Research Design: Case-Control Studies

Case-control studies are observational studies in which cases are subjects who have a characteristic of interest, such as a clinical diagnosis, and controls are (usually) matched subjects who do not have that characteristic. After cases and controls are identified, researchers “look back” to determine what past events (exposures), if any, are significantly associated with caseness. For “looking back,” data may be obtained by clinical history-taking or from medical records such as case files or large electronic health care databases. The data are analyzed using logistic regression, which adjusts for confounding variables and yields an odds ratio and a probability value for the association between the exposure of interest (independent variable) and caseness (dependent variable). Because case-control studies are not randomized controlled studies, cause–effect relationships do not necessarily explain significant associations detected in the regressions; unexplored confounding may be responsible. These concepts are explained with the help of examples.