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

Research in context

Evidence before this study

We searched Medline, Embase, and the Cochrane Central Register of Controlled Trials for studies published from database inception to November 7, 2025. Our search strategy utilized terms including “European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for bone metastases 22 (EORTC QLQ-BM22)” and variations of “EORTC bone metastases module”. We included English-language articles reporting on the development, psychometric evaluation, or clinical application of the EORTC QLQ-BM22. We excluded studies that solely used the module as a clinical outcome measure without reporting original psychometric data, as well as systematic reviews and meta-analyses. Before this study, the QLQ-BM22 was widely recognized as the standard health-related quality of life instrument for patients with bone metastases. However, it was developed and validated in 2009. Since then, the clinical management of bone metastases has evolved significantly with the introduction of stereotactic body radiotherapy, potent bone-modifying agents, and targeted therapies. Prior to this review, there was no comprehensive synthesis evaluating whether the module's historical measurement properties remained robust across these newer therapeutic contexts and diverse international settings.

Added value of this study

To our knowledge, this is the most comprehensive systematic review evaluating the contemporary clinical utility and measurement performance of the QLQ-BM22. By synthesizing data from 49 studies evaluating the module across 16 language versions, we confirmed its overall strong psychometric performance and responsiveness, particularly in traditional palliative radiotherapy settings. Crucially, we identified specific methodological and conceptual gaps: inconsistent internal consistency in the Painful Sites subscale (which may reflect its structure as an anatomical checklist rather than a reflective scale), a heavy reliance on historical validation data in modern clinical trials, and a lack of systematic cross cultural measurement equivalence. Furthermore, our findings highlight that the current module does not capture emerging health-related quality of life challenges related to recent treatment advances, such as treatment-induced vertebral fractures, fear-avoidance behaviors, and issues of long-term functional survivorship.

Implications of all the available evidence

While the QLQ-BM22 remains a psychometrically sound tool, the shifting paradigm of metastatic bone disease from short-term palliation to chronic disease management for selected patients strongly supports the development of a next-generation EORTC module. Future research should focus on modernizing the item content to capture contemporary symptom profiles and treatment toxicities, ensuring systematic cross-cultural validation across translations, and optimizing feasibility to reduce patient burden. Given the clinical heterogeneity of this population, this update may be best achieved through a flexible or hierarchical design that balances comprehensiveness for long-term survivors with brevity for frailer patients. Ultimately, a revised module will improve the precision, relevance, and global applicability of patient-reported outcomes in metastatic bone disease research and clinical practice.

Introduction

Bone metastasis is the most frequent site of metastatic disease for many cancers. The most common primary cancers associated with bone metastases are breast, lung, and prostate carcinomas. 1 Patients require treatment for bone metastases because the median survival time of many of these primary tumors is quite long, and bone metastases can result in local pain and skeletal-related events, like hypercalcemia, pathological fractures, impaired mobility, and spinal cord compression. 1 , 2 These complications can significantly decrease patients’ functionality and health-related quality of life (HRQoL). In line with this, addressing pain and delaying the progression of bone metastases are critical objectives in the treatment of bone metastases.

The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for bone metastases 22 (EORTC QLQ-BM22) is a site-specific module designed to supplement the Quality of Life Questionnaire Core 30 (QLQ-C30) for assessing HRQoL in patients with bone metastases ( Table 1 ). 3 It consists of 22 items grouped into four multi-item scales: pain sites, pain characteristics, functional interference, and psychosocial aspects. 4 Each item is rated on a 4-point Likert scale (1 = “not at all” to 4 = “very much”), referring to the patient's experiences during the past week. 4 Scores are linearly transformed to a 0–100 scale, with higher scores representing greater symptom burden or functional impact, and higher scores on functional domains indicating better functioning. 5 The QLQ-BM22 was developed and validated through international Phase 1–4 testing and is available in 32 EORTC-approved language versions. 3 , 5 , 6 During development, Phase 3 pre-testing enrolled 170 patients from nine countries across seven languages, and subsequent international field testing included 400 patients across seven countries. 3 , 5

Since the development of QLQ-BM22, 3 stereotactic body radiotherapy, bone-modifying agents, immunotherapy, and multidisciplinary supportive care, and survivorship has lengthened in many cancer types. 7 , 8 , 9 , 10 These advancements have extended survival in some cases and introduced distinct toxicity profiles, such as treatment-induced vertebral fractures or osteonecrosis of the jaw, that differ substantially from the original validation cohorts. 11 Although the QLQ-BM22 has been widely adopted, the extent to which its measurement properties remain stable across newer clinical settings, languages, and modes of administration is uncertain. Accordingly, we conducted a systematic review to assess how the QLQ-BM22 has been used in clinical studies and its contemporary measurement performance across settings and languages. We also sought to identify evidence gaps and areas for methodological and content refinement to inform future work within the EORTC module development framework. 12

Methods

The protocol was registered in PROSPERO (CRD420251052602) and is available at: https://www.crd.york.ac.uk/PROSPERO/view/CRD420251052602 .

Search strategy and eligibility criteria

A comprehensive literature search was conducted using Medline (via PubMed), Embase, and Cochrane Central Register of Controlled Trials from January 1, 1946 to November 7, 2025. This search aimed to identify studies that detailed the development, validity, and reliability of the QLQ-BM22. Detailed search strategies are listed in Appendix 1 . Inclusion criteria required that articles discuss the development, evaluation, and/or application of the QLQ-BM22 in any clinical or observational study, and that they be published in English. Studies were excluded if they utilized the QLQ-BM22 solely as a clinical outcome measure without reporting any original psychometric data (reliability coefficients, validity analyses, or responsiveness statistics) within the manuscript. Systematic reviews, meta-analyses, and studies that did not provide methodological or implementation-related insights regarding the module were also excluded.

Screening and data extraction

Key data extracted included details on the development, questionnaire characteristics, content, reliability, validity, responsiveness, and other pertinent attributes. Additional properties, such as person separation reliability in Rasch analysis, were extracted when reported. Covidence systematic review software (Veritas Health Innovation, Melbourne, Australia) was used for screening. Two reviewers (N.W. and B.Z.) independently screened titles, abstracts, and full texts. Any discrepancies were resolved through adjudication by a third investigator (S.F.L.). To ensure comprehensive coverage, the reference lists of all eligible publications were manually hand-searched for additional relevant studies. Grey literature (e.g., conference abstracts without full text, unpublished theses) was excluded to maintain the standard of peer-reviewed psychometric evidence. Data extraction was subsequently performed via independent data entry by two reviewers (N.W. and B.Z.) and cross-checked for accuracy, with final review by the third reviewer (S.F.L.).

Approach to evidence synthesis

We used a structured narrative synthesis to summarize the reported psychometric findings, feasibility, and implementation characteristics of the QLQ-BM22 across included studies. This approach was chosen because the literature was heterogeneous in design, population, language version, administration context, assessment timepoint, and psychometric methods. Several studies also reported multiple psychometric estimates from the same patient cohort across different subscales or timepoints, limiting the interpretability of pooled summary estimates. A formal study-level risk-of-bias or methodological quality assessment was not undertaken, as no single appraisal tool was considered methodologically appropriate across all included designs.

Role of the funding source

This research was funded by the EORTC Quality of Life Group (QLG), grant number 005/2023. The EORTC QLG business model involves license fees for commercial use of their instruments. Academic use of EORTC instruments is free of charge. The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.

Results

Study characteristics and use contexts

The systematic literature search yielded 221 studies. 84 duplicates were removed; 137 citations were screened by title and abstract. Of these, 64 were excluded, leaving 73 articles for full-text assessment. Finally, 49 studies met the inclusion criteria and were included in this review ( Fig. 1 ). These included studies were published between 2012 and 2025. A steady increase in research activity was observed over time, with approximately 77·6% of the studies published in the last decade (2015–2025).

A combination of randomized and nonrandomized study designs were included. The distribution of study design is shown in Supplementary Figure S1 . Eleven studies (22·5%) were prospective interventional studies, nine (18·4%) were prospective validation studies, eight (16·3%) were prospective cohort studies, eight (16·3%) were retrospective cohort studies, seven (14·3%) were secondary analyses of randomized controlled trial (RCT) cohorts, three (6·1%) were RCTs, and three (6·1%) were cross-sectional studies. A summary of core study characteristics is provided in Table 2 .

When not explicitly stated, language was approximated according to the official language of the study country. In multinational studies where patients were enrolled in different countries, multiple languages were assumed to have been used unless stated otherwise. One multinational study did not specify the participating countries or the languages of administration. 17 Based on reported or inferred administration language, the QLQ-BM22 was represented in at least 16 language versions across the included studies. English was explicitly reported in 11 studies, 1 , 23 , 26 , 29 , 30 , 33 , 34 , 38 , 41 , 46 , 54 and Chinese Mandarin (China) in 10 studies. 31 , 32 , 36 , 47 , 48 , 49 , 51 , 56 , 57 , 58 Additional Chinese-language variants included Chinese Cantonese (Hong Kong) and Chinese Mandarin (Taiwan), represented in single-country studies and in some multinational studies. 5 , 14 , 16 , 21 , 25 German and Japanese were each represented in four single-country studies, 13 , 19 , 20 , 39 , 40 , 52 , 55 , 59 and Italian in three. 24 , 44 , 50 Other reported language versions included Arabic, Dutch, French (Europe), Greek, Korean, Persian, Polish, Portuguese (Brazil), and Spanish. 5 , 14 , 15 , 16 , 18 , 22 , 25 , 27 , 28 , 35 , 37 , 42 , 43 , 45 , 53

The geographic distribution of included studies is shown in Fig. 2 , and a regional summary by continent is provided in Supplementary Figure S2 . Most studies did not focus on a specific primary cancer. Most studies included mixed primary cancer types, predominantly breast, prostate, and lung, alongside a diverse range of other solid and hematological malignancies.

Categorization of included studies

Included studies were grouped into six categories based on primary objectives and methodologies: development, 5 , 15 translations and cultural adaptations, 18 , 22 , 27 , 28 , 31 correlation and cross-validation with other instruments, 17 responsiveness and minimal clinically important difference (MCID), 14 , 29 , 35 , 44 , 54 , 55 , 59 clinical utility and intervention studies, 1 , 13 , 19 , 20 , 21 , 23 , 24 , 26 , 30 , 32 , 33 , 34 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 56 , 57 , 58 and symptom clustering and factor analysis. 16 , 25 Table 3 presents the complete overview of included studies organized according to these six categories.

Reliability

Reliability of the QLQ-BM22 was formally evaluated in a limited number of studies (n = 9), 5 , 16 , 18 , 22 , 25 , 27 , 28 , 30 , 31 primarily in initial validation and cultural adaptation papers, with most subsequent clinical or interventional studies referencing these prior findings rather than re-evaluating psychometric properties.

The international field-testing study reported high internal consistency across the four QLQ-BM22 subscales (α = 0·67–0·94) and excellent test-retest reliability (intraclass correlation coefficients [ICCs] = 0·93–0·98). 5 A subsequent multinational psychometric evaluation confirmed acceptable to excellent internal consistency (α = 0·68–0·93), 25 with only the Painful Sites domain slightly below the conventional 0·70 threshold. Rasch analysis demonstrated high item separation reliability (0·97–0·99), while person separation reliability ranged from 0·55 to 0·85.

Cultural adaptations conducted in diverse countries and languages demonstrated reliability comparable to the original field testing. The Chinese study found acceptable to excellent internal consistency (α = 0·69–0·93) across domains, and the Iranian study reported Cronbach's α ranging from 0·73 to 0·93 with ICCs >0·93. 22 , 31 The Polish validation demonstrated α values ranging from 0·68 to 0·95 with ICCs running from 0·91 to 0·93. 18 The Brazilian study showed α values of 0·70–0·94 across domains, with Pearson's r and ICCs >0·98, indicating high temporal stability. 27

Other studies have also supported the reliability of the QLQ-BM22 in specific contexts. In a Canadian palliative radiotherapy RCT, Cronbach's α values ranging from 0·34 to 0·88. 30 Reliability was lowest for the Painful Sites (α = 0·34) and Painful Characteristics (α = 0·49) subscales at baseline, and for Painful Sites (α = 0·45) and Psychosocial Aspects (α = 0·58) at follow-up. A symptom cluster analysis found α values of 0·61 to 0·92 for symptom clusters derived from QLQ-BM22 items, suggesting acceptable internal consistency in cluster-level analyses. 16 Temporal stability was additionally confirmed over two weeks in a Polish cohort. 28 Internal consistency scores across subscales reported by individual studies are summarized in Table 4 .

Validity

Validity of the QLQ-BM22 was formally evaluated in 12 studies. 5 , 15 , 17 , 18 , 22 , 25 , 26 , 27 , 29 , 30 , 31 , 34 International field testing confirmed convergent, divergent, and known-group validity. Correlations between QLQ-BM22 and QLQ-C30 scores were generally weak for distinct constructs (r < 0·40), supporting the divergent validity of the QLQ-BM22. 5 Another international validation study further demonstrated construct validity by showing that QLQ-BM22 scores significantly differed across radiotherapy response groups, with pain relief associated with improvements across the QLQ-BM22 domains. 15

Several country-specific validation studies provided consistent findings. A Chinese study differentiated patients by Karnofsky Performance Status (KPS) and demonstrated strong correlations with conceptually related scales and negligible correlations with unrelated constructs. 31 The Polish and Iranian versions also confirmed convergent, discriminant, and known-group validity, with stronger within-subscale correlations (r ≥ 0·53) and negative associations between pain and functioning. 18 , 22 The Brazilian adaptation demonstrated cross-cultural validity based on correlations with the 36-Item Short Form Survey (SF-36), showing significant associations between the Painful Sites and Painful Characteristics subscales and multiple SF-36 domains, including Physical Functioning, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health (all p < 0·05), but no correlation with Role-Physical; overall, QLQ-BM22 total and subscale scores showed moderate-to-strong correlations. 27 Another multinational analysis confirmed the four-domain structure with good model fit, though Item 17 showed differential functioning by gender and country. 25

In clinical trial and observational settings, a Canadian RCT found strongest construct validity for Functional Interference, with weaker validity for the pain domains—specifically Painful Sites and Painful Characteristics. 30 For MCID analysis, all four QLQ-BM22 subscales showed moderate correlations with the 15-item palliative core questionnaire (QLQ-C15-PAL) HRQoL scores (r = 0·39–0·48), exceeding the ≥0·30 threshold. 29 Known-group validity was further supported by secondary analysis of Canadian trial data, which linked pain severity cut points to HRQoL subscales, an international retrospective study, which found KPS and cancer site differentiated scores, and another Canadian study, which showed change scores distinguished pain responders from non-responders after radiotherapy. 17 , 26 , 34

Additional studies indirectly supported validity. 13 , 14 , 16 , 43 , 44 A cluster analysis reproduced the four-component structure (61·5% of variance), while additional international and Japanese studies provided further evidence for construct validity. 13 , 14 , 16 An Italian study showed QLQ-BM22 composite scores predicted overall survival in metastatic prostate cancer, and a Spanish prospective study linked improvements after radiotherapy and tapentadol with reduced neuropathic pain. 43 , 44 Several other studies reference previous validation without re-assessing validity in their samples. 20 , 24 , 33 , 35 , 37 , 42 , 51

Feasibility, acceptability, and implementation

Feasibility reporting was heterogeneous across studies. Where item-level missingness within completed QLQ-BM22 questionnaires was reported, it was generally low. In validation settings, the original field-testing studies reported approximately 1% missing responses, 5 , 13 the Iranian validation reported <1% missing items, 22 and the Chinese validation reported 2·1% overall missing responses, with the highest item-level non-response ranging from 3·6% to 4·1%. 31 The Polish cross-sectional study did not report a single summary percentage, but all patients completed both questionnaires and only questionnaires with ≥80% item completion were analyzed. 28 By contrast, questionnaire completion over follow-up was more variable in interventional and prospective observational studies. In the SC23 trial platform, QLQ-BM22 compliance declined from 99% at baseline to 84% at day 10 and 82% at day 42, 23 while complete follow-up HRQoL data were available for 72·1% and 62·7% of patients at day 10 and day 42, respectively. 34 Other studies reported 64% completion at 2 months among surviving patients, 42 6-month return rates of 83% and 84%, declining to 53% and 58% at 12 months, in the two radiotherapy groups, 45 and 67·0% compliance at 12 weeks in a prospective observational cohort. 59 In the nationwide multicenter study by Utsumi et al., BM22 completion declined from approximately 95%–97% of patients at baseline to approximately 54% at 6 months. 55

Administration method was infrequently reported. When specified, the QLQ-BM22 was self-administered by patients, typically in clinic and often alongside the QLQ-C30 or QLQ-C15-PAL. 13 , 31 , 37 Completion time was reported in several validation studies: the Chinese validation reported a mean of 10·6 min (median 6), 31 the Brazilian validation reported approximately 8 min (range 5–14), 27 and the Iranian validation reported approximately 13 min. 22 In the international field testing, 72% of patients completed the questionnaire within 15 min, 5 and the Japanese Sr-89 study also reported completion within this timeframe. 13

Patient-reported acceptability was assessed in several studies. In the international field testing, 93% of participants reported no wording problems and 89–94% reported no difficulty or upset. 5 The Chinese validation reported that the questionnaire was easy to understand, 31 while the Portuguese adaptation identified <10% of patients reporting difficulty with the terms “constant/intermittent” during pilot testing but required no translation changes. 27 The Polish validation also reported no need for translation modifications. 18

Responsiveness and MCID

Responsiveness of the QLQ-BM22 was demonstrated most consistently in palliative radiotherapy and supportive-care settings. 5 , 14 , 29 In a Canadian palliative radiotherapy trial, responders showed improvement across all four subscales by day 42, and a companion analysis established anchor- and distribution-based MCID thresholds for interpreting those changes. 29 , 30 International field testing likewise detected significant change in Painful Sites, Painful Characteristics, and Functional Interference among radiotherapy responders. 5 , 14 Similar patterns, with the largest effects seen in the pain domains, were also reported in Iranian and international validation studies. 17 , 22

Responsiveness was also evident in selected targeted and procedural interventions. After strontium-89, improvements were observed in Painful Characteristics, Functional Interference, and Psychosocial Aspects within 1–3 months in a Japanese study. 13 With radium-223 dichloride, an Italian study reported fluctuations in QLQ-BM22 scores over time, indicating sensitivity to both improvement and deterioration. 44 In a Chinese study of posterior decompression and instrumentation for spinal metastases, scores on Painful Sites, Painful Characteristics, and Psychosocial Aspects decreased at 1 month, while Functional Interference improved. 51 In another Chinese study of magnetic resonance-guided focused ultrasound surgery, the Painful Sites subscale did not change significantly, whereas Functional Interference decreased significantly over 12 months and Pain Characteristics decreased significantly from 2 months onward; psychosocial scores also improved after treatment. 36 In a later Chinese study of percutaneous microwave ablation and cementoplasty for painful pelvic bone metastases, the total QLQ-BM22 score decreased significantly from baseline at 1 week, 1 month, and 3 months. 48

Discussion

Since its introduction in 2009, the QLQ-BM22 has been widely adopted as a disease-specific HRQoL measure for patients with bone metastases. 3 A critical finding of this review is that despite its widespread inclusion in clinical trials, the majority of studies rely on historical validation data rather than re-evaluating its psychometric performance in contemporary settings. This reliance raises concerns regarding whether the module's measurement properties remain robust across the diverse clinical and cultural contexts of modern oncology, particularly as treatments and patient trajectories have evolved substantially since its development.

The QLQ-BM22 has demonstrated robust psychometric properties in both its initial validation and subsequent cultural adaptations. Internal consistency was good to excellent for most subscales (Cronbach's α typically >0·70), with some variability for “Painful Sites” and “Pain Characteristics.” High test-retest reliability was reported across multiple language versions, with ICCs above 0·90 in most studies. 5 , 18 , 22 , 25 , 27 , 31 Large-scale psychometric analyses, such as Rasch modelling and confirmatory factor analysis, provided further evidence for the reliability of item performance and stability of the four domain structure. 25 Responsiveness has also been consistently demonstrated, particularly in radiotherapy settings where improvements in pain and function were captured effectively. 5 , 13 , 24 , 29 , 36 , 44 , 48 , 51 These findings support the QLQ-BM22 as a psychometrically sound tool capable of detecting clinically meaningful change.

Although the QLQ-BM22 has demonstrated overall strong psychometric performance, some variability was observed across domains. In particular, internal consistency appears less stable in the “Painful Sites” and, to a lesser extent, “Pain Characteristics” scales, possibly reflecting heterogeneity in pain presentation, recall accuracy, and cultural interpretation of “site-specific pain”. 60 This variability may also reflect the measurement structure of the Painful Sites domain. The items may function more as an anatomical checklist or index than as a reflective scale, such that pain at one site would not necessarily be expected to correlate with pain at another. 61 These findings suggest that while the QLQ-BM22 retains acceptable reliability, its sensitivity may vary depending on treatment modality, disease extent, and symptom distribution.

Although the module is widely available internationally, formal psychometric evaluation has been conducted for only a limited number of its language versions. Published evidence on cross-cultural validation appeared limited within the literature captured by this review, although this finding may partly reflect the exclusion of non-English-language studies. Existing studies generally support reliability and construct validity across languages, yet minor inconsistencies have been reported in specific subscales, suggesting possible cultural or linguistic influences in interpretation. Moreover, most multinational analyses have pooled data across languages without evaluating measurement equivalence, which may obscure language-specific differences. To strengthen the module's global applicability, systematic cross-cultural validation efforts—including differential item functioning, multi-group confirmatory factor analysis, and assessments of item- and scale-level invariance—are warranted across all available language versions. Such work would help ensure that the QLQ-BM22 can be used reliably in multinational trials and multicultural clinical settings.

Overall, the available feasibility data support use of the QLQ-BM22 in clinical and research settings, although respondent burden remains relevant in patients with poor performance status and in longitudinal follow-up. An important distinction is that item-level missingness within completed questionnaires was generally low, supporting the acceptability and clarity of the instrument itself, whereas completion rates over follow-up were more variable and often declined over time in prospective and interventional studies. This pattern suggests that missing data in many longitudinal studies may reflect clinical deterioration, disease progression, or death rather than poor comprehensibility of the questionnaire. These findings reinforce the importance of minimizing respondent burden, particularly when the instrument is used repeatedly in frailer palliative populations. In this context, the QLQ-BM22 was originally developed alongside the QLQ-C30, 3 but in palliative bone metastasis populations it has also been paired with the QLQ-C15-PAL, 62 a shorter core questionnaire that can be used in conjunction with the module to reduce burden. 26 , 29 , 30 , 37 , 63 This approach may be particularly useful in frailer patients, although the use of different core questionnaires across studies may still influence content coverage and limit direct comparability. These findings support continued use of the instrument while underscoring the importance of respondent burden in any future revision. Studies using the QLQ-BM22 should also distinguish clearly between item-level missingness and loss of assessable data over follow-up, as these represent different methodological and clinical challenges. Future adaptation of the QLQ-BM22 should therefore balance comprehensiveness with practicality across diverse clinical contexts.

The responsiveness findings suggest that the QLQ-BM22 is particularly useful in settings where symptom change is expected over relatively short timeframes, such as palliative radiotherapy and selected procedural interventions. At the same time, we need more evidence in contemporary systemic therapy and survivorship contexts, although early findings suggest the potential for responsiveness in these settings. The QLQ-BM22 has also been used to classify pain improvement after radiotherapy and to distinguish responders from non-responders; however, limited evidence is available regarding its ability to predict clinical outcomes. 30 Future research should evaluate whether the QLQ-BM22 can be integrated into prognostic modelling, guide clinical decision-making, or support individualized treatment planning, particularly as therapeutic strategies for bone metastases evolve.

The necessity for an update is further underscored by the evolution of treatment strategies. With a shift from short-term palliation to chronic disease management, new HRQoL challenges arose that are not captured. For instance, the increasing use of stereotactic body radiotherapy for oligometastases has introduced a specific risk of treatment-induced vertebral compression fractures. 64 This risk profile drives distinct psychological burdens, specifically the fear of skeletal-related events and fear-avoidance behaviors, where patients limit movement due to fracture-related anxiety rather than pain, a domain currently absent from the QLQ-BM22. 65 Similarly, the adoption of potent bone-modifying agents (e.g., denosumab) has extended survival and prevented skeletal-related events in selected patients, shifting the clinical goal to chronic functional maintenance. 66 In this chronic context, measuring adaptation (e.g., the use of walking aids, orthoses, or modification of daily duties) becomes as important as measuring physical inability. 67 , 68 , 69 Furthermore, as patients manage chronic pain over longer trajectories, anxiety regarding dependence on pain medication has emerged as a critical psychosocial theme that warrants specific consideration and assessment in future modular updates. 70 , 71

This review has several limitations. First, we restricted our search to English-language publications. While the QLQ-BM22 is available in 32 language versions, our review identified use of only 16 across the included studies, potentially underestimating the module's global clinical application and missing psychometric or validation studies published in local-language journals. This limitation is particularly relevant to the interpretation of cross-cultural validation, as some translated or locally validated versions of the QLQ-BM22 may not have been captured. Second, in studies where the language of administration was not explicitly stated, we inferred based on the country of the study, which may introduce classification errors. Third, regarding exclusion criteria, it is possible that studies reporting minor psychometric details (e.g., Cronbach's α) in the body text without mentioning them in the abstract or title may have been missed during the initial screening process. Fourth, the absence of a formal study-level quality assessment means that our findings should be interpreted as a synthesis of reported evidence rather than a graded assessment of evidence certainty. Some psychometric and implementation findings may therefore have been influenced by limitations in the design or reporting of the original studies. Despite these limitations, this review represents the most comprehensive synthesis of the performance of the QLQ-BM22 to date. By rigorously evaluating the studies across diverse clinical settings, including radiotherapy, surgical intervention, and contemporary systemic therapy, and adhering to a strict double-reviewer methodology with reference list checking, these findings provide a robust evidence base to guide the future update of the EORTC bone metastases module.

Future work should prioritize the development of an updated EORTC bone metastases module that remains relevant across the clinical spectrum of metastatic bone disease. The updated module should capture symptom patterns, functional concerns, and treatment-related effects that are important in contemporary care, including neuropathic pain, mobility limitations, and selected longer-term skeletal events where relevant. At the same time, the marked heterogeneity of patients with bone metastases means that a single fixed questionnaire may not be optimal for all clinical contexts, particularly if additional survivorship- or treatment-specific domains increase response burden and reduce relevance for patients with limited prognosis, in whom short-term symptom control remains the primary focus.

Future refinement may therefore be better achieved through a hierarchical structure, with a core set of universally relevant items and optional domains for specific clinical situations, or through electronic approaches using item libraries, branching logic, or computerized adaptive test. 72 , 73 , 74 Within such a framework, additional psychosocial themes, such as fear-avoidant behaviors or concerns related to prolonged analgesic use, could be explored through qualitative interviews, item generation, and cognitive debriefing before consideration for inclusion. Equally, future revision should assess whether existing items can be simplified, combined, or removed in order to preserve feasibility and minimize respondent burden. Against this background, a rigorous psychometric re-evaluation across treatment modalities and tumor types is required, with explicit assessment of structural validity, internal consistency, test-retest reliability, responsiveness, and MCID. Formal cross-cultural validation and testing of score comparability across languages and settings should also remain priorities. Ultimately, the goal is a contemporary, flexible, and psychometrically robust instrument that integrates modern concepts of pain, function, and survivorship while adhering to the methodological standards that define EORTC instruments. 12 , 74

The QLQ-BM22 has served as a key tool for assessing HRQoL in patients with bone metastases for more than a decade. Its strengths in reliability and validity have supported widespread use in clinical trials worldwide. In light of substantial changes in treatments, care pathways and patient trajectories, an updated bone metastases module is now warranted. The forthcoming revision should preserve the conceptual foundation of the QLQ-BM22 while modernizing content and ensuring cross-cultural comparability. A revised instrument is likely to better reflect current standards of care and to improve the precision and global applicability of HRQoL research in metastatic bone disease.

Contributors

NW and BZ share co-first authorship and contributed equally to the conceptualization, methodology, investigation, data curation, formal analysis, and writing—original draft. EC and SFL share co-senior authorship and contributed to the conceptualization, methodology, formal analysis, writing—original draft, project administration, and supervision. HCYW, SK, CY, SV, SB, HS, AR, AWC, BAV, DR, AA, PB, MA, GNM, DSMdO, VV, MG, VK, and ZL contributed to writing—review & editing. NW, BZ, and SFL directly accessed and verified the underlying data reported in the manuscript. All authors had full access to all the data in the study, accepted responsibility to submit for publication, and read and approved the final version of the manuscript.

Data sharing statement

The data are reported in previously published studies and accessible in corresponding publications. The datasets of abstracts and analyzed materials are available from the corresponding author on reasonable request.

Editor note

The Lancet Group takes a neutral position with respect to territorial claims in published maps and institutional affiliations.

Declaration of interests

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: DR reports that he received grants from the European Development Fund (Interreg), honoraria as Guest Editor for Elsevier, and support for attending meetings from Spanish Society for Radiation Oncology (SEOR), outside the submitted work. The other authors declare no competing interest associated with this manuscript.

Footnotes

Supplementary data related to this article can be found at https://doi.org/10.1016/j.eclinm.2026.103970 .

Supplementary data

Supplementary Figures

References

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