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

Document Type


Publication Date



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.




Published in a Special Issue of Suicide and Life-Threatening Behavior.