Sprangers M A, Cull A, Groenvold M, Bjordal K, Blazeby J, Aaronson N K
Department of Medical Psychology, Academic Hospital, University of Amsterdam, The Netherlands.
Qual Life Res. 1998 May;7(4):291-300. doi: 10.1023/a:1024977728719.
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Study Group has adopted a modular approach to quality of life (QoL) assessment in cancer clinical trials. The core instrument (the EORTC QLQ-C30) covers a range of QoL issues relevant to a broad spectrum of patients with cancer. The QLQ-C30 is designed to 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 established. The primary aim of these guidelines was to standardize the module development process in order to ensure uniformly high quality across modules. This paper gives an update of the work completed to date. First, while the guidelines proved practical for module development, producing modules that exhibit adequate levels of psychometric and cross-cultural validity, experience pointed to three areas where the guidelines required more precision. These amendments will be provided and include (1) stricter monitoring of the developmental process from within the study group, (2) the explicit requirement of involvement of the study group and (3) a more precise definition of the criteria to be fulfilled before modules are allowed to be called 'EORTC modules'. Second, an overview of the modules currently under development or available for general use is provided. These modules include those for body image, high-dose chemotherapy, leukaemia, myeloma, palliative care and the following cancers: bladder, brain, breast, colorectal, head and neck, lung, oesophageal, ophthalmic, ovarian, pancreas and prostate. Finally, the need for the coordination of efforts in module development, both from within and outside the EORTC, is discussed.
欧洲癌症研究与治疗组织（EORTC）生活质量研究组在癌症临床试验中采用模块化方法进行生活质量（QoL）评估。核心工具（EORTC QLQ-C30）涵盖了一系列与广泛癌症患者相关的生活质量问题。QLQ-C30旨在通过更具体的子量表（“模块”）进行补充，以评估对特定患者亚组特别重要的生活质量方面。由于研究组的个别成员将参与模块开发，因此制定了指南。这些指南的主要目的是规范模块开发过程，以确保各模块质量始终保持高水平。本文介绍了迄今为止已完成工作的最新情况。首先，虽然这些指南在模块开发中证明是实用的，所产生的模块具有足够的心理测量学和跨文化效度水平，但经验表明在三个方面指南需要更精确。将提供这些修订内容，包括（1）研究组内部对开发过程进行更严格的监测，（2）明确要求研究组参与，以及（3）更精确地定义在模块被允许称为“EORTC模块”之前需满足的标准。其次，提供了目前正在开发或可供普遍使用的模块概述。这些模块包括用于身体形象、高剂量化疗、白血病、骨髓瘤、姑息治疗以及以下癌症的模块：膀胱癌、脑癌、乳腺癌、结直肠癌、头颈癌、肺癌、食管癌、眼科癌、卵巢癌、胰腺癌和前列腺癌。最后，讨论了EORTC内部和外部在模块开发中协调工作的必要性。
