Real-World Evidence BRIDGE: A Tool to Connect Protocol With Code Programming.

ABSTRACT:

Objective

To enhance documentation on programming decisions in Real World Evidence (RWE) studies.

Materials and methods

We analyzed several statistical analysis plans (SAP) within the Vaccine Monitoring Collaboration for Europe (VAC4EU) to identify study design sections and specifications for programming RWE studies. We designed a machine-readable metadata schema containing study sections, codelists, and time anchoring definitions specified in the SAPs with adaptability and user-friendliness.

Results

We developed the RWE-BRIDGE, a metadata schema in form of relational database divided into four study design sections with 12 tables: Study Variable Definition (two tables), Cohort Definition (two tables), Post-Exposure Outcome Analysis (one table), and Data Retrieval (se

SUBMITTER: Royo AC 

PROVIDER: S-EPMC11602246 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature