中医临床研究中“核心结局指标集”测量工具的选择
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摘要
核心结局指标集(core outcome set,COS)是健康或卫生保健特定领域中,临床试验应测量和报告的最小的、公认的和标准化的指标集合。近期,COMET和COSMIN两个工作组联合发布了《How to select outcome measurement instruments for outcomes included in a"Core Outcome Set"-a practical guideline》(《为"核心结局指标集"选择结局测量工具的实践指南》),以帮助研究者在完成COS后为结局评价选择合适的测量工具。作者对该指南的关键点进行解读,并结合中医临床研究特点,探讨该指南对中医临床研究中结局测量工具选择的意义,以期为相关研究者提供参考。
A core outcome set(COS) is identified by key stakeholders as a minimal set of important outcome measures that should be collected and reported in all clinical trials of a specific health area. Recently,the COMET and COSMIN working groups jointly released‘How to select outcome measurement instruments for outcomes included in a‘Core Outcome Set'-a practical guideline'to help researchers select the right measurement instruments for outcome after the COS is completed. This article interprets the key points of the guideline, combines the characteristics of traditional Chinese medicine to explore the guideline's views on the selection of outcome measurement instructions,to provide reference for relevant researchers.
A core outcome set(COS) is identified by key stakeholders as a minimal set of important outcome measures that should be collected and reported in all clinical trials of a specific health area. Recently,the COMET and COSMIN working groups jointly released‘How to select outcome measurement instruments for outcomes included in a‘Core Outcome Set'-a practical guideline'to help researchers select the right measurement instruments for outcome after the COS is completed. This article interprets the key points of the guideline, combines the characteristics of traditional Chinese medicine to explore the guideline's views on the selection of outcome measurement instructions,to provide reference for relevant researchers.
引文
[1]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[J].中华中医药杂志,2014,29(5):1352-1355.
[2]WILLIAMSON P R,ALTMAN D G,BLAZEBY J M,et al.Developing core outcome sets for clinical trials:issues to consider[J].Trials,2012,13(1):132.
[3]GORST S L,GARGON E,WILLIAMSON P R.Choosing important health outcomes for comparative effectiveness research:an updated review and user survey[J].Trials,2015,16(S3):8.
[4]MIYAR J,ADAMS C E.Content and quality of 10,000 controlled trials in schizophrenia over 60 years[J].Schizophrenia Bulletin,2013,39(1):226-229.
[5]MOKKINK L B,TERWEE C B,PATRICK D L,et al.The COS-MIN study reached international consensus on taxonomy,terminology,and definitions of measurement properties for health-related patientreported outcomes[J].Journal of Clinical Epidemiology,2010,63(7):737-745.
[6]PRINSEN C A C,VOHRA S,ROSE M R,et al.How to select outcome measurement instruments for outcomes included in a“Core Outcome Set”-a practical guideline[J].Trials,2016,17(1):449.
[7]TERWEE C B,BOT S D M,BOER M R D,et al.Quality criteria were proposed for measurement properties of health status questionnaires[J].Journal of Clinical Epidemiology,2007,60(1):1-42.
[8]MOKKINK L B,TERWEE C B,PATRICK D L,et al.The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments:an international Delphi study[J].Quality of Life Research,2010,19(4):539-549.
[9]于长禾,孙亚男,何丽云,等.中医生活质量量表心理测量性能证据的系统评价[J].中华中医药杂志,2015,30(5):1631-1635.
[10]杨洋.评价中医心病相关量表心理测量性能的研究[D].沈阳:辽宁中医药大学,2015.
[11]US Department of Health and Human Services Food and Drug Administration,CDER,CBER,CDRH.Guidance for industry patientreported outcome measures:use in medical product development to support labeling claims:draft guidance[S].Health Qual Life Outcomes,2006,4:79.
[12]刘保延.患者报告结局的测量[M].北京:人民卫生出版社,2011.
[13]STREINER D L,NORMAN G R.Health measurement scales:a practical guide to their development and use[M].4th ed.New York:Oxford University Press,2004.
[14]方积乾.生存质量测定方法及应用[M].北京:北京医科大学出版社,2000.
[15]EIGNOR D R.The standards for educational and psychological testing[m]//system and protocol considerations for a high density wavelength switched all-optical network.Washington:American Psychological Association,2013:245-250.
[16]MOKKINK L B,TERWEE C B,VET H C W D.COSMIN:Consensus-based standards for the selection of health status measurement instruments[M]//Encyclopedia of quality of life and well-being research.Berlin:Springer Netherlands,2014.
[17]OMERACT.The OMERACT Handbook[EB/OL].[2016-04-25]http://www.omeract.org/pdf/OMERACT_Handbook.pdf.
[18]BOERS M,KIRWAN J R,WELLS G,et al.Developing core outcome measurement sets for clinical trials:OMERACT filter 2.0[J].Journal of Clinical Epidemiology,2014,67(7):745-753.
[19]商洪才,张伯礼,李幼平.中医药临床疗效评价实践中的思路与方法[J].中国中西医结合杂志,2008,28(3):266-268.
[20]李德新.中医基础理论[M].北京:人民卫生出版社,2001.
[21]姚实林.中医测量工具条目库的建立及筛选思路[C]//安徽省科学技术协会学会部.中医药理论与应用研究--安徽中医药继承与创新博士科技论坛论文集.合肥:徽大学出版社,2008:4.
[22]吴大嵘,杨小波,赖世隆.中医药研究中软指标测量工具的建立和应用探讨[J].中国中西医结合杂志,2006,26(4):293-297.
[2]WILLIAMSON P R,ALTMAN D G,BLAZEBY J M,et al.Developing core outcome sets for clinical trials:issues to consider[J].Trials,2012,13(1):132.
[3]GORST S L,GARGON E,WILLIAMSON P R.Choosing important health outcomes for comparative effectiveness research:an updated review and user survey[J].Trials,2015,16(S3):8.
[4]MIYAR J,ADAMS C E.Content and quality of 10,000 controlled trials in schizophrenia over 60 years[J].Schizophrenia Bulletin,2013,39(1):226-229.
[5]MOKKINK L B,TERWEE C B,PATRICK D L,et al.The COS-MIN study reached international consensus on taxonomy,terminology,and definitions of measurement properties for health-related patientreported outcomes[J].Journal of Clinical Epidemiology,2010,63(7):737-745.
[6]PRINSEN C A C,VOHRA S,ROSE M R,et al.How to select outcome measurement instruments for outcomes included in a“Core Outcome Set”-a practical guideline[J].Trials,2016,17(1):449.
[7]TERWEE C B,BOT S D M,BOER M R D,et al.Quality criteria were proposed for measurement properties of health status questionnaires[J].Journal of Clinical Epidemiology,2007,60(1):1-42.
[8]MOKKINK L B,TERWEE C B,PATRICK D L,et al.The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments:an international Delphi study[J].Quality of Life Research,2010,19(4):539-549.
[9]于长禾,孙亚男,何丽云,等.中医生活质量量表心理测量性能证据的系统评价[J].中华中医药杂志,2015,30(5):1631-1635.
[10]杨洋.评价中医心病相关量表心理测量性能的研究[D].沈阳:辽宁中医药大学,2015.
[11]US Department of Health and Human Services Food and Drug Administration,CDER,CBER,CDRH.Guidance for industry patientreported outcome measures:use in medical product development to support labeling claims:draft guidance[S].Health Qual Life Outcomes,2006,4:79.
[12]刘保延.患者报告结局的测量[M].北京:人民卫生出版社,2011.
[13]STREINER D L,NORMAN G R.Health measurement scales:a practical guide to their development and use[M].4th ed.New York:Oxford University Press,2004.
[14]方积乾.生存质量测定方法及应用[M].北京:北京医科大学出版社,2000.
[15]EIGNOR D R.The standards for educational and psychological testing[m]//system and protocol considerations for a high density wavelength switched all-optical network.Washington:American Psychological Association,2013:245-250.
[16]MOKKINK L B,TERWEE C B,VET H C W D.COSMIN:Consensus-based standards for the selection of health status measurement instruments[M]//Encyclopedia of quality of life and well-being research.Berlin:Springer Netherlands,2014.
[17]OMERACT.The OMERACT Handbook[EB/OL].[2016-04-25]http://www.omeract.org/pdf/OMERACT_Handbook.pdf.
[18]BOERS M,KIRWAN J R,WELLS G,et al.Developing core outcome measurement sets for clinical trials:OMERACT filter 2.0[J].Journal of Clinical Epidemiology,2014,67(7):745-753.
[19]商洪才,张伯礼,李幼平.中医药临床疗效评价实践中的思路与方法[J].中国中西医结合杂志,2008,28(3):266-268.
[20]李德新.中医基础理论[M].北京:人民卫生出版社,2001.
[21]姚实林.中医测量工具条目库的建立及筛选思路[C]//安徽省科学技术协会学会部.中医药理论与应用研究--安徽中医药继承与创新博士科技论坛论文集.合肥:徽大学出版社,2008:4.
[22]吴大嵘,杨小波,赖世隆.中医药研究中软指标测量工具的建立和应用探讨[J].中国中西医结合杂志,2006,26(4):293-297.