Introduction of COS-STAD recommendations and its application of TCM_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Mingyan ¹ ,  ZHANG Junhua ¹ , DU Liang ² , ZHANG Yonggang ² , ZHAO Hongjie ¹ , FENG Rui ¹ , WANG Hucheng ¹ , HU Haiyin ¹ , ZHAO Mengyu ¹

1. Centre for Evidence-Based Medicine, Tianjin University of TCM, Tianjin, 300193, P.R.China;
2. The Chinese Cochrane Center, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;

Corresponding author：

ZHANG Junhua, Email: zjhtcm@foxmail.com

Keywords：

Core Outcome Set-STAndards for Development (COS-STAD); Core Outcome Set; Clinical trial; Tranditional Chinese Medicine

DOI：

10.7507/1672-2531.201802009

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Core Outcome Set (COS) is an important approach to address problems in which the outcomes are inconsistent, non-essential and reporting biased in clinical researches. In order to ensure the standardization of the COS development process, the Core Outcome Measures in Effectiveness Trials (COMET) has initiatively developed the Core Outcome Set-STAndards for Development (COS-STAD). The recommendation includes 11 minimum standards, involving 3 common key domains: the scope, the stakeholders, and the consensus process. The COS-STAD is used by COS developers for standardizing research design, determining the quality of the methodology to develop a COS. Based on the background and conditions of clinical practice and clinical trials in China, especially the characteristics of the development of Core Outcome Set of Traditional Chinese Medicine (TCM-COS), this paper interprets the recommendations of COS-STAD, providing a reference for the potential users of COS in China.

Citation： ZHANG Mingyan, ZHANG Junhua, DU Liang, ZHANG Yonggang, ZHAO Hongjie, FENG Rui, WANG Hucheng, HU Haiyin, ZHAO Mengyu. Introduction of COS-STAD recommendations and its application of TCM. Chinese Journal of Evidence-Based Medicine, 2018, 18(4): 392-396. doi: 10.7507/1672-2531.201802009 Copy

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14.	Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1.0. Trials, 2017, 18(Suppl 3): 280.
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17.	Available at: http://www.comet-initiative.org/studies/ details/391?result=true.

1. Thornley B, Adams C. Content and quality of 2000 controlled trials in schizophrenia over 50 years. BMJ, 1998, 317(7167): 1181-1184.
2. 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.
3. Macleod MR, Michie S, Roberts I, et al. Biomedical research: increasing value, reducing waste. Lancet, 2014, 383(9912): 101-104.
4. Williamson PR, Altman DG, Blazeby JM, et al. Developing core outcome sets for clinical trials: issues to consider. Trials, 2012, 13: 132.
5. 张明妍, 杨丰文, 李越, 等. 核心指标集报告规范(COS-STAR)介绍. 中国循证医学杂志, 2017, 17(7): 857-861.
6. 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.
7. Gargon E, Gurung B, Medley N, et al. Choosing important health outcomes for comparative effectiveness research: a systematic review. PLoS One, 2014, 9(6): e99111.
8. Gorst SL, Gargon E, Clarke M, et al. Choosing important health outcomes for comparative effectiveness research: an updated review and user survey. PLoS One, 2016, 11(1): e0146444.
9. Gorst SL, Gargon E, Clarke M, et al. Choosing important health outcomes for comparative effectiveness research: an updated review and identification of gaps. PLoS One, 2016, 11(12): e0168403.
10. Available at: http://www.comet-initiative.org/.
11. Kirkham JJ, Gorst S, Altman DG, et al. COS-STAR: a reporting guideline for studies developing core outcome sets (protocol). Trials, 2015, 16: 373.
12. Kirkham JJ, Gorst S, Altman DG, et al. Core Outcome Set-STAndards for Reporting: The COS-STAR Statement. PLoS Med, 2016, 13(10): e1002148.
13. Kirkham JJ, Davis K, Altman DG, et al. Core Outcome Set-STAndards for Development: The COS-STAD recommendations. PLoS Med, 2017, 14(11): e1002447.
14. Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1.0. Trials, 2017, 18(Suppl 3): 280.
15. Chiarotto A, Deyo RA, Terwee CB, et al. Core outcome domains for clinical trials in non-specific low back pain. Eur Spine J, 2015, 24(6): 1127-1142.
16. Potter S, Holcombe C, Ward JA, et al. Development of a core outcome set for research and audit studies in reconstructive breast surgery. Br J Surg, 2015, 102(11): 1360-1371.
17. Available at: http://www.comet-initiative.org/studies/ details/391?result=true.

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