International development of an EORTC questionnaire for assessing health-related quality of life in chronic myeloid leukemia patients: The EORTC QLQ-CML24

Fabio Efficace, Michele Baccarani, Massimo Breccia, Susanne Saussele, Gregory Abel, Giovanni Caocci, Francois Guilhot, Kim Cocks, Adel Naeem, Mirjam Sprangers, Simone Oerlemans, Weichu Chie, Fausto Castagnetti, Felice Bombaci, Giora Sharf, Annarita Cardoni, Lucien Noens, Stephan Pallua, Marzia Salvucci, Ourania Nicolatou-GalitisGianantonio Rosti, Franco Mandelli

Research output: Contribution to journalArticleScientificpeer-review

66 Citations (Scopus)


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.
Patients and 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.
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.
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.
Keywords: Quality of life, Chronic myeloid leukemia, Questionnaire
Original languageEnglish
Pages (from-to)825-836
JournalQuality of Life Research
Issue number3
Publication statusPublished - Apr 2014


  • Quality of life
  • Chronic myeloid leukemia
  • Questionnaire


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