Eur Urol. 2014 Dec;66(6):1148-56. doi: 10.1016/j.eururo.2014.02.034. Epub 2014 Feb 25.

Validation and reliability testing of the EORTC QLQ-NMIBC24 questionnaire module to assess patient-reported outcomes in non-muscle-invasive bladder cancer.

Blazeby JM¹, Hall E², Aaronson NK³, Lloyd L², Waters R², Kelly JD⁴, Fayers P⁵.

Author information

1: Centre for Surgical Research, School of Social and Community Medicine, Bristol, UK; Division of Surgery, Head and Neck, University Hospitals NHS Foundation Trust, Bristol, UK. Electronic address: j.m.blazeby@bris.ac.uk.
2: Institute of Cancer Research Clinical Trials and Statistics Unit, London, UK.
3: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
4: Division of Surgery and Interventional Science, University College London, London, UK.
5: Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.

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.