心力衰竭患者生活质量评估：通用 EQ-5D-5L™ 德语版的效度。
Quality of life assessment in patients with heart failure: validity of the German version of the generic EQ-5D-5L™.
机构信息
Department of General Practice / Primary Care, Center for Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Germany, Martinistraße 52, 20246, Hamburg, Germany.
Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Germany, Martinistraße 52, 20246, Hamburg, Germany.
出版信息
BMC Public Health. 2019 Nov 6;19(1):1464. doi: 10.1186/s12889-019-7623-2.
BACKGROUND
Chronic heart failure patients typically suffer from tremendous strain and are managed mainly in primary care. New care concepts adapted to the severity of heart failure are a challenge and need to consider health-related quality of life aspects. This is the first psychometric validation of the German EQ-5D-5L™ as a generic instrument for assessing health-related quality of life (HRQOL) in a primary care heart failure patient sample.
METHODS
Confirmatory factor analysis (CFA) was performed on the baseline EQ-5D-5L™ data from the RECODE-HF study (responses to all items from n = 3225 of 3778 patients). Basic CFA models for HRQOL were calculated based on the EQ-5D-5L™ items using the maximum likelihood (ML) and the asymptotic distribution-free method. In an extended CFA, physical activity and depression were added. The basic CFA ML model was verified for the reduced number of cases of the extended CFA model (n = 3064). In analyses of variance the association of the EQ-5D-5L™ visual analogue scale (VAS) and both the German and the British EQ-5D-5L™ crosswalk index with the SF-36 measure of general health were examined. The discriminant validity was analysed using Pearson's chi-squared tests applying the New York Heart Association classification, for the VAS and indices analyses of variance were calculated.
RESULTS
In the basic CFA models the root mean square error of approximation was 0.095 with the ML method, and 0.081 with the asymptotic distribution-free method (Comparative Fit Index > 0.90 for both). Physical activity and depression were confirmed as influential factors in the extended model. The VAS and indices were strongly associated with the SF-36 measure of general health (partial eta-squared 0.525/0.454/0.481; all p < 0.001; n = 3155/3210/3210, respectively), also for physical activity and depression when included together (partial eta-squared 0.050, 0.200/0.047, 0.213/0.051 and 0.270; all p < 0.001; n = 3015/n = 3064/n = 3064, respectively). The discriminant validity analyses showed p-values < 0.001 and small to moderate effect sizes for all EQ-5D-5L™ items. Analyses of variance demonstrated moderate effect sizes for the VAS and indices (0.067/0.087/0.084; all p < 0.001; n = 3110/3171/3171).
CONCLUSION
The German EQ-5D-5L™ is a suitable method for assessing HRQOL in heart failure patients.
背景
慢性心力衰竭患者通常承受着巨大的压力，主要在初级保健中得到管理。适应心力衰竭严重程度的新护理理念是一个挑战，需要考虑与健康相关的生活质量方面。这是首次对德国 EQ-5D-5L™ 进行心理测量验证，将其作为评估初级保健心力衰竭患者样本中与健康相关的生活质量 (HRQOL) 的通用工具。
方法
对 RECODE-HF 研究的基线 EQ-5D-5L™ 数据（来自 3778 名患者中的 3225 名患者的所有项目的回答）进行验证性因子分析 (CFA)。基于 EQ-5D-5L™ 项目，使用最大似然法 (ML) 和渐近无分布法计算了 HRQOL 的基本 CFA 模型。在扩展的 CFA 中，加入了体力活动和抑郁。在分析方差时，EQ-5D-5L™ 视觉模拟量表 (VAS) 以及德国和英国 EQ-5D-5L™ 交叉步行指数与 SF-36 一般健康测量的相关性进行了检验。使用 Pearson's chi-squared 检验分析判别效度，适用于纽约心脏协会分类，对 VAS 和指数进行方差分析。
结果
在基本 CFA 模型中，ML 方法的均方根误差为 0.095，渐近无分布法为 0.081（两种方法的可比性拟合指数均大于 0.90）。体力活动和抑郁被确认为扩展模型中的重要影响因素。VAS 和指数与 SF-36 一般健康测量高度相关（偏 eta 平方 0.525/0.454/0.481；所有 p 值均小于 0.001；n=3155/3210/3210，分别），当包括体力活动和抑郁时，相关性也很强（偏 eta 平方 0.050、0.200/0.047、0.213/0.051 和 0.270；所有 p 值均小于 0.001；n=3015/n=3064/n=3064，分别）。判别效度分析显示，所有 EQ-5D-5L™ 项目的 p 值均小于 0.001，效应量较小至中等。方差分析显示，VAS 和指数的效应量中等（0.067/0.087/0.084；所有 p 值均小于 0.001；n=3110/3171/3171）。
结论
德国 EQ-5D-5L™ 是评估心力衰竭患者 HRQOL 的合适方法。
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