Health-care workers now accept quality of life (QOL) as an important outcome to evaluate in clinical research and as a useful measure of quality care. Indeed, current demand for QOL assessment in clinical practice has outpaced the availability of valid, streamlined, cost-effective methods for carrying out such assessment, although new tools are in the offing. This paper will highlight some of the major challenges facing outcomes management and outcomes research, with particular focus on the development of a QOL instrument to evaluate and manage anemia and fatigue in cancer patients--the Functional Assessment of Cancer Therapy-Anemia (FACT-An). The newest version of broader QOL assessment system, the Functional Assessment of Chronic Illness Therapy (FACIT), will also be described.