欧洲老年患者慢性肾脏病筛查的设计与方法（SCOPE）研究：一项多中心队列观察性研究
Design and methodology of the screening for CKD among older patients across Europe (SCOPE) study: a multicenter cohort observational study.
作者信息
Corsonello Andrea, Tap Lisanne, Roller-Wirnsberger Regina, Wirnsberger Gerhard, Zoccali Carmine, Kostka Tomasz, Guligowska Agnieszka, Mattace-Raso Francesco, Gil Pedro, Fuentes Lara Guardado, Meltzer Itshak, Yehoshua Ilan, Formiga-Perez Francesc, Moreno-González Rafael, Weingart Christian, Freiberger Ellen, Ärnlöv Johan, Carlsson Axel C, Bustacchini Silvia, Lattanzio Fabrizia
机构信息
Italian National Research Center on Aging (INRCA), Ancona, Fermo and Cosenza, Italy.
Section of Geriatric Medicine, Department of Internal Medicine, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands.
出版信息
BMC Nephrol. 2018 Oct 11;19(1):260. doi: 10.1186/s12882-018-1030-2.
BACKGROUND
Decline of renal function is common in older persons and the prevalence of chronic kidney disease (CKD) is rising with ageing. CKD affects different outcomes relevant to older persons, additionally to morbidity and mortality which makes CKD a relevant health burden in this population. Still, accurate laboratory measurement of kidney function is under debate, since current creatinine-based equations have a certain degree of inaccuracy when used in the older population. The aims of the study are as follows: to assess kidney function in a cohort of 75+ older persons using existing methodologies for CKD screening; to investigate existing and innovative biomarkers of CKD in this cohort, and to align laboratory and biomarker results with medical and functional data obtained from this cohort. The study was registered at ClinicalTrials.gov, identifier NCT02691546, February 25th 2016.
METHODS/DESIGN: An observational, multinational, multicenter, prospective cohort study in community dwelling persons aged 75 years and over, visiting the outpatient clinics of participating institutions. The study will enroll 2450 participants and is carried out in Austria, Germany, Israel, Italy, the Netherlands, Poland and Spain. Participants will undergo clinical and laboratory evaluations at baseline and after 12 and 24 months- follow-up. Clinical evaluation also includes a comprehensive geriatric assessment (CGA). Local laboratory will be used for 'basic' parameters (including serum creatinine and albumin-to-creatinine ratio), whereas biomarker assessment will be conducted centrally. An intermediate telephone follow-up will be carried out at 6 and 18 months.
DISCUSSION
Combining the use of CGA and the investigation of novel and existing independent biomarkers within the SCOPE study will help to provide evidence in the development of European guidelines and recommendations in the screening and management of CKD in older people.
TRIAL REGISTRATION
This study was registered prospectively on the 25th February 2016 at clinicaltrials.gov ( NCT02691546 ).
背景
肾功能下降在老年人中很常见，慢性肾脏病（CKD）的患病率随着年龄增长而上升。CKD除了影响发病率和死亡率外，还会影响与老年人相关的不同结局，这使得CKD成为该人群的一个重要健康负担。然而，肾功能的准确实验室测量仍存在争议，因为目前基于肌酐的公式在老年人群中使用时存在一定程度的不准确性。本研究的目的如下：使用现有的CKD筛查方法评估75岁及以上老年人群的肾功能；调查该队列中现有的和创新的CKD生物标志物，并将实验室和生物标志物结果与从该队列中获得的医学和功能数据进行比对。该研究已在ClinicalTrials.gov注册，标识符为NCT02691546，注册时间为2016年2月25日。
方法/设计：一项针对75岁及以上社区居住者的观察性、跨国、多中心、前瞻性队列研究，这些参与者前往参与机构的门诊就诊。该研究将招募2450名参与者，在奥地利、德国、以色列、意大利、荷兰、波兰和西班牙开展。参与者将在基线时以及随访12个月和24个月后接受临床和实验室评估。临床评估还包括全面老年评估（CGA）。当地实验室将用于检测“基本”参数（包括血清肌酐和白蛋白与肌酐比值），而生物标志物评估将集中进行。在6个月和18个月时将进行中期电话随访。
讨论
在SCOPE研究中结合使用CGA以及对新的和现有的独立生物标志物进行调查，将有助于为制定欧洲老年人CKD筛查和管理指南及建议提供证据。
试验注册
本研究于2016年2月25日在clinicaltrials.gov上进行前瞻性注册（NCT02691546）。
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