ABSTRACT

This chapter presents a broad introduction to the opportunities available through the use of large data sets to conduct observational clinical research. Analytics using these data sets are explored, which allow the clinical researcher to formulate and to test important hypotheses related to clinical care and outcomes. The chapter discusses their advantages and limitations as well as the overall spectrum of evidence in clinical medicine and how studies using these data sets fit into this paradigm. It reviews examples of available data sets and analytical methods that will guide clinical researchers in identifying the best sources of data and the optimal methodological approaches for their research question. Government agencies, such as the Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare & Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC), are common sources of data used in observational clinical studies.