| 周虎子威,赖雪峰,孙凤,Munyaradzi Dimairo,詹思延,王胜锋.使用适应性设计的随机对照试验报告规范解读[J].Chinese journal of Epidemiology,2022,43(3):409-417 |
| 使用适应性设计的随机对照试验报告规范解读 |
| How to report adaptive design randomized trials—A interpretation of international reporting guideline ACE |
| Received:March 19, 2021 |
| DOI：10.3760/cma.j.cn112338-20210319-00230 |
| KeyWord: 适应性设计 随机对照试验 报告规范 条目清单 |
| English Key Word: Adaptive designs Randomized controlled trial Report specification Checklist |
| FundProject:国家自然科学基金（81502884）；国家重点研发计划（2018YFC1311704） |
| Author Name | Affiliation | E-mail | | Zhou Huziwei | 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 | | | Lai Xuefeng | 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 | | | Sun Feng | 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 | | | Munyaradzi Dimairo | School of Health and Related Research, The University of Sheffield, Sheffield S1 4DP, UK | | | Zhan Siyan | 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 | | | Wang Shengfeng | 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 | wangshengfeng@bjmu.edu.cn |
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| Abstract: |
| 如何提高适应性设计随机对照试验报告质量成为目前的关注热点。使用适应性设计的随机对照试验研究报告规范（adaptive designs CONSORT Extension，ACE）在CONSORT 2010声明基础上进行了针对适应性设计随机对照试验的拓展，为规范适应性设计随机对照试验报告提供了指导。本文将重点对ACE拓展和新增的条目进行解读，同时结合实例说明ACE条目清单在实际中的应用。 |
| English 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. |
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