Update of the EORTC Health-related Quality of Life Modules for Bladder Cancer: Phase 1-2 of the Development Process

To determine whether the existing European Organisation for Research and Treatment of Cancer (EORTC) QLQ-NMIBC24 and QLQ-BLM30 modules remain fit for purpose and to assess health-related quality of life (HRQoL) issues relevant for patients with metastatic bladder cancer (mBC).

Following the EORTC Quality of Life Group (QLG) guidelines, phase 1 included an expert meeting, five systematic reviews, and interviews with 14 healthcare professionals (HCPs) and 48 bladder cancer (BC) patients across six countries. HRQoL issues were identified through the literature and rated by HCPs and patients for relevance and importance. Decision rules guided selection for phase 2. In phase 2, selected issues were translated into items using the EORTC Item Library and expert consensus.

A total of 443 articles and 62 interviews yielded 150 unique HRQoL issues; 40 issues and two branching questions were retained for the provisional module. Seventeen new items were added beyond the existing EORTC BC modules, while 11 existing items were excluded. Issues specific to mBC and newer treatments, such as immunotherapy, were identified. Limitations include potential selection bias due to purposive sampling and small sample sizes per treatment subgroup.

This phase 1-2 study supports the need to update the existing EORTC BC modules and incorporate additional items relevant to all disease stages, including mBC. A single, flexible module with branching logic may improve clinical applicability across patient subgroups. The provisional module will undergo international pretesting and psychometric evaluation in phase 3.