OBJECTIVES: The EORTC QLQ-C30 and NMIBC-24 are PRO measures developed to assess symptoms and health-related quality of life (HRQoL) in cancer patients and those diagnosed with NMIBC, respectively. There are unique considerations regarding HR-NMIBC in terms of presentation, prognosis and treatments that must be captured in clinical trial endpoints. This study aimed to summarize evidence regarding the patient experience of HR-NMIBC and the suitability of the EORTC QLQ-C30 and NMIBC-24 for assessing concepts considered relevant to HR-NMIBC patients.

METHODS: Two targeted literature reviews (TLR) were conducted. TLR 1 examined published qualitative literature to summarize evidence of the patient experience of HR-NMIBC. TLR 2 focussed on literature regarding the development and validation of the EORTC QLQ-C30 and NMIBC-24. A critical review and gap analysis were conducted to evaluate the adequacy of both PRO measures for assessing symptoms and impacts among patients with HR-NMIBC.

RESULTS: TLR 1 identified the key symptoms (such as hematuria, dysuria, urinary urgency/frequency, pain) and associated impacts reported by patients relating to HR-NMIBC or treatments. Concept mapping supports the EORTC QLQ-C30 as providing coverage of HRQoL impacts, while NMIBC-24 provides direct coverage of most key HR-NMIBC symptoms and treatment side effects identified; omissions including haematuria and cystectomy concerns.

TLR 2 identified that a 10-point Clinically Important Difference (CID) threshold is typically considered appropriate for the EORTC QLQ-C30. However, limited evidence is currently available to support the reliability and validity of the EORTC QLQ-C30 and NMIBC-24 in patients with HR-NMIBC specifically.

CONCLUSIONS: The EORTC QLQ-C30 and NMIBC-24 generally provide good coverage and measurement of the key concepts of importance to patients with HR-NMIBC when jointly administered. Evidence supports the measurement properties of the PROs generally, but further evidence is required to establish reliability, validity and definitions of clinically meaningful change in PRO scores specific to patients with HR-NMIBC.