THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER QLQ-C30 - A QUALITY-OF-LIFE INSTRUMENT FOR USE IN INTERNATIONAL CLINICAL-TRIALS IN ONCOLOGY
THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER QLQ-C30 - A QUALITY-OF-LIFE INSTRUMENT FOR USE IN INTERNATIONAL CLINICAL-TRIALS IN ONCOLOGY
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DOI：
10.1093/jnci/85.5.365
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发表时间：
1993-03-03
期刊：
影响因子：
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通讯作者：
TAKEDA, F
中科院分区：
文献类型：
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作者：
AARONSON, NK;AHMEDZAI, S;TAKEDA, F
背景：1986 年，欧洲癌症研究与治疗组织 (EORTC) 启动了一项研究计划，旨在开发一种综合的、模块化的方法来评估参加国际临床试验的患者的生活质量。目的：我们在此报告对当前核心调查问卷 EORTC QLQ-C30 的实用性、可靠性和有效性进行的国际实地研究的结果。 QLQ-C30 包含九个多项目量表：五个功能量表（身体、角色、认知、情感和社交）；三个症状量表（疲劳、疼痛、恶心和呕吐）；以及全球健康和生活质量量表。还包括几个单项症状测量。方法：对来自 13 个国家的中心的 305 名不可切除肺癌患者在治疗前和治疗期间进行一次问卷调查。评估的临床变量包括疾病阶段、体重减轻、体能状态和治疗毒性。结果：完成问卷的平均时间约为 11 分钟，大多数患者不需要帮助。数据支持了问卷的假设量表结构，但角色功能（工作和家庭活动）除外，这也是唯一一个在治疗前或治疗期间未能达到最低可靠性标准（Cronbach α 系数大于或等于 0.70）的多项目量表。三项研究结果证明了有效性。首先，虽然所有量表间的相关性均具有统计显着性，但相关性为中等，表明这些量表正在评估生活质量结构的不同组成部分。其次，大多数功能和症状测量明显区分了临床状态不同的患者，临床状态由东部肿瘤合作组的体能状态量表、体重减轻和治疗毒性定义。第三，对于在治疗期间表现状态有所改善或恶化的患者，在身体和角色功能、整体生活质量、疲劳、恶心和呕吐方面，在预期方向上出现了统计学上的显着变化。调查问卷的信度和效度在所研究的三个语言文化群体中高度一致：来自英语国家、北欧和南欧的患者。结论：这些结果支持 EORTC QLQ-C30 作为多文化临床研究环境中癌症患者生活质量的可靠且有效的衡量标准。目前正在开展工作，以检查问卷在更多异质性患者样本以及 II 期和 III 期临床试验中的表现。
Background: In 1986, the European Organization for Research and Treatment of Cancer (EORTC) initiated a research program to develop an integrated, modular approach for evaluating the quality of life of patients participating in international clinical trials. Purpose: We report here the results of an international field study of the practicality, reliability, and validity of the EORTC QLQ-C30, the current core questionnaire. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures are also included. Methods: The questionnaire was administered before treatment and once during treatment to 305 patients with nonresectable lung cancer from centers in 13 countries. Clinical variables assessed included disease stage, weight loss, performance status, and treatment toxicity. Results: The average time required to complete the questionnaire was approximately 11 minutes, and most patients required no assistance. The data supported the hypothesized scale structure of the questionnaire with the exception of role functioning (work and household activities), which was also the only multi-item scale that failed to meet the minimal standards for reliability (Cronbach's alpha coefficient greater-than-or-equal-to .70) either before or during treatment. Validity was shown by three findings. First, while all interscale correlations were statistically significant, the correlation was moderate, indicating that the scales were assessing distinct components of the quality-of-life construct. Second, most of the functional and symptom measures discriminated clearly between patients differing in clinical status as defined by the Eastern Cooperative Oncology Group performance status scale, weight loss, and treatment toxicity. Third, there were statistically significant changes, in the expected direction, in physical and role functioning, global quality of life, fatigue, and nausea and vomiting, for patients whose performance status had improved or worsened during treatment. The reliability and validity of the questionnaire were highly consistent across the three language-cultural groups studied: patients from English-speaking countries, Northern Europe, and Southern Europe. Conclusions: These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to examine the performance of the questionnaire among more heterogenous patient samples and in phase II and phase III clinical trials.