Evidence-Based Clinical Practice Guidelines for Pediatricians

Evidence-Based Clinical Practice
Guidelines
for Pediatricians
Dr. Yasser Sami Amer
MBBCh, 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 knowledg
e (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 CPGs
IOM 2011 – G-I-N 2012 – AGREE 2013

Standards for trustworthy CPGs
IOM 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
AGREE II . . . . .Alexandria Pediatric Center - Scientific

Evidence Pyramid (Study design)
SR
RCT
Cohort
Case control
Case series
Case report
Expert opinion
I
II
III
IV
A
B
C
LevelsofEvidence
GradesofRecommendations
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 pyramid

methods

Benefits Risks/ Burden
QoE!

Level
Evidence
(LoE)
Grade
Recomm.
(GoR)
Strength
EVIDENCE PYRAMIDAlexandria Pediatric Center - Scientific

Why
Do 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?

CPGs
What to do?

Read
Adopt
Adapt
Develop
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
CPGs
Or
Both (if mixed
methods)
Primary/ secondary
studies
Evidence syntheses/
summaries
 Evidence Base

CPG development (de novo)

CPG development
methodologies

What is CPG adaptation?
“Guideline adaptation is 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. Where high quality guidelines are already
available, adaptation may be used as an alternative to
de novo guideline development to customize the
existing guideline to the needs of local users.”
The ADAPTE Collaboration (2006-2010)

Why CPG Adaptation?
• Proper development and updating of high-quality CPGs
require substantial time, expertise and resources.
• Need of HCOs to standardize health policies and
practices to promote optimal EBHC.
• Pressure on HCOs to produce CPGs rapidly, to ensure
that medical practice is consistent with current,
emerging medical knowledge. This work is often done
with limited resources.

The ADAPTE postulates that
. . . .
. . . . .existing high quality CPGs as a resource may
be an alternative to de novo development to
reduce duplication of effort, enhance efficiency,
and promote local uptake of quality CPG
recommendations.

G-I-N Adaptation Working Group

A methodological survey identified 8
frameworks 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 Name
Country
URL
Produc
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
=ourguidance
P
Scottish Intercollegiate Guidelines Network
(SIGN)
UK
http://www.sign.ac.uk/guidelines/ind
ex.html
P
National Guidelines Clearinghouse (NGC),
AHRQ
USA 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 USA
https://scholar.google.com/?hl=ar&sa
fe=on
F

CPG Producers: National
Agencies
NICE
National
Institute for
Health &
Clinical
Excellence
www.nice.org.
uk Alexandria Pediatric Center - Scientific

CPG Producers: National
Agencies
SIGN
Scottish
Intercollegiate
Guidelines Network
www.sign.ac.uk
14 groups

World Health Organization
• WHO guidelines for safe surgery: safe surgery
saves lives (2009)
• Best Practice Guidelines on Emergency Surgical
Care in Disaster Situations (2007)

DynaMed
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
Clearingho
use
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 2017/2018
1. 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,
BaltimoreAlexandria Pediatric Center - Scientific

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 single
authors.
3. Country: International not national CPGs.
4. Date of Publication: range of year of publications: last 5
years or less (e.g. 2011 – 2016) – except if none!
5. Language: English CPGs only
6. Status: only Original source CPG (de novo developed) rather
than 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 website
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 and
interventions undertaken to turn
policies 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!”

“Multi-faceted” are more
effective than single
strategies in CPGI!

Facilitators and Barriers in
CPGI

Facilitators of CPGI
Domain
Positive attitude
Learning through small group interaction
Individual
Leadership support
Champions
Team work collaboration
Organizational
Scientific specialized association support
Inter-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

CPG Implementation cycle

CPG Implementation cycle
FinalCPGApproved+CPGITools+Plan
FormulateImplementation
multidisciplinaryteam
Baseline(Pre-)Auditofcurrent
CP
PilotImplementation
Identifybarriers
Prioritizedisseminationstrategies
andstart
Prioritize1–3keyRsto
implement
Prioritizeimplementation
strategies
Post-implementationM&ERegular
checkpoints(PIPOH-KPI)
Regularreview&updateofpublished
sourceCPG+/-evidence

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-Based
Medicine, Ain Shams University, Cairo.
• Alexandria Center for Evidence-Based
Medicine, MRI, Alex. University, Alex.
• Alexandria Center for Evidence-Based
Clinical 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 Hospitals
Healthcare 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)

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 CPGs
2009 (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)

J Eval Clin Pract 2015, 21: 1095-1106.
doi:10.1111/jep.12479
Link:
http://onlinelibrary.wiley.com/doi/10.1111/jep.12479/abstractAlexandria Pediatric Center - Scientific

Regional: WHO-EMRO
Nov. 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

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 Amer
M Pedia, M H Informatics, CPHQ, FISQua
CPGs Advisor & TrainerAlexandria Pediatric Center - Scientific

Questions?

Contact Information
Email Addresses:
yasser3amer@yahoo.com; yamer@ksu.edu.sa;
yasser.sami.amer@gmail.com
yasser.sami@alexmed.edu.eg
My Research:
https://www.researchgate.net/profile/Yasser_Amer2
My Slides:
https://www.slideshare.net/yassersami/presentations

Evidence-Based Clinical Practice Guidelines for Pediatricians

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