Current issues in guideline development and implementation

1. Current issues in guideline development and implementation Sara Twaddle Director Scottish Intercollegiate Guidelines Network

2. Outline What are the issues facing the guideline world? Guideline development Implementation support Wider contextual issues Others International collaboration – the example of Guidelines International Network Working together to develop solutions

3. Issues in the guideline world I Issues in guideline development • Quality of development process • Conflicts of interest • Multidisciplinary involvement • Grading systems • Resources required • Adaptation / accreditation of others’ work • Updating • Etc…

4. Issues in the guideline world II Issues in implementation • Dissemination • Formats • Links with electronic decision support systems • Demonstrating impact • Etc…..

5. Issues in the guideline world III Wider contextual issues Defining a role for clinical guidelines Managing expectations Managing political interest Other issues Non clinical guidelines Rare diseases Multiple pathologies Special needs of low / middle income countries Etc…

6. Issues in guideline development

7. Quality of guideline development Research shows that the validity of a guideline is improved if : the guideline development group is multidisciplinary it is evidence based recommendations are explicitly linked to evidence Grimshaw and Russell (Qual Health Care 1993;2(4):243-8)

8. Ensuring high quality development Quality of the guideline development process can be analysed using the AGREE instrument - a real world example of international collaboration The AGREE Instrument has been translated into 7 European languages The Council of Europe has formally recommended its use and all EU-funded projects requested to assess guidelines with the AGREE Instrument

9. Structure Six domains • 23 items • 4-point Likert Scale 1. Scope & purpose (3) 2. Stakeholder involvement (4) 3. Rigour of development (7) 4. Clarity & presentation (4) 5. Applicability (3) 6. Editorial independence (2) Overall assessment User guide

10. Ensuring high quality development WHO has endorsed the AGREE Instrument AGREE II has recently been launched and is being translated in to many languages BUT Despite AGREE there are still issues in guideline development….

11. Conflicts of interest AGREE criteria - conflicts of interest of guideline development members should be recorded. It is not possible to completely eradicate competing interests They need to be managed not demonised Most important issue is making them explicit at all stages of the guideline development process May be particular issues from patient interest groups

12. Multidisciplinary and patient involvement AGREE criteria - the guideline development group should include individuals from all the relevant professional groups. AND - the patients' views and preferences should be sought Multidisciplinary involvement promotes a sense of ownership and facilitates implementation Many guideline developers have made this a centrepiece of their process, but not all Scepticism about contributions from non specialists is still common Even those that do may not do this that well…

13. SIGN experience - Contribution of individual members to GDG discussions Chair consultants advisors GPs AHPs Pagliari HC et al. Psychosocial influences on multidisciplinary guideline development.

14. Grading systems AGREE criteria - there should be an explicit link between the recommendations and the supporting evidence. And, the health benefits, side effects and risks should be considered in formulating the recommendations. There are a number of different grading systems available – all have advantages & disadvantages GRADE

15. Limited resources Guideline development is expensive and time consuming Average time to develop a full clinical guideline in SIGN is around 29 months and can involve around 20 guideline development group members and the majority of SIGN staff at some stage Likewise, keeping extant guidelines up to date is an increasing problem As a result, guideline developers are looking for ways to reduce costs and duplication of effort

16. Adaptation “A systematic approach to considering the use and/or modification of guidelines produced in one cultural and organizational setting for application in another context.” ADAPTE Collaboration, 2006 • Reduce duplication of effort, especially for the systematic review portion of guideline • Potentially less time and fewer resources required than for de novo development

17. Issues in implementation

18. Council of Europe 2001 The success and failure of clinical practice guidelines depend on: Their quality and medical value Social, legal and ethical aspects involved Their implementation in daily practice Council of Europe Rec. No. R (01) 13

19. Barriers to implementation Dissemination issues Timing issues Individual healthcare professional issues Quality issues Fiscal reasons Legal/social/ ethical issues

20. Dissemination issues - you cannot implement something you do not know about… The effort to get dissemination right is nearly always underestimated Content of the dissemination tools – full guideline or just the recommendations Format: Electronic versus hard copy Targeted versus broad brush approaches Inclusion in decision support tools and clinical pathways Dissemination is NOT an end in its own right

21. Timing issues – a guideline is nearly always out of date as soon as it is published! Shelf life – is there an explicit statement about this? Need to ensure that the period of evidence that has been reviewed is clearly stated Are there other ways of presenting guidelines which may make them more up to date – living guidelines ?? Need to ensure that any major changes are able to be flagged up to the audience – updates on websites may not be enough

22. Individual healthcare professional issues – people won’t implement guidelines they don’t agree with Some people have a high index of suspicion about any aspect of EBM and others will never accept guidelines from elsewhere You can ensure that: guidelines have been developed by a credible group of people all relevant professional groups have been represented recommendations are locally relevant guidelines are important and have management buy in - individuals will then need to justify why they are not following recommended practice

23. Quality issues – poor quality guidelines are less likely to be implemented Quality of the guideline development process can be analysed using the AGREE instrument But, this does not analyse the quality of the recommendations Also need to ensure that guideline recommendations are clear and address all the relevant issues (benefits, harms, costs etc) and that information on underlying evidence is easy to obtain

24. Fiscal issues – if the recommendations are unaffordable then they won’t be implemented Affordability vs cost effectiveness in guideline development – even if something is cost effective it may not be affordable Although affordability is a political issue, resource implications in terms of people, facilities, training and timing should all be addressed in the guideline However ‘there has been no widely accepted successful way of incorporating economic considerations into guidelines’ (Eccles & Mason, 2001)

25. Legal / social / ethical issues – a guideline which is not context specific is unlikely to be implemented If the guideline is adapted from elsewhere has it been looked at locally to see if it reflects the local situation? Have individual recommendations been written in such a way as to address these issues for specific groups? What are the legal implications of the use or not of a guideline?

26. Why collaborate? Survey of guideline programmes 2001 showed Concerns about guideline quality and effectiveness Similar goals and strategies worldwide Avoid duplication of effort and waste of resources

27. The G-I-N Story November 2002 “AGREE” partners from 8 countries consent on a constitution for The Guidelines International Network February 2003 G-I-N recognised as a Scottish Charity with 37 organisational members. April 2010 G-I-N has a membership of 93 organisations and 62 individuals from 38 countries and an international guideline library on www.g-i-n.net containing more than 6700 guidelines and related documents.

28. Aims and Objectives of G-I-N Quality improvement in healthcare by promoting systematic guideline development, dissemination, implementation, and evaluation International collaboration to avoid duplication of effort and to support harmonisation to facilitate information sharing, education, knowledge transfer to improve coordination with other health care quality initiatives Prioritisation and support of guideline research Information and training via annual conferences, trans-national project groups, training courses and events

29. 93Organisationsfrom38 Countries April 2010 Institute for Quality and Efficiency in Healthcare (IQWIG), DE The Mental Health Commission (MHC), IE Centre for Evaluation and Effectivenessof Healthcare, IT Italian Evidence-Based Medicine Group (GIMBE), IT Italian National Institute of Health (ISS), IT Regional Agency for Health in Tuscany, Quality Unit (ASR), IT Regional Health Agency Emilia Romagna (ASR), IT Dep. of Quality Management & Standards of Treatment, MoH (MS), MD Dutch Association of Comprehensive Cancer Centres (ACCC), NL Dutch College of General Practitioners (NHG), NL Dutch Institute for Healthcare Improvement (CBO), NL Netherlands Centre for Excellence in Nursing (LEVV), NL Royal Dutch Society for Physical Therapy (KNGF), NL Trimbos-Inst. - NL Institute of Mental Health & Addiction, NL Directorate for Health (SHdir), NO Norwegian Electronic Health Library (NEHL), NO Center for EBM, Univ. of Lisbon School of Medicine (CEMBE), PT Center for Health Policies and Services (CPSS), RO National Center for Studies in Family Medicine (CNSMF), RO Nat.l School of Public Health and Health Services Management (INCDS), RO Romanian-Swiss Centre for Health Sector Development (CRED), RO Basque Office for HTA (OSTEBA), ES Catalan Agency for Health Technology Assessment and Research (AATRM), ES GuíaSalud-Health Sciences Institute of Aragón (IACS), ES Spanish Network for Research on Guidelines (REDEGUIAS), ES National Board of Health and Welfare, Socialstyrelsen (SOS), SE ClinicalEpidemiology Centre (CePiC), Univ. Hospital Lausanne, CH Swiss Federal Office of Public Health (BAG), CH Swiss Medical Association (FMH), CH National Institute for Health and Clinical Excellence (NICE), UK Royal College of Nursing (RCN), UK Scottish Intercollegiate Guidelines Network (SIGN), UK Sowerby Centre for Health Informatics at Newcastle (SCHIN), UK OCEANIA Cari Guidelines (CARI), AU Centre for Clinical Effectiveness (CCE), AU Joanna Briggs Institute (JBI), AU National Breast and Ovarian Cancer Centre (NBOCC), AU National Health & Medical Research Council (NHMRC), AU National Heart Foundation of Australia (NHFA), AU Therapeutic Guidelines Ltd (TGL), AU New Zealand Accident Compensation Corporation (ACC), NZ New Zealand Guidelines Group (NZGG), NZ INTERNATIONAL European Region of the World Confederation of Physical Therapy (WCPT) European Union of Medical Specialists (UEMS) G-I-N Partner AGREE Research Trust (ART) GRADE Working Group (GRADE) The ADAPTE Collaboration (ADAPTE) The International Network ofAgenciesforHealth Technology Assessment (INAHTA) World Medical Association (WMA) AFRICA and MIDDLE EAST Healthcare Quality and Accreditation Unit of Alexandria Univ. Hospitals, EG Chair of Evidence-based Healthcare and Knowledge Translation, College of Medicine, King Saud University, Riyadh, Kingdom of Saudi Arabia National & Gulf Center for Evidence Based Medicine, SA Sudan Evidence-based Association (SEA), SD AMERICA Brazilian Medical Association (AMB), BR National AgencyofSupplementary Health, BR Québec Governm. Agency for Health Services & TA (AETMIS), CA Canadian Partnership against Cancer (CPACC), CA Canadian Thoracic Society (CTS), CA Guidelines Advisory Committee (GAC), CA National Cancer Institute, CO National Center for Health Technology Excellence (CENETEC), MX Agency for Healthcare Research and Quality (AHRQ), US American Academy of Otolaryngology - Head & Neck Surgery Found., US American College of Chest Physicians (CHEST), US American College of Physicians (ACP), US American Society of Clinical Oncology (ASCO), US American Urological Association (AUA), US Center for International Rehabilitation (CIR), US Infectious Diseases Society of America (IDSA), US National Kidney Foundation (NKF), US ASIA Med. Inform. Netw. Distr. Serv. Center, Jap. Counc. for Quality Healthc., JP Central Asian Network of EbMCenters (CAREBMC Network), KZ Healthcare Development Institute, KZ Korean Academy of Medical Sciences (KAMS), KR HTA Unit, Ministry of Health, Malaysia (HTA-DoH), MY Center for Health Policy Res. & Develop., Nat. Health Res. Inst. (NHRI), TW EUROPE Health Austria, Federal Institute for Quality in Health Care (GOEG), AT Vienna Medical Chamber (AEKW), AT Belgian Centre for Evidence-Based Medicine (CEBAM), BE DomusMedica; Flemish College of General Practitioners (DM), BE National Board of Health (SST), DK Estonian Health Insurance Fund (EHIF), EE Centre for Pharmacotherapy Development (ROHTO), FI Current Care; Finnish Medical Society DUODECIM, FI Duodecim Medical Publications (DUODECIM), FI Centre LéonBérard (CLB), FR French National Cancer Institute (INCa), FR French National Health Authority (HAS), FR Agency for Quality in Dentistry (ZZQ), DE Agency for Quality in Medicine (AEZQ/AQuMed), DE Association of Scientific Medical Societies (AWMF), DE Berlin Chamber of Physicians (AEKB), DE German Cancer Society (DKG), DE German National Institute for Quality Measurement in Health Care (BQS), DE German Society of Thoracic and Cardiovascular Surgery (DGTHG), DE Federal Joint Committee (GBA), DE

30. G-I-N website www.g-i-n.net International guideline library Information on working groups and activities with discussion boards Relevant tools and resources Relevant literature The enGINe, the G-I-N newsletter

31. Collaborative work

32. G-I-N activities – guideline development Adaptation International guideline library provides a single source of other guidelines Since November 2009 the ADAPTE Collaboration has become part of G-I-N, providing access to all materials related to adaptation G-I-N Adaptation Working Group will take this work forward

33. G-I-N activities – guideline development Quality of guideline development Raison d'être for G-I-N Encouraging improvements in the credibility of guideline development: Sharing and encouraging good practice Planning to run educational sessions alongside annual conferences Providing leadership to guideline world through production of position statements on relevant issues Conflicts of interest Developing a clear position statement on this issue

34. G-I-N activities – guideline development Multi-disciplinary involvement Guideline development methods courses G-I-N Allied Health Professions Working Group ser up to address issues of non medical professionals involvement in guidelines G-I-N PUBLIC Working Group developing a toolkit to support consumer involvement in guideline development Grading systems G-I-N partnership with GRADE

35. G-I-N activities – guideline development Reducing duplication of effort Big barrier to regular updating is the cost of updating the evidence base Evidence Tables Working Group have defined a common format of evidence tables for intervention and diagnostic studies to facilitate the development of a database of critically appraised papers The group is now developing common formats for evidence tables for economic and prognostic studies

36. G-I-N activities - dissemination Web based products, and in particular the International Guideline Library, bring together guidelines and supporting material in a single location Sharing of good practice via annual conferences and in Working Groups and Communities of Practice

37. GIN activities - implementation Key theme of all G-I-N conferences G-I-N Implementation Group - bringing people together with a common aim of getting guidelines used in practice to improve healthcare across the world First task – developing a taxonomy of implementation support methods

38. Summary • Across the world there are very similar issues facing those tasked with developing, adapting and supporting implementation of evidence based guidelines • There is huge potential to reduce duplication of effort • International collaborations such as G-I-N should help with this • There is a need to ensure that we learn from each other

39. Thank yousara.twaddle@nhs.net