Gonzalez-Quiroz Marvin, Nitsch Dorothea, Hamilton Sophie, O'Callaghan Gordo Cristina, Saran Rajiv, Glaser Jason, Correa-Rotter Ricardo, Jakobsson Kristina, Singh Ajay, Gunawardena Nalika, Levin Adeera, Remuzzi Giuseppe, Caplin Ben, Pearce Neil
Research Centre on Health, Work and Environment (CISTA), National Autonomous University of Nicaragua, León, Nicaragua
Centre for Nephrology, University College London, London, UK.
BMJ Open. 2019 Sep 24;9(9):e031169. doi: 10.1136/bmjopen-2019-031169.
A recently recognised form of chronic kidney disease (CKD) of unknown origin (CKDu) is afflicting communities, mostly in rural areas in several regions of the world. Prevalence studies are being conducted in a number of countries, using a standardised protocol, to estimate the distribution of estimated glomerular filtration rate (eGFR), and thus identify communities with a high prevalence of reduced glomerular filtration rate (GFR). In this paper, we propose a standardised minimum protocol for cohort studies in high-risk communities aimed at investigating the incidence of, and risk factors for, early kidney dysfunction.
This generic cohort protocol provides the information to establish a prospective population-based cohort study in low-income settings with a high prevalence of CKDu. This involves a baseline survey that included key elements from the DEGREE survey (eg, using the previously published DEGREE methodology) of a population-representative sample, and subsequent follow-up visits in young adults (without a pre-existing diagnosis of CKD (eGFR<60 mL/min/1.73m), proteinuria or risk factors for CKD at baseline) over several years. Each visit involves a core questionnaire, and collection and storage of biological samples. Local capacity to measure serum creatinine will be required so that immediate feedback on kidney function can be provided to participants. After completion of follow-up, repeat measures of creatinine should be conducted in a central laboratory, using reference standards traceable to isotope dilution mass spectrometry (IDMS) quality control material to quantify the main outcome of eGFR decline over time, alongside a description of the early evolution of disease and risk factors for eGFR decline.
Ethical approval will be obtained by local researchers, and participants will provide informed consent before the study commences. Participants will typically receive feedback and advice on their laboratory results, and referral to a local health system where appropriate.
一种最近被认识的不明原因慢性肾脏病（CKD）形式（CKDu）正在困扰着一些社区，主要是世界上几个地区的农村地区。许多国家正在使用标准化方案进行患病率研究，以估计估算肾小球滤过率（eGFR）的分布，从而确定肾小球滤过率（GFR）降低患病率高的社区。在本文中，我们提出了一种针对高危社区队列研究的标准化最低方案，旨在调查早期肾功能障碍的发病率和危险因素。
这个通用队列方案提供了在CKDu患病率高的低收入环境中建立基于人群的前瞻性队列研究的信息。这包括一项基线调查，该调查纳入了具有人群代表性样本的DEGREE调查的关键要素（例如，使用先前发表的DEGREE方法），以及随后对年轻成年人（基线时无CKD预先诊断（eGFR<60 mL/min/1.73m²）、蛋白尿或CKD危险因素）进行数年的随访。每次随访都涉及一份核心问卷，以及生物样本的采集和储存。将需要当地测量血清肌酐的能力，以便能够向参与者提供关于肾功能的即时反馈。随访结束后，应在中央实验室使用可追溯到同位素稀释质谱（IDMS）质量控制材料的参考标准重复测量肌酐，以量化eGFR随时间下降的主要结果，同时描述疾病的早期演变和eGFR下降的危险因素。
当地研究人员将获得伦理批准，参与者将在研究开始前提供知情同意。参与者通常会收到关于其实验室结果的反馈和建议，并在适当时转诊至当地卫生系统。
