Core Outcome Set-STAndards for Reporting: The COS-STAR Statement_Chinese Journal of Evidence-Based Medicine

Authors：

Translated by: ZHANG Mingyan , YANG Fengwen , LI Yue ,  ZHANG Junhua , 譯

Evidence-based Medicine Center, Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, P. R. China;

Corresponding?author：

ZHANG Junhua, Email: tjzyxy@126.com

Keywords：

DOI：

10.7507/1672-2531.201702053

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背景通過確保對衛生服務使用者和其他特定領域衛生保健決策者關注的指標進行常規測量，核心指標集（core outcome set，COS）可以提高研究的相關性。到目前為止，已經形成了 200 多個 COS，但這些報告的透明度還不理想。如果 COS 的報告不夠完整和透明，COS 研究將無法實現其目標。 方法與結果 鑒于這些問題，由經驗豐富的 COS 制定者、方法學家、期刊編輯、COS 潛在用戶（臨床試驗者、系統評價員和臨床指南制定者）以及患者代表組成的一個國際性工作組，制定了核心指標集報告標準（Core Outcome Set-STAndards for Reporting，COS-STAR）聲明，作為 COS 研究報告的指南。其形成過程先后包括初始報告條目產生階段、代表關鍵利益相關方群體的 200 名人員的兩輪德爾菲問卷調查，最后是一個共識會議。COS-STAR 聲明由一個包含 18 個條目的清單組成，這些條目是確保所有 COS 研究報告透明度和完整性的必要條目。條目清單重點規范了形成特定 COS 的研究報告需涉及的前言、方法、結果和討論部分。COS-STAR 聲明的一個局限性在于其形成過程中缺乏低、中收入國家的代表性意見。而 COS 對在這些國家和地區開展的研究具有同等的相關性，故今后該指南可能需要不斷完善，以應對這些國家和地區 COS 形成的任何其他挑戰。結論隨著 COS 研究的不斷開展，COS-STAR 聲明將成為提高 COS 研究報告質量的有力工具，并使所有 COS 使用者受益。

Citation： Translated by: ZHANG Mingyan, YANG Fengwen, LI Yue, ZHANG Junhua. Core Outcome Set-STAndards for Reporting: The COS-STAR Statement. Chinese Journal of Evidence-Based Medicine, 2017, 17(4): 470-474. doi: 10.7507/1672-2531.201702053 Copy

1.	?Gorst SL, Gargon E, Clarke M, et al. Choosing important healthoutcomes for comparative effectiveness research: an updated review and user survey. PLoS One, 2016, 11(1): e0146444.
2.	Williamson PR, Altman DG, Blazeby JM, et al. Developing core outcome sets for clinical trials: issues to consider. Trials, 2012, 13: 132.
3.	COMET Initiative 2016. Avaliable at: .
4.	Gargon E, Gurung B, Medley N, et al. Choosing Important HealthOutcomes for Comparative Effectiveness Research: A Systematic Review. PLoS One, 2014, 9(6): e99111.
5.	Sinha I, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med, 2011, 8(1): e1000393.
6.	Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reportingguidelines. PloS Med, 2010, 7(2): e1000217.
7.	Clarke M, Williamson PR. Core outcome sets and systematic reviews. Syst Rev, 2016, 5: 11.
8.	Kirkham JJ, Gorst S, Altman DG, et al. COS-STAR: a reporting guideline for studies developing core outcome sets (protocol). Trials, 2015, 16: 373.
9.	Schmitt J, Spuls PI, Thomas KS, et al. The Harmonising OutcomeMeasures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials. J Allergy Clin Immunol, 2014, 134(4): 800-807.
10.	Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trial. BMJ, 2010, 340: c869.
11.	Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA Statementfor reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: Explanation and Elaboration. PLoS Med, 2009, 6(7): e1000100.
12.	Schmitt J, Apfelbacher C, Spuls PI, et al. The Harmonizing OutcomeMeasures for Eczema (HOME) roadmap: A methodological framework to develop core sets of outcome measurements in dermatology. J Invest Dermatol, 2015, 135(1): 24-30.
13.	Smith MA, Leeder SR, Jalaludin B, et al. The asthma health outcome indicators study. Aust N Z J Public Health, 1996, 20(1): 69-75.
14.	Sinha I, Gallagher R, Williamson PR, et al. Development of a core outcome set for clinical trials inchildhood asthma: a survey of clinicians, parents, and young people. Trials, 2012, 13: 103.
15.	Reddel HK, Taylor DR, Bateman ED, et al. An official AmericanThoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med, 2009, 180(1): 59-99.
16.	Busse WW, Morgan WJ, Taggart V, et al. Asthma outcomes workshop: overview. J Allergy Clin Immunol, 2012, 129(3 Suppl): 1-8.
17.	Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updatedguidelines for reporting parallel group randomised trials. PLoS Med, 2010, 7(3): e1000251.
18.	Brookes S, Macefield R, Williamson P, et al. Three nested RCTs ofdual or single stakeholder feedback within Delphi surveys during core outcome and information setdevelopment. Trials, 2015, 16(Suppl 2): 51.
19.	Committee for medicinal products for human use (CHMP) (2015). Guideline on the clinical investigation of medicinal products for the treatment of asthma.Avaliable at: .

1. ?Gorst SL, Gargon E, Clarke M, et al. Choosing important healthoutcomes for comparative effectiveness research: an updated review and user survey. PLoS One, 2016, 11(1): e0146444.
2. Williamson PR, Altman DG, Blazeby JM, et al. Developing core outcome sets for clinical trials: issues to consider. Trials, 2012, 13: 132.
3. COMET Initiative 2016. Avaliable at: .
4. Gargon E, Gurung B, Medley N, et al. Choosing Important HealthOutcomes for Comparative Effectiveness Research: A Systematic Review. PLoS One, 2014, 9(6): e99111.
5. Sinha I, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med, 2011, 8(1): e1000393.
6. Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reportingguidelines. PloS Med, 2010, 7(2): e1000217.
7. Clarke M, Williamson PR. Core outcome sets and systematic reviews. Syst Rev, 2016, 5: 11.
8. Kirkham JJ, Gorst S, Altman DG, et al. COS-STAR: a reporting guideline for studies developing core outcome sets (protocol). Trials, 2015, 16: 373.
9. Schmitt J, Spuls PI, Thomas KS, et al. The Harmonising OutcomeMeasures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials. J Allergy Clin Immunol, 2014, 134(4): 800-807.
10. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trial. BMJ, 2010, 340: c869.
11. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA Statementfor reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: Explanation and Elaboration. PLoS Med, 2009, 6(7): e1000100.
12. Schmitt J, Apfelbacher C, Spuls PI, et al. The Harmonizing OutcomeMeasures for Eczema (HOME) roadmap: A methodological framework to develop core sets of outcome measurements in dermatology. J Invest Dermatol, 2015, 135(1): 24-30.
13. Smith MA, Leeder SR, Jalaludin B, et al. The asthma health outcome indicators study. Aust N Z J Public Health, 1996, 20(1): 69-75.
14. Sinha I, Gallagher R, Williamson PR, et al. Development of a core outcome set for clinical trials inchildhood asthma: a survey of clinicians, parents, and young people. Trials, 2012, 13: 103.
15. Reddel HK, Taylor DR, Bateman ED, et al. An official AmericanThoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med, 2009, 180(1): 59-99.
16. Busse WW, Morgan WJ, Taggart V, et al. Asthma outcomes workshop: overview. J Allergy Clin Immunol, 2012, 129(3 Suppl): 1-8.
17. Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updatedguidelines for reporting parallel group randomised trials. PLoS Med, 2010, 7(3): e1000251.
18. Brookes S, Macefield R, Williamson P, et al. Three nested RCTs ofdual or single stakeholder feedback within Delphi surveys during core outcome and information setdevelopment. Trials, 2015, 16(Suppl 2): 51.
19. Committee for medicinal products for human use (CHMP) (2015). Guideline on the clinical investigation of medicinal products for the treatment of asthma.Avaliable at: .

Chinese Journal of Evidence-Based Medicine

Core Outcome Set-STAndards for Reporting: The COS-STAR Statement

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