Translated by HU Jiayuan 1 , LI Jiang 2 , ZHAI Jingbo 3 , LI Bo 4 , TIAN Jinhui 5 , MA Bin 5 , YANG Kehu 5 , DAI Min 2 , TIAN Guihua 6 , SHANG Hongcai 6 , ZHANG Chi 6 , DUAN Yuting 7,8 , BIAN Zhaoxiang 7,8 , 译
  • 1. Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing 100010, P.R.China;
  • 2. National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union, Beijing 100021, P.R.China;
  • 3. Tianjin University of Traditional Chinese Medicine, Tianjin 301617, P.R.China;
  • 4. Beijing Institute of Traditional Chinese Medicine, Beijing 100010, P.R.China;
  • 5. Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P.R.China;
  • 6. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, P.R.China;
  • 7. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong 999077, P.R.China;
  • 8. Chinese EQUATOR Centre, Hong Kong 999077, P.R.China;
DUAN Yuting, Email: shanghongcai@foxmail.com; BIAN Zhaoxiang, Email: bianzxiang@gmail.com
CONSORT; 单病例随机对照试验; 中医药; 报告规范
10.7507/1672-2531.202008173
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背景  单病例随机对照试验是评价中医药干预措施有效性和安全性较为理想和适宜的方法之一。目前已有一定数量的中医药单病例随机对照试验发表。然而，由于缺乏相应的报告规范，这些试验的报告质量普遍较差。鉴于中医药临床研究的独特性，工作组制定了单病例随机对照试验报告标准（CONSORT extension for reporting N-of-1 trials，CENT 2015）的中医药扩展版（中医药 CENT），以帮助研究者报告中医药单病例试验。 方法  我们在提高健康研究质量和透明度协作网（Enhancing the QUAlity and Transparency Of health Research，EQUATOR）上注册了中医药 CENT。中医药单病例随机对照试验报告规范的制定是一个综合过程，包括收集初始报告条目，与 17 名专家小组成员进行两轮科学的德尔菲共识调查，修订和形成最终报告清单。 结果  清单共包括 6 个领域的 25 项条目，其中的 8 项对 CENT 2015 清单条目进行了扩展和详细说明。中医药 CENT 清单充分考虑了中医药的诊疗特点，并详细阐释了中医药单病例随机对照试验中辨证的概念和不同的中医药干预措施。 结论  中医药 CENT 是中医临床研究的一个实用工具，可用于评价中医药单病例对照试验报告的完整性，并可指导中医药单病例对照试验的设计、实施和报告，期望此报告规范可切实提高中医药单病例试验的全面性和透明度。

Citation： Translated by HU Jiayuan, LI Jiang, ZHAI Jingbo, LI Bo, TIAN Jinhui, MA Bin, YANG Kehu, DAI Min, TIAN Guihua, SHANG Hongcai, ZHANG Chi, DUAN Yuting, BIAN Zhaoxiang. CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM): recommendations, explanation and elaboration. Chinese Journal of Evidence-Based Medicine, 2021, 21(3): 338-346. doi: 10.7507/1672-2531.202008173 Copy

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