CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement
CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement
复制标题
DOI：
10.1136/bmj.h1738
复制
发表时间：
2015-05-14
影响因子：
105.7
通讯作者：
Moher, David
中科院分区：
文献类型：
--
作者：
Vohra, Sunita;Shamseer, Larissa;Moher, David
N-of-1试验为个体患者提供了一种基于证据的治疗决策机制。他们使用组临床试验的关键方法要素来评估单个患者的治疗效果，用于无法始终适应大规模试验的情况：罕见疾病，共病或使用并发治疗的患者。改进N-of-1试验的报告和方法和结果的清晰度对于读者衡量试验的有效性和复制成功的结果至关重要。N-of-1试验的CONSORT扩展（CENT 2015）为单个和系列N-of-1试验的报告提供了指导。CENT为CONSORT 2010检查表的25项中的14项提供了额外指南，并推荐了描述单个N-of-1试验的图表，并修改了CONSORT流程图，以说明一系列N-of-1试验的流程。本文档报告了基本原理、开发过程和CENT 2015检查表和图表。
N-of-1 trials provide a mechanism for making evidence based treatment decisions for an individual patient. They use key methodological elements of group clinical trials to evaluate treatment effectiveness in a single patient, for situations that cannot always accommodate large scale trials: rare diseases, comorbid conditions, or in patients using concurrent therapies. Improvement in the reporting and clarity of methods and findings in N-of-1 trials is essential for reader to gauge the validity of trials and to replicate successful findings. A CONSORT extension for N-of-1 trials (CENT 2015) provides guidance on the reporting of individual and series of N-of-1 trials. CENT provides additional guidance for 14 of the 25 items of the CONSORT 2010 checklist and recommends a diagram for depicting an individual N-of-1 trial and modifies the CONSORT flow diagram to address the flow of a series of N-of-1 trials. The rationale, development process, and CENT 2015 checklist and diagrams are reported in this document.