Study designs and statistical approaches to suicide and prevention research in real-world data

Objective To provide researchers, clinicians and policy makers with a primer to study designs, statistical approaches and graphical reporting methods for suicide research in real world data (RWD). Methods Study designs, statistical method and graphical reporting standards are detailed with examples from the recently published literature. Results Data sources and codes for identifying suicidal behavior are described. Study designs are described in detail for post-market surveillance, retrospective cohort studies, case control and nested case-control studies, and self-controlled (within-individual) studies including applications of marginal structural models. Graphical reporting of designs is described using an original research study. Conclusions Compared to RCTs, RWE studies offer larger sample sizes, greater generalizability, and real-world validity. However, these non-experimental data risk uncontrolled confounding and potential introduction of bias unless data, design and statistical approaches are rigorously aligned.