Capacity building for Adaptation of CPGs for the IV IG CPG Working Group

Intravenous Immunoglobulins

CPG Adaptation Proposal

Dr. Yasser S. AmerMBBCh, MS Ped, MS HCI, CPHQ, FISQua

Coordinator, KSUMC-Wide CPG Steering Committee

CPG Methodologist, CPGs Unit, Quality Management Dept.6/30/2016 1

Capacity Building for CPG Adaptation at KSUMC SeriesJune 2016/ Ramadan 1437

مبســـــم هللا الرحمـــــن الرحـــــي

In the name of Allah. Most Gracious, Most Merciful

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Statement of disclosure

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Dr. Yasser S. AmerMBBCh, MPedia, MHCI, CPHQ, FISQua

I have no actual or potential, commercial or

academic conflict of interest to declare in relation to

this presentation/ project

The EBM Triad

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Definition: (old)

“Systematically developed statements to assist

practitioner and patient decisions about appropriate

health care for specific clinical circumstances”

(IOM 1990)

Clinical Practice Guidelines (CPGs)

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CPGs Definition (New)

“Statements that include Recommendations

intended to optimize patient care that are

informed by a Systematic Review of evidence

and an assessment of the benefits and harms of

alternative care options”

Committee on Standards for Developing Trustworthy

CPGs (IOM-AHRQ 2011)

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Evidence Pyramid (Study design)

SR

RCT

Cohort

Case control

Case series

Case report

Expert opinion

I

II

III

IV

A

B

C

Leve

ls o

f E

vid

en

ce

Gra

des o

f Reco

mm

en

datio

ns

MA

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methods

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Benefits Risks/ Burden

QoE!

Level

Evidence

(LoE)

Grade

Recomm.

(GoR)

Strength

EVIDENCE PYRAMID6/30/2016 9

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What makes a trustworthy CPG?

Standards for high quality CPGsIOM 2011 – G-I-N 2012 – AGREE 2013

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Standards for trustworthy CPGsIOM 2011 G-I-N 2012

1- Establishing Transparency 1- Decision making process. 2- Methods

2- Management of COI 3- COI

3- (GDG) composition 4- GDG composition

4- (CPG – SR) intersection 5- Evidence reviews

5- Assign/ link to (LoE) & (GoR) 6- Rating of E & Rs

6- Articulation of (Rs) 7- CPG Rs (formulation/ wording)

7- External Review 8- Peer review & stakeholder consultation

8- Updating 9- Expiration & updating

10- Scope of CPG

11- Financial support/ sponsoring organization

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How to assess of the quality of any CPG ?

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CPG development methodologies

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CPGsWhat to do?

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Read

Adopt

AdaptDevelop

CPGs ?

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Different Options to deal with CPG

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CPGsDEVELOPMENT

(de novo)

vs.

ADAPTATION6/30/2016 18

Types of CPGs

1.Evidence-Based CPGs (evidence-based methodology)

2.Consensus/ expert-based CPGs

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Which type do you think is better?

The EBM Triad

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Process/ Methods

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Adaptation of CPGsIs the systematic approach to the endorsement and/or

modification of a guideline(s) produced in one cultural and organizational setting for application in a different context. Adaptation may be used as an alternative to de novo guideline development, e.g., for customizing (an) existing guideline(s) to suit the local context.

http://www.adapte.org/

http://www.g-i-n.net/

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Hospital-Wide Policy & Procedure for

Hospital CPGs Adaptation-SEPT 2013- in process for update WITH “NEW TOOLS”

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Formulation of a CPG Adaptation Working Group

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In collaboration with:

• Departmental CPG Committee

• Departmental Quality Team

Selecting a CPG Topic

Prevalence of the condition (high volume)

Patient safety concern (high risk)

Under-, over-, misuse of intervention(s)

Burden due to the condition

Practice variation

Costs of different practice options

Likelihood of effectiveness of CPG

Potential for improving quality of care and/or outcomes

Existence of relevant good quality CPGs

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Topic (concerns?)

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• Disease/ condition (Clinical Diagnosis) versus Healthcare Technology? CPG vs. HTA http://www.inahta.org/hta-tools-resources/

• Another CPG Dept. Committee may work on another CPG that includes IV IG as one option for management (conflict?)

• Decision according to priority Dx vs. HT?

http://www.inahta.org/hta-tools-resources/

HTA – IV IG in Sepsis (2012)

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KSUMC Protocol for New CPG

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Health/ Clinical/ Key Questions

Patient (& disease characteristics)

Intervention(s)

Professionals (Target users)

Outcomes (purpose of the CPGs)

Healthcare settings (& context)

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CPG Scope: PIPOH Model

Health Question Tool (modif.)

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Inclusion / Exclusion CPGs Selection Criteria (6)1. Methods of Development: Evidence-Based CPGs: (Detailed

Methodology not Consensus-based CPGs (Expert opinion)

2. Author(s): Organization and Specialized Society not single authors.

3. Country: International not national CPGs.

4. Date of Publication: range of year of publications: last 5 years or less(e.g. 2010 – 2014) – except if none!

5. Language: English CPGs only

6. Status: only Original source CPG (de novo developed) rather thanadapted CPGs

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CPG selection criteria Tool (new)

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Search and Screen for Source CPGs

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Producers Finders

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CPGs Finders

“Baseline Search List”

• National Guidelines Clearinghouse (NGC/ AHRQ)

• Guidelines International Network (G-I-N)

• EBSCO DynaMed

• PubMed/ MedLine

• Google Scholar

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> 408 CPGs

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AHRQ-NGC National Guideline Clearinghousewww.guidelines.gov

http://www.guidelines.gov/

Shaikh Bahamdan’s Research Chair for Evidence-Based Health Care & Knowledge Translation

Member of G-I-N since Oct. 2009Free access to International CPG Library of G-I-N

http://c.ksu.edu.sa/ebhc

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http://c.ksu.edu.sa/ebhc

http://c.ksu.edu.sa/ebhc/en

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http://c.ksu.edu.sa/ebhc/en

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DynaMedhttps://dynamed.ebscohost.com/

https://dynamed.ebscohost.com/

Some CPGs are only retrievable by “Googling” them!

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Specialized Scientific (Specialty) Societies

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Assessment of retrieved source CPGs

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Instructor

Dr. Yasser Sami AmerMS Pediatrics, MS Healthcare Informatics, CPHQ

Supervisor, EBPU, QMD, KSUMCCPGs Advisor , KSUHs, AUHs

Member, G-I-N Adaptation & Implementation Working Groups

The AGREE Research TeamPI: Melissa Brouwers, PhD

Head, HSR Oncology Dept., McMaster Univ.

https://youtu.be/z8nfqwvH4eM

Watch this video!

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https://youtu.be/z8nfqwvH4eM

Purpose

To guide on how to use and apply the AGREE II forassessing CPGS

Items

Domains

User’s Manual

Website

Outlines

• Overview of AGREE II including the items and domains.

• Present the scoring method of the CPG.

• How to use and apply the AGREE II for assessing CPG.

• Share the overall scoring.

• The AGREE Enterprise Website

What is the AGREE II Tool ?

• Quality (Methodological rigor & transparency; confident in resulting

Recommendations)

57 Using the AGREE II Instrument

Assess

Guide •CPGs Development •CPGs Reporting

History

1st AGREE was published in 2003,then refined in 2009 AGREE II (New scoring “7 point scale” – Items modifications – New user’s manual) – 11 YEARS !

Can be applied to any CPG in any Disease area !

• Healthcare providers/ clinicians

• CPG developers/ adapters

• Policy makers

• Educators

Who can use the AGREE II ?

Considerations before a CPG Assessment

• increase the reliability of the assessment

2 – 4 Appraisers

• in full and obtain all related information and needed documents before undertaking the AGREE II assessment ( to make a well informed assessment)

Read CPG first

Rating Scale• All AGREE II Items are rated on the following 7-point scale

Score Meaning

7 (Strongly Agree)

= If the quality of reporting is exceptional and full criteria and considerations in User’s manual are met.

1 (Strongly Disagree)

= No information relevant to AGREE II item OR the concept is very poorly reported

2 – 6 = when the reporting of the item does not meet the full criteria or considerations, depending on the completeness & quality of reporting .

The AGREE II Includes….

•Core Items•(6 Domains)

23

•Overall Assessment Items

2

23 Items in 6 DomainsUSER’S MANUAL page 7

DOMAINS No. of Items

1 Scope & Purpose 3

2 Stakeholder Involvement 3

3 Rigour of Development 8

4 Clarity & Presentation 4

5 Applicability 3

6 Editorial Independence 2

Items and Domains: A Closer Look

AGREE II:USER’S MANUAL

Per each Domain (guidance for rating the 23 items) Pages 11 – 41

User’s Manual Description:Where to Look:How to Rate:Item content includes the following CRITERIA:Additional CONSIDERATIONS:

Domain 1

DOMAIN 1. SCOPE AND PURPOSE

1. Objective(s):

Health impact & benefits of a CPG on target population

Introduction, scope, purpose, rationale, background & objectives

DOMAIN 1 - Q1 - Objective(s)

2. Health Question(s):-Questions, Scope, Purpose, Rationale and

Background

3. Target population:-Pt. population, target population, relevant pt.s,

scope and purpose

DOMAIN 1. SCOPE AND PURPOSE

DOMAIN 1 – Q2 - Health Question(s)

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Health/ Clinical/ Key Questions

Patient (& disease characteristics)

Intervention(s)

Professionals (Target users)

Outcomes (purpose of the CPGs)

Healthcare settings (& context)

19th March 2013 EBCPGs: Dr. Yasser Sami Amer 69

CPG Scope: PIPOH Model

DOMAIN 1 – Q3 – Target population

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Domain 2

4. Guideline groupMethods, guideline panel list, acknowledgements, & appendices

DOMAIN 2. STAKEHOLDER INVOLVEMENT

5. Patient preference Scope, methods, guideline panel list, external review &target

population perspectives


6. Target usersTarget user & intended user


Domain 3

7. Systematic methods for E search

8. Selection Criteria of E

9. Strengths & Limitations of E

10. Methods of Rs

11. Benefits , side effect and risks in Rs

12. Evidence Links (Gs of Rs – LoE)

13. External Review

14. Update Procedure

DOMAIN 3. RIGOUR OF DEVELOPMENT

Methods, literature search strategy & appendices+ inclusion/ exclusion criteria+ Evidence tables, clinical evidence, evidence description (results), evidence interpretation (discussion)Methods, CPG Development process same sections+ Rs, Key Evidence+ acknowledgements+ CPG update, date of CPG

Level

Evidence

(LoE)

Grade

Recomm.

(GoR)

Strength

EVIDENCE PYRAMID6/30/2016 77

Methodology of development

• In same CPG document (in brief or detailed)

• In a separate document or supplement (usu. Detailed)

• Not documented

Within CPG document (ENT IDSA ABRS CPG)

Mentioned but not documented

KSUMC CPGs: Adaptation Process Methodology

Separate Methodology document (SIGN 50: A guideline developer’s handbook -2011)

NICE: The guideline manual (2012)


8. Selection Criteria of E9. Strengths & Limitations of E

10. Methods of Rs



13. External Review



Methods, literature search strategy & appendices

+ inclusion/ exclusion criteria+ Evidence tables, clinical evidence, evidence description (results), evidence interpretation (discussion)Methods, CPG Development process same sections+ Rs, Key Evidence+ acknowledgements+ CPG update, date of CPG

Selection Criteria of E

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9. Strengths & Limitations of E10. Methods of Rs



13. External Review



Methods, literature search strategy & appendices+ inclusion/ exclusion criteria

+ Evidence tables, clinical evidence, evidence description (results), evidence interpretation (discussion)Methods, CPG Development process same sections+ Rs, Key Evidence+ acknowledgements+ CPG update, date of CPG

Strengths/ Limitations of E

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10. Methods of Rs 11. Benefits , side effect and risks in Rs


13. External Review



Methods, literature search strategy & appendices+ inclusion/ exclusion criteria+ Evidence tables, clinical evidence, evidence description (results), evidence interpretation (discussion)

Methods, CPG Development process same sections+ Rs, Key Evidence+ acknowledgements+ CPG update, date of CPG

Methods of Rs

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10. Methods of Rs



13. External Review



Methods, literature search strategy & appendices+ inclusion/ exclusion criteria+ Evidence tables, clinical evidence, evidence description (results), evidence interpretation (discussion)Methods, CPG Development process

same sections+ Rs, Key Evidence+ acknowledgements+ CPG update, date of CPG

Benefits, SE’s, Risks in Rs

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10. Methods of Rs


12. Evidence Links (Gs of Rs – LoE)13. External Review



Methods, literature search strategy & appendices+ inclusion/ exclusion criteria+ Evidence tables, clinical evidence, evidence description (results), evidence interpretation (discussion)Methods, CPG Development process same sections

+ Rs, Key Evidence+ acknowledgements+ CPG update, date of CPG

Evidence Links (Rs-LoE)

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10. Methods of Rs



13. External Review 14. Update Procedure


Methods, literature search strategy & appendices+ inclusion/ exclusion criteria+ Evidence tables, clinical evidence, evidence description (results), evidence interpretation (discussion)Methods, CPG Development process same sections+ Rs, Key Evidence

+ acknowledgements+ CPG update, date of CPG

External Review

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10. Methods of Rs



13. External Review



Methods, literature search strategy & appendices+ inclusion/ exclusion criteria+ Evidence tables, clinical evidence, evidence description (results), evidence interpretation (discussion)Methods, CPG Development process same sections+ Rs, Key Evidence+ acknowledgements

+ CPG update, date of CPG

Update procedure

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Domain 4

DOMAIN 4. CLARITY OF PRESENTATION

15. Rs are specific Rs & executive summary

16. Options for management + discussion, Treatment (options/alternatives)

17. Recommendation identifiableKey Rs; separate (e.g. QRG)

Rs are specific

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Options for management ((? IV IG))

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Rs are identifiable

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Domain 5

DOMAIN 5. APPLICABILITY

18. Facilitators & barriers CPG dissemination/ implementation, barriers, CPG utilization &

Quality indicators

19. Tools+ tools, resources, appendices

20. Resource implicationsMethod, cost utility, cost effectiveness, acquisition costs &

implications for budgets

21. Monitoring /audit criteria Rs, Quality indicators & audit criteria

Facilitators & Barriers

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Implementation Tools

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Resource implications

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Monitoring/ audit criteria

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Domain 6

DOMAIN 6. EDITORIAL INDEPENDENCE

22. Funding bodyDisclaimer & funding source

23. Competing interestsMethods, Conflicts of interest (COI), CPG panel &

appendices

Funding body

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DCOI

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Overall Assessment

OVERALL CPG ASSESSMENT1. Rate the overall quality of this CPG

2. I would recommend this CPG for use

3. Notes

YES

Yes ,with modification

No

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Selected CPG DomainsOverall

Is CPG

Recommended for

use ?1 2 3 4 5 6

CPG 1

CPG 2

CPG 3

CPG 4

CPG 5

Finally AGREE II Domain Scores Color Coding (Prof. Lubna Al-Ansary)

< 40 % Red >41-70 Yellow >71 Green

AGREE Domains Scores Table

CPG 1: SIGN CPG 2: EPR3 CPG 3: GINA CPG 4: ICSI CPG 5: Singapore MOH

Domain 1 60 % 74 % 45 % 61 % 42 %Domain 2 55 % 56 % 60 % 58 % 63 %

Domain 3 92 % 83 % 79 % 38 % 43 %

Domain 4 95 % 90 % 92 % 75 % 87 %Domain 5 70 % 82 % 80 % 33 % 58 %Domain 6 80 % 60 % 22 % 50 % 10 %Overall assessment 7 6 5 3 4Recommended for use Yes Yes (w M) Yes (w M) No No

Graphical Representation

AGREE II DOMAINS

(ENT-ABRS CPG)

IDSA CPG 2012 Canadian CPG 2011

D1: Scope & Purpose 86 % 80 %D2: Stakeholder Involvement 86 % 69 %D3: Rigour of Development 90 % 85 %D4: Clarity & Presentation 92 % 90 %D5: Applicability 67 % 64 %D6: Editorial Independence 96 % 76 %Overall assessment 7 5Recommended for use Yes No

This table uses the AGREE II Domain Score Colour Coding proposed by Dr. Lubna Alansary

(< 40% red - > 41 – 70% yellow - > 71 % green)

AGREE II DOMAINS CPG1 (Singapore) CPG2 (WFSBP) CPG3 (Canada)

D1: Scope & Purpose 90.7% 90.7% 96.3 %D2: Stakeholder Involvement 72.2% 65 % 81.5 %D3: Rigour of Development 39. 5% 84.5 % 90.3 %D4: Clarity & Presentation 98.1% 88.9 % 87.03 %D5: Applicability 34.7% 23.6% 40.3 %D6: Editorial Independence ZERO % 86.1% 55.6 %Overall assessment 4 5 6Recommended for use NO NO YES

This table uses the AGREE II Domain score colour coding proposed by Dr Lubna Al-Ansary

(< 40% Red - >41-70% Yellow - >71% Green)

The paper tool (handout!)

Using the AGREE II Instrument 123

AGREE II rater concordance calculator (EXCEL)

AGREE II rater concordance calculator(McMaster University)

AGREE Enterprise websitehttp://www.agreetrust.org/

http://www.agreetrust.org/

The online tool “My AGREE PLUS”

My AGREE PLUS(OR Our AGREE!)

My AGREE II Report PDF

A tool for evaluation of clinical validity/ credibility of CPGs (in progress)

AGREE-REX: Recommendation EXcellence:Innovations to enhance the capacity of practice guidelines to

improve health and health care systems

Develop a useful, reliable, and valid knowledge resource tocomplement the AGREE II, which will guide the development,reporting, and evaluation of the clinical credibility of CPGrecommendations.

Volunteers Needed for AGREE-REX Testing

April 2016

Other AGREE Resources

• AGREE Reporting Checklist (PDF, Word)Brouwers MC, Kerkvliet K, Spithoff K, on behalf of the AGREE Next Steps Consortium. The AGREE Reporting Checklist: a tool to improve reporting of clinical practice guidelines. BMJ 2016;352:i1152. doi: 10.1136/bmj.i1152.

A checklist based on the domains and items of the AGREE II intended to assist in the completeness of reporting in practice guidelines.

• AGREE II-GRS InstrumentA short item tool to evaluate the quality and reporting of practice guidelines. Get the AGREE II-GRS here.

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http://www.bmj.com/content/352/bmj.i1152

CPG Implementation

“The concrete activities and interventions undertaken to turn policies into desired results“

Guidelines for clinical practice: from development to use. IOM, 1992

CPGs Practice

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CPG Implementability

Set of characteristics that PREDICT the relative ease of implementation of CPG recommendations.

Implementability…….BEFORE implementation

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CPG implementation Strategies (SIGN)

Dissemination Process (print/ e-/website).

Local Clinical Champions.

Awareness raising/ training activities.

Regular M & E (Auditing) (The ‘living’ CPG concept!).

Networking and linking with existing projects (e.g. Dept. Clinical Rounds, CPD/CME activities, Accreditation, etc..).

Patients as champions for change.

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CPG implementation Toolsavailable at the point of care (* MR)

Examples

1.Clinical Algorithm

2. Integrated Care/ Clinical Pathways

3.Protocol and/ or Policy & Procedure

4.Chart Documentation/ forms (e.g. Physician Order Sets: eSIHI

CPOE PowerPlans)

5.Quick Reference Guides/ Physician Guides & Pocket

Guide/Reference Cards (at-a-glance summary of key

recommendations 5 or 1-2 pages).

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1.Clinical audit criteria (tool)

2.Quality (outcome/performance) measures

3.Slide Presentation.

4.Wall Poster.

5.Patient Resources/ Information (health education guides).

6.Foreign language Translation (Non-English, Non-Arabic).

7.Implementation Tool Kits (collections of tools and/or strategies).

8.Staff Training/ Competency Material.

CPG implementation tools (cont’d)

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Mobile Apps

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Individual Positive attitude Learning through small

group interaction

Environmental• Professional

association/society support• Inter-organizational

collaboration networks

Facilitators

Organizational• Leadership support• Champions• Team work

collaboration

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CPG Implementation Failure….WHY?

Extrinsic to CPG:

provider & care system-related

Intrinsic to CPG:

ambiguity – inconsistency - incompleteness

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The concept of

the ‘LIVING’ CPG

CPG Adaptation ProgramCurrent status 2016 - 1437

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Clinical Practice Guidelines (CPGs) Adaptation

Program at King Saud University Medical City

KSUMC CPG Program Partners:-

KSUMC-Wide CPGs Steering Committee

Clinical Department(s); CPGs Dept. Committees)

Research Chair for Evidence-Based Health Care &Knowledge Translation

Quality Management Department; DQTs

Top Management of KSUMC; Medical Director(s), Dept. Chairperson(s), Unit Head(s)

IMPLEMENTQIP

ADAPTMethods

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Guidelines International Network (G-I-N)www.g-i-n.net

EBHC-KT Chair, King Saud University: Org. Member

since 2009

(1st Member from Gulf & 3rd Member from MENA

Countries)

Founded in Nov.

2002

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http://www.g-i-n.net/

23 KSUMC CPGs Subcommittees1. Department of Pediatrics

2. Department of Critical Care

3. Department of Psychiatry

4. Primary Care/ Family Medicine Clinics

5. Department of Pharmacy

6. Department of Emergency Medicine

7. Department of Medicine

8. Department of Orthopedic Surgery

9. Department of Otorhinolaryngology

10. Department of Ophthalmology

11. Department of Cardiac Sciences/ KFCC

12. Department of Surgery

13. Department of Obstetrics & Gynecology

14. Department of Dermatology

15. Department of Anesthesiology

16. Department of Laboratory Medicine &

Pathology

17. Department of Nursing

18. Department of Radiology

19. Health Education Center

20. Department of Rehabilitation Medicine

21. Department of Infection Control

22. Department of Occupational Health & Safety

23. Department of Clinical Nutrition

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How to access the KSUMC CPGs?

• PAPER1. CPG Binder (full document)

2. Forms (Implementation tools)

3. Algorithm Booklet

• ELECTRONICOnline:1. ICity website (KSU email)

2. G-I-N website (EBHCKT)

Offline: (intranet)Desktop Icon (IP Address?)

PARADIGMSHIFT: eSiHi

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How to access CPGs on Intranet City (ICity)

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Desktop Icon

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Type: MED

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Currently, 18 out of the 29 adapted CPGs are already built on eSiHi as ‘CPOE with Order Sets’ (i.e. Cerner POWERPLANS). The rest are in progress!

5 PowerPlans from Medicine CPGs

1. MED Diabetic Ketoacidosis CPG (adults)

2. MED Gout CPG

3. MED Hypertensive emergencies/urgencies CPG

4. MED oncology premedication

5. PULM Asthma CPG (adults)

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1 from DEM/ ICU CPGsED septic shock (adults)

1 from Cardiology (KFCC) CPGsCARD Heart Failure CPG

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29

KSUMC CPG PROGRAM IN NUMBERS

Who is the contact person for EBCPGs in each clinical department?

Chairperson, CPG Departmental Committee

Members, CPG Departmental Committee

Department Quality Team (former Accreditation teams)

Department Chairman & Units’ Heads

General Coordinator, CPG Steering Committee

Medical Secretary, CPG Steering Committee

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Medicine (6 +5)

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1. Asthma (Adult)

2. Diabetic ketoacidosis (Adult)

3. Hypertensive emergencies & urgencies

4. Gout (acute gouty arthritis/ hyperuricemia)

5. Lung Cancer

6. Antiemetics for Chemotherapy-induces nausea & vomiting

7. Venous Thromboembolism Prophylaxis

8. Dyslipidemia

9. Vancomycin dosing and monitoring (Adult)

10. Surgical Antibiotic prophylaxis (Adult)

11. Heart Failure (Adult)

Pharmacy Services (3)

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• Vancomycin dosing and monitoring (Adult)

• Pediatric and neonatal parenteral nutrition (TPN)

• Antiemetics for Chemotherapy-induces nausea & vomiting

How to read the KSUMC CPGs full documents?

Table of contents

• Preface by authors

• Acknowledgments

• Abbreviations

• Overview material

• Introduction

• Disclaimer/

Statement of intent

• Scope & Purpose (PIPOH)

• Recommendations (Key & details)

• External review & consensus

• Plan for scheduled review & update

• List of funding sources

• Adaptation process methodology

• Implementation considerations & Tools

• References

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Role as a Physician in CPGs

1) CPG implementers/users:

“Your continuous feedback!”

2) CPG developers/adapters.

3) Improvement research projects.

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Thank you!

Email: [email protected]; [email protected]

Ext. #: 91341, 91281

mailto:[email protected]

mailto:[email protected]