Zafari Neda, Churilov Leonid, MacIsaac Richard J, Torkamani Niloufar, Baxter Helen, Kiburg Katerina V, Ekinci Elif
Department of Medicine, The University of Melbourne, Austin Health, Melbourne, Victoria, Australia
Florey Institute of Neuroscience and Mental Health, Heidelberg,Melbourne, Victoria, Australia.
BMJ Open. 2019 Aug 30;9(8):e031558. doi: 10.1136/bmjopen-2019-031558.
Timely detection leading to the implementation of reno-protective measures reduces the progression of diabetic kidney disease. Estimated glomerular filtration rate (eGFR) is a major surrogate of kidney function. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Equation is a tool to estimate GFR. This protocol outlines a systematic-review, assessing the diagnostic accuracy of the CKD-EPI equation in adults with diabetes.
MEDLINE, Embase, Cochrane Central Register of Controlled Trials and grey literature will be searched for publications in English, Farsi, Dutch and Chinese from 2009 (when CKD-EPI was first introduced) to January 2019. Bridging searches will be conducted to capture literature published from January 2019 until final review publication. The inclusion criteria will be (1) study participants with diabetes; (2) age ≥18 years; (3) creatinine-based CKD-EPI eGFR as index test; (4) measured GFR using the clearance/plasma disappearance of inulin, iohexol, iothalamate, diethylenetriamine-pentaacetic acid (DTPA) or chromium labelled ethylenediaminetetraacetic acid (Cr-EDTA) as reference test; (5) report of the diagnostic accuracy of the index test. Exclusion criteria will be participants with renal transplant, chronic use of corticosteroids, chronic inflammatory diseases, pregnancy, non-diabetes related kidney disease, thalassaemia, heart failure, pregnancy and potential kidney donors as well as critically ill patients. Screening, eligibility check, risk of bias assessment and data extraction will be carried out by two independent reviewers. Any discrepancies will be discussed, and third-party opinion will be sought. The risk of bias will be assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. A quantitative synthesis of the aggregated-data will be used if the included studies are homogenous.
No ethics approval is required. The outcome will be published in a peer-reviewed journal. The results will help researchers and clinicians evaluate the diagnostic accuracy of the creatinine-based CKD-EPI eGFR in adults with diabetes.
CRD42018108776.
及时检测并采取肾脏保护措施可减缓糖尿病肾病的进展。估计肾小球滤过率(eGFR)是肾功能的主要替代指标。慢性肾脏病流行病学协作组(CKD-EPI)公式是一种估算肾小球滤过率的工具。本方案概述了一项系统评价,评估CKD-EPI公式在成年糖尿病患者中的诊断准确性。
将检索MEDLINE、Embase、Cochrane对照试验中心注册库及灰色文献,查找2009年(CKD-EPI首次推出)至2019年1月以英文、波斯文、荷兰文和中文发表的文献。进行补充检索以获取2019年1月至最终综述发表期间发表的文献。纳入标准为:(1)糖尿病研究参与者;(2)年龄≥18岁;(3)基于肌酐的CKD-EPI eGFR作为指标检测;(4)使用菊粉、碘海醇、碘他拉酸、二乙烯三胺五乙酸(DTPA)或铬标记乙二胺四乙酸(Cr-EDTA)的清除率/血浆消失法测量肾小球滤过率作为参考检测;(5)指标检测诊断准确性的报告。排除标准为肾移植患者、长期使用皮质类固醇患者、慢性炎症性疾病患者、孕妇、非糖尿病相关性肾病患者、地中海贫血患者、心力衰竭患者、孕妇及潜在肾脏供体以及危重症患者。由两名独立的审阅者进行筛选、资格检查、偏倚风险评估和数据提取。如有任何差异将进行讨论,并征求第三方意见。将使用诊断准确性研究质量评估-2工具评估偏倚风险。如果纳入的研究具有同质性,将对汇总数据进行定量综合分析。
无需伦理批准。研究结果将发表在同行评审期刊上。研究结果将有助于研究人员和临床医生评估基于肌酐的CKD-EPI eGFR在成年糖尿病患者中的诊断准确性。
PROSPERO注册号:CRD42018108776。