LI Yanfei 1,2,3 , CHU Xiajing 1,2,3 , LU Cuncun 4 , HAN Jiani 1,2,3 , ZHENG Zhongli 1,2,3 , LI Xiuxia 1,2,3 , YANG Kehu 1,2,3
  • 1. Evidence Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P. R. China;
  • 2. Key Laboratory of Evidence Based Medicine and Knowledge Translation of Gansu Province, Lanzhou 730000, P. R. China;
  • 3. Evidence Based Social Science Research Center, School of Public Health, Lanzhou University, Lanzhou 730000, P. R. China;
  • 4. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;
LI Xiuxia, Email: yangkh-ebm@lzu.edu.cn
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N-of-1 trials are prospective clinical randomized cross-over controlled trials with multiple rounds of trial phase alternation designed with regard to a single patient. N-of-1 trials can provide clinical decision-makers with high-level evidence of the comparison of effect of intervention measures. Recently, an international team composed of many scholars published a SPIRIT extension for N-of-1 trials list (SPENT 2019) on the BMJ, with the purposes of clarifying the content design and improving the integrity and transparency of N-of-1 trial protocols. This article showed a detailed interpretation of the 14 main extension sub-items of the SPENT 2019 list with specific cases, aiming to further standardize the publication of domestic N-of-1 trials.

Citation: LI Yanfei, CHU Xiajing, LU Cuncun, HAN Jiani, ZHENG Zhongli, LI Xiuxia, YANG Kehu. Interpretation of SPIRIT extension for N-of-1 trials (SPENT 2019). Chinese Journal of Evidence-Based Medicine, 2022, 22(4): 475-482. doi: 10.7507/1672-2531.202112091 Copy

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