Interpretation of the COMET handbook (version 1.0) and its insight for developing core outcome sets in clinical trials of traditional Chinese medicine_Chinese Journal of Evidence-Based Medicine

Authors：

QIU Ruijin ¹ , LI Min ¹ , HAN Songjie ¹ , HE Tianmai ¹ , HUANG Ya 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. Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, P.R.China;

Corresponding?author：

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

Keywords：

The COMET handbook; Core outcome set; Traditional Chinese medicine; Clinical trial

DOI：

10.7507/1672-2531.201707047

Video：

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A core outcome set (COS) is an agreed minimum set of outcomes that should be reported in all clinical trials in specific areas of health care. The use of COS can reduce the heterogeneity of outcomes reporting in different trials and enhance evidence synthesis in systematic review/meta-analysis by including more studies with the same outcome. It can also enhance the value of trials and reduce cost waste to some extent. Recently, Core Outcome Measures in Effectiveness Trials (COMET) initiative has developed the COMET handbook (version 1.0). This handbook discussed the problems of COS research and made some recommendations. This paper interprets the COMET handbook (version 1.0) and analyses its insight on the construction of TCM clinical research COS, combined with the characteristics of TCM clinical research, in order to provide a reference for related researchers.

Citation： QIU Ruijin, LI Min, HAN Songjie, HE Tianmai, HUANG Ya, CHEN Jing, SHANG Hongcai. Interpretation of the COMET handbook (version 1.0) and its insight for developing core outcome sets in clinical trials of traditional Chinese medicine. Chinese Journal of Evidence-Based Medicine, 2017, 17(12): 1482-1488. doi: 10.7507/1672-2531.201707047 Copy

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2.	Kirkham JJ, Dwan KM, Altman DG, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ, 2010, 340: c365.
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34.	Heneghan C, Goldacre B, Mahtani KR. Why clinical trial outcomes fail to translate into benefits for patients. Trials, 2017, 18(1): 122.

1. Kirkham JJ, Gargon E, Clarke M, et al. Can a core outcome set improve the quality of systematic reviews?-a survey of the Coordinating Editors of Cochrane Review Groups. Trials, 2013, 14: 21.
2. Kirkham JJ, Dwan KM, Altman DG, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ, 2010, 340: c365.
3. Hirsch BR, Califf RM, Cheng SK, et al. Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov. JAMA Intern Med, 2013, 173(11): 972-979.
4. Clarke M, Williamson PR. Core outcome sets and systematic reviews. Syst Rev, 2016, 5: 11.
5. Chan AW, Hróbjartsson A, Haahr MT, et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA, 2004, 291(20): 2457-2465.
6. Available at: www.comet-initiative.org.
7. Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res, 2010, 19(4): 539-549.
8. Kirkham JJ, Gorst S, Altman DG, et al. Core outcome set-standards for reporting: The COS-STAR Statement. PLoS Med, 2016, 13(10): e1002148.
9. 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.
10. Zhang L, Zhang JH, 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.
11. 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.
12. Available at: http://www.comet-initiative.org/studies/details/391.
13. Available at: http://www.comet-initiative.org/studies/details/669.
14. Available at: http://www.comet-initiative.org/studies/details/941.
15. Available at: http://www.comet-initiative.org/studies/details/976.
16. Available at: http://www.comet-initiative.org/studies/details/983.
17. Williamson PR, Altman DG, Bagley H, et al. The COMET Handbook: version 1.0. Trials, 2017, 18(Suppl 3): 280.
18. Kirkham JJ, Dwan KM, Altman DG, et al. The impact of outcome reporting bias in randomized controlled trials on a cohort of systematic reviews. BMJ, 2010, 340: c365.
19. Boers M, Tugwell P, Felson DT, et al. World Health Organization and International League of Associations for Rheumatology core endpoints for symptom modifying antirheumatic drugs in rheumatoid arthritis clinical trials. J Rheumatol Suppl, 1994, 41: 86-89.
20. Kirchhof P, Auricchio A, Bax J, et al. Outcome parameters for trials in atrial fibrillation. EP Europace, 2007, 28: 2803-2817.
21. 王慧, 楊波, 周三鳳. 穩心顆粒聯合胺碘酮治療心房顫動有效性和安全性的 Meta 分析. 中國循證心血管醫學雜志, 2015, 7(2): 161-164.
22. 陳可冀. 病證結合治療觀與臨床實踐. 中國中西醫結合雜志, 2011, 31(8): 1016-1017.
23. Available at: http://www.sda.gov.cn/WS01/CL0055/27432.html.
24. Available at: http://www.sda.gov.cn/WS01/CL1616/134582.html.
25. 邱瑞瑾, 張曉雨, 商洪才. 證候類中藥新藥臨床療效評價方法探索. 世界中醫藥, 2017, 12(6): 1230-1234.
26. 王妍, 張弛, 查青林, 等. 丹紅注射液治療冠心病心絞痛隨機對照試驗報告質量評價. 中國循證醫學雜志, 2011, 11(2): 161-167.
27. 毛兵, 王剛, 陳小東, 等. 《中國中西醫結合雜志》發表隨機對照試驗報告的質量評價. 中國循證醫學雜志, 2006, 6(4): 297-304.
28. Cené CW, Halladay JR, Gizlice Z, et al. Associations between subjective social status and physical and mental health functioning among patients with hypertension. J Health Psychol, 2015, pii: 1359105315581514.
29. Euteneuer F. Subjective social status and health. Curr Opin Psychiatry, 2014, 27(5): 337-343.
30. Hutton JL, Williamson PR. Bias in meta-analysis due to outcome variable selection within studies. Appl Stat, 2000, 49: 359-370.
31. Blackwood B, Marshall J, Rose L. Progress on core outcome sets for critical care research. Curr Opin Crit Care, 2015, 21(5): 439-444.
32. Chan AW, Song F, Vickers A, et al. Increasing value and reducing waste: addressing inaccessible research. Lancet, 2014, 383(9913): 257-266.
33. Ioannidis JP, Greenland S, Hlatky MA, et al. Increasing value and reducing waste in research design, conduct, and analysis. Lancet, 2014, 383(9912): 166-175.
34. Heneghan C, Goldacre B, Mahtani KR. Why clinical trial outcomes fail to translate into benefits for patients. Trials, 2017, 18(1): 122.

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Interpretation of the COMET handbook (version 1.0) and its insight for developing core outcome sets in clinical trials of traditional Chinese medicine

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