Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 3

This report describes the activity of the Mini-Sentinel Year 3 Taxonomy workgroup, including development of a Taxonomy Selection Tool that guides users to recommended Mini-Sentinel Prospective Routine Observational Monitoring Program Tool (PROMPT) methods to perform rapid semi-automated monitoring of a given medical product-outcome pair within Mini-Sentinel. The Taxonomy PROMPT Selection Tool is an interactive Excel spreadsheet that considers the number of comparator groups, characteristics of the exposure of interest (e.g., whether it is acute or sustained) and the likelihood of potential biases, such as within-person confounding, between-person confounding, exposure misclassification, and outcome misclassification when selecting the most appropriate PROMPT. In addition, the report describes current gaps in the PROMPT methods and makes recommendations for future development activities.

If you are using a web page screen reader and are unable to access these documents, please contact the entinel Operations Center for assistance by clicking on the Submit Comments link above or sending an email requesting assistance to info@sentinelsystem.org.