基于患者报告的心力衰竭中医临床结局评价量表的科学性考评  

Scientific Evaluation of TCM Clinical Outcomes Rating Scale for Heart Failure Based on Patients' Report

作　　者：赵志强[1] 毛静远[1] 王贤良[1] 侯雅竹[1] 毕颖斐[1] 

机构地区：[1]天津中医药大学第一附属医院心血管科,天津300193

出　　处：《中国中西医结合杂志》2016年第3期300-305,共6页Chinese Journal of Integrated Traditional and Western Medicine

基　　金："十一五"国家科技支撑计划项目(No.2006BAI08B02-01);国家中医药行业科研专项(No.201007001-02);教育部创新团队发展计划(No.IRT1276);国家自然科学基金青年基金项目(No.81202852)

摘　　要：目的评价基于患者报告的心力衰竭（heart failure,HF）中医临床结局评价量表的信度、效度和反应度。方法采用基于患者报告的心力衰竭中医临床结局评价量表（简称TCM-HF-PRO量表）对多中心收集的340例心力衰竭患者进行调查,记录调查完成情况,并对量表进行考评,采用克朗巴赫α系数、折半信度进行信度分析。采用因子分析考核量表的建构效度;采用Pearson相关分析考察量表的标准效度;采用判别分析检验横向反应度,340例HF患者中具有完整TCM-HF-PRO量表数据者采用中央随机分为治疗组和对照组,采用配对t检验分别比较2组治疗前和治疗2周后TCM-HF-PRO量表总分,以反映量表的＂纵向＂反应度。结果 （1）量表回收率为100%,其中1份填写不完整,予以剔除,完成率为99.7%。TCM-HF-PRO量表完成时间基本在15~25 min内。（2）总量表的克朗巴赫α系数为0.903,分半信度为0.844和0.849。（3）验证性因子分析显示按照最大因子负荷组成的7个因子及其条目与本量表的设计构成基本吻合,7个因子累计贡献率达43.8%;TCM-HF-PRO量表与明尼苏达生存质量量表总分之间具有较好的相关性（r=0.726,P〈0.001）。（4）判别分析显示采用量表能够对初始明确辨证的78.8%以上病例进行正确分类;治疗后两组量表总积分均较治疗前降低,差异有统计学意义（P〈0.01）。结论基于患者报告的心力衰竭中医临床结局评价量表具有较好的信度、效度和反应度,可用于心力衰竭患者的临床疗效评价。Objective To evaluate the reliability,validity,and responsiveness of traditional Chinese medicine（ TCM） clinical outcomes rating scale for heart failure（ HF） based on patients＇ report. Methods TCM clinical outcomes rating scale for HF（ TCM-HF-PRO） were evaluated based on 340 HF patients＇ report from multiple centers. The completion of the investigation was recorded. Cronbach＇s α coefficient and split-half reliability were used for reliability analysis,and factor analysis was used to assess the construct validity of the rating scale. Pearson correlation analysis was then used for criterion validity analysis. Discriminant analysis was used to assess the responsiveness of the scale. All 340 HF patients having complete TCM-HF-PRO data were assigned to the treatment group and the control group by central randomization. The total TCMHF-PRO scores of the two groups were compared using pairedt-test to reflect the longitude responsiveness of the scale before treatment and at week 2 after treatment. Results（ 1） The recycling rate of the scale was 100. 0%. One of them was not filled completely,which was rejected thereby. So the completion rate was 99. 7%. The completion time for TCM-HF-PRO scale ranged 15 to 25 min.（ 2） The Cronbach＇s α coefficient of rating scale was 0. 903,split-half reliability was 0. 844 and0. 849.（ 3） Confirmatory factor analysis showed that 7 factors and items formed according to maximum load factor basically coincided with the construct of the rating scale,7 factors accumulated contribution rate was 43. 8%. TCM clinical outcomes rating scale for HF based on patients＇ report was relatively better correlated with the Minnesota living with HF questionnaire（r =0. 726,P 0. 01）.（ 4） Discriminant analysis showed that the rating scale correctly classified more than 78. 8% of case studies having confirmed initial differential diagnosis by experts. The total scale of the rating scale decreased more in the two groups after treatment,with significant difference as comp

关 键 词：中医 心力衰竭 患者报告 量表 信度 效度 反应度 

分 类 号：R259[医药卫生—中西医结合]