Unique Study Designs in Nephrology: N-of-1 Trials and Other Designs

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• 作者：Joyce P. Samuel ; ^{joyce.samuel@uth.tmc.edu} ; Cynthia S. Bell
• 关键词：Research design ; Random allocation ; Crossover studies ; N-of-1 trial
• 刊名：Advances in Chronic Kidney Disease
• 出版年：2016
• 出版时间：November 2016
• 年：2016
• 卷：23
• 期：6
• 页码：351-354
• 全文大小：358 K
• 卷排序：23

文摘

Alternatives to the traditional parallel-group trial design may be required to answer clinical questions in special populations, rare conditions, or with limited resources. N-of-1 trials are a unique trial design which can inform personalized evidence-based decisions for the patient when data from traditional clinical trials are lacking or not generalizable. A concise overview of factorial design, cluster randomization, adaptive designs, crossover studies, and n-of-1 trials will be provided along with pertinent examples in nephrology. The indication for analysis strategies such as equivalence and noninferiority trials will be discussed, as well as analytic pitfalls.