本文選題：原發(fā)性骨質(zhì)疏松癥 + PRO　； 參考：《廣州中醫(yī)藥大學(xué)》2015年碩士論文

【摘要】：目的：在中西醫(yī)學(xué)理論以及計算機自適應(yīng)和條目反應(yīng)測試理論的指導(dǎo)下,通過多種統(tǒng)計分析方法,研制原發(fā)性骨質(zhì)疏松癥PRO量表。方法：1.成立研究組首先建立原發(fā)性骨質(zhì)疏松癥工作組,分為概念框架組、條目數(shù)據(jù)管理組、組外專家、學(xué)術(shù)委員會、學(xué)術(shù)顧問組、數(shù)據(jù)協(xié)作組共6個小組組,每組由3-5人組成,各組規(guī)定各自任務(wù)。2.制定量表的基本特征設(shè)定原發(fā)性骨質(zhì)疏松癥量表的測試對象、測試目的、測試量表類型、條目的數(shù)量、條目反應(yīng)尺度、計分規(guī)則、條目的管理方式等基本特征。3.規(guī)范基本概念和術(shù)語4.構(gòu)建量表的概念框架結(jié)合國外骨質(zhì)疏松癥相關(guān)量表,并依據(jù)項目研究中概念框架的理論要求,建立并制定本研究的概念框架結(jié)構(gòu)。然后通過患者和專家調(diào)查問卷對原發(fā)性骨質(zhì)疏松癥患者和專家進行定性采訪,制定出量表初步的概念框架模型。5.條目庫構(gòu)建和條目的初步篩選。5.1條目的收集互聯(lián)網(wǎng)搜索檢索原發(fā)性骨質(zhì)疏松癥的相關(guān)條目,結(jié)合國內(nèi)外相關(guān)量表、原發(fā)性骨質(zhì)疏松癥相關(guān)教材、指南和診療標準,納入所有相關(guān)條目以形成原發(fā)性骨質(zhì)疏松癥PRO量表的條目清單。5.2建立條目庫數(shù)據(jù)管理組及條目管理組完成條目的管理,并將原發(fā)性骨質(zhì)疏松癥PRO量表所有條目清單納入該數(shù)據(jù)庫。5.3條目初篩運用倉儲法與精選法的納入和刪除標準進行條目初步篩選。5.4概念框架的修訂參考概念框架的修改標準,概念框架組對概念框架模型進行進一步修訂。6.條目定性評閱6.1專家評閱條目管理組先制定條目的答題選項,并預(yù)先制定條目刪除標準、增加和修改標準以及概念框架的修改標準以及研究的中止標準。專家組通過上述標準對條目進行再修改,評估概念框架的合理性,然后各個小組在標準下共同討論,確定最終意見。6.2核心組討論核心組由5-8患者組成,且兩輪均為條目篩選成立核心組。召開核心組會議進行相關(guān)討論,要求核心組患者對量表條目進行評價,然后由概念框架組評估概念框架的合理性,最后由條目管理組對條目的信息進行綜合評估及整合,同時依據(jù)原發(fā)性骨質(zhì)疏松癥的納入和排除標準篩選患者。6.3認知采訪規(guī)定每次認知采訪參與者至少5名以上,條目管理組依據(jù)原發(fā)性骨質(zhì)疏松癥的納入和排除標準篩選患者,然后召開核心組會議進行討論,核心組患者對量表條目進行認知和理解方面的評價,然后由概念框架組來評估概念框架的合理性,最后由條目管理組對條目的信息進行綜合評估及整合。7.現(xiàn)場調(diào)查經(jīng)過上述步驟形成了的原發(fā)性骨質(zhì)疏松癥PRO量表初稿,然后在2014.03-2015.02期間對原發(fā)性骨質(zhì)疏松癥患者進行現(xiàn)場問卷調(diào)查并簽署知情同意書。調(diào)查地點選取在在廣州中醫(yī)藥大學(xué)第三附屬醫(yī)院、廣州市荔灣區(qū)正骨醫(yī)院、深圳市寶安區(qū)中醫(yī)院、順德中醫(yī)院門診及住院部。8.統(tǒng)計分析8.1定性研究成立研究組,預(yù)設(shè)量表的基本結(jié)構(gòu)特征、基本概念和術(shù)語,制定量表的初步概念理論框架,建立條目庫,條目的初篩選以及條目的定性評閱(復(fù)篩)共6個步驟。首先對采集的信息資料進行定性化分析,然后對各收集的資料進行統(tǒng)計描述分析。8.2數(shù)據(jù)分析使用SPSS20.0里的離散趨勢發(fā)法、區(qū)分度法、因子分析法對、相關(guān)系數(shù)法、克朗巴赫系數(shù)法對量表進行條目篩選,同時運用IRT的Multilog7.03軟件分析條目的特征曲線、條目的信息曲線,各條目的難度及區(qū)分度系數(shù),最后進行綜合篩選。9.量表的科學(xué)性考核最后運用經(jīng)典和現(xiàn)代測試理論的相關(guān)統(tǒng)計分析方法對量表進行難度、區(qū)分度、信度、效度、可行性考量。結(jié)果：1.原發(fā)性骨質(zhì)疏松癥的概念回顧相關(guān)文獻、指南、診療標準,確定本研究原發(fā)性骨質(zhì)疏松癥定義為：是以單位體積內(nèi)骨量絕對減少,骨組織的顯微結(jié)構(gòu)退化為特征,以致骨的脆性增大及骨折危險性增加的一種全身骨病。2.OPPRO量表的初步概念框架回顧國內(nèi)外相關(guān)專業(yè)量表念框架結(jié)構(gòu),通過分析,制成概念框架草稿模型進行問卷調(diào)查,選擇10名原發(fā)性骨質(zhì)疏松癥患者和5名專家進行采訪,制定出本研究的概念框架,其中包括疾病生理、心理、社會、治療領(lǐng)域4個領(lǐng)域,疾病表現(xiàn)、全身表現(xiàn)、心理表現(xiàn)、社會關(guān)系、日�；顒幽芰ΑM意度等6個維度的的概念框架結(jié)構(gòu)。3.條目搜集3.1檢索收集條目條目管理組回顧2個國內(nèi)相關(guān)量表,得到89個條目,回顧2個國外量表得到93個條目,回顧2個臨床研究標準得到個52個條目,共收集到183條相關(guān)條目形成原發(fā)性骨質(zhì)疏松癥PRO量表條目清單(附錄1)。3.2條目庫建立數(shù)據(jù)管理組提供原發(fā)性骨質(zhì)疏松癥PRO量表條目清單的結(jié)構(gòu)化變量,然后,由條目管理組對條目清單進行結(jié)構(gòu)化處理,包括條目內(nèi)容、條目所屬量表、包括條目所屬領(lǐng)域等,建立Excel軟件數(shù)據(jù)庫。構(gòu)建原發(fā)性骨質(zhì)疏松癥PRO量表條目庫。3.3條目初篩運用倉儲法和精選法對條目進行初篩,最終形成包含71個條目的原發(fā)性骨質(zhì)疏松癥PRO量表條目庫,其中主要癥狀特征方面24個條目,全身臨床表現(xiàn)方面18個條目,心理領(lǐng)域方面有8個條目,社會關(guān)系領(lǐng)域9有個條目,獨立性領(lǐng)域8有個條目,滿意度方面有4個條目。4.條目復(fù)篩4.1專家評閱條目首先制定調(diào)查問卷的卷首語,再按照相關(guān)程度制定條目的回答選項。專家組評估概念框架的合理性后,最終確定概念框為原發(fā)性骨質(zhì)疏松癥主要臨床癥狀、生理領(lǐng)域、心理領(lǐng)域、社會關(guān)系領(lǐng)域、獨立性領(lǐng)域、滿意度領(lǐng)域等表現(xiàn)共6個維度。條目管理組根據(jù)概念框架初步評閱條目,并提出修改意見。4.2核心組討論建立包含15名患者的2個核心組,經(jīng)討論,形成一致的條目意見,組建包含71個條目的原發(fā)性骨質(zhì)疏松癥PRO量表條目倉庫并根據(jù)條目制成專家和患者調(diào)查問卷(附錄2、3),其中主要癥狀特征方面有24個條目,全身癥狀表現(xiàn)18方面有個條目,心理方面有8個條目,社會關(guān)系維度9有個條目,獨立性方面8有個條目,滿意度方面有4個條目。4.3認知采訪對5位患者分別進行采訪,遵循采訪意見,患者均表示理解條目庫的所有內(nèi)容,確定了最終OPPRO量表的條目庫清單,無需再作進一步修改。5.標定測試研究5.1一般特征在2014.03-2015.02期間,在廣州中醫(yī)藥大學(xué)第三附屬醫(yī)院、廣州市荔灣區(qū)正骨醫(yī)院、深圳市寶安中醫(yī)院、順德中醫(yī)院門診及住院部就醫(yī)現(xiàn)場進行患者的報告的數(shù)據(jù)收集,12個月期間共發(fā)放量表580分,收回完整無缺失患者問卷380份,重測患者52份,健康者92份,回收率90.34%。5.2概念框架研究組參照各患者和專家建議,同意概念框架定義為包含“概念-領(lǐng)域-維度-條目”四級結(jié)構(gòu),通過各種經(jīng)典及現(xiàn)代理論方篩選得到含1個疾病,4個領(lǐng)域,6個維度,44個條目的PRO量表。5.3概念框架的評價和調(diào)整工具量表總的克朗巴赫系數(shù)為0.801,提示有良好的內(nèi)部一致性,無需調(diào)整。5.4經(jīng)典測試理論分析經(jīng)過因子分析檢測刪除18個條目,相關(guān)分析刪除23個條目,區(qū)分度分析刪除0個條目,克朗巴赫系數(shù)共刪除14個條目、離散趨勢分析示刪除3個條目.5.5IRT模型參數(shù)分析對各條目的條目特征曲線(ICCs)和條目信息曲線(IIC)進行難度和區(qū)分度分析以及條目特征和信息曲線的分析,共刪除25個條目。5.6綜合分析通過六種方法綜合評價,其中5種級以上的方法都沒被刪除的條目予以保留,共44條,最終得出終量表。6量表的科學(xué)性考核對量表的信度、效度、區(qū)分度、可行性進行考核。信度方面：總量表的克朗巴赫a系數(shù)為0.801,疾病主要癥狀克朗巴赫系數(shù)為0.907,全身表現(xiàn)的系數(shù)為0.780,心理維度的表現(xiàn)為0.849,社會關(guān)系維度的表現(xiàn)為0.807,日常活動能力方面的表現(xiàn)為0.799,滿意度方面的表現(xiàn)為0.877,具有較好的內(nèi)部一致性。重測信度為pearson相關(guān)系數(shù)為0.925,Kendall相關(guān)系數(shù)為0.759,提示良好的重測信度；效度分析：結(jié)構(gòu)效度結(jié)果說明量表中多維度的測量滿足專業(yè)上的預(yù)想結(jié)構(gòu)；區(qū)分度分析：患者和健康者之間的T檢驗顯示量表具有很好的區(qū)分度；可行性分析：抽樣調(diào)查原發(fā)性骨質(zhì)疏松癥患者,量表總完成率為90.34%,作答時間均小15分鐘。結(jié)論：運用經(jīng)典測試理論和現(xiàn)代項目測試反應(yīng)理論進行研制的原發(fā)性骨質(zhì)疏松癥患者報告結(jié)局條目,最終研制出包含1個疾病、4個領(lǐng)域、6個維度的44個條目的骨質(zhì)疏松癥PRO量表。測量概念為原發(fā)性骨質(zhì)疏松癥的癥狀和體征,反應(yīng)尺度分為1-5級等級區(qū)分,數(shù)據(jù)收集方式為患者自己提供信息并獨立填寫。對量表的科學(xué)性考核表明具有較好的難度、區(qū)分度、信度、效度和可行性。本研究步驟標準且嚴謹,體現(xiàn)中醫(yī)內(nèi)容,且具有中華文化特色,研究范圍來源廣泛,方法學(xué)和報道質(zhì)量較高,有良好的創(chuàng)新性和科研及臨床意義,可用于原發(fā)性骨質(zhì)疏松癥患者的臨床療效評價。
[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.
【學(xué)位授予單位】：廣州中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2015
【分類號】：R580

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