International validation of the EORTC QLQ-PRT20 module for assessment of quality of life symptoms relating to radiation proctitis: a phase IV study Academic Article uri icon


  • 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 .


  • Halkett, Georgia KB
  • Wigley, Charles Adam
  • Aoun, Samar M
  • Portaluri, Maurizio
  • Tramacere, Francesco
  • Livi, Lorenzo
  • Detti, Beatrice
  • Arcangeli, Stefano
  • Lund, Jo-Asmund
  • Kristensen, Are
  • McFadden, Nathalie
  • Grun, Arne
  • Bydder, Sean
  • Sackerer, Irina
  • Greimel, Elfriede
  • Spry, Nigel

publication date

  • 2018