ADVANCE database characterisation and fit for purpose assessment for multi-country studies on the coverage, benefits and risks of pertussis vaccinations. (22nd December 2020)

• Record Type: Journal Article
• Authors: Sturkenboom, Miriam; Braeye, Toon; van der Aa, Lieke; Danieli, Giorgia; Dodd, Caitlin; Duarte-Salles, Talita; Emborg, Hanne- Dorthe; Gheorghe, Marius; Kahlert, Johnny; Gini, Rosa; Huerta-Alvarez, Consuelo; Martín-Merino, Elisa; McGee, Chris; de Lusignan, Simon; Picelli, Gino; Roberto, Giuseppe; Tramontan, Lara; Villa, Marco; Weibel, Daniel; Titievsky, Lina
• Is Part Of: Vaccine. Volume 38(2020)Supplement 2
• Page Start: B8
• Page End: B21
• Publication Date: 2020-12-22
• Subjects: Electronic health data -- Big data -- Fit-for-purpose -- Vaccination -- Real world evidence; ADVANCE Accelerated development of vaccine benefit-risk collaboration in Europe -- AUH Aarhus University Hospital datasources -- ARS Agenzia regionale di sanità -- ATSVP ATS (Local Health Agency) della Val Padana -- BIFAP Base de Datos para la Investigación Farmacoepidemiológica en Atencion Primaria -- CDM common data model -- DAP Data access provider -- EHDEN European Health Data & Evidence Network -- ENCePP European Network of Centres of excellence in Pharmacoepidemiology & Pharmacovigilance -- HHE hypotonic hyporesponsive episode -- ICD-9/ICD-10 International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9) and tenth revision (ICD-10) -- ICPC International Classification of Primary Care -- MMR measles, mumps, rubella -- OMOP Observational Medical Outcomes Partnership -- POC proof of concept -- PRISM Post-licensure Rapid Immunization Safety Monitoring program -- RCGP RSC Royal College of General Practitioners Research and Surveillance Centre -- RRE remote research environment -- SIDIAP The Information System for Research in Primary Care -- SSI Staten Serum Institute -- THIN Health Improvement Network -- USA United States of America -- VAC4EU Vaccine monitoring collaboration for Europe -- VSD Vaccine Safety Datalink -- WHO World Health Organization; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2020.01.100
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: This paper describes 9 electronic healthcare datasources covering more than 40 million persons. Background rates for 11 events of interest and pertussis vaccine coverage were benchmarked. All datasources were fit-for-purpose to generate reliable evidence on vaccine coverage, benefits and risks. Abstract: 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.