Final development and validation of the BOMET-QoL questionnaire for assessing quality of life in patients with malignant bone disease due to neoplasia

SUMMARY This paper describes the final development and validation of the BOMET-QoL questionnaire for assessing health-related quality of life (HRQoL) in patients with malignant bone disease due to neoplasia (MBDN). An observational prospective study was conducted of 263 patients with MBDN. Sociodemographic and clinical variables, Eastern Cooperative Oncology Group (ECOG) Performance Scale Index and Pain Management Index (PMI) were gathered. Patients completed the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and BOMET-QoL questionnaires and the perception of general health status. Both questionnaires were completed again 15 days after the baseline visit by 98 clinically stable patients (Group A), and 3 months and 6 months after the baseline visit by 165 clinically unstable patients (Group B). Prior to validation of the BOMETQoL questionnaire, a factor analysis and psychometric selection of the original items was developed by means of Rasch analysis. The BOMET-QoL questionnaire consisting of 25 items was reduced to an integrated version of 10 items. Scores on the BOMET-QoL-10 questionnaire were shown to be related to the presence, number and duration of irruptive pain crises, the PMI and the ECOG index (p<0.001), and with changes in the perception of general health status and ECOG index (p<0.01). The internal consistency of the questionnaire and the intraclass correlation coefficient (ICC) were high (Cronbach's α=0.93; ICC =0.97). BOMET-QoL-10 is an easy to manage and valid questionnaire in clinical practice conditions.