THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER APPROACH TO QUALITY-OF-LIFE ASSESSMENT - GUIDELINES FOR DEVELOPING QUESTIONNAIRE MODULES
THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER APPROACH TO QUALITY-OF-LIFE ASSESSMENT - GUIDELINES FOR DEVELOPING QUESTIONNAIRE MODULES
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DOI：
10.1007/bf00434800
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发表时间：
1993-08-01
影响因子：
3.5
通讯作者：
AARONSON, NK
中科院分区：
文献类型：
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作者：
SPRANGERS, MAG;CULL, A;AARONSON, NK
EORTC生活质量研究组（研究组）在癌症临床试验中采用模块化方法评估生活质量（QOL）。一个“核心”工具-QLQ-C30-已被设计为涵盖一系列的生活质量问题相关的广泛的癌症患者。本QLQ-C30计划由更具体的子量表（“模块”）补充，以评估对特定患者亚组特别重要的QOL方面。由于研究组的个别成员将参与模块开发，因此需要制定准则，使模块开发过程标准化，以确保各模块的质量一致。本文介绍了这些准则。定义了术语“模块”，概述了模块的组成，并指定了用于开发模块的标准。模块的开发过程，包括四个阶段（生成相关的生活质量问题，操作的生活质量问题到一组项目，预测试的模块问卷，和大规模的现场测试）进行了详细描述。此外，跨文化工具的发展，并从研究小组内部监测模块开发过程的必要性有关的问题进行了讨论。最后，介绍开发两个特定于站点的模块的经验（即，头颈部和乳腺癌），并在何种程度上满足实际要求的准则进行了讨论。该指南似乎提供了一个实用的工具，模块建设，可以促进发展一个全面的系统，用于评估国际癌症患者的生活质量。
The EORTC Study Group on Quality of Life (the Study Group) has adopted a modular approach to quality of life (QOL) assessment in cancer clinical trials. A 'core' instrument-the QLQ-C30-has been designed to cover a range of QOL issues relevant to a broad spectrum of cancer patients. It is intended that this QLQ-C30 be supplemented by more specific subscales ('modules') to assess aspects of QOL of particular importance to specific subgroups of patients. Since individual members of the Study Group were to be involved in module development, guidelines were required to standardize the module development process in order to ensure uniformly high quality across modules. These guidelines are presented in this paper. The term 'module' is defined, the composition of modules is outlined, and the criteria used to develop modules are specified. The module development process, consisting of four phases (generation of relevant QOL issues, operationalization of the QOL issues into a set of items, pretesting the module questionnaire, and large-scale field-testing) is described in detail. Further, issues related to cross-cultural instrument development, and the need for monitoring the module development process from within the Study Group are discussed. Finally, experiences with developing two site-specific modules (i.e., for head and neck, and breast cancer), are presented and the extent to which the guidelines meet practical requirements is discussed. The guidelines appear to provide a practical tool for module construction, that can facilitate the development of a comprehensive system for assessing the QOL of cancer patients internationally.