title: Minimal clinically important differences in the EORTC QLQ-BN20 in patients with brain metastases.
abstract: BACKGROUND
  Quality of life (QOL) is an important treatment endpoint in advanced cancer patients with brain metastases. In clinical trials, statistically significant changes can be reached in a large enough population; however, these changes may not be clinically relevant.
  
  
  OBJECTIVE
  The objective of this study was to determine the minimal clinically important difference (MCID) for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire brain module (EORTC QLQ-BN20) in patients with brain metastases.
  
  
  METHODS
  Patients undergoing radiotherapy for brain metastases completed the EORTC QLQ-BN20 and QLQ-C30/C15-PAL at baseline and 1-month follow-up. MCIDs were calculated for both improvement and deterioration using anchor- and distribution-based approaches. The anchor of overall QOL (as assessed by question 30 or question 15 on the QLQ-C30 and QLQ-C15-PAL, respectively) was used to determine meaningful change.
  
  
  RESULTS
  A total of 99 patients were included. The average age was 61 years, and the most common primary cancer sites were the lung and breast. Statistically significant meaningful differences were seen on two scales. A decrease of 6.1 (95 % confidence interval (CI) 0.8 to 11.4) units and 13.8 (0.2 to 27.4) units was required to represent clinically relevant deterioration of seizures and weakness of legs, respectively. Distribution-based MCID estimates tended to be closer to 0.5 SD on the EORTC QLQ-BN20.
  
  
  CONCLUSIONS
  Understanding MCIDs allows physicians to determine the impact of treatment on patients' QOL and allows for determination of sample sizes for clinical trials. Future studies should be conducted to validate our findings in a larger population of patients with brain metastases.
authors: Rapid Response Radiotherapy Program, Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, 2075 Bayview Avenue, Toronto, ON, Canada, M4N 3M5.
authors: Erin
authors: E
authors: Wong
authors: Liying
authors: L
authors: Zhang
authors: Marc
authors: M
authors: Kerba
authors: Palmira Foro
authors: PF
authors: Arnalot
authors: Brita
authors: B
authors: Danielson
authors: May
authors: M
authors: Tsao
authors: Gillian
authors: G
authors: Bedard
authors: Nemica
authors: N
authors: Thavarajah
authors: Paul
authors: P
authors: Cheon
authors: Cyril
authors: C
authors: Danjoux
authors: Natalie
authors: N
authors: Pulenzas
authors: Edward
authors: E
authors: Chow
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001921:Brain / Q000473:pathology; D001932:Brain Neoplasms / Q000473:pathology / Q000523:psychology* / Q000556:secondary*; D001943:Breast Neoplasms / Q000473:pathology; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011788:Quality of Life / Q000523:psychology*; D011795:Surveys and Questionnaires; D055815:Young Adult