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Kidney Disease Improving Global Outcomes (KDIGO)

Kidney Disease Improving Global Outcomes (KDIGO). Established in 2003 as an independently incorporated, non-profit foundation governed by an international board of directors and managed by the NKF. . KDIGO Mission Statement.

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Kidney Disease Improving Global Outcomes (KDIGO)

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  1. Kidney Disease Improving Global Outcomes (KDIGO) Established in 2003 as an independently incorporated, non-profit foundation governed by an international board of directors and managed by the NKF. 

  2. KDIGO Mission Statement To improve the care and outcomes of kidney disease patients worldwide by promoting coordination, collaboration, and integration of initiatives to develop and implement clinical practice guidelines.

  3. Why Do We Need KDIGOTransplant Guidelines? • Encourage transplantation worldwide by: • Defining minimum standards • Removing misconceptions and barriers • Improve patient care by encouraging: • Evidence-based practice • Research, when evidence is poor

  4. Scope • After transplantation • Does not include pre-transplant • Does not include donor issues • Aspects unique to transplantation • Immunosuppressive medications • Focus on prevention

  5. Target Audience • Care-givers • Physicians • Nurses • Coordinators • Pharmacists

  6. Core Principles of KDIGO Guideline Development • Evidence-based methods • Grade evidence • Grade recommendations • Interdisciplinary work groups • Appropriate expertise • International representation • Independent work groups • Openness & transparency • Public review

  7. Jonathan Craig, MD Westmead, AUSTRALIA Cathy Garvey, RN, BA, CCTC St. Paul, USA Michael D. Green, MD Pittsburgh, USA Vivekanand Jha, MD Chandigarh, INDIA Michelle Josephson, MD Chicago, USA Bryce Kiberd, MD Halifax, CANADA Henrik Ekberg, MD Malmö, SWEDEN Henri Kreis, MD Paris, FRANCE Guidelines Work Group Co-Chairs Bertram Kasiske, MD Minneapolis, USA Martin Zeier, MD Heidelberg, GERMANY Ruth McDonald, MD Seattle, USA John Newmann, PhD, MPH Reston, USA Gregorio Tomas Obrador, MD Mexico City, MEXICO Work Group on Immunosuppression Liaison Members American Society Transplantation Flavio Vincenti, MD San Francisco, USA Global Alliance of Transplantation Jeremy Chapman, MD Westmead, AUSTRALIA

  8. Evidence Review Team Tufts-New England Medical Center Evidence-Based Practice Center Boston, MA Joseph Lau, Ethan Balk, Katrin Uhlig, Martin Wagner, Gowri Raman, Samuel Abariga, Amy Earley

  9. Guidelines Timeline Frame Questions Draft Guidelines Evaluate Evidence Finalize ERT Begins Collecting Evidence 2nd WG Meeting 3rd WG Meeting 4th WG Meeting 1st WG Meeting 2006 2009 Dec 05 Sep 06 Dec 06 Feb 07 Sep 07 Dec 07 Feb 08 Sep 08 Dec 08 KDIGO Board Approval Co-Chairs & WG Selected KDIGO Board Review Public Comment Submit for Publication

  10. Step by Step Approach • Define systematic review research questions • Perform literature searches • Screen abstracts and full text articles • Perform data extraction • Summarize evidence in • Summary Tables • Evidence Profiles • Formulate guideline recommendations based on evidence

  11. Searching for Evidence Total Abstracts: 12,327 RCT: 3,168 Cohort: 7,543 Cochrane: 1,609 • Closer scrutiny: 1,347 Immunosuppression: 137 Monitoring/Infections: 670 CVD and Risk Factors: 244 Malignancies, Other: 296

  12. Study Data Extraction • Pre-specified study data elements extracted • Study design • Population and demographics • Intervention(s) and comparator • Outcomes • Results • Study quality and applicability features

  13. Grade the evidence1st step: Quality of the Study • Based on • study design • randomization procedure • allocation concealment • ITT analysis • proportion of patients lost to follow-up

  14. Grade the evidence2nd step: Quality of each Outcome Starting with the quality level of the study, adjustment according to clear definition, precise reporting of the results, based on ITT analysis or with clear description of numbers of patients at risk

  15. Summary Table: Tac vs. CsA, example mortality

  16. Summary Table: Tac vs. CsA, example mortality A A B C C

  17. Importance of Outcomes

  18. Evidence Profile Evidence Profile: Topic 2.1: Tac vs. CsA No difference between Tac and CsA-ME Critical

  19. Grade the recommendationsStrength of statement

  20. Grade the recommendationsStrength of evidence

  21. Grade the recommendationsStatements not graded • Taken for granted • Not sufficiently specific to allow application of evidence • Not subjected to formal review

  22. Grade the recommendationsStatements graded Graded 198 (80.5%) Not Graded 45 (19.5%)

  23. Strength of evidence Low Moderate C (38.9%) B (13.6%) High A (2.0%) D (45.5%) Very Low

  24. Strength of statements 1 50 (25.3%) 2 148 (74.7%) Recommend Suggest

  25. KDIGO Graded Transplant Statements 1A (1.5%) 2D (38.9.%) 1B (8.1%) 2C + 2D = 69% Suggested with Low or Very Low Strength of Evidence 1C (9.1%) 1D (6.6%) 2A (0.5%) 2B (5.6%) 2C (29.8.%)

  26. Guideline Statements • 27 guideline statements • Major content areas: • Immunosuppression • Graft monitoring and infections • Cardiovascular disease • Malignancies • Other complications

  27. Chapters for Guideline StatementsImmunosuppression • Induction Therapy • Initial Maintenance IS Medications • Long-term Maintenance IS Medication • Strategies to Reduce Drug Costs • Monitoring IS Medication • Treatment of Acute Rejection • Treatment of Chronic Allograft Injury

  28. Should we use induction with a biological agent?

  29. Induction • 1.2: We recommend including induction therapy with a biologic agent as part of the initial immunosuppressive regimen in KTRs. (1A) • 1.2.1: We recommend that an IL-2 RA be the first-line induction therapy. (1B) • 1.2.2: We suggest using a lymphocyte depleting agent, rather than an IL-2 RA, for KTR at high immunological risk. (2B)

  30. What is the best maintenance immunosuppressive medication regimen?

  31. Initial Maintenance 2.1: We recommend using a combination of immunosuppressive medications as maintenance therapy, including a CNI and an antiproliferative agent, with or without corticosteroids. (1B)

  32. Initial Maintenance 2.2: We suggest that tacrolimus be the first line CNI used. (2A) 2.3: We suggest that MMF be the first-line anti-proliferative agent. (2B)

  33. Recommended Initial IS Regimen Induction IL-2RA in normal risk and ATG in high risk patients Tacrolimus MMF corticosteroids

  34. Can we reduce medication cost in transplantation?

  35. How should patients be monitored after transplantation?

  36. How can infections be prevented or detected early?

  37. How can cardiovascular disease morbidity and mortality be prevented?

  38. How can cancer be prevented or detected early?

  39. Summary of KDIGO • KDIGO in AJT: Nov 2009, suppl 3, vol 9. • Free download from the AJT website, or www.TTS.org (search: KDIGO)

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