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[如何报告适应性设计随机试验——国际报告指南ACE解读]

[How to report adaptive design randomized trials-A interpretation of international reporting guideline ACE].

作者信息

Zhou H Z W, Lai X F, Sun F, Dimairo D I M A I R O, Zhan S Y, Wang S F

机构信息

School of Public Health/Department of Epidemiology and Biostatistics, School of Public Health/Key Laboratory for Research and Evaluation of Pharmacovigilance, National Medical Products Administration/Clinical Epidemiology Research Center, Peking University, Beijing 100191, China.

School of Health and Related Research, The University of Sheffield, Sheffield S1 4DP, UK.

出版信息

Zhonghua Liu Xing Bing Xue Za Zhi. 2022 Mar 10;43(3):409-417. doi: 10.3760/cma.j.cn112338-20210319-00230.

DOI:10.3760/cma.j.cn112338-20210319-00230
PMID:35345299
Abstract

Concerns has been raised in improving the quality of adaptive design randomized trials reports. Based on the CONSORT 2010 (Consolidated Standards of Reporting Trials), The Adaptive designs CONSORT Extension (ACE) has developed items and reporting specifications for adaptive design trials. This paper presents a brief explanation of the extension and new items of ACE and introduces the applications of ACE checklist with examples.

摘要

在提高适应性设计随机试验报告质量方面已引发关注。基于CONSORT 2010(试验报告统一标准),适应性设计CONSORT扩展版(ACE)已制定了适应性设计试验的条目和报告规范。本文简要解释了ACE的扩展内容和新条目,并举例介绍了ACE清单的应用。

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