基于中国文化改良明尼苏达心力衰竭生存质量量表的临床应用评价

Evaluation of the Clinical Application of the Modified Minnesota Living with Heart Failure Questionnaire Based on Chinese Culture

目的评价基于中国文化改良明尼苏达心力衰竭生存质量量表(C-MLHF)的可行性、信度、效度及反应度。方法依托芪参益气滴丸干预冠心病心力衰竭的推广应用研究——多中心前瞻性队列研究,在全国19省市84所二级、三级医院纳入1288例符合纳入标准的冠心病心力衰竭病人,按照治疗方式的不同(病人意愿)分为对照组及治疗组,其中对照组584例,治疗组644例。对照组接受西药常规治疗,治疗组给予西药常规治疗联合芪参益气滴丸治疗。两组疗程均为3个月,访视时点为入组时、入组后第1个月、入组后第3个月,各访视时点均同时采用C-MLHF和明尼苏达心力衰竭生存质量量表(MLHF)条目混编表评估每例心力衰竭病人的生存质量。采用分半信度、克朗巴赫α系数、相关分析关分析及因子分析、重复测量方差分析等方法再考评C-MLHF的信度、效度和反应度。结果可行性:C-MLHF回收率为100.0%(1228/1228),有效率为99.3%(1219/1228)。信度:C-MLHF中总量表、形领域、神领域及其他领域分半信度系数分别为0.974,0.960,0.911,0.886,克朗巴赫α系数分别为0.963,0.944,0.920,0.830。标准效度:C-MLHF与MLHF呈正相关(r=0.977,P<0.01)。结构效度:①相关分析,形领域和神领域条目得分与各自领域得分的相关系数分别为0.535~0.806和0.832~0.885;各条目与其所属的领域的相关较强,而与其他领域的相关较弱。②因子分析,总量表、形领域、神领域及其他领域的比较拟合指数分别为0.96,0.95,0.97,0.86。反应度:两组入组后第1个月、入组后第3个月C-MLHF总分及各领域评分均较入组时提高(P<0.01);入组时治疗组C-MLHF总分及各领域评分低于对照组(P<0.01);入组后第1个月,两组C-MLHF总分及各领域评分比较,差异均无统计学意义(P>0.05);入组后第3个月,治疗组C-MLHF总分及各领域评分均高于对照组(P<0.01)。结论C-MLHF具有良好的信度、效度、反应度及可行性,可用于我国心力衰竭病人生存质量评价。

Objective To evaluate the feasibility,reliability,validity,and responsiveness of the Minnesota Living with Heart Failure Questionnaire based on Chinese culture(C-MLHF).Methods Based on a multi-center prospective cohort study on the popularization and application of the Qishenyiqi Dripping Pill in treating heart failure caused by coronary heart disease,1288 patients with heart failure caused by coronary heart disease who met the inclusion criteria were enrolled from 84 secondary and tertiary hospitals of 19 provinces and cities in China.The patients were divided into control group and treatment group according to different treatment methods,including 584 cases in control group and 644 cases in treatment group.The patients in control group received conventional treatment of western medicine,and the patients in treatment group received conventional treatment of western medicine combined with Qishenyiqi Dropping Pills.The treatment course of both groups was 3 months,and the visits were at enrollment,1 month,and 3 months after enrollment.The quality of life of each patient with heart failure was assessed by the mixed C-MLHF and Minnesota Living with Heart Failure Questionnaire(MLHF)items at each interview point.The reliability,validity,and responsiveness of C-MLHF were evaluated by split-half reliability,Cronbachs′alpha coefficient,correlation analysis,factor analysis,repeated measurement analysis of variance,and so on.Results Feasibility:the recovery rate of C-MLHF was 100.0%(1228/1228),and the effective rate was 99.3%(1219/1228).Reliability:the split-half reliability coefficients of the total table,body,spirit,and other fields in C-MLHF were 0.974,0.960,0.911,and 0.886,respectively,and the Cronbachs′alpha coefficients were 0.963,0.944,0.920,and 0.830,respectively.Criteria validity:C-MLHF was significantly correlated with MLHF(r=0.977,P<0.01).Contract validity:①The correlation coefficients between the scores of body-domain items and spirit-domain items and the score of their own domain were 0.535~0.806 and 0.832~0.885,respectively,each item showed strong correlation with its domain,but weak correlation with other domains.②The comparative fitting indexes of total table,body,spirit,and other fields were 0.96,0.95,0.97,and 0.86,respectively.Responsiveness:the total C-MLHF score and scores in all fields in both groups at 1 and 3 months after treatment were significantly higher than those at baseline(P<0.01).The total C-MLHF score and scores in all fields at baseline in treatment group were lower than those in control group(P<0.01),there were no significant differences between the two groups at 1 month after treatment(P>0.05),but the total C-MLHF score and scores in all fields in treatment group were higher than those in control group at 3 months after treatment(P<0.01).Conclusion C-MLHF is reliability,validity,responsiveness,and feasibility,and can be used to evaluate the quality of life of patients with heart failure in China.