International validation of the EORTC QLQ-CLL17 questionnaire for assessment of health-related quality of life for patients with chronic lymphocytic leukaemia

International validation of the EORTC QLQ-CLL17 questionnaire for assessment of health-related quality of life for patients with chronic lymphocytic leukaemia
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DOI:
10.1111/bjh.18072
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发表时间:
2022-03-07
影响因子:
6.5
通讯作者:
van de Poll-Franse, Lonneke
van de Poll-Franse, Lonneke
中科院分区:
医学2区
文献类型:
--
作者:
Oerlemans, Simone;Efficace, Fabio;van de Poll-Franse, Lonneke

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选择最合适的慢性淋巴细胞白血病(CLL)治疗是具有挑战性的。因此,患者报告的健康相关生活质量(HRQOL)是一个需要考虑的关键方面。这项由欧洲癌症研究和治疗组织(EORTC)进行的国际研究测试了一种新开发的CLL患者测量工具的心理测量学特性:EORTC QLQ-CLL17,以补充核心问卷(EORTC QLQ-C30)。来自12个国家的341名慢性淋巴细胞性白血病患者完成了QLQ-C30、QLQ-CLL17和汇报问卷。从医疗记录中记录社会人口学和临床数据。高比例(30%-66%)报告了症状和/或担忧(例如肌肉酸痛、精力不足和对健康的担忧/恐惧)。验证性因素分析表明,3个量表的17个条目(即症状负担、身体状况/疲劳和对健康和功能的担忧/恐惧)符合可接受到良好的匹配。平均完成时间为8分钟。重测效度和收敛效度得到验证。QLQ-CLL17在东部合作肿瘤组(ECOG)表现为0和1-3的患者之间有区别(p‘s<0.01和临床相关)。新开发的EORTC QLQ-CLL17将提高CLL患者HRQOL评估的敏感性。在临床研究和实践中实施这份问卷将有助于产生独特的临床相关数据,以便更好地为CLL治疗决策提供信息。
Selecting the most appropriate chronic lymphocytic leukaemia (CLL) treatment is challenging. Patient-reported health-related quality of life (HRQoL) is therefore a critical aspect to consider. This international study by the European Organization for Research and Treatment of Cancer (EORTC) tested the psychometric properties of a newly developed measure for CLL patients: the EORTC QLQ-CLL17 to supplement the core questionnaire (EORTC QLQ-C30). Patients with CLL (n = 341) from 12 countries completed the QLQ-C30, QLQ-CLL17 and a debriefing questionnaire. Sociodemographic and clinical data were recorded from medical records. A high percentage (30%-66%) reported symptoms and/or worries (e.g. aches/pains in muscles, lack of energy and worry/fears about health). Confirmatory factor analysis showed an acceptable to good fit of the 17 items on the three scales (i.e. symptom burden, physical condition/fatigue and worries/fears about health and functioning). Completion took on average 8 min. Test-retest and convergent validity was demonstrated. The QLQ-CLL17 differentiated between patients with an Eastern Cooperative Oncology group (ECOG) performance of 0 versus 1-3 (p's < 0.01 and clinically relevant). The newly developed EORTC QLQ-CLL17 will increase sensitivity of HRQoL assessment in patients with CLL. Implementation of this questionnaire both in clinical research and practice will help to generate unique clinically relevant data to better inform CLL treatment decision-making.