Massol Jacques, Janin Gérard, Bachot Camille, Gousset Christophe, Sainte-Claire Deville Geoffroy, Chalopin Jean-Marc
Institut PHISQUARE, 20, rue Saint Saëns, 75015, Paris, France.
Centre Hospitalier de Mâcon, 350, boulevard Escande, 71018, Mâcon Cedex, France.
BMC Nephrol. 2016 Jul 22;17(1):92. doi: 10.1186/s12882-016-0307-6.
Chronic kidney disease (CKD) amounts to a heavy burden for health services. There is no long-running epidemiological tool for CKD before dialysis. We here present the protocol for a cohort of patients with "non-dialysis" CKD receiving care in the Bourgogne-Franche-Comté region of France. The aim of this cohort was to periodically describe the characteristics of patients included and their care provision, to analyse evolution in care and patients' kidney function outcomes.
The ND-CRIS cohort is prevalent and incident. Patients are included in the cohort if over 18, with a glomerula filtration rate (GFR) <60 ml/min/1.73 m2, non-dialysed, informed on the research and not having opposed it, and followed by a nephrologist in one of the 9 centres in the region, (3 pilot centres joined by 6 others in 2015). All the patients are followed up, with varying time lapses according to the degree of GFR deterioration. Data is collected by clinical research assistants (CRAs) using a dedicated computerised case-report form (CRF). Professional practices are assessed using indicators defined by the French Health Authority. The follow-up of patients included should enable assessment of the evolution of their GFR and co-morbidities. The periodic descriptions should give insight into evolution in epidemiological terms.
The ND-CRIS meets a need in epidemiological tools in France for CKD. The cohort does claim to be representative, of ND-CKD patients receiving care from nephrologists. The open and incident nature of the cohort and the number of patients included in the ND-CRIS should provide answers to questions that cannot be answered by smaller solely prevalent cohorts. The numbers of patients included over the study period (2391 patients in 3 centres in 3 years) suggests that the figure of 5000 patients should be reached by 2017. The participation of nephrologists and the rate of inclusions point to the feasibility of the implementation of this cohort. Beyond the information to be found in the CRFs, this cohort should also enable ad hoc studies, in particular in the area of pharmaco-epidemiology, and it could later serve as a research platform and as a public health surveillance tool.
慢性肾脏病（CKD）给卫生服务带来了沉重负担。在透析前，尚无用于CKD的长期流行病学工具。我们在此介绍一项针对法国勃艮第-弗朗什-孔泰地区接受治疗的“非透析”CKD患者队列的方案。该队列的目的是定期描述纳入患者的特征及其护理情况，分析护理的演变以及患者的肾功能结局。
ND-CRIS队列既有现患病例也有新发病例。如果患者年龄超过18岁，肾小球滤过率（GFR）<60 ml/min/1.73 m²，未接受透析，了解该研究且未表示反对，并且由该地区9个中心之一的肾病专家进行随访（2015年3个试点中心与另外6个中心联合），则将其纳入队列。所有患者均接受随访，根据GFR恶化程度，随访间隔时间不同。数据由临床研究助理（CRA）使用专用的计算机化病例报告表（CRF）收集。专业实践使用法国卫生当局定义的指标进行评估。对纳入患者的随访应能够评估其GFR和合并症的演变情况。定期描述应能从流行病学角度洞察演变情况。
ND-CRIS满足了法国对CKD流行病学工具的需求。该队列声称代表了接受肾病专家治疗的非透析CKD患者。该队列的开放性和新发病例性质以及ND-CRIS纳入的患者数量应能为规模较小的仅包含现患病例的队列无法回答的问题提供答案。研究期间纳入的患者数量（3年内3个中心有2391名患者）表明到2017年应能达到5000名患者。肾病专家的参与和纳入率表明实施该队列是可行的。除了在CRF中可获取的信息外，该队列还应能开展特别研究，尤其是在药物流行病学领域，并且它以后可作为研究平台和公共卫生监测工具。
