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01.12.2018 | Research | Ausgabe 1/2018 Open Access

Radiation Oncology 1/2018

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

Zeitschrift:
Radiation Oncology > Ausgabe 1/2018
Autoren:
Georgia K. B. Halkett, Charles Adam Wigley, Samar M Aoun, Maurizio Portaluri, Francesco Tramacere, Lorenzo Livi, Beatrice Detti, Stefano Arcangeli, Jo-Asmund Lund, Are Kristensen, Nathalie McFadden, Arne Grun, Sean Bydder, Irina Sackerer, Elfriede Greimel, Nigel Spry, on behalf of the EORTC Quality of Life Group
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13014-018-1107-x) contains supplementary material, which is available to authorized users.

Abstract

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) ACTRN12609000972​224.
Zusatzmaterial
Additional file 1: Treatment received by participants. (DOCX 18 kb)
13014_2018_1107_MOESM1_ESM.docx
Additional file 2: Number of patients with existing co-morbidities and type. (DOCX 13 kb)
13014_2018_1107_MOESM2_ESM.docx
Additional file 3: Means and 95% confidence intervals, range of the proposed QLQ PRT20 Proposed Scale compared to the RTOG score ratings indicting no symptoms (score = 0) vs. acute symptoms (score = 1+). (DOCX 13 kb)
13014_2018_1107_MOESM3_ESM.docx
Literatur
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