McCabe Ryan M, Grutsch James F, Nutakki Swetha B, Braun Donald P, Markman Maurie
Medicine & Science, Cancer Treatment Centers of America at Midwestern Regional Medical Center, Zion, Illinois, United States of America.
Medicine & Science, Cancer Treatment Centers of America at Midwestern Regional Medical Center, Zion, Illinois, United States of America; Department of Epidemiology, University of Illinois School of Public Health, Chicago, Illinois, United States of America.
PLoS One. 2014 Jun 11;9(6):e99445. doi: 10.1371/journal.pone.0099445. eCollection 2014.
This research conducted a face validation study of patient responses to the application of an HRQOL assessment research tool in a comprehensive community cancer program setting across a heterogeneous cohort of cancer patients throughout the natural history of diagnosed malignant disease, many of whom would not be considered candidates for clinical research trial participation.
Cancer registries at two regional cancer treatment centers identified 11072 cancer patients over a period of nine years. The EORTC QLQ-C30 was administered to patients at the time of their initial clinical presentation to these centers. To determine the significance of differences between patient subgroups, two analytic criteria were used. The Mann-Whitney test was used to determine statistical significance; clinical relevance defined a range of point differences that could be perceived by patients with different health states.
Univariate analyses were conducted across stratification variables for population, disease severity and demographic characteristics. The largest differences were associated with cancer diagnosis and recurrence of disease. Large differences were also found for site of origin, mortality and stage; minimal differences were observed for gender and age. Consistently sensitive QoL scales were appetite loss, fatigue and pain symptoms, and role (work-related), social and physical functions.
本研究针对在一个综合社区癌症项目环境中应用健康相关生活质量(HRQOL)评估研究工具时患者的反应进行了一项表面效度研究,该研究涵盖了被诊断患有恶性疾病自然病程中的异质性癌症患者队列,其中许多患者不被视为临床研究试验的参与者。
两个地区癌症治疗中心的癌症登记处确定了在九年期间的11072名癌症患者。在这些患者首次到这些中心就诊时,对他们进行欧洲癌症研究与治疗组织核心问卷(EORTC QLQ-C30)的测评。为了确定患者亚组之间差异的显著性,使用了两个分析标准。采用曼-惠特尼检验来确定统计学显著性;临床相关性定义了不同健康状态患者能够察觉到的一系列分值差异。
针对人群、疾病严重程度和人口统计学特征的分层变量进行了单因素分析。最大的差异与癌症诊断和疾病复发相关。在疾病起源部位、死亡率和分期方面也发现了较大差异;在性别和年龄方面观察到的差异最小。始终具有敏感性的生活质量量表是食欲减退、疲劳和疼痛症状,以及角色(与工作相关)、社会和身体功能。
1)EORTC QLQ-C30在基于非研究的临床护理背景下收集到了有意义的患者健康评估结果;2)患者评估差异在15个生活质量领域中表现各异;3)除了表明患者在某个时间点的感受外,生活质量指标还可能揭示有关对疾病进展、治疗和预期生存的潜在生物学反应的信息。