Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.
Department of Palliative Care, King Hussein Cancer Center, Amman, Jordan.
Lancet Oncol. 2020 May;21(5):723-732. doi: 10.1016/S1470-2045(20)30093-0. Epub 2020 Mar 23.
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) assesses quality of life (QOL) in patients with lung cancer and was the first EORTC module developed for use in international clinical trials. Since its publication in 1994, major treatment advances with possible effects on QOL have occurred. These changes called for an update of the module and its international psychometric validation. We aimed to investigate the scale structure and psychometric properties of the updated lung cancer module, QLQ-LC29, in patients with lung cancer.
This international, observational field study was done in 19 hospitals across 12 countries. Patients aged older than 18 years with a confirmed diagnosis of lung cancer and no other previous primary tumour, and who were mentally fit with sufficient language skills to understand and complete the questionnaire were included. Patients were asked during a hospital visit to fill in the paper versions of the core questionnaire EORTC QLQ-C30 plus QLQ-LC29, and investigators selected half of these patients to complete the questionnaire again 2-4 weeks later. Our primary aim was to assess the scale structure and psychometric properties of EORTC QLQ-LC29. We analysed scale structure using confirmatory factor analysis; reliability using Cronbach's α value (internal consistency) and intra-class coefficient (test-retest reliability); sensitivity using independent t tests stratified by Karnofsky performance status; and responsiveness to change over time by ANOVA. This study is registered with ClinicalTrials.gov, NCT02745691.
Between April 12, 2016, and Sept 26, 2018, 523 patients with a confirmed diagnosis of either non-small-cell lung cancer (n=442) or small-cell lung cancer (n=81) were recruited. Confirmatory factor analysis provided a solution composed of five multi-item scales (coughing, shortness of breath, fear of progression, hair problems, and surgery-related symptoms) plus 15 single symptom or side-effect items: χ=370·233, root mean square error of approximation=0·075, and comparative-fit index=0·901. Cronbach's α for internal consistencies of all multi-item scales were above the threshold of 0·70. Intra-class coefficients for test-retest reliabilities ranged between 0·82 and 0·97. Three (shortness of breath, fear of progression, and hair problems) of the five multi-item scales showed responsiveness to change over time (p values <0·05), as did nine of 15 single symptom items. Four (coughing, shortness of breath, fear of progression, and surgery-related symptoms) of the five multi-item scales and ten of the 15 single symptom items were sensitive to known group differences (ie, lower vs higher Karnofsky performance status).
Results determined the psychometric properties of the updated lung cancer module, which is ready for use in international clinical studies.
EORTC Quality of Life Group.
欧洲癌症研究与治疗组织（EORTC）肺癌生命质量问卷-13（QLQ-LC13）用于评估肺癌患者的生命质量（QOL），是第一个为国际临床试验开发的 EORTC 模块。自 1994 年发表以来，主要的治疗进展可能会对 QOL 产生影响。这些变化要求对该模块及其国际心理测量学验证进行更新。我们旨在研究更新后的肺癌模块 QLQ-LC29 在肺癌患者中的量表结构和心理测量特性。
这是一项在 12 个国家的 19 家医院进行的国际观察性现场研究。纳入年龄大于 18 岁、经确诊患有肺癌且无其他先前原发性肿瘤、精神状态良好、具有足够语言技能以理解和完成问卷的患者。在医院就诊期间，患者被要求填写纸质版核心问卷 EORTC QLQ-C30 加 QLQ-LC29，研究人员从中随机选择一半患者在 2-4 周后再次填写问卷。我们的主要目的是评估 EORTC QLQ-LC29 的量表结构和心理测量特性。我们采用验证性因子分析评估量表结构；采用 Cronbach's α 值（内部一致性）和组内相关系数（重测信度）评估可靠性；采用独立 t 检验（按卡氏行为状态评分分层）评估敏感性；采用方差分析评估随时间变化的反应能力。这项研究在 ClinicalTrials.gov 注册，编号为 NCT02745691。
2016 年 4 月 12 日至 2018 年 9 月 26 日，共纳入 523 例经确诊患有非小细胞肺癌（n=442）或小细胞肺癌（n=81）的患者。验证性因子分析提供了一个由五个多项目量表（咳嗽、呼吸困难、对进展的恐惧、头发问题和手术相关症状）加 15 个单项症状或副作用项目组成的解决方案：χ=370.233，均方根误差逼近值=0.075，和比较拟合指数=0.901。所有多项目量表的内部一致性 Cronbach's α 值均高于 0.70 的阈值。重测信度的组内相关系数在 0.82 至 0.97 之间。五个多项目量表中的三个（呼吸困难、对进展的恐惧和头发问题）和 15 个单项症状中的九个在随时间变化的反应能力方面具有统计学意义（p 值均<0.05）。五个多项目量表中的四个（咳嗽、呼吸困难、对进展的恐惧和手术相关症状）和 15 个单项症状中的十个对已知的组间差异（即，卡氏行为状态评分较高与较低）具有敏感性。
结果确定了更新后的肺癌模块的心理测量特性，该模块已准备好用于国际临床研究。
EORTC 生活质量组。
