title: International field testing of the reliability and validity of the EORTC QLQ-BM22 module to assess health-related quality of life in patients with bone metastases.
abstract: BACKGROUND
  The objective of this international field study was to test the reliability, validity, and responsiveness of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-BM22 module to assess health-related quality of life (HRQOL) in patients with bone metastases.
  
  
  METHODS
  Patients undergoing a variety of bone metastases-specific treatments were accrued. The QLQ-BM22 was administered with the QLQ-C30 at baseline and at 1 follow-up time point internationally. A debriefing questionnaire was administered to determine patient acceptability and understanding.
  
  
  RESULTS
  Large-scale field testing of the QLQ-BM22 in addition to the QLQ-C30 took place in 7 countries: Brazil, Canada, Cyprus, Egypt, France, India, and Taiwan. A total of 400 patients participated. Multitrait scaling analyses confirmed 4 scales in the 22-item module. The scales were able to discriminate between clinically distinct patient groups, such as between those with a poor and those with a better performance status. The QLQ-BM22 was well received in all 7 countries, and the majority of patients did not recommend any significant changes from the module in its current form.
  
  
  CONCLUSIONS
  The final QLQ-BM22 module contains 22 items and 4 scales assessing Painful Sites, Painful Characteristics, Functional Interference, and Psychosocial Aspects. Results confirmed the validity, reliability, cross-cultural applicability, and sensitivity of the 22-item EORTC QLQ-BM22. It is therefore recommended that the QLQ-BM22 be used in addition to the QLQ-C30 in clinical trials to assess HRQOL in patients with bone metastases.
authors.affiliation: Department of Radiation Oncology, Odette Cancer Centre, University of Toronto, Toronto, Ontario, Canada. edward.chow@sunnybrook.ca
authors.forename: Edward
authors.initials: E
authors.lastname: Chow
authors.forename: Janet
authors.initials: J
authors.lastname: Nguyen
authors.forename: Liying
authors.initials: L
authors.lastname: Zhang
authors.forename: Ling-Ming
authors.initials: LM
authors.lastname: Tseng
authors.forename: Ming-Feng
authors.initials: MF
authors.lastname: Hou
authors.forename: Alysa
authors.initials: A
authors.lastname: Fairchild
authors.forename: Vassilios
authors.initials: V
authors.lastname: Vassiliou
authors.forename: Reynaldo
authors.initials: R
authors.lastname: Jesus-Garcia
authors.forename: Mohamed A
authors.initials: MA
authors.lastname: Alm El-Din
authors.forename: Aswin
authors.initials: A
authors.lastname: Kumar
authors.forename: Fabien
authors.initials: F
authors.lastname: Forges
authors.forename: Wei-Chu
authors.initials: WC
authors.lastname: Chie
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
mesh_terms: D000328:Adult; D000368:Aged; D001859:Bone Neoplasms / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000556:secondary*; D002277:Carcinoma / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000556:secondary*; D005260:Female; D005843:Geography; D006304:Health Status; D006305:Health Status Indicators; D006801:Humans; D038622:Internationality; D008297:Male; D008495:Medical Oncology / Q000379:methods / Q000458:organization & administration; D008875:Middle Aged; D011379:Prognosis; D011788:Quality of Life / Q000523:psychology; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012955:Societies, Medical; D011795:Surveys and Questionnaires