• 1. School of Chinese Medicine, Hong Kong Baptist University, HongKong 999077, P.R.China;
  • 2. Chinese EQUATOR Center, HongKong 999077, P.R.China;
  • 3. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P.R.China;
  • 4. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, P.R.China;
  • 5. Evidence-based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 73000, P.R.China;
  • 6. Chinese GRADE Center, Lanzhou 73000, P.R.China;
  • 7. Lanzhou University Institute of Health Data Science, Lanzhou 73000, P.R.China;
BIAN Zhaoxiang, Email: bianzxiang@gmail.com
Export PDF Favorites Scan Get Citation

背景  研发随机对照试验报告规范 CONSORT 声明旨在帮助生物医学研究人员透明地报告随机对照试验(randomised controlled trials,RCTs)。我们已针对社会和心理干预措施制定了 CONSORT 2010 声明扩展版(CONSORT-SPI 2018),以帮助行为和社会科学家透明地报告这些研究。 方法  在对现有报告规范进行系统评价之后,我们进行了在线德尔菲流程(Delphi process)以优先考虑从系统评价中确定的 CONSORT-SPI 2018 清单的潜在条目。384 位国际参与者中有 321 位(84%)完成了 2 次调查。然后我们召开了由 31 位科学家、期刊编辑和研究资助者组成的共识会议(2014 年 3 月),最终确定 CONSORT-SPI 2018 检查清单和流程图的内容。 结果  CONSORT-SPI 2018 扩展了 CONSORT 2010 检查清单中的 9 个条目(包括亚条目在内的 14 个条目),增加了一个与利益相关方参与试验有关的新条目(包括 3 个亚条目),并修改了 CONSORT 2010 流程图。本解释与说明(E&E)文件是 CONSORT-SPI 2018 的用户手册,可帮助使用者更好地理解 CONSORT-SPI 2018。本文讨论了每个清单条目的含义和原理,并提供了完整及明晰的报告示例。 结论  CONSORT-SPI 2018 扩展版、解释与说明文件及 CONSORT 网站(www.consort-statement.org)是有助于改善社会和心理干预措施 RCTs 报告的有用资源。

Citation: Translated by WONG Yiulin, LIU Fan, DUAN Yuting, BIAN Zhaoxiang, ZHANG Chi, CHEN Yaolong. CONSORT-SPI 2018 explanation and elaboration: guidance for reporting social and psychological intervention trials. Chinese Journal of Evidence-Based Medicine, 2020, 20(12): 1458-1470. doi: 10.7507/1672-2531.202008181 Copy

Copyright © the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved

  • Previous Article

    Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension
  • Next Article

    Development, elaboration and application of grade summary of finding table for network meta-analysis