Kaatje Bollaerts1, Tom de Smedt2, Chris McGee3, Hanne-Dorthe Emborg4, Marco Villa5, Maria Alexandridou6, Talita Duarte-Salles7, Rosa Gini8, Claudia Bartolini9, Simon de Lusignan10, Myint Tin Tin Htar11, Lina Titievsky12, Miriam Sturkenboom13, Vincent Bauchau14. 1. P95 Epidemiology and Pharmacovigilance, Koning Leopold III laan 1, 3001 Heverlee, Belgium. Electronic address: kaatje.bollaerts@p-95.com. 2. P95 Epidemiology and Pharmacovigilance, Koning Leopold III laan 1, 3001 Heverlee, Belgium. Electronic address: tom.desmedt@p-95.com. 3. Royal College of General Practitioners Research and Surveillance Centre, London, UK; Department of Clinical and Experimental Medicine, University of Surrey, Guildford, UK. Electronic address: c.mcgee@surrey.ac.uk. 4. Statens Serum Institut, Artillerivej 5, 2300 Copenhagen, Denmark. Electronic address: HDE@ssi.dk. 5. ATS della Val Padana, Cremona, Italy. Electronic address: marco.villa@ats-valpadana.it. 6. P95 Epidemiology and Pharmacovigilance, Koning Leopold III laan 1, 3001 Heverlee, Belgium. Electronic address: maria.alexandridou@p-95.com. 7. Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain. Electronic address: tduarte@idiapjgol.org. 8. Agenzia regionale di sanità della Toscana, Osservatorio di epidemiologia, Florence, Italy. Electronic address: rosa.gini@ars.toscana.it. 9. Agenzia regionale di sanità della Toscana, Osservatorio di epidemiologia, Florence, Italy. Electronic address: claudia.bartolini@ars.toscana.it. 10. Royal College of General Practitioners Research and Surveillance Centre, London, UK; Department of Clinical and Experimental Medicine, University of Surrey, Guildford, UK. Electronic address: s.lusignan@surrey.ac.uk. 11. Pfizer, 23-25 Avenue du Dr Lannelongue, 75014 Paris, France. Electronic address: myint.tintinhtar@pfizer.com. 12. Pfizer, 219 East 42nd St, NY, NY 10017, USA. Electronic address: lina.titievsky@pfizer.com. 13. P95 Epidemiology and Pharmacovigilance, Koning Leopold III laan 1, 3001 Heverlee, Belgium; Julius Global Health, University Medical Center Utrecht, Heidelberglaan 100, the Netherlands; VACCINE.GRID Foundation, Basel, Switzerland. Electronic address: miriam.sturkenboom@p-95.com. 14. GSK, Av. Fleming 20, 1300 Wavre, Belgium. Electronic address: vincent.g.bauchau@gsk.com.
Abstract
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.
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.
Authors: Matthew M Loiacono; Nicholas Mitsakakis; Jeffrey C Kwong; Gabriela B Gomez; Ayman Chit; Paul Grootendorst Journal: JAMA Netw Open Date: 2020-06-01
Authors: Matthew Deady; Hussein Ezzeldin; Kerry Cook; Douglas Billings; Jeno Pizarro; Amalia A Plotogea; Patrick Saunders-Hastings; Artur Belov; Barbee I Whitaker; Steven A Anderson Journal: Front Digit Health Date: 2021-12-22
Authors: Javier Díez-Domingo; Esther Redondo Margüello; Raúl Ortiz de Lejarazu Leonardo; Ángel Gil de Miguel; José María Guillén Ortega; Jesús Rincón Mora; Federico Martinón-Torres Journal: BMC Public Health Date: 2022-04-25 Impact factor: 4.135