1 Madrid - 30/11/2006 - B. Fervers. Copyright © 2006 Béatrice Fervers [email protected] Madrid 30 novembre 2006 Guideline adaptation: the way forward?

1Madrid - 30/11/2006 - B. Fervers. Copyright © 2006

Béatrice [email protected]

Madrid 30 novembre 2006

Guideline adaptation:

the way forward?


www.adapte.org

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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Set-UpPhase


Preparation Module

Scope and Purpose Module Search and Screen Module Assessment Module Decision and Selection

Module Customization 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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Set-UpPhase


Preparation Module

Scope and Purpose Module Search and Screen Module Assessment Module Decision and Selection Module Customization 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

Documents

1 Madrid - 30/11/2006 - B. Fervers. Copyright © 2006 Béatrice Fervers [email protected] Madrid 30 novembre 2006 Guideline adaptation: the way forward?