Summary of Recommendation Statements
Summary of Recommendation Statements
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DOI：
10.1038/ki.2013.91
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发表时间：
2013-01-01
影响因子：
5.5
通讯作者：
Stevens, Paul E.
中科院分区：
文献类型：
--
作者：
Levin, Adeera;Stevens, Paul E.
肾脏科的临床试验侧重于实现目标、补充不足和纠正过度，以改善患者的预后。大多数干预措施都没有显示出好处，有些已经造成了伤害。这可能是因为旨在使参数“正常化”的疗法实际上可能会干扰进化适应，从而造成伤害。通过重新关注疾病的生理学和适应的复杂性，我们可能会设计出更好的试验。我们回顾了肾脏病学和其他学科的成功和失败的试验，并提出了一套设计未来临床试验的原则：(1)承认慢性肾脏疾病人群的异质性，并适当地描述研究人群；(2)开发更有效的生物标记物(通过蛋白质组学、基因组学和代谢组学)来识别干预的应答者和无应答者；(3)设计模拟生理过程而没有附带有害影响的干预措施；(4)重新考虑随机对照试验作为唯一“黄金标准”的地位，并进行大规模的务实试验，将当前护理与感兴趣的干预(S)进行比较；(5)拓宽肾病研究文化，使大多数患者纳入观察性队列和干预研究，从而促进更大的知识获取和传播。加强对病理生理机制的理解，结合更具创新性但更严格的临床试验设计，最终将导致患者结果的改善。肾脏疾病：改善全球结局(KDIGO)2012年慢性肾脏疾病(CKD)评估和管理临床实践指南旨在更新2002年KDOQI慢性肾脏疾病临床实践指南：评估、分类和分层，在CKD的十年重点研究和临床实践之后。该文件旨在为所有CKD患者的评估、管理和治疗提供最先进的指导。具体地说，该指南保留了CKD的定义，但提出了一个增强的CKD分类框架；详细阐述了CKD的识别和预后；讨论了CKD的进展和并发症的管理；并扩展了CKD护理的连续性：专家转诊的时间安排、进展性CKD患者的持续管理、开始透析的时间安排，以及包括全面保守管理的治疗计划的实施。该指南的制定遵循了明确的证据审查和评估程序。治疗方法在每一章中都有论述，指南建议是基于对相关试验的系统审查。作为教育目的的实用评论或陈述不评分，但作为对读者的重要信息包括在内。对证据质量和建议力度的评价遵循等级办法。讨论了正在进行的争议领域、证据的局限性和国际相关性，并为未来的研究提供了其他建议。
Clinical trials in nephrology have focused on achieving targets, supplementing deficiencies, and correcting excesses in order to improve patient outcomes. The majority of interventions have failed to demonstrate benefit and some have caused harm. It may be that therapies aiming to 'normalize' parameters may actually disturb evolutionary adaptation, thus causing harm. By refocusing on the physiology of disease, and complexity of adaptation, we may design better trials. We review successful and unsuccessful trials in nephrology and other disciplines and suggest a set of principles by which to design future clinical trials: (1) acknowledge heterogeneity of chronic kidney disease populations and appropriately characterize populations for studies; (2) develop better validated biomarkers (through proteomics, genomics, and metabolomics) to identify responders and nonresponders to interventions; (3) design interventions that mimic physiological processes without collateral detrimental effects; (4) reconsider the status of the randomized-controlled trial as the only 'gold standard' and perform large-scale pragmatic trials comparing current care with the intervention(s) of interest, and (5) broaden nephrology research culture so that the majority of patients are enrolled into observational cohorts and intervention studies, which foster greater knowledge acquisition and dissemination. Improved understanding of pathophysiological mechanisms, in conjunction with more innovative but stringent clinical trial design, will ultimately lead to improved patient outcomes.The Kidney Disease: Improving Global Outcomes (KDIGO) 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD) serves to update the 2002 KDOQI Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification, and Stratification following a decade of focused research and clinical practice in CKD. The document aims to provide state-of-the-art guidance on the evaluation, management and treatment for all patients with CKD. Specifically, the guideline retains the definition of CKD but presents an enhanced classification framework for CKD; elaborates on the identification and prognosis of CKD; discusses the management of progression and complications of CKD; and expands on the continuum of CKD care: timing of specialist referral, ongoing management of people with progressive CKD, timing of the initiation of dialysis, and finally the implementation of a treatment program which includes comprehensive conservative management. The development of the guideline followed an explicit process of evidence review and appraisal. Treatment approaches are addressed in each chapter and guideline recommendations are based on systematic reviews of relevant trials. Practical comments or statements which serve as educational purposes are ungraded, but included as important information for the readership. Appraisal of the quality of the evidence and the strength of recommendations followed the GRADE approach. Ongoing areas of controversies, limitations of the evidence, and international relevance are discussed and additional suggestions are provided for future research.