世界中医药
文章摘要
引用本文:李硕1,3,4,郭姣1,2.糖脂代谢病患者报告结局量表的初步研制[J].世界中医药,2019,(01):.  
糖脂代谢病患者报告结局量表的初步研制
Preliminary Development of Patient Reported Outcomes Instrument for Glucolipid Metabolic Disorders
投稿时间:2018-12-10  
DOI:10.3969/j.issn.1673-7202.2019.01.003
中文关键词:  糖脂代谢病  患者报告结局  量表  研制
English Keywords:Glycolipid metabolic disease  Patient reported outcomes  Instrument  Development
基金项目:国家自然科学基金重点项目(81530102,81830113);广东省科技计划项目(2017B050504005);广州市科技计划项目(201803010069);广东省科技厅实验室建设项目(2017B030314064)
作者单位
李硕1,3,4,郭姣1,2 1 广东省代谢病中西医结合研究中心广州510006 2 广东省代谢性疾病中医药防治重点实验室广州510006 3 广州中医药大学临床药理研究所广州510006 4 珠海市人民医院中医科珠海519000 
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中文摘要:
      目的:研制糖脂代谢病患者报告结局量表,使软指标量化和便于统计,为更加综合、客观地评价糖脂代谢病的临床疗效提供一种测评工具。方法:遵循国际量表研制程序规范,结合现代医学模式和中医理论,以及糖脂代谢病临床诊疗经验,构建糖脂代谢病患者报告结局量表的概念框架;主要通过对糖脂代谢病患者的访谈提出条目,结合查阅文献、小组讨论的方式,对条目进行初筛,然后进行小范围试用及预调查,对条目进行修改和筛选,形成调查量表初稿;用量表初稿进行临床调查,回收466例有效资料,采用条目分布法、离散趋势法、Cronbach's α系数法、因子分析法、相关系数法、t检验法和项目反应理论等7种统计学分析方法对条目进行筛选,形成糖脂代谢病患者报告结局量表。结果:研制出包含生理、心理、社会和治疗4个领域,共54个条目的糖脂代谢病患者报告结局量表,其中生理领域36个条目,心理领域6个条目,社会领域3个条目和治疗领域9个条目。结论:糖脂代谢病患者报告结局量表初步研制过程严谨可靠,可用于临床做进一步性能测评。
English Summary:
      To develop patient reported outcomes (PRO) of glucolipid metabolic disease (GLMD) by soft index quantitative and easily to be valued. To provide a more comprehensively and objectively measurement tool for the clinical curative effect of GLMD. Methods:According to the international PRO scale development norms,the conceptual framework of the GLMD-PRO was constructed,combining the modern medical model and traditional Chinese medicine theory,as well as the clinical diagnosis and treatment experience of GLMD. Items were put forward by interviews over patients with GLMD,and were discussed by consulting literature and group discussion. Preliminary screening,small-scale trial and pre-survey were carried out to modify and screen the items,and then form the preliminary draft of the questionnaire. It was used for clinical investigation and valid data of 466 cases selected from January 2014 to January 2016 were collected. A total of 7 statistical analysis methods,such as item distribution method,discrete trend method,Cronbach's alpha coefficient method,factor analysis method,correlation coefficient method,test method and item response theory were used to screen items,and finally form the glucolipid metabolic disease-patient reported outcomes (GLMD-PRO) instrument. Results:The GLMD-PRO instrument was developed,which included physiological,psychological,social and therapeutic fields. There were 54 items,including 36 items in physiological field,6 items in psychological field,3 items in social field and 9 items in therapeutic field. Conclusion:The preliminary development process of the GLMD-PRO is rigorous and reliable,which can be used for further performance evaluation in clinical practice.
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