Clinical Epidemiology and Pathophysiology of Renal Diseases and Hypertension, Azienda Ospedaliera Bianchi Melacrino Morelli, CNR-IFC, Reggio Calabria, Italy.
Fresenius Medical Care, Bad Homburg, Germany.
J Nephrol. 2018 Feb;31(1):119-127. doi: 10.1007/s40620-016-0372-8. Epub 2017 Feb 16.
In 2013, the Italian Society of Nephrology joined forces with Nephrocare-Italy to create a clinical research cohort of patients on file in the data-rich clinical management system (EUCLID) of this organization for the performance of observational studies in the hemodialysis (HD) population. To see whether patients in EUCLID are representative of the HD population in Italy, we set out to compare the whole EUCLID population with patients included in the regional HD registries in Emilia-Romagna (Northern Italy) and in Calabria (Southern Italy), the sole regions in Italy which have systematically collected an enlarged clinical data set allowing comparison with the data-rich EUCLID system. An analysis of prevalent and incident patients in 2010 and 2011 showed that EUCLID patients had a lower prevalence of coronary heart disease, peripheral vascular disease, heart failure, valvular heart disease, liver disease, peptic ulcer and other comorbidities and risk factors and a higher fractional urea clearance (Kt/V) than those in the Emilia Romagna and Calabria registries. Accordingly, survival analysis showed a lower mortality risk in the EUCLID 2010 and 2011 cohorts than in the combined two regional registries in the corresponding years: for 2010, hazard ratio (HR) EUCLID vs. Regional registries: 0.80 [95% confidence interval: 0.71-0.90]; for 2011, HR: 0.76 [0.65-0.90]. However, this difference was nullified by statistical adjustment for the difference in comorbidities and risk factors, indicating that the longer survival in the EUCLID database was attributable to the lower risk profile of patients included in that database. This preliminary analysis sets the stage for future observational studies and indicates that appropriate adjustment for difference in comorbidities and risk factors is needed to generalize to the Italian HD population analyses based on the data-rich EUCLID database.
2013 年，意大利肾脏病学会与 Nephrocare-Italy 合作，在该组织数据丰富的临床管理系统（EUCLID）中创建了一个患者档案临床研究队列，以进行血液透析（HD）人群的观察性研究。为了确定 EUCLID 中的患者是否代表意大利的 HD 人群，我们着手将整个 EUCLID 人群与意大利艾米利亚-罗马涅（意大利北部）和卡拉布里亚（意大利南部）地区 HD 登记处中纳入的患者进行比较，这两个地区是意大利唯一系统收集扩展临床数据集的地区，允许与数据丰富的 EUCLID 系统进行比较。2010 年和 2011 年的现患和新发患者分析显示，EUCLID 患者的冠心病、外周血管疾病、心力衰竭、瓣膜性心脏病、肝病、消化性溃疡和其他合并症及危险因素的患病率较低，而分数尿素清除率（Kt/V）较高。因此，生存分析显示，EUCLID 2010 年和 2011 年队列的死亡率低于相应年份两个地区登记处的死亡率：2010 年，EUCLID 与地区登记处的危险比（HR）：0.80 [95%置信区间：0.71-0.90]；2011 年，HR：0.76 [0.65-0.90]。然而，通过对合并症和危险因素差异的统计学调整，这种差异被消除，这表明 EUCLID 数据库中患者的生存时间更长归因于该数据库中患者的风险状况较低。这项初步分析为未来的观察性研究奠定了基础，并表明需要对合并症和危险因素的差异进行适当调整，以根据数据丰富的 EUCLID 数据库对意大利 HD 人群的分析进行推广。
