EORTC QLQ-C30量表汇总评分在中国结直肠癌患者中的验证

Validation of the summary score of the EORTC QLQ-C30 scale in Chinese patients with colorectal cancer

目的在中国结直肠癌患者中验证基于13个维度[除去总体健康状况(QL)和经济困难(FI)]单因子高阶模型构建的欧洲癌症研究与治疗组织生命质量量表(EORTC QLQ-C30)中文版(V3.0)汇总评分。方法收集2016-06-01-2017-08-31新疆医科大学第三附属医院住院治疗的296例结直肠癌患者临床资料,采用EORTC QLQ-C30中文版量表对患者健康相关生活质量进行问卷调查。验证性因子分析(CFA)验证构建EORTC QLQ-C30量表汇总评分的单因子高阶模型,并比较该汇总评分和EORTC QLQ-C30量表每个维度在分辨不同性别、肿瘤TNM分期和卡氏功能状态(KPS)评分生活质量差异的有效性和对时间变化的敏感性。结果构建汇总评分的单因子高阶模型拟合优度较好,近似均方根误差(RMSEA)为0.080,比较拟合指数(CFI)为0.844,Tucker-Lewis指数(TLI)为0.828。在分辨不同性别、肿瘤TNM分期和KPS评分的生活质量得分差异及对时间变化的敏感性上,EORTC QLQ-C30汇总评分在≥11个维度上优于单个维度测量,且优于QL维度。结论基于13个维度单因子高阶评分模型的EORTC QLQ-C30汇总评分在中国结直肠癌患者生活质量的研究中有一定的适用性。EORTC QLQ-C30汇总评分有助于减少使用单独的EORTC QLQ-C30问卷量表进行多重测试时产生的潜在问题,并可做为未来结直肠癌患者临床试验的结局变量。

Objective To validate summary score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items(EORTC QLQ-C30)based on a single higher-order factor model constructed on 13 dimensions,excluding global quality of life(QL)and financial difficulties(FI),in Chinese patients with colorectal cancer.Methods The clinical data of 296 colorectal cancer patients hospitalized at the Third Affiliated Hospital of Xinjiang Medical University from June 1,2016 to August 31,2017 were collected,and the Chinese EORTC QLQ-C30 scale(3 rd version)was used to investigate the health-related quality of life of the patients.Confirmatory factor analysis(CFA)was used to validate the single high-order factor model for constructing the summary scores of the EORTC QLQ-C30 scale,and to compare the validity and sensitivity to temporal changes of this summary score and each dimension of the EORTC QLQ-C30 scale in discriminating differences in quality of life by gender,tumor TNM stage and KPS score.Results The single high-order factor model was well fit for constructing the summary scores,with a root mean square error of approximation(RMSEA)of 0.080,a comparative fit index(CFI)of 0.844,and a Tucker-Lewis index(TLI)of 0.828.In discriminating differences in quality of life scores by gender,tumor TNM stage,and KPS score and sensitivity to temporal changes,the EORTC QLQ-C30 summary scores were superior to individual dimensional measures on at least 11 dimensions and superior to the QL dimension.Conclusions The EORTC QLQ-C30 summary score based on a 13-dimensional single high-order factor model has some applicability in studies of quality of life in Chinese patients with colorectal cancer.The EORTC QLQ-C30 summary score can help reduce potential problems that arise when multiple testing is performed using the separate EORTC QLQ-C30 questionnaire scale and may facilitate the design of clinical trials for patients with colorectal cancer in the future.