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

Jane M. Blazeby; Emma Hall; Neil K. Aaronson; Lisa Lloyd; Rachel Waters; John D. Kelly; Peter Fayers

doi:10.1016/j.eururo.2014.02.034

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

Jane M. Blazeby^* (Corresponding Author), Emma Hall, Neil K. Aaronson, Lisa Lloyd, Rachel Waters, John D. Kelly, Peter Fayers

^*Corresponding author for this work

Applied Health Sciences

Research output: Contribution to journal › Article › peer-review

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Abstract

Background Well-developed and well-tested patient-reported outcome measures for non-muscle-invasive bladder cancer (NMIBC) are required.

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.

Original language	English
Pages (from-to)	1148-1156
Number of pages	9
Journal	European Urology
Volume	66
Issue number	6
Early online date	25 Feb 2014
DOIs	https://doi.org/10.1016/j.eururo.2014.02.034
Publication status	Published - Dec 2014

Bibliographical note

Funding/Support and role of the sponsor: Trial recruitment was
facilitated within centres by the National Institute for Health Research
Cancer Research Network. Pfizer provided study medication free of
charge within the BOXIT trial.

Keywords

Bladder cancer
EORTC questionnaire
Quality of life
Validation

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.eururo.2014.02.034Licence: CC BY-NC-ND

Validation and Reliability Testing of the EORTC QLQ-NMIBC24 Questionnaire Module to Assess Patient-reported Outcomes in Non–Muscle-invasive Bladder Cancer
© 2014. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/
Final published version, 391 KBLicence: CC BY-NC-ND

Cite this

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

abstract = "Background Well-developed and well-tested patient-reported outcome measures for non-muscle-invasive bladder cancer (NMIBC) are required.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.",

keywords = "Bladder cancer, EORTC questionnaire, Quality of life, Validation",

author = "Blazeby, {Jane M.} and Emma Hall and Aaronson, {Neil K.} and Lisa Lloyd and Rachel Waters and Kelly, {John D.} and Peter Fayers",

note = "Funding/Support and role of the sponsor: Trial recruitment was facilitated within centres by the National Institute for Health Research Cancer Research Network. Pfizer provided study medication free of charge within the BOXIT trial.",

year = "2014",

month = dec,

doi = "10.1016/j.eururo.2014.02.034",

language = "English",

volume = "66",

pages = "1148--1156",

journal = "European Urology",

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AU - Hall, Emma

AU - Aaronson, Neil K.

AU - Lloyd, Lisa

AU - Waters, Rachel

AU - Kelly, John D.

AU - Fayers, Peter

N1 - Funding/Support and role of the sponsor: Trial recruitment was facilitated within centres by the National Institute for Health Research Cancer Research Network. Pfizer provided study medication free of charge within the BOXIT trial.

PY - 2014/12

Y1 - 2014/12

N2 - Background Well-developed and well-tested patient-reported outcome measures for non-muscle-invasive bladder cancer (NMIBC) are required.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.

AB - Background Well-developed and well-tested patient-reported outcome measures for non-muscle-invasive bladder cancer (NMIBC) are required.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.

KW - Bladder cancer

KW - EORTC questionnaire

KW - Quality of life

KW - Validation

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ER -

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

Abstract

Bibliographical note

Keywords

UN SDGs

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