Italian Group for Adult Hematologic Diseases, Data Center and Health Outcomes Research Unit, Rome, Italy.
Italian Group for Adult Hematologic Diseases, Data Center and Health Outcomes Research Unit, Rome, Italy.
Value Health. 2019 Nov;22(11):1303-1310. doi: 10.1016/j.jval.2019.06.004. Epub 2019 Aug 7.
We investigated the validity of the recently developed European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) summary score in patients with hematologic malignancies. Specifically, we evaluated the adequacy of a single-factor measurement model for the QLQ-C30, and its known-groups validity and responsiveness to change over time.
We used confirmatory factor analysis to test the single-factor model of the QLQ-C30, using baseline QLQ-C30 data (N = 2134). The QLQ-C30 summary score was compared to the original QLQ-C30 scales using general (age, sex, Eastern Cooperative Oncology Group performance status, comorbidity) and disease-specific (red blood cell transfusion dependency) groups. Repeated measurements allowed us to investigate responsiveness to change in a subgroup of patients with acute myeloid leukemia.
The single-factor model of the QLQ-C30 exhibited adequate fit in patients with hematologic malignancies. Known-group comparisons generally supported the construct validity of the summary score when using more general grouping variables (sociodemographics, broad clinical parameters). Nevertheless, when groups were formed on the basis of disease-specific variables (eg, transfusion dependency), the summary score performed less well the some of the original, separate scales of the QLQ-C30.
Our findings provide support for the validity of the single-factor model of the EORTC QLQ-C30 in patients with hematologic malignancies. Specifically, the results suggest that the summary score can be used as an endpoint in this population when symptom- or other health domain-specific hypotheses are not available.
我们旨在调查欧洲癌症研究与治疗组织(EORTC)生活质量问卷核心 30 量表(EORTC QLQ-C30)总评分在血液恶性肿瘤患者中的有效性。具体而言,我们评估了 EORTC QLQ-C30 单因素测量模型的充分性,以及其已知群组的有效性和对随时间变化的反应性。
我们使用验证性因子分析来测试 EORTC QLQ-C30 的单因素模型,使用基线 EORTC QLQ-C30 数据(N=2134)。通过一般(年龄、性别、东部肿瘤协作组体能状态、合并症)和疾病特异性(红细胞输血依赖性)群组,将 EORTC QLQ-C30 总评分与原始 EORTC QLQ-C30 量表进行比较。重复测量允许我们在急性髓细胞白血病患者亚组中调查对变化的反应性。
EORTC QLQ-C30 的单因素模型在血液恶性肿瘤患者中表现出足够的拟合度。当使用更一般的分组变量(社会人口统计学、广泛的临床参数)时,已知群组的比较通常支持总评分的结构有效性。然而,当根据疾病特异性变量(例如输血依赖性)分组时,总评分在一些 EORTC QLQ-C30 的原始、独立量表上的表现不如某些量表。
我们的研究结果为 EORTC QLQ-C30 的单因素模型在血液恶性肿瘤患者中的有效性提供了支持。具体而言,结果表明,当不存在症状或其他健康领域特定的假设时,该评分可作为该人群的终点。