Validation and reliability testing of the EORTC QLQ-NMIBC24 questionnaire module to assess patient-reported outcomes in non-muscle-invasive bladder cancer.
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Embargo End Date
ICR Authors
Authors
Blazeby, JM
Hall, E
Aaronson, NK
Lloyd, L
Waters, R
Kelly, JD
Fayers, P
Hall, E
Aaronson, NK
Lloyd, L
Waters, R
Kelly, JD
Fayers, P
Document Type
Journal Article
Date
2014-12-01
Date Accepted
2014-02-13
Abstract
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.
Citation
European urology, 2014, 66 (6), pp. 1148 - 1156
Source Title
Publisher
ELSEVIER
ISSN
0302-2838
eISSN
1873-7560
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Research Team
ICR-CTSU Urology and Head and Neck Trials Team