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基于慢性胃肠疾病患者报告临床结局测量量表条目筛选
引用本文:王萍,唐旭东,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条目筛选[J].中西医结合学报,2012,10(10):1092-1098.
作者姓名:王萍  唐旭东  刘保延  訾明杰
作者单位:1. 中国中医科学院西苑医院消化科,北京,100091
2. 中国中医科学院评价中心,北京,100700
3. 中国中医科学院西苑医院GCP中心,北京,100091
基金项目:国家科技基础条件平台工作项目
摘    要:目的:研制基于慢性胃肠疾病患者报告临床结局测量量表,筛选和优化条目。方法:通过查阅文献、参考现有量表、访谈患者、核心小组讨论等方法收集测量指标,经过条目优化、问卷形成、预调查等研制基于慢性胃肠疾病患者报告临床结局测量量表,现场调查慢性胃肠疾病患者274例,通过对调查结果进行离散趋势分析、因子分析、逐步回归分析、t检验和克朗巴赫系数法分析等筛选条目。结果:量表的35条条目中删除2条条目,6条需调整后进一步考查,同时还综合临床调查反馈信息对部分条目进行修改。结论:条目的科学筛选为量表调整提供了依据,今后将在更大样本调查基础上进行测试,使之不断完善。

关 键 词:胃肠疾病  结果评价(卫生保健)  条目筛选  临床试验

Development of a patient-reported outcome instrument for chronic gastrointestinal diseases: item selection
Ping Wang , Xu-dong Tang , Bao-yan Liu , Ming-jie Zi.Development of a patient-reported outcome instrument for chronic gastrointestinal diseases: item selection[J].Journal of Chinese Integrative Medicine,2012,10(10):1092-1098.
Authors:Ping Wang  Xu-dong Tang  Bao-yan Liu  Ming-jie Zi
Institution:1. Department of Gastroenterology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 10091, China 2. Clinical Evaluation Center, China Academy of Chinese Medical Sciences, Beijing 10091, China 3. GCP Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 10091, China
Abstract:To develop a patient-reported outcome instrument for chronic gastrointestinal diseases and to select items by analyzing the data from clinical investigation. METHODS: The instrument was developed by establishing the item pool through reviewing the literature on subject of chronic gastrointestinal diseases, interviewing typical cases, focus group discussion and referring to related instruments, and then the processes of selecting and optimizing items, forming primary instrument and testing in a small sample pilot survey. A clinical investigation was conducted in 4: hospitals in Beijing. The data of 274 effective respondents with chronic gastrointestinal diseases were obtained and analyzed for selecting items using SPSS 16.0 software by applying methods such as Cronbach' s a coefficient, correlation coefficient, t test, dispersion logistic regression and factor analysis. RESULTS= In the patient-reported outcome instrument, 35 items were selected from investigation. Among the 35 items, 2 items were deleted, and 6 items were modified for further investigation. CONCLUSION: The results of item selection provide a good reference for the primary instrument, which still needs further modification, and lots of work needed to be done, at the base of large sample size.
Keywords:gastrointestinal diseases  outcome assessment (health care)  item selection  clinical trials
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