Jesse D. Schold, PhD, John Fung, MD, PhD, Laura Buccini, PhD Transplant Center

1. The Attenuation of National Kidney Volume is Strongly Associated with Center Performance Evaluations Jesse D. Schold, PhD, John Fung, MD, PhD, Laura Buccini, PhD Transplant Center Cleveland Clinic, Cleveland, Ohio

2. Introduction • In the United States, there has been an unprecedented attenuation of the growth of kidney transplantation • The stagnation in national kidney transplant volume may have multiple etiologies but is of clear concern to prospective transplant recipients and caregivers • One source of this limited growth in volume may be associated with increased emphases on regulatory oversight of center performance • We hypothesized that centers with low performance evaluations may have become more conservative and limited transplant growth in the current era.

3. 2007 Conditions of Participation

5. Methods • We evaluated data directly from archived SRTR performance reports from 2007 through 2009 • We compared the change in transplant volume for each kidney transplant center in the US over the study period relative to the incidence of low performance evaluation • In addition, we evaluated changes in recipient and donor characteristics between centers based on receipt of a low performance evaluation • We then tested the association between changes in kidney transplant volume with incidence of low performance evaluations

6. Study Design / Aims End Cohort January, 2010 PSR (transplants 1/2007 – 6/2009) Baseline Cohort January, 2007 PSR (transplants 1/2004 – 6/2006)* * Study excludes centers with < 10 transplants in January, 2007 PSR 1/2007 7/2007 1/2008 7/2008 1/2009 7/2009 Program-Specific Report (PSR) Periods • Specific Aims: • Evaluate the difference in patient characteristics between centers that did or did not have at least one low performance evaluation between 2007 and 2009 • Test for changes in recipient characteristics from the baseline cohort to the end cohort within centers with and without at least one low performance evaluation between 2007 and 2009 • Test for changes in overall transplant volume from the baseline cohort to the end cohort between centers with and without at least one low performance evaluation between 2007 and 2009 • Test for changes in transplant volume from the baseline cohort to the end cohort by type of transplants (standard criteria, expanded criteria and living donor) between centers with and without at least one low performance evaluation between 2007 and 2009

7. Study Population

8. Distribution of Flagged Centers 90.0 N=203 Centers n=157 80.0 70.0 60.0 50.0 Proportion of Adult Kidney Transplant Centers 12% of Centers with 1-2 Low Performance Evaluations between 2007-2009 11% of Centers with 3-6 Low Performance Evaluations between 2007-2009 40.0 30.0 20.0 n=13 10.0 n=11 n=10 n=5 n=5 n=2 0.0 6 0 1 2 3 4 5 Number of Program-Specific Reports with a One-Year Low Performance Evaluation (out of six consecutive cohorts)

9. Distribution of Flagging by Center Volume

10. Change in Kidney Volume by Performance 20 p=0.0002 p=0.001 p=0.002 10 Low Performance Centers (n=46) Low Performance Centers (n=39) Low Performance Centers (n=26) 0 Centers without Low Performance (n=176) Centers without Low Performance (n=157) Centers without Low Performance (n=163) Change in Volume between 1/2007 and 1/2010 PSR Cohorts -10 -20 -30 Overall Graft Survival Either Graft or Patient Survival Patient Survival Centers with Low Performance Evaluations Centers without Low Performance Evaluations -40

11. Change in Kidney Volume by Performance by Transplant Type Standard Criteria Donor Transplants Expanded Criteria Donor Transplants Living Donor Transplants 15 +10.3 10 +3.9 5 p=0.01* 0 Average Center Change in Transplant Volume: January 2007 to January 2010 Cohorts -5 -3.7 -3.1 -4.7 p=0.02* -10 p=0.001* -15 -14.7 -20 Centers with Low Performance Evaluations Centers without Low Performance Evaluations

13. Change in Transplant Characteristics by Center Performance

14. Summary and Conclusions • There is a significant association between changes in transplant volume and receipt of low performance evaluations for US kidney transplant centers • Results may suggest that centers that receive low performance evaluations react by reducing their transplant volume and changing selection criteria of donors and candidates • This change may or may not improve measured performance but may be a significant source of the lack of transplant growth in the United States