Béatrice Fervers fervers@lyon.fnclcc.fr Madrid 30 novembre 2006

1. Guideline adaptation:the way forward? Béatrice Fervers fervers@lyon.fnclcc.fr Madrid 30 novembre 2006

2. 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

3. Guideline adaptation: the way forward? • Many guidelines on the same topic • Convergence of key methods for guideline development But • Guidelines 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

4. Evidence and evidence judgments Organisational context Cultural context and value judgments Translation of evidence into guideline recommendations

5. 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 perspectives • Wils 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

6. Guideline adaptation Definition Modification 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

7. '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 Broad Narrow There Here Different forms of guideline adaptation

8. 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?

9. MANUAL FOR GUIDELINE ADAPTATION Version 1.0 Prepared by theADAPTEGROUP 2006 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

10. 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

11. 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

12. 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

13. 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

14. 3 Phases and Various Modules of Process

15. 3 Phases and Various Modules of Process

16. 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

17. Adaptation PhaseScope and Purpose Module PIPOH Patient population and disease characteristics Intervention (s) of interest Professionals targeted by the guideline Outcomes and endpoints to be taken into consideration Healthcare setting and context

18. 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

19. Adaptation PhaseAssessment Module

20. 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

21. 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?

22. 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?

23. 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

24. 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

25. 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

26. 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

27. 3 Phases and Various Modules of Process

28. 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 study • Assessment of use, acceptability, relevance and benefits to different user groups

29. 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 guidelines • Reduce 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 recommendations • Educative process • Respects evidence-based principles of guideline development • Explicit consideration of the context of use • Favors confidence, acceptance and ownership • Advantage for countries and organisations with small budgets and limited experience

30. 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

31. Guideline adaptation: First step to shared development and updating?

32. Step 0 Topic selection Step 1 Constitution of multidisciplinary working group Step 2 Literature search Step 3 Critical appraisal / systematic review Multinational collaboration to avoid duplication of effort Formulation of the recommendations Step 4 Step 5 External review Step 6 Dissemination Step 7 Publication Step 8 Literature monitoring to identify needed updates CoCanCPG - What aspects can be shared at a multi-national level ?

33. 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 thetrans-national level

34. P9 – Spain: AATRM P1 – Coordinator: INCa P10 – UK: SIGN P2 – Belgium: KCE P3 – France: HAS P11 – UK: NICE P4 – Hungary: EUMIN P12 – Italy: ASR E-R P5 – Israel: CSMOH P13 – France: FNCLCC P14 – Lithuania: Institute of Oncology, Vilnius University P6 – Lithuania: DSPP P15 – Germany: IQWiG P16 – Quebec: DLCC P8 – Spain: AETSA CoCanCPG www.cocancpg.eu16 Partners from 11 countries P7 – Netherlands: ACCC

35. Translation of new knowledge into clinical practice and health decision making Basic biomedical research Clinical research Improved health Clinical Research Continuum Sung et al, JAMA 2003;289:1278-86 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 from basic sciences to human sciences