原发性骨质疏松症PRO量表的初步研制与评价

发布时间：2018-06-29 12:48

本文选题：原发性骨质疏松症 + PRO　；参考：《广州中医药大学》2015年硕士论文

【摘要】：目的：在中西医学理论以及计算机自适应和条目反应测试理论的指导下,通过多种统计分析方法,研制原发性骨质疏松症PRO量表。方法：1.成立研究组首先建立原发性骨质疏松症工作组,分为概念框架组、条目数据管理组、组外专家、学术委员会、学术顾问组、数据协作组共6个小组组,每组由3-5人组成,各组规定各自任务。2.制定量表的基本特征设定原发性骨质疏松症量表的测试对象、测试目的、测试量表类型、条目的数量、条目反应尺度、计分规则、条目的管理方式等基本特征。3.规范基本概念和术语4.构建量表的概念框架结合国外骨质疏松症相关量表,并依据项目研究中概念框架的理论要求,建立并制定本研究的概念框架结构。然后通过患者和专家调查问卷对原发性骨质疏松症患者和专家进行定性采访,制定出量表初步的概念框架模型。5.条目库构建和条目的初步筛选。5.1条目的收集互联网搜索检索原发性骨质疏松症的相关条目,结合国内外相关量表、原发性骨质疏松症相关教材、指南和诊疗标准,纳入所有相关条目以形成原发性骨质疏松症PRO量表的条目清单。5.2建立条目库数据管理组及条目管理组完成条目的管理,并将原发性骨质疏松症PRO量表所有条目清单纳入该数据库。5.3条目初筛运用仓储法与精选法的纳入和删除标准进行条目初步筛选。5.4概念框架的修订参考概念框架的修改标准,概念框架组对概念框架模型进行进一步修订。6.条目定性评阅6.1专家评阅条目管理组先制定条目的答题选项,并预先制定条目删除标准、增加和修改标准以及概念框架的修改标准以及研究的中止标准。专家组通过上述标准对条目进行再修改,评估概念框架的合理性,然后各个小组在标准下共同讨论,确定最终意见。6.2核心组讨论核心组由5-8患者组成,且两轮均为条目筛选成立核心组。召开核心组会议进行相关讨论,要求核心组患者对量表条目进行评价,然后由概念框架组评估概念框架的合理性,最后由条目管理组对条目的信息进行综合评估及整合,同时依据原发性骨质疏松症的纳入和排除标准筛选患者。6.3认知采访规定每次认知采访参与者至少5名以上,条目管理组依据原发性骨质疏松症的纳入和排除标准筛选患者,然后召开核心组会议进行讨论,核心组患者对量表条目进行认知和理解方面的评价,然后由概念框架组来评估概念框架的合理性,最后由条目管理组对条目的信息进行综合评估及整合。7.现场调查经过上述步骤形成了的原发性骨质疏松症PRO量表初稿,然后在2014.03-2015.02期间对原发性骨质疏松症患者进行现场问卷调查并签署知情同意书。调查地点选取在在广州中医药大学第三附属医院、广州市荔湾区正骨医院、深圳市宝安区中医院、顺德中医院门诊及住院部。8.统计分析8.1定性研究成立研究组,预设量表的基本结构特征、基本概念和术语,制定量表的初步概念理论框架,建立条目库,条目的初筛选以及条目的定性评阅(复筛)共6个步骤。首先对采集的信息资料进行定性化分析,然后对各收集的资料进行统计描述分析。8.2数据分析使用SPSS20.0里的离散趋势发法、区分度法、因子分析法对、相关系数法、克朗巴赫系数法对量表进行条目筛选,同时运用IRT的Multilog7.03软件分析条目的特征曲线、条目的信息曲线,各条目的难度及区分度系数,最后进行综合筛选。9.量表的科学性考核最后运用经典和现代测试理论的相关统计分析方法对量表进行难度、区分度、信度、效度、可行性考量。结果：1.原发性骨质疏松症的概念回顾相关文献、指南、诊疗标准,确定本研究原发性骨质疏松症定义为：是以单位体积内骨量绝对减少,骨组织的显微结构退化为特征,以致骨的脆性增大及骨折危险性增加的一种全身骨病。2.OPPRO量表的初步概念框架回顾国内外相关专业量表念框架结构,通过分析,制成概念框架草稿模型进行问卷调查,选择10名原发性骨质疏松症患者和5名专家进行采访,制定出本研究的概念框架,其中包括疾病生理、心理、社会、治疗领域4个领域,疾病表现、全身表现、心理表现、社会关系、日常活动能力、满意度等6个维度的的概念框架结构。3.条目搜集3.1检索收集条目条目管理组回顾2个国内相关量表,得到89个条目,回顾2个国外量表得到93个条目,回顾2个临床研究标准得到个52个条目,共收集到183条相关条目形成原发性骨质疏松症PRO量表条目清单(附录1)。3.2条目库建立数据管理组提供原发性骨质疏松症PRO量表条目清单的结构化变量,然后,由条目管理组对条目清单进行结构化处理,包括条目内容、条目所属量表、包括条目所属领域等,建立Excel软件数据库。构建原发性骨质疏松症PRO量表条目库。3.3条目初筛运用仓储法和精选法对条目进行初筛,最终形成包含71个条目的原发性骨质疏松症PRO量表条目库,其中主要症状特征方面24个条目,全身临床表现方面18个条目,心理领域方面有8个条目,社会关系领域9有个条目,独立性领域8有个条目,满意度方面有4个条目。4.条目复筛4.1专家评阅条目首先制定调查问卷的卷首语,再按照相关程度制定条目的回答选项。专家组评估概念框架的合理性后,最终确定概念框为原发性骨质疏松症主要临床症状、生理领域、心理领域、社会关系领域、独立性领域、满意度领域等表现共6个维度。条目管理组根据概念框架初步评阅条目,并提出修改意见。4.2核心组讨论建立包含15名患者的2个核心组,经讨论,形成一致的条目意见,组建包含71个条目的原发性骨质疏松症PRO量表条目仓库并根据条目制成专家和患者调查问卷(附录2、3),其中主要症状特征方面有24个条目,全身症状表现18方面有个条目,心理方面有8个条目,社会关系维度9有个条目,独立性方面8有个条目,满意度方面有4个条目。4.3认知采访对5位患者分别进行采访,遵循采访意见,患者均表示理解条目库的所有内容,确定了最终OPPRO量表的条目库清单,无需再作进一步修改。5.标定测试研究5.1一般特征在2014.03-2015.02期间,在广州中医药大学第三附属医院、广州市荔湾区正骨医院、深圳市宝安中医院、顺德中医院门诊及住院部就医现场进行患者的报告的数据收集,12个月期间共发放量表580分,收回完整无缺失患者问卷380份,重测患者52份,健康者92份,回收率90.34%。5.2概念框架研究组参照各患者和专家建议,同意概念框架定义为包含“概念-领域-维度-条目”四级结构,通过各种经典及现代理论方筛选得到含1个疾病,4个领域,6个维度,44个条目的PRO量表。5.3概念框架的评价和调整工具量表总的克朗巴赫系数为0.801,提示有良好的内部一致性,无需调整。5.4经典测试理论分析经过因子分析检测删除18个条目,相关分析删除23个条目,区分度分析删除0个条目,克朗巴赫系数共删除14个条目、离散趋势分析示删除3个条目.5.5IRT模型参数分析对各条目的条目特征曲线(ICCs)和条目信息曲线(IIC)进行难度和区分度分析以及条目特征和信息曲线的分析,共删除25个条目。5.6综合分析通过六种方法综合评价,其中5种级以上的方法都没被删除的条目予以保留,共44条,最终得出终量表。6量表的科学性考核对量表的信度、效度、区分度、可行性进行考核。信度方面：总量表的克朗巴赫a系数为0.801,疾病主要症状克朗巴赫系数为0.907,全身表现的系数为0.780,心理维度的表现为0.849,社会关系维度的表现为0.807,日常活动能力方面的表现为0.799,满意度方面的表现为0.877,具有较好的内部一致性。重测信度为pearson相关系数为0.925,Kendall相关系数为0.759,提示良好的重测信度；效度分析：结构效度结果说明量表中多维度的测量满足专业上的预想结构；区分度分析：患者和健康者之间的T检验显示量表具有很好的区分度；可行性分析：抽样调查原发性骨质疏松症患者,量表总完成率为90.34%,作答时间均小15分钟。结论：运用经典测试理论和现代项目测试反应理论进行研制的原发性骨质疏松症患者报告结局条目,最终研制出包含1个疾病、4个领域、6个维度的44个条目的骨质疏松症PRO量表。测量概念为原发性骨质疏松症的症状和体征,反应尺度分为1-5级等级区分,数据收集方式为患者自己提供信息并独立填写。对量表的科学性考核表明具有较好的难度、区分度、信度、效度和可行性。本研究步骤标准且严谨,体现中医内容,且具有中华文化特色,研究范围来源广泛,方法学和报道质量较高,有良好的创新性和科研及临床意义,可用于原发性骨质疏松症患者的临床疗效评价。
[Abstract]:Objective: under the guidance of the theory of Chinese and Western medicine and the theory of computer adaptive and item response test, the PRO scale of primary osteoporosis was developed by a variety of statistical analysis methods. Methods: 1. the group of primary osteoporosis was established first in the study group, which was divided into conceptual framework group, entry data management group, and foreign experts. The operation Committee, the academic advisory group and the data cooperation group were composed of 6 groups of 3-5 people. Each group stipulated the basic characteristics of the.2. formulation of each task, set the test object of the primary osteoporosis scale, test purpose, test scale type, number of items, item response scale, score rule, management mode and so on. The basic concept of feature.3. and the concept framework of the term 4. construction scale combined with the foreign osteoporosis related scale, and based on the theoretical requirements of the conceptual framework in the project research, the conceptual framework of this study was established and formulated. Then the patients and experts of the primary osteoporosis patients and experts were identified by the patient and the expert questionnaire. An initial conceptual framework model.5. entry library construction and a preliminary screening of.5.1 items for the purpose of collecting Internet search for primary osteoporosis related entries, combined with relevant domestic and foreign related questionnaires, primary osteoporosis related textbooks, guidelines, and medical standards for the formation of primary related items. The list.5.2 of the PRO scale of osteoporosis establishes the management of the entry library data management group and the entry management group, and integrates all the items list of the primary osteoporosis PRO scale into the initial screening of the.5.3 entry of the database using the warehousing method and the selection method for the inclusion and deletion of the criteria for the preliminary screening of the.5.4 conceptual framework. Revising the revised standard for the reference concept framework, the conceptual framework group further revises the conceptual framework model to review the.6. entries qualitatively and reviews the 6.1 experts to review the item selection options in the entry management group, and pre enact the entry deleting standards, add and modify the standard as well as the modification standards of the conceptual frame and the suspension standard of the study. The family group revise the items through the above criteria and evaluate the rationality of the conceptual framework. Then each group is discussed together under the standard. The final opinion.6.2 core group discusses the core group composed of 5-8 patients, and two rounds are all selected to set up the core group. The list is evaluated, then the conceptual framework is evaluated for the rationality of the conceptual framework. Finally, the entry management group evaluates and integrates the item information. At the same time, according to the inclusion and exclusion criteria of primary osteoporosis, the.6.3 cognitive interview provides for the participants at least 5 or more participants in each cognitive interview. The group was selected according to the inclusion and exclusion criteria of primary osteoporosis, and then the core group meeting was held to discuss. The patients in the core group evaluated the cognitive and understanding aspects of the scale items. Then the concept frame group was used to evaluate the rationality of the conceptual framework. Finally, the item information was evaluated synthetically by the management group. The first draft of the primary osteoporosis PRO scale was formed by the.7. field survey, and then a field questionnaire was conducted on the patients with primary osteoporosis and the informed consent was signed during 2014.03-2015.02. The site was selected at the Third Affiliated Hospital of Guangzhou University of Chinese Medicine, Liwan District orthopedics hospital, Guangzhou, Shenzhen Baoan District traditional Chinese medicine hospital, Shunde traditional Chinese medicine hospital outpatient and inpatient department.8. statistical analysis 8.1 qualitative research set up the research group, the basic structural features of the presupposition scale, the basic concepts and terms, the preliminary conceptual framework of the scale, the establishment of the entry library, the initial selection of entries and the qualitative evaluation of entries (rescreening), the first of the 6 steps. Qualitative analysis of the information and information of the collection, and then the statistical description of the collected data analysis and analysis of the.8.2 data analysis using the discrete trend in SPSS20.0, differentiation, factor analysis, the correlation coefficient method, Krone Bach coefficient method for entry screening, and the use of IRT Multilog7.03 software to analyze the special items. Sign curve, information curve of entry, degree of difficulty and division coefficient of each item. Finally, the scientific assessment of the comprehensive screening.9. scale was carried out with the correlation statistical analysis method of classical and modern test theory. The degree, reliability, validity and feasibility of the scale were studied. Results: the concept review of 1. primary osteoporosis was reviewed. Relevant literature, guidelines, diagnosis and treatment standards, and determine the definition of primary osteoporosis in this study: a preliminary conceptual framework of a.2.OPPRO scale for systemic bone disease, characterized by absolute reduction in bone mass within a unit volume and microstructural degeneration of bone tissue, resulting in increased bone fragility and increased fracture risk, and a review of relevant professional quantities at home and abroad. By analyzing the frame structure, a questionnaire survey was made to make a conceptual framework draft model. 10 patients with primary osteoporosis and 5 experts were interviewed to formulate a conceptual framework for the study, including 4 areas of disease physiology, psychology, society, and treatment, disease performance, general performance, psychological performance, social relations, and daily life. 6 dimensions of 6 dimensions, such as constant activity, satisfaction, and so on, 3.1 retrieval collection entry management group review 2 domestic related scales, get 89 entries, review 2 foreign scales to get 93 items, review 2 clinical research standards and get 52 items, and collect 183 related items to form primary bone. The PRO item list of the osteoporosis (Appendix 1).3.2 item bank establishes the data management group to provide the structured variables for the primary osteoporosis PRO list items list, and then the entry management group deals with the list of items, including the contents of the entries, the scale of the entries, the domain of the entries, and so on, and establishes the software data of the Excel. The primary screening of the entry Library of the PRO item Library of primary osteoporosis was initially screened using the warehousing method and the selection method. Finally, 71 items of primary osteoporosis PRO items were formed, including 24 items in the main symptom features, 18 items in the general clinical table and 8 in the psychological field. There are 9 items in the field of social relations, there are 8 entries in the field of independence, there are 4 entries in the field of satisfaction, there are 4 entries in the degree of satisfaction, the rescreening 4.1 of the entries, the first language of the questionnaire, and the answer options according to the degree of relevance. After the expert group is assessing the rationality of the conceptual framework, the concept frame is finally identified as the original bone. The main clinical symptoms, physiological fields, psychological fields, social relations, independence, and satisfaction were 6 dimensions. The entry management group reviewed the items according to the conceptual framework, and proposed the revision.4.2 core group to discuss the establishment of 2 core groups including 15 patients. Set up 71 items of primary osteoporosis PRO item warehouse and make an expert and patient questionnaire (Appendix 2,3) according to the entries. There are 24 entries in the main symptom features, 18 items in 18 aspects, 8 items in the psychological aspect, 9 in the social relation dimension, and 8 in the independence aspect. In terms of satisfaction, 4 items of.4.3 cognitive interview were interviewed for 5 patients, followed by interviews. All the patients expressed their understanding of all the contents of the item library, determined the list of the final OPPRO list, and did not need to further modify the.5. demarcation test study 5.1 in the period of 2014.03-2015.02, in the Guangzhou Chinese medicine. Third affiliated hospitals, Guangzhou Liwan District orthopedics hospital, Shenzhen Baoan Hospital of traditional Chinese medicine, the outpatient and inpatient department of the Shunde traditional Chinese medicine hospital were collected the data of the patients' reports. The total amount of the questionnaire was 580 points during the 12 month period, and the complete and complete patient questionnaire was recovered, 52 of the patients were remeasured, 92 of the healthy persons, and the recovery rate 90.34%.5.2 concept frame. According to the patients and experts, the study group agreed that the conceptual framework was defined as a four level structure containing "concept domain dimension item". Through a variety of classical and modern theoretical sides, 1 diseases, 4 areas, 6 dimensions, and 44 PRO.5.3 conceptual frameworks were evaluated and the overall Krone Bach coefficient of the adjustment tool scale. For 0.801, it has good internal consistency, and there is no need to adjust the.5.4 classic test theory to delete 18 entries by factor analysis, delete 23 entries by correlation analysis, delete 0 entries by distinction analysis, delete 14 entries by Krone Bach coefficient, discrete trend analysis and delete 3 items to analyze the parameters of each item to each item. Objective feature curve (ICCs) and entry information curve (IIC) for difficulty and segmentation analysis, and the analysis of item features and information curves. A total of 25 items of.5.6 comprehensive analysis are deleted by six methods, of which 5 kinds of methods are not deleted and 44 are not deleted. Finally, the final scale.6 scale is obtained. The reliability, validity, distinction and feasibility of the scale were examined. Reliability: the Krone Bach a coefficient of the total scale was 0.801, the main symptoms of the disease were 0.907, the coefficient of the body was 0.780, the psychological dimension was 0.849, the social relationship dimension was 0.807, and the daily activity capacity was 0.807. The performance is 0.799, the performance of satisfaction is 0.877, with good internal consistency. Retest reliability is Pearson correlation coefficient 0.925, Kendall correlation coefficient is 0.759, indicating good retest reliability; validity analysis: structural validity results show that the measurement of multi dimension in the scale satisfies the professional preconceived structure; distinction analysis: The T test between the patient and the healthy person showed a good division of the scale; feasibility analysis: a sample survey of primary osteoporosis patients, the total completion rate of the scale was 90.34%, and the answer time was 15 minutes. Conclusion: the primary osteoporosis patients developed by the classical test theory and the modern project test reaction theory. The outcome items were reported, and 44 PRO scales including 1 diseases, 4 fields and 6 dimensions were developed. The measurement concept was the symptoms and signs of primary osteoporosis, the response scale was divided into 1-5 grades, the data collection method provided information for the patient and was filled out independently. The scientific examination of the scale It has good difficulty, distinction, reliability, validity and feasibility. This research step is standard and rigorous. It embodies Chinese medicine content, has Chinese cultural characteristics, has a wide range of research sources, high quality of methodology and reporting, good innovation and scientific research and clinical significance. It can be used in the clinical treatment of patients with primary osteoporosis. Evaluation.
【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R580

【参考文献】