Journal
EUROPEAN UROLOGY
Volume 66, Issue 6, Pages 1148-1156Publisher
ELSEVIER
DOI: 10.1016/j.eururo.2014.02.034
Keywords
Bladder cancer; Quality of life; EORTC questionnaire; Validation
Categories
Funding
- MRC ConDuCT Hub for trials methodology research
- UCLH Biomedical Research Centre
- Cancer Research UK [CRUK/07/004, C8262/A5669, C1491/A9895]
- Kyowa Hakko UK
- Cambridge Laboratories
- Institute of Cancer Research
- Cancer Research UK [5669] Funding Source: researchfish
- Medical Research Council [MR/K025643/1, G0800800] Funding Source: researchfish
- MRC [G0800800, MR/K025643/1] Funding Source: UKRI
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Background: Well-developed and well-tested patient-reported outcome measures for non-muscle-invasive bladder cancer (NMIBC) are required. Objective: To test and adapt the scale structure and explore the psychometric properties of the European Organisation for Research and Treatment of Cancer (EORTC) questionnaire for NMIBC. Design, setting, and participants: A total of 433 patients in the Bladder COX-2 Inhibition Trial (BOXIT) completed the EORTC QLQ-C30 and NMIBC questionnaires. BOXIT is evaluating the addition of celecoxib to standard treatment in high- and intermediate-risk NMIBC. Outcome measurements and statistical analysis: Multitrait scaling investigated and adapted the questionnaire scale structure and evaluated the reliability and validity of the revised scales, as well as responsiveness to change. Results and limitations: A total of 410 patients (94.7%) (79.3% men, 74.6% high risk) returned baseline forms, and the questionnaire response rate was 88.2%. Multitrait scaling confirmed six scales and five single items. Scales and items demonstrated significant differences between patients with good and poor performance status scores (p < 0.001). Men reported better sexual function than women (p < 0.001). Scale and single-item module scores were not highly correlated with QLQ-C30 scores (evidence of discriminant validity), and the module was responsive to changes in health over time. International and test-retest data are required. Conclusions: This study demonstrates the evidence-driven adapted scale structure and psychometric data of the EORTC QLQ-NMIBC24 module to use in clinical trials of patients with high-or intermediate-risk bladder cancer. (C) 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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