International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26
International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26
BACKGROUND: Given the high cure-rate for testicular cancer (TC) and the patients' young age, comprehensive evaluation of health-related quality of life (HRQOL) is an important consideration in this patient population. The EORTC QLQ-TC26 questionnaire module has been developed to supplement the EORTC QLQ-C30 in assessing TC-specific HRQOL in clinical trials and routine clinical practice. This international, multicentre phase IV validation study evaluated the psychometric properties of the new module. METHODS: This international, multicentre phase IV validation study enrolled testicular cancer patients from seven European countries. Patients completed the EORTC quality of life core questionnaire EORTC QLQ-C30 and the QLQ-TC26 at two consecutive time points and a debriefing questionnaire regarding the QLQ-TC26 after baseline assessment. Psychometric evaluation included examination of the hypothesized module scale structure, internal consistency and test-retest reliability, known-groups validity, responsiveness to change over time and cross-cultural acceptability. RESULTS: Data from 313 patients (mean age 38.6, SD 9.5) were analysed. All items exhibited a high completion rate with less than 2.4% missing values except for the sexuality items (up to 8.8%). The confirmatory factor analysis supported the hypothesised scale structure of the QLQ-TC26. Test-retest reliability was good for 8 of 12 scales (intraclass correlation: R t1|t2 ranged from 0.71-0.91) and four scales did not meet the acceptable criteria. Internal consistency was good for all twelve scales (Cronbach alpha = 0.79-0.90), except Communication (alpha = 0.67) and Sexual Functioning (alpha = 0.62). The module was able to distinguish clearly between patients with differing clinical status. Responsiveness to change over time was acceptable. CONCLUSION: The EORTC QLQ-TC26 is a valid, reliable and well-accepted condition-specific questionnaire, supplementing the EORTC QLQ-C30, for the assessment of testicular cancer patients' HRQOL in clinical trials.
EORTC, Health-related quality of life, Patient-reported outcome, Psychometric validation, Testicular cancer
Sztankay, Monika
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Aaronson, Neil K.
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Arraras, Juan I.
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Basso, Umberto
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Bumbasirevic, Uros
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Efficace, Fabio
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Giesinger, Johannes M.
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Johnson, Colin D.
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van Leeuwen, Marieke
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Oberguggenberger, Anne S.
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Sosnowski, Roman
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Young, Teresa
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Holzner, Bernhard
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European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG)
12 November 2018
Sztankay, Monika
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Aaronson, Neil K.
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Arraras, Juan I.
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Basso, Umberto
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Bumbasirevic, Uros
ac560487-9e63-4707-b126-6ebfddaf6630
Efficace, Fabio
487f70ae-2ae9-49d9-b86f-672050fa71af
Giesinger, Johannes M.
71e4f064-9f9a-4c34-a666-df0c3056a93f
Johnson, Colin D.
e50aa9cd-8c61-4fe3-a0b3-f51cc3a6c74a
van Leeuwen, Marieke
a3ee2ae1-0142-4eee-be35-3e6e5a67f9c9
Oberguggenberger, Anne S.
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Sosnowski, Roman
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Young, Teresa
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Holzner, Bernhard
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Sztankay, Monika, Aaronson, Neil K., Arraras, Juan I., Basso, Umberto, Bumbasirevic, Uros, Efficace, Fabio, Giesinger, Johannes M., Johnson, Colin D., van Leeuwen, Marieke, Oberguggenberger, Anne S., Sosnowski, Roman, Young, Teresa and Holzner, Bernhard
,
European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG)
(2018)
International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26.
BMC cancer, 18 (1), [1104].
(doi:10.1186/s12885-018-5036-8).
Abstract
BACKGROUND: Given the high cure-rate for testicular cancer (TC) and the patients' young age, comprehensive evaluation of health-related quality of life (HRQOL) is an important consideration in this patient population. The EORTC QLQ-TC26 questionnaire module has been developed to supplement the EORTC QLQ-C30 in assessing TC-specific HRQOL in clinical trials and routine clinical practice. This international, multicentre phase IV validation study evaluated the psychometric properties of the new module. METHODS: This international, multicentre phase IV validation study enrolled testicular cancer patients from seven European countries. Patients completed the EORTC quality of life core questionnaire EORTC QLQ-C30 and the QLQ-TC26 at two consecutive time points and a debriefing questionnaire regarding the QLQ-TC26 after baseline assessment. Psychometric evaluation included examination of the hypothesized module scale structure, internal consistency and test-retest reliability, known-groups validity, responsiveness to change over time and cross-cultural acceptability. RESULTS: Data from 313 patients (mean age 38.6, SD 9.5) were analysed. All items exhibited a high completion rate with less than 2.4% missing values except for the sexuality items (up to 8.8%). The confirmatory factor analysis supported the hypothesised scale structure of the QLQ-TC26. Test-retest reliability was good for 8 of 12 scales (intraclass correlation: R t1|t2 ranged from 0.71-0.91) and four scales did not meet the acceptable criteria. Internal consistency was good for all twelve scales (Cronbach alpha = 0.79-0.90), except Communication (alpha = 0.67) and Sexual Functioning (alpha = 0.62). The module was able to distinguish clearly between patients with differing clinical status. Responsiveness to change over time was acceptable. CONCLUSION: The EORTC QLQ-TC26 is a valid, reliable and well-accepted condition-specific questionnaire, supplementing the EORTC QLQ-C30, for the assessment of testicular cancer patients' HRQOL in clinical trials.
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Sztankay2018_Article_InternationalPhaseIVValidation
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Accepted/In Press date: 4 September 2018
e-pub ahead of print date: 12 November 2018
Published date: 12 November 2018
Keywords:
EORTC, Health-related quality of life, Patient-reported outcome, Psychometric validation, Testicular cancer
Identifiers
Local EPrints ID: 426505
URI: http://eprints.soton.ac.uk/id/eprint/426505
ISSN: 1471-2407
PURE UUID: 7e91d927-7327-49f0-ae37-072496c04a46
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Date deposited: 29 Nov 2018 17:30
Last modified: 15 Mar 2024 23:07
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Contributors
Author:
Monika Sztankay
Author:
Neil K. Aaronson
Author:
Juan I. Arraras
Author:
Umberto Basso
Author:
Uros Bumbasirevic
Author:
Fabio Efficace
Author:
Johannes M. Giesinger
Author:
Marieke van Leeuwen
Author:
Anne S. Oberguggenberger
Author:
Roman Sosnowski
Author:
Teresa Young
Author:
Bernhard Holzner
Corporate Author: European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG)
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