摘要
[目的]建立中西医结合的胃食管反流病(GERD)PRO量表,以供临床疗效评价。[方法]以脾胃系疾病PRO量表条目为基础,在生理领域增加GERD相关的条目,严格按照国际通用的PRO量表制定的程序方法和步骤,确立量表结构、建立条目池、优化条目、编制量表、测试文化适应性,形成初量表,并进行临床预调查和条目筛选。[结果]对158例GERD患者和158例健康人进行了临床预调查,通过探索性因子分析法、逐步回归分析法、离散趋势法、克朗巴赫系数法、频数分布法、专家重要性评分法等多种统计方法对结果进行分析,最后删除了"面色、胸闷、口腔疼痛、声嘶、呼吸不畅、腹中重坠、腹部痉挛、大便夹黏液"等8个条目,确定了包括生理领域、独立性领域、心理性领域、环境领域在内的4个领域、8个方面、54个条目的终量表。[结论]本量表严格按照国际通用程序步骤和方法制定,适用于GERD临床疗效评价。
[Objective]To develop agastroesophageal reflux disease PRO(GERD-PRO)scale with good reliability,validity and responsiveness for the evaluation of TCM clinical efficacy.[Methods]Early GERDPRO scale was developed based on the PRO scale of spleen and stomach diseases with added items related to gastroesophageal reflux disease.According to procedures used in the guideline of international general scale development,we completed the initial scale by establishing the scale structure and the pool of items,optimizing the items,compiling scales,testing cultural adaptability.The initial scale was applied for clinical investigation and item screening.[Results]158patients with gastroesophageal reflux disease and 158 healthy persons were investigated with the initial scale.Through exploratory factor analysis,stepwise regression analysis,discrete trend method,Cronbach’s alpha,frequency distribution method,expert importance were applied to analyze the results of the survey.Finally,8items including'face color,chest tightness,oral pain,hoarseness,poor breathing,heavy abdominal abdomen,abdominal cramps,and stool clip mucus'were deleted,and finally determined 42 items in the physiological domain,2items in the independence,4items in the psychological,and 6items in the environmental.The final scale consists of 4domains and 8facets with 54 items.[Conclusion]The gastroesophageal reflux disease PRO scale,which developed according to the strict procedures,is a reliable and valid disease-specific instrument.It is suitable for the evaluation of clinical efficacy of traditional Chinese medicine,Western medicine and integrated traditional Chinese and Western medicine for patients with gastroesophageal reflux disease.
作者
刘凤斌
余纯梓
陈卓群
陈新林
杨云英
LIU Feng-bin;YU Chun-zi;CHEN Zhuo-qun;CHEN Xin-lin;YANG Yun-ying(Department of Gastroenterology,The First Affiliated Hospital of Guangzhou University of TraditionalChinese Medicine,Guangzhou 510405,China;Guangdong Jianxin Pharmaceutical Co.,Ltd.,Shantou515041,China;Academic Affairs Office,Guangzhou University of Traditional Chinese Medicine,Guangzhou 510405,China;Department of Basic Medical Science College,Guangzhou University of TraditionalChinese Medicine Medical College,Guangzhou 510405,China)
出处
《中国中西医结合消化杂志》
CAS
2019年第2期92-96,共5页
Chinese Journal of Integrated Traditional and Western Medicine on Digestion
基金
国家自然科学基金面上项目(No:30873215
81774264)
关键词
胃食管反流病
PRO量表
条目筛选
clinical evaluation
gastroesophageal reflux disease(GERD)
module
development
