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

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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.

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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).

Author information

Authors and Affiliations

  1. Italian Group for Adult Hematologic Diseases GIMEMA, Data Center and Health Outcomes Research Unit, Via Benevento, 6, 00161, Rome, Italy

    Fabio Efficace, Annarita Cardoni & Franco Mandelli

  2. Department of Hematology-Oncology, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy

    Michele Baccarani, Fausto Castagnetti & Gianantonio Rosti

  3. Department of Cellular Biotechnologies and Hematology, University of Rome “Sapienza”, Rome, Italy

    Massimo Breccia

  4. Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany

    Susanne Saussele

  5. Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA

    Gregory Abel

  6. Department of Internistic Medical Sciences, University of Cagliari, Cagliari, Italy

    Giovanni Caocci

  7. Oncologie Hématologique et Thérapie Cellulaire, Centre Hospitalier Universitaire de Poitiers, Inserm CIC 0802, Poitiers, France

    Francois Guilhot

  8. York Trials Unit, Department of Health Sciences, University of York, York, UK

    Kim Cocks

  9. Department of Hematology, Baghdad Teaching Hospital, Baghdad, Iraq

    Adel Naeem

  10. Department of Medical Psychology, University of Amsterdam, Amsterdam, The Netherlands

    Mirjam Sprangers

  11. Comprehensive Cancer Centre South, Eindhoven, The Netherlands

    Simone Oerlemans

  12. Department of Public Health, Graduate Institute of Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan

    Weichu Chie

  13. Gruppo AIL Pazienti LMC (Italian Member of CML Advocates Network), Turin, Italy

    Felice Bombaci

  14. CML Advocates Network, Tel Aviv, Israel

    Giora Sharf

  15. Department of Hematology, Ghent University Hospital, Ghent, Belgium

    Lucien Noens

  16. Department for Psychiatry and Psychotherapy, Innsbruck Medical University, Innsbruck, Austria

    Stephan Pallua

  17. Hematology Unit, Azienda Usl Ravenna, Ravenna, Italy

    Marzia Salvucci

  18. Clinic of Hospital Dentistry, Dental Oncology Unit Dental School, University of Athens, Athens, Greece

    Ourania Nicolatou-Galitis

Authors
  1. Fabio Efficace
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  2. Michele Baccarani
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  3. Massimo Breccia
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  4. Susanne Saussele
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  5. Gregory Abel
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  6. Giovanni Caocci
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  7. Francois Guilhot
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  8. Kim Cocks
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  9. Adel Naeem
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  10. Mirjam Sprangers
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  11. Simone Oerlemans
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  12. Weichu Chie
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  13. Fausto Castagnetti
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  14. Felice Bombaci
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  15. Giora Sharf
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  16. Annarita Cardoni
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  17. Lucien Noens
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  18. Stephan Pallua
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  19. Marzia Salvucci
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  20. Ourania Nicolatou-Galitis
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  21. Gianantonio Rosti
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  22. Franco Mandelli
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Corresponding author

Correspondence to Fabio Efficace.

Additional information

This study was conducted on behalf of EORTC Quality of Life Group.

Presented in part at the 53rd Annual Meeting of the American Society of Hematology (ASH). December 10–13, 2011, San Diego (CA), USA.

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Efficace, F., Baccarani, M., Breccia, M. et al. International development of an EORTC questionnaire for assessing health-related quality of life in chronic myeloid leukemia patients: the EORTC QLQ-CML24. Qual Life Res 23, 825–836 (2014). https://doi.org/10.1007/s11136-013-0523-5

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