Novel Study Designs and Their Application in Reproductive and Perinatal Epidemiology

The ultimate goal of epidemiology is to uncover the determinants of health and disease. In the absence of experimental designs, we must rely upon observational designs, which necessitate caution in interpretation. Reproductive and perinatal epidemiology faces many unique study design challenges when evaluating etiologic or predictive questions. This chapter reviews a description of select novel study designs with relevancy for reproductive and perinatal epidemiology, viz., case-cohort study, case-crossover study, case-time-control study, a hybrid design for studies of biomarkers, case-only studies of gene-environment interactions, the case-parent-triad design, a hybrid design for genetic studies, and time-to-pregnancy and current duration approaches. Strengths and limitations of each study design are noted, as well as the appropriate setting for application along with examples for each design. While these designs hold promise for application to many areas of reproductive and perinatal epidemiology and provide avaluable set of tools, many unresolved issues remain and support the need for even more design options.