Understanding the EORTC QLQ-BM22, the module for patients with bone metastases.

Bone metastases are a frequent complication of cancer. With advances in effective systemic treatment and supportive care, the survival of patients with bone metastases has improved substantially. Treatment options for bone metastases have been expanding, as reflected in the latest clinical trials testing newer generations of bisphosphonates and increased use of orthopedic surgery. There is a great need to monitor not only the benefits but also the side effects of these treatments. Any interventions should aim primarily at improving the quality of life (QoL) in this group of terminal patients. The use of validated bone metastases-specific QoL instruments should be promoted for use in both daily practice and clinical trials. In response to the need for a comprehensive bone metastases-specific QoL instrument, which has been lacking until now, we have developed the European Organization for Research and Treatment of Cancer (EORTC) QoL Group Bone Metastases Module (QLQ-BM22) according to the module development guidelines of the EORTC Quality of Life Group (QLG). As bone metastases patients are palliative and often demonstrate rapid deterioration, we will conduct Phase IV testing of the EORTC QLQ-BM22 alongside the EORTC QLQ-C15-PAL palliative core questionnaire to ease patient burden when completing the study assessments. The international validation of the Bone Metastases Module will facilitate measurement of important QoL issues in palliative care trials. Healthcare professionals will be able to reliably follow their patients' QoL, help patients in choosing treatments and assess the cost-effectiveness of the treatments. Bone metastases clinical trial QoL outcomes will be compared across trials through the utilization of a consistent and valid module questionnaire.