The comparison of research and reporting guideline for core outcome sets and the significance for research in traditional Chinese medicine_Chinese Journal of Evidence-Based Medicine

Authors：

QIU Ruijin ¹ , HU Jiayuan ¹ , LI Min ¹ , ZHONG Changming ¹ , GUAN Manke ¹ , HUANG Ya ¹ , HAN Songjie ¹ , HE Tianmai ¹ ,  CHEN Jing ² ,  SHANG Hongcai ¹

1. Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China;
2. Baokang Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, P.R.China;

Corresponding author：

CHEN Jing, Email: cjshcsyc@126.com; SHANG Hongcai, Email: shanghongcai@foxmail.com

Keywords：

Core outcome sets; Traditional Chinese medicine; Core Outcome Set-STAndardised Protocol Items (COS-STAP); Core Outcome Set-STAndards for Reporting (COS-STAR); Core Outcome Set-STAndards for Development (COS-STAD); Methodology

DOI：

10.7507/1672-2531.201905092

Video：

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The Core Outcome Measures in Effectiveness Trials (COMET) Working Group has published a series of research and reporting guidelines related to core outcome sets since it was established. This article introduces and interprets the Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement which is developed by the COMET and published in February 2019. It will then be compared with Core Outcome Set-STAndards for Reporting (COS-STAR) and Core Outcome Set-STAndards for Development (COS-STAD), which have been introduced to China. The significance of these guidelines for the development of core outcomes in the field of traditional Chinese medicine is discussed, so as tp draw researchers' attention to this area.

Citation： QIU Ruijin, HU Jiayuan, LI Min, ZHONG Changming, GUAN Manke, HUANG Ya, HAN Songjie, HE Tianmai, CHEN Jing, SHANG Hongcai. The comparison of research and reporting guideline for core outcome sets and the significance for research in traditional Chinese medicine. Chinese Journal of Evidence-Based Medicine, 2019, 19(12): 1492-1497. doi: 10.7507/1672-2531.201905092 Copy

1.	Kirkham JJ, Gorst S, Altman DG, et al. Core Outcome Set-STAndards for Reporting: The COS-STAR Statement. PLoS Med, 2016, 13(10): e1002148.
2.	Kirkham JJ, Davis K, Altman DG, et al. Core Outcome Set-STAndards for Development: The COS-STAD recommendations. PLoS Med, 2017, 14(11): e1002447.
3.	Kirkham JJ, Gorst S, Altman DG, et al. Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement. Trials, 2019, 20(1): 116.
4.	张明妍, 杨丰文, 李越, 等. 核心指标集报告规范:COS-STAR 声明. 中国循证医学杂志, 2017, 17(4): 470-474.
5.	张明妍, 张俊华, 杜亮, 等. 核心指标集研制规范 (COS-STAD) 介绍及其在中医药领域应用的思考. 中国循证医学杂志, 2018, 18(4): 392-396.
6.	邱瑞瑾, 李敏, 韩松洁, 等. 《COMET 手册》1.0 版解读及其对构建中医临床研究核心指标集的启示. 中国循证医学杂志, 2017, 17(12): 1482-1488.
7.	Prinsen CA, Vohra S, Rose MR, et al. How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline. Trials, 2016, 17(1): 449.
8.	邱瑞瑾, 孙杨, 胡嘉元, 等. 临床研究中选择结局指标测量工具的方法. 中国循证医学杂志, 2018, 18(2): 238-243.
9.	Williamson PR, Altman DG, Bagley H, et al. The COMET Handbook: version 1.0. Trials, 2017, 18(Suppl 3): 280.
10.	Karas J, Ashkenazi S, Guarino A, et al. A core outcome set for clinical trials in acute diarrhoea. Arch Dis Child, 2015, 100(4): 359-363.
11.	Haywood KL, Griffin XL, Achten J, et al. Developing a core outcome set for hip fracture trials. Bone Joint J, 2014, 96-B(8): 1016-1023.
12.	Kirchhof P, Auricchio A, Bax J, et al. Outcome parameters for trials in atrial fibrillation: executive summary. Eur Heart J, 2007, 28(22): 2803-2817.
13.	Zannad F, Garcia AA, Anker SD, et al. Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document. Eur J Heart Fail, 2013, 15(10): 1082-1094.
14.	Biggane AM, Brading L, Ravaud P, et al. Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys. Trials, 2018, 19(1): 113.
15.	邱瑞瑾. 中医临床研究核心指标集的方法构建. 北京中医药大学, 2018.
16.	Fish R, Sanders C, Adams R, et al. A core outcome set for clinical trials of chemoradiotherapy interventions for anal cancer (CORMAC): a patient and health-care professional consensus. Lancet Gastroenterol Hepatol, 2018, 3(12): 865-873.
17.	Ruperto N, Ravelli A, Murray KJ, et al. Preliminary core sets of measures for disease activity and damage assessment in juvenile systemic lupus erythematosus and juvenile dermatomyositis. Rheumatology (Oxford), 2003, 42(12): 1452-1459.
18.	Vargus-Adams JN, Martin LK. Measuring what matters in cerebral palsy: a breadth of important domains and outcome measures. Arch Phys Med Rehabil, 2009, 90(12): 2089-2095.
19.	Brookes ST, Macefield RC, Williamson PR, et al. Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development. Trials, 2016, 17(1): 409.
20.	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.
21.	张莉, 张俊华, 陈静,等. 中医药临床研究评价指标体系中应引入核心结局指标集概念. 北京: 中国科技论文在线. Available at: http://www.paper.edu.cn/releasepaper/content/201305-366.
22.	Zhang J, Xing D, Shang H. Developing a core outcome set for traditional Chinese medicine for stable angina pectoris. Available at: http://www.comet-initiative.org/studies/details/391?result=true.
23.	COMET Initiative. Available at: http://www.comet-initiative.org/.
24.	Qiu R, Li M, Zhang X, et al. Development of a core outcome set (COS) and selecting outcome measurement instruments (OMIs) for non-valvular atrial fibrillation in traditional Chinese medicine clinical trials: study protocol. Trials, 2018, 19(1): 541.
25.	Li G, Zhou L, Ouyang W, et al. A core outcome set for clinical trials of Chinese medicine for hyperlipidemia: a study protocol for a systematic review and a Delphi survey. Trials, 2019, 20(1): 14.
26.	于丹丹, 谢雁鸣, 廖星, 等. 《中国中药杂志》发表随机对照试验方法学和报告质量评价研究. 中国中药杂志, 2018, 43(4): 833-839.
27.	邱瑞瑾, 陈诗琪, 韩松洁, 等. 基于 COMET 数据库的核心指标集研究现状及进展. 中国循证医学杂志, 2019, 19(5): 622-629.
28.	邢冬梅, 张俊华, 张伯礼. 中医临床研究核心结局指标集形成路径. 中华中医药杂志, 2014, 29(5): 1352-1355.
29.	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.

1. Kirkham JJ, Gorst S, Altman DG, et al. Core Outcome Set-STAndards for Reporting: The COS-STAR Statement. PLoS Med, 2016, 13(10): e1002148.
2. Kirkham JJ, Davis K, Altman DG, et al. Core Outcome Set-STAndards for Development: The COS-STAD recommendations. PLoS Med, 2017, 14(11): e1002447.
3. Kirkham JJ, Gorst S, Altman DG, et al. Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement. Trials, 2019, 20(1): 116.
4. 张明妍, 杨丰文, 李越, 等. 核心指标集报告规范:COS-STAR 声明. 中国循证医学杂志, 2017, 17(4): 470-474.
5. 张明妍, 张俊华, 杜亮, 等. 核心指标集研制规范 (COS-STAD) 介绍及其在中医药领域应用的思考. 中国循证医学杂志, 2018, 18(4): 392-396.
6. 邱瑞瑾, 李敏, 韩松洁, 等. 《COMET 手册》1.0 版解读及其对构建中医临床研究核心指标集的启示. 中国循证医学杂志, 2017, 17(12): 1482-1488.
7. Prinsen CA, Vohra S, Rose MR, et al. How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline. Trials, 2016, 17(1): 449.
8. 邱瑞瑾, 孙杨, 胡嘉元, 等. 临床研究中选择结局指标测量工具的方法. 中国循证医学杂志, 2018, 18(2): 238-243.
9. Williamson PR, Altman DG, Bagley H, et al. The COMET Handbook: version 1.0. Trials, 2017, 18(Suppl 3): 280.
10. Karas J, Ashkenazi S, Guarino A, et al. A core outcome set for clinical trials in acute diarrhoea. Arch Dis Child, 2015, 100(4): 359-363.
11. Haywood KL, Griffin XL, Achten J, et al. Developing a core outcome set for hip fracture trials. Bone Joint J, 2014, 96-B(8): 1016-1023.
12. Kirchhof P, Auricchio A, Bax J, et al. Outcome parameters for trials in atrial fibrillation: executive summary. Eur Heart J, 2007, 28(22): 2803-2817.
13. Zannad F, Garcia AA, Anker SD, et al. Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document. Eur J Heart Fail, 2013, 15(10): 1082-1094.
14. Biggane AM, Brading L, Ravaud P, et al. Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys. Trials, 2018, 19(1): 113.
15. 邱瑞瑾. 中医临床研究核心指标集的方法构建. 北京中医药大学, 2018.
16. Fish R, Sanders C, Adams R, et al. A core outcome set for clinical trials of chemoradiotherapy interventions for anal cancer (CORMAC): a patient and health-care professional consensus. Lancet Gastroenterol Hepatol, 2018, 3(12): 865-873.
17. Ruperto N, Ravelli A, Murray KJ, et al. Preliminary core sets of measures for disease activity and damage assessment in juvenile systemic lupus erythematosus and juvenile dermatomyositis. Rheumatology (Oxford), 2003, 42(12): 1452-1459.
18. Vargus-Adams JN, Martin LK. Measuring what matters in cerebral palsy: a breadth of important domains and outcome measures. Arch Phys Med Rehabil, 2009, 90(12): 2089-2095.
19. Brookes ST, Macefield RC, Williamson PR, et al. Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development. Trials, 2016, 17(1): 409.
20. 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.
21. 张莉, 张俊华, 陈静,等. 中医药临床研究评价指标体系中应引入核心结局指标集概念. 北京: 中国科技论文在线. Available at: http://www.paper.edu.cn/releasepaper/content/201305-366.
22. Zhang J, Xing D, Shang H. Developing a core outcome set for traditional Chinese medicine for stable angina pectoris. Available at: http://www.comet-initiative.org/studies/details/391?result=true.
23. COMET Initiative. Available at: http://www.comet-initiative.org/.
24. Qiu R, Li M, Zhang X, et al. Development of a core outcome set (COS) and selecting outcome measurement instruments (OMIs) for non-valvular atrial fibrillation in traditional Chinese medicine clinical trials: study protocol. Trials, 2018, 19(1): 541.
25. Li G, Zhou L, Ouyang W, et al. A core outcome set for clinical trials of Chinese medicine for hyperlipidemia: a study protocol for a systematic review and a Delphi survey. Trials, 2019, 20(1): 14.
26. 于丹丹, 谢雁鸣, 廖星, 等. 《中国中药杂志》发表随机对照试验方法学和报告质量评价研究. 中国中药杂志, 2018, 43(4): 833-839.
27. 邱瑞瑾, 陈诗琪, 韩松洁, 等. 基于 COMET 数据库的核心指标集研究现状及进展. 中国循证医学杂志, 2019, 19(5): 622-629.
28. 邢冬梅, 张俊华, 张伯礼. 中医临床研究核心结局指标集形成路径. 中华中医药杂志, 2014, 29(5): 1352-1355.
29. 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.

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