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.	張明妍, 楊豐文, 李越, 等. 核心指標集報告規范:COS-STAR 聲明. 中國循證醫學雜志, 2017, 17(4): 470-474.
5.	張明妍, 張俊華, 杜亮, 等. 核心指標集研制規范 (COS-STAD) 介紹及其在中醫藥領域應用的思考. 中國循證醫學雜志, 2018, 18(4): 392-396.
6.	邱瑞瑾, 李敏, 韓松潔, 等. 《COMET 手冊》1.0 版解讀及其對構建中醫臨床研究核心指標集的啟示. 中國循證醫學雜志, 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, 孫楊, 胡嘉元, 等. 臨床研究中選擇結局指標測量工具的方法. 中國循證醫學雜志, 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. 中醫臨床研究核心指標集的方法構建. 北京中醫藥大學, 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.	張莉, 張俊華, 陳靜,等. 中醫藥臨床研究評價指標體系中應引入核心結局指標集概念. 北京: 中國科技論文在線. 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, 謝雁鳴, 廖星, 等. 《中國中藥雜志》發表隨機對照試驗方法學和報告質量評價研究. 中國中藥雜志, 2018, 43(4): 833-839.
27.	邱瑞瑾, 陳詩琪, 韓松潔, 等. 基于 COMET 數據庫的核心指標集研究現狀及進展. 中國循證醫學雜志, 2019, 19(5): 622-629.
28.	邢冬梅, 張俊華, 張伯禮. 中醫臨床研究核心結局指標集形成路徑. 中華中醫藥雜志, 2014, 29(5): 1352-1355.
29.	邱瑞瑾, 張曉雨, 李敏, 等. 中醫證候命名規范化研究在核心指標集構建中的意義及方法. 中華中醫藥雜志, 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. 張明妍, 楊豐文, 李越, 等. 核心指標集報告規范:COS-STAR 聲明. 中國循證醫學雜志, 2017, 17(4): 470-474.
5. 張明妍, 張俊華, 杜亮, 等. 核心指標集研制規范 (COS-STAD) 介紹及其在中醫藥領域應用的思考. 中國循證醫學雜志, 2018, 18(4): 392-396.
6. 邱瑞瑾, 李敏, 韓松潔, 等. 《COMET 手冊》1.0 版解讀及其對構建中醫臨床研究核心指標集的啟示. 中國循證醫學雜志, 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, 孫楊, 胡嘉元, 等. 臨床研究中選擇結局指標測量工具的方法. 中國循證醫學雜志, 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. 中醫臨床研究核心指標集的方法構建. 北京中醫藥大學, 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. 張莉, 張俊華, 陳靜,等. 中醫藥臨床研究評價指標體系中應引入核心結局指標集概念. 北京: 中國科技論文在線. 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, 謝雁鳴, 廖星, 等. 《中國中藥雜志》發表隨機對照試驗方法學和報告質量評價研究. 中國中藥雜志, 2018, 43(4): 833-839.
27. 邱瑞瑾, 陳詩琪, 韓松潔, 等. 基于 COMET 數據庫的核心指標集研究現狀及進展. 中國循證醫學雜志, 2019, 19(5): 622-629.
28. 邢冬梅, 張俊華, 張伯禮. 中醫臨床研究核心結局指標集形成路徑. 中華中醫藥雜志, 2014, 29(5): 1352-1355.
29. 邱瑞瑾, 張曉雨, 李敏, 等. 中醫證候命名規范化研究在核心指標集構建中的意義及方法. 中華中醫藥雜志, 2018, 33(6): 2240-2243.

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