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 , 译

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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背景通过确保对卫生服务使用者和其他特定领域卫生保健决策者关注的指标进行常规测量，核心指标集（core outcome set，COS）可以提高研究的相关性。到目前为止，已经形成了 200 多个 COS，但这些报告的透明度还不理想。如果 COS 的报告不够完整和透明，COS 研究将无法实现其目标。 方法与结果 鉴于这些问题，由经验丰富的 COS 制定者、方法学家、期刊编辑、COS 潜在用户（临床试验者、系统评价员和临床指南制定者）以及患者代表组成的一个国际性工作组，制定了核心指标集报告标准（Core Outcome Set-STAndards for Reporting，COS-STAR）声明，作为 COS 研究报告的指南。其形成过程先后包括初始报告条目产生阶段、代表关键利益相关方群体的 200 名人员的两轮德尔菲问卷调查，最后是一个共识会议。COS-STAR 声明由一个包含 18 个条目的清单组成，这些条目是确保所有 COS 研究报告透明度和完整性的必要条目。条目清单重点规范了形成特定 COS 的研究报告需涉及的前言、方法、结果和讨论部分。COS-STAR 声明的一个局限性在于其形成过程中缺乏低、中收入国家的代表性意见。而 COS 对在这些国家和地区开展的研究具有同等的相关性，故今后该指南可能需要不断完善，以应对这些国家和地区 COS 形成的任何其他挑战。结论随着 COS 研究的不断开展，COS-STAR 声明将成为提高 COS 研究报告质量的有力工具，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: .
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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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