Opportunities and challenges for near real time monitoring (NRTM) of vaccine exposures and outcomes in the participating databases of the ADVANCE consortium

Background: The Accelerated Development of VAccine beNefit–risk Collaboration in Europe (ADVANCE) is a public‐private collaboration aiming to develop and test a system for rapid Benefit–Risk (B/R) monitoring of vaccines using electronic health record databases in Europe. Rapid B/R monitoring or Near Real Time Monitoring (NRTM) is a periodic collection and analysis of several key variables (e.g. coverage, adverse events, and vaccine preventable diseases) where an alert is triggered when these data suggest variations in the expected B/R profile in the population. NRTM can serve as an important tool for various stakeholders such as public health institutes, vaccine manufacturers and regulatory authorities. Objectives: To understand opportunities and challenges of conducting NRTM (defined as a weekly refresh of data for analyses and visualization) using databases of the ADVANCE consortium. Methods: A survey was developed and administered to all databases (DB) of ADVANCE Consortium (N = 10) that participated in the prior DB characterization activities. Responses were further discussed during an in‐person meeting. The survey assessed delays and barriers to NRTM including data entry delay: an interval between the health encounter and system dates (the date on which the record is actually entered in the system that feeds the DB) and data release delay: an interval between the system or last collection date (the date on which data are last entered into a DB) and internal release date (the date on which the data are ready for querying internally). Results: Information was received from 9 out of 10 DBs. These included 3 DBs from Italy: Val Padana, Tuscany, PEDIANET; 2 from the UK: the Health Improvement Network, Royal College of General Practitioners Research and Surveillance Centre (RCGP‐RSC); 2 from Denmark: Statens Serum Institut (SSI), Aarhus Universitets Hospital; and 2 from Spain:the Primary Care Research Informatics Network (SIDIAP), Base de datos para la investigación Farmacoepidemiológica en Atención Primaria (BIFAP). Five DBs (Val Padana, Tuscany, SIDIAP, RCGP‐RSC and SSI) concluded that they would in principle be able to implement NRTM of various types of outcomes during the ADVANCE project. Estimated data entry delay varied from <24 hours to several months depending on the DB and outcome of interest and data release delays varied from being instantaneous to up to 12 months. Conclusions: NRTM is deemed feasible in some databases within ADVANCE, based on the qualitative assessment. Specific challenges will become clear upon the implementation of the NRTM.