International validation of the EORTC QLQ-PRT20 module for assessment of quality of life symptoms relating to radiation proctitis: a phase IV study.
Halkett, Georgia K.B.; Wigley, Charles Adam; Aoun, Samar M.; Portaluri, Maurizio; Tramacere, Francesco; Livi, Lorenzo; Detti, Beatrice; Arcangeli, Stefano; Lund, Jo-Åsmund; Kristensen, Are Korsnes; McFadden, Nathalie; Grun, Arne; Bydder, Sean; Sackerer, Irina; Greimel, Elfriede; Spry, Nigel
Peer reviewed, Journal article
Published version
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https://hdl.handle.net/11250/3042069Utgivelsesdato
2018Metadata
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Sammendrag
Background - Although patients experience radiation proctitis post radiotherapy no internationally tested instruments exist to measure these symptoms. This Phase IV study tested the scale structure, reliability and validity and cross-cultural applicability of the EORTC proctitis module (QLQ-PRT23) in patients who were receiving pelvic radiotherapy.
Methods - Patients (n = 358) from six countries completed the EORTC QLQ-C30, QLQ-PRT23 and EORTC Quality of Life Group debriefing questions. Clinicians completed the EORTC Radiation Therapy Oncology Group scale. Questionnaires were completed at four time-points. The module’s scale structure was examined and validated using standard psychometric analysis techniques.
Results - Three items were dropped from the module (QLQ-PRT23 → QLQ-PRT20). Factor analysis identified five factors in the module: bowel control; bloating and gas; emotional function/lifestyle; pain; and leakage. Inter-item correlations were within r = 0.3–0.7. Test-Retest reliability was high. All multi-item scales discriminated between patients showing symptoms and those without symptomology. The module discriminated symptoms from the clinician completed scoring and for age, gender and comorbidities.
Conclusion - The EORTC QLQ-PRT20 is designed to be used in addition to the EORTC QLQ-C30 to measure quality of life in patients who receive pelvic radiotherapy. The EORTC QLQ-PRT20 is quick to complete, acceptable to patients, has good content validity and high reliability.