THE -ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER APPROACH TO DEVELOPING QUESTIONNAIRE MODULES - AN UPDATE AND OVERVIEW

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 instrume nt (the EORTC QLQ-C30) covers a range of QoL issues relevant to a broa d spectrum of patients with cancer. The QLQ-C30 is designed to be supp lemented by more specific subscales (`modules') to assess aspects of Q oL of particular importance to specific subgroups of patients. Since i ndividual members of the study group were to be involved in module dev elopment, guidelines were established. The primary aim of these guidel ines was to standardize the module development process in order to ens ure uniformly high quality across modules. This paper gives an update of the work completed to date. First, while the guidelines proved prac tical 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 am endments will be provided and include (1) stricter monitoring of the d evelopmental process from within the study group, (2) the explicit req uirement of involvement of the study group and (3) a more precise defi nition of the criteria to be fulfilled before modules are allowed to b e called `EORTC modules'. Second, an overview of the modules currently under development or available for general use is provided. These mod ules include those for body image, high-dose chemotherapy, leukaemia, myeloma, palliative care and the following cancers: bladder, brain, br east, colorectal, head and neck, lung, oesophageal, ophthalmic, ovaria n, pancreas and prostate. Finally, the need for the coordination of ef forts in module development, both from within and outside the EORTC, i s discussed. (C) 1998 Lippincott-Raven Publishers.