Novel Control Group to Expand the Scope of the RELIVE Living Kidney Donor Study

描述（由申请人提供）：尽管有近50年的临床经验，但活体肾脏捐献的长期安全性尚不明确。在捐赠之前，活体肾脏捐赠者要接受仔细的医学筛查。排除患有肾脏或心血管疾病或风险因素（如糖尿病或高血压）以及其他严重疾病（如癌症）的候选供体。一些先前的研究试图通过比较活体肾脏捐献者与未筛查的一般人群队列的结果来估计活体捐献的风险。然而，这些未经筛选的队列不允许进行有意义的比较，因为它们不可避免地包括了患有排除捐赠的条件的个人。此外，以前大多数活体供者结局的研究仅检查了死亡率或终末期肾病（ESRD）的患病率。 相比之下，我们提出的研究将使用两个现有的数据来源来比较一个良好描述的队列的长期结果，这些队列的活体肾脏捐赠者在捐赠年龄时与具有相似特征和筛选的对照组相匹配。我们将确定死亡、终末期肾病、慢性肾脏疾病、心血管疾病、高血压和/或贫血在活体肾脏捐赠后是否比这些匹配的非捐赠者更常见，否则这些非捐赠者将健康到足以捐赠。 活体肾脏供体数据来自肾脏和肺活体供体评估（RELIVE）数据库，其中包含1963年至2007年期间在美国三家移植中心之一捐赠的8，951名活体肾脏供体的详细信息。RELIVE数据与来自国家死亡指数（NDI），医疗保险和医疗补助服务中心（CMS），社会保障死亡主文件（SSDMF）和移植受体科学登记处/器官采购和移植网络（SRTR/OPTN）的数据相关联，以进一步确定死亡和ESRD。此外，2010年至2012年期间，一部分存活的RELIVE供体（N= 2，857）参与了随访调查和身体评估，以检测ESRD和肾脏相关疾病，如慢性肾脏疾病，心血管疾病，高血压和贫血。 控制数据将收集从六个横截面的国家健康和营养检查调查（NHANES）队列涵盖1971年和2004年之间的大部分年份，与新提供的纵向随访的死亡率和健康状况的NDI和CMS的联系。在NHANES参与时存在的无数健康状况的数据是可用的，允许用于控制的选择算法接近活体肾脏捐赠的筛选过程。RELIVE捐赠和NHANES参与者的年份范围在很大程度上重叠，允许对年龄和出生队列匹配的配对进行类似的随访。由于本研究将使用适当的对照组，包括最长的随访，并评估多种结果，因此它将提供迄今为止对活体肾脏捐赠的最佳长期评估。 公共卫生相关性：肾和肺活体捐赠者评估研究（RELIVE）项目研究了1963年至2007年在美国三个移植中心捐赠的活体肾捐赠者的医疗和生活质量结果。为了帮助医生，以前的捐赠者和正在考虑活体肾脏捐赠的人了解捐赠肾脏如何影响预期寿命，未来的肾脏健康和整体健康，我们计划将RELIVE研究中的近9，000名活体捐赠者与参加另一项研究的人进行比较美国的整体健康（NHANES）。将选择来自NHANES的匹配对照组，这些对照组在各方面与RELIVE肾脏供体相似且同样健康，但没有捐献肾脏除外。由于供体和对照组之间的唯一区别是肾脏捐赠，我们将能够得出与捐赠本身有关的肾脏捐赠结果的更准确结论。

DESCRIPTION (provided by applicant): Despite nearly 50 years of clinical experience, the long-term safety of living kidney donation is not confidently known. Prior to donation, living kidney donors undergo careful medical screening. Candidate donors with kidney or cardiovascular disease or risk factors (such as diabetes or hypertension), and other serious medical conditions such as cancer are excluded. Some previous studies attempted to estimate the risk of living donation by comparing the outcomes of living kidney donors to unscreened general population cohorts. However, these unscreened cohorts do not allow for meaningful comparison, as they inevitably included individuals with conditions that would preclude donation. In addition, most previous investigations of living donor outcomes have examined only mortality or the prevalence of end-stage renal disease (ESRD). In contrast, our proposed study will use two existing data sources to compare long-term outcomes of a well-described cohort of living kidney donors matched at the age of donation to similarly-characterized and screened controls. We will determine whether death, ESRD, chronic kidney disease, cardiovascular disease, hypertension, and/or anemia become more common following living kidney donation than in these matched non-donors who would otherwise have been healthy enough to donate. Living kidney donor data are derived from the Renal and Lung Living Donors Evaluation (RELIVE) database, containing detailed information on 8,951 living kidney donors who donated at one of three US transplant centers between 1963 and 2007. The RELIVE data have been enriched with linkages to data from the National Death Index (NDI), Centers for Medicare & Medicaid Services (CMS), Social Security Death Master File (SSDMF), and Scientific Registry of Transplant Recipients/Organ Procurement and Transplantation Network (SRTR/OPTN) for additional ascertainment of death and ESRD. In addition, a subset of surviving RELIVE donors (N= 2,857) participated in follow-up surveys and physical assessments between 2010 and 2012 to detect ESRD and kidney-related morbidities such as chronic kidney disease, cardiovascular disease, hypertension, and anemia. Control data will be assembled from six cross-sectional National Health and Nutrition Examination Survey (NHANES) cohorts covering most years between 1971 and 2004, with newly available longitudinal follow-up of mortality and health status from NDI and CMS linkages. Data are available on myriad health conditions existing at the time of NHANES participation, allowing a selection algorithm for controls approximating the screening process for living kidney donation. The year ranges for RELIVE donations and NHANES participants are largely overlapping, allowing similar follow-up for age- and birth-cohort matched pairs. Because this study will use an appropriate control group, include the longest follow-up, and assess multiple outcomes, it will provide the best long-term assessment of live kidney donation to date. PUBLIC HEALTH RELEVANCE: The Renal and Lung Living Donors Evaluation Study (RELIVE) project studied medical and quality of life outcomes for living kidney donors who donated between 1963 and 2007 at three US transplant centers. In order to help doctors, previous donors, and people who are considering living kidney donation understand how donating a kidney affects life expectancy, future kidney health, and overall health, we plan to compare the nearly 9,000 living donors from the RELIVE study with people who participated in another study that looked at overall health in the United States (NHANES). The matched controls from NHANES will be chosen to be similar to and just as healthy as the RELIVE kidney donors in every way, except for not having donated a kidney. Since the only difference between the donors and the controls will be the kidney donation, we will be able to draw more accurate conclusions about kidney donor outcomes that are connected to the donation itself.