摘要
研究目的
1.系统总结国内外偏头痛疗效评价现状
偏头痛是一种以患者自身不适为主要症状的复发-缓解类疾病,以其高发病率和高复发率严重影响着患者的生活质量。患病人群以25-45岁的中青年为主,对社会劳动力影响巨大,同时与中风病、抑郁症等多种疾病密切相关,给患者造成了严重的经济、生理和心理负担。偏头痛的防治已成为目前医学界面临的重要课题之一,而科学的疗效评价是进行防治的前提。笔者对近二十年国内外偏头痛临床研究的相关文献进行搜索、筛选,对文献中使用的疗效评价方法进行总结、归类,以系统总结国内外偏头痛疗效评价现状,并探讨适合偏头痛特点的系统的疗效评价方法。
2.对偏头痛PRO量表进行文献比较研究
为了对课题组已经研制成功的偏头痛PRO量表进行改良和性能评价,本文将其与国内现有的PRO量表进行对比,通过对国内现有的涉及各系统疾病的PRO量表的内容、评价方法进行分析归类,并通过不同疾病PRO量表的设计内容和性能评价方法的不同,与偏头痛基于患者报告的结局评价量表初稿的性能考评进行比较,探索适合偏头痛PRO量表的内容和性能评价方法,为量表的内容完善和进行全面的性能评价奠定基础。
研究方法
在国家知识基础设施(Chinese National Knowledge Infrastructure, CNKI)中国学术文献网络出版总库和PubMed中,分别以“偏头痛治疗”、"Migraine treatment"为关键词,检索出1990年1月至2011年12月年国内外有关偏头痛治疗的中英文文献,选取文献中对偏头痛进行疗效评价的方法,并加以分类和总结。
以“PRO量表、患者报告结局、PRO评价、PRO测评、PRO考核”等为主题,在CNKI中国学术文献网络出版总库中进行检索,对这些搜索出的文献进行归纳、总结,去除没有详细描述制定、考评量表过程的文献,将对同一量表进行研制、考评的文献进行合并,区分对同一量表进行不同数量调查的考评的文献,对总结出的不同研究报告或文献,分析其量表内容、结构及评价方法。
研究结果
目前对于偏头痛的疗效评价侧重于对头痛发作情况本身的评价,如头痛时间、头痛频率、头痛缓解时间等,没有体现患者除头痛相关症状外的精神心理改变和功能损伤；鉴于目前偏头痛的发病原因不确定,因而目前的检查、化验指标不可能直接而又全面地反映偏头痛患者的头痛情况和疗效；国内外针对偏头痛的疗效评价量表多分为头痛生活质量、头痛影响及残疾两个方面,或借用疼痛的评价量表,特异度不够好敏感度不够高,不能概括偏头痛对患者造成影响的所有方面。因此可以说,每一种评价方法都不能概括偏头痛对患者造成影响的所有方面,目前偏头痛的疗效评价体系有待完善。PRO量表对于以患者自身感受为主要特征的疾病,适合对疗效进行评价。由于偏头痛患者的各种不适大多是患者的主观感受,因此PRO量表对于偏头痛疾病的疗效评价具有重要意义。
PRO量表的结构一般分为人口学和一般资料及量表正文两部分。在对量表的人口学及一般资料进行统计时,多根据疾病特点及设想评价疾病的内容或方面进行设计。此外,通过统计36份研究对量表正文的术语,可以将量表的结构术语统一为：条目/变量/项目-方面/亚域-领域/维度的形式,并根据临床采用率的高低,结合美国食品药品管理局(FDA)发布的《PRO研究应用于临床药物研制和疗效评价的指南草案》,建议统一采用条目-方面-领域的结构术语。偏头痛PRO量表的内容和结构术语都较为规范。
国内PRO量表的评价方法大致相同,但不同方法的归类不是十分统一,PRO量表基本可以从信度、效度、反应度、可行性等方面进行评价。对量表信度进行评价时,克朗巴赫α系数、分半信度、重测信度三种最为常用,信度达到0.7以上为良好,克朗巴赫α系数和分半信度又可合称为内部一致性信度,重测信度又可称为外在信度。效度多用内容效度、结构效度、标准关联效度、区分效度,维度相关性分析、回归分析来进行评价。反应度多从区分不同人群、区分同一人群不同时间这两个方面来评价。可行性通常通过量表接受率、完成率、完成时间三个方面反映出来。除了以上评价方法,临床应用较少的方法还有项目区分度、项目反应理论、协方差分析等。
偏头痛PRO量表通过分半信度和Cronbach' s α系数评价得出其信度良好,从内容效度、标准效度和结构效度三个方面评价出量表具有良好的效度,通过量表总体反应度及各条目、各维度评分得出其反应度良好,从量表接受率、完成率、完成时间三个方面来看,其可行性也相对较好。
在下一步研究中,应当扩大样本量,根据文献比较结果改良加量表内容,除以上已经检验过的量表性能外,增加量表性能检测方法,更加深入、全面地评价量表性能。结论
偏头痛疗效评价体系尚未完全建立,PRO量表适合对偏头痛的临床特点,是较为科学的疗效评价方法。课题组已经研制的偏头痛PRO量表内容完整、结构合理,初步性能评价结果可信,下一步研究中可进一步进行更全面的性能评价。
Objective
1. Summarize the present evaluation methods on migraine Home and abroad
Migraine is a kind of disease taking the patients'subjective discomfort as the main performance.It has great influence to the quality of life of patients, and it can make patients labor fell rapidly which can cause serious economic, physiological and psychological burden. For such a disease, the treatment effect is of concern for the patients and doctors, so making a standard of the methods of outcomes assessment is very necessary. But in migraine clinical research at home and abroad, there is no scientific and normative system of curative effective evaluation methods. The author search for the articles about the migraine treatment in clinical research at home and abroad in recent ten years, screen, summary,and classify the curative effect of evaluation methods, to find the system for migraine evaluation method of curative effect.
2. Compare the migraine PRO scale with other PRO scales on literature
Our research group has already successfully developed the Migraine PRO Scale. In order to improve the content and take the evaluation futher more, this article compare the Migraine PRO Scale with all the domestic existing PRO scale. Through analying the differences in PRO scale content and evaluation methods, we draw lessons from them for migraine PRO scale, to facilitate the next step of the scale improvement and further evaluation.
Research method
Search out literatures about Migraine from January1990to December2011in CNKI Chinese academic literature network edition database and PubMed, respectively taking "偏头痛治疗","Migraine treatment" for the subject or keywords. Then select the methods to evaluate the clinical efficacy, and make them classified and summarized.
With "PRO scale, patients report end, PRO evaluation, PRO evaluation, PRO assessment" as the theme, we searched for the academic literature in CNKI Chinese academic literature network edition database. We combined the articles on the same scale, distinguish different quantity survey evaluation literature on the same scale, wipe off articles without detailed description of formulation, then we summed up contents, structure and the evaluation method.
Result
Migraine is characterized by remission and relapse, with pain as the main symptoms of the recurrence-of-ease diseases, at present the curative effect of migraine focused on headache attacks, such as headache time, headache frequencies, headache ease time, etc. It has not been reflected in symptoms of the mental change and function damage, and the current examination, assay index can not directly and fully reflect the patients with migraine headache and curative effect. The domestic and foreign migraine evaluation seals are divided into two aspects, of life quality, and headache influence and disability, or borrowing pain assessment scales. The specific degree is not good enough and sensitivity is not quite high. None of them can generalize all aspects of the impact. As one of scale marked by the patients, PRO scale is more and more emphased by people at present. Also because most migraineurs take all kinds of discomfort as their subjective feeling, PRO scale effect assessment of migraine has important significance.
PRO scale can be separated into two parts of the structure of population, general information and scale text. In the statistic of general population information, most researchs are according to the disease characteristics and the content and evaluation disease in design.Through the statistical of36studies on the main body of the scale terms, we can sum up the scale structure term as:entries/variable/item-field/subdomain-domain/dimension, and according to the clinical acceptance of high and low, combined with the draft guidelines issued by the food and drug administration (FDA) applied to clinical effect assessment and the drug development in the PRO study, we suggested the item-field-domain term structure to be used. Migraine PRO scale are standard in the content and structure.
PRO scale evaluation methods are roughly the same, but the classification of methods is not very united. PRO scale can basically evaluated from the reliability and validity, reaction degree, feasibility evaluation, etc.To evaluate the reliability, according to frequency of high and low, they can be divided into Cronbach's αcoefficient, half the reliability and the test-retest reliability. Simple and complex correlation coefficient matrix related reference is usd less. Cronbach's α coefficient and half the reliability and can also be called internal consistency reliability,while test-retest reliability can also be called as the external reliability. Validity can be divided into content validity, contract val idity, criterion-related validity, discriminant validity, correlation analysis and regression analysis. Reaction can be devided into the ability distinguishing different crowda and distinguishing different time of the same people crowd. Feasibility is usually evaluated by scale accept rate, completion rate, and completion time. Accept and accomplish rate are usually required to be above85%. Finish time usually should be controlled in20minutes or less. In addition to the evaluation methods above, the less application of the methods are differentiate, project item response theory, covariance analysis, etc.
Through the half reliability and Cronbach's aevaluation,we can prove the rel iability of Migraine PRO scale is good, and from the content validity, standard validity and structural validity,we comfirmed Migraine PRO scale had good validity. Through the scale overall reaction degree and the item/domain reaction degree, we knew that its reaction degree is good. From three perspective of scale accept rate, completion rate and finish time, its feasibility was also proved to be relatively well.
In the next step of research, based on the own characteristics of migraine, we will reference to the contents and evaluation method of the domestic PRO scale, improve the contents of migraine PRO scale, and using a variety of methods to evaluate performance evaluation.
Conclusion
Migraine curative effect evaluation system has not been fully set up. PRO scale fit for migraine to carry on the curative effect evaluation systemly. Our reaearch group has developed migraine PRO scale in2011. The content and structure of it is reasonable, and the performance evaluation of the preliminary results are reliable. The next step in the research can be improving the contents and making comprehensive evaluation based on the literature comparison.
引文
[1]美·伦道夫,W.埃文斯.头痛诊疗手册[M].科学出版社,2007.31-63.
[2]Menken M, Munsat TL, Toole JF. The global burden of disease study implications for neurology[J]. Arch Neurol,2000,57:418-420.
[3]WHO. The World Health Report 2001:Mental Health:New Understanding, New Hope.Accessed January 12,2009.
[4]俞丽华.偏头痛基于患者报告的结局评价量表研制及性能初步考评[D].北京中医药大学：北京中医药大学,2011.
[5]FDA. Guidance for industry:patient-reported outcome measures:use in medical product development to support labeling claims:draft guidance. Health and Quality of Life Outcomes,2006,4:79-98.
[6]刘风斌.中医临床疗效评价量表实施设想[J].中国中医药报,2003,3：17.
[7]Tfelt-Hansen P, Block G, Dahlof C, et al. Guidelines for controlled trials of drugs in migraine:second edition[J]. Cephalalgia,2000,20 (9):765-786.
[8]Susanna Usai, Licia Grazzi, Frank Andrasik Gennaro Bussone. An innovative approach for migraine prevention in young age:a preliminary study [J]. Neurol Sci,2010,31(1):181-183.
[9]李英杰.颈交感神经节阻滞治疗偏头痛及其对交感神经皮肤反应的影响[J].卒中与神经疾病,2008,15(6)：347-348.
[10]黄赛娥.养血清脑颗粒对偏头痛患者超敏C反应蛋白的影响及疗效的观察检测项目和方法[J].中国医院用药评价与分析,2008.8(1)：58-59.
[11]Gianni Allais, Giancarlo Acuto,Chiara Benedetto,Giovanni D'Andrea,Licia Grazzi, Gian Camillo Manzoni, Franca Moschiano, Florindo d'Onofrio,Fabio Valguarnera,and Gennaro Bussone. Evolution of migraine-associated symptoms in menstrually related migraine following symptomatic treatment with almotriptan[J]. Neurol Sci,2010.31 (1):115-119.
[12]曹克刚,李焕芹.具有中医内涵的偏头痛疗效评价指标研究[J].辽宁中医杂志.2007,34(7)：889-8901.
[13]王江峰,王伟.偏头痛患者TCD检查结果分析[J].中国医药指南,2008,6(4)：126.
[14]冷闻辉.盐酸氟桂利嗪胶囊治疗月经期偏头痛的临床疗效观察[J].脑与神经疾病杂志,2011.19(2)：107-108.
[15]贾春生等.电针丘墟穴治疗偏头痛多中心随机对照研究[J].WorldJ. Acu-moxi.Vol.18, No.1, March,2008:2-3.
[16]Tepper SJ,Kori SH,Goadsby PJ, Winner PK, Wang MH, Silberstein SD,Cutrer FM. Orally Inhaled Dihydroergotamine for Acute Treatment of Migraine:Efficacy of Early and Late Treatments[J]. Mayo Clin Proc. 2011,86 (10):948-55.
[17]Raskin NH. Repetitive intravenous dihydroergotamine as therapy for intractable migraine[J]. Neurology.1986,36(7):995-997.
[18]戴自英.实用内科学[M].北京：人民卫生出版社,1994.203.
[19]刘红建,黄永秋,王小平.养血清脑颗粒对偏头痛患者头痛症状及血液流变学的影响[J].中国临床康复,2005,(17)：108-109.
[20]曹奔放.通脉止痛方与尼莫地平治疗偏头痛临床疗效分析[J].中国实验方剂学杂志,2011,17(14)：275-276.
[21]焦明德.实用经颅多普勒超声学[M].北京：北京医科大学、中国协和医科大学联合出版社,1995.89.
[22]孙增华,杨玉金.偏头痛诊断、疗效评定标准意见[J].中风与神经疾病杂志,1995,12(2)：110.
[23]王世琳,吴凤刚.艾司西酞普兰联合氟桂利嗪治疗偏头痛80例临床研究[J].天津药学,2011,23(2).
[24](ZY/T001.1-94),中华人民共和国中医药行业标准——《中医病证诊断疗效标准》[S].1994：36-37.
[25]国家中医药管理局全国脑病急症协作组.头风病证候诊断标准[J].北京中医学院学报,1997,5(3)：144-147.
[26]郑莜萸.中药新药临床研究指导原则(试行)[M].北京：中国医药科技出版社,2002.
[27](美)罗伯特·M.赫登(Robert M.Herndon).神经疾病分级评分量表(原著第二版)[M].化学工业出版社,2010.
[28]吴家萍.针刺治疗无先兆偏头痛临床随机对照观察[J].针刺研究,2011,36(2)128-129.
[29]雷革胜,林宏,苗建亭,宿长军,李柱一.预防性治疗对偏头痛患者生活质量的影响[J].中国疼痛医学杂志,2008(5)：263-264.
[30]吕华燕,周冀英.关于偏头痛对患者影响的评价工具[J].国际神经病学神经外科学杂志,2011(1)：91-94.
[31]杨彩凤,曹茜,沈永明.国内期刊偏头痛中医药治疗性文章的文献学质量分析[J].天津中医药,2008(3).
[32]单秋华等.耳穴综合疗法治疗发作期普通偏头痛疗效评价[J].中国针灸,2006,26(10)：687-688.
[33]杨洪军,边宝林,王永炎.中药治疗偏头痛研究现状及相关问题探讨[J].中国中医药信息杂志,2003,10(1)：86-88.
[34]HuntSM,McKennaSP, McEwenJ, et al.The Nottingham Health Profile:subjective health status and medica consultations[J]. SocSciMed,1981,15(13):221-229.
[35]Stewart AL, Ware JE. Measuring functional and well-being. the medical outcomes study approach[M]. Durham, N. C.:Duke UniversityPress,1992.
[36]Kaplan RM, Bush JW, Berry CC. Health status types of validity and the index of wellbeing[J]. Health Serv Res,1976,11:478-507.
[37]The Patient-Reported Outeome and Quality Of life Instruments Database.http://www. proqolid. org/,2006-08-11.
[38]罗仕娟.中医肝病临床疗效评价PRO量表的研制与考核[D].广州中医药大学：广州中医药大学,2006.
[39]陈非凡.中医肝病PRO量表的研制与考核[D].广州中医药大学：广州中医药大学,2007.
[40]刘玉红.逍遥散加味合甘利欣治疗慢性乙型肝炎生存质量观察[D].广州中医药大学：广州中医药大学,2008.
[41]刘凤斌,刘玉红.逍遥散加味合甘利欣治疗慢性乙型肝炎生存质量观察[C].第十八次全国中西医结合肝病学术会议论文汇编.2009.
[42]警明杰.中风痉挛性偏瘫患者自觉症状的评价及方法学探讨[D].中国中医科学院：中国中医科学院,2006.
[43]刘求红.消渴目病临床疗效评价量表体系的研制和初步应用[D].广州中医药大学：广州中医药大学,2007.
[44]郭丽.重症肌无力患者PRO量表的研制与考核[D].广州中医药大学：广州中医药大学,2007.
[45]王其进.中医重症肌无力患者报告结局量表反应度考核[D].广州中医药大学：广州中医药大学,2008.
[46]郭丽,刘凤斌,陈新林,.重症肌无力患者PRO量表的研制和条目筛选[J].广州中医药大学学报,2009,26(6)：570-573.
[47]陈新林,刘凤斌,郭丽,刘小斌,.重症肌无力患者报告结局指标量表的研制——计量心理学测评[J].中西医结合学报,2010,8(2)：121-125.
[48]王雪飞.《基于中风病患者报告的临床结局评价量表》的研制及其性能考评[D].北京中医药大学：北京中医药大学,2010.
[49]王维琼.中医脾胃系疾病PRO量表的研制和考核[D].广州中医药大学：广州中医药大学,2007.
[50]刘凤斌,王维琼.中医脾胃系疾病PRO量表的研制[A].中华中医药学会脾胃病分会第十九次全国脾胃病学术交流会论文汇编[C].河北石家庄,2007.
[51]张祚铭.中医脾胃系疾病患者报告的结局指标量表的反应度考核[D].广州中医药 大学：广州中医药大学,2008.
[52]刘凤斌,李培武.中医脾胃系疾病PRO量表在中医药辨证论治功能性胃肠病疗效评价中的应用初探[A].中华中医药学会第二十二届全国脾胃病学术交流会暨2010年脾胃病诊疗新进展学习班论文汇编[C].江西井冈山,2010：297-302.
[53]刘凤斌,王维琼,.中医脾胃系疾病PRO量表的研制与条目筛选[J].世界科学技术(中医药现代化),2009,11(4).527-530.
[54]刘凤斌,王维琼,中医脾胃系疾病PRO量表的研制与条目筛选[A].中医药中青年科技创新与成果展示论坛论文集[C],中国重庆,2009：343-347.
[55]刘凤斌,王维琼,陈新林,.脾胃系疾病PRO量表的计量心理学特性考核[J].广州中医药大学学报,2012,29(1)：82-86.
[56]张艳宏.“基于中风痉挛性瘫痪患者报告的临床结局评价量表”的编制与初步检验[D].中国中医科学院：中国中医科学院,2007.
[57]王扬.“中风痉挛性偏瘫PRO量表”修订及信度、效度、反应度检验[D].中国中医科学院：中国中医科学院,2009.
[58]王扬,赵宏,刘志顺,刘保延.基于中风痉挛性瘫痪患者报告的临床结局评价量表的信度、效度及反应度[J].中国全科医学,2009,12(7A)：1168-1170.
[59]杨小兰.中医肝病(肝硬化)患者报告结局量表的研究及考核[D].广州中医药大学：广州中医药大学,2008.
[60]刘格.绝经综合征评定量表与KI、更年期生存质量量表的比较研究[D].广州中医药大学：广州中医药大学,2008.
[61]李芳.基于女性慢性盆腔痛患者报告的临床疗效评价指标研究[D].北京中医药大学：北京中医药大学,2008.
[62]熊晓芳.肝硬化腹水患者生存质量评价研究[D].广州中医药大学：广州中医药大学,2009.
[63]黄尧达.中医脾胃系疾病PRO量表之慢性胃炎模块的研制和考核[D].广州中医药大学：广州中医药大学,2009.
[64]刘宏潇,姜泉,刘保延,訾明杰,母小真,王海隆.基于类风湿关节炎患者报告的临床结局测量量表的初步构建[J].中医杂志,2009,50(6)：503-505.
[65]郭小玲.冠心病PRO量表的研制与评价[D].山西医科大学：山西医科大学,2010.
[66]张丹婷.慢性阻塞性肺病合并肺源性心脏病中医主症病人报告结局量表的评价[D].广州中医药大学：广州中医药大学,2010.
[67]胡绚.基于现代文献的COPD合并肺心病PRO量表理论框架的初步研究[D].广州中医药大学：广州中医药大学,2008.
[68]陈鹿鸣.COPD合并肺源性心脏病中医主症PRO量表的初步构建[D].广州中医药大学：广州中医药大学,2009.
[69]梁炳君.中医脾胃系疾病PRO量表之肠易激综合征量表的研制与考核[D].广州中医药大学：广州中医药大学,2010.
[70]唐旭东,王萍,刘保延,訾明杰.基于慢性胃肠疾病患者报告临床结局测量量表的编制及信度、效度分析[J].中医杂志,2009,50(1)：27-29.
[71]李开春.腰椎间盘突出症PRO量表的初步研究[D].北京中医药大学：北京中医药大学,2011.
[72]逯金金.慢性心衰中西医结合生存质量量表的研究及应用[D].北京中医药大学：北京中医药大学,2011
[73]何庆勇.冠心病心绞痛病证结合疗效评价体系研究[D].北京中医药大学：北京中医药大学,2011.
[74]朱燕波,李友林,王伟,江芳超.慢性阻塞性肺疾病稳定期患者报告结局量表的研制与临床适用性[J].中西医结合学报,2011,9(8)：857-865.
[75]胡鑫才,张华,周扬,刘平.乙肝后肝硬化患者报告结局评价量表条目的建立及筛选[A].第二十次全国中西医结合肝病学术会议论文汇编[C].2011.
[76]金洵.慢性便秘患者报告临床结局(PRO)评估量表的研制和考评[D].南京中医药大学：南京中医药大学,2011.
[77]张珺.乳腺癌术后中医PRO量表的研制与考核[D].南京中医药大学：南京中医药大学,2011.
[78]贺建红.中医乳腺增生病的PRO量表的研制与考核[D].南京中医药大学：南京中医药大学,2010.
[79]马永浩.肝炎后肝硬化中医PRO量表的修订与考核[D].辽宁中医药大学：辽宁中医药大学,2011.
[80]刘巧君.“基于高血压患者报告的临床结局评价量表”的编制与评价[D].山西医科大学：山西医科大学,2011.
[81]白文瑾.关节炎PRO量表的研制与评价[D].山西医科大学：山西医科大学,2011.
[82]刘力,常玉双,沈舒文,宇文亚,惠建萍,黄毓娟.慢性萎缩性胃炎癌前病变患者报告临床结局评价量表的编制及信度、效度分析[J].中医杂志,2011,52(10)：834-836.
[83]余纯梓.脾胃系疾病PRO量表之胃食管病模块的研制与考核[D].广州中医药大学：广州中医药大学,2011.
[84]张海娇,赵芝焕,万崇华,张晓馨,李晓梅.慢性病患者生命质量测定量表体系之支气管哮喘量表的考评[J].中国全科医学,2011,14(9A)：2871-2874.
[85]刘秀惠.结核病患者生存质量测定量表的研制及应用[D].山东大学：山东大学,2008.
[86]Anronson NK, MeyeroMts BE, BardM, et al. Quality of life research in oneology:Past achievements and future priorities[J]. Cancer,1991, 67:839-843.
[87]HaysRD, Anderson R,Revicki D. Psychometric considerations in evaluating Healthrelated quaiity of life measures[J]. Quality of Life Research,1993,2(2):441-449.
[88]孙振球.医学统计学[M].人民卫生出版社,2008：535-541.
[89]苏中华,李四劝,成义仁.量表评估的内部一致性与克朗巴赫α系数的应用评价[J].临床心身疾病杂志,2009,15(1)：68-70.
[90]刘秀惠.结核病患者生存质量测定量表的研制及应用[D].山东大学：山东大学,2008.
[91]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,2000：24-27.
[92]彭凯平.心理测验-原理与实践.华夏出版社,1989：149～150.
[93]王才康,胡中锋,刘勇一般自我效能感量表的信度和效度研究[J].应用心理学,2001,7(1)：37-40.
[94]Kennetn A Bollen. Struetural equations with latent variables [J].New York:John Wiley & Sons,1989,:432-447.
[95]郝元涛,方积乾.证实性因子分析在量表等价性评价中的应用研究[J].中国卫生统计,2003,20(3)：130-132.
[96]Siu AL, Ouslander JG, Weil DO. Change in self reported functioning in elder persons Entering a residential care faeility [J]. Clin Epiderniol,1993,46(10):1093-1101.
[97]金瑜.心理测量[M].上海：华东师范大学出版社,2001,147-189.
[98]张学中,张建方.药品临床研究中的ITT原则[J].中国新药杂志,2000,(1).
[99]Zhu YB. Measurement and evaluation of quality of life[M]. Beijing:People s Military Medical Press.2010:55-75.
[100]Husted JA, Cook RJ, Farewell VT, Gladman DD. Methods for assessing responsiveness:a critical review and recommendations[J]. Clin Epidemiol. 2000; 53 (5):459-468.
[101]Hays RD, Anderson R, Revieki D.Psyehometric considerations in evaluating health-related quality of life measures[J]. Quality of Life Researeh,1993, 2 (2):441-449.
[102]漆书清,戴海崎,丁树良.现代教育与心理测量学原理[M].高等教育出版社,2002：12.
[103]Mehorney CA. Generie health measurement:Past aeeomplishments and a measurement paradigm for the 21st century[J]. Ann Intern Med,1997, 127:743-750.
[104]Kennetn A Bollen.Structural equations with latent variables[J].New York:John Wiley & Sons,1989,:432-447.