Epidemiology and Clinical Research Design, Part 1: Study Types

Selecting the best available preventive and therapeutic measures to avoid disability and death is an important goal for all health care practitioners. To achieve this goal, we need to perform studies that determine the value of these measures. In this article, we discuss the possible study designs that can be used for evaluating new approaches to prevention and treatment. The gold standard study design is a randomized, controlled, double-blind trial. In many instances, a randomized controlled trial may not be ethically or practically feasible. Other study types, such as case series, case-control studies, cohort studies, cross-sectional studies, crossover designs, and open-label studies, may be required to hypothesize and evaluate the link between an exposure or predictor variable and an outcome variable. Various study types pertaining to neonatal-perinatal medicine are reviewed in this article.