title: International development of an EORTC questionnaire for assessing health-related quality of life in chronic myeloid leukemia patients: the EORTC QLQ-CML24.
abstract: BACKGROUND
  Health-related quality of life (HRQOL) is a key aspect for chronic myeloid leukemia (CML) patients. The aim of this study was to develop a disease-specific HRQOL questionnaire for patients with CML to supplement the European Organization for Research and Treatment of Cancer (EORTC)-QLQ C30.
  
  
  METHODS
  The process followed a predefined and systematic stepwise iterative process as defined by the EORTC guidelines for questionnaire development. The process was divided into 3 phases: (1) generation of relevant HRQOL issues, (2) operationalization of the HRQOL issues into a set of items, and (3) pretesting the questionnaire for relevance and acceptability. Descriptive statistics and psychometric analyses were also performed.
  
  
  RESULTS
  Overall, 655 CML patients were enrolled in 10 countries including the USA and countries in Europe and Asia. Interviews with health-care professionals experienced in CML (n = 59) were also conducted. Results from the interviews, clinical experiences, and statistical analyses were used to develop the EORTC QLQ-CML24. The final module consists of 24 items assessing the following aspects: symptom burden, impact on daily life and on worry/mood, body image problems, and satisfaction with care and with social life. Internal consistency, assessed with Cronbach's alpha coefficients, ranged from 0.73 to 0.83 for the proposed scales.
  
  
  CONCLUSIONS
  The EORTC QLQ-CML24 is an internationally developed HRQOL questionnaire for CML patients, and its implementation in clinical research and practice can provide important information to facilitate clinical decision-making.
authors.affiliation: Italian Group for Adult Hematologic Diseases GIMEMA, Data Center and Health Outcomes Research Unit, Via Benevento, 6, 00161, Rome, Italy, f.efficace@gimema.it.
authors.forename: Fabio
authors.initials: F
authors.lastname: Efficace
authors.forename: Michele
authors.initials: M
authors.lastname: Baccarani
authors.forename: Massimo
authors.initials: M
authors.lastname: Breccia
authors.forename: Susanne
authors.initials: S
authors.lastname: Saussele
authors.forename: Gregory
authors.initials: G
authors.lastname: Abel
authors.forename: Giovanni
authors.initials: G
authors.lastname: Caocci
authors.forename: Francois
authors.initials: F
authors.lastname: Guilhot
authors.forename: Kim
authors.initials: K
authors.lastname: Cocks
authors.forename: Adel
authors.initials: A
authors.lastname: Naeem
authors.forename: Mirjam
authors.initials: M
authors.lastname: Sprangers
authors.forename: Simone
authors.initials: S
authors.lastname: Oerlemans
authors.forename: Weichu
authors.initials: W
authors.lastname: Chie
authors.forename: Fausto
authors.initials: F
authors.lastname: Castagnetti
authors.forename: Felice
authors.initials: F
authors.lastname: Bombaci
authors.forename: Giora
authors.initials: G
authors.lastname: Sharf
authors.forename: Annarita
authors.initials: A
authors.lastname: Cardoni
authors.forename: Lucien
authors.initials: L
authors.lastname: Noens
authors.forename: Stephan
authors.initials: S
authors.lastname: Pallua
authors.forename: Marzia
authors.initials: M
authors.lastname: Salvucci
authors.forename: Ourania
authors.initials: O
authors.lastname: Nicolatou-Galitis
authors.forename: Gianantonio
authors.initials: G
authors.lastname: Rosti
authors.forename: Franco
authors.initials: F
authors.lastname: Mandelli
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001549:Benzamides / Q000627:therapeutic use; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D000068877:Imatinib Mesylate; D007391:International Cooperation; D007407:Interviews as Topic; D017567:Karnofsky Performance Status; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000627:therapeutic use; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D011594:Psychometrics / Q000295:instrumentation*; D011743:Pyrimidines / Q000627:therapeutic use; D011788:Quality of Life; D012111:Residence Characteristics; D012923:Social Class; D011795:Surveys and Questionnaires / Q000592:standards*; D055815:Young Adult
chemical_list: D001549:Benzamides; D010879:Piperazines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D000068877:Imatinib Mesylate
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