护理学报2025，Vol.32Issue(23)：54-60,7.DOI:10.16460/j.issn2097-6569.2025.23.054
肺癌气阴两虚证患者报告结局疗效评估工具的研制及信效度检验
Development and validation of a Patient-reported Outcome Assessment Tool for Evaluating Therapeutic Efficacy in lung cancer patients with qi-yin deficiency syndrome
摘要
Abstract
Objective To develop and validate a patient-reported outcome assessment tool for evaluating therapeutic efficacy in lung cancer patients with qi-yin deficiency syndrome,and to provide objective method for assessing traditional Chinese medicine(TCM)in-terventions in this population.Methods The item pool was constructed based on qualitative research,systematic reviews,and medi-cal record analysis.After expert consultation and pre-survey for item screening and optimization,the initial draft was established.From June to December 2024,a total of 610 lung cancer patients with qi-yin deficiency syndrome were recruited from 2 tertiary grade-A TCM hospitals in Guangzhou as subjects for the survey.Item analysis and psychometric evaluation of the tool were performed using a combination of Classical Test Theory and Item Response Theory.Results The final version of the tool consisted of 3 dimensions(lung qi deficiency,lung yin deficiency,and disease-specific)with 22 items.The total Cronbach's α coefficient of the scale was 0.933,and the split-half reliability 0.852.Exploratory factor analysis extracted 3 common factors,with a cumulative variance contribution rate of 65.232%.The fitting indices of the confirmatory factor model indicated that the three-factor structure was reasonable.Content validi-ty index of each item ranged from 0.846 to 1.000,with an average of 0.925.Each item showed good discrimination and difficulty param-eters,and the item information met the criteria.Conclusion The patient-reported outcome assessment tool for lung cancer patients with qi-yin deficiency syndrome has good reliability,validity and item information,and can be used to reflect dynamic changes of syn-dromes and efficacy of TCM interventions.关键词
肺癌/气阴两虚证/患者报告结局/疗效评估/项目反应理论Key words
lung cancer/qi-yin deficiency syndrome/patient-reported outcome/efficacy evaluation/Item Response Theory分类
医药卫生引用本文复制引用
魏佳豪,谢静,白子叶,刘恩情,熊月,江鸿浪,周瑾..肺癌气阴两虚证患者报告结局疗效评估工具的研制及信效度检验[J].护理学报,2025,32(23):54-60,7.基金项目
广东省教育厅特色创新项目(2024KTSCX072) （2024KTSCX072）
