【作者】 王伟；

【导师】 阮新民；

【作者基本信息】 广州中医药大学 ， 中西医结合临床， 2009， 博士

【摘要】 研究背景冠心病作为临床的常见疾病,严重威胁人类健康,是多数发达国家和许多发展中国家成人的主要死亡原因。目前针对冠心病的治疗的研究方法较多,但主要集中在对症状改善的评价上,而随着医学模式的改变,单纯依靠主要症状难以全面评价该病的治疗。冠心病病人康复主要目标之一是提高生存质量(QOL),因而如何评估QOL是冠心病康复治疗研究热点之一。多年来,流行病学家应用一般人群评定量表对各种疾病患者生存质量进行测定,而心血管领域QOL量表大多集中于高血压、慢性心衰和心脏移植方面,缺乏针对冠心病病人的QOL量表。又国内外量表存在文化、社会背景与价值观念的差异,中西医对疾病和健康的认识方法不同,采用此类量表难以客观评价中医药的临床疗效,而影响中医药在治疗冠心病的推广应用,故构建针对适合我国国情的综合评价冠心病病人生活质量量表非常必要。研究目的结合健康人及冠心病患者的生存质量情况对自制冠心病中西医结合生存质量量表条目进行筛选,制定一个具有中西医结合特色的冠心病患者生存质量量表,并用于冠心病中西医结合治疗(血运重建后中医药干预)患者,对量表的信度、效度和反应度进行考评。从而初步建立用于评价冠心病患者临床疗效的中西医结合特色生存质量表,为冠心病患者在自我评价和治疗的疗效评价提供一种量化标准。研究方法1设计方案采取横断面纵向研究与前瞻性随访研究相结合的方法。2研究地点及对象量表调查在广东省中医院、广州中医药大学第一附属医院、广东省人民医院住院患者及广州市健康人群,编制量表调查纳入冠心病患者和健康人群。量表考评研究纳入冠心病血运重建后中医干预的患者,研究对象的纳入以诊断、纳入、排除标准进行。3量表编制与考评方案采用用国内外量表学研究方法,根据量表的研究目标与原则,参考国内外公认的、有较好信度、效度、反应度的量表条目的基础上,结合中医冠心病的临床特征,筛选有关条目形成条目池。通过对健康人及冠心病患者的生存质量调查,应用专家重要性评分,及离散趋势法、判别分析法、因子分析法、逐步回归法、判别分析法、克朗巴赫系数法等统计分析方法对量表的条目进行筛选,形成具有中西医结合特色的冠心病患者生存质量量表。再对符合研究对象的调查,应用一系列统计方法对量表的可行性、信度、效度和反应度进行考评。研究结果1量表特征结合中西医冠心病特点,以量表学为研究方法,对建立的条目池进行筛选,确立由四个维度34条条目组成的初步冠心病中西医结合生存质量量表。对量表调查通过因子分析等统计方法,对保留的条目再筛选,形成以中西医症状维度8个条目、生理维度5个条目、心理维度5个条目、社会维度3个条目的正式冠心病中西医结合生存质量量表,量表为冠心病专用量表,属于评定量表,评定方式为自评。2量表的考评2.1可行性量表的回收率为100%。量表的完成时间为4-16分钟,平均为11.36分钟。在量表的测试过程中除了6.6%文盲因不理解内容需在调查员帮助下填写外,其余受试者均能正确理解并自行填写量表。2.2量表信度内部一致性信度:冠心病中西医结合生存质量量表的症状维度、生理维度、心理维度、社会维度和总表的克朗巴赫系数分别为0.765、0.890、0.847、0.853、0.936;分半信度:四个维度和总表的分半信度系数分别为0.753、0.839、0.847、0.616、0.912;重测信度:四个维度和总表两侧评测的相关系数分别为0.970、0.984、0.980、0.971、0.988。信度较好。2.3量表效度内容效度:对各条目与维度、维度与总表之间的得分进行相关性分析,结果示:症状维度条目与症状维度之间的相关系数在0.384到0.813之间,生理维度条目与生理维度之间相关系数在0.676到0.937之间,心理维度条目与心理维度之间的相关系数在0.671到0.876之间,社会维度条目与社会维度之间的相关系数在0.815到0.921之间,各维度与总表之间的相关系数在0.817到0.925之间,量表具有较好的内容效度;结构效度:量表数据经因子分析后,根据累计贡献率达到70%以上和特征根≥1两个因素综合提取了5个主成份,累积贡献率达73.08%,因子的条目组成基本符合量表的理论构想,除了社会维度中的条目在各公因子上的载荷值较小之外其他各因子均得到了较好的专业解释,该量表结构效度较好;标准关联效度:用西雅图心绞痛量表(SAQ)作为效标,分别对患者进行同时测量,并将相关数据进行相关分析以检验本量表的标准关联效度。分析结果示相关系数为0.901,p＜0.01,有较强的相关性,也就说明该量表具有较强的标准关联效度。2.4量表反应度将健康人与冠心病患者的症状维度、生理维度、心理维度、社会维度、总分进行t检验P均小于0.01,即两者比较差异有显著性意义,说明该量表具有区分健康人和冠心病患者生存质量的能力;对冠心病患者血运重建前后的生存质量进行比较,t检验结果表明两次评测的症状维度、生理维度、心理维度、社会维度和总分之间的差异有显著性意义。结论本量表的研制根据冠心病的概念,在中西医理论指导下,根据冠心病发病的特点,建立了冠心病评定量表的理论构架,即量表由中西医症状、生理、心理、社会四个维度组成。按照心理测量学的方法,进行量表的研制,并经过临床考评,在量表的研制、临床试用与考评中,进一步完善了量表制定的方法与步骤等,较为全面地从定量化角度反映了冠心病患者的内涵。1.本研究中,在遵循生存质量研究一般方法与步骤的同时,依据量表制定中各步骤的对传统方法重新分解、组合,将某些步骤进一步细化、深化、专业化,从而形成了一个步骤更清晰、更具体、更易操作的生存质量量表制定方法,并在研究中有针对性地引入生存质量研究特点的统计方法。2.按照量表研制的方法与步骤研究,大量征集专家、患者关于量表研制的各种意见,培训调查员、对病人进行认真的宣传工作,遵守临床科研原则、质量控制人员定期和不定期检查等多种方法,保证了量表研究的顺利进行及量表的质量。3.本量表编制中采用多维方法,包含中西医症状、生理、心理、社会四个维度,使量表可以反映冠心病疾病的中西医症状特点、特殊不适及疗效满意性等。条目初筛后经专家与病人多次增删、修改、合并、调整,并通过重要性评分、相关系数法、离散程度法、因子分析法、区分度分析、克朗巴赫系数法来筛选条目,使条目的质量大为提高,更符合临床运用的需要。形成了上述四个维度,共21条条目的冠心病患者生存质量测定量表。量表以自评为主,结果分析以维度为主,且各个维度可以独立统计,有利于临床的分类比较研究。4.调查表的回收率、应答率均较高,完成问卷所需时间为4-16分钟,表明该表具有较高的可行性。5.临床考评信度、效度和反应度分析结果表明,本量表具有较好的内在一致性信度、分半信度、重测信度,说明量表具有较好的稳定性、跨条目一致性、精确性,量表条目的内部一致性很好。同时量表具有较好的内容效度、适度的标准关联效度,维度相关性较好,结构效度部分领域需进行再调整,但总体结构效度较好。说明量表具有较高的准确度、有效性和正确性。6.本量表能区分不同人群(健康人与中风患者)生存质量的变化,具有区分不同干预措施所致不同疗效的能力,甚至能区分不同组别横向资料的差异及程度,对各种生存质量资料得分的变化较为敏感,具有较好的反应度。更多还原

【Abstract】 BackgroundCoronary heart disease as a common Clinical disease,a serious threat to human health,is the most developed and many developing countries the leading cause of death for adults。At present,for the treatment of coronary heart disease research methods,it is mainly concentrated in the evaluation of symptom improvement,but with the medical model of change,simply it is difficult to rely on a comprehensive evaluation of the main symptoms of the disease treatment。Coronary heart disease patients one of the main objectives is to improve the quality of life(QOL),and thus how to assess coronary heart disease rehabilitation QOL studies are one of the hotspots。Over the years, the application of the general population epidemiologists rating scale for quality of life in patients with various diseases were measured,and the field of cardiovascular QOL scale were mainly centered on high blood pressure、chronic heart failure and cardiac transplantation,the lack of QOL for patients with coronary artery disease Scale。Scale also exist at home and abroad culture、social background and values of the difference between Chinese and Western medicine on the disease and health awareness methods,the adoption of such a scale difficult to objectively evaluate the clinical efficacy of Chinese medicine and the impact of Chinese medicine in treatment of coronary artery disease popularization and application,so suitable for building a comprehensive evaluation of the condition of our country the quality of life in patients with coronary artery disease is necessary scale。Objective Combination of health and quality of life in patients with coronary artery disease on coronary heart disease in self-control-made quality of life,scale entry should be screened for the development of a unique combination of Chinese and Western Medicine Quality of Life Scale for patients with coronary artery disease and has been used in traditional Chinese and western medicine treatment ofcoronaryheartdisease(Traditional Chinese Medicine after revascularization intervention) patients,on the scale reliability、validity and responsiveness evaluation。Thus the initial set up for evaluating the clinical efficacy of coronary heart disease in patients with traditional Chinese and western medicine table features quality of life for patients with coronary heart disease in self-evaluation and evaluation of the therapeutic effect of providing a quantitative criteria。Methods1 DesignTo take cross-sectional longitudinal study with follow-up study of a combination of forward-looking approach。2 Study sites and objectsScale investigate Guangzhou City inpatients at Guangdong Provincial TCM Hospital、First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine、Guangdong Provincial People’s Hospital and healthy people, scale investigation into the preparation of patients with coronary artery disease and healthy population。Scale evaluation studies in coronary heart disease after revascularization in patients with Chinese medicine intervention,research subjects into the diagnosis、inclusion criteria excluded。3 Scale preparation and appraisal programsUsed by domestic and international scale study research methods,According to the study of scale goals and principles,References recognized at home and abroad,there is good reliability、validity、responsiveness of the scale on the basis of entries,Chinese medicine combined with the clinical characteristics of coronary heart disease,screening the entry form the entry pool。People through health and quality of life in patients with coronary artery disease investigation,the importance of the application of the expert score, and discrete trends in law、discriminant analysis、factor analysis、stepwise regression、discriminant、Cronbach’a analysis method on the scale screening, Forming characteristics of traditional Chinese and western medicine in patients with coronary heart disease quality of life scale。Again in line with survey research,applied a series of statistical methods to scale the feasibility、reliability、validity and responsiveness evaluation。Results1 Scale CharacteristicsCoronary heart disease combined with the characteristics of Chinese and Western medicine in order to scale study to examine methods to set up the entry pool filter,established by the four domains,composed of 34 entries in the initial coronary heart disease in the Quality of Life Scale Integrated Traditional and Western Medicine。Investigate on the scale through factor analysis of statistical methods,to retain the reentry screening,the formation of Chinese and Western medicine symptoms of domain eight entries, five entries in the physical domain,the psy- chological domain of five entries, three entries in the social domain of coronary heart disease of Traditional Chinese and Western Medicine formal quality of life Scale,Scale for coronary heart disease-specific scale,belong to rating scale to assess for self-assessment。2 Scale evaluation2.1 feasibilityScale of the recovery was 100%。Scale finish time for 4-16 minutes,with an average of 11.36 minutes。Scale at the testing process apart from 6.6 percent ill- iteracy because they do not understand the content at the help investigators fill in the remaining subjects are able to understand and to fill in the correct scale.2.2 Scale ReliabilityCronbach:Coronary heart disease in traditional Chinese and western medicine symptoms of quality of life scale domains,physical domains, psychological domain,social domain and the total table’s coefficients were 0.765、0.890、0.847、0.853、0.936;split-half reliability:four domains and the total table split-half reliability coefficients were 0.753、0.839、0.847、0.616、0.912;test-retest reliability:the four domains and the overall evaluation form on both sides of the correlation coefficients were for 0.970、0.984、0.980、0.971、0.988。Better reliability。2.3 Scale Validity Content Validity:Of all entries with the domain,the domain table and the total scores between the correlation analysis,the results show:Symptoms and Symptom Domains of entries of the correlation coefficient between the domains at between 0.384 to 0.813,physical domain of the entry and physiology domain between the correlation coefficient at 0.676 to 0.937 between the psychological domain of entries with the psychological domain of the correlation coefficient between at between 0.671 to 0.876,social domain and social domain of entry between the correlation coefficients at 0.815 to 0.921 between the domain table with the total at between the correlation coefficient from 0.817 to 0.925 between the scale has good content validity;Construct Validity:Inventory data by factor analysis,based on the cumulative contribution rate of over 70%and》1 eigenvalue two factors extracted five principal components,the cumulative contribution rate of 73.08%,factor of the entries in line with the scale of the composition of the basic theory the concept of social domain in addition to the entries in the common factor in all the load on a relatively small addition to other factors have been a better professional interpretation,validity of the scale structure better;standard related validity:The Seattle Heart Colic Scale(SAQ) as the criterion, respectively,of patients with simultaneous measurements and related data analysis to test the scale of standard-related validity.The results of the analysis showed a correlation coefficient of 0.901,p＜0.01,there is a strong correlation,it shows that the scale has a strong standard-related validity。2.4 Scale responsivenessHealthy people and patients with coronary heart disease symptoms domains、physical domains、psychological domains、social domains,scores for both t test P less than 0.01,that is,the difference was significant,indicating that the scale has distinction between health and quality of life in patients with coronary artery disease capacity;revas- cularization of patients with coronary artery disease before and after comparison of quality of life,t test results showed that the symptoms of the two evaluation domains,physical domains,psychological domain,social domain and the difference between total scores was significant。ConclusionThe development of this scale in accordance with the concept of coronary heart disease,in theory,under the guidance of Chinese and Western medicine, according to the characteristics of coronary heart disease,Established coronary heart disease rating scale theoretical framework,that is,scale from Chinese and Western medicine symptoms、physiological、psychological、social composition of the four domains。In accordance with the psychometric approach to scale development,And through clinical evaluation,Scale at the development,clinical trial and evaluation to further improve the scale formulate methods and procedures and so on,are more comprehensive from the quantitative point of view reflects the connotation of patients with coronary artery disease。1.The present study,In complying with the general quality of life measures and steps at the same time,Scale based on the various steps in the development of the traditional methods of decomposition、composition,Certain steps will be further refined、deepened、specialization,Steps to form a clearer and more specific、easier to scale operations to develop methods of quality of life, And in the study has targeted the introduction of the characteristics of quality of life study of statistical methods。2.In accordance with the scale of the measures and steps to develop research, Substantial collection of experts and the patient developed on the scale of the various views,Training for investigators,Carefully to the patient advocacy work,Comply with the principles of clinical research,quality control and regular check-ups from time to time a number of ways,Study on the scale to ensure the smooth progress of the quality and scale。3.The scale used in the preparation of multi-domainal approach,including Chinese and Western medicial symptoms、physiological、psychological、social four domains,So that scale can be reflected in coronary heart disease symptoms characteristic of Western medicine and the special does not apply,such as satisfaction and efficacy。After screening the entry of experts with many additions and deletions sick、modify、merge、adapt,By the importance score、the correlation coefficient method、the degree of dispersion method、factor analysis、discrimination analysis、’s coefficient method to filter entries, So greatly improve the quality of entries,more in line with the needs of clinical application。The formation of the above four domains,a total of 21 patients with coronary artery disease,were the purpose of determination of the quality of life scale。Scale-based self-assessment,Domains of the main results of analysis and statistics in various domains can be independent and is conducive to comparative study of the clinical classification。4.The recovery rate of the questionnaire and response rates are higher,The time required to complete a questionnaire for 4-16 minutes,indicating that the table has a high feasibility。5.Clinical evaluation of reliability、validity and responsiveness the results of the analysis indicate that this scale has good internal consistency reliability、split-half reliability、test-retest reliability,that scale has good stability、consistent cross-entries nature、accuracy,scale entry very good internal consistency。At the same time scale has good content validity、an appropriate standards-related validity,Showing the better correlation domain,structural part of the area of validity need to re-adjust,but overall a good construct validityo Noting scale with high accuracy、validity and correctness。6.This scale can distinguish between different groups(healthy people and stroke patients) the changes in quality of life,distinguish between different interventions have different effects due to the ability to even distinguish between different groups and differences in the horizontal extent of the information,information on various quality of life more sensitive to changes in scoring,with good responsiveness。更多还原