医生报告结局量表在中医临床结局评价中的研究现状分析及展望
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摘要
通过分析医生报告结局(CRO)的概念及国内外研究现状,发现国外CRO量表涉及领域广、研究规范程度高;而国内CRO量表起步较晚,大多从国外翻译而来,自行研制及严格考评的量表欠缺。提出CRO量表符合中医四诊特点,有助于丰富中医临床结局评价方法、量化中医临床结局评价指标等,但仍需要建立严谨的指导规范,建立健全医生报告结局量表体系,加强其在中医临床疗效评价中的支持力度,扩大宣传及推广,加强地域及学科合作等,提高中医CRO量表的质量及推动其临床应用,使得中医CRO更好地服务临床。
This study found that the abroad clinician-reported outcomes( CRO) scale had features of wide range and higher standard of research specification by analyzing the contents of CRO and the research status at home and abroad. The CRO scale in China has a much shorter history and most of the contents were translation work,lacking of self-developing ability and strict evaluation standard. The CRO scales in this paper presents the feature of four diagnoses,which is helpful in enriching the evaluating method of clinical outcomes in traditional Chinese medicine and specifying the evaluation indexes of clinical outcomes in traditional Chinese medicine. However,strict direction standard and scale system of doctoral outcomes' report still need to be established. Efforts should also be paid into strengthening its support in clinical efficacy evaluation in traditional Chinese medicine,expanding publicity and increasing the cooperation with other area or subjects,etc.,so as to increase the qualification of CRO in traditional Chinese medicine and promote its efficacy in clinical practice.
This study found that the abroad clinician-reported outcomes( CRO) scale had features of wide range and higher standard of research specification by analyzing the contents of CRO and the research status at home and abroad. The CRO scale in China has a much shorter history and most of the contents were translation work,lacking of self-developing ability and strict evaluation standard. The CRO scales in this paper presents the feature of four diagnoses,which is helpful in enriching the evaluating method of clinical outcomes in traditional Chinese medicine and specifying the evaluation indexes of clinical outcomes in traditional Chinese medicine. However,strict direction standard and scale system of doctoral outcomes' report still need to be established. Efforts should also be paid into strengthening its support in clinical efficacy evaluation in traditional Chinese medicine,expanding publicity and increasing the cooperation with other area or subjects,etc.,so as to increase the qualification of CRO in traditional Chinese medicine and promote its efficacy in clinical practice.
引文
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[13]GIUSTINA A,BEVAN JS,BRONSTEIN MD,et al.SAGITOR:clinician-reported outcome instrument for managing acromegaly in clinical practice-development and results from a pilot study[J].Pituitary,2016,19(1):39-49.
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[16]吴毅,胡永善,杨晓冰,等.功能综合评定量表信度和效度的研究[J].中国临床康复,2002,6(14):2036-2037.
[17]张鸣生,林仲民,钟思琳,等.腰腿痛评价量表的可行性研究[J].中华理疗杂志,2000,23(4):4-7.
[18]张永爱,李小妹,张海苗,等.月经症状量表中文版的信度和效度评价[J].中华护理杂志,2015,50(3):374-377.
[19]范大超.PRO量表在新药临床试验中的应用[J].中国处方药,2009,92(11):64-65.
[20]罗迪.基于德尔菲法的功能性胃肠病医生报告结局推荐条目研究[D].广州:广州中医药大学,2014.
[21]李建生,王明航,余学庆,等.社区获得性肺炎疗效测评工具的研制与评价[J].中医学报,2016,31(11):1654-1661.
[22]冀瑞俊,贾建平,许燕,等.椎-基底动脉系统急性缺血性卒中溶栓干预预测量表的编制及其应用价值研究[J].脑与神经疾病杂志,2010,18(1):54-59.
[23]盛锋,沈国权,孙武权.神经根型颈椎病疗效评价量表的研究近况[J].中西医结合学报,2010,8(9):824-828.
[24]周建伟,张凡,李春雨,等.颈椎病(神经根型)中医证候测评量表编制及信度测试[J].四川中医,2006,24(8):31-33.
[25]皮燕.神经根型颈椎病病证结合评价量表的初步编制[D].成都:成都中医药大学,2009.
[26]吕映华,何迎春,杨娟,等.冠心病心绞痛(气虚血瘀证)症状疗效评分量表的研究[J].中国临床药理学与治疗学,2008,13(7):786-791.
[27]孔秀路,徐田华,胡思源,等.小儿厌食(喂养障碍)中医证候疗效评价量表的信度、效度和反应度测评[J].中医杂志,2015,56(9):753-758.
[28]朱燕波,骆晓霞,唐芳.心功能不全中医症状评分表的研制与临床适用性[J].中医杂志,2012,53(6):482-484.
[29]林色奇,查青林,薛汉荣,等.支气管哮喘的中医临床信息评价:中医症状问卷的研制[J].中国医药导报,2012,9(13):105-107.
[30]赵国青.强直性脊柱炎肾虚督寒证中医疗效评价量表的建立与评价[D].广州:广州中医药大学,2013.
[31]于长江,赖治生,邓少珍.辨证分型治疗慢性胃炎随机平行对照研究[J].实用中医内科杂志,2015,29(8):40-42.
[32]金红莲,徐玉锦.健脾益气化瘀法联合泮托拉唑治疗30例慢性胃炎临床观察[J].延边大学医学学报,2016,39(2):137-139.
[33]万霞,陈家旭,胡立胜.围绝经期综合征中医症状学量表信度评价[J].辽宁中医杂志,2009,36(10):1682-1683.
[2]ISPOR.ISPOR is the leading global professional society in pharmacoeconomics and outcomes research[R/OL].(2012-01-16)[2017-07-26].https://www.ispor.org/aboutispor.asp.
[3]WALTON MK,POWERS JH 3RD,HOBART J,et al.Clinical outcome assessments:conceptual foundation-report of the ISPOR clinical outcomes assessment-emerging good practices for outcomes research task force[J].Value Health,2015,18(6):741-752.
[4]POWERS JH 3RD,PATRICK DL,WALTON MK,et al.Clinician-reported outcome assessments of treatment benefit:report of the ISPOR clinical outcome assessment emerging good practices task force[J].Value Health,2017,20(1):2-14.
[5]ISPOR.ISPOR clinical outcomes assessment and clinicianreported outcomes emerging good research practices task force[R/OL].(2016-01-16)[2017-07-26].https://www.ispor.org/Task Forces/ClinRO Forum presentation-2016DC.pdf.
[6]张艳宏.“中医医生报告结局”概念框架研究[D].北京:中国中医科学院,2012.
[7]姚飞翔.慢性前列腺炎中医证候临床疗效评价域体系构成的相关探讨[D].北京:中国中医科学院,2013.
[8]LURIE JD,DOMAN DM,SPRATT KF,et al.Magnetic resonance imaging interpretation in patients with symptomatic lumbar spine disc herniations:comparison of clinician and radiologist readings[J].Spine,2009,34(7):701-705.
[9]GOWERS SG,HARRINGTON RC,WHITTON A,et al.Inter-rater reliability of clinician-rated outcome measures in child and adolescent mental health services[J].Br J Psychiatry,1999,174(5):413-416.
[10]SHAFFER D,GOULD MS,BRASIC J,et al.A children's global assessment scale(CGAS)[J].Arch Gen Psychiatry,1983,40(11):1228-1231.
[11]KRAMER TL,OWEN RR,WILSON C,et al.Relationship between self-report and clinician-rated impairment in depressed outpatients[J].Community Ment Health J,2003,39(4):299-307.
[12]VAN DE WATER AT,DAVIDSON M,SHIELDS N,et al.The Shoulder Function Index(SFIn X):a clinicianobserved outcome measure for people with a proximal humeral fracture[J].BMC Musculoskelet Disord,2016,17:295.doi:10.1186/S12891-016-1138-0.
[13]GIUSTINA A,BEVAN JS,BRONSTEIN MD,et al.SAGITOR:clinician-reported outcome instrument for managing acromegaly in clinical practice-development and results from a pilot study[J].Pituitary,2016,19(1):39-49.
[14]CAPPELLERI JC,DEAL LS,PETRIE CD.Reflections on ISPOR's clinician-reported outcomes good measurement practice recommendations[J].Value Health,2017,20(1):15-17.
[15]李海燕,靳兵,吴辉.肩关节功能评价量表及可靠性研究[J].中国康复医学杂志,1993,8(5):223-224.
[16]吴毅,胡永善,杨晓冰,等.功能综合评定量表信度和效度的研究[J].中国临床康复,2002,6(14):2036-2037.
[17]张鸣生,林仲民,钟思琳,等.腰腿痛评价量表的可行性研究[J].中华理疗杂志,2000,23(4):4-7.
[18]张永爱,李小妹,张海苗,等.月经症状量表中文版的信度和效度评价[J].中华护理杂志,2015,50(3):374-377.
[19]范大超.PRO量表在新药临床试验中的应用[J].中国处方药,2009,92(11):64-65.
[20]罗迪.基于德尔菲法的功能性胃肠病医生报告结局推荐条目研究[D].广州:广州中医药大学,2014.
[21]李建生,王明航,余学庆,等.社区获得性肺炎疗效测评工具的研制与评价[J].中医学报,2016,31(11):1654-1661.
[22]冀瑞俊,贾建平,许燕,等.椎-基底动脉系统急性缺血性卒中溶栓干预预测量表的编制及其应用价值研究[J].脑与神经疾病杂志,2010,18(1):54-59.
[23]盛锋,沈国权,孙武权.神经根型颈椎病疗效评价量表的研究近况[J].中西医结合学报,2010,8(9):824-828.
[24]周建伟,张凡,李春雨,等.颈椎病(神经根型)中医证候测评量表编制及信度测试[J].四川中医,2006,24(8):31-33.
[25]皮燕.神经根型颈椎病病证结合评价量表的初步编制[D].成都:成都中医药大学,2009.
[26]吕映华,何迎春,杨娟,等.冠心病心绞痛(气虚血瘀证)症状疗效评分量表的研究[J].中国临床药理学与治疗学,2008,13(7):786-791.
[27]孔秀路,徐田华,胡思源,等.小儿厌食(喂养障碍)中医证候疗效评价量表的信度、效度和反应度测评[J].中医杂志,2015,56(9):753-758.
[28]朱燕波,骆晓霞,唐芳.心功能不全中医症状评分表的研制与临床适用性[J].中医杂志,2012,53(6):482-484.
[29]林色奇,查青林,薛汉荣,等.支气管哮喘的中医临床信息评价:中医症状问卷的研制[J].中国医药导报,2012,9(13):105-107.
[30]赵国青.强直性脊柱炎肾虚督寒证中医疗效评价量表的建立与评价[D].广州:广州中医药大学,2013.
[31]于长江,赖治生,邓少珍.辨证分型治疗慢性胃炎随机平行对照研究[J].实用中医内科杂志,2015,29(8):40-42.
[32]金红莲,徐玉锦.健脾益气化瘀法联合泮托拉唑治疗30例慢性胃炎临床观察[J].延边大学医学学报,2016,39(2):137-139.
[33]万霞,陈家旭,胡立胜.围绝经期综合征中医症状学量表信度评价[J].辽宁中医杂志,2009,36(10):1682-1683.