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Validation and Reliability Testing of the EORTC QLQ-NMIBC24 Questionnaire Module to Assess Patient-reported Outcomes in Non–Muscle-invasive Bladder Cancer

European Urology, Volume 66, Issue 6, December 2014, Pages 1148 - 1156

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.

Take Home Message

The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-NMIBC24 questionnaire is a reliable and valid measure to use with the EORTC QLQ-C30 in clinical trials in non–muscle-invasive bladder cancer.

Keywords: Bladder cancer, Quality of life, EORTC questionnaire, Validation.

Footnotes

a Centre for Surgical Research, School of Social and Community Medicine, Bristol, UK

b Division of Surgery, Head and Neck, University Hospitals NHS Foundation Trust, Bristol, UK

c Institute of Cancer Research Clinical Trials and Statistics Unit, London, UK

d Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands

e Division of Surgery and Interventional Science, University College London, London, UK

f Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK

g Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway

Corresponding author. University Hospitals NHS Foundation Trust, Bristol Royal Infirmary, Upper Maudlin Street, Bristol, Avon BS2 8HW, UK.