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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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.
KeywordsQuality of life Chronic myeloid leukemia Questionnaire
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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