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Evidence-Based
  Clinical Practice Guidelines
           (EBCPGs)
           For Medical Staff of

Healthcare Organizations (HCOs)

                 Introduction
                          By
    Dr. Yasser Sami A. Amer, MBBCh, MS
            Pediatrician - HC Informatician
              EBCPGs Advisor & Trainer

                       2013
Concepts & Definitions
Two Different Approaches to Evidence-Based
               Practice (EBP)

Clinical Practice Guidelines (CPGs)
  •“Top-down” approach
  • Tell clinicians how to practice
  • Favored by health care systems


Evidence-Based Medicine (EBM)
  •“Bottom-up” approach
  • Teach clinicians how to find answers
  • Favored by medical educators
EBM definition
The integration of best research evidence
                  Clinical
 with clinical expertise and patient
 values          Expertise
  Sackett et al 2000
          Research       Patient
          Evidence     Preferences
What is “EBM” NOT?
• What we have always done !;
   (not old hat or just the same old medical practice; as evidenced in wide
   practice variation)
• “Cookbook Medicine”!
   EBM specifically advocates for individualized application of evidence to patient
   care, not forcing patient care to conform to generalized evidence
• Only a cost-cutting trick !;
   it is intended to guide practitioners to provide the best, not necessarily the cheapest,
   care.
• Only RCTs !;
  (Also with best relevant evidence applicable to the situation in
  question)

             – EBM is tracking down the best external evidence from
               scientific research to answer our clinical question(s)…
Clinical Practice Guidelines (CPGs)

Definition: (old)
 “Systematically developed statements to assist
  practitioner and patient decisions about
  appropriate health care for specific clinical
  circumstances” (Institute of Medicine 1990).


           Increasing international interest in the
           development and implementation of CPGs.
CPGs New Definition
CPGs are “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)
Why do we need guidelines?
Rationale for CPGs
• Worldwide concerns about:
 ▫ Unexplained variations in clinical practice
 ▫ Rising health care costs
 ▫ Exponential growth of information
• Aim of Clinical Practice Guidelines:
 ▫ To facilitate more consistent, effective and
   efficient practice and improve health outcomes for
   patients
Clinical     Best
Care GAP    Practice
Who needs guidelines?
• Doctors
• Nurses
• Decision makers
• Patients
• Public
CPG Producers:
Specialized Societies: e.g. AAP
CPG Producers:
          National Agencies


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


       NICE
National Institute for
  Health & Clinical
     Excellence
 www.nice.org.uk
AHRQ
National Guideline
   Clearinghouse
 www.guidelines.gov
Guidelines
 Internationa
   l Network
   (G-I-N)
www.g-i-n.net
PubMed
US National Library of
       Medicine
National Institutes of
     Health (NIH)
Some CPGs are only retrievable by
       “Googling” them!
How do we react to
   guidelines?
Develop
               Adapt
       Adopt

Read


                       CPGs ?
Topic

                      Team

                    Content

                     Search

   FOUND                           NOT FOUND

  Appraise                          Develop

Adopt or Adapt                      Appraise

                   Implement

                 Evaluate impact
Adaptation of Clinical Practice
             Guidelines



      The        ADAPTE                collaboration      is an
international collaboration of CPG researchers, developers and
implementers. Their main aim is to develop and validate a
generic adaptation process that will foster valid and high-quality
adapted guidelines as well as the user’s sense of ownership of
the adapted guideline.
  Since 2009 The ADAPTE Collaboration has merged into the Guidelines
  International Network (G-I-N) with all its resources to form the G-I-N
                      Adaptation Working Group
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. 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/
©Copyright ADAPTE 2007
Adaptation Phase
We identified 3 main ADAPTE steps:-

       Search & Selection of source CPGs
             Health Questions (PIPOH)
             AGREE II Instrument
              Assess source CPGs quality

                External Review
             (Departmental Consensus)
CPG Scope: PIPOH Model

Patient (& disease characteristics)
Intervention(s)
Professionals (Target users)
Outcomes (purpose of the CPGs)
Healthcare settings (& context)
      = Health/ Clinical/ Key Questions
Evidence Pyramid




                                                    Grades of Recommendations
                                    MA
Levels of Evidence


                       I                        A
                                    RCT

                                  Cohort
                     II
                                Case control
                                                B
                                Case series
                     III
                                Case report


                     IV        Expert opinion   C
How to assess of the quality of any CPG ?
Assess guideline
  quality

ADAPTE TOOL 9      AGREE II Instrument


23 items in 6 domains
 7 point response scale
 Domain scores
 Recommendations
AGREE II
DOMAINS
          Domains
   1      Scope & Purpose
   2      Stakeholder Involvement
  3       Rigour of Development
   4      Clarity & Presentation
   5      Applicability
   6      Editorial Independence
Hospital Official CPGs:
       Two separate documents
FIRST (Clinicians’ Version)
• Accessible from ALL points-of-care
  for the hospital staff:
• Details of evidence-based
  recommendations for management
  (with only references to the other
  document)
SECOND:
           (Methodologist’s Version) ;
• Accessible from Libraries
  of e.g. Department,
  College of Medicine, CPG
  Committee, QMD,
  Authorship group,…etc.
  (Reference for Replication &
  Documentation)
• Detailed description of the
  CPG Adaptation process
  with ALL relevant data.
Dissemination & Implementation
  Nothing could be more
frustrating than producing
a CPG that is then ignored
by not being disseminated
     nor implemented
Dissemination of CPGs
• Full CPGs documents published on
 websites - integrated into HCO’s Health Information
 System (HIS) & Electronic Medical Records (EMRs)
• Implementation tools will also be published:
 examples for choice:-
 ▫   Quick Reference Guide (Summary Key Rs)
 ▫   Clinical Algorithms (decision tree)
 ▫   Clinical pathways (Integrated care pathways)
 ▫   Patient Information (Education Guide)
 ▫ Gantt chart for dissemination & Implementation
 ▫ Audit and Research Rs.
Implementing Guidelines
• If CPGs are to have a positive impact on
  patient care outcomes they must be
  implemented and incorporated into everyday
  clinical practice

• The identification of any barriers to
  implementation, and strategies for
  overcoming them, will form an essential
  part of discussions at CPGs
  Subcommittee/ Adaptation Group
  meetings
Launching of
Clinical Practice Guidelines
    Taskforce members
     TEAM WORK
2006


1999



       2004
Alexandria University Hospitals
          Healthcare Quality Directorate
Center for Evidence-Based Clinical Practice Guidelines
               (AUH – HCQD, CEBCPGs)
                 (Founded Nov. 2008)

  Member of Guidelines International Network (G-I-N)
                 (Since May 2009)
Founding Members 2008
•   Prof. Dr. Mahmoud Elzalabany
•   Prof. Dr. Tarek Omar
•   Prof. Dr. Afaf Ibrahim
•   Prof. Dr. Nabil Dowidar
•   Dr. Yasser S. Amer
•   Dr. Hossam Ashour
•   Eng. Ahmed Mourady
G-I-N Annual Report 2009
     EGYPT (EG)
First Workshop in Egypt: Adaptation of CPGs
           2009 (AFM-GIN-ADAPTE)
*12 M.Sc. Theses plus 1 Ph.D. thesis to produce 13 Adapted EBCPGs
4 Finalized Adapted CPGs by CEBCPGs, HCQD-AUHs through MSc
Theses (till 3/2012) in PEDIATRICS DEPT.:
1- Treatment of Acute Childhood Asthma in ER - AUCH: Dr. Yasser Sami Amer
(Finalized, Approved , Disseminated & Implemented).
2- Treatment of Positioning & Attachment Breast Feeding Problems in BFCC - AUCH:
Dr. Georgina Ramsis (Finalized & Approved).
3- Triage and Acuity Scale in A & E Dept., AMUH: Dr. Mary Christeen Nabiel Sharobeem
(Finalized, Approved & Disseminated ) – the only thesis outside the Pediatrics Dept.
4- Treatment of HIE in Neonates in NICU: Dr. Walid Gamal AbdelKhaliq
(Finalized & Approved).
5- Treatment of ADHD in children in AUCH: Dr. Mariana Iskander Amin
9 Adapted CPGs in progress by Pediatrics Dept. & CEBCPGs, HCQD-AUHs
through MSc/PhD Theses (till 8/2012):
1. Diagnosis of acute attack of seizures in AUCH: Dr. Soheir Farouk AbdelSalam (Set
   Up Phase).
2. Treatment of acute attack of seizures in AUCH : Dr. Islam Yousry A.Moneium (Set Up
   Phase).
3. Management of Epilepsy in children in AUCH: Dr. Shimaa Anwar (Set Up Phase)
4. Treatment of Childhood Autism in AUCH: Dr. Farioz Ibrahim (Set Up Phase).
5. Management of Acute Bacterial Meningitis in AUCH: Dr Mariam Adly (Set Up Phase).
6. Treatment of Chronic Asthma in AUCH: Dr. Reem Galal Ghazal (Set Up Phase).
7. Treatment of Community Acquired Pneumonia in AUCH: Dr. Zobaida Eltazmany (Set
   Up Phase).
8. Treatment of Allergic Rhinitis in AUCH: Dr. Shahinaz (Set Up Phase).
Alexandria CEBCPGs
 Adapted ADAPTE
     Methods
for CPGs adaptation
5 Finalized Adapted CPGs
Official website:
http://www.alexmed.edu.eg/?page_id=1278
            Last accessed 8/2012
https://www.facebook.com/pages/Alexandria-Center-for-Evidence-Based-Clinical-Practice-
                       Guidelines/124300224291530?ref=hl
Prof. Dr. Nabil Dowidar
Professor of General Surgery , MRI
Head, Alexandria Center for EBM, MRI
Founding Member, Health Governance Unit, MRI
Former Dean, MRI
Medical Research Institute (MRI)

Prof. Dr. Afaf Ibrahim
Professor of Public Health, Social & Preventive Medicine, AFM
Head, Community Medicine Dept.
Director, CEBCPGs , HCQD-AUHs
Dr. Yasser Sami Amer
M.Sc. Pediatrics, M.Sc. Healthcare Informatics
Hospital Clinical Guidelines & Pathway General Coordinator, CEBCPGs, HCQD-AUHs, Primary
Contact Person for G-I-N

Dr. Hossam Dhorgham
M.Sc. Pediatrics, M.Sc. Healthcare Management
Former Healthcare Quality Coordinator, HCQD-AUHs
Former Head, Accreditation & Licensure Directorate, HCQD-AUHs

Eng. Ahmed Mourady
Communication & Electronics Engineer
E-Learning Consultant,
Former Local Project Manager, Modernization of AUHs in Smouha
Prof. Dr. Tarek Omar
Professor of Pediatrics & Ped. Neurology, AFM
   General Supervisor CEBCPGs & HCQD-AUHs.
           Former Head, AUHs Sector
Prof. Dr. Mahmoud El-Zalabany
Professor of Pediatrics & Ped. Respiratory, Allergy & Immunology
                        Former Dean, AFM
                 Former Chairman, AUHs Board
G-I-N 2009 Lisbon




                    G-I-N 2012 Berlin
Dr. Yasser Sami Amer
 MSc Pediatrics, MSc HC Informatics
   EBCPGs Advisor & Trainer

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Evidence-Based Clinical Practice Guidelines for Medical Staff of Health Care Organizations

  • 1.
  • 2. Evidence-Based Clinical Practice Guidelines (EBCPGs) For Medical Staff of Healthcare Organizations (HCOs) Introduction By Dr. Yasser Sami A. Amer, MBBCh, MS Pediatrician - HC Informatician EBCPGs Advisor & Trainer 2013
  • 4. Two Different Approaches to Evidence-Based Practice (EBP) Clinical Practice Guidelines (CPGs) •“Top-down” approach • Tell clinicians how to practice • Favored by health care systems Evidence-Based Medicine (EBM) •“Bottom-up” approach • Teach clinicians how to find answers • Favored by medical educators
  • 5. EBM definition The integration of best research evidence Clinical with clinical expertise and patient values Expertise Sackett et al 2000 Research Patient Evidence Preferences
  • 6. What is “EBM” NOT? • What we have always done !; (not old hat or just the same old medical practice; as evidenced in wide practice variation) • “Cookbook Medicine”! EBM specifically advocates for individualized application of evidence to patient care, not forcing patient care to conform to generalized evidence • Only a cost-cutting trick !; it is intended to guide practitioners to provide the best, not necessarily the cheapest, care. • Only RCTs !; (Also with best relevant evidence applicable to the situation in question) – EBM is tracking down the best external evidence from scientific research to answer our clinical question(s)…
  • 7. Clinical Practice Guidelines (CPGs) Definition: (old) “Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” (Institute of Medicine 1990). Increasing international interest in the development and implementation of CPGs.
  • 8. CPGs New Definition CPGs are “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)
  • 9. Why do we need guidelines?
  • 10. Rationale for CPGs • Worldwide concerns about: ▫ Unexplained variations in clinical practice ▫ Rising health care costs ▫ Exponential growth of information • Aim of Clinical Practice Guidelines: ▫ To facilitate more consistent, effective and efficient practice and improve health outcomes for patients
  • 11. Clinical Best Care GAP Practice
  • 13. • Doctors • Nurses • Decision makers • Patients • Public
  • 14.
  • 15.
  • 17. CPG Producers: National Agencies SIGN Scottish Intercollegiate Guidelines Network www.sign.ac.uk
  • 18. CPG Producers: National Agencies NICE National Institute for Health & Clinical Excellence www.nice.org.uk
  • 19. AHRQ National Guideline Clearinghouse www.guidelines.gov
  • 20. Guidelines Internationa l Network (G-I-N) www.g-i-n.net
  • 21. PubMed US National Library of Medicine National Institutes of Health (NIH)
  • 22. Some CPGs are only retrievable by “Googling” them!
  • 23. How do we react to guidelines?
  • 24. Develop Adapt Adopt Read CPGs ?
  • 25. Topic Team Content Search FOUND NOT FOUND Appraise Develop Adopt or Adapt Appraise Implement Evaluate impact
  • 26.
  • 27. Adaptation of Clinical Practice Guidelines The ADAPTE collaboration is an international collaboration of CPG researchers, developers and implementers. Their main aim is to develop and validate a generic adaptation process that will foster valid and high-quality adapted guidelines as well as the user’s sense of ownership of the adapted guideline. Since 2009 The ADAPTE Collaboration has merged into the Guidelines International Network (G-I-N) with all its resources to form the G-I-N Adaptation Working Group
  • 28. 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. 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/
  • 30. Adaptation Phase We identified 3 main ADAPTE steps:- Search & Selection of source CPGs Health Questions (PIPOH) AGREE II Instrument Assess source CPGs quality External Review (Departmental Consensus)
  • 31.
  • 32. CPG Scope: PIPOH Model Patient (& disease characteristics) Intervention(s) Professionals (Target users) Outcomes (purpose of the CPGs) Healthcare settings (& context) = Health/ Clinical/ Key Questions
  • 33. Evidence Pyramid Grades of Recommendations MA Levels of Evidence I A RCT Cohort II Case control B Case series III Case report IV Expert opinion C
  • 34. How to assess of the quality of any CPG ?
  • 35. Assess guideline quality ADAPTE TOOL 9 AGREE II Instrument 23 items in 6 domains 7 point response scale Domain scores Recommendations
  • 36. AGREE II DOMAINS Domains 1 Scope & Purpose 2 Stakeholder Involvement 3 Rigour of Development 4 Clarity & Presentation 5 Applicability 6 Editorial Independence
  • 37. Hospital Official CPGs: Two separate documents FIRST (Clinicians’ Version) • Accessible from ALL points-of-care for the hospital staff: • Details of evidence-based recommendations for management (with only references to the other document)
  • 38. SECOND: (Methodologist’s Version) ; • Accessible from Libraries of e.g. Department, College of Medicine, CPG Committee, QMD, Authorship group,…etc. (Reference for Replication & Documentation) • Detailed description of the CPG Adaptation process with ALL relevant data.
  • 39. Dissemination & Implementation Nothing could be more frustrating than producing a CPG that is then ignored by not being disseminated nor implemented
  • 40. Dissemination of CPGs • Full CPGs documents published on websites - integrated into HCO’s Health Information System (HIS) & Electronic Medical Records (EMRs) • Implementation tools will also be published: examples for choice:- ▫ Quick Reference Guide (Summary Key Rs) ▫ Clinical Algorithms (decision tree) ▫ Clinical pathways (Integrated care pathways) ▫ Patient Information (Education Guide) ▫ Gantt chart for dissemination & Implementation ▫ Audit and Research Rs.
  • 41. Implementing Guidelines • If CPGs are to have a positive impact on patient care outcomes they must be implemented and incorporated into everyday clinical practice • The identification of any barriers to implementation, and strategies for overcoming them, will form an essential part of discussions at CPGs Subcommittee/ Adaptation Group meetings
  • 42. Launching of Clinical Practice Guidelines Taskforce members TEAM WORK
  • 43.
  • 44. 2006 1999 2004
  • 45.
  • 46. Alexandria University Hospitals Healthcare Quality Directorate Center for Evidence-Based Clinical Practice Guidelines (AUH – HCQD, CEBCPGs) (Founded Nov. 2008) Member of Guidelines International Network (G-I-N) (Since May 2009)
  • 47.
  • 48.
  • 49. Founding Members 2008 • Prof. Dr. Mahmoud Elzalabany • Prof. Dr. Tarek Omar • Prof. Dr. Afaf Ibrahim • Prof. Dr. Nabil Dowidar • Dr. Yasser S. Amer • Dr. Hossam Ashour • Eng. Ahmed Mourady
  • 50. G-I-N Annual Report 2009 EGYPT (EG)
  • 51. First Workshop in Egypt: Adaptation of CPGs 2009 (AFM-GIN-ADAPTE)
  • 52. *12 M.Sc. Theses plus 1 Ph.D. thesis to produce 13 Adapted EBCPGs 4 Finalized Adapted CPGs by CEBCPGs, HCQD-AUHs through MSc Theses (till 3/2012) in PEDIATRICS DEPT.: 1- Treatment of Acute Childhood Asthma in ER - AUCH: Dr. Yasser Sami Amer (Finalized, Approved , Disseminated & Implemented). 2- Treatment of Positioning & Attachment Breast Feeding Problems in BFCC - AUCH: Dr. Georgina Ramsis (Finalized & Approved). 3- Triage and Acuity Scale in A & E Dept., AMUH: Dr. Mary Christeen Nabiel Sharobeem (Finalized, Approved & Disseminated ) – the only thesis outside the Pediatrics Dept. 4- Treatment of HIE in Neonates in NICU: Dr. Walid Gamal AbdelKhaliq (Finalized & Approved). 5- Treatment of ADHD in children in AUCH: Dr. Mariana Iskander Amin 9 Adapted CPGs in progress by Pediatrics Dept. & CEBCPGs, HCQD-AUHs through MSc/PhD Theses (till 8/2012): 1. Diagnosis of acute attack of seizures in AUCH: Dr. Soheir Farouk AbdelSalam (Set Up Phase). 2. Treatment of acute attack of seizures in AUCH : Dr. Islam Yousry A.Moneium (Set Up Phase). 3. Management of Epilepsy in children in AUCH: Dr. Shimaa Anwar (Set Up Phase) 4. Treatment of Childhood Autism in AUCH: Dr. Farioz Ibrahim (Set Up Phase). 5. Management of Acute Bacterial Meningitis in AUCH: Dr Mariam Adly (Set Up Phase). 6. Treatment of Chronic Asthma in AUCH: Dr. Reem Galal Ghazal (Set Up Phase). 7. Treatment of Community Acquired Pneumonia in AUCH: Dr. Zobaida Eltazmany (Set Up Phase). 8. Treatment of Allergic Rhinitis in AUCH: Dr. Shahinaz (Set Up Phase).
  • 53. Alexandria CEBCPGs Adapted ADAPTE Methods for CPGs adaptation
  • 57. Prof. Dr. Nabil Dowidar Professor of General Surgery , MRI Head, Alexandria Center for EBM, MRI Founding Member, Health Governance Unit, MRI Former Dean, MRI Medical Research Institute (MRI) Prof. Dr. Afaf Ibrahim Professor of Public Health, Social & Preventive Medicine, AFM Head, Community Medicine Dept. Director, CEBCPGs , HCQD-AUHs
  • 58. Dr. Yasser Sami Amer M.Sc. Pediatrics, M.Sc. Healthcare Informatics Hospital Clinical Guidelines & Pathway General Coordinator, CEBCPGs, HCQD-AUHs, Primary Contact Person for G-I-N Dr. Hossam Dhorgham M.Sc. Pediatrics, M.Sc. Healthcare Management Former Healthcare Quality Coordinator, HCQD-AUHs Former Head, Accreditation & Licensure Directorate, HCQD-AUHs Eng. Ahmed Mourady Communication & Electronics Engineer E-Learning Consultant, Former Local Project Manager, Modernization of AUHs in Smouha
  • 59. Prof. Dr. Tarek Omar Professor of Pediatrics & Ped. Neurology, AFM General Supervisor CEBCPGs & HCQD-AUHs. Former Head, AUHs Sector
  • 60. Prof. Dr. Mahmoud El-Zalabany Professor of Pediatrics & Ped. Respiratory, Allergy & Immunology Former Dean, AFM Former Chairman, AUHs Board
  • 61. G-I-N 2009 Lisbon G-I-N 2012 Berlin
  • 62. Dr. Yasser Sami Amer MSc Pediatrics, MSc HC Informatics EBCPGs Advisor & Trainer