Defining end-stage renal disease in clinical trials: a framework for adjudication

Defining end-stage renal disease in clinical trials: a framework for adjudication
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DOI:
10.1093/ndt/gfv289
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发表时间:
2016-06-01
影响因子:
6.1
通讯作者:
Agarwal, Rajiv
Agarwal, Rajiv
中科院分区:
医学1区
文献类型:
--
作者:
Agarwal, Rajiv

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与卒中和心肌梗死的定义不同,终末期肾病(ESRD)的判定尚无统一的定义。对于临床试验者、监管者、支付者和慢性肾病患者来说,ESRD仍然是最明确和临床相关的终点。对晚期慢性肾脏病患者的透析处方具有主观性,并且在医生和国家之间存在很大差异。鉴于诊断ESRD的困难,估计GFR的存在
Unlike definition of stroke and myocardial infarction, there is no uniformly agreed upon definition to adjudicate end-stage renal disease (ESRD). ESRD remains the most unambiguous and clinically relevant end point for clinical trialists, regulators, payers and patients with chronic kidney disease. The prescription of dialysis to patients with advanced chronic kidney disease is subjective and great variations exist among physicians and countries. Given the difficulties in diagnosing ESRD, the presence of estimated GFR