TY - JOUR
T1 - ADVANCE
T2 - Towards near real-time monitoring of vaccination coverage, benefits and risks using European electronic health record databases
AU - Bollaerts, Kaatje
AU - de Smedt, Tom
AU - McGee, Chris
AU - Emborg, Hanne-Dorthe
AU - Villa, Marco
AU - Alexandridou, Maria
AU - Duarte-Salles, Talita
AU - Gini, Rosa
AU - Bartolini, Claudia
AU - de Lusignan, Simon
AU - Tin Tin Htar, Myint
AU - Titievsky, Lina
AU - Sturkenboom, Miriam
AU - Bauchau, Vincent
N1 - Funding Information:
The Innovative Medicines Initiative Joint Undertaking funded this project under ADVANCE grant agreement n° 115557 , resources of which were composed of a financial contribution from the European Union's Seventh Framework Programme ( FP7/2007-2013 ) and in kind contributions from EFPIA member companies.
Funding Information:
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Tom de Smedt, Chris McGee, Hanne-Dorthe Emborg, Marco Villa, Talita Duarte-Salles, declared no potential conflicts of interest. Kaatje Bollaerts and Maria Alexandridou received consultancy fees from GSK for work unrelated to the submitted work. Rosa Gini declared that her institution is participating in studies funded by Novartis, Eli Lilly, and Daiichi outside the scope of this project. Claudia Bartolini declared she has received grants from PHARMO Institute for work outside the submitted work. Simon de Lusignan declared he has received funding through his University to conduct enhanced surveillance of influenza vaccine (GSK), and is a member Seqirus and Sanofi Pasteur advisory boards for which he received personal payment within the limits defined by his university. Myint TinTin Htar declared that she is employed by Pfizer and holds company shares. Miriam Sturkenboom declared that she has received grants from Novartis, CDC and Bill & Melinda Gates Foundation, for work unrelated to the submitted work. Lina Titievsky declared that she is employed by Pfizer and holds company stocks/shares. Vincent Bauchau declared that he is employed by GSK and holds company shares.
Publisher Copyright:
© 2019 The Author(s)
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/12/22
Y1 - 2020/12/22
N2 - BACKGROUND: The Accelerated Development of VAccine beNefit-risk Collaboration in Europe (ADVANCE) is a public-private partnership aiming to develop and test a system for rapid benefit-risk (B/R) monitoring of vaccines using European electronic health record (eHR) databases. This proof-of-concept study aimed to test the feasibility of near real-time (NRT) monitoring of vaccination coverage, benefits and risks based on multiple European eHR databases, using acellular pertussis vaccination in children aged <6 years as test case.METHODS: A qualitative feasibility assessment on NRT monitoring was carried out using a survey and face-to-face discussion with ADVANCE data partners. Subsequently, a dynamic cohort study was conducted containing two distinct observation periods: a first period to establish a baseline (Jan 2014 to Mar 2018) and a subsequent 3-month period to test the actual feasibility of weekly NRT monitoring, based on which data latencies were calculated. An interactive web-application was additionally developed to facilitate the visual monitoring of vaccination coverage, the vaccine preventable disease incidence rates (benefits) and the incidence rates of adverse events (risks).RESULTS: Nine databases from four countries (Denmark, Italy, Spain and UK) participated in the qualitative feasibility assessment. Of them, five databases took part in the dynamic cohort study, with 5 databases providing baseline data and 3 databases participating to the NRT monitoring, providing data extractions on an almost weekly basis. The median data latency (time between event date and data release date) was between 1 and 2 weeks except for the benefit and risk events in one of the databases (latency 16 weeks).CONCLUSION: Three European eHR databases successfully demonstrated the feasibility of providing data for weekly NRT monitoring, with short data latencies of 1-2 weeks for most events.
AB - BACKGROUND: The Accelerated Development of VAccine beNefit-risk Collaboration in Europe (ADVANCE) is a public-private partnership aiming to develop and test a system for rapid benefit-risk (B/R) monitoring of vaccines using European electronic health record (eHR) databases. This proof-of-concept study aimed to test the feasibility of near real-time (NRT) monitoring of vaccination coverage, benefits and risks based on multiple European eHR databases, using acellular pertussis vaccination in children aged <6 years as test case.METHODS: A qualitative feasibility assessment on NRT monitoring was carried out using a survey and face-to-face discussion with ADVANCE data partners. Subsequently, a dynamic cohort study was conducted containing two distinct observation periods: a first period to establish a baseline (Jan 2014 to Mar 2018) and a subsequent 3-month period to test the actual feasibility of weekly NRT monitoring, based on which data latencies were calculated. An interactive web-application was additionally developed to facilitate the visual monitoring of vaccination coverage, the vaccine preventable disease incidence rates (benefits) and the incidence rates of adverse events (risks).RESULTS: Nine databases from four countries (Denmark, Italy, Spain and UK) participated in the qualitative feasibility assessment. Of them, five databases took part in the dynamic cohort study, with 5 databases providing baseline data and 3 databases participating to the NRT monitoring, providing data extractions on an almost weekly basis. The median data latency (time between event date and data release date) was between 1 and 2 weeks except for the benefit and risk events in one of the databases (latency 16 weeks).CONCLUSION: Three European eHR databases successfully demonstrated the feasibility of providing data for weekly NRT monitoring, with short data latencies of 1-2 weeks for most events.
KW - Electronic health record databases
KW - Europe
KW - Methodological study
KW - Near real-time monitoring
UR - http://www.scopus.com/inward/record.url?scp=85097969263&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2019.08.012
DO - 10.1016/j.vaccine.2019.08.012
M3 - Article
C2 - 31677951
SN - 0264-410X
VL - 38 Suppl 2
SP - B76-B83
JO - Vaccine
JF - Vaccine
IS - 2
ER -