Conceptual Framework for OPO Measures

1. A Guide to the Scientific Registry of Transplant Recipients Organ Procurement Organization Reportswww.srtr.org

2. Conceptual Framework for OPO Measures • OPOs can be assessed for performance at several points during the organ procurement process. • Steps are discussed in the following slides, including the current state of development of each metric and data limitations.

3. Step 1: Identify Eligible Deaths • Metric: • Eligible deaths per notifiable death. • Development: • Historically available on the SRTR website with comparisons to expected rates before January 2008. • Limitations: • Eligible deaths historically self-reported aggregate counts.

4. Step 2: Convert Eligible Deaths to Donors • Metric: • Donors per eligible death. • Development: • Historically available on the SRTR website with comparison to expected rates (not in January 2008). • Limitations • Eligible deaths are currently self-reported aggregate counts. • Does not include DCD or donors aged > 70 years. • Current models for “expected” donation rates are limited to information about the hospitals where the deaths occurred, which is not much better than crude rates. • Models will likely be improved by accounting for the characteristics of individual eligible deaths (data to be collected by the OPTN beginning January 9, 2008). • Specific underlying adjustment data from AHA cannot be shared. Alternative sources are being explored.

5. Step 3: Recovered and Transplanted Organs • Metric: • Organs recovered and transplanted per donor. • Development: • Crude rates available on the SRTR website, stratified by donor type. • Methods for modeling an expected yield per donor are under consideration. • Limitations: • Statistical test is not straightforward for the combined observed vs. expected yield because recovery of different organs from the same donor are not independent events. • Multiple factors, including factors external to the OPO, influence this outcome.

6. www.srtr.org

7. Table 1: Organs Recovered/Transplanted per Deceased Donor • N and % of recovered (and transplanted) organs or donors per donor type. • includes organs exported to other DSAs. • segmented organs may count for more than one transplant (n transplants may be > n recovered). • National averages. • Separate reporting by donor type (instead of adjustment). • “Donors”: at least one organ recovered for transplant.

8. 793 organs recovered from 239 donors

9. = 3.32 organs recovered per donor

10. 664 organs transplanted from 239 donors

11. = 2.78 transplanted organs per donor

12. 664/793 (83.7%) of organs recovered were transplanted

13. All of the statistics from this DSA were lower than the US averages

14. Reporting by Donor Types • Heart-beating. • SCD: standard criteria donor. • Aged younger than 60 years and not DCD or ECD. • ECD: expanded criteria donor (KI-donor type). • Heart-beating donors aged older than 60 years and aged between 50 and 59 years meeting 2 of the following 3 conditions: died of stroke, history of hypertension, serum creatinine > 1.5 mg/dL. • Non-heart beating. • DCD: donation after cardiac death.

15. Table 3: Measures of Donation Rates: Two Processes Donation Rate: Deceased Donors Eligible Deaths* Notification Rate: Eligible Deaths* Notifiable Deaths, DSA • Notifiable deaths: DSA-wide in-hospital deaths of patients aged 0-70 years with no exclusionary medical diagnosis for possible donation,† mean 5.4 (eligible deaths per 100 notifiable deaths). • Eligible deaths*: OPO-reported aggregate eligible deaths from hospitals (excludes cardiac deaths). • Deceased donors: at least 1 organ recovered. *Eligible: Aged 0-70 years, death by neurological criteria, no exclusionary medical conditions. †Ojo AO, et al. A practical approach to evaluate the potential donor pool and trends in cadaveric kidney donation. Transplantation 1999; 67:548-566. and

16. Crude (Observed) Donation Rate • Eligible deaths. • OPTN definition (heart-beating, aged < 71 years, acceptable cause of death). • Eligible donors (subset of eligible deaths). • Aged < 71 years and not DCD becoming donors. • Crude donation rate. • 100 * eligible donors/eligible deaths. • Additional donors. • Not eligible deaths. • Aged > 70 years plus DCD.

17. 135 eligible donors/232 eligible deaths = 58% donation rate.

18. 27 additional donors not included in the donation rate calculations.

19. Percentage of Additional Donors* Among All Deceased Donors by OPO *Donors aged >70 years and donors after cardiac death not currently included in SRTR conversion calculations.

20. Average Conversion and Discard Rates for All OPOs 2002-2006 HRSA collaboratives began in April 2003. Source: SRTR analysis, August 2007.

21. Adjustments Used for Expected Rates • Notification rate: age, sex, race, and cause of death. Source: NCHS Population Death Record • Donation rate 1: trauma center, MSA size, CMS case mix index, total bed size, ICU beds, children’s hospital, resident training program, neurological services, hospital control/ownership. Source: AHA Survey. • Donation rate 2: as above, plus notification rate.

22. Standardized Donation Rate Model • “What donation rate would we expect for this DSA, given the characteristics of the hospitals in its service area?” • Trauma center, MSA size, CMS case mix index, total bed size, ICU beds, neurological service, resident training program, children’s hospital, hospital control/ownership. Source: AHA Survey • ASDR = SDR with an adjustment for notifiable deaths. • Standardized ratio: observed rate/expected rate. • Statistical comparisons: • Compare observed to expected counts, 2-sided p-value. • 95% confidence limits for standardized ratio.

23. How to Compare Crude Rates to Expected Rates Almost 8 fewer organs were recovered than expected. Given the characteristics of the hospitals in this DSA, this difference is significantly lower than expected.

24. The observed donation rate is 12% lower than the expected donation rate.

25. Donation rates adjusted for hospital characteristics AND notification rate.

26. Why Suppress Expected Rates Now? • Statistics intended for quality improvement purposes. • Lack of data for individual eligible deaths does not allow for substantive statistical adjustment. • Data currently available for use in the models cannot currently be released to OPOs or the public. • Important to assess the sources of variation in donation rates among the OPOs before finalizing the methods for assigning statistical significance to the comparisons.

27. Future Changes • Donation rates will be adjusted when eligible death characteristics are collected: • Age • Race • Sex • Cause of death

28. Pilot Study of Individual Eligible Death Data • 11 OPOs were selected as a representative sample. • A multivariate model with age, race, sex, US citizenship, cause of death was highly significant (chi-square = 130, P < 0.0001), indicating that the factors were useful predictors of donation.

29. OPTN Collection of Individual Eligible Death Data • Began January 9, 2008. • Includes data on age, sex, race/ethnicity, and cause of death for each eligible death. • Improves the modeling of expected conversion rates. • Expect to begin using models after 1 year of data collection.

30. Additional Measures: Access to Transplant • Components of variation: OPO and transplant center. • OPO Table 6: percent transplanted by point in time. • OPO Table 7: median waiting time. • CSR Table 3: adjusted transplant rate.

31. Contact the SRTR • www.srtr.org • (877) 970-SRTR • srtr@srtr.org