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.

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.