Interpretation of the guidelines for reporting outcomes in trials and its significance and insight for research in the area of traditional Chinese medicine_Chinese Journal of Evidence-Based Medicine

Authors：

QIU Ruijin ^1,2 , ZHANG Xinyi ¹ , LIU Shuling ¹ , GUAN Zhiyue ¹ , CHEN Zhuo ¹ , WANG Wenhui ³ ,  SHANG Hongcai ^1,3

1. Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine, Beijing 100029, P. R. China;
2. University of Liverpool, Liverpool L693GL, UK;
3. Hunan University of Traditional Chinese Medicine, Changsha 410208, P. R. China;

Corresponding author：

SHANG Hongcai, Email: shanghongcai@126.com

Keywords：

Outcomes; Reporting guidelines; Clinical trials; Traditional Chinese medicine

DOI：

10.7507/1672-2531.202307127

Video：

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To solve the problems such as the incomplete and non-standard reporting outcomes in clinical trials, international methodologists have simultaneously launched guidelines for reporting outcomes in trial protocols and reports in 2022 on the basis of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and the Consolidated Standards of Reporting Trials (CONSORT) statement 2010. The SPIRIT-Outcomes 2022 extension and CONSORT-Outcomes 2022 extension recommend outcome-specific reporting items should be included prospectively in trial protocols and reports, regardless of trial design or population. This paper introduces and interprets the two guidelines for reporting outcomes, and discusses their significance and enlightenment to the research in the field of traditional Chinese medicine. For example, using the outcome reporting guidelines will help clinical researchers comprehensively consider issues related to outcomes when reporting protocols or results, which may improve the quality of research design and reporting. For core outcome set, the five core elements of outcomes may help researchers extracting and analyzing outcomes, which will standardize research; the explanation of medical terminology in the outcome reporting guidelines will contribute to the improvement of methodology in the field of traditional Chinese medicine.

Citation： QIU Ruijin, ZHANG Xinyi, LIU Shuling, GUAN Zhiyue, CHEN Zhuo, WANG Wenhui, SHANG Hongcai. Interpretation of the guidelines for reporting outcomes in trials and its significance and insight for research in the area of traditional Chinese medicine. Chinese Journal of Evidence-Based Medicine, 2024, 24(1): 119-124. doi: 10.7507/1672-2531.202307127 Copy

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3.	Jiang T, Jiang S, Cui Y, et al. Assessment of reporting quality in randomized controlled trials of acupuncture for labor pain. Front Pain Res (Lausanne), 2022, 3: 999162.
4.	Zhang X, Zhang L, Xiong W, et al. Assessment of the reporting quality of randomised controlled trials of massage. Chin Med, 2021, 16(1): 64.
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6.	Qiu R, Hu J, Huang Y, et al. Outcome reporting from clinical trials of non-valvular atrial fibrillation treated with traditional Chinese medicine or western medicine: a systematic review. BMJ Open, 2019, 9(8): e028803.
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8.	Butcher NJ, Monsour A, Mew EJ, et al. Guidelines for reporting outcomes in trial protocols: the SPIRIT-outcomes 2022 extension. JAMA, 2022, 328(23): 2345-2356.
9.	Butcher NJ, Monsour A, Mew EJ, et al. Guidelines for reporting outcomes in trial reports: the CONSORT-outcomes 2022 extension. JAMA, 2022, 328(22): 2252-2264.
10.	Mokkink LB, Prinsen CA, Bouter LM, et al. The consensus-based standards for the selection of health measurement instruments (COSMIN) and how to select an outcome measurement instrument. Braz J Phys Ther, 2016, 20(2): 105-113.
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15.	Zhang L, Zhang J, Chen J, et al. Clinical research of traditional Chinese medicine needs to develop its own system of core outcome sets. Evid Based Complement Alternat Med, 2013, 2013: 202703.
16.	邱瑞瑾, 魏旭煦, 关之钥, 等. 中医药领域核心指标集研究现状及展望. 中国循证医学杂志, 2023, 23(2): 211-220.
17.	Matvienko-Sikar K, Avery K, Blazeby JM, et al. Use of core outcome sets was low in clinical trials published in major medical journals. J Clin Epidemiol, 2022, 142: 19-28, 142-119.
18.	Hughes KL, Clarke M, Williamson PR. A systematic review finds core outcome set uptake varies widely across different areas of health. J Clin Epidemiol, 2021, 129: 114-123, 129-114.
19.	Williamson PR, Barrington H, Blazeby JM, et al. Review finds core outcome set uptake in new studies and systematic reviews needs improvement. J Clin Epidemiol, 2022, 150: 154-164.
20.	Young AE, Brookes ST, Avery KNL, et al. A systematic review of core outcome set development studies demonstrates difficulties in defining unique outcomes. J Clin Epidemiol, 2019, 115: 14-24.
21.	张英, 陈红, 孙亚男, 等. 临床疗效评价结局指标的理论框架概述. 中国医药导报, 2021, 18(18): 183-188.
22.	Dodd S, Clarke M, Becker L, et al. A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery. J Clin Epidemiol, 2018, 96: 84-92.
23.	邱瑞瑾, 张晓雨, 李敏, 等. 中医证候命名规范化研究在核心指标集构建中的意义及方法. 中华中医药杂志, 2018, 33(6): 2240-2243.
24.	邱瑞瑾, 孙杨, 钟长鸣, 等. 中医核心证候指标集的构建思路. 中国循证医学杂志, 2021, 21(11): 1353-1357.
25.	邱瑞瑾, 孙杨, 韩松洁, 等. 非瓣膜性房颤中医核心证候指标集的构建. 中国循证医学杂志, 2021, 21(12): 1480-1488.

1. EAUATOR. EQUATOR-Network.
2. Bai AD, Komorowski AS, Lo CKL, et al. Methodological and reporting quality of noninferiority randomized controlled trials comparing antibiotic therapies: a systematic review. Clin Infect Dis, 2021, 73(7): e1696-e1705.
3. Jiang T, Jiang S, Cui Y, et al. Assessment of reporting quality in randomized controlled trials of acupuncture for labor pain. Front Pain Res (Lausanne), 2022, 3: 999162.
4. Zhang X, Zhang L, Xiong W, et al. Assessment of the reporting quality of randomised controlled trials of massage. Chin Med, 2021, 16(1): 64.
5. Cheng CW, Wu TX, Shang HC, et al. CONSORT extension for Chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration. Ann Intern Med, 2017, 167(2): 112-121.
6. Qiu R, Hu J, Huang Y, et al. Outcome reporting from clinical trials of non-valvular atrial fibrillation treated with traditional Chinese medicine or western medicine: a systematic review. BMJ Open, 2019, 9(8): e028803.
7. Butcher NJ, Mew EJ, Monsour A, et al. Outcome reporting recommendations for clinical trial protocols and reports: a scoping review. Trials, 2020, 21(1): 620.
8. Butcher NJ, Monsour A, Mew EJ, et al. Guidelines for reporting outcomes in trial protocols: the SPIRIT-outcomes 2022 extension. JAMA, 2022, 328(23): 2345-2356.
9. Butcher NJ, Monsour A, Mew EJ, et al. Guidelines for reporting outcomes in trial reports: the CONSORT-outcomes 2022 extension. JAMA, 2022, 328(22): 2252-2264.
10. Mokkink LB, Prinsen CA, Bouter LM, et al. The consensus-based standards for the selection of health measurement instruments (COSMIN) and how to select an outcome measurement instrument. Braz J Phys Ther, 2016, 20(2): 105-113.
11. Ioannidis JP, Evans SJ, Gøtzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med, 2004, 141(10): 781-788.
12. Zarin DA, Tse T, Williams RJ, et al. The clinicaltrials. gov results database-update and key issues. N Engl J Med, 2011, 364(9): 852-860.
13. OMERACT. OMERACT domain resources.
14. Qureshi R, Mayo-Wilson E, Li T. Harms in systematic reviews paper 1: an introduction to research on harms. J Clin Epidemiol, 2022, 143: 143-196.
15. Zhang L, Zhang J, Chen J, et al. Clinical research of traditional Chinese medicine needs to develop its own system of core outcome sets. Evid Based Complement Alternat Med, 2013, 2013: 202703.
16. 邱瑞瑾, 魏旭煦, 关之钥, 等. 中医药领域核心指标集研究现状及展望. 中国循证医学杂志, 2023, 23(2): 211-220.
17. Matvienko-Sikar K, Avery K, Blazeby JM, et al. Use of core outcome sets was low in clinical trials published in major medical journals. J Clin Epidemiol, 2022, 142: 19-28, 142-119.
18. Hughes KL, Clarke M, Williamson PR. A systematic review finds core outcome set uptake varies widely across different areas of health. J Clin Epidemiol, 2021, 129: 114-123, 129-114.
19. Williamson PR, Barrington H, Blazeby JM, et al. Review finds core outcome set uptake in new studies and systematic reviews needs improvement. J Clin Epidemiol, 2022, 150: 154-164.
20. Young AE, Brookes ST, Avery KNL, et al. A systematic review of core outcome set development studies demonstrates difficulties in defining unique outcomes. J Clin Epidemiol, 2019, 115: 14-24.
21. 张英, 陈红, 孙亚男, 等. 临床疗效评价结局指标的理论框架概述. 中国医药导报, 2021, 18(18): 183-188.
22. Dodd S, Clarke M, Becker L, et al. A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery. J Clin Epidemiol, 2018, 96: 84-92.
23. 邱瑞瑾, 张晓雨, 李敏, 等. 中医证候命名规范化研究在核心指标集构建中的意义及方法. 中华中医药杂志, 2018, 33(6): 2240-2243.
24. 邱瑞瑾, 孙杨, 钟长鸣, 等. 中医核心证候指标集的构建思路. 中国循证医学杂志, 2021, 21(11): 1353-1357.
25. 邱瑞瑾, 孙杨, 韩松洁, 等. 非瓣膜性房颤中医核心证候指标集的构建. 中国循证医学杂志, 2021, 21(12): 1480-1488.

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Interpretation of the guidelines for reporting outcomes in trials and its significance and insight for research in the area of traditional Chinese medicine

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