International validation of the EORTC QLQ-PRT20 module for assessment of quality of life symptoms relating to radiation proctitis: A phase IV study
Halkett, G. K.,
Wigley, C. A.,
Aoun, S. M.,
EORTC Quality of Life Group
International validation of the EORTC QLQ-PRT20 module for assessment of quality of life symptoms relating to radiation proctitis: A phase IV study.
Radiation Oncology, 13.
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.
Trial registration: Australian and New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000972224
measurement of symptoms, measurement instrument, EORTC QLQ-PRT20, radiotherapy, radiation proctitis