title: Minimal important differences for interpreting health-related quality of life scores from the EORTC QLQ-C30 in lung cancer patients participating in randomized controlled trials.
abstract: BACKGROUND
  The aim of this study was to determine the smallest changes in health-related quality of life (HRQOL) scores in a subset of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) scales, which could be considered as clinically meaningful in patients with non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  WHO performance status (PS) and weight change were used as clinical anchors to determine minimal important differences (MIDs) in HRQOL change scores (range, 0-100) in the EORTC QLQ-C30 scales. Selected distribution-based methods were used for comparison.
  
  
  RESULTS
  In a pooled dataset of 812 NSCLC patients undergoing treatment, the values determined to represent the MID depended on whether patients were improving or deteriorating. MID estimates for improvement (based on a one-category change in PS, 5 - <20% weight gain) were physical functioning (9, 5); role functioning (14, 7); social functioning (5, 7); global health status (9, 4); fatigue (14, 5); and pain (16, 2). The respective MID estimates for deterioration (based on PS, weight loss) were physical (4, 6); role (5, 5); social (7, 9); global health status (4, 4); fatigue (6, 11); and pain (3, 7).
  
  
  CONCLUSIONS
  Based on the selected QLQ-C30 scales, the MID may depend upon whether the patients' PS is improving or worsening, but our results are not definitive. The MID estimates for the specified scales can help clinicians and researchers evaluate the significance of changes in HRQOL and assess the value of a health care intervention or compare treatments. The estimates also can be useful in determining sample sizes in the design of future clinical trials.
authors.affiliation: Quality of Life Department, EORTC, Brussels, Belgium. john.maringwa@eortc.be
authors.forename: John T
authors.initials: JT
authors.lastname: Maringwa
authors.forename: Chantal
authors.initials: C
authors.lastname: Quinten
authors.forename: Madeleine
authors.initials: M
authors.lastname: King
authors.forename: Jolie
authors.initials: J
authors.lastname: Ringash
authors.forename: David
authors.initials: D
authors.lastname: Osoba
authors.forename: Corneel
authors.initials: C
authors.lastname: Coens
authors.forename: Francesca
authors.initials: F
authors.lastname: Martinelli
authors.forename: Jurgen
authors.initials: J
authors.lastname: Vercauteren
authors.forename: Charles S
authors.initials: CS
authors.lastname: Cleeland
authors.forename: Henning
authors.initials: H
authors.lastname: Flechtner
authors.forename: Carolyn
authors.initials: C
authors.lastname: Gotay
authors.forename: Eva
authors.initials: E
authors.lastname: Greimel
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Taphoorn
authors.forename: Bryce B
authors.initials: BB
authors.lastname: Reeve
authors.forename: Joseph Schmucker-Von
authors.initials: JS
authors.lastname: Koch
authors.forename: Joachim
authors.initials: J
authors.lastname: Weis
authors.forename: Egbert F
authors.initials: EF
authors.lastname: Smit
authors.forename: Jan P
authors.initials: JP
authors.lastname: van Meerbeeck
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
mesh_terms: D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology / Q000523:psychology* / Q000628:therapy; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000523:psychology* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012189:Retrospective Studies; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires