Assessment of the psychometric properties of the Spanish version of EORTC QLQ-MY20 and evaluation of health-related quality of Life outcomes in patients with relapsed and/or refractory multiple myeloma in the real-world setting in Spain: results from the CharisMMa study

Abstract

We evaluated the psychometric properties of the Spanish version of the European Organization for Research and Treatment of Multiple Myeloma (MM) specific quality-of-life (QoL) questionnaire module (QLQ-MY20) in relapsed/refractory MM (RRMM) patients. This was an observational, cross-sectional, multicenter study using EORTC QLQ-C30 and QLQ-MY20 in RRMM patients (ClinicalTrials.gov ID NCT03188536). We assessed the non-response rate, ceiling/floor effects, internal consistency, test-retest reliability, and validity. The study included 276 patients (53.3% males, mean [SD] age of 67.4 [10.5] years). The EORTC QLQ-MY20 showed a low non-response rate, very low ceiling and floor effects, and good internal consistency. The test-retest reliability assessment revealed good temporary stability, the construct validity analysis stated four main factors similar to the ones of the original version, and the criterion validity assessment showed no differences between groups. In conclusion, the Spanish version of EORTC QLQ-MY20 is a reliable and valid tool for assessing QoL in RRMM patients.

Keywords:

• Multiple myeloma
• relapsed/refractory multiple myeloma
• quality of life
• health‐related quality of life
• EORTC QLQ-MY20 assessment
• burden of the disease

Acknowledgements

The authors would like to thank the AEAL (Asociación de Pacientes de Linfoma, Mieloma, Leucemia y Síndromes Mieloproliferativos [Spanish Association of Patients with Lymphoma, Myeloma, Leukemia and Myeloproliferative Disorders]) and the researchers of the CharisMMa study group: Fernando Escalante Barrigón (H. León), Cristina Encinas (H. Gregorio Marañón), Marta Sonia González Pérez (C.H.U. Santiago), Miguel Teodoro Hernández (C.H.U. Canarias), Esperanza Lavilla Rubira (H. Lucus Agusti, Santiago), Francisco Javier Capote (H. Puerta del Mar), Joan Bargay Lleonart (H. Son Llátzer), Josep Sarrá Escarre (H.U. Joan XXIII, Tarragona), María Casanova Espinosa (H. Costa Sol), Juan Nicolás Rodríguez Rodríguez (H. Juan Ramon Jiménez, Huelva), Juan José Lahuerta (H. Doce de Octubre), Felipe Casado Montero (C.H. Toledo). Josep Puig provided statistical support on behalf of BioClever, 2005, S.L.U and Beatriz Albuixech-Crespo and Alba Rebollo provided medical writing support on behalf of i2e3 Biomedical Research Institute.

Disclosure statement

LR-D has received honoraria from Janssen, Celgene, Amgen, and Takeda. SG has received fees as speaker from Celgene, Takeda, Janssen, and Amgen. EP-P has received fees as a consultant from Celgene, Amgen, Takeda, GSK, and Janssen; and fees as a speaker from Roche, Celgene, Amgen, Janssen, and Abbvie. VG-C has received consultancy fees from Janssen and Prothena; and fees as speaker from Janssen and Celgene. MS-A has received honoraria as a lecturer and member of the advisory board of BMS/Celgene and Janssen. JMA-P has received consultancy fees from Celgene, Amgen, Janssen, and Abbvie; and honoraria from Novartis, Takeda, Janssen, Celgene, Abbie and Roche. RR-T has received honoraria from Becton-Dickinson, Sanofi, and The Binding Site. LP-B has received honoraria from Janssen and Celgene. EMO has received honoraria from Janssen, Sanofi, BMS/Celgene, Amgen, MSD, Takeda, GSK, Secura Bio, Oncopeptides, and Asofarma. MG, AF-N, and AN are employees of Takeda. CM-G, GB, EG, YG, DM, AS-M, and CC-C declare no conflicts of interest.

Additional information

Funding

The study was sponsored and funded by Takeda Farmacéutica España.