1. GDG Meeting Wednesday November 9, 2011 9:30 – 11:30 am

2. TimeAgendaLead 9:30 - 9:35Review objectives for the teleconferenceJess Rogers 9:35 - 9:45Business rising from previous meeting: Conflict of interest Analytic framework Literature research and review Jess Rogers 9:45 - 10:00Review of guideline methodsJess Rogers 10:00 - 10:20Confirming OutcomesValerie Palda 10:20 - 11:15GRADE: What does GRADE offer? Review GRADE process/methodology Walk though GRADE tables How do you combine evidence? Valerie Palda Dave Hallett 11:15 - 11:30 Questions Overview of training session agenda Dec 6-7 Action items All Agenda

3. Objectives  Confirm outcomes for analytic framework  Review Guideline Development Process  Review rationale and purpose of GRADE  Review a sample GRADE table to ensure everyone is comfortable using them

4. GRADE: An Overview Grading of Recommendations Assessment, Development and Evaluation

5. Agenda  What is GRADE?  Importance of Evidence  Determining Quality of Evidence  Methods for Summarizing Evidence Evidence Profile Tables Summary of Findings Tables  Determining Strength of Recommendations

6. What is GRADE?  A transparent and structured process for developing and presenting evidence summaries for systematic reviews and guidelines in health care and for carrying out the steps involved in developing recommendations.

7. The GRADE Approach  Considers All factors to determine how confident we are in the results (quality of evidence) The evidence for each outcome Magnitude of the effect  Ensures Systematic process Transparency

9. Importance of Evidence When making guideline recommendations:  The quality of evidence reflects the extent to which our confidence in an estimate of the effect is adequate to support a particular recommendation.

10. Quality of the Body of Evidence

11. Determining Quality  RCTs start  (high)  Observational studies start at   (low)

12. Determining Quality 5 factors that can lower quality 1.Limitations in detailed design and execution (risk of bias criteria) 2.Inconsistency (or heterogeneity) 3.Indirectness (PICO and applicability) 4.Imprecision (number of events and confidence intervals) 5.Publication bias

13. Summarizing Evidence  Evidence Profiles and Summary of Findings Tables An EP includes a detailed quality assessment in addition to a SoFs. The SoF table includes an assessment of the quality of evidence for each outcome but not the detailed judgments on which that assessment is based.

14. Evidence Profile Table

15. Summary of Findings Table

16. Determining Strength of Recommendations

17. 4 key Factors Influence the Strength of a Recommendation 1. Quality of the evidence  The higher the quality of evidence, the more likely is a strong recommendation. 2. Balance between desirable and undesirable effects  The larger the difference between the desirable and undesirable consequences, the more likely a strong recommendation warranted. The smaller the net benefit and the lower certainty for that benefit, the more likely weak recommendation warranted. 3. Values and preferences  The greater the variability in values and preferences, or uncertainty in values and preferences, the more likely weak recommendation warranted. 4. Costs (resource allocation)  The higher the costs of an intervention – that is, the more resources consumed – the less likely is a strong recommendation warranted