Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.
Regional Advisory Unit for Palliative Care, Department of Oncology, Oslo University Hospital, Oslo, and European Palliative Care Research Center (PRC), Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology and St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
Ann Oncol. 2017 Nov 1;28(11):2874-2881. doi: 10.1093/annonc/mdx453.
The European Organization for Research and Treatment of Cancer (EORTC) QLQ-LC13 was the first module to be used in conjunction with the core questionnaire, the QLQ-C30. Since the publication of the LC13 in 1994, major advances have occurred in the treatment of lung cancer. Given this, an update of the EORTC QLQ-LC13 was undertaken.
The study followed phases I to III of the EORTC Module Development Guidelines. Phase I generated relevant quality-of-life issues using a mix of sources including the involvement of 108 lung cancer patients. Phase II transformed issues into questionnaire items. In an international multicenter study (phase III), patients completed both the EORTC QLQ-C30 and the 48-item provisional lung cancer module generated in phases I and II. Patients rated each of the items regarding relevance, comprehensibility, and acceptance. Patient ratings were assessed against a set of prespecified statistical criteria. Descriptive statistics and basic psychometric analyses were carried out.
The phase III study enrolled 200 patients with histologically confirmed lung cancer from 12 centers in nine countries (Cyprus, Germany, Italy, Israel, Spain, Norway, Poland, Taiwan, and the UK). Mean age was 64 years (39 - 91), 59% of the patients were male, 82% had non-small-cell lung cancer, and 56% were treated with palliative intent. Twenty-nine of the 48 questions met the criteria for inclusion.
The resulting module with 29 questions, thus currently named EORTC QLQ-LC29, retained 12 of the 13 original items, supplemented with 17 items that primarily assess treatment side-effects of traditional and newer therapies.
欧洲癌症研究与治疗组织（EORTC）的 QLQ-LC13 是第一个与核心问卷 QLQ-C30 联合使用的模块。自 1994 年 LC13 发表以来，肺癌治疗取得了重大进展。有鉴于此，对 EORTC QLQ-LC13 进行了更新。
该研究遵循 EORTC 模块开发指南的 I 至 III 阶段。第一阶段使用多种来源（包括 108 名肺癌患者的参与）产生了相关的生活质量问题。第二阶段将问题转化为问卷项目。在一项国际多中心研究（第三阶段）中，患者同时完成了 EORTC QLQ-C30 和第一和第二阶段生成的 48 项暂定肺癌模块。患者对每个项目的相关性、可理解性和可接受性进行了评分。根据一套预先指定的统计标准评估患者的评分。进行了描述性统计和基本心理测量分析。
第三阶段研究纳入了来自 9 个国家（塞浦路斯、德国、意大利、以色列、西班牙、挪威、波兰、中国台湾和英国）的 12 个中心的 200 名经组织学证实的肺癌患者。患者的平均年龄为 64 岁（39-91），59%为男性，82%患有非小细胞肺癌，56%接受姑息治疗。48 个问题中有 29 个符合纳入标准。
由此产生的包含 29 个问题的模块，目前命名为 EORTC QLQ-LC29，保留了原始 13 个项目中的 12 个，补充了 17 个主要评估传统和新型疗法治疗副作用的项目。
