A Guide to the Scientific Registry of Transplant Recipients Organ Procurement Organization Reports

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.

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 Limitations:  Eligible deaths historically self-reported aggregate counts.

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.

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.

TableDescription 1Organs recovered and transplanted per donor 2Centers transplanting organs/exports 3Adjusted measures of donation rates, DSA 3AAdjusted measures of donation rates, hospital 4Donor characteristics 5Donor characteristics by organ 6Percent undergoing transplant, waitlisted patients 7Time to transplant, waitlisted patients 8Recipient characteristics 9Coverage area: Counties assigned to DSA

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.

This DSAUS DonorsOrgans RecoveredTransplantedRec.Transplanted CountPer Donor type CountPer Donor type CountPer Donor Type % TXPer Donor Type % TX All Donors239/239= Intestine Kidney Pancreas Liver Lung Heart organs recovered from 239 donors

This DSAUS DonorsOrgans RecoveredTransplantedRec.Transplanted CountPer Donor type CountPer Donor type CountPer Donor Type % TXPer Donor Type % TX All Donors239/239= Intestine Kidney Pancreas Liver Lung Heart = 3.32 organs recovered per donor

This DSAUS DonorsOrgans RecoveredTransplantedRec.Transplanted CountPer Donor type CountPer Donor type CountPer Donor Type % TXPer Donor Type per Donor Type % TX All Donors239/239= Intestine Kidney Pancreas Liver Lung Heart organs transplanted from 239 donors

This DSAUS DonorsOrgans RecoveredTransplantedRec.Transplanted CountPer Donor type CountPer Donor type CountPer Donor Type % TXPer Donor Type % TX All Donors239/239= Intestine Kidney Pancreas Liver Lung Heart = 2.78 transplanted organs per donor

This DSAU.S. DonorsOrgans RecoveredTransplantedRec.Transplanted CountPer Donor type CountPer Donor type CountPer Donor Type % TXPer Donor Type % TX All Donors239/239= Intestine Kidney Pancreas Liver Lung Heart /793 (83.7%) of organs recovered were transplanted

This DSAUS DonorsOrgans RecoveredTransplantedRec.Transplanted CountPer Donor type CountPer Donor type CountPer Donor Type % TXPer Donor Type % TX All Donors239/239= Intestine Kidney Pancreas Liver Lung Heart All of the statistics from this DSA were lower than the US averages

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.

Table 3: Measures of Donation Rates: Two Processes 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: Donation Rate: Deceased Donors Eligible Deaths * Notification Rate: Eligible Deaths * Notifiable Deaths, DSA and

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.

This DSA/OPOAverage Observed donation measures Deceased donors (all) Deceased donors meeting eligibility criteria Additional donors (aged > 70 years, DCD)2717 Eligible deaths Crude donation rate 1 (donors per 100 eligible deaths) Crude organ-specific rates 2 (organs per 100 eligible deaths) Kidney Liver Heart Lung Pancreas eligible donors/232 eligible deaths = 58% donation rate.

This DSA/OPOAverage Observed donation measures Deceased donors (all) Deceased donors meeting eligibility criteria Additional donors (aged > 70 eyars, DCD)2717 Eligible deaths Crude donation rate 1 (donors per 100 eligible deaths) Crude organ specific rates 2 (organs per 100 eligible deaths) Kidney Liver Heart Lung Pancreas additional donors not included in the donation rate calculations.

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.

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

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.

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.

How to Compare Crude Rates to Expected Rates Measure of DonationObservedExpected 5,6,7 p-value 8 Notification rate (eligible deaths per 100 notifiable deaths) Donation rate (hospital characteristics) Kidney-specific rate Liver-specific rate Heart-specific rate Lung-specific rate Pancreas-specific rate Almost 8 fewer organs were recovered than expected. Given the characteristics of the hospitals in this DSA, this difference is significantly lower than expected.

This DSA/OPOStandardized 95% Confidence Interval 10 Measure of Donation ObservedExpected 5,6,7 P-value 8 Ratio 9 LowerUpper Notification rate Donation rate (hospital) Kidney-specific rate Liver-specific rate Heart-specific rate Lung-specific rate Pancreas-specific rate The observed donation rate is 12% lower than the expected donation rate.

This DSA/OPO Measure of donationObservedExpected 5,6,7 P-value 8 Notification rate (eligible deaths per 100 notifiable deaths) Donation rate (hospital characteristics) Kidney-specific rate Liver-specific rate Heart-specific rate Lung-specific rate Pancreas-specific rate Donation rate (hospital characteristics, notification rate) Kidney-specific rate Liver-specific rate Heart-specific rate Lung-specific rate Pancreas-specific rate Donation rates adjusted for hospital characteristics AND notification rate.

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.

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

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 < ), indicating that the factors were useful predictors of donation.

OPTN Collection of Individual Eligible Death Data Began January 9, 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.

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.

Contact the SRTR (877) 970-SRTR