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)

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.