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，活体肾脏捐献的长期安全性尚不确定。在捐赠之前，活体肾脏捐赠者要经过仔细的医疗筛选。有肾脏或心血管疾病或危险因素（如糖尿病或高血压）以及其他严重疾病（如癌症）的候选捐献者被排除在外。一些先前的研究试图通过比较活体肾脏供者与未筛选的普通人群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那些有条件阻止捐赠的个体。此外，大多数先前的活体供体结果调查只检查了死亡率或终末期肾脏疾病（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描述良好的活体肾脏供者队列的长期结果，该队列在捐赠年龄与相似特征和筛选的对照组相匹配。我们将确定在活体肾脏捐献后，死亡、ESRD、慢性肾脏疾病、心血管疾病、高血压和/或贫血是否比这些匹配的、本来足够健康的非捐赠者更常见。活体肾供者数据来源于肾和肺活体供者评估（live）数据库，包含1963年至2007年间在美国三家移植中心之一捐赠的8,951名活体肾供者的详细信息。通过与国家死亡指数（NDI）、医疗保险和医疗补助服务中心（CMS）、社会保障死亡主档案（SSDMF）和移植受者科学登记/器官获取和移植网络（SRTR/OPTN）的数据联系，RELIVE数据得到了丰富，以进一步确定死亡和ESRD。此外，2010年至2012年间，一部分幸存的RELIVE供者（N= 2,857）参与了随访调查和体格评估，以检测ESRD和肾脏相关的发病率，如慢性肾病、心血管疾病、高血压和贫血。对照数据将从六个横断面国家健康和营养检查调查（NHANES）队列中收集，涵盖1971年至2004年的大部分年份，并通过NDI和CMS联系对死亡率和健康状况进行最新的纵向随访。在参与NHANES时存在的无数健康状况的数据是可用的，允许选择算法作为对照，近似于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是重叠的，允许对年龄和出生队列匹配的配对进行类似的随访。因为这项研究将使用合适的对照组，包括最长的随访，并评估多种结果，它将提供迄今为止最好的活体肾脏捐赠的长期评估。

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.