Transition of Care in CKD (TC-CKD)

描述（由申请人提供）：在极晚期非透析依赖性（NDD）CKD（eGFR <25 ml/min/1.73 m2）患者中，治疗向肾脏替代治疗（RRT，即，透析或移植）是未知的。在以下几个关键领域中，关于不同年龄和人口统计学特征以及不同RRT前合并症和事件的差异或个体化治疗过渡的主要不确定性和重大知识差距持续存在：（1）RRT启动的最佳时机;（2）最佳RRT 类型（透析与移植）;在透析的情况下，最佳方式（血液与腹膜），格式（中心与家庭），频率（每日与不频繁）和血管通路准备;（3）RRT前共病病症和事件的RRT后影响，包括血压和血糖控制、急性肾损伤发作，和CKD特异性疾病（如贫血和矿物质紊乱）的管理;以及（4）上述RRT前疾病对临终护理和决策的影响。鉴于我们的医疗保健系统发生了巨大变化，透析治疗的成本高且结局持续不佳，因此迫切需要回答与CKD向RRT过渡相关的这些重要问题。 考虑到USRDS的固有局限性，即在RRT过渡截距之前缺乏大多数核心数据，我们提出了一种高度创新的USRDS与两个非常丰富和大型的极晚期NDD-CKD患者纵向数据库之间的联系方法，即，国家（整个美国）退伍军人事务部（VA）数据库和地区（南加州）Kaiser Permanente（KPSC）数据库，每个数据库由数百万人组成，包括20，000多名eGFR<25 ml/min的NDD-CKD患者，他们在2008年1月1日至2013年1月1日的5年期间过渡到RRT。这些队列还将提供与来自超过4，000例事件ESRD患者（包括每年数百例肾移植受者）的预计（2013- 2016年）数据的年度关联，持续4年，因此增加了超过16，000例将过渡到RRT的关联患者。我们假设：（1）如果决定是基于RRT前因素，如临床和实验室变量（包括CKD进展率和合并症）以及人口统计学，则RRT前数据驱动的个体化方法将治疗过渡到RRT治疗极晚期CKD与更有利的结局相关，包括生存率更高、住院率更少和费用更低，和（2）从这些RRT前数据中得出的评分系统可以确定RRT的时间、准备和方式，以获得更好的结局。在将国家VA和地区KPSC数据与USRDS联系起来以识别那些已经过渡到透析或移植的患者后，我们将检查短期-（前6个月）和长期死亡率、住院和费用，通过生成相关的从头变量，包括RRT前eGFR斜率、实验室数据趋势和合并症指数;超过36，000例过渡期患者的这些RRT前变量将被链接并每年报告，最终可供USRDS与研究人员共享。

DESCRIPTION (provided by applicant): In patients with very-late-stage non-dialysis dependent (NDD) CKD (eGFR <25 ml/min/1.73 m2) the optimal transition of care to renal replacement therapy (RRT, i.e., dialysis or transplantation) is not known. Major uncertainty and significant knowledge gaps have persisted pertaining to differential or individualized transitions of care across different age and demographics and different pre-RRT comorbid conditions and events in several key areas including: (1) the best timing for RRT initiation; (2) the optimal RRT type (dialysis vs. transplant); and in the case of dialysis, the best modality (hemo- vs. peritoneal), format (in-center vs. home), frequency (daily vs. infrequent) and vascular access preparation; (3) the post-RRT impact of pre-RRT comorbid conditions and events including blood pressure and glycemic control, acute kidney injury episodes, and management of CKD specific conditions such as anemia and mineral disorders; and (4) the impact of the above pre-RRT conditions on end-of-life care and decision-making. Given the enormous changes occurring in our health care system and given the high costs of dialysis therapy with persistently poor outcomes, there is an urgent need to answer these important questions related to CKD transitions to RRT. Given the inherent limitations of the USRDS that lacks most core data prior to the RRT transition intercept, we propose a highly innovative linkage approach between the USRDS and two exceptionally rich and large longitudinal databases of very-late-stage NDD-CKD patients, i.e., the national (entire US) Veterans Affairs (VA) database and the regional (Southern California) Kaiser Permanente (KPSC) database, each consisting of millions of people including over 20,000 NDD-CKD patients with eGFR<25 ml/min who transitioned to RRT over the 5-year period 1/1/2008-1/1/2013. These cohorts will also provide annual linkage to projected (2013- 2016) data from over 4,000 incident ESRD patients including several hundred kidney transplant recipients each year for 4 years, hence adding over 16,000 linked patients who will transition to RRT. We hypothesize that (1) a pre-RRT data-driven individualized approach to the transition of care into RRT in very-late-stage CKD is associated with more favorable outcomes including greater survival, fewer hospitalizations and reduced costs, if the decision is based on pre-RRT factors such as clinical and lab variables including the CKD progression rate and comorbid conditions combined with demographics, and (2) that a scoring system derived from these pre-RRT data can determine the timing, preparation and modality of RRT to achieve better outcomes. Upon linking the national VA and regional KPSC data with the USRDS to identify those who have transitioned to dialysis or transplantation, we will examine the predictors of short- (first 6 months) and long-term mortality, hospitalizations and costs by generating pertinent de novo variables including pre-RRT eGFR slope, laboratory data trends and comorbidity indices; and these pre-RRT variables on >36,000 transitioned patients will be linked and reported annually and eventually become available to the USRDS to share with researchers.