title: A prospective study validating the EORTC QLQ-BM22 bone metastases module in patients with painful bone metastases undergoing palliative radiotherapy.
abstract: Quality of life (QOL) can be compromised in patients with bone metastases, and validated QOL instruments are required to accurately measure QOL outcomes in this population. This study investigated the validity, reliability and responsiveness of the EORTC QLQ-BM22 module with the EORTC QLQ-C15-PAL instrument in bone metastases.
  
  
  
  The studied patients underwent palliative radiotherapy to bone metastases in the randomized NCIC CTG SC 23 trial. Multi-trait scaling analysis was performed to determine convergent and divergent validity among scales. Pearson coefficients were calculated to determine the correlation between items of the two instruments. The clinical validity and responsiveness of the QLQ-BM22 was tested by known group comparisons of different performance status and response to radiotherapy.
  
  
  
  204 patients completed both questionnaires at baseline and 42day follow-up. On multi-trait scaling analysis, there was mixed evidence of construct validity (explained by the questionnaire format and population characteristics). There was little correlation between most QLQ-BM22 and QLQ-C15-PAL items (except for conceptually related scales) validating their complementary nature. There were statistically significant differences in all QLQ-BM22 scale scores in groups with KPS<80 vs. KPS⩾80 and three out of four QLQ-BM22 scale scores in "responders" vs. "non-responders" to radiotherapy. In patients who responded to radiotherapy, there were statistically significant differences in all QLQ-BM22 scale scores between baseline and follow-up.
  
  
  
  This study further validates the use of the QLQ-BM22 as a robust and sensitive instrument to assess QOL in patients with bone metastases treated with palliative radiotherapy.
authors.affiliation: Sunnybrook Odette Cancer Centre, University of Toronto, Canada.
authors.forename: Srinivas
authors.initials: S
authors.lastname: Raman
authors.affiliation: Canadian Clinical Trials Group, Cancer Research Institute, Queen's University, Kingston, Canada.
authors.forename: Keyue
authors.initials: K
authors.lastname: Ding
authors.affiliation: Sunnybrook Odette Cancer Centre, University of Toronto, Canada. Electronic address: Edward.Chow@sunnybrook.ca.
authors.forename: Edward
authors.initials: E
authors.lastname: Chow
authors.affiliation: Juravinski Hospital and Cancer Centre and McMaster University, Hamilton, Canada.
authors.forename: Ralph M
authors.initials: RM
authors.lastname: Meyer
authors.affiliation: Centre Hospitalier Universitaire de Sherbrooke, Canada.
authors.forename: Abdenour
authors.initials: A
authors.lastname: Nabid
authors.affiliation: Hopital Maisonneuve-Rosemont, Montreal, Canada.
authors.forename: Pierre
authors.initials: P
authors.lastname: Chabot
authors.affiliation: CHUM-Hopital Notre-Dame, Montreal, Canada.
authors.forename: Genevieve
authors.initials: G
authors.lastname: Coulombe
authors.affiliation: CancerCare Manitoba, Winnipeg, Canada.
authors.forename: Shahida
authors.initials: S
authors.lastname: Ahmed
authors.affiliation: Grand River Regional Cancer Centre, Grand River Hospital, Kitchener, Canada.
authors.forename: Joda
authors.initials: J
authors.lastname: Kuk
authors.affiliation: London Regional Cancer Program, Canada.
authors.forename: A Rashid
authors.initials: AR
authors.lastname: Dar
authors.affiliation: Cancer Centre of Southeastern Ontario, Kingston General Hospital, Canada.
authors.forename: Aamer
authors.initials: A
authors.lastname: Mahmud
authors.affiliation: Cross Cancer Institute, Edmonton, Canada.
authors.forename: Alysa
authors.initials: A
authors.lastname: Fairchild
authors.affiliation: Canadian Clinical Trials Group, Cancer Research Institute, Queen's University, Kingston, Canada.
authors.forename: Carolyn F
authors.initials: CF
authors.lastname: Wilson
authors.affiliation: Tom Baker Cancer Centre, University of Calgary, Canada.
authors.forename: Jackson S Y
authors.initials: JS
authors.lastname: Wu
authors.affiliation: University of Ottawa, Ottawa Hospital Research Institute, Canada.
authors.forename: Kristopher
authors.initials: K
authors.lastname: Dennis
authors.affiliation: Sunnybrook Odette Cancer Centre, University of Toronto, Canada.
authors.forename: Carlo
authors.initials: C
authors.lastname: DeAngelis
authors.affiliation: Princess Margaret Hospital, Radiation Medicine Program, Ontario Cancer Institute, University of Toronto, Canada.
authors.forename: Rebecca K S
authors.initials: RK
authors.lastname: Wong
authors.affiliation: Canadian Clinical Trials Group, Cancer Research Institute, Queen's University, Kingston, Canada.
authors.forename: Liting
authors.initials: L
authors.lastname: Zhu
authors.affiliation: Queen's University, Kingston, Canada.
authors.forename: Michael
authors.initials: M
authors.lastname: Brundage
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001859:Bone Neoplasms / Q000150:complications / Q000532:radiotherapy* / Q000556:secondary*; D002170:Canada; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology*; D010166:Palliative Care / Q000379:methods*; D011446:Prospective Studies; D011788:Quality of Life; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires
keywords: Bone metastases; EORTC QLQ-BM22 module; EORTC QLQ-C15-PAL instrument; Radiation; Validation