TY - JOUR
T1 - ADVANCE database characterisation and fit for purpose assessment for multi-country studies on the coverage, benefits and risks of pertussis vaccinations
AU - Sturkenboom, Miriam
AU - Braeye, Toon
AU - van der Aa, Lieke
AU - Danieli, Giorgia
AU - Dodd, Caitlin
AU - Duarte-Salles, Talita
AU - Emborg, Hanne-Dorthe
AU - Gheorghe, Marius
AU - Kahlert, Johnny
AU - Gini, Rosa
AU - Huerta, Consuelo
AU - Martín-Merino, Elisa
AU - McGee, Chris
AU - de Lusignan, Simon
AU - Picelli, Gino
AU - Roberto, Giuseppe
AU - Tramontan, Lara
AU - Villa, Marco
AU - Weibel, Daniel
AU - Titievsky, Lina
N1 - Funding Information:
The Innovative Medicines Initiative Joint Undertaking funded this project under ADVANCE grant agreement n° 115557 , composed of a financial contribution from the European Union's Seventh Framework Programme ( FP7/2007-2013 ) and in kind contributions from EFPIA member companies.
Publisher Copyright:
© 2020
PY - 2020/12/22
Y1 - 2020/12/22
N2 - 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.
AB - 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.
KW - Big data
KW - Electronic health data
KW - Fit-for-purpose
KW - Real world evidence
KW - Vaccination
UR - http://www.scopus.com/inward/record.url?scp=85079409831&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2020.01.100
DO - 10.1016/j.vaccine.2020.01.100
M3 - Article
C2 - 32061385
SN - 0264-410X
VL - 38
SP - B8-B21
JO - Vaccine
JF - Vaccine
IS - 2
ER -