ADVANCE database characterisation and fit for purpose assessment for multi-country studies on the coverage, benefits and risks of pertussis vaccinations.

Introduction: The public-private ADVANCE consortium (Accelerated development of vaccine benefit-risk collaboration in Europe) aimed to assess if electronic healthcare databases can provide fit-for purpose data for collaborative, distributed studies and monitoring of vaccine coverage, benefits and risks of vaccines.
Objective: To evaluate if European healthcare databases can be used to estimate vaccine coverage, benefit and/or risk using pertussis-containing vaccines as an example.
Methods: Characterisation was conducted using open-source Java-based (Jerboa) software and R scripts. We obtained: (i) The general characteristics of the database and data source (meta-data) and (ii) a detailed description of the database population (size, representatively of age/sex of national population, rounding of birth dates, delay between birth and database entry), vaccinations (number of vaccine doses, recording of doses, pattern of doses by age and coverage) and events of interest (diagnosis codes, incidence rates). A total of nine databases (primary care, regional/national record linkage) provided data on events (pertussis, pneumonia, death, fever, convulsions, injection site reactions, hypotonic hypo-responsive episode, persistent crying) and vaccines (acellular pertussis and whole cell pertussis) related to the pertussis proof of concept studies.
Results: The databases contained data for a total population of 44 million individuals. Seven databases had recorded doses of vaccines. The pertussis coverage estimates were similar to those reported by the World Health Organisation (WHO). Incidence rates of events were comparable in magnitude and age-distribution between databases with the same characteristics. Several conditions (persistent crying and somnolence) were not captured by the databases for which outcomes were restricted to hospital discharge diagnoses.
Conclusion: The database characterisation programs and workflows allowed for an efficient, transparent and standardised description and verification of electronic healthcare databases which may participate in pertussis vaccine coverage, benefit and risk studies. This approach is ready to be used for other vaccines/events to create readiness for participation in other vaccine related studies.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Toon Braeye, Lieke van der Aa, Giorgia Danieli, Caitlin Dodd, Talita Duarte-Salles, Hanne- Dorthe Emborg, Marius Gheorge, Consuelo Huerta, Elisa Martín-Merino, Chris McGee, Gino Picelli Giuseppe Roberto, Lara Tramontan, Marco Villa and Daniel Weibel declared no potential conflicts of interest. Miriam Sturkenboom, declared that she has received grants from Novartis, CDC and Bill & Melinda Gates Foundation, for work unrelated to the submitted work. Johnny Kahlert declared that he is employed at Department of Clinical Epidemiology, Aarhus University Hospital, which is involved in studies with research grants from various companies that are administered by Aarhus University; he does not receive fees, honoraria, grants or consultancies personally. Simon de Lusignan declared that he is Director of RCGP RSC that he has received funding through his University for vaccine-related studies from GSK and Seqirus and he is also a member of advisory groups for Seqirus and Sanofi. Lina Titievsky declared that she is employed by Pfizer and holds company stocks/shares. Rosa Gini's institution is involved in studies funded by Novartis, Eli Lilly, and Daiichi, compliant with the ENCePP CoC“.
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