Introduction

Outcomes research may be defined as the systematic collection and analysis of data regarding the results of medical care. In a broad sense, all clinical medical research, ranging from observational epidemiologic studies to randomized clinical trials, could be considered outcomes research since it is concerned with the results of the presence of disease or its treatment. Outcomes research in the present discussion, however, refers more specifically to several overlapping areas of research within the broader field of health services research which are directed at analyzing the results of medical care in real patients in real health care systems with the goal of improving their care. There is nothing fundamentally or conceptually novel about outcomes research, but in the current understanding of the term it is represented by a multidisciplinary field reliant upon contributions from physicians, health services researchers, economists, epidemiologists, statisticians, and others. Although it enjoys a strong commitment from national and private funding agencies, it is a young field whose benefits may only become apparent and generally accepted several years from now.

This chapter will provide an overview of the historical roots of outcomes research, describe the different types of studies which fall under the rubric of outcomes research, and discuss some of the major methodological issues which face the investigator interested in this area. The role of outcomes research in clinical neurology will be stressed, and examples from the neurologic literature, particularly from the authors' specialty field of stroke, will be used to illustrate our points.

Historical perspective

Historically, in the United States, outcomes research as it is currently conceived originated in the growing sense of a health care crisis that came about in the 1980s.