麻豆传媒

Background

Patients with metastatic renal cell carcinoma (mRCC) require a tailored health-related quality-of-life (HRQOL) assessment. Previous research (; ) explored FKSI-19, EORTC QLQ-C30, and EQ-5D item relevance. We aimed to develop a tailored HRQOL measure for patients with mRCC through a three-phase approach involving patient engagement, expert input, and advocacy.

Methods

In Phase 1, 117 patients with mRCC (83:34 M:F, median age 64) from the U.S., Europe, and Brazil participated in a survey study to assess the relevance of items from established measures (FKSI-19, EORTC QLQ-C30, EQ-5D). In this cohort, 88% of patients had clear cell histology and 35%, 30%, and 19% received immunotherapy alone, targeted therapy alone, or combination therapy, respectively. Questions identified as relevant (base on ≥66% consensus) were selected for inclusion in a preliminary survey. Phase 2 involved assembling a panel of 11 experts who rigorously reviewed and refined the survey questions. In Phase 3, preliminary versions were presented to eight patient advocates (5:3 F:M; 6:2 patients:caregivers) to ensure alignment with patients' needs and experiences.

Results

Phase 1 analysis identified 10 items. Patients requested the inclusion of a question about social/family issues and better coverage of emotional symptoms. A 12-item questionnaire was created, and the expert committee refined three items to incorporate patient suggestions and added one item related to functional status. This questionnaire included one cancer-specific item, three cancer- or treatment-specific items, three non-specific emotional items, and four non-specific physical items. Patient advocates provided feedback, agreeing with the items excluded from previous questionnaires and those included. They suggested minor edits to item wording.

Conclusions

The novel approach holds the potential to replace traditional HRQOL measures that may lack relevance to specific clinical circumstances. Further validation is planned in a phase III trial, ensuring its applicability in clinical practice.

Read an interview about the study here and expert commentary about it here.