1. Illustrating the GRADE Methodology: The Cather Associated-UTI Case Study TEACH Level II Workshop 5 NYAM August 9 th, 2013 Craig A Umscheid, MD, MSCE, FACP Assistant Professor of Medicine and Epidemiology Director, Center for Evidence-based Practice University of Pennsylvania

2. 2 CDC Guideline on Preventing CAUTI Full guideline at http://www.cdc.gov/hicpac/index.html

3. 3 G rades of R ecommendation A ssessment, D evelopment and E valuation

4. 4 The GRADE Working Group  Since 2000  Researchers/guideline developers with interest in methodology  Goal to develop one worldwide system of rating quality of evidence and strength of recommendations  Clear separation of 2 elements:  Quality of evidence: very low, low, moderate, or high quality  Strength of recommendation: weak or strong www.GradeWorking-Group.org

5. 5 GRADE Uptake  World Health Organization  National Institute Clinical Excellence (NICE)  British Medical Journal  Infectious Disease Society of America  Centers for Disease Control and Prevention (HICPAC and ACIP)  American College of Chest Physicians  UpToDate  American College of Physicians  Cochrane Collaboration  Agency for Healthcare Research and Quality (AHRQ)  Over 20 other major organizations

6. 6 Example key question in guideline: VS. Do Texas catheters impact UTI outcomes differently than Foley catheters?

7. 7 ComparisonOutcomeQuantity and Type of Evidence Findings Texas vs. Foley catheter Symptomatic UTI1 RCTDecreased risk Bacteriuria1 RCTNo difference Bacteremia1 OBSNo difference Patient Satisfaction1 RCT 1 OBS Increased satisfaction Risks and benefits associated with Texas vs. Foley catheters?

8. 8 Determinants of quality  RCTs start high  Observational studies start low  5 factors lower the quality of evidence  3 factors can increase the quality of evidence

9. 9 Grading the Evidence Type of evidence Initial grade Criteria to decrease gradeCriteria to increase gradeOverall quality grade RCTHighStudy quality limitations Serious (-1) or very serious (-2) study quality limitations Inconsistency Important inconsistency (-1) Indirectness Some (-1) or major (-2) uncertainty about directness Imprecision Imprecise or sparse data (-1) Publication bias High risk of bias (-1) Strength of Association Strong (+1) or very strong evidence of association (+2) Dose-Response Evidence of a dose-response gradient (+1) Confounding Inclusion of unmeasured confounders increases the magnitude of effect (+1) High Moderate Observational study Low Any other evidence (e.g. expert opinion) Very low Very Low

10. 10 Overall Quality Grades  High further research is very unlikely to change confidence in the estimate of effect  Moderate further research is likely to impact confidence in the estimate and may change the estimate  Low further research is very likely to impact confidence in the estimate and is likely to change the estimate  Very low any estimate is very uncertain

11. 11 Grading the Evidence for Each Outcome ComparisonOutcome Quantity and Type of Evidence Findings GRADE of Evidence for Outcome GRADE of Evidence for Overall Evidence Base Texas vs. Foley catheter Symptomatic UTI 1 RCT Decreased risk Moderate Bacteriuria1 RCTNo differenceModerate Bacteremia1 OBSNo differenceVery Low Patient Satisfaction 1 RCT 1 OBS Increased satisfaction High

12. 12 Grading the Evidence for Each Outcome ComparisonOutcome Quantity and Type of Evidence Findings GRADE of Evidence for Outcome GRADE of Evidence for Overall Evidence Base Texas vs. Foley catheter Symptomatic UTI* 1 RCT Decreased risk Moderate Bacteriuria1 RCTNo differenceModerate Bacteremia1 OBSNo differenceVery Low Patient Satisfaction* 1 RCT 1 OBS Increased satisfaction High * = CRITICAL OUTCOMES

13. 13 Grading the Evidence for Each Outcome ComparisonOutcome Quantity and Type of Evidence Findings GRADE of Evidence for Outcome GRADE of Evidence for Overall Evidence Base Texas vs. Foley catheter Symptomatic UTI* 1 RCT Decreased risk Moderate Bacteriuria1 RCTNo differenceModerate Bacteremia1 OBSNo differenceVery Low Patient Satisfaction* 1 RCT 1 OBS Increased satisfaction High * = CRITICAL OUTCOMES

14. 14 Q2A1. Condom versus indwelling urethral There was moderate quality evidence to support the use of condom catheters over indwelling urethral catheters in male patients. This was based on decreased risk of symptomatic UTI as well as increased patient satisfaction with condom catheters. Narrative Evidence Summary

15. 15  Three key inputs: Values and preferences used to determine the “critical” outcomes Overall GRADE of the evidence for the “critical” outcomes Net benefits, net harms, or trade-offs that result from weighing the "critical" outcomes Formulating Recommendations

16. 16 Grading the Evidence for Each Outcome ComparisonOutcome Quantity and Type of Evidence Findings GRADE of Evidence for Outcome GRADE of Evidence for Overall Evidence Base Texas vs. Foley catheter Symptomatic UTI* 1 RCT Decreased risk Moderate Bacteriuria1 RCTNo differenceModerate Bacteremia1 OBSNo differenceVery Low Patient Satisfaction* 1 RCT 1 OBS Increased satisfaction High * = CRITICAL OUTCOMES

17. 17 GRADE Recommendation Weighing Risks and Benefits Quality of Evidence STRONG (I)Net Benefits Net Harms IA – High-Moderate IB – Low-Very Low IC – High-Very Low WEAK (II)Trade-offsII – High to Very Low Recommendation for further research Uncertain Trade-offsLow to Very Low CDC Recommendation Scheme

18. 18 Example: Condom catheter drainage should be used in cooperative male patients without urinary retention or bladder outlet obstruction. (Category IA) Recommendation

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20. 20 Questions?