St Peter Wendy L, Liu Jiannong, Weinhandl Eric D, Fan Qiao
The College of Pharmacy, University of Minnesota, Minneapolis, Minnesota, USA.
Hemodial Int. 2008 Oct;12(4):480-91. doi: 10.1111/j.1542-4758.2008.00312.x.
The Dialysis Clinical Outcomes Revisited (DCOR) trial was a large randomized, multicenter 3-year trial comparing the effects of sevelamer with calcium-based binders on mortality, hospitalization, morbidity, and medical costs in hemodialysis subjects. Dialysis Clinical Outcomes Revisited was prospectively designed to link subjects to the Centers for Medicare & Medicaid Services End-Stage Renal Disease (CMS ESRD) database to collect additional baseline characteristic data and to enhance outcome evaluation. Subjects were linked to the CMS ESRD database by means of an algorithm using several patient identifiers. Some baseline characteristic data were collected exclusively from the CMS ESRD database. Mortality and hospitalization end points were obtained from the CMS ESRD database and compared with similar data collected prospectively into a case-report form (CRF) database. Of the 2103 patients who participated in the DCOR study, 2101 were successfully linked to the CMS ESRD database. Patient baseline data showed that treatment groups were well-balanced, except that a higher proportion of subjects in the calcium-based binder group had atherosclerotic heart disease. Calculated mortality rates were similar between databases, but more deaths were identified in the CMS than in the CRF database. These additional deaths were verified through several sources. More hospitalizations were also detected in the CMS than in the CRF database. The CMS database was a good source of death end points and hospitalization occurrence. Linking patients to the data-rich CMS ESRD database allowed assessment of additional important secondary end points at a relatively low cost compared with prospective data collection.
透析临床结局再评估（DCOR）试验是一项大型随机、多中心的3年试验，比较了司维拉姆与钙基结合剂对血液透析患者死亡率、住院率、发病率和医疗费用的影响。透析临床结局再评估试验前瞻性地设计将受试者与医疗保险和医疗补助服务中心的终末期肾病（CMS ESRD）数据库相链接，以收集额外的基线特征数据并加强结局评估。通过使用多个患者标识符的算法将受试者与CMS ESRD数据库相链接。一些基线特征数据仅从CMS ESRD数据库收集。死亡率和住院终点数据从CMS ESRD数据库获取，并与前瞻性收集到病例报告表（CRF）数据库中的类似数据进行比较。在参与DCOR研究的2103名患者中，有2101名成功链接到CMS ESRD数据库。患者基线数据显示，各治疗组均衡良好，只是钙基结合剂组中患动脉粥样硬化性心脏病的受试者比例较高。两个数据库计算出的死亡率相似，但在CMS数据库中识别出的死亡病例比CRF数据库中更多。这些额外的死亡病例通过多个来源得到了核实。在CMS数据库中检测到的住院病例也比CRF数据库中更多。CMS数据库是死亡终点和住院发生情况的良好来源。与前瞻性数据收集相比，将患者与数据丰富的CMS ESRD数据库相链接能够以相对较低的成本评估额外的重要次要终点。
