Division of Pediatric Nephrology and Hypertension, University of Texas Medical School at Houston, TX 77030, USA.
Adv Chronic Kidney Dis. 2012 Jan;19(1):40-6. doi: 10.1053/j.ackd.2012.01.009.
The randomized controlled trial (RCT) remains the "gold standard" for the evaluation of therapies. Despite some progress during the past decade, the number and quality of published RCTs addressing the core issues for patients with CKD and with renal diseases, in general, lag behind other areas in internal medicine. The paucity of robust evidence results in fewer patients receiving evidence-based therapies in nephrology and fewer rigorous systematic reviews to inform nephrology practice and health care policy. Because trials of lower methodologic rigor continue to be published, the evidence-based practitioner must evaluate new evidence from the medical literature carefully before incorporating that evidence into their clinical practice. The types of errors that may limit the validity or applicability of evidence from RCTs is outlined. A detailed discussion of the most important design elements for the conduct of a high-quality RCT is described in the text. These considerations are placed into the context of critical appraisal tools. These tools allow the clinician to efficiently assess the quality of published RCTs and to determine how the new RCT evidence should change current best practice.
随机对照试验（RCT）仍然是评估疗法的“金标准”。尽管在过去十年中取得了一些进展，但发表的 RCT 的数量和质量，以及针对慢性肾脏病患者和一般肾脏疾病患者的核心问题，仍落后于内科的其他领域。由于缺乏有力的证据，接受肾脏病学循证治疗的患者较少，为肾脏病学实践和医疗保健政策提供信息的严格系统评价也较少。由于低方法学严谨性的试验继续发表，因此循证从业者在将证据纳入临床实践之前，必须仔细评估来自医学文献的新证据。本文概述了可能限制 RCT 证据的有效性或适用性的错误类型。文中详细讨论了进行高质量 RCT 的最重要设计要素。这些考虑因素被置于关键评估工具的背景下。这些工具使临床医生能够有效地评估已发表 RCT 的质量，并确定新的 RCT 证据应如何改变当前的最佳实践。
