1. 1 Implementing GRADE Experience of the Tufts Center for Kidney Disease Guideline Development and Implementation Tufts Medical Center, Boston MA Guideline methodology since 2000 (18 GL) Implementing GRADE since 2007 (6 GL) Ethan Balk, MD MPH Associate Director

2. 2 Evidence Review Team for KDOQI & KDIGO –Kidney guidelines Full-time guideline & systematic review methodologists –~6 FTE MDs, “guideline fellows”, research associates (MPH-level) Work Group of ~15-20 international domain experts 18 month process; 3 meetings Tufts Center for Kidney Disease Guideline Development and Implementation

3. 3 Advantages compared to previous systems Formal approach, standardized steps & tables Gets Work Group to consider may aspects of evidence as they pertain to guidelines –Overall evidence quality, consistency, applicability –Rank outcomes (clinically important outcomes) –Balance benefits and harms Simpler descriptions of recommendation levels (1, 2) and evidence quality (A, B, C, D) –Less arbitrary, more consistent connection between level of recommendations and quality of evidence –Eliminates reinventing the wheel

4. 4 Disadvantages compared to previous Increased organizational workload –  # summary tables for specific outcomes –Evidence Profile creation resource intensive –Training Work Group in GRADE methods, Evidence Profiles complicated Increases # of arbitrary formal decisions to maintain consistency –Study quality: (A/B/C)  Methodological quality (0, -1, -2) 2A + 4B + 1C = -1? 2B + 2C = -1? -2? –Translating consistency  (0, -1, -2) –Translating directness  (0, -1, -2)

5. 5 Responses to use of GRADE Work Group likes because –it sets a standard structure and seems less arbitrary –simplifies decisionmaking about strength and content of recommendation –focuses on clinically important outcomes But, large # of steps =  resources, time –Difficult for domain experts –Some frustration about highly detailed work of filling every cell of Evidence Profile –Added work load may diminish participation

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