Department of Social Pharmacy, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.
Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.
Curr Med Res Opin. 2021 Jul;37(7):1163-1169. doi: 10.1080/03007995.2021.1929136. Epub 2021 May 28.
Multiple myeloma (MM) is a rare but treatable hematological cancer, which makes the health-related quality of life (HRQoL) an important patient-report outcome measure in clinical studies. The Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20) was developed by the European Organization for Research and Treatment of Cancer (EORTC) to measure HRQoL in people with MM. However, the Brazilian Portuguese version of QLQ-MY20 has not yet been validated for Brazil. This study aimed to evaluate the validity and reliability of the instrument for application in Brazilian patients with MM.
This is a cross-sectional methodological study with patients seen in health services in Belo Horizonte, Brazil. The variables were collected through face-to-face interviews with the QLQ-MY20 instrument and complemented with data from medical records. Content validity analyses (content validity coefficient [CVC]; correctness ratio), convergent and divergent validity (Spearman's correlation coefficient [CC]), internal consistency, and temporal reproducibility (test-retest; intraclass correlation coefficient [ICC]) were performed.
225 patients were included and 71.1% were older than 60. The analysis of the judging committee showed adequate content validity. We observed mainly a good internal consistency of the items and good discrimination power in the convergent and divergent validity. High ICC values were observed through the test-retest, and there was no difference in the scores between the two moments, which shows good temporal stability of the instrument.
The study allowed us to conclude that the Brazilian version of the QLQ-MY20 module is valid and reliable, and thus suitable for application in Brazilians living with MM.
多发性骨髓瘤（MM）是一种罕见但可治疗的血液系统恶性肿瘤，这使得健康相关生活质量（HRQoL）成为临床研究中重要的患者报告结局指标。欧洲癌症研究与治疗组织（EORTC）开发了生活质量问卷多发性骨髓瘤模块（QLQ-MY20），用于测量 MM 患者的 HRQoL。然而，QLQ-MY20 的巴西葡萄牙语版本尚未在巴西得到验证。本研究旨在评估该工具在巴西 MM 患者中的适用性的有效性和可靠性。
这是一项在巴西贝洛奥里藏特的医疗服务机构中进行的横断面方法学研究。通过面对面访谈使用 QLQ-MY20 工具收集变量，并补充病历数据。进行了内容有效性分析（内容有效性系数[CVC]；正确性比）、收敛和发散有效性（Spearman 相关系数[CC]）、内部一致性和时间重现性（测试-再测试；组内相关系数[ICC]）。
共纳入 225 例患者，其中 71.1%年龄大于 60 岁。判断委员会的分析显示，内容有效性适中。我们主要观察到项目具有较好的内部一致性和收敛、发散有效性的良好辨别力。通过测试-再测试观察到较高的 ICC 值，且两个时间点之间的评分无差异，表明该工具具有良好的时间稳定性。
本研究表明，QLQ-MY20 模块的巴西版本是有效且可靠的，因此适用于巴西 MM 患者。
