Surgical outcomes research--a new paradigm for clinical research?

OBJECTIVE: To define outcomes research in terms of a paradigm, grouping six existing research methodologies. BACKGROUND: Although outcomes research is becoming an increasingly popular area in clinical research, an accepted definition is difficult to find. The term 'outcomes research' is often used in the context of a research methodology. METHODS: Topics in dinical research which have been termed 'outcomes research' are discussed including: databases, quality of life studies, effectiveness studies, economic evaluations, small-area rate variation analysis and volume outcome studies, as well as practice guideline development. RESULTS: Outcomes research is not a research methodology in its own right, but a paradigm which groups existing methodologies, providing a structured approach to evaluating the outcomes which are most important to patients, society and those who pay for health care.