机构地区:[1]中国中医科学院中医临床基础医学研究所,北京市100700 [2]广州中医药大学第一附属医院脾胃病科,广东省广州市510405 [3]陕西中医药大学第一临床医学院,陕西省咸阳市712000 [4]天津中医药大学实验针灸学研究中心,天津市301617 [5]中国中医科学院中医药信息研究所,北京市100700
出 处:《中国全科医学》2023年第18期2277-2285,共9页Chinese General Practice
基 金:国家自然科学基金面上项目(81673964)——基于多尺度非完整数据的中医个体知识图谱构建及其诊疗规律研究;中国中医科学院科技创新工程中医临床基础学科创新团队项目(CI2021B003)——基于真实世界诊疗数据的辨证论治有效方药发现与疗效评价的研究;中国中医科学院自选课题“‘一招鲜’诊疗技术规范和评价方法与策略研究”(ZZ13-026)。
摘 要:背景胃肠道症状作为临床常见评价指标需要通用的评价工具,胃肠道症状评定量表(GSRS)在国内研究中被广泛应用,但所用版本均非规范汉化版,其测量学性能少见报道。目的对中文版GSRS的测量学性能进行研究,为该量表扩大应用提供客观依据。方法2021年10月至2022年3月,选取在吉林省人民医院、北京市昌平区城区社区卫生服务中心等45家医院/社区卫生服务中心脾胃科或消化内科门诊就诊的肠易激综合征(IBS)、慢性肠炎、慢性胃炎患者,于治疗第0、3、7、14天采用中文版GSRS评价胃肠道症状。对中文版GSRS进行信、效度分析,应用配对Wilcoxon符号秩和检验比较患者治疗前后得分变化,使用效应值(ES)、标准化反应均数(SRM)和得分变化率(CR)评估量表的反应度。结果共纳入并随访了554例患者,其中IBS 127例(22.93%),慢性肠炎244例(44.04%),慢性胃炎183例(33.03%)。中文版GSRS的Cronbach'sα系数为0.896,Guttman折半系数为0.920,Spearman-Brown系数为0.926,两次重测结果组内相关系数(ICC)为0.589,Spearman秩相关系数为0.662。各条目内容效度指数为0.78~1.00,量表水平的全体一致内容效度指数为0.73,平均内容效度指数为0.96。探索性因子分析提取到特征值>1的公因子共3个,累计方差贡献率为60.721%。验证性因子分析显示数据样本与初始模型M0拟合不理想,根据指标提示修正后得到模型M1的各拟合指标均在接受范围:χ^(2)/df<3.000,近似误差均方根(RMSEA)<0.800,各项拟合指数均>0.900。患者治疗14 d后中文版GSRS总分低于治疗前(P<0.001),ES=1.03,SRM=1.01,CR=74.32%。结论中文版GSRS具有较高的测量性能水平,其信效度、反应度良好,适用于对表现胃肠道症状的普遍人群进行测量及其治疗效果评估。Background Gastrointestinal symptoms as a common clinical evaluation index require a universal evaluation tool,and the Gastrointestinal Symptom Rating Scale(GSRS)has been widely applicated in domestic studies.However,the versions used are not standardized Chinese versions and their measurement performance has not been reported yet.Objective To explore the measurement performance of the Chinese version of the GSRS,in order to provide an objective basis for expanding the application of the scale.Methods From October 2021 to March 2022,patients with irritable bowel syndrome(IBS),chronic enteritis and chronic gastritis who attended outpatient clinics of splenogastroenterology or gastroenterology in 45 hospitals(community health service centers),including Jilin Provincial People's Hospital and Beijing Changping District Urban Community Health Service Center,etc.The Chinese version of GSRS was used to evaluate the gastrointestinal symptoms of the included patients on treatment days 0,3,7 and 14.Reliability and validity analyses were conducted on the Chinese version of GSRS,and the paired Wilcoxon signed rank sum test was applied to compare the changes in the scores of patients before and after treatment.Additionally,effect size(ES),standardized response mean(SRM),and score change rate(CR)were used to assess the responsiveness of the scales.Results A total of 554 patients were included and followed up,including 127 patients(22.93%)with IBS,244(44.04%)patientswith chronic enteritis and 183(33.03%)patients with chronic gastritis.The Cronbach's alpha coefficient for the Chinese version of GSRS was 0.896,the Guttman Split-half coefficient was 0.920,the Spearman-Brown coefficient was 0.926,the intraclass correlation coefficient(ICC)for the two retest results was 0.589,and the Spearman correlation coefficient was 0.662.The content validity index for each item ranged from 0.78 to 1.00.The content validity index(CVI)for the scale-level universal agreement was 0.73,and the average CVI was 0.96.Exploratory factor analysis extract
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