Clinical Outcomes of Live Organ Donors - Data Coordinating Center

描述(由申请人提供)：我们建议建立和维护一个数据协调中心(DCC)，通过对捐献肾脏或肺叶进行移植的在世个人的医学和功能结果进行流行病学研究，为移植中心(临床中心)联盟提供支持。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保健数据库链接的研究、肺部医学、肾脏病和活体器官捐赠者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职能，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密切结合。DCC和参与的临床中心拟议的科学活动包括：1)确定以前活体捐赠者的研究小组和适当的对照；2)将临床中心的回溯性捐赠者数据与外部数据来源联系起来，以加强和验证现有的临床信息；3)分析死亡的短期和长期风险以及与主要捐献相关的发病率；4)研究知情同意程序；5)对捐赠者当前的健康、残留器官功能、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。 与公共卫生相关：社会和专业移植团体有义务向过去和未来的活体器官捐赠者研究捐赠者的经验及其结果，以便提供有关捐赠者安全的准确信息，并与我们关于受者受益的知识相一致。虽然医学界和公众认为活人捐赠的肾和肺总体上是安全的，但捐赠对活体捐赠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、全国性的长期分析的问题，该项目将研究来自美国选定移植中心的活体肺和活体肾捐赠者的医疗(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.