Validation of the Chinese EORTC chronic lymphocytic leukaemia module – application of classical test theory and item response theory

Abstract

Purpose: 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). Conclusion: 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.

How can organizations measure the integration of environmental, social, and governance (ESG) criteria? Validation of an instrument using item response theory to capture workers' perception

“…These requirements guarantee the psychometric quality of the instrument being evaluated. FA confirms construct validity (Bin Kim et al, 2023), while IRT ensures the quality of item discrimination (Dong et al, 2020). Consequently, IRT has proven to be a suitable method for validating and re‐evaluating research instruments.…”

Health‐related quality of life for patients with chronic lymphocytic leukaemia – A critical outcome measure in the era of highly effective therapies

“…The study is not without its limitations. The patients within the generation and validation cohorts are from European countries in the vast majority, casting uncertainty over the value of this tool in other demographics; however, it has been validated in a cohort of Chinese patients in a separate publication 19 . Moreover, it is unclear how this tool performs among patients receiving targeted agents and to assess the impact of time‐limited versus indefinite therapy.…”

“…The patients within the generation and validation cohorts are from European countries in the vast majority, casting uncertainty over the value of this tool in other demographics; however, it has been validated in a cohort of Chinese patients in a separate publication. 19 Moreover, it is unclear how this tool performs among patients receiving targeted agents and to assess the impact of time-limited versus indefinite therapy. Common toxicities of targeted-agent regimens are not specifically addressed; these include rash, hypertension, headache, the need for day centre and hospital admissions, infusion reactions, pill burden, neutropenic monitoring, growth factor use and infections.…”