ADVANCE system testing: Can safety studies be conducted using electronic healthcare data? An example using pertussis vaccination

Autor: Giorgia Danieli, Caitlin Dodd, Consuelo Huerta-Alvarez, Vincent Bauchau, Klara Berencsi, Chris McGee, Tom De Smedt, Talita Duarte-Salles, Lara Tramontan, Ana Correa, Daniel Weibel, Hanne-Dorthe Emborg, François Haguinet, Gino Picelli, Kaatje Bollaerts, Olivia Mahaux, Lina Titievsky, Elisa Martín-Merino, Miriam C. J. M. Sturkenboom
Přispěvatelé: Medical Informatics
Rok vydání: 2020
Předmět:
Zdroj: Vaccine, 38, B38-B46. Elsevier
Weibel, D, Dodd, C, Mahaux, O, Haguinet, F, De Smedt, T, Duarte-Salles, T, Picelli, G, Tramontan, L, Danieli, G, Correa, A, McGee, C, Martín-Merino, E, Huerta-Alvarez, C, Berencsi, K, Emborg, H D, Bollaerts, K, Bauchau, V, Titievsky, L & Sturkenboom, M 2020, ' ADVANCE system testing : Can safety studies be conducted using electronic healthcare data? An example using pertussis vaccination ', Vaccine, vol. 38, pp. B38-B46 . https://doi.org/10.1016/j.vaccine.2019.06.040
ISSN: 0264-410X
Popis: Introduction: The Accelerated Development of Vaccine benefit-risk Collaboration in Europe (ADVANCE) public-private collaboration, aimed to develop and test a system for rapid benefit-risk monitoring of vaccines using healthcare databases in Europe. The objective of this proof-of-concept (POC) study was to test the feasibility of the ADVANCE system to generate incidence rates (IRs) per 1000 person-years and incidence rate ratios (IRRs) for risks associated with whole cell- (wP) and acellular- (aP) pertussis vaccines, occurring in event-specific risk windows in children prior to their pre-school-entry booster. Methods: The study population comprised almost 5.1 million children aged 1 month to
Databáze: OpenAIRE