Developing theoretical constructs for outcomes research

Background: In March of 1998, The Advisory Commission on Consumer Protection and Quality in Health Industry released a report in response to the US Presidential Executive Order that recommended increasing funding for outcomes research. This report indicated that outcomes research was critical to assessing the effectiveness of treatment and the quality of care. Methods: A systematic review was conducted of the pertinent English literature that describes the development, methods, and limitations of outcomes research to identify methods for minimizing its limitations. Results: Current evidence indicates that approximately 80% of commonly used medical treatments have not been shown to be efficacious, primarily because the necessary randomized controlled trials have not been conducted because of methodological problems, the time required for their execution, the expense, or ethical reasons. Therefore, physicians disagree on the value of many common clinical practices, which is reflected in the large variation in medical care prescribed for different populations. Outcomes research, which is conducted under actual clinical practice conditions using effectiveness studies, offers an efficient approach for investigating the link between medical care and outcomes. However, the major limitation of past outcomes research has been its limited ability to link medical care with outcomes, because of the lack of theory development to guide the research process, inadequate data sources, or both. Conclusions: The literature review suggests that the use of pertinent theoretical constructs to guide the outcomes research process will generate the results needed to assess the effectiveness of treatment and the quality of care.