Béatrice Fervers [email protected] Madrid 30 novembre 2006
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Transcript of Béatrice Fervers [email protected] Madrid 30 novembre 2006
1Madrid - 30/11/2006 - B. Fervers. Copyright © 2006
Béatrice [email protected]
Madrid 30 novembre 2006
Guideline adaptation:
the way forward?
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Challenges for guideline developers
Produce high quality guidelines in a timely manner
Keep guidelines up-to-date
Work with increasingly limited resources
Foster ownership and acceptance of guidelines
Improve effective use of guidelines
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Guideline adaptation: the way forward?
Many guidelines on the same topic
Convergence of key methods for guideline developmentButGuidelines on the same topic vary in coverage and scope
Inconsistency of recommendations with cited evidence Lack of transparency in the formulation of recommendations
Legitimate variations of guideline recommendations based on the same evidence
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Organisational context
Evidence and evidence judgments
Cultural context andvalue judgments
Translation of evidence into guideline recommendations
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Legitimate variations of guideline recommendations
Initial treatment of women with early stage breast cancer. Clinical recommendations in France and Ontario
Fervers B et al. 1997 Cultural basis for differences between US and French clinical
recommendations for women at increased risk of breast and ovarian cancer
Eisinger F et al. 1999 Adjuvant treatment of colorectal cancer at the turn of the century:
European and US perspectivesWils J et al 2001
Ethnic specific recommendations in CPG Manna DR et al. 2003
Culturally appropriate guidelines for alcohol and drug abuse prevention
Shoultz et al 2000
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Guideline adaptation
DefinitionModification of guideline(s) produced in one cultural and organizational setting to be used in a different cultural organizational context
Alternative to de novo guideline development
Take advantage of existing guidelines to reduce duplication of effort
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Different forms of guideline adaptation
'Broad to narrow' adaptation From national level to local or
regional context Implementation: tailoring of a
national guideline to local context
'Transcontextual' adaptation Distinct cultural and organisational
setting Alternative to de novo guideline
development Implementation of an international
guideline
HereThereNarrowBroad
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Guideline adaptation:practical questions
How to identify relevant guidelines?
How to assess guideline quality?
How to assess fidelity?
How to assess applicability ?
How to adapt the recommendations?
How to ensure acceptance and ownership of adapted guideline?
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ADAPTE
Aims Promote the efficient production and use of clinical practice
guidelines through the adaptation of existing guidelines Develop a systematic approach to aid in the adaptation of
guidelines
MANUAL FOR GUIDELINE ADAPTATIONVersion 1.0
Prepared by the ADAPTE GROUP
2006
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The ADAPTE group
International collaboration of researchers and guideline developers Fervers B, Burgers JS, Haugh MC, Latreille J, Mlika-Cabanne
N, Paquet L, Coulombe M, Poirier M, Burnand B. Adaptation of clinical guidelines: literature review and proposition for a framework and procedure. International Journal of Quality in Health Care 2006:18(3):167-176
Graham, I. D., Harrison, M. B., & Brouwers, M. (2003). Evaluating and adapting practice guidelines for local use: a conceptual framework. In S.Pickering & J. Thompson (Eds.), Clinical Governance in Practice (pp. 213-229). London: Harcourt
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ADAPTE - a systematic approach to guideline adaptation
Why develop a systematic approach ?
Help ensure the quality and validity of the adapted guideline
Enhance relevance of adapted guideline to the context of use
Encourage confidence in and acceptance of the guidelines by targeted users
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ADAPTE process
Target audience Guideline developers, health care professionals and decision makers Groups from local to international level Manual takes into account level of experience with guideline
development and available resources
Applications Groups interested in selecting 1 cpg and adapting it to the local
context Groups wishing to identify all high quality guidelines and customize
one that meets their needs Manual designed to be flexible
Scope CPGs of any disease area Screening, diagnosis, treatment, supportive care, health promotion
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Principles guiding ADAPTE
Respect of evidence-based principles for guideline development
Reliable methods to ensure quality and validity of adapted guidelines
Participative approach involving all key stakeholders to foster acceptance and ownership
Explicit consideration of context to ensure relevance for practice
Transparent reporting to favor confidence
Flexible format to accommodate specific needs and circumstances
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3 Phases and Various Modules of Process
Set-UpPhase
Adaptation Phase FinalizationPhase
Preparation Module
Scope and Purpose Module Search and Screen Module Assessment Module Decision and Selection
Module Customization Module
External Review, Consultation and Accountability Module
Final Production Module
Scheduled Review and Update Module
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3 Phases and Various Modules of Process
Set-UpPhase
Adaptation Phase FinalizationPhase
Preparation Module
Scope and Purpose Module Search and Screen Module Assessment Module Decision and Selection
Module Customization Module
External Review, Consultation and Accountability Module
Final Production Module
Scheduled Review and Update Module
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Adaptation phase
Assists users in moving from selection of a topic to identification of
specific clinical questions searching for and retrieving guidelines assessing the consistency of the evidence
therein, their quality, currency, content and applicability
decision making around adaptation and preparing the draft adapted guideline
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Adaptation PhaseScope and Purpose Module
Patient population and disease characteristicsIntervention (s) of interest
Professionals targeted by the guideline
Outcomes and endpoints to be taken into consideration
Healthcare setting and context
PIPOH
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Adaptation Phase Search and Screen Module
Searching for guidelines Guideline clearinghouses (e.g. www.g-i-n.net,
ww.guideline.gov) Guideline developing organisations' websites Bibliographic databases (eg MEDLINE, Embase) Internet
Screen retrieved guidelines Relevance to defined key questions Publication date Modify clinical questions, expand search Reduce a large number of retrieved guidelines
Rigor dimension of the AGREE instrument
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Adaptation PhaseAssessment Module
Aims/ Tasks Products/ Deliverables
Skills/ Organizational Requirements
Helpful Tools
Assess the consistency, quality, currency, content and applicability of
source guidelines
AGREE scores Search and
selection evaluation Consistency of
evidence and interpretations
Consistency of interpretations and recommendations
Summary of currency
Recommendations Matrices
Evaluation of applicability
Methodological expertise
Information retrieval skills
Clinical expertise
Evaluation – Search and selection of evidence
Evaluation – Scientific validity of guidelines with respect to clinical questions
AGREE instrument
AGREE inter-rater agreement and scored spreadsheets
Sample currency survey
Sample recommendations matrices
Worksheet - Applicability
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Assessment Module -Quality
Agree Instrument Framework for assessing the methods
used for developing the guideline and the quality of the reporting
6 domains and 23 items Raw AGREE scores Dimensions graphs
Overall assessment item ·strongly recommend· ·recommend with alterations· ·would not recommend· ·unsure·
Discussion of differences with the panel
Educational process Confidence
0
10
20
30
40
50
60
70
80
90
CPG1
CPG2
CPG3
CPG4
CPG5
CPG6
CPG7
Clarity andPresentation
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Assessment Module – Consistency
Evaluation of search strategy and selection of evidence Comprehensive search for evidence? No biases in the selection of articles?
Consistency between evidence and interpretations, interpretations and recommendations Overall the evidence is valid? Recommendations based on data / interpretations?
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Assessment Module -Currency
Rapidly evolving evidence [Shekelle et al 2001]
Guidelines may be outdated in as little as 3 years Assement of currency
When was the guideline last updated?
Any plans to update the guideline in near future?
Any new evidence to invalidate any of the recommendations?
Any new evidence relevant to guideline?
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Assessment Module – Applicability / Acceptability
To ensure that the adapted guideline will be relevant for the context of use and that it is suited to the needs, priorities, legislation, policies and resources in the targeted setting
Can the recommendation be put into practice? Applicability to targeted patients
Characteristics Organizational barriers (health care system and local)
Availability of interventions Availability of necessary expertise Economic/resource barriers
Value judgements and cultural differences Is the benefit from this recommendation worth implementing?
Strength of supporting evidence Value judgements
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Adaptation PhaseDecision and Selection Module
Results of the assessment module provide an explicit basis for informed and transparent decision making around the selection and modifications of source guidelines
Review assessments to aid in decision making Panel discussion Select between guidelines and recommendations to
create an adapted guideline
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Decision and Selection Module
Results of the assessment module Explicit basis for informed and transparent decision making
Options ACCEPT a guideline as a whole and all of its recommendations
May include translation and adaptation of format
Production of a customized guideline from one or more source guidelines involving ACCEPT single recommendations ADAPT - Modify single recommendations ACCEPT evidence summary of guideline UPDATE of evidence
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Customization Module
Important sections of adapted guideline:
Transparency of all decision making (e.g., consensus process described, how decisions were arrived at/resolved, if recommendations were modified – how and why they were modified)
Acknowledgement of source guideline developers and where necessary, permission granted by source developers
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3 Phases and Various Modules of Process
Set-UpPhase
Adaptation Phase FinalizationPhase
Preparation Module
Scope and Purpose Module Search and Screen Module Assessment Module Decision and Selection Module Customization Module
External Review, Consultation and Accountability Module
Final Production Module
Scheduled Review and Update Module
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ADAPTE – next steps
Dissemination of ADAPTE Manual
Evaluation of ADAPTE process and tools ‘Does ADAPTE aid in the development of high
quality, unbiased guidelines, produced efficiently and likely to be used in practice?’
International studyAssessment of use, acceptability, relevance and
benefits to different user groups
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Guideline adaptation: the way forward?Potential benefits
Potentially less time and fewer resources required than for de novo development
SOR : 10 months with ADAPTE vs 16-18 month
Efficient use and rigorous review of existing guidelinesReduce duplication of effort, especially for the systematic review portion of
guideline
Improved quality and consistency of the guidelines produced? Promotes explicitness and transparency of guideline recommendationsEducative process Respects evidence-based principles of guideline development
Explicit consideration of the context of useFavors confidence, acceptance and ownership
Advantage for countries and organisations with small budgets and limited experience
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Guideline adaptation: the way forward?Potential barriers
Heterogeneous quality of existing guidelines
Currency of source guidelines
Transparency of reporting in guidelines
Reluctance of panel members Before - After Transparent explanation of the process is
important !
Reluctance to use adapted guidelines
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Guideline adaptation:
First step to shared
development and updating?
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CoCanCPG - What aspects can be shared at a multi-national level ?
Topic selection
Constitution of multidisciplinary working group
Publication
Dissemination
Literature monitoring to identify needed updates
Literature search
External review
Critical appraisal / systematic review
Formulation of the recommendationsMultinational collaboration
to avoid duplication
of effort
Step 0Step 0
Step 1Step 1
Step 2Step 2
Step 4Step 4
Step 3Step 3
Step 5Step 5
Step 6Step 6
Step 8Step 8
Step 7Step 7
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CoCanCPG : Co-ordination of Cancer guideline programs
Coordination Action under the ERA-Net scheme Overcome existing fragmentation and duplication between
cancer guidelines programs Support the coherent development of policies at regional,
national and European level to improve equitable access to high quality cancer care
Establish sustainable cooperation at the program management level for guideline development and research Set up a framework for sharing of information, methods and skills Benchmark guideline development methods Identify and implement activities that can be shared at the
trans-national level
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CoCanCPG www.cocancpg.eu16 Partners from 11 countries
P7 – Netherlands: ACCC
P10 – UK: SIGN
P12 – Italy: ASR E-R
P11 – UK: NICE
P9 – Spain: AATRM
P13 – France: FNCLCC
P14 – Lithuania: Institute of Oncology, Vilnius University
P15 – Germany: IQWiG
P16 – Quebec: DLCC
P5 – Israel: CSMOH
P4 – Hungary: EUMIN
P2 – Belgium: KCE
P6 – Lithuania: DSPP
P3 – France: HAS
P1 – Coordinator: INCa
P8 – Spain: AETSA
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Globalise the evidenceLocalise the decisionJohn Eisenberg
Adaptation and shared development to overcome duplication
Taking into account the local context is necessary to bridge the gap
Translation frombasic sciences tohuman sciences
Clinical Research ContinuumSung et al, JAMA 2003;289:1278-86
Basicbiomedicalresearch
Clinicalresearch
Translation of new knowledge into clinical
practice and health decision making
Improvedhealth