Evidence-Based Clinical Practice Guidelines for Pediatricians

Evidence-Based Clinical Practice Guidelines

for Pediatricians

Dr. Yasser Sami AmerMBBCh, MPed, MHI, CPHQ, FISQua

General Pediatrician – CPGs Methodologist

Alexandria Pediatric Center - Scientific Meeting Series 2017 - Meeting No. (7)

22/8/2017 - Yasser Sami Amer





Table of Contents

(Learning Objectives)

• Definitions & Concepts

• Standards for Trustworthy CPGs

• Development vs. Adaptation

• CPGs on the Web

• ADAPTE Method

• Implementation

• CPGs in AlexMed ‘Adapted ADAPTE’

• Roles/ Take Home Message



Definitions & Concepts



Evidence-Based Medicine (EBM) Movement: Not new!

• 865–925 Al-Razi (Rhazes)1st need for experiments, comparisons in clinical studies

• 981–1037 Ibn Sina (Avicenna)test effect of drugs on humans not animals only

• 1987 David M. Eddy, MD, PhD ‘EB’ in EBCPGs, policies in workshops, manual

• 1992 Gordon Guyatt, MD‘EBM’ term in JAMA

• 1996 David Sackett, MD‘EBM’ definition in BMJ



Ebers Papyrus• The Ebers Papyrus, is

an Egyptian medical papyrus of herbal knowledge (c. 1550 BC).

• Among the oldest and most important medical papyri of ancient Egypt, it was purchased at Luxor (Thebes) in the winter of 1873–74 by Georg Ebers.

• Currently, library of the University of Leipzig, in Germany.



Roots of ‘Rx’ prescription

symbol? Latin? No!



The EBM Triad





What is ‘real EBM’ and how to achieve it?



What is ‘real EBM’ and how to achieve it? (cont’d)



Haynes’ “6 S” Information

Pyramid for EBHC



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)



“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”

(IOM-AHRQ 2011)



Trustworthy CPGs?



What makes a trustworthy CPG?Un-manageable volume

of published CPGs !Improved patient

outcomes…..But



It’s peer-reviewed, therefore it must be OK?

Slide courtesy of Dr. Paul Glasziou



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



Standards for trustworthy CPGs

IOM 2011 G-I-N 20121- 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

AGREE II . . . . . Alexandria Pediatric Center - Scientific Meeting Series 2017 - Meeting No. (7)


Evidence Pyramid (Study design)

SR

RCT

Cohort

Case control

Case series

Case report

Expert opinion

I

II

III

IV

A

B

C

Le

ve

ls o

f E

vid

en

ce

Gra

de

s o

f Re

co

mm

en

datio

ns

MA



The proposed new EBM pyramid.

M Hassan Murad et al. Evid Based Med 2016;21:125-127

©2016 by BMJ Publishing Group Ltd

New evidence pyramidAlexandria Pediatric Center - Scientific Meeting Series 2017 - Meeting No. (7)


methods



Benefits Risks/ Burden

QoE!



Level

Evidence

(LoE)

Grade

Recomm.

(GoR)

Strength

EVIDENCE PYRAMIDAlexandria Pediatric Center - Scientific Meeting Series 2017 - Meeting No. (7)


WhyDo we need

CPGs?



Rationale for CPGs• Worldwide concerns about:-

▫ Unexplained variation/ variability in CP!

▫ Rising healthcare costs!

▫ Exponential growth of health information!

• Aim of CPGs:-To facilitate more consistent, effective and efficient practice and

improve health outcomes for patients



CPGs:For whom?



• Physicians

• Nurses

• Pharmacists

• Technicians

• Technologists

• Decision makers

• Patients

• Public



Types of CPGs

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

2. Consensus/ expert-based CPGs

Which type do you think is better?



CPGsWhat to do?



Read

Adopt

AdaptDevelop

CPGs ?Slide courtesy of Prof. Nabil Dowidar



Different Options to deal with CPG



CPG

Development (de novo)

vs. Adaptation



Main differences Develop vs. ADAPTE

ADAPTEDEVELOP (de novo)

AdaptationDevelopment (GDG) Working groups

Check whether adaptation is feasible then TEAM formation

Team formation Sequence of steps (starting)

PIPOHPICO(T) Health/ Clinical questions

CPGsOrBoth (if mixed methods)

Primary/ secondary studiesEvidence syntheses/summaries

Evidence Base



CPG development (de novo)



CPG development

methodologies



What is CPG adaptation?

“Guideline adaptation is the systematicapproach to the endorsement and/or modification of aguideline(s) produced in one cultural andorganizational setting for application in a differentcontext. Where high quality guidelines are alreadyavailable, adaptation may be used as an alternative tode novo guideline development to customize theexisting guideline to the needs of local users.”

The ADAPTE Collaboration (2006-2010)



Why CPG Adaptation?

• Proper development and updating of high-quality CPGsrequire substantial time, expertise and resources.

• Need of HCOs to standardize health policies andpractices to promote optimal EBHC.

• Pressure on HCOs to produce CPGs rapidly, to ensurethat medical practice is consistent with current,emerging medical knowledge. This work is often donewith limited resources.



The ADAPTE postulates that

. . . .

. . . . .existing high quality CPGs as a resource maybe an alternative to de novo development toreduce duplication of effort, enhance efficiency,and promote local uptake of quality CPGrecommendations.



G-I-N Adaptation Working Group



A methodological survey identified 8frameworks for adaptation of CPGs

Darzi AJ et al. J Clin Epi 2017 (AUB):-

ADAPTE (original), Adapted ADAPTE, Alberta Program, GRADE-ADOLOPMENT, MAGIC, RAPADAPTE, RCN, and SGR



Producers Finders



• Specialized (professional) societies

• Healthcare Organizations

• Governmental (National) organizations: NICE, SIGN, NHMRC, ,etc.

• International organizations



Organization NameCountry

URLProduc

er

Find

er

Guidelines International Network (G-I-N)Internatio

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

World Health Organization (WHO)Internatio

nal http://www.who.int/topics P

National Institute for Health & Care

Excellence (NICE)UK

http://www.nice.org.uk/page.aspx?o

=ourguidanceP

Scottish Intercollegiate Guidelines Network

(SIGN)UK

http://www.sign.ac.uk/guidelines/ind

ex.htmlP

National Guidelines Clearinghouse (NGC),

AHRQUSA http://www.guidelines.gov F

EBSCO DynaMed USA dynamed.ebscohost.com/user/login

Institute for Clinical Systems Improvement

(ICSI)USA http://www.icsi.org/knowledge/ P

F

US National Library of Medicine, National

Institutes of Health (PubMed)USA

http://www.ncbi.nlm.nih.gov/pubme

d

OR http://www.pubmed.gov

F

Google Scholar USAhttps://scholar.google.com/?hl=ar&sa

fe=onF



http://www.pubmed.gov/

https://scholar.google.com/?hl=ar&safe=on

CPG Producers: National

Agencies

NICENational Institute for Health & Clinical Excellencewww.nice.org.uk Alexandria Pediatric Center - Scientific

Meeting Series 2017 - Meeting No. (7) 22/8/2017 - Yasser Sami Amer

http://www.nice.org.uk/

CPG Producers: National

Agencies

SIGNScottish Intercollegiate Guidelines Networkwww.sign.ac.uk

14 groups



http://www.sign.ac.uk/

World Health Organization

• WHO guidelines for safe surgery: safe surgery saves lives (2009)

• Best Practice Guidelines on Emergency Surgical Care in Disaster Situations (2007)



DynaMedhttps://dynamed.ebscohost.com/



https://dynamed.ebscohost.com/

CPGs Finders• National Guidelines Clearinghouse (NGC/

AHRQ)

• Guidelines International Network (G-I-N)

• EBSCO DynaMed

• PubMed/ MedLine

• Google Scholar



AHRQ-NGC

National Guideline

Clearinghouse

www.guidelines.gov

> 408



http://www.guidelines.gov/



PubMed: US National Library of Medicine,

National Institutes of Health (NIH)



CPGs from Best Children’s Hospitals



Best Children’s Hospitals: USA

Top 5 for 2017/20181. Boston Children's Hospital

2. Children's Hospital of Philadelphia

3. Cincinnati Children's Hospital Medical Center

4. Texas Children's Hospital, Houston

5. Johns Hopkins Children's Center, Baltimore



Best Children’s Hospitals: UK

NHS Foundation Trust:

1. Great Ormond Street Hospital for Children

2. Birmingham Children's Hospital

3. Sheffield Children’s



Best Children’s Hospitals: EGYPT(Alexandria)

• Alexandria University Children’s Hospital at ElShatby (AUCH)

• Alexandria Pediatric Center (APC)



Specialized Pediatric societies

• American Academy of Pediatrics

• Canadian Paediatric Society

• European Academy of Paediatrics

• European Society for Paediatric Research

• …….etc.!





Specialized Societies:

PEDIA AAP



The ADAPTE Method



3 Phases, 9 Modules, 23 Steps





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



Health/ Clinical/ Key Questions

Patient (& disease characteristics)

Intervention(s)

Professionals (Target users)

Outcomes (purpose of the CPGs)

Healthcare settings (& context)

CPG Scope: PIPOH Model



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 singleauthors.

3. Country: International not national CPGs.

4. Date of Publication: range of year of publications: last 5years or less (e.g. 2011 – 2016) – except if none!

5. Language: English CPGs only

6. Status: only Original source CPG (de novo developed) ratherthan adapted CPGs



How to assess of the quality of any CPG ?



23 Items in 6 Domains USER’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



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







Implementation



:: Evidence to practice/ knowledge to action cycle ::

CPG Implementation

(CPGI)

Strategies & Tools



CPGI

“The concrete activities andinterventions undertaken to turnpolicies into desired results“Guidelines for clinical practice: from development to use. IOM, 1992

CPGs Practice



CPGI Tools



Adapt/ design CPGI Tools

to be made available at the point of care (* MR/ EMR)

Examples• Clinical Algorithms

• Integrated Care/ Clinical Pathways

• Protocols

• Policies & Procedures

• Chart Documentation/ forms (e.g. Physician Order

Sets: paper vs. CPOE system +/- CDSS)

• Quick Reference Guides/ Physician Guides &

Pocket Guide/Reference Cards (at-a-glance

summary of key recommendations).

• Mobile Apps



• Clinical audit criteria (tool)

• Quality/ Performance measures (process, outcome KPIs)

• Quality Tools (e.g. FMEA)

• Slide Presentation.

• Wall Poster.

• Patient Resources/ Information (HE guides).

• Foreign language Translation (Non-Arabic, Non-French).

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

• Staff Training/ Competency Material.

CPGI tools (cont’d)





CPGI

Strategies/ Interventions

1) Leadership engagement and commitment

2) Local Clinical and Quality Champions.

3) Dissemination (print/ e-/web)

4) Education and Training

5) Regular Audit & Feedback (The ‘living’ CPG concept!)

6) Networking and linking with existing projects (e.g. CPD/CME activities, Accreditation, UG/PG Edu,..etc..).

“Patients as champions for change!”Alexandria Pediatric Center - Scientific Meeting Series 2017 - Meeting No. (7)


“Multi-faceted” are more

effective than single

strategies in CPGI!



Facilitators and Barriers in

CPGI



Facilitators of CPGI

Domain

Positive attitudeLearning through small group interaction

Individual

Leadership supportChampionsTeam work collaboration

Organizational

Scientific specialized association supportInter-organizational collaboration

networks

Environmental



Disseminat. & Implement.:

‘Mission Aborted!’

Nothing could be more frustrating than producing a CPG that is

then ignored by not being disseminated nor implemented

nor updated.

The concept of the ‘LIVING’ CPG



CPG Implementation Failure!

BARRIERS!

Extrinsic to CPG:provider & care system-related

Intrinsic to CPG: (>Methodology!)

ambiguity – inconsistency -

incompletenessAlexandria Pediatric Center - Scientific Meeting Series 2017 - Meeting No. (7)


CPG Implementation cycle



CPG Implementation cycleFi

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Effectiveness of CPGs

implementation interventions

Slide courtesy of Dr. Ulfat Shaikh



The CPG lifecycle



The concept of the ‘LIVING’ CPG

Development

Dissemination

Implementation

Evaluation

Review/ updating



EBM-CPG Initiatives in Egypt



• Egyptian Center for Evidence-BasedMedicine, Ain Shams University, Cairo.

• Alexandria Center for Evidence-BasedMedicine, MRI, Alex. University, Alex.

• Alexandria Center for Evidence-BasedClinical Practice Guidelines, AlexMed,Alex. University, Alex.

• (Next) Alexandria Pediatric Center, Alex.



Evidence-Based Clinical Practice Guidelines

Adaptation

In Alexandria University Hospitals in Alexandria, Egypt





Alexandria University HospitalsHealthcare Quality Directorate

Center for Evidence-Based Clinical Practice Guidelines

(AUH – HCQD, CEBCPGs)(Founded Nov. 2008)

http://www.med.alexu.edu.eg/cebcpgs/

Member of Guidelines International Network (G-I-N)(2009-2012)



http://www.med.alexu.edu.eg/cebcpgs/





G-I-N

Founded in Nov. 2002



Founding Members 2008

• Prof. Dr. Mahmoud Elzalabany

• Prof. Dr. Tarek Omar

• Prof. Dr. Nabil Dowidar

• Prof. Dr. Afaf Ibrahim

• Dr. Yasser S. Amer

• Dr. Hossam Ashour

• Eng. Ahmed Mourady



First Workshop in Egypt: Adaptation of CPGs2009 (AFM-GIN-ADAPTE)



ADAPTE CPG Thesis/ Book Title (AUCH Library)

1. Acute Asthma, Treatment

2. Positioning & Attachment Breast Feeding Problems, Treatment

3. Hypoxic ischemic Encephalopathy, Treatment

4. ADHD, Treatment

5. Bacterial Meningitis, Management

6. Community Acquired Pneumonia, Treatment

7. First unprovoked epileptic seizure, Diagnosis

8. Chronic Asthma, Treatment

9. Autism Spectrum Disorders, Treatment

10. Epilepsy, Management – MD

11. Juvenile Rheumatoid Arthritis – MD

12. Cerebral Palsy, Treatment

Triage and Acuity Scale (A&E)

Acute organophosphorus poisoning (A&E)



“The Adapted ADAPTE Process for CPGs Adaptation”







3 New Tools3 Modified Tools

For the Guideline Adaptation: A Resource Toolkit Version 2.0





http://qualitysafety.bmj.com/content/22/Suppl_1/43.1.abstract?sid=302fcfca-c444-4bd3-a295-c75c811b7d49 (last cited 7/6/2014 in BMJ Quality & Safety)



http://qualitysafety.bmj.com/content/22/Suppl_1/43.1.abstract?sid=302fcfca-c444-4bd3-a295-c75c811b7d49

J Eval Clin Pract 2015, 21: 1095-1106. doi:10.1111/jep.12479

Link: http://onlinelibrary.wiley.com/doi/10.1111/jep.12479/abstract



http://onlinelibrary.wiley.com/doi/10.1111/jep.12479/abstract

Regional: WHO-EMRONov. 2015



G-I-N Arab



Participating in the

Evidence-Based Health

Care Initiatives

WIN – WIN !



MY PATIENTS/

CLIENTS

MY DEPARTMENT

MY HOSPITAL



WIN – WIN !

Participating in the EBCPGs

1) Improve our Life-long learning & Information Mastery Skills;

2) Improve our EB-informed Clinical Decisions;

3) Improve our patients (clients) outcomes;

4) Improve our UG/ PG Teaching tools;

5) International collaborations in EB-CPGs;

6) Authorship of Publications

(CPG Book/ Articles); ……

and more!Alexandria Pediatric Center - Scientific Meeting Series 2017 - Meeting No. (7)


Roles

Take Home Message!



Role as a HCP in CPGs

1) CPG implementers/users:

“Your continuous feedback!”

2) CPG developers/adapters.

3) Improvement research projects.



Acknowledgments



Dr. Yasser Sami AmerM Pedia, M H Informatics, CPHQ, FISQua

CPGs Advisor & TrainerAlexandria Pediatric Center - Scientific Meeting Series 2017 - Meeting No. (7)


Questions?



Contact Information

Email Addresses:

[email protected]; [email protected];

[email protected]

[email protected]

My Research:

https://www.researchgate.net/profile/Yasser_Amer2

My Slides: https://www.slideshare.net/yassersami/presentations



mailto:[email protected]




https://www.researchgate.net/profile/Yasser_Amer2

https://www.slideshare.net/yassersami/presentations