Clinical Outcomes of Live Organ Donors - Data Coordinating Center

描述（由申请人提供）：我们建议开发和维护一个数据协调中心（DCC），该中心将通过对捐赠肾脏或肺叶用于移植的活体个体的医学和功能结局进行流行病学研究，支持移植中心（临床中心）联盟。拟议的DCC将由流行病学、生物统计学、临床研究设计、数据库管理、涉及大型公共和私人电子卫生保健数据库链接的研究、肺医学、肾脏病学和活体器官供体移植等领域的合作专家组成。 DCC将为参与的临床中心和NIAID项目科学家提供主要支持功能，包括研究协调、沟通和后勤支持、临床研究设计、集中数据管理和分析专业知识。DCC的具体科学目标将与临床中心和NIAID项目科学家合作制定，并将与临床中心的目标紧密结合。DCC和参与临床中心的拟定科学活动包括：1）确定既往活体供体和适当对照的研究组; 2）将临床中心的回顾性供体数据与外部数据源联系起来，以增强和验证可用的临床信息; 3）分析死亡和重大供体相关发病率的短期和长期风险;（4）知情同意过程的研究;（5）对捐献者目前的健康状况、残余器官功能、生活质量、捐献后的心理社会适应、经济后果和风险感知进行横断面评估。 与公共卫生的相关性：社会和专业移植界有义务对过去和未来的活体器官捐赠者进行研究，以提供有关捐赠者安全性的准确信息，并沿着我们对接受者利益的了解。虽然医学界和公众都认为活人捐献肾脏和肺一般是安全的，但捐献对活体捐献者健康和福祉的实际影响并不完全清楚。为了解决缺乏全面，系统，国家，长期分析的问题，该项目将研究来自美国选定移植中心的活肺和活肾供体的医学（死亡和并发症）和功能（生活质量，社会，心理和经济）结果。

DESCRIPTION (provided by applicant): We propose to develop and maintain a Data Coordinating Center (DCC) that will support a consortium of transplant centers (Clinical Centers) by conducting epidemiological research on the medical and functional outcomes of living individuals who have donated a kidney or a lobe of a lung for transplantation. The proposed DCC will be made up of collaborating experts in the fields of epidemiology, biostatistics, clinical research design, database management, research involving linkages of large public and private electronic health care databases, pulmonary medicine, nephrology, and live organ donor transplantation. The DCC will provide major support functions for the participating Clinical Centers and the NIAID Project Scientist, including research coordination, communication and logistical support, clinical study design, centralized data management, and analytical expertise. The specific scientific aims of the DCC will be developed in collaboration with the Clinical Centers and the NIAID Project Scientist, and will be closely integrated with those of the Clinical Centers. Proposed scientific activities of the DCC and participating Clinical Centers include 1) identification of study groups of previous live donors and appropriate controls; 2) linkage of retrospective donor data from the Clinical Centers with external data sources to enhance and validate available clinical information; 3) analyses of short- and long-term risks of death and major donation related morbidity; 4) studies of the informed consent process; and 5) cross-sectional assessments of donors' current health, residual organ function, quality of life, post-donation psychosocial adaptation, economic consequences, and perception of risk. Relevance to Public Health: Society and the professional transplant community are obligated to past and future live organ donors to study the donor experience and its outcomes in order to provide accurate information about donor safety and to go along with our knowledge about the benefits to recipients. While it is believed by the medical community and the public that kidney and lung donation by living persons is generally safe, the actual impact of donation on live donor health and well being is not completely understood. To address the lack of comprehensive, systematic, national, long-term analyses, this project will study the medical (death and complications) and functional (quality of life, social, psychological, and economic) outcomes of live lung and live kidney donors from selected transplant centers in the United States.