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Development and Implementation of Clinical Practice Guidelines

This article discusses the development and implementation of clinical practice guidelines, including the importance of evidence-based recommendations to optimize patient care. It also highlights the process and stakeholders involved in guideline development and the need for editorial independence and management of conflicts of interest.

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Development and Implementation of Clinical Practice Guidelines

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  1. Development and Implementation of Clinical Practice GuidelinesbyProf. Dr. H. Reinauer Associationofthe Scientific Medical Societiesof Germany (AWMF)

  2. New Structure of the Guidelines of the Medical Association on Quality Assurance in Medical Laboratories Part A:General Requirements Basic Requirements on the Quality Assurance in Medical Laboratories Part B: Special Fields: B1 Quantitative Analyses in Medical Laboratories B2 Qualitative Analyses in Medical Laboratories B3 Analyses of infections agents (bacteria, viruses) B4 Analyses of ejaculate B5 Analyses in the human genetics NEW

  3. Clinical Practice Guidelines: Definitions Systematically developed statements to assist physicians and, if necessary, other healthcare professionals and patients with decisionsabout appropriate health care in specific clinical circumstances 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. Institute of Medicine 1990, 2011: http://www.iom.edu

  4. Basic statement on clinical practice guidelines (CPGs) CPGs are recommendations in patient care. They do not replace the knowledge and experience of the single medical doctor.

  5. Background to Guideline Development • concern about variation, quality, efficiency, • and evidence for effectiveness of interventions in health care • professional interest to define current optimal practice • in an era of cost containment • interest of purchasers (governments, insurers) and patients • rapid expansion of medical knowledge • (more than 1 Million new entries in Medline/PubMed per year) • understanding of a need for decision aids (not standards) • for health care professionals and patients in the individual encounter

  6. Background to Guideline Development in the German Health Care System • ownership and responsibility lie with the profession: • guidelines are developed by scientific medical societies • support, coordination and quality assurance are provided by a national umbrella organisation, AWMF • (Association of the Scientific Medical Societies in Germany – currently representing 168 member societies) • AWMF strives for networking with national quality initiatives to promote implementation and evaluation of guidelines • AWMF is the primary contact to the Guidelines • International Network (G-I-N)

  7. Consensprocess DraftversionReviewing Implementation Publication Clinical need Reviewing Expert group Final version Financial limits?

  8. Guideline Development:International Consensuson Methodological Principles agreetrust.org http://www.awmf.org iom.edu/Reports/2011 http://www.g-i-n.net The process by which a clinical practice guideline (CPG) is developed and funded should be detailed explicitly and publicly accessible.

  9. Who should develop and monitor the clinical practice guidelines ?

  10. Interested organisations • Federal Medical Association (Bundesärztekammer) • Association of the Health Insurance Companies • Scientific-medical societies • Patient organisations

  11. Open access to methodological support:The Guideline Development Checklist http://cebgrade.mcmaster.ca/guidecheck.html

  12. StakeholderInvolvement: Compositionofthe Guideline Development Group The GDG should be multidisciplinary and balanced including representatives of Professional groups - medical speciality societies - professional associations - methodological experts Target population and patients those, who are adressed/affected by the recommedations German National Disease Management Guideline Unipolar Depression: n= 31 Example:. www.awmf.org

  13. Rigor of Development: Systematic Review oftheEvidence • Document strategy used to search and select evidence in a way it can be reproduced by others • Identify risks of bias- • critically appraise evidence • Document results: • evidence tables / profiles http://www.g-i-n.net - GIN EvidenceTables Working Group: Template for summarising studies addressing Intervention questions NICE Clinical Guideline 118, March 2011: Evidence profile Colonoscopic surveillance for prevention of CRC in patients with ulcerative colitis, Crohn's disease or adenomas

  14. Editorial Independence ManangementofConflictsof Interest • Source(s) of funding • - declare sources of funding • - make sure funders have no role in CPG development • and can not influence the content of the guideline • Competing interests of guideline development group • - declare all interests and activities potentially resulting in COI • (commercial, academical and institutional) • - document measures taken to minimize the influence of competing • interests on guideline development or formulation of the • recommendations

  15. Force Field Analysis 1. Learning Theory 2. Behavioral Theory 3. Social Theory

  16. Implementation: evidence-basedstrategies (e.g. auditandfeedback, professional peerreview)

  17. Clinical Practice Guidelines atthe Core ofthe PDCA Cycle Act Plan Act Do Check

  18. Criteria for the extraction of guideline recommendations • impact on patient outcome • level of evidence, grade of recommendation • potential for improvement • measurability • relevance • ….

  19. Rigor of Development: fromEvidencetoRecommendations Quality of evidence Strength of recommendation do / don´t do „we recommend“ 1 – high probably do/don´t do „we suggest“ 2 - moderate 3 - low uncertain „can be considered“ „we do not know“ 4 - very low considered judgment a criteria-guided group decisionusing formal consensus methods (e.g. Nominal Group Technique) DM-CPG programme – methodreport (www.versorgungsleitlinien.de/english/methods) European Council, Recommendation (2001) 13 GRADE 2004 (www.gradeworkinggroup.org)

  20. Classification of the practice guidelines

  21. Actual list of the published clinical practice guidelines

  22. Number of guidelines in different classes

  23. Frequency of reviewing the CPGs in Germany Hypertension 15.000/6 months Diabetes therapy 2.800/6 months Coronary heart disease 2.500/6 months Infectious of urinary tract 15.000/6 months

  24. Clinical Practice Guidelines at the Core of the PDCA Cycle Act Plan Act Do Check

  25. Become a G-I-N member TheGuidelines International Networkis the leading organisation that enables organisations And individuals to work together on issues and projects related to guideline development, implementation and research.

  26. G-I-N aims to • Provide easy access to resources for organisations and individuals across the world • Facilitate and foster collaborating within the network • Provide a platform for members to share their expertise and information on their activities and projects

  27. Main Critics • The full versions of the Guidelines are too long to be red and followed immediately. Short versions are rare. • To follow the original version in diagnosis and therapy may be too expensive and the costs are not covered by the health insurance companies. • The CPGs do not regard the different health care systems (climate, culture, professions, age and gender of the patients). • The patients may have different interacting diseases. This is not considered in the guidelines. • Judgement of Court of justice on malpractice of medical doctors are primarily oriented by CPGs.

  28. Conclusions: • „For the future, systematic clinical practice guidelines of the highest quality are on the way , to assure implementation of the best research results in clinical practice – so that EbM is used in each and every patient treatment, everywhere“ • (Implementation of Medical Research in Clinical Practice www.esf.org) • concept: • national guidelines / evidence profiles as • basis for european consensus on best diagnostic and • therapeutic procedures • outlook: • networking to avoid duplication of efforts!

  29. Thank you for your attention !

  30. Clinical Practice Guidelines atthe Core ofthe PDCA Cycle Act Plan Act Do Check

  31. Clinical Practice Guidelines at the Core of the PDCA Cycle Act Plan Act Do Check

  32. Clinical Practice Guidelines at the Core of the PDCA Cycle Act Plan Act Do Check

  33. Implementation and Monitoring / Evaluation: Networking with existing quality initiatives • National Network of Certified Centers /Reference Centers • supportimplementation, transferofguidelinesintopractice • National Network of Registers • assess and reportprocesses and outcomes, providefeedback • Externalqualityassurance • (Germany: implemented in theSocial Code book, carried out by a • centralinstitution) • assess and reportprocesses and providefeedback • Outlook: Networking with international initiatives? OECD Health Indicator Project

  34. OECD Indicator:Antidepressants Consumption Quality Assessment: Mental Health Care Example OECD (2013), Health at a Glance 2013: OECD Indicators, OECD Publishing. http://dx.doi.org/10.1787/health_glance-2013-en

  35. Is this indicator useful?:remaining questions...- overdiagnosis?- lack of specification of patient target group (denominator) ?- underuse of non pharmacological interventions? Quality Assessment: Mental Health Care Example

  36. Enhancing Quality: ColorectalCancerExample Documentation according to Mercury (n= 173) Patients receiving TME Performance Measure: Total MesorectalExcision in PatientswithRectalCancer (LoE 2a) Source: M. F. Hofstädter, M. Klinkhammer-Schalke 2008 Data base: German CancerRegistries

  37. Enhancing Medical ProfessionalismandInterdisciplinarity: isthe German bottom-upapproachsuccessful? Enhancing professionalism- improvement in systematic development: Quality Improvement of Guidelines in the AWMF-Register over time S1 - expert recommendations S2 - guidelines based on a systematic review of the evidence or on structured consensus of a multidisciplinary group S3 – evidence and consenus

  38. Movingforwardtowardsnetworking withguidelines: conceptualsuggestion • national developmentofevidenceprofilesand guidelines • europeanguidelines: distillationofkeyrecommendations • networking: • umbrellaorganisations like AWMF, G-I-N • EU-Network of Reference Centers and Registries? European Guideline

  39. Clinical Practice Guidelinesand Quality Management Association of the Scientific Medical Societies in GermanyInstitute for Medical Knowledge ManagegementPhilipps-University Marburg

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