Outcomes Research in Orthopaedics.

A new agenda in outcomes research has developed in the past decade. The stimulus has come as the result of rapidly increasing health care costs, marked variations in utilization of health care services, and deficiencies in the research literature. Outcomes research includes methods such as analysis of large databases, small-area analysis, structured literature reviews (meta-analysis), prospective clinical trials, decision analysis, and guideline development. Clinical research should be prospective and should employ modern statistical and assessment methods. The focus of this research is on patient-oriented outcomes of care rather than on assessments of the process of care. To illustrate these applications in orthopaedics, lumbar spine fusion with internal fixation for "spinal instability" is presented as an example. Completed large-database analyses, small-area variation studies, and a meta-analysis indicate the need for clinical studies. An outline of the form and content of such a study is presented.