Validation and reference values of the EORTC QLQ-CML24 questionnaire to assess health-related quality of life in patients with chronic myeloid leukemia

Efficace F 1 , Iurlo A 2 , Patriarca A 3 , Stagno F 4 , Bee PC 5 , Ector G 6 Show all authors , Capodanno I 7 , Elena C 8 , Bonifacio M 9 , Blijlevens NMA 6 , Caocci G 10 , Wan C 11 , Abruzzese E 12 , Breccia M 13 , Cottone F 1 , Okumura I 14 , Oerlemans S 15 , Cascavilla N 16 , Albano F 17 , Kota V 18 , Sztankay M 19 , Miggiano MC 20 , Saussele S 21 , Di Renzo N 22 , Sorà F 23 , Castagnetti F 24 , Baccarani M 24 , Vignetti M 1 , Rosti G 24

Affiliations 

  • 1 Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Rome, Italy
  • 2 Hematology Division, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
  • 3 Department of Translational Medicine, Division of Hematology, University of Eastern Piedmont, Novara, Italy
  • 4 Hematology Section with BMT Unit, AOU Policlinico - V. Emanuele, Catania, Italy
  • 5 Department of Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia
  • 6 Department of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands
  • 7 Hematology, AUSL-IRCCS, Reggio Emilia, Italy
  • 8 Division of Hematology, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy
  • 9 Department of Medicine, Section of Hematology, University of Verona, Verona, Italy
  • 10 Dipartimento Scienze Mediche e Sanità Pubblica, Università di Cagliari, Ospedale Businco, Cagliari, Italy
  • 11 School of Humanities and Management, Research center for quality of life and applied psychology, Key Laboratory for Quality of Life and Psychological Assessment and Intervention, Guangdong Medical University, Dongguan, China
  • 12 Division of Hematology, Ospedale S. Eugenio, Tor Vergata University, ASL Roma 2, Roma, Italy
  • 13 Department of Cellular Biotechnologies and Hematology, "Sapienza" University of Rome, Rome, Italy
  • 14 Unidade de Hematologia, Hemoterapia e Oncologia (UHHO), Serviço de Transplante de Medula Óssea (STMO), Complexo Hospital de Clínicas da Universidade Federal do Paraná, Curitiba, Brazil
  • 15 Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands
  • 16 Department of Hematology and Stem Cell Transplant Unit, Fondazione IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Italy
  • 17 Department of Emergency and Transplantation, Hematology Section, University of Bari Medical School, Bari, Italy
  • 18 Winship Cancer Institute of Emory University, Atlanta, GA, USA
  • 19 Medical University of Innsbruck, University Hospital Innsbruck, Psychiatry II, Innsbruck, Austria
  • 20 Hematology Unit, San Bortolo Hospital, Vicenza, Italy
  • 21 III. Med. Klinik, Universitätsmedizin Mannheim, Theodor-Kutzer-Ufer 1-3, Mannheim, Germany
  • 22 Haematology and SCT Unit, Vito Fazzi Hospital, Lecce, Italy
  • 23 Istituto di Ematologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy
  • 24 Department of Experimental, Diagnostic and Specialty Medicine (DIMES), Institute of Hematology "L. & A. Seràgnoli", "Sant'Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy
Leuk Lymphoma, 2021 03;62(3):669-678.
PMID: 33153355 DOI: 10.1080/10428194.2020.1838509

Abstract

Health-related quality of life (HRQOL) assessment is important to facilitate decisions in the current treatment landscape of chronic myeloid leukemia (CML). Therefore, the availability of a validated HRQOL questionnaire, specifically developed for CML patients treated with tyrosine kinase inhibitors (TKIs), may enhance quality of research in this area. We performed an international study including 782 CML patients to assess the validity of the EORTC QLQ-CML 24 questionnaire, and to generate HRQOL reference values to facilitate interpretation of results in future studies. Internal consistency, assessed with Cronbach's alpha coefficients, ranged from 0.66 to 0.83. In the confirmatory factor analysis, all standardized factor loadings exceeded the threshold of 0.40 (range 0.49-0.97), confirming the hypothesized scale structure. Reference values stratified by age and sex were also generated. Our findings support the use of the EORTC QLQ-CML 24, in conjunction with the EORTC QLQ-C30, as a valuable measure to assess HRQOL in CML patients.

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