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Methods

Canadian Diabetes Association 2013 Clinical Practice Guidelines. Methods. Chapter 2 Gillian Booth, Alice YY Cheng. Methods – Guiding Principles. Building on 2008 CPGs Rigorous, evidence-based Transparency – process, evidence that guidelines are based on and how we evaluated that evidence

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Methods

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  1. Canadian Diabetes Association 2013 Clinical Practice Guidelines Methods Chapter 2 Gillian Booth, Alice YY Cheng

  2. Methods – Guiding Principles • Building on 2008 CPGs • Rigorous, evidence-based • Transparency – process, evidence that guidelines are based on and how we evaluated that evidence • Fulfill criteria outlined in AGREE II instrument • Harmonization with other guidelines

  3. International Recognition of 2008 CDA CPGs

  4. International Recognition of 2008 CDA CPGs (continued) • Systematic review of 11 international guidelines on oral medication for T2DM • Assessed for consistency with the evidence • Assessed for quality • Rigor of development • Editorial independence • Conducted by the Johns Hopkins University Evidence-Based Practice Center

  5. The Process • Develop clinical questions • Centralized literature search (X3) • Review of literature search • Write preamble and recommendations • Every recommendation reviewed and approved by 100% consensus of Steering Committee

  6. The Process (continued) • External Review (national, international) • Independent Methods Review • Final approval of Steering Committee • Publication • Dissemination and Implementation

  7. Identifying Articles • Identifying clinically important questions • Treatment or prevention • Diagnosis • Prognosis • Centralized literature search • Systematically conducted lit searches • Known articles • Manual search of listed citations from articles

  8. Rating the Evidence Highestavailable level of evidence Relevant studies Formally assign each a level of evidence

  9. Rating the Evidence (continued) • Same standardized approach as in 2008 • Set of ‘rules’ to rate studies of a certain type (prevention/treatment, diagnosis, prognosis) • Rating depends on study design plus strengths and weaknesses of the study

  10. Formulating a Recommendation • Recommendation What the evidence says • Grade What the highest level of evidence is • Reference(s) Study which provides the highest level of evidence

  11. Grading Recommendations Grade Best Evidence A Level 1 B Level 2 C Level 3 D Level 4 High level RCT(s) or systematic review / meta-analysis of RCTs RCT(s) or systematic review/meta-analysis Cohort studies Case control studies, case series

  12. Grading Recommendations (continued) Grade Level of confidence A Higher B C D Lower

  13. AGREE II • Scope and Purpose • Stakeholder involvement • Rigour of development • Applicability • Editorial independence

  14. AGREE II Criteria

  15. AGREE II Criteria (continued)

  16. AGREE II Criteria (continued)

  17. AGREE II Criteria (continued)

  18. AGREE II Criteria (continued)

  19. AGREE II Criteria (continued)

  20. Independent Methods Review Process 2013 More than 200 articles 85 recommendations 27 chapters 17 hours of meeting time 10 hour face to face meeting 2 - 3 hour teleconferences x 3

  21. Independent Methods Review Committee 2013 Gillian Booth (Chair) University of Toronto Doreen Rabi University of Calgary Dereck Hunt McMaster University Charlotte McDonald University of Western Ontario Valerie Palda University of Toronto Sonia Butalia University of Calgary

  22. Changes to Methods in 2013 2013 • Multiple literature searches throughout period • Evidence resource persons as chapter authors • Publishing evidence-based worksheets • Committee struck to consider how to incorporate cost and/or cost-effectiveness into CPGs

  23. Duality of Interest 2013 • No employees of a pharmaceutical or device company • No board membership of a pharmaceutical or device company • Disclosure of duality of interest at the beginning of each steering committee meeting • Duality of interest details publicly available

  24. http://www.icmje.org/ethical_4conflicts.html

  25. Funding Sources 2013 • Canadian Diabetes Association (general funds) • Unrestricted educational grants • Merck Canada Inc, Novo Nordisk Canada Inc, Eli Lilly Canada Inc, Bristol-Myers Squibb / AstraZeneca collaboration, Novartis Pharmaceuticals Canada Inc. • Companies were not involved in any aspect of guideline development and did not have access to guideline meetings, guideline drafts or committee deliberations

  26. CDA Clinical Practice Guidelines http://guidelines.diabetes.ca – for professionals 1-800-BANTING (226-8464) http://diabetes.ca – for patients

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