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欧洲癌症研究与治疗组织(EORTC)QLQ-CML24问卷西班牙语版本用于评估慢性髓性白血病患者健康相关生活质量的验证

Validation of the Spanish version of the EORTC QLQ-CML24 questionnaire for assessment of health-related quality of life in patients with chronic myeloid leukemia.

作者信息

Lopez-Fernández Elisa, de Linares-Fernández Soledad, Perez-Marfil Maria Nieves, Rodríguez-Fernández Alicia, Anguita-Arance Magdalena, Del Carmen Fernández-Valle Maria, Ramírez-Sánchez Maria Jose, Ruiz-Nuño Maria Concepción, González-Molina Werner, Ferrer-Chaves Carmen, Avellaneda-Molina Carmen, Puerta-Puerta Jose Manuel

机构信息

Hospital Universitario Virgen de las Nieves, Granada, Spain.

Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.

出版信息

Ann Hematol. 2025 Jul 22. doi: 10.1007/s00277-025-06516-6.

DOI:10.1007/s00277-025-06516-6
PMID:40694077
Abstract

OBJECTIVE

The EORTC QLQ-CML24 questionnaire was developed and validated to enhance research in the health-related quality of life (HRQoL) of patients with chronic myeloid leukemia (CML) as a way to more thoroughly capture the burden of disease and therapy and facilitate treatment decisions in this population. We aimed to examine the structure and psychometric properties of the Spanish version.

METHODS

Data were collected from 186 CML patients in 9 centers of Andalusia (Spain). The validation process integrated the analysis of feasibility, internal consistency, construct validity and convergent validity. The core EORTC QLQ-C30, Short Form-36 (SF-36), Hospital Anxiety and Depression Scale (HADS) and the Connor-Davison Resilience Scale (CD-RISC-10) were used to assess convergent validity.

RESULTS

Feasibility of the Spanish version was excellent, with all patients self-completing the questionnaire and with no missing answers. Internal consistency, assessed by Cronbach's alpha coefficients, was 0.88. The CFA goodness-of-fit indicators confirmed that the model is acceptable (Comparative Fit Index (CFI)=0.87; Tucker-Lewis Index (TLI)=0.85 and Root Mean Square Error of Approximation (RMSEA)=0.07). Strong and moderate correlations (Spearman rho values ranging from 0.4 to >0.6) were found with the scales of QLQ-C30 addressing functioning, symptoms and fatigue and with all domains of the SF-36.

CONCLUSIONS

Our findings support the use of the Spanish version of the EORTC QLQ-CML24 as a valuable complementary measure to the EORTC QLQ-C30, for providing a comprehensive assessment of HRQoL in patients with CML.

摘要

目的

欧洲癌症研究与治疗组织(EORTC)的QLQ-CML24问卷已开发并验证,以加强对慢性髓性白血病(CML)患者健康相关生活质量(HRQoL)的研究,作为更全面了解疾病和治疗负担并促进该人群治疗决策的一种方式。我们旨在检验西班牙语版本的结构和心理测量特性。

方法

从西班牙安达卢西亚9个中心的186例CML患者中收集数据。验证过程综合了可行性分析、内部一致性分析、结构效度分析和收敛效度分析。使用EORTC QLQ-C30核心问卷、简短健康调查问卷(SF-36)、医院焦虑抑郁量表(HADS)和康纳-戴维森韧性量表(CD-RISC-10)来评估收敛效度。

结果

西班牙语版本的可行性极佳,所有患者均自行完成问卷且无缺失答案。通过克朗巴哈α系数评估的内部一致性为0.88。验证性因素分析的拟合优度指标证实该模型是可接受的(比较拟合指数(CFI)=0.87;塔克-刘易斯指数(TLI)=0.85;近似误差均方根(RMSEA)=0.07)。发现与QLQ-C30中涉及功能、症状和疲劳的量表以及SF-36的所有领域存在强相关性和中度相关性(斯皮尔曼等级相关系数值范围为0.4至>0.6)。

结论

我们的研究结果支持将EORTC QLQ-CML24的西班牙语版本作为EORTC QLQ-C30的一种有价值的补充测量方法,用于全面评估CML患者的HRQoL。

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