patient’s value
Cost-effective
5. Assessing the
performance
How could you do it better
next time
EBHC is simple! The 5 “A”s
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Cli i l ti & t d d i t
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Clinical questions &study design to
answer them
You accompany a relative to the clinic
suspected to have DM.
List at least three questions that your relativethink important to inquire about
Q.1
Q.2
Q.3
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Typology for question building
Type of question Meaning Study design
Aetiology/Harm The causes of a disease Case – control or
Cohort study
Diagnosis Signs , symptoms or tests for
diagnosing a disorder. Comparison togoal standard
Diagnostic validation
study
Prognosis The probable course of disease over
time
Inception cohort
Therapy/Prevention Effective treatments which meet your
patient's values
Systematic review,
Randomized controltrial
Cost-effectiveness Is one intervention more cost-effective
than others?
Economic evaluation
Quality of life What will be the quality of life of the
patient?
Qualitative study
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Hierarchy of Evidence
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A question about effectiveness
Where do you look for information first?
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Cochrane Library
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CRD
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What is a Systematic Review?
• More than one study addressing a particular
health question. It is logical to collect all these
studies together and base conclusions on the
cumulated results.• The most obvious sign that a review is
systematic will be the presence of a methods
section. Meta-analysis is the statistical processof combining the results from several studies
that is often part of a systematic review.
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What is a Randomised Controlled
Trial (RCT)?
• An RCT is a type of interventional or experimentalstudy design. Participants (individuals or groups)are randomly allocated to receive either the newintervention or a control treatment (usually thestandard treatment or a placebo).
• Each arm of the study is then followed up and theamount or severity of the disease measured in
the intervention group and compared with thecontrol group.
• RCTs are by definition prospective.
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What is a Cohort study?
• Cohort study, also known as a follow-up or longitudinalstudy, is another observational study design. In thisstudy a population who do not have the healthoutcome or disease of interest
• Are first divided into those who are exposed to a riskfactor, often over long periods of time.
• At the end of the period of observation the incidenceof disease or frequency of health outcome in the
exposed group is compared to that in the unexposedgroup. The study is generally prospective as it looksforward from potential cause to consequence.
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What is a Case-Control study?
• A case-control study belongs to the observationalgroup of studies. It begins by choosing individuals whohave a health outcome or disease whose cause youwant to investigate. These are the cases.
•
Controls without the health outcome are then chosen.• You then determine the proportion of cases who were
exposed to any risk factor of interest in the past, andcompare this with the proportion exposed in thecontrol group.
• The study is generally retrospective because it looksbackwards in time to the earlier exposures ofindividuals.
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https://www.google.com.sa/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=https://123library.org/ebook/isbn/9781405172363/&ei=IEgSVer8Lsz8UM-QgEA&psig=AFQjCNEXAYz25WNF9ilDebNC1j_BJRxtCQ&ust=1427347810627389https://www.google.com.sa/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=https://123library.org/ebook/isbn/9781405172363/&ei=IEgSVer8Lsz8UM-QgEA&psig=AFQjCNEXAYz25WNF9ilDebNC1j_BJRxtCQ&ust=1427347810627389
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A simple & easy to read EBM book!
https://www.google.com.sa/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=https://123library.org/ebook/isbn/9781405172363/&ei=IEgSVer8Lsz8UM-QgEA&psig=AFQjCNEXAYz25WNF9ilDebNC1j_BJRxtCQ&ust=1427347810627389https://www.google.com.sa/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=https://123library.org/ebook/isbn/9781405172363/&ei=IEgSVer8Lsz8UM-QgEA&psig=AFQjCNEXAYz25WNF9ilDebNC1j_BJRxtCQ&ust=1427347810627389https://www.google.com.sa/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=https://123library.org/ebook/isbn/9781405172363/&ei=IEgSVer8Lsz8UM-QgEA&psig=AFQjCNEXAYz25WNF9ilDebNC1j_BJRxtCQ&ust=1427347810627389
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Clinical Practice
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Clinical Practice
Guideline (CPG)
What is a Clinical Practice
Guideline (CPG) ?
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How many CPGs are there?
GIN Library contains 6476
(by 29 March 2015) guidelines registered
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What should be thestandard number
“ONE”that makes a CPG trustworthy?
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The eight standards from the IOM
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1. Establishing transparency
The processes by which a
CPG is developed and funded
should be detailed explicitly
and publicly accessible.
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Vague recommendations e.g.
Patient with such (x) condition shouldbe offered the intervention (y) if
clinically appropriate.
Clinicians should follow up with
patients given the intervention every 4
weeks, or sooner if necessary .
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2. Conflict of interest (COI) -Definition
• Any clash between the member's self-interest (personal gain or to their family)
&
• CPG recommendations
3 Guideline development group
http://www.businessdictionary.com/definition/self-interest.htmlhttp://www.businessdictionary.com/definition/self-interest.htmlhttp://www.businessdictionary.com/definition/self-interest.htmlhttp://www.businessdictionary.com/definition/self-interest.htmlhttp://www.businessdictionary.com/definition/self-interest.htmlhttp://www.businessdictionary.com/definition/self-interest.htmlhttp://www.businessdictionary.com/definition/person.html
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3.Guideline development group
composition (GDG)
•A multidisciplinary team
•Patient /carer/representative
Why it is important?
The Hypertension Clinical Guideline
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The Hypertension Clinical Guideline
CG127, Aug 2011
4 Clinical practice guideline–
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4. Clinical practice guideline
systematic review (SR) intersection
The new definition by the IOM of CPG:
“CPGs are statements that include
recommendations intended to optimizedpatient care that are informed by a systematic
review of evidence and an assessment of
benefits and harms of alternative options”
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An interactive slide from IOM
5. Establishing (QoE) and rating
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5. Establishing (QoE) and rating
strength of recommendations
Each recommendation should provide:
• A clear description of potential benefits or/harms.
• Supporting evidence /or lack of it
• Strength of recommendation
How is the (QoE) evidence
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How is the (QoE) evidence
categorized in ?++++ High We are very confident that the true effect is close
to that of the estimate of the effect.
+++ Moderate We are moderately confident in the effect
estimate: The true effect is likely to be close to the
estimate of the effect, but there is a possibility thatit is substantially different.
++ Low Our confidence in the effect estimate is limited:
The true effect may be substantially different from
the estimate of the effect.
+ Very low We have very little confidence in the effect
estimate: The true effect is likely to be
substantially different from the estimate of effect.
Strength of recommendation in
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Strength of recommendation in
“GRADE”
What is meant by the
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What is meant by the
"strength of recommendation"?
Recommendations to administer, or not administer,an intervention, should be based on the tradeoffs
between benefits on the one hand, and risks, burden
and, potentially, costs on the other.
If benefits outweigh risks and burden, experts will
recommend that clinicians offer a treatment to typical
patients.
’ d i if
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GRADE’s strong recommendation if...
• Strong methods
• Large & precise effect
•
Few down sides of therapy
k d i if
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A weak recommendation if ...
• Benefits and risks and burdens are finelybalanced,
• Weak methods
• Small effect
•Imprecise estimate
• Substantial down sides
6 A i l i f d i
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6. Articulation of recommendations
•Under what circumstances•A patient should be given theintervention
• QoE
•The strength of recommendation
should be stated in proximity to eachrecommendation.
e g 2 from the ACP:
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e.g. 2 from the ACP: Ann Intern Med. 2011;155:625-632
ACP recommends:Pharmacologic prophylaxis with heparin or a
related drug for venous thromboembolism in
medical (including stroke) patients unless theassessed risk for bleeding outweighs the likely
benefits.
( Moderate-quality evidence , Strong recommendation ).
Factors panels should consider in deciding
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Factors panels should consider in deciding
on a strong /weak recommendations
1. Magnitude of treatment effect (large effect?)
2. Precision of estimate of treatment Effect (95% CI)
3. Method design & [ Bias , confounding, chance]
4. Burden of Therapy
5. Risks associated with therapy
6. Costs
7. Patient’s values
• Study limitations
• Inconsistency of results
• Indirectness of evidence
• Imprecision
• Reporting bias
The State of Art: QoE, Recommendation
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The State of Art: QoE, Recommendation
& Interpretation
QoE Recommendation InterpretationHigh Strong Apply to most patients without
reservation. (RCTs/SRs)High Weak Most patients would want, some would
not, depends on individual’s
circumstances, (RCT, or overwhelming
observational) e.g.Low Strong
Apply but may change if new evidencebecomes available (Observational)
e.g. from the past {HRT}
Low Weak Decision can NOT be made
7 E t l i
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7. External review
•Full spectrum or stakeholders
•
Addressing Responses•Should be made available to thegeneral public for comment before
publication
8 U d ti
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8. Updating
• Proposing a date for updating
• Monitoring the literature
• Modification in response to new evidence
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F b
2012
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Feb 2012
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T f CPG
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Types of CPGs
• DE novo
• Adapted
• Adopted
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A new approach to CPG adaptation in
Saudi Arabia:
Adaptation of practice guidelines to a
country-specific context using the
GRADE/DECIDE evidence to decision
framework
P j M h d l
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DevelopmentAdaptation
“Adolopmen”t
Adaptation Development
AdoptionAdoption
Project Methodology
G id li ‘Ad l t’
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Guideline ‘Ad-o-lopment’
• Ad-o-lopment = Adaptation + Adoption +Development
• Approach to the development of guidelines thatbegins with identifying existing evidence syntheses,including systematic reviews, HTAs, and evidencereports, which may have been produced to supportprevious guidelines and address specific clinical
questions.• Followed by the updating of the evidence syntheses
and development of guideline recommendationsspecific to the healthcare setting.
E id S th i
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Evidence Synthesis
• Panels prioritized questions to be included inguidelines (online surveys)
• McMaster guideline leaders updated literature
searches• Conducted literature searches specific to the
Saudi healthcare setting: patients’ values and
preferences, cost-effectiveness & economic data• Produced evidence summaries: GRADE Evidence
Profiles and Summary of Findings Tables
F l ti R d ti
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Formulating Recommendations
• Online training modules for panels and 1-dayworkshop on guideline development
• In-person panel meetings, facilitated by
McMaster guideline leaders
• Recommendations formulated using the
Evidence-to-Decision (EtD) framework
E id t D i i F k
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Evidence-to-Decision Framework
• Factors that bear on recommendations andtheir strength
• Enables formulation of recommendations
tailored to the specific healthcare setting,through consideration of the factors outlined
in the framework (e.g. patients’ values and
preferences in local setting, resourcesacceptability, feasibility)
Collaboration Model
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Saudi Experts (Medical
Societies)
Saudi Center for EBHC
Project Management & Facilitation
• Project coordination (e.g. workshops, panel meetings, communication etc.)
• Facilitate guideline topics selection by stakeholders and decision makers
• Recruit panel members• Facilitate communication with panels
• Review final reports
• Disseminate guidelines (website, mobile apps, print media, BMJ, newsletters)
Our mission at the Saudi Center for EBHC
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Our mission at the Saudi Center for EBHC
To promote the awareness and practice of Evidence-based
medicine across the Kingdom, through training, awarenesscampaigns, and the creation of robust and nationally agreed on
clinical practice guidelines (CPGs)
InitiativeThe Ministry of Health of Saudi Arabia (KSA) partnered with McMaster
University to develop multiple CPGs for the local healthcare setting
based on the GRADE approach and the GRADE/DECIDE evidence to
decision (EtD) framework
TargetProduced 10 CPGs in a 4-month time period (Sep – Dec 2013)
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10 Completed CPGs
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10 Completed CPGs
Diagnosis of Deep Vein Thrombosis Saudi Scientific Hematology Society
Anticoagulant Therapy for Atrial Fibrillation Saudi Heart Association
Anticoagulant Therapy for Venous Thromboembolism Saudi Scientific Hematology Society
Anticoagulant Therapy for Acute Stroke Management Saudi Stroke Association
Venous Thromboembolism prevention in Stroke Saudi Stroke Association
Allergic Rhinitis in Asthma Saudi Allergy, Asthma and Immunology Society
Cervical Cancer Screening and Treatment Saudi Obstetric and Gynecology Society
Breast Cancer Screening Saudi Oncology Society
Role of Vitamin D, Calcium, and Exercise in Fracture
Prevention
Saudi Osteoporosis Society
Timing of Initiation of Hemodialysis Saudi Society of Nephrology and Transplantation
Diagnosis of Deep Vein Thrombosis Saudi Scientific Hematology Society
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How were the CPG topics selected?
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Number of topics suggested by individual departments of the Ministry of Health
Suggested topics screened by McMaster Group for feasibility of adaptation
Screened topics presented to Ministry decision makers for final selection of
guideline topics
Recruited multidisciplinary panel of local experts relevant to each CPG topic
Results
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• Produced 10 CPGs with 80 recommendations achieved in 4
month time period• Produced a Manual for CPG development for Saudi Arabia
Dissemination
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Printed CPGs EBHC website Mobile apps
Newsletters BMJ Best Practice
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E v i d e n c e
t o d e
c i s i o n
• Question/Problem
• Benefits and harms
• Quality of evidence
• Values and
Preferences
• Resource use
• Impact on health
equity
• Acceptability
• Feasibility
• Recommendation
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Where is CPGs in the
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Hierarchy of Evidence
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Where to search for CPG?• Guidelines International Network (G-I-N)
– www.g-i-n.net
• National Guidelines Clearing House
– www.guidelines.gov
• PubMed
• Google
Guideline international network (GIN)
http://www.g-i-n.net/http://www.g-i-n.net/http://www.guidelines.gov/http://www.guidelines.gov/http://www.guidelines.gov/http://www.g-i-n.net/
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Guideline international network (GIN)
National Guideline Clearing House
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(NGCH)
National institute for health and care
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excellence (NICE)
A tool to assess the CPGs
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A tool to assess the CPGs
Agree II domains
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Agree II domains
Domain 1. Scope and Purpose
Domain 2. Stakeholder Involvement
Domain 3. Rigour of Development
Domain 4. Clarity of Presentation
Domain 5. Applicability
Domain 6. Editorial Independence
Overall Assessment
Conclusions 1
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•
In this unique collaboration, we established and applied amethodology for adaptation of CPGs in 4-month period
• The experience to produce adapted CPGs in a short period is
feasible but challenging
• We succeeded because we had:
o Committed stakeholders
o Strong scientific support (McMaster Group)
o Effective project management (EBHC and McMaster Group)
Conclusions 2
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Conclusions 2
• Ad-o-lopment approach allows for efficientproduction of guidelines
• Support and facilitation from trained
methodologists to help with development ofguidelines
• Evidence-to-Decision framework allows for
formulation of recommendations specific tothe local healthcare setting
http://www.google.com.sa/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://www.ministryofpropaganda.co.uk/2008propaganda/20080518-canalwalk.shtml&ei=OvITVZzSOMrkUfrUgegB&psig=AFQjCNH2muRmAaPjmGcwOBvx72uJCLgpqQ&ust=1427456946933290
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The MOH/EBHC Mobile App
http://www.google.com.sa/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://www.ministryofpropaganda.co.uk/2008propaganda/20080518-canalwalk.shtml&ei=OvITVZzSOMrkUfrUgegB&psig=AFQjCNH2muRmAaPjmGcwOBvx72uJCLgpqQ&ust=1427456946933290
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8/17/2019 Saudi Center EB
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The MOH/EBHC Mobile App
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8/17/2019 Saudi Center EB
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8/17/2019 Saudi Center EB
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Acknowledgment
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g
• Canadian McMaster working group
• EBHC Staff
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