Database Use in Outcomes Research StudiesClinical research includes the traditional prospective clinical trials, cohort studies, and case-control studies, while outcomes research (OR) has now solidified itself as a separate class of clinical research.

OR is an evolving and critical part of health sciences research due to its focus on the improvement of patient care in the practice setting. Evidence included in OR spans all available clinical information, from data generated by randomized controlled trials to real-world clinical, economic, humanistic, patient-reported, and patient satisfaction data. Comparative effectiveness research (CER) is a branch of OR that compares the overall benefit or cost of two active interventions. The use of databases has emerged as a valid, rigorous, and efficient source of data for CER.

One increasingly emergent trend in OR is the evaluation of existing information that has been captured and stored for the primary purpose of processing payment claims for health care services rendered. The employment of these secondary or administrative databases is a distinctly useful method. Large-volume and clinical and administrative databases are used to study regional practice pattern variations, health care disparities, and resource utilization. Generally, large-volume databases can be broadly categorized as either administrative or clinical based on where the data are derived. Administrative databases are largely based on billing information while clinical databases are populated with defined patient information. The geographic catchment areas of individual databases may also vary. They may be national, state-based, or limited to specific geographic areas. All patients in a particular catchment area may be included, or limited to a representative sample.

As their names suggest, the primary purposes of research and administrative databases are different. Typically, it can be assumed that information provided by a research database would be more in-depth and valid than that provided by administrative database. However, researchers may find it more difficult to obtain access to research databases than to administrative claims databases. Moreover, most research databases are specific to a single’ disease category, which limits their applicability for research in other disease categories. These factors highlight the practical utility of administrative claims databases in outcomes research.

Popular databases include the U.S. Health Care Financing Administration’s Medicaid and Medicare databases, the National Ambulatory Medical Care Survey, the National Health Interview Survey, and the Healthcare Cost and Utilization Project; which are relatively inexpensive and offer several advantages. Decision makers often want answers to questions about health care delivery in a relatively short time, too short for long-term prospective studies. Administrative patient databases are appropriate tools for this type of research. They offer ready access to the longitudinal data needed for retrospective studies on medical practice issues that would otherwise require lengthy prospective studies, especially in assessing the effectiveness of interventions in managing chronic diseases.

Many of the benefits of these databases, such as greater efficiency, lower expense, and reduction of bias have been described previously and often outweigh their limitations, including incomplete or missing data and a lack of integration of different types of claims data (medical versus mental health versus prescription drug claims). This positive balance of attributes affords investigators a tool with great versatility and convenience. The lack of head-to-head active treatment comparison trials, especially with interventions past their patent expiration and many newer agents, can be addressed by evaluating multiple clinical and economic effects of interventions in a real-world environment using database studies. Evolving research design and analysis techniques for databases and the minimization of bias coupled with the rapid availability of results collected from patient encounters in a realistic setting have all combined to increase its popularity and acceptance in the scientific community.

These administrative and clinical databases serve as well-powered tools to evaluate regional treatment variation and disparities in care. Use of population-based data permits investigations with adequate power that would not be possible with more limited single-site clinical data. Careful study design, appropriate database selection, and rigorous analyses allow investigators to answer key clinical questions in research.

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