目的:慢性淋巴细胞白血病(CLL)与健康相关生活质量(HRQoL)的相关性在全球范围内很少进行研究。这项研究评估了EORTC-慢性淋巴细胞白血病(CLL17[III期])模块的心理测量特性,一项新开发的CLL患者HRQoL评估,在中国CLL患者中。
方法:中国CLL17,由三个分量表组成(症状负担[SB],身体状况[PC]和担忧/恐惧[WF]),由开发团队通过EORTC提供。进行了横断面在线调查以收集数据。经典传统理论(CTT)和项目反应理论(IRT)用于评估CLL17的心理测量特性。内部一致性可靠性由Cronbach的α和项目总相关性确定。维度通过验证性因子分析(CFA)进行验证。还评估了收敛效度。IRT采用广义部分信用模型。困难,歧视,项目适合,并计算微分项功能(DIF)以评估仪器的心理测量特性。
结果:总而言之,318名患者,年龄在26至82岁之间,完成问卷。达到了良好的内部可靠性水平(Cronbach'sα=0.92)。项目总相关系数为0.46~0.72。CLL17与EQ-5D和QLQ-C30的结构域之间存在中高相关性。IRT模型显示出令人满意的均匀性,项目适合和项目的良好辨别,除第4、6和16项(<1.0)外。项目16和17提供的信息较低。SB和PC在θ>0时提供了更多信息,而WF在θ<0时提供了更多信息。项目17对于来自不同年龄段(DIF)的受访者表现不一致。
结论:EORTC-CLL17中文版具有可接受的信度和效度,使其成为评估对中国CLL患者HRQoL影响的有价值的工具。
OBJECTIVE: The association of chronic lymphocytic leukemia (CLL) with health-related quality of life (HRQoL) is rarely studied globally. This study evaluated the psychometric properties of the EORTC-Chronic Lymphocytic Leukaemia (CLL17 [phase III]) module, a newly developed assessment on CLL patients\' HRQoL, among Chinese CLL patients.
METHODS: The Chinese CLL17, comprised of three subscales (symptom burden [SB], physical condition [PC] and worries/fears [WF]), was provided by the developer team through EORTC. A cross-sectional online survey was conducted to collect data. The classical traditional theory (CTT) and the item response theory (IRT) were used to evaluate the psychometric properties of CLL17. Internal consistency reliability was determined by the Cronbach\'s alpha and item-total correlation. Dimensionality was verified through confirmatory factor analysis (CFA). Convergent validity was also assessed. The generalized partial credit model was used for the IRT. The difficulty, discrimination, item fit, and differential item functioning (DIF) were calculated to assess the instrument\'s psychometric properties.
RESULTS: In all, 318 patients, aged between 26 and 82 years, completed the questionnaire. A good level of internal reliability was achieved (Cronbach\'s alpha = 0.92). The item-total correlation coefficient ranged from 0.46 to 0.72. There was a mid-to-high correlation between CLL17 and domains of EQ-5D and QLQ-C30. The IRT model showed a satisfactory homogeneity, item fit and good discrimination of items, except for item 4, 6 and 16 (< 1.0). low information provided by item 16 and 17. SB and PC provided more information with theta > 0, whereas WF provided more information with theta < 0. Item 17 perform inconsistently for respondents from different age groups (DIF).
CONCLUSIONS: The EORTC-CLL17 Chinese version shows acceptable reliability and validity, making it a valuable instrument to evaluate the impact on the HRQoL of Chinese CLL patients.