Gynecologic oncology · 2026
Phase 1-3 cross-cultural development and pre-testing of the European Organisation of Research and Treatment of Cancer Vulva cancer questionnaire module (EORTC QLQ- VU).
СтатьяНазвание и аннотация: Перевод в очереди
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Froeding Ligita Paskeviciute, Greimel Eva, Nordin Andy, Vistad Ingvild, Lanceley Anne, Bjelic-Radisic Vesna, Kuljanic Karin, Schmalz Claudia, Toelen Hilde, Vanden Boer Lotte, Dehandschutter Sara, Serpentini Samantha, Galalae Razvan, Tomaszewska Iwona M, Oberguggenberger Anne, van Dorst Eleonora, Di Donato Violante, Sodergren Samantha C, Jensen Pernille T, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group
Аннотация
OBJECTIVE: The aim of the study was to develop and pre-test a quality of life (QOL) measure for vulva cancer (VC) patients to supplement the EORTC QLQ-C30 core questionnaire. The overall purpose was to ensure content validity and to identify and solve potential conceptual and operational problems to ensure broad cross-cultural adaptation.
METHODS: According to EORTC guidelines, a list of QOL issues relevant to VC patients undergoing surgery and/or chemo-radiotherapy was generated from a systematic literature review. The issue list underwent critical appraisal and revision by the EORTC QOL gynecological steering group (GSG). Semi-structured interviews followed patients' and health care professionals' scoring and priority rating to include issues of highest relevance and priority. The issues were operationalized into a provisional questionnaire that underwent pre-testing.
RESULTS: An initial list of 104 issues was critically appraised by 25 members of the EORTC Gynecological Cancer Group and scored for relevance and priority by 47 patients and a further 18 HCPs with broad cross-country distribution. Based on pre-determined selection criteria, seven domains were retained for operationalization. The provisional questionnaire, the EORTC QLQ-VU consisted of 36 items and was pre-tested including debriefing in 77 patients, well-balanced across 12 centers in nine European countries. The pre-test resulted in deletion (4 items), re-phrasing (4 items), conditionality (5 items), and adding of two clarifying items. Patients' feedback resulted in significant changes enhancing patient acceptance and applicability.
CONCLUSION: Cross-cultural pre-testing of the preliminary EORTC QLQ-VU demonstrates high relevance, applicability, and comprehensiveness for phases 1-3. Phase 4 psychometric validation is in progress.
METHODS: According to EORTC guidelines, a list of QOL issues relevant to VC patients undergoing surgery and/or chemo-radiotherapy was generated from a systematic literature review. The issue list underwent critical appraisal and revision by the EORTC QOL gynecological steering group (GSG). Semi-structured interviews followed patients' and health care professionals' scoring and priority rating to include issues of highest relevance and priority. The issues were operationalized into a provisional questionnaire that underwent pre-testing.
RESULTS: An initial list of 104 issues was critically appraised by 25 members of the EORTC Gynecological Cancer Group and scored for relevance and priority by 47 patients and a further 18 HCPs with broad cross-country distribution. Based on pre-determined selection criteria, seven domains were retained for operationalization. The provisional questionnaire, the EORTC QLQ-VU consisted of 36 items and was pre-tested including debriefing in 77 patients, well-balanced across 12 centers in nine European countries. The pre-test resulted in deletion (4 items), re-phrasing (4 items), conditionality (5 items), and adding of two clarifying items. Patients' feedback resulted in significant changes enhancing patient acceptance and applicability.
CONCLUSION: Cross-cultural pre-testing of the preliminary EORTC QLQ-VU demonstrates high relevance, applicability, and comprehensiveness for phases 1-3. Phase 4 psychometric validation is in progress.