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(ESRD) Quality Measure Development and Maintenance Hemodialysis Adequacy Clinical Technical Expert Pane

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(ESRD) Quality Measure Development and Maintenance Hemodialysis Adequacy Clinical Technical Expert Pane End Stage Renal Disease (ESRD) Quality Measure Development and Maintenance Hemodialysis Adequacy Clinical Technical Expert Panel Summary Report Prepared by: Arbor Research Collaborative for Health and the University of Michigan Kidney Epidemiology and Cost Center Conducted April 16-17, 2013 in Baltimore, MD Sent to CMS on June 28, 2013 Contract No. 500-2008-00022I, Task Order No. HHSM-500-T0001 1 Table of Contents Technical Expert Panel Summary .................................................................................................................. 5 1. Introduction/Background: ........................................................................................................................ 7 2. Discussion of Urea Kinetics ....................................................................................................................... 8 2.1 Standardized (Std) Kt/V ....................................................................................................................... 9 2.1.1 Literature Review & Scientific Importance .................................................................................. 9 2.1.2 Scientific acceptability: .............................................................................................................. 10 2.1.3 Feasibility and usability: ............................................................................................................. 10 2.1.4 Review of existing measures: ..................................................................................................... 10 2.1.5 Recommendations ..................................................................................................................... 10 2.2 Surface Area Normalized (SAN) kt/V ................................................................................................ 10 2.2.1. Literature Review & Scientific Importance ............................................................................... 10 2.2.2 Scientific acceptability ............................................................................................................... 11 2.2.3 Feasibility and usability .............................................................................................................. 11 2.2.4 Review of existing measures ...................................................................................................... 11 2.2.5 Recommendations ..................................................................................................................... 11 3. Discussion of Adequacy Based on Nutritional Status ............................................................................. 12 3.1 Normalized Protein Catabolic Rate (nPCR) ....................................................................................... 12 3.1.1 Literature Review & Scientific Importance ................................................................................ 12 3.1.2 Feasibility & usability ................................................................................................................. 13 3.1.3. Scientific acceptability (reliability & validity) ............................................................................ 13 3.1.4 Review of existing measures ...................................................................................................... 14 3.1.5 Recommendations ..................................................................................................................... 14 3.1.6 Other recommendations ............................................................................................................ 14 3.2 Serum Albumin.................................................................................................................................. 14 3.2.1 Literature Review & Scientific Importance ................................................................................ 14 3.2.2 Scientific acceptability (reliability & validity) ............................................................................. 15 3.2.3 Feasibility & usability ................................................................................................................. 15 3.2.4 Review of existing measures: ..................................................................................................... 15 3.2.5 Recommendations ..................................................................................................................... 15 3.2.6 Other recommendations: .......................................................................................................... 16 2 4. Discussion of Adequacy Based on Considerations of Patient Safety as well as Optimum Fluid and Larger Molecular Clearance ........................................................................................................................ 16 4.1 Ultrafiltration Rate (UFR) .................................................................................................................. 16 4.1.1 Literature Review & Scientific Importance ................................................................................ 16 4.1.2 Feasibility & usability: ................................................................................................................ 17 4.1.3 Scientific acceptability (reliability & validity) ............................................................................. 17 4.1.4 Review of existing measures ...................................................................................................... 17 4.1.5 Recommendations* ................................................................................................................... 18 4.1.5 Other recommendations: .......................................................................................................... 18 4.2 Minimum time (length of dialysis) per session ................................................................................. 18 4.2.1 Literature Review & Scientific Importance: ............................................................................... 18 4.2.1 Feasibility & usability ................................................................................................................. 19 4.2.2 Scientific acceptability (reliability & validity) ............................................................................. 19 4.2.3 Review of existing measures ...................................................................................................... 20 4.2.4 Recommendation* *Please See Addendum for Revised Recommendations............................ 20 4.3 Rate of hospitalization due to fluid overload ................................................................................... 20 4.3.1 Literature Review & Scientific Importance: ............................................................................... 20 4.3.2 Review of existing measures ...................................................................................................... 21 4.3.3 Potential measure discussed at the TEP meeting, but not recommended ............................... 21 4.4 Interdialytic Weight Gain (IDWG) ..................................................................................................... 21 4.4.1 Literature Review & Scientific Importance: ............................................................................... 21 4.1.2 Scientific Acceptability (reliability & validity) ............................................................................ 21 4.2.2 Review of existing measures ...................................................................................................... 21 4.2.3 Measure discussed, but not recommended .............................................................................. 21 4.5 Intradialytic hypotension .................................................................................................................. 22 4.5.1 Literature Review & Scientific Importance ................................................................................ 22 4.5.2 Review of existing measures ...................................................................................................... 22 4.5.3 Measures discussed but not recommended .............................................................................. 22 4.6 Dialysate composition ....................................................................................................................... 22 4.6.1 Literature Review & Scientific Importance ................................................................................ 22 4.6.2 Review of existing measures ...................................................................................................... 23 4.6.3 Measures discussed but not recommended .............................................................................. 23 3 5. Additional Discussion on Impact of Timing on Kt/V: .............................................................................. 23 6. Conclusions ............................................................................................................................................. 24 7. Summary or Recommendations ............................................................................................................. 25 8. References .............................................................................................................................................. 27 4 Technical
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