Translated by CHEN Ze 1 , CHEN Juexuan 2 , DUAN Yuting 3,4 , ZHANG Chi 5 , CHEN Yaolong 6,7,8 , BIAN Zhaoxiang 3,4 , 译
  • 1. Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou 510006, P.R.China;
  • 2. American Academy of Acupuncture and Oriental Medicine, Roseville, Minnesota 55113, USA;
  • 3. School of Chinese Medicine, HongKong Baptist University, HongKong 999077, P.R.China;
  • 4. Chinese EQUATOR Centre, HongKong 999077, P.R.China;
  • 5. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, P.R.China;
  • 6. Evidence-based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 73000, P.R.China;
  • 7. Chinese GRADE Center, Lanzhou 73000, P.R.China;
  • 8. Lanzhou University, Institute of Health Data Science, Lanzhou 73000, P.R.China;
CHEN Yaolong, Email: ; BIAN Zhaoxiang, Email: bianzxiang@gmail.com
10.7507/1672-2531.202008183
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临床试验报告规范 CONSORT（Consolidated Standards of Reporting Trials，CONSORT）声明旨在提高随机对照试验（randomized controlled trail，RCT）的报告质量，然而该声明却缺少专门关于患者报告结局（patient-reported outcomes，PROs）的指引，而这部分内容恰恰也是临床试验经常报告不足的内容。患者报告结局指标数据的缺失影响了临床试验结果的价值。本文报告了依据“提高医疗卫生研究的质量和透明度协作网”（EQUATOR Network）所提出的报告规范研发方法学框架制定的临床试验报告规范—CONSORT 患者报告结局扩展版（CONSORT PROs）。最终推荐 5 个 CONSORT 患者报告结局清单条目，用于以患者报告结局为主要或关键的次要结局指标的随机对照试验。这些推荐条目强烈要求：① 在摘要中需明确说明将患者报告结局作为主要或次要结局指标；② 提供针对患者报告结局指标及其相关适用范畴的假设（如是否使用了多维度患者报告结局指标的检测工具）；③ 提供或引用患者报告结局测量工具效度和信度的证据；④ 明确说明处理缺失数据的统计学方法；⑤ 讨论以患者报告结局指标为研究结果指标的特定局限性和结果对其他人群和临床实践的影响。本文还提供了相关条目的示例和附有患者报告结局的 CONSORT 流程图。建议在报告以患者报告结局作为主要结局指标或关键的次要结局指标时，以 CONSORT 患者报告结局扩展版与原版的 CONSORT 报告规范相互参考进行报告。改进后的患者报告结局试验数据将大大促进对随机对照试验结果的全面解释，并较好指导患者的治疗。

Citation： Translated by CHEN Ze, CHEN Juexuan, DUAN Yuting, ZHANG Chi, CHEN Yaolong, BIAN Zhaoxiang. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. Chinese Journal of Evidence-Based Medicine, 2021, 21(3): 347-354. doi: 10.7507/1672-2531.202008183 Copy

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