Transition of Care in CKD (TC-CKD)

描述(由申请人提供)：在极晚期非透析依赖(NDD)CKD患者(EGFR和lt；25ml/min/1.73m2)中，最佳的治疗过渡到肾脏替代疗法(RRT，即透析或移植)尚不清楚。在以下几个关键领域中，关于不同年龄和人口统计以及不同RRT前共病情况和事件的差别化或个体化护理过渡仍然存在重大不确定性和显著的知识差距，包括：(1)启动RRT的最佳时机；(2)最佳RRT 这些因素包括：(1)透析类型(透析与移植)；(2)透析的最佳方式(血液与腹膜)、透析形式(中心内与家庭)、频率(每天与不频繁)和血管通路准备；(3)RRT前并存条件和事件的影响，包括血压和血糖控制、急性肾损伤发作，以及贫血和矿物质障碍等CKD特殊条件的处理；以及(4)上述RRT前条件对临终关怀和决策的影响。鉴于我们的医疗保健系统发生了巨大的变化，考虑到透析治疗的高昂成本和持续糟糕的结果，迫切需要回答这些与CKD向RRT过渡相关的重要问题。鉴于USRDS在RRT过渡截获之前缺乏大部分核心数据的固有局限性，我们建议在USRDS与两个非常丰富和大型的非常晚期NDD-CKD患者的纵向数据库之间建立高度创新的链接方法，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，每个数据库都由数百万人组成，其中包括超过20,000名患有EGFR和lt的NDD-CKD患者；25ml/min在5年1/1/2008-1/1/2013期间过渡到RRT。这些队列还将提供与预测(2013-2016)4,000多名终末期肾病患者(包括4年内每年数百名肾移植受者)数据的年度关联，从而增加将过渡到RRT的16,000多名关联患者。我们假设：(1)如果基于RRT前的因素，如临床和实验室变量，包括CKD的进展率和合并症，结合人口统计学，从RRT前的数据驱动的个体化治疗过渡到CKD的治疗与更有利的结果相关，包括更长的存活率、更少的住院和更低的费用，以及(2)根据这些RRT前数据得出的评分系统可以确定RRT的时机、准备和方式，以获得更好的结果。在将国家VA和地区KPSC数据与USRDS联系起来以确定那些过渡到透析或移植的人时，我们将通过产生相关的从头变量来检验短期(前6个月)和长期死亡率、住院和费用的预测因素，包括RRT前EGFR斜率、实验室数据趋势和共病指数；这些关于&GT；36,000名过渡患者的RRT前变量将被链接并每年报告，最终可供USRDS与研究人员分享。

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.