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Action plan for optimizing the design of clinical trials in chronic kidney disease 优化慢性肾脏疾病临床试验设计的行动计划
IF 5.5 2区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2017-10-01 DOI: 10.1016/j.kisu.2017.07.009
Vlado Perkovic , Jonathan C. Craig , Worawon Chailimpamontree , Caroline S. Fox , Guillermo Garcia-Garcia , Mohammed Benghanem Gharbi , Meg J. Jardine , Ikechi G. Okpechi , Neesh Pannu , Benedicte Stengel , Katherine R. Tuttle , Katrin Uhlig , Andrew S. Levey

High-quality clinical trials are the cornerstone of evidence-based prevention and treatment of a disease, but nephrology has a strikingly weak base of such trials. Building the evidence base to improve outcomes for people with a kidney disease, therefore, requires both greater quantity and quality of clinical trials. To address these issues, we propose that we aim to enroll 30% of people with chronic kidney disease in trials by 2030. Goal 1: Strongly encourage and promote the conduct of clinical trials in people with chronic kidney disease to increase the number of clinical trials conducted. Goal 2: Optimize the design of clinical trials in people with chronic kidney disease. Goal 3: Increase the capacity for conducting clinical trials in people with chronic kidney disease.

高质量的临床试验是基于证据的疾病预防和治疗的基石,但肾脏病学的此类试验基础非常薄弱。因此,建立改善肾病患者预后的证据基础,需要更多数量和质量的临床试验。为了解决这些问题,我们建议我们的目标是到2030年将30%的慢性肾脏疾病患者纳入试验。目标1:大力鼓励和推动在慢性肾脏疾病患者中开展临床试验,增加临床试验数量。目标2:优化慢性肾病患者的临床试验设计。目标3:提高对慢性肾脏疾病患者进行临床试验的能力。
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引用次数: 18
Action plan for determining and monitoring the prevalence of chronic kidney disease 确定和监测慢性肾脏疾病流行的行动计划
IF 5.5 2区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2017-10-01 DOI: 10.1016/j.kisu.2017.07.002
Josef Coresh , Jiun-Ruey Hu , Aminu K. Bello , Harold I. Feldman , Agnes B. Fogo , Mohammad Reza Ganji , David C. Harris , Andrew S. Levey , Ikechi G. Okpechi , Benedicte Stengel , Bernadette Thomas , Andrzej Wiecek , Ron T. Gansevoort

Chronic kidney disease (CKD) continues to remain high globally, up to 13.4% by one estimate. Although the number, geographic distribution, size, and quality of the studies examining CKD prevalence and incidence have increased over the past decade, the global capacity for CKD surveillance is still far less developed than that for hypertension, diabetes, and cardiovascular disease. Estimating CKD prevalence is constrained by inadequate standardization of serum creatinine and urine albumin assays, heterogeneity in study designs, lack of national registries in many countries, incomplete adoption of disease classification guidelines, and inconsistent use of evidence-based equations for estimating glomerular filtration rate.

Goal 1: Improve monitoring of CKD prevalence. To achieve this, disseminate the rationale for CKD prevalence monitoring, achieve uniform measurement of CKD markers, promote inclusion of CKD measurements in all large chronic disease cohorts and health surveys, harness administrative claims data for CKD surveillance, and incorporate the new CKD classification system in the International Classification of Diseases.

Goal 2: Improve CKD monitoring of populations underrepresented in studies to date. To achieve this, establish registries of chronic dialysis and transplantation in all countries; establish registries for special CKD groups, such as children, patients with rare diseases, and patients with special etiologies of CKD.

Goal 3: Improve identification of individuals with CKD. To achieve this, implement the Kidney Disease: Improving Global Outcomes guidelines for screening and testing, carry out randomized studies on screening strategies, ensure that estimated glomerular filtration rate is reported with all reports of serum creatinine, and leverage new software for identification and follow-up of CKD cases.

慢性肾脏疾病(CKD)在全球范围内仍然居高不下,据估计高达13.4%。尽管在过去十年中,CKD患病率和发病率研究的数量、地理分布、规模和质量都有所增加,但全球CKD监测能力仍远低于高血压、糖尿病和心血管疾病的监测能力。由于血清肌酐和尿白蛋白检测的不标准化、研究设计的异质性、许多国家缺乏国家登记、疾病分类指南的不完全采用以及估计肾小球滤过率的循证方程的不一致,CKD患病率的估计受到限制。目标1:改善CKD患病率监测。为了实现这一目标,传播CKD流行监测的基本原理,实现CKD标志物的统一测量,促进将CKD测量纳入所有大型慢性疾病队列和健康调查,利用CKD监测的行政索赔数据,并将新的CKD分类系统纳入国际疾病分类。目标2:改善迄今为止研究中代表性不足人群的CKD监测。为此,在所有国家建立慢性透析和移植登记;建立特殊CKD群体的登记,如儿童、罕见疾病患者和特殊病因的CKD患者。目标3:提高CKD患者的识别。为了实现这一目标,实施肾脏疾病:改善筛查和检测的全球结果指南,开展筛查策略的随机研究,确保在报告所有血清肌酐的同时报告估计的肾小球滤过率,并利用新的软件来识别和随访CKD病例。
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引用次数: 18
Strategies to improve monitoring disease progression, assessing cardiovascular risk, and defining prognostic biomarkers in chronic kidney disease 改善慢性肾病疾病进展监测、心血管风险评估和预后生物标志物定义的策略
IF 5.5 2区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2017-10-01 DOI: 10.1016/j.kisu.2017.07.005
Michelle J. Pena , Peter Stenvinkel , Matthias Kretzler , Dwomoa Adu , Sanjay Kumar Agarwal , Josef Coresh , Harold I. Feldman , Agnes B. Fogo , Ron T. Gansevoort , David C. Harris , Vivekanand Jha , Zhi-Hong Liu , Valerie A. Luyckx , Ziad A. Massy , Ravindra Mehta , Robert G. Nelson , Donal J. O'Donoghue , Gregorio T. Obrador , Charlotte J. Roberts , Laura Sola , Hiddo J.L. Heerspink

Chronic kidney disease (CKD) is a major global public health problem with significant gaps in research, care, and policy. In order to mitigate the risks and adverse effects of CKD, the International Society of Nephrology has created a cohesive set of activities to improve the global outcomes of people living with CKD. Improving monitoring of renal disease progression can be done by screening and monitoring albuminuria and estimated glomerular filtration rate in primary care. Consensus on how many times and how often albuminuria and estimated glomerular filtration rate are measured should be defined. Meaningful changes in both renal biomarkers should be determined in order to ascertain what is clinically relevant. Increasing social awareness of CKD and partnering with the technological community may be ways to engage patients. Furthermore, improving the prediction of cardiovascular events in patients with CKD can be achieved by including the renal risk markers albuminuria and estimated glomerular filtration rate in cardiovascular risk algorithms and by encouraging uptake of assessing cardiovascular risk by general practitioners and nephrologists. Finally, examining ways to further validate and implement novel biomarkers for CKD will help mitigate the global problem of CKD. The more frequent use of renal biopsy will facilitate further knowledge into the underlying etiologies of CKD and help put new biomarkers into biological context. Real-world assessments of these biomarkers in existing cohorts is important, as well as obtaining regulatory approval to use these biomarkers in clinical practice. Collaborations among academia, physician and patient groups, industry, payer organizations, and regulatory authorities will help improve the global outcomes of people living with CKD.

慢性肾脏疾病(CKD)是一个重大的全球公共卫生问题,在研究、护理和政策方面存在重大差距。为了减轻慢性肾病的风险和不良影响,国际肾脏病学会创建了一套有凝聚力的活动来改善慢性肾病患者的全球预后。在初级保健中,可以通过筛查和监测蛋白尿和估计肾小球滤过率来改善对肾脏疾病进展的监测。对于蛋白尿和肾小球滤过率的测量次数和频率应该有一致的定义。应确定两种肾脏生物标志物有意义的变化,以确定哪些与临床相关。提高社会对慢性肾病的认识,并与科技界合作,可能是吸引患者的方法。此外,改善CKD患者心血管事件的预测可以通过在心血管风险算法中加入肾脏风险标记物蛋白尿和肾小球滤过率,并鼓励全科医生和肾病学家评估心血管风险来实现。最后,研究进一步验证和实施CKD新生物标志物的方法将有助于缓解CKD的全球问题。肾脏活检的频繁使用将有助于进一步了解CKD的潜在病因,并有助于将新的生物标志物纳入生物学背景。在现有队列中对这些生物标志物进行实际评估是很重要的,同时获得监管机构批准在临床实践中使用这些生物标志物也是很重要的。学术界、医生和患者团体、行业、付款组织和监管机构之间的合作将有助于改善慢性肾病患者的全球预后。
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引用次数: 19
Subscription Information 订阅信息
IF 5.5 2区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2017-10-01 DOI: 10.1016/S2157-1716(17)30040-0
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引用次数: 0
Global Kidney Health Atlas (GKHA): design and methods 全球肾脏健康图谱(GKHA):设计和方法
IF 5.5 2区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2017-10-01 DOI: 10.1016/j.kisu.2017.08.001
Aminu K. Bello , David W. Johnson , John Feehally , David Harris , Kailash Jindal , Meaghan Lunney , Ikechi G. Okpechi , Babatunde L. Salako , Natasha Wiebe , Feng Ye , Marcello Tonelli , Adeera Levin

There has been considerable effort within individual countries to improve the care of patients with kidney disease. There has been no concerted attempt to summarize these efforts, and therefore little is known about structuring health systems to facilitate acute kidney injury and chronic kidney disease (CKD) care and integration with national and international noncommunicable disease strategies. As part of the “Closing the Gaps Initiative,” the International Society of Nephrology will conduct for the first time a survey of the current state of global kidney care covering both acute kidney injury and CKD and present the results in a Global Kidney Health Atlas. Data will be collected via an online questionnaire and targeted at national nephrology societies, policymakers, and consumer organizations. Individual country information will be provided by at least 3 stakeholders. The Global Kidney Health Atlas will provide concise, relevant, and synthesized information on the delivery of care across different health systems to facilitate understanding of performance variations over time and between countries. First, it will provide an overview of existing CKD care policy and context in the health care system. Second, it will provide an overview of how CKD care is organized in individual countries and a description of relevant CKD epidemiology between countries and regions, focusing on elements that are most germane to service delivery and policy development. Finally, synthesis, comparison, and analysis of individual country/regional data will be provided as a platform for recommendations to policymakers, practitioners, and researchers.

个别国家在改善对肾病患者的护理方面作出了相当大的努力。目前还没有协调一致的尝试来总结这些努力,因此对构建卫生系统以促进急性肾损伤和慢性肾病(CKD)的护理以及与国家和国际非传染性疾病战略的整合知之甚少。作为“弥合差距倡议”的一部分,国际肾脏病学会将首次对全球肾脏护理现状进行调查,包括急性肾损伤和慢性肾病,并将结果发表在全球肾脏健康地图集上。数据将通过在线问卷收集,并针对国家肾脏病学会、政策制定者和消费者组织。个别国家的信息将由至少3个利益攸关方提供。全球肾脏健康地图集将提供关于不同卫生系统提供护理的简明、相关和综合信息,以促进了解不同时期和国家之间的绩效差异。首先,它将提供现有的慢性肾病护理政策和卫生保健系统的背景概述。其次,它将概述各个国家如何组织CKD护理,并描述国家和地区之间相关CKD流行病学,重点关注与服务提供和政策制定最相关的因素。最后,将对各个国家/地区的数据进行综合、比较和分析,作为向决策者、从业者和研究人员提出建议的平台。
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引用次数: 39
Title Page 标题页
IF 5.5 2区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2017-10-01 DOI: 10.1016/S2157-1716(17)30041-2
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引用次数: 0
Closing the gap between evidence and practice in chronic kidney disease 缩小慢性肾脏疾病的证据与实践之间的差距
IF 5.5 2区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2017-10-01 DOI: 10.1016/j.kisu.2017.07.006
Meg J. Jardine , Bertram Kasiske , Dwomoa Adu , Mona Alrukhaimi , Gloria E. Ashuntantang , Shakti Basnet , Worawon Chailimpamontree , Jonathan C. Craig , Donal J. O'Donoghue , Vlado Perkovic , Neil R. Powe , Charlotte J. Roberts , Yusuke Suzuki , Tetsuhiro Tanaka , Katrin Uhlig

There are major gaps between our growing knowledge of effective treatments for chronic kidney disease (CKD), and the delivery of evidence-based therapies to populations around the world. Although there remains a need for new, effective therapies, current evidence suggests that many patients with CKD are yet to fully realize the benefits of blood pressure–lowering drugs (with and without reducing proteinuria with renin-angiotensin system blockade), wider use of statins to reduce atherosclerotic cardiovascular disease events, and better glycemic control in both type 1 and type 2 diabetes. There are many barriers to optimizing evidence-based nephrology care around the world, including access to health care, affordability of treatments, consumer attitudes and circumstances, the dissemination of appropriate knowledge, the availability of expertise and structural impediments in the delivery of health care. Further investment in implementation science that addresses the major barriers to effective care in a cost-effective manner could yield both local and global benefits.

我们对慢性肾脏疾病(CKD)有效治疗的知识不断增长,与向世界各地的人群提供循证治疗之间存在重大差距。尽管仍然需要新的、有效的治疗方法,但目前的证据表明,许多CKD患者尚未充分认识到降压药的益处(有或没有通过肾素血管紧张素系统阻断降低蛋白尿),更广泛地使用他汀类药物来减少动脉粥样硬化性心血管疾病事件,以及1型和2型糖尿病患者更好的血糖控制。在世界各地优化循证肾病护理方面存在许多障碍,包括获得卫生保健的机会、治疗的可负担性、消费者的态度和情况、适当知识的传播、专业知识的可得性以及提供卫生保健方面的结构性障碍。进一步投资于实施科学,以具有成本效益的方式解决有效护理的主要障碍,可以产生地方和全球效益。
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引用次数: 13
The establishment and validation of novel therapeutic targets to retard progression of chronic kidney disease 延缓慢性肾脏疾病进展的新治疗靶点的建立和验证
IF 5.5 2区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2017-10-01 DOI: 10.1016/j.kisu.2017.07.008
Carol Pollock , Anna Zuk , Hans-Joachim Anders , Mohammad Reza Ganji , David W. Johnson , Bertram Kasiske , Robyn G. Langham , Roberto Pecoits-Filho , Giuseppe Remuzzi , Jerome Rossert , Yusuke Suzuki , Tetsuhiro Tanaka , Robert Walker , Chih-Wei Yang , Joseph V. Bonventre

The focus of this article is to define goals and resulting action plans that can be collectively embraced by interested stakeholders to facilitate new therapeutic approaches to mitigate chronic kidney disease progression. The specific goals include identifying druggable targets, increasing the capacity for preclinical and early clinical development, broadening the availability of new therapeutic approaches, and increasing investment in the development of new therapies to limit chronic kidney disease. Key deliverables include the establishment of new regional, national, and global consortia; development of clinical trial networks; and creation of programs to support the temporary mutual movement of scientists between academia and the biotechnology and pharmaceutical sector. Other deliverables include cataloging and maintaining up-to-date records to collate progress in renal research and development, inventorying the capacity of research and clinical networks, and describing methods to ensure novel drug development.

本文的重点是定义目标和由此产生的行动计划,这些目标和行动计划可以被感兴趣的利益相关者共同接受,以促进新的治疗方法来缓解慢性肾脏疾病的进展。具体目标包括确定可药物靶点,增加临床前和早期临床开发的能力,扩大新治疗方法的可用性,以及增加对开发新疗法的投资,以限制慢性肾脏疾病。主要成果包括建立新的区域、国家和全球联盟;临床试验网络建设;建立支持学术界与生物技术和制药部门之间科学家临时相互流动的项目。其他可交付成果包括编目和维护最新的记录,以整理肾脏研究和开发的进展,对研究和临床网络的能力进行盘点,以及描述确保新药开发的方法。
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引用次数: 9
The Global Kidney Health Summit Outputs: details to guide the nephrology community along the road to global kidney health 全球肾脏健康峰会成果:详细指导肾脏病界沿着全球肾脏健康之路
IF 5.5 2区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2017-10-01 DOI: 10.1016/j.kisu.2017.07.001
Adeera Levin , Kai-Uwe Eckardt , Marcello Tonelli
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引用次数: 3
Subscription Information 订阅信息
IF 5.5 2区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2017-07-01 DOI: 10.1016/S2157-1716(17)30005-9
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引用次数: 0
期刊
Kidney International Supplements
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