Psychometric properties and clinical utility of the EORTC QLQ-BM22 in patients with bone metastases: a systematic review

Background: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for bone metastases 22 (EORTC QLQ-BM22) is a site-specific health-related quality-of-life instrument for patients with bone metastases. However, modern treatments and extended survivorship have introduced new toxicity profiles and clinical challenges. We systematically assessed the measurement performance of QLQ-BM22 to determine if contemporary evidence supports updating the module. Methods: A search was conducted using Medline, Embase, and Cochrane Central Register of Controlled Trials from inception to November 7, 2025. Two independent reviewers screened English-language articles reporting on the development, psychometric evaluation, or clinical application of the QLQ-BM22. Data regarding reliability, validity, responsiveness, and feasibility were extracted and synthesized. Studies using the module solely as an outcome measure without psychometric data were excluded. The review protocol was registered with PROSPERO (CRD420251052602). Findings: 49 publications were included. While available in 32 language versions, clinical use was identified in at least 16. Internal consistency was generally high (Cronbach's α > 0·70), although variability was observed in the Painful Sites subscale (range α = 0·34-0·93). Test-retest reliability was excellent (intraclass correlation coefficient >0·90). Construct validity was supported by weak correlations (r < 0·40) with unrelated domains in the EORTC core questionnaire, confirming the module's divergent validity. Item-level missingness was generally low in completed questionnaires, although follow-up completion was more variable in longitudinal studies. Responsiveness was strongest in palliative radiotherapy settings, whereas evidence in surgical and systemic therapy settings remains limited. Interpretation: While psychometrically sound, the reliance of QLQ-BM22 on historical validation data, limited cross-cultural validation, and inconsistent reliability in the Painful Sites subscale warrant an update. A modernized module is needed to capture contemporary symptom profiles, standardize cross-cultural measurement, and reduce burden. Funding: This research was funded by the EORTC Quality of Life Group, grant number 005/2023.