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西班牙版EORTC QLQ-MY20心理测量特性评估及西班牙真实世界中复发和/或难治性多发性骨髓瘤患者健康相关生活质量结果评价:CharisMMa研究结果

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.

作者信息

Dachs Laura Rosiñol, Gaisán Carmen Montes, Bustamante Gabriela, López Sebastián Garzón, García Esther González, Persona Ernesto Pérez, González-Calle Verónica, Auzmendi Maialen Sirvent, Pérez José Maria Arguiñano, González Montes Yolanda, Ríos Tamayo Rafael, de Miguel Llorente Dunia, Bernal Luis Palomera, Mayol Antonia Sampol, Caro Carmen Couto, Grande Marta, Fernández-Nistal Alonso, Naves Andrea, Miguel Enrique M Ocio San

机构信息

Hospital Clinic, Barcelona, Barcelona, Spain.

Hospital Universitario Marqués de Valdecilla (IDIVAL). Universidad de Cantabria. Santander, Spain.

出版信息

Leuk Lymphoma. 2023 Nov-Dec;64(11):1847-1856. doi: 10.1080/10428194.2023.2240922. Epub 2023 Aug 4.

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.

摘要

我们评估了欧洲癌症研究与治疗组织(EORTC)多发性骨髓瘤(MM)特异性生活质量(QoL)问卷模块(QLQ-MY20)西班牙语版本在复发/难治性MM(RRMM)患者中的心理测量学特性。这是一项在RRMM患者中使用EORTC QLQ-C30和QLQ-MY20的观察性、横断面、多中心研究(ClinicalTrials.gov标识符NCT03188536)。我们评估了无应答率、天花板/地板效应、内部一致性、重测信度和效度。该研究纳入了276例患者(53.3%为男性,平均[标准差]年龄为67.4[10.5]岁)。EORTC QLQ-MY20显示出低无应答率、极低的天花板和地板效应以及良好的内部一致性。重测信度评估显示出良好的短期稳定性,结构效度分析表明有四个主要因素与原始版本相似,标准效度评估显示组间无差异。总之,EORTC QLQ-MY20西班牙语版本是评估RRMM患者QoL的可靠且有效的工具。

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