Outcomes research is a life sciences field that focuses on patient-oriented outcomes, which are important to a wide range of stakeholders, including patients, physicians, health care systems and payers, and society. An important emphasis of outcomes research is assessment of medical processes and interventions in "real world" settings rather than under experimental conditions. A condition of this approach is that many studies are observational in design. This article reviews the methodologies that are typical of outcomes research and discusses the strengths and weaknesses of these methodologies. Controversial topics in respiratory diseases such as intensive care unit (ICU) organization and relationships of hospital volume to patient mortality are discussed to illustrate how different study designs and analytic techniques can lead to discrepant study results. Outcomes research will increase in importance and application as health care systems and payers become more interested in maximizing patient outcomes relative to resources used. Resources should be made available to enhance the training of new investigators and provide sufficient expertise for the design and analysis of influential studies.
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