The Scientific Registry of Transplant Recipients (SRTR) supports the ongoing evaluation of the scientific and clinical status of solid organ transplantation including kidney, heart, liver, heart-lung, lung, and pancreas transplants. At present the SRTR contains information on approximately 200,000 transplant recipients. The size of this database will continue to expand given the tremendous demand for organ transplants. There were approximately 21,000 organ transplants performed in the U.S. in calendar year 1999. As of the end of February 2000, there were approximately 68,000 individuals with end-stage organ failure awaiting organ transplants in the U.S. The demand for organs for transplants far surpasses and will continue to surpass the number of organs donated each year. There is a clear need for the monitoring and evaluation of advances in transplant surgery techniques and organ preservation, improvements in matching donor organs with recipients, and developments in immunosuppressive therapies in order to reduce the size of the waiting list and to improve transplant outcomes. With oversight and funding from the Health Resources and Services Administration (HRSA), a division of the U.S. Department of Health and Human Services (DHHS), the SRTR is administered by University Renal Research and Education Association (URREA), a not for profit health research organization, in collaboration with the University of Michigan.

Our work involves:

• Plans
• Committees
• Analyses
• Requests
• Reports

Plans

• The SRTR has developed a work plan that addresses, as appropriate, the following issues: facility requirements; equipment; project time schedule; project staffing and organization; work processes used to receive, maintain, and make available data collected by the Organ Procurement and Transplantation Network (OPTN); and testing and validation procedures that evaluate the quality and completeness of the data provided by the OPTN.

• The SRTR will develop an annual plan for proposed research and evaluation studies based on input from the SAC, the OPTN Board of Directors and Committees, the Secretary of the Department of Health and Human Services' Advisory Committee for Organ Transplantation, and the Government. The plan will be accompanied by a brief summary of the research problem/question and its importance to the field of solid organ transplantation, the proposed hypothesis to be tested, and the methodological approach to be used.

Committees

• The SRTR has established a Scientific Advisory Committee (SAC) to advise the SRTR staff, the joint OPTN/SRTR Data Working Group, the OPTN Board of Directors and the various OPTN committees, subcommittees and working groups on issues that affect clinical and scientific data. These issues include enhancement of data collected on transplant candidate and transplant recipient morbidity and functional impairment; data collected and reported concerning the cost and/or resource utilization associated with transplantation; new areas of research that should be addressed; and research reports and articles submitted to peer-reviewed journals.

• The SRTR has established a Post-Transplant Tumor Registry Technical Advisory Committee (PTTRTAC) to advise the SRTR and the OPTN on scientific and medical issues concerning post-transplant tumors with particular emphasis on the collection and reporting of post-transplant tumor incidence data collected by the OPTN. The PTTRTAC provides scientific and technical advice on issues relating to the development and modification of organ transplantation policies and procedures.

Analyses

• The SRTR operates a secure computer system to support the research and analysis of pre- and post-transplant data collected by the OPTN. The system is capable of storing, manipulating and analyzing large volumes of data. The current OPTN and SRTR database includes approximately 150 gigabytes of data, 10,000 database elements, 350 tables, 250 million records, information on 260,000 transplant recipients, and information on approximately 81,500 transplant candidates at any point in time.

• The SRTR provides ongoing research and analytic support to the OPTN. This support includes conducting research to help answer questions posed by the OPTN. The SRTR also provides research and analytic support to the Secretary of DHHS' Advisory Committee. The Advisory Committee provides advice to the Secretary on issues relating to scientific, medical, ethical, and public health concerns raised by organ procurement, organ allocation, and transplantation.

• The SRTR conducts on-going analyses of pre- and post-transplant data and makes these data available via the Internet and by printed media. These analyses include transplant candidate analyses, transplant recipient analyses, risk-adjusted probabilities of receiving a transplant or dying while awaiting a transplant, risk-adjusted graft and patient survival following the transplant, risk-adjusted overall survival following listing, and data on the standardized cost and/or resource utilization by transplant program. Organ procurement organization data include the number of organ donors recovered per 1,000 deaths (or other appropriate measures of organ donor potential) and the number of organs recovered by organ type.

Requests

• The SRTR responds to non-government data requests. The majority of these data requests are routine and require minimal preparation or programming to obtain the data. Data requests in support of complex research studies that require several person days of effort to prepare can be quite intricate. Fees may be charged to non-Federal entities to cover the reasonable costs of providing data or data analyses.

Reports

• The SRTR works jointly with the OPTN to develop an Annual Report containing information on the scientific and clinical status of solid organ transplantation in the United States. The report presents timely and accurate transplant program-specific information on the performance of transplant programs using appropriate risk-adjusted statistical methods to control for variation in the patient mix among transplant programs. It also presents appropriate longitudinal analyses that describe trends over time and show variations among organizational units, cohorts, interventions, or other appropriate factors.

• The SRTR prepares for the Congress and for public release by HRSA a report describing the scientific and clinical status of organ transplantation in the United States. This report is published every two years in accordance with the National Organ Transplant Act. The report describes the major clinical and scientific advances/set-backs in organ transplantation including new surgical techniques, pharmaceuticals, organ donation, etc. It also describes issues concerning access to transplantation for various sub-populations and additional areas for research.