Vjola Hoxhaj

STRENGTH AND LIMITATIONS OF THIS STUDY A systematic component algorithm strategy to identify gestational diabetes mellitus (GDM) was applied in five European countries using harmonised data mapped to a common data model. Multiple algorithms—based on diagnostic codes, prescriptions and specific birth registry variables—were used to estimate GDM prevalence, providing insights into how choices of algorithm components affect prevalence estimates.

Health data collected via electronic records (real-world data) have shown to be a valuable source of information to generate evidence on effectiveness and safety of medicines and vaccines. Due to the heterogenous and diverse nature of real-world data, ensuring data is appropriate for analyses impose challenges on the extension and complexity of data quality assessment.

RWE-BRIDGE addresses the methodological gap in translating study protocols into executable analytical pipelines for real-world evidence (RWE) studies increasing transparency and communication between researchers and scientific programmers. Moroever, this methodology aligns with HARmonized Protocol Template to Enhance Reproducibility (HARPER) and Structured Preapproval and Postapproval. Comparative study design framework to generate valid and transparent real-world Evidence (SPACE) protocols.