Quality of Life Research

, Volume 23, Issue 3, pp 825–836 | Cite as

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-Galitis
  • Gianantonio Rosti
  • Franco Mandelli
Article

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.

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.

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.

Conclusion

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 

Notes

Acknowledgments

This study was supported by a research grant from the EORTC Quality of Life Group. Also, additional support for the conduct of the study was provided by the Italian Group for Adult Hematologic Diseases (GIMEMA). We are grateful to all the patients who participated in this study. We also thank Felice Bombaci and Giora Sharf (from the CML Advocates Network) for their invaluable help in representing the unique patients’ perspective throughout the development process. We also thank Dagmara Kulis from the EORTC Quality of Life Department (Brussels) for support in coordinating language translations. Finally, we also express our gratitude to Bernhard Holzner and Marianne Hjermstad for reviewing the module development report on behalf of the EORTC Quality of Life Group. Dr. Susanne Saussele is supported by DJCLS R 10/20.

Conflict of interest

Consultancy: F. E (Novartis Pharma, Bristol Myers Squibb), Honoraria: F. C (Novartis Pharma, Bristol Myers Squibb), and Speaking fees: F. G (Novartis Pharma, Bristol Myers Squibb, Ariad).

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Copyright information

© Springer Science+Business Media Dordrecht 2013

Authors and Affiliations

  • Fabio Efficace
    • 1
  • Michele Baccarani
    • 2
  • Massimo Breccia
    • 3
  • Susanne Saussele
    • 4
  • Gregory Abel
    • 5
  • Giovanni Caocci
    • 6
  • Francois Guilhot
    • 7
  • Kim Cocks
    • 8
  • Adel Naeem
    • 9
  • Mirjam Sprangers
    • 10
  • Simone Oerlemans
    • 11
  • Weichu Chie
    • 12
  • Fausto Castagnetti
    • 2
  • Felice Bombaci
    • 13
  • Giora Sharf
    • 14
  • Annarita Cardoni
    • 1
  • Lucien Noens
    • 15
  • Stephan Pallua
    • 16
  • Marzia Salvucci
    • 17
  • Ourania Nicolatou-Galitis
    • 18
  • Gianantonio Rosti
    • 2
  • Franco Mandelli
    • 1
  1. 1.Italian Group for Adult Hematologic Diseases GIMEMAData Center and Health Outcomes Research UnitRomeItaly
  2. 2.Department of Hematology-Oncology, S. Orsola-Malpighi HospitalUniversity of BolognaBolognaItaly
  3. 3.Department of Cellular Biotechnologies and HematologyUniversity of Rome “Sapienza”RomeItaly
  4. 4.Medizinische Fakultät MannheimUniversität HeidelbergMannheimGermany
  5. 5.Division of Population Sciences, Department of Medical OncologyDana-Farber Cancer InstituteBostonUSA
  6. 6.Department of Internistic Medical SciencesUniversity of CagliariCagliariItaly
  7. 7.Oncologie Hématologique et Thérapie Cellulaire, Centre Hospitalier Universitaire de PoitiersInserm CIC 0802PoitiersFrance
  8. 8.York Trials Unit, Department of Health SciencesUniversity of YorkYorkUK
  9. 9.Department of HematologyBaghdad Teaching HospitalBaghdadIraq
  10. 10.Department of Medical PsychologyUniversity of AmsterdamAmsterdamThe Netherlands
  11. 11.Comprehensive Cancer Centre SouthEindhovenThe Netherlands
  12. 12.Department of Public Health, Graduate Institute of Preventive Medicine, College of Public HealthNational Taiwan UniversityTaipeiTaiwan
  13. 13.Gruppo AIL Pazienti LMC (Italian Member of CML Advocates Network)TurinItaly
  14. 14.CML Advocates NetworkTel AvivIsrael
  15. 15.Department of HematologyGhent University HospitalGhentBelgium
  16. 16.Department for Psychiatry and PsychotherapyInnsbruck Medical UniversityInnsbruckAustria
  17. 17.Hematology UnitAzienda Usl RavennaRavennaItaly
  18. 18.Clinic of Hospital Dentistry, Dental Oncology Unit Dental SchoolUniversity of AthensAthensGreece

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