[Quality of life in oncological studies].

During the past 20 years many efforts were made in oncology to establish quality-of-life research within clinical trials. The first step was to introduce research questions regarding the quality of life (QoL) of patients into the clinical oncological study context. Particularly after publication of the QLQ C 30 questionnaire by the EORTC Quality of Life Study Group a valid and reliable standard instrument for QoL evaluation was available, and many study groups started to include research questions on QoL in their trial protocols. However, it became obvious during the last years that the necessary integration of these methods into the treatment-oriented study protocols was only in part successful. Although QoL is mentioned more and more as a primary or secondary endpoint, the number of investigations that actually employ QoL for answering clinically relevant questions is still very limited. Moreover, under the growing economic pressure in health care during the last years, a shift occurred towards the development of 'general health measures' and towards the economic evaluation of treatment outcome. These developments are very closely linked to quality control and quality assurance issues in regard to the structures of medical decision making. The implications of these developments for QoL research in oncology are addressed.