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- Title
International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26.
- Authors
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; Holzner, Bernhard; European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG)
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusion: </bold>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.
- Subjects
COMPARATIVE studies; RESEARCH methodology; MEDICAL cooperation; QUALITY of life; QUESTIONNAIRES; RESEARCH; RESEARCH evaluation; TESTIS tumors; EVALUATION research
- Publication
BMC Cancer, 2018, Vol 18, Issue 1, p1
- ISSN
1471-2407
- Publication type
journal article
- DOI
10.1186/s12885-018-5036-8