THE EORTC QLQ-LC13 - A MODULAR SUPPLEMENT TO THE EORTC CORE QUALITY-OF-LIFE QUESTIONNAIRE (QLQ-C30) FOR USE IN LUNG-CANCER CLINICAL-TRIALS
THE EORTC QLQ-LC13 - A MODULAR SUPPLEMENT TO THE EORTC CORE QUALITY-OF-LIFE QUESTIONNAIRE (QLQ-C30) FOR USE IN LUNG-CANCER CLINICAL-TRIALS
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DOI：
10.1016/0959-8049(94)90535-5
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发表时间：
1994-01-01
影响因子：
8.4
通讯作者：
SULLIVAN, M
中科院分区：
文献类型：
--
作者：
BERGMAN, B;AARONSON, NK;SULLIVAN, M
EORTC生活质量研究小组开发了一个模块系统，用于在临床试验中评估癌症患者的生活质量，该系统由两个基本要素组成：(1)核心生活质量问卷EORTC QLQ-C30，涵盖与健康相关的生活质量的一般方面，以及(2)附加的针对疾病或治疗的问卷模块。开展了两项国际研究，以评估核心问卷的实用性、可靠性和有效性，并辅之以13个项目的肺癌特有问卷模块--EORTC QLQ-LC13。本文报道了QLQ-LC13的评估结果。肺癌问卷单元包括多项和单项肺癌相关症状(即咳嗽、咯血、呼吸困难和疼痛)以及常规化疗和放射治疗的副作用(如脱发、神经病变、口腔痛和吞咽困难)的测量。它被用于从17个国家招募的不可切除肺癌患者。总共有883名和735名患者分别在治疗前和治疗期间完成了问卷调查。症状测量在表现状态不同的患者之间有明显的区分。在治疗过程中，所有项目的得分都朝着预期的方向发生了显着变化(即肺癌症状减少，治疗毒性增加)。除了一个例外(口腔疼痛的问题)，随着时间的推移，毒性措施的变化与化疗或放射治疗特别相关。然而，关于神经病的单一项目并没有充分衡量所有症状。问卷假设的量表结构部分得到了数据的支持。多个项目的呼吸困难量表达到了最低可靠性标准(Cronbachα系数>；0.70)，而疼痛项目没有形成一个具有可接受的组比较可靠性估计的量表，总之，国际现场测试的结果支持EORTC QLQ-LC13作为临床有效和有用的工具，结合EORTC核心生活质量问卷，评估参与临床试验的肺癌患者的疾病和治疗特定症状。然而，在一些领域，问卷模块可从进一步完善中受益。此外，它在更长一段时间内的表现仍有待调查。
The EORTC Study Group on Quality of Life has developed a modular system for assessing the quality of life of cancer patients in clinical trials composed of two basic elements: (1) a core quality of life questionnaire, the EORTC QLQ-C30, covering general aspects of health-related quality of life, and (2) additional disease- or treatment-specific questionnaire modules. Two international held studies were carried out to evaluate the practicality, reliability and validity of the core questionnaire, supplemented by a 13-item lung cancer-specific questionnaire module, the EORTC QLQ-LC13. In this paper, the results of an evaluation of the QLQ-LC13 are reported. The lung cancer questionnaire module comprises both multi-item and single-item measures of lung cancer-associated symptoms (i.e. coughing, haemoptysis, dyspnoea and pain) and side-effects from conventional chemo- and radiotherapy (i.e. hair loss, neuropathy, sore mouth and dysphagia). It was administered to patients with non-resectable lung cancer recruited from 17 countries. In total, 883 and 735 patients, respectively, completed the questionnaire prior to and once during treatment. The symptom measures discriminated clearly between patients differing in performance status. All item scores changed significantly in the expected direction (i.e. lung cancer symptoms decreased and treatment toxicities increased) during treatment. With one exception (problems with a sore mouth), the change of toxicity measures over time was related specifically to either chemo- or radiotherapy. However, the single item on neuropathy did not measure adequately the full range of symptoms. The hypothesised scale structure of the questionnaire was partially supported by the data. The multi-item dyspnoea scale met the minimal standards for reliability (Cronbach alpha coefficient >0.70), while the pain items did not form a scale with reliability estimates acceptable for group comparisons, In conclusion, the results from international field testing lend support to the EORTC QLQ-LC13 as a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in lung cancer patients participating in clinical trials, when combined with the EORTC core quality of life questionnaire. In a few areas, however, the questionnaire module could benefit from further refinements. In addition, its performance over a longer period of time still needs to be investigated.