The European Organisation for Research and Treatment of Cancer Quality of Life Multiple Myeloma Questionnaire (EORTC QLQ-MY20) was developed in 1996 to assess health-related quality of life (HRQoL) in patients with multiple myeloma. Since its development new therapies have prolonged survival in patients with myeloma and new combination agents are likely to impact HRQoL outcomes and its measurement. The aim of this review was to explore the use of the QLQ-MY20 and reported methodological issues. An electronic database search was conducted (1996-June 2020) to identify clinical studies/research that used the QLQ-MY20 or assessed its psychometric properties. Data were extracted from full-text publications/conference abstracts and checked by a second rater. The search returned 65 clinical and 9 psychometric validation studies. The QLQ-MY20 was used in interventional (n = 21, 32%) and observational (n = 44, 68%) studies and the publication of QLQ-MY20 data in clinical trials increased over time. Clinical studies commonly included relapsed patients with myeloma patients (n = 15, 68%) and assessed a range of combinations therapies. QLQ-MY20 subscales (disease symptoms [DS], side effects of treatment [SE], future perspectives [FP], body image [BI]) were defined as secondary (n = 12, 55%) or exploratory (n = 7, 32%) trial endpoints, particularly DS (n = 16, 72%) and SE (n = 16, 72%). Validation articles demonstrated that all domains performed well regarding internal consistency reliability (>0.7), test-reset reliability (intraclass correlation coefficient > =0.85), internal and external convergent and discriminant validity. Four articles reported a high percentage of ceiling effects in the BI subscale; all other subscales performed well regarding floor and ceiling effects. The EORTC QLQ-MY20 remains a widely used and psychometrically robust instrument. While no specific problems were identified from the published literature, qualitative interviews are ongoing to ensure new concepts and side effects are included that may arise from patients receiving novel treatments or from longer survival with multiple lines of treatment.
欧洲癌症研究与治疗组织多发性骨髓瘤生活质量问卷（EORTC QLQ-MY20）于1996年开发，用于评估多发性骨髓瘤患者健康相关生活质量（HRQoL）。自其开发以来，新疗法已延长了骨髓瘤患者的生存期，且新型联合治疗方案可能影响HRQoL结果及其测量方式。本综述旨在探讨QLQ-MY20的应用情况及已报告的方法学问题。通过电子数据库检索（1996年至2020年6月），筛选出使用QLQ-MY20或评估其心理测量学特性的临床研究/学术论文。数据从全文出版物/会议摘要中提取，并由第二位评审员核对。检索共获得65项临床研究和9项心理测量学验证研究。QLQ-MY20被应用于干预性研究（21项，占32%）和观察性研究（44项，占68%），且临床试验中QLQ-MY20数据的发表随时间推移逐步增加。临床研究常纳入复发型骨髓瘤患者（15项，占68%），并评估多种联合治疗方案。QLQ-MY20子量表（疾病症状[DS]、治疗副作用[SE]、未来展望[FP]、身体意象[BI]）多被定义为次要终点（12项，占55%）或探索性终点（7项，占32%），其中DS（16项，占72%）和SE（16项，占72%）最为常见。验证性文献表明，所有子量表在内一致性信度（>0.7）、重测信度（组内相关系数≥0.85）及内外收敛效度与区分效度方面均表现良好。四篇文献报告BI子量表存在较高比例的天花板效应；其余子量表在地板效应和天花板效应方面均表现良好。EORTC QLQ-MY20仍然是广泛应用且心理测量学特性稳健的工具。虽然现有文献未发现特定问题，但当前正在进行定性访谈，以确保涵盖接受新型治疗或经多线治疗长期生存患者可能产生的新症状和副作用概念。
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