摘要
目的研制符合中国国情、体现中医特色且具有较高信度与效度的早发性卵巢功能不全(Premature ovarian insufficiency,POI)生存质量量表并进行初步考评。方法参照生存质量量表研制方法,在中医理论指导下,构建量表理论框架。采用文献分析法、病例回顾法、患者访谈法、德尔菲专家咨询法及临床调查法建立、完善、筛选量表条目,形成终选量表,并考评其信度、效度、区分度及可行性。结果经德尔菲法及临床调查筛选条目后,共形成包含生理、心理、社会3个领域,月经、生育力、躯体症状等11个方面,30个条目及2个总体评价的中国早发性卵巢功能不全生存质量量表。本量表的克朗巴赫系数为0.910,折半系数为0.956,重测相关系数为0.868,内部一致性信度、折半信度及重测信度良好;量表提取了9个特征根>1的因子,累计方差贡献率为71.063%,比较拟合指数为0.959,拟合优度指数为0.919,经检验相关程度提示内容效度、结构效度及校标关联效度良好;POI患者与健康人群的量表总分差异具有统计学意义,量表具有较好的区分度。结论本研究研制的中国早发性卵巢功能不全生存质量量表具有较好的信度、效度、区分度和可行性,可以作为评价我国POI患者生存质量的工具,丰富了中医药治疗POI的疗效评价体系,适合临床推广应用。
Objective To develop a quality of life(QoL)scale for Premature Ovarian Insufficiency(POI)with high reliability and validity in accordance with China′s national conditions.Methods The theoretical framework of the scale was constructed under the guidance of traditional Chinese medicine theory with reference to the development method of the QoL scale.Literature analysis method,medical record review method,patient interview method,Delphi expert consultation method and clinical investigation were used to establish,improve and screen the scale items to form the final scale,and the characteristics and differentiation in terms of reliability and validity and feasibility of the final scale were evaluated.Results After screening the entries by the Delphi method and clinical surveys,the Chinese Premature Ovarian Insufficiency Quality of Life Scale was formed,which included three domains of physiology,psychology,and society,and eleven aspects such as menstruation,fertility,and physical symptoms,with 30 entries and two overall evaluations.The Cronbach’s coefficient of this scale was 0.910,the fold-half coefficient was 0.956,and the re-test correlation coefficient was 0.868,which showed good internal consistency,fold-half and re-test reliabilities;the scale extracted 9 factors with characteristic root>1,and the cumulative variance contribution rate was 71.063%,the comparative fit index was 0.959,and the goodness-of-fit index was 0.919,and the degree of correlation was tested has showed that the content validity,structural validity and calibration correlation validity were good;the difference in the total scores of the scale between patients with POI and the healthy population was statistically significant,and the scale had a good degree of differentiation.Conclusion As confirmed by this study,the Chinese Premature Ovarian Insufficiency Quality of Life Scale has good reliability,validity,differentiation and feasibility,and can be used as a tool for evaluating the quality of life of POI patients in China as well as enriching the efficacy evaluation system of TCM in treating POI,and it is suitable for clinical popularization and application.
作者
郑允玲
邹宇馨
李堉成
陈卓婷
黄柳倩
潘欣仪
朱玲
ZHENG Yunling;ZOU Yuxin;LI Yucheng;CHEN Zhuoting;HUANG Liuqian;PAN Xinyi;ZHU Ling(The First Clinical Medical College,Guangzhou University of Chinese Medicine,Guangzhou 510405,China;The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510400,China;Guangdong Clinical Research Institute of Traditional Chinese Medicine,Guangzhou 510400,China)
出处
《世界科学技术-中医药现代化》
北大核心
2025年第5期1287-1296,共10页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
国家自然科学基金委员会面上项目(82174418):补肾填精法调控Notch1/Nrf2信号通路改善卵巢生殖干细胞组蛋白乙酰化修饰治疗早发性卵巢功能不全的研究,负责人:朱玲
广州市科技计划重点研发计划(2024B03J1259):补肾填精法调控Notch1/NF-κB信号通路改善卵巢衰老生殖干细胞免疫微环境失衡的作用及机制研究,负责人:朱玲
国家中医药管理局(国中医药人教函[2022]5号):罗颂平全国名中医工作室,负责人:朱玲。
关键词
早发性卵巢功能不全
生存质量量表
研制
考评
Premature ovarian insufficiency
Quality of life scale
Development
Evaluation
