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Observational Studies

1. Learning Objectives

After reviewing this chapter readers should be able to:

  • Recognize that controlled experimentation (the ability to systematically manipulate variable of interest) is often not possible, and understand that alternative observational study designs are possible but that they entail many potential pitfalls;
  • Describes the major threats to the integrity of observational research results such as threats to validity, reliability, statistical inference and generalizability;
  • Outlines some ways to improve each step in the research process, including choosing the most appropriate research design, obtaining meaningful measurements, conducting sound statistical analyses and creating adequate standards for the reporting of study findings;
  • Understand the many challenges to all observational studies and the need for transparent reporting of any aspect of study design, data collection, or analysis that could materially affect study findings and their generalizability.