Evidence map›Paper›PMID 24612661›Full record

Trial reportEuropean urology2014

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

Abstract readRandomized Controlled TrialValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European urology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 9 pooled it
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 9 syntheses or guidelines pooled it.

  1. Pooled it
  2. The current use of the EORTC QLQ-NMIBC24 and QLQ-BLM30 questionnaires for the assessment of health-related quality of life in bladder cancer patients: a systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Jane M BlazebyCentre 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.
Emma HallInstitute of Cancer Research Clinical Trials and Statistics Unit, London, UK.
Neil K AaronsonDivision of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Lisa LloydInstitute of Cancer Research Clinical Trials and Statistics Unit, London, UK.
Rachel WatersInstitute of Cancer Research Clinical Trials and Statistics Unit, London, UK.
John D KellyDivision of Surgery and Interventional Science, University College London, London, UK.
Peter FayersInstitute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.

Funding

Cancer Research UK 5669Cancer Research UK C1491/A9895Cancer Research UK C8262/A5669Cancer Research UK CRUK/07/004Medical Research Council G0800800Medical Research Council MR/K025643/1
6 · The paper itself

Abstract

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

objectiveTo 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

participantsA 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.

conclusionsThis 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.

Indexed as

Quality of LifeSurveys and QuestionnairesAdultAgedAged, 80 and overAnxietyCelecoxibCombined Modality TherapyCyclooxygenase 2 InhibitorsFemaleFeverHealth StatusHumansLower Urinary Tract SymptomsMaleMiddle AgedCelecoxibCyclooxygenase 2 InhibitorsBladder cancerEORTC questionnaireQuality of lifeValidation

Identifiers

PMID24612661
PMCPMC4410297

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.