Saudi Center EB

8/17/2019 Saudi Center EB

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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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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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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



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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



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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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The MOH/EBHC Mobile App


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Acknowledgment


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g

• Canadian McMaster working group

• EBHC Staff


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Saudi Center EB

Documents

Transcript of Saudi Center EB