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3. Describing diversity of real world data sources in pharmacoepidemiologic studies: The DIVERSE scoping review

Author

Gini, Rosa, primary, Pajouheshnia, Romin, additional, Gardarsdottir, Helga, additional, Bennett, Dimitri, additional, Li, Lin, additional, Gulea, Claudia, additional, Wientzek‐Fleischmann, Angelika, additional, Bazelier, Marloes T., additional, Burcu, Mehmet, additional, Dodd, Caitlin, additional, Durán, Carlos E., additional, Kaplan, Sigal, additional, Lanes, Stephan, additional, Marinier, Karine, additional, Roberto, Giuseppe, additional, Soman, Kanaka, additional, Zhou, Xiaofeng, additional, Platt, Robert, additional, Setoguchi, Soko, additional, and Hall, Gillian C., additional

Published
2024
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5. Describing diversity of real world data sources in pharmacoepidemiologic studies: The DIVERSE scoping review

Author

Gini, Rosa, Pajouheshnia, Romin, Gardarsdottir, Helga, Bennett, Dimitri, Li, Lin, Gulea, Claudia, Wientzek-Fleischmann, Angelika, Bazelier, Marloes T, Burcu, Mehmet, Dodd, Caitlin, Durán, Carlos E, Kaplan, Sigal, Lanes, Stephan, Marinier, Karine, Roberto, Giuseppe, Soman, Kanaka, Zhou, Xiaofeng, Platt, Robert, Setoguchi, Soko, Hall, Gillian C, Gini, Rosa, Pajouheshnia, Romin, Gardarsdottir, Helga, Bennett, Dimitri, Li, Lin, Gulea, Claudia, Wientzek-Fleischmann, Angelika, Bazelier, Marloes T, Burcu, Mehmet, Dodd, Caitlin, Durán, Carlos E, Kaplan, Sigal, Lanes, Stephan, Marinier, Karine, Roberto, Giuseppe, Soman, Kanaka, Zhou, Xiaofeng, Platt, Robert, Setoguchi, Soko, and Hall, Gillian C

Abstract

PURPOSE: Real-world evidence (RWE) is increasingly used for medical regulatory decisions, yet concerns persist regarding its reproducibility and hence validity. This study addresses reproducibility challenges associated with diversity across real-world data sources (RWDS) repurposed for secondary use in pharmacoepidemiologic studies. Our aims were to identify, describe and characterize practices, recommendations and tools for collecting and reporting diversity across RWDSs, and explore how leveraging diversity could improve the quality of evidence.METHODS: In a preliminary phase, keywords for a literature search and selection tool were designed using a set of documents considered to be key by the coauthors. Next, a systematic search was conducted up to December 2021. The resulting documents were screened based on titles and abstracts, then based on full texts using the selection tool. Selected documents were reviewed to extract information on topics related to collecting and reporting RWDS diversity. A content analysis of the topics identified explicit and latent themes.RESULTS: Across the 91 selected documents, 12 topics were identified: 9 dimensions used to describe RWDS (organization accessing the data source, data originator, prompt, inclusion of population, content, data dictionary, time span, healthcare system and culture, and data quality), tools to summarize such dimensions, challenges, and opportunities arising from diversity. Thirty-six themes were identified within the dimensions. Opportunities arising from data diversity included multiple imputation and standardization.CONCLUSIONS: The dimensions identified across a large number of publications lay the foundation for formal guidance on reporting diversity of data sources to facilitate interpretation and enhance replicability and validity of RWE.

Published
2024

6. Describing diversity of real world data sources in pharmacoepidemiologic studies: The DIVERSE scoping review

Author

Apotheek O&O&O, Child Health, Infection & Immunity, Regenerative Medicine and Stem Cells, RWE/Causal inference, Gini, Rosa, Pajouheshnia, Romin, Gardarsdottir, Helga, Bennett, Dimitri, Li, Lin, Gulea, Claudia, Wientzek-Fleischmann, Angelika, Bazelier, Marloes T., Burcu, Mehmet, Dodd, Caitlin, Durán, Carlos E., Kaplan, Sigal, Lanes, Stephan, Marinier, Karine, Roberto, Giuseppe, Soman, Kanaka, Zhou, Xiaofeng, Platt, Robert, Setoguchi, Soko, Hall, Gillian C., Apotheek O&O&O, Child Health, Infection & Immunity, Regenerative Medicine and Stem Cells, RWE/Causal inference, Gini, Rosa, Pajouheshnia, Romin, Gardarsdottir, Helga, Bennett, Dimitri, Li, Lin, Gulea, Claudia, Wientzek-Fleischmann, Angelika, Bazelier, Marloes T., Burcu, Mehmet, Dodd, Caitlin, Durán, Carlos E., Kaplan, Sigal, Lanes, Stephan, Marinier, Karine, Roberto, Giuseppe, Soman, Kanaka, Zhou, Xiaofeng, Platt, Robert, Setoguchi, Soko, and Hall, Gillian C.

Published
2024

7. Describing diversity of real world data sources in pharmacoepidemiologic studies: The DIVERSE scoping review

Author

Afd Pharmacoepi & Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Pharmacoepidemiology and Clinical Pharmacology, Gini, Rosa, Pajouheshnia, Romin, Gardarsdottir, Helga, Bennett, Dimitri, Li, Lin, Gulea, Claudia, Wientzek-Fleischmann, Angelika, Bazelier, Marloes T, Burcu, Mehmet, Dodd, Caitlin, Durán, Carlos E, Kaplan, Sigal, Lanes, Stephan, Marinier, Karine, Roberto, Giuseppe, Soman, Kanaka, Zhou, Xiaofeng, Platt, Robert, Setoguchi, Soko, Hall, Gillian C, Afd Pharmacoepi & Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Pharmacoepidemiology and Clinical Pharmacology, Gini, Rosa, Pajouheshnia, Romin, Gardarsdottir, Helga, Bennett, Dimitri, Li, Lin, Gulea, Claudia, Wientzek-Fleischmann, Angelika, Bazelier, Marloes T, Burcu, Mehmet, Dodd, Caitlin, Durán, Carlos E, Kaplan, Sigal, Lanes, Stephan, Marinier, Karine, Roberto, Giuseppe, Soman, Kanaka, Zhou, Xiaofeng, Platt, Robert, Setoguchi, Soko, and Hall, Gillian C

Published
2024

9. Applicability of the GAIA Maternal and Neonatal Outcome Case Definitions for the Evaluation of Adverse Events Following Vaccination in Pregnancy in High-income Countries

Author

Watson, Gabriella, Dodd, Caitlin, Munoz, Flor M., Eckert, Linda O., Jones, Christine E., Buttery, Jim P., Yildirim, Inci B., Kachikis, Alisa, Heath, Paul T., Schlaudecker, Elizabeth P., Bond, Nanette H., Santarcangelo, Patricia L., Wilcox, Christopher R., Bellamy, Karen, Elmontser, Mohnd, Sienas, Laura, Simon, Rebecca, Khalil, Asma, Townsend, Rosemary, Sturkenboom, Miriam, and Black, Steve

Published
2021
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12. Enhancing global vaccine pharmacovigilance: Proof-of-concept study on aseptic meningitis and immune thrombocytopenic purpura following measles-mumps containing vaccination

Author

Kuli-Lito, Georgina, Kostaqi, Entela, Petrela, Elizana, Castellano, Vanesa E., Chiarvetti, Lucia, Falcó, Adriana, Gentile, Angela, Guirau, Karina, Carrega, Maria Eugenia Pérez, Rasjido, Susana, Testino, Sofía, Vizzotti, Carla, Buttery, Jim, Mcminn, Alissa, Quinn, Julie, Avendaño, Marcela, González, Marcela, Lagos, Rosanna, Maturana, Marcelo, Muñoz, Fernando, Saldaña, Adiela, Soza, Guillermo, Zhang, Tao, Zhang, Xiyan, Ding, Yunfang, Zhang, Jun, Alvarez-Olmos, Martha I., Sastoque, Luz Amparo, Mezerville, Marcela Hernández-de, Machado, Vicenta, Roverssi, Ileana, Camacho, Angélica Vargas, Luque, Marco Tulio, Mendoza, Liset, Ravi, Mandyam, Manjunath, V.G., Karimi, Abdollah, Ghanaie, Roxana Mansour, Seifi, Kimia, Shirvani, Fariba, Ashrafi, Mahmoud Reza, Parvaneh, Nima, Kochakzadeh, Leily, Mamishi, Sertareh, Kompani, Farzad, Eshaghi, Hamid, Pirmoazen, Vahideh, Aquije Hernández, Renne F., Díaz, Maria Esther Castillo, Mamani, Gladys Turpo, Thoon, Koh Cheng, Oh, Bee Khiam, Yelen, Cutland, Clare, Madhi, Shabir A., Groome, Michelle, Velaphi, Sithembiso, Izu, Alane, Diep, Linh, Hwinya, Cleopas, Pérez-Vilar, Silvia, Díez-Domingo, Javier, Martín-Navarro, Marian, Soriano-García, Esther, Tuells, Jose, Pande, Stephen Legesi, Alaroker, Florence, Amulen, Dorothy, Akareut, Margaret, Areto, Esther, Komo, Richard Samson, Quinto, Ogwang, Giachetto, Gustavo, Speranza, Noelia, Zunino, Carlos, Perez-Vilar, Silvia, Weibel, Daniel, Sturkenboom, Miriam, Black, Steven, Maure, Christine, Castro, Jose Luis, Bravo-Alcántara, Pamela, Dodd, Caitlin N., Romio, Silvana A., de Ridder, Maria, Nakato, Swabra, Molina-León, Helvert Felipe, Elango, Varalakshmi, and Zuber, Patrick L.F.

Published
2018
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17. Standardizing case definitions for monitoring the safety of maternal vaccines globally: GAIA definitions, a review of progress to date

Author

Davies, Hannah G., Bowman, Conor, Watson, Gabriella, Dodd, Caitlin, Jones, Christine E., Munoz, Flor M., Heath, Paul T., Cutland, Clare L., and Le Doare, Kirsty

Abstract

In 2014, the Global Alignment on Immunization safety Assessment in pregnancy consortium (GAIA) was formed, with the goal of developing a harmonized, globally-concerted approach to actively monitor the safety of vaccines in pregnancy. A total of 26 standardized definitions for the classification of adverse events have been developed. The aim of this review was to identify and describe studies undertaken to assess the performance of these definitions. A literature search was undertaken to identify published studies assessing the performance of the definitions, and reference lists were snowballed. Data were abstracted by two investigators and a narrative review of the results is presented. Four studies that have evaluated 13 GAIA case definitions (50%) were identified. Five case definitions have been assessed in high-income settings only. Recommendations have been made by the investigators to improve the performance of the definitions. These include ensuring consistency across definitions, removal of the potential for ambiguity or variations in interpretation and ensuring that higher-level criteria are acceptable at lower levels of confidence. Future research should prioritize the key case definitions that have not been assessed in low- and middle-income settings, as well as the 13 that have not undergone any validation.

Published
2023

19. Impact of EU label changes and revised pregnancy prevention programme for medicinal products containing valproate: utilisation and prescribing trends

Author

Klungel, Olaf, Sturkenboom, Miriam, Abtahi, Shahab, Pajouheshnia, Romin, Durán Salinas, Carlos, Riera Arnau, Judit, Dodd, Caitlin, Gardarsdottir, Helga, Souverein, Patrick, Hoxhaj, Vjola, Siiskonen, Satu Johanna, Gamba, Magdalena, Alsina, Ema, Huerta, Consuelo, Bermejo, Diana Gonzalez, Corominas, Dolores Montero, Martín-Pérez, Mar, Garcia-Poza, Patricia, García, Ana Llorente, Ibanez, Luisa, Douglas, Ian, Wing, Kevin, Brown, Jeremy, Herings, Ron, Houben, Eline, Penning-van Beest, Fernie, Swart, Karin, Holthuis, Emily, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen. Sarah Brøgger, Hallgreen, Christine Erikstrup, Kant, Agnes, van Puijenbroek, Eugene, and Lely, Titia

Subjects
Sodium valproate, congenital abnormalities, contraceptive agents, pregnancy, risk minimisation measures (RMMs), bipolar disorder, epilepsy, migraine prophylaxis
Abstract

Rationale and background In March 2018, the European risk minimisation measures (RMMs) with a Pregnancy Prevention Program (PPP) for valproate-containing medicines was updated. A pharmacoepidemiological study was conducted using longitudinal data collected in five electronic health care databases from four EU countries and the UK to investigate the use of valproates authorised in the EU before and after implementation of the 2018 revised measures for pregnancy prevention in clinical practice, and effectiveness of the 2018 intervention. Objectives Objective 1: To determine drug utilisation and prescription patterns of valproate-containing medicinal products in females of childbearing potential, and to investigate whether significant changes in prescribing patterns occurred (pre-/post-intervention). Objective 2: To determine prescribers’ compliance with the recommendations in the Summary of Products Characteristics (SmPC) for valproate-containing medicinal products, by indication, age group, duration of use, and database. Objective 3: To determine patients’ use of effective contraception in compliance with recommendations in the SmPC for valproate-containing medicinal products, by indication, age group, method of contraception, and database. Objective 4: To determine drug utilisation and prescription patterns over time for alternative medicines prescribed in women who became pregnant, where valproate-containing medicinal products had previously been prescribed or discontinued, by indication, by age group and by database. Objective 5: Based on the results of the above, to estimate the effectiveness of the 2018 RMMs for valproates. Methods We performed an observational times series study including all female subjects of childbearing age (aged 12 to 55 years) from the corresponding databases in Denmark (Danish National Registers, DNR), Italy (ARS Tuscany), the Netherlands (PHARMO Database Network), Spain (Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria, BIFAP), and UK (Clinical Practice Research Datalink, CPRD) between 01 January 2010 to 31 December 2020. In Objective 1, the incident use, prevalent use and rate of discontinuation thereof was estimated per month in each data source, in addition to the change in level and trend in use after the implementation of the 2018 EU RMMs, using an interrupted time series (ITS) analysis design. In Objective 2, first, we separately estimated the proportion of valproate users with a record of a pregnancy test within the 90 days i) before and ii) after the date of valproate prescribing or dispensing per month. We estimated the change in level and trend in these proportions after the implementation of the 2018 EU RMMs. Second, we estimated the proportion of valproate users with a record of contraceptive (prescribed or dispensed with a prescription, or identified through medical events or procedures records) in 90-days before the prescription, or prescribed/dispensed during a contraceptive episode. We then estimated the change in level and trend in this proportion after the implementation of the 2018 EU intervention, using an ITS analysis design. In Objective 3, we estimated the incidence of new pregnancies during a period of valproate use per month and the change in level and trend in this rate after the implementation of the 2018 EU intervention, using an ITS analysis design. In Objective 4, we estimated the rates of alternative medication prescriptions/dispensings for the indications epilepsy, bipolar disorder, and migraine among valproate users and the rate of switching from valproate to an alternative medicine per month. Then, the change in trend of switches from valproate to alternative medications before and after the implementation of the 2018 EU intervention was estimated, using an ITS analysis design. In Objective 5, evidence generated from Objectives 1-4, weighed by the strengths and limitations of the analyses, was used to draw conclusions on the effectiveness of the RMMs, per country and across European countries included in the study. Results Objective 1: There were 69,533 valproate users out of a total of 9,699,371 female subjects of childbearing age from the five participating centres during the study period. The median follow-up time of the study population ranged between 3.5-10.0 years and the mean age at the start of follow-up was always ≥30 years in different centres. The monthly incidence rate of valproate use ranged between 0.01-0.47 per 1000 persons months across databases and the prevalence rate ranged between 1.2-7.7 per 1000 female subjects. While the observed rates were similar for DNR, PHARMO, BIFAP and CPRD, the rates of prevalent use were much higher in ARS Tuscany. We observed a statistically significant declining trend in prevalent use of valproates in all countries/regions, for which an ITS analysis could be performed, but no significant decreasing trend in incidence rates after the 2018 RMMs compared to the period before. The monthly rate of valproate discontinuers ranged between 1-8% across all databases, and in no database we observed a significant increase in trend or level of valproate discontinuation after the 2018 intervention compared to time prior. Objective 2: We included 69,533 female valproate users from the five participating centres during the study period, with a median follow-up time between 4.4-11.0 years and the mean age at the start of follow-up ≥34 years. Due to the limited data on pregnancy tests from all databases, modelling of any trend change in proportion of valproate prescriptions or dispensings with an adherent pregnancy test before versus after 2018 RMMs was not possible. The rate of recorded contraceptive coverage at the start of valproate treatment was low across all centres, as only 0.5-23% of valproate prescriptions/dispensings each month were accompanied by a contraceptive prescription in 90-days before, and only between 0.5-25% of new valproate treatment episode had started during contraceptive use. There was no increasing trend in compliant valproate prescriptions/ dispensings with a contraceptive coverage after the 2018 RMMs across the studied databases, and the only increase in level was observed in PHARMO. Objective 3: We included 69,533 female valproate users from the five participating centres during study period, with a median follow-up time between 4.4-11.0 years and the mean age at the start of follow-up ≥34 years. In general, we observed a substantial number of concurrent new valproate prescriptions/dispensings during a pregnancy time window in ARS Tuscany (386 pre- and 40 post 2018 intervention), BIFAP (330 pre and 20 post) and CPRD (204 pre and 56 post), while there were fewer concurrent events in PHARMO (27 pre and 0 post). However, the rates of concurrent events declined for most databases after the 2018 intervention. There was no data on pregnancy counts available from DNR. Objective 4: We included 69,533 female valproate users from the five participating centres during study period, with a median follow-up time between 4.4-11.0 years and the mean age at the start of follow-up ≥34 years. We found an increasing trend in rates of alternative medicine use for epilepsy and bipolar diseases indications of valproates across the study period in most databases (i.e., DNR, ARS Tuscany, PHARMO and CPRD), while the rates for migraine were mostly steady. The monthly rate of switch from a valproate to an alternative medication was similar across all DAPs and ranged between 1-8%. Running an ITS analysis was not possible for most of the included databases due to the low frequency of switching, but there was a significant increase in trend in switching rates from valproates to alternative medicine after the 2018 RMMs in ARS Tuscany. Objective 5: We found a generally declining trend in prevalence rate of valproate use after the 2018 RMMs in almost all databases (Objective 1), but also no increasing trend in compliant valproate prescriptions/dispensings with a contraceptive coverage (Objective 2). There was a substantial number of occurrences of pregnancy events (as the final endpoint) concurrently with valproate exposure across most included databases, but the rates declined after 2018 (Objective 3). Furthermore, we observed a significant increase in switching rates from valproates to alternative medications only in few regions (such as ARS Tuscany) (Objective 4). Noteworthy, these findings should be interpreted in context of the limitations that we faced, such as an inability to investigate some objectives due to limited data availability on pregnancy test or over-the-counter use of some contraceptives, and the occurrence of COVID-19 pandemic, which has shortened and impacted our post-intervention period and limited our ability to run ITS analyses for some objectives and some databases. Conclusions Objective 1: We observed declining trends in prevalent use of valproates after the 2018 RMMs across all databases. However, there were no declining trends in incidence rate of valproates in none of databases. The rate of discontinuation of valproates was not affected by the 2018 RMMs. Objective 2: We found in general low rates of recorded adherent contraceptive coverage with valproate use across all studied regions/countries, and there was no increased trend in compliant valproate prescriptions/dispensings with a contraceptive coverage after the 2018 RMMs compared to time prior. Due to limited data availability, rates of adherent pregnancy tests and the trend change after the intervention could not be studied. Objective 3: Despite the declining rates after the 2018 intervention, high counts and rates of concurrent pregnancy events with a valproate prescription/dispensing were observed across most studied countries/regions. Objective 4: Although the trend in alternative medication use for most indications of valproates (epilepsy and bipolar disorder) was increasing during the study period, the only significant increase in trend in switching rates from valproates to alternative medications after the 2018 RMMs was observed in ARS Tuscany. Objective 5: Based on the findings on various objectives in this study, we can conclude that there was a small impact of the 2018 RMMs on valproate use and prescribing in the studied European countries/regions. Considering the limitations of this study (such as not studying all PPP elements, the included databases had important limitations, and the study period after 2018 intervention was rather short), the results of other currently ongoing studies are needed to have a clearer picture of the appropriate implementation of 2018 RMMs on valproate use in Europe., The research leading to these results was conducted as part of the activities of the EU PE&PV (Pharmacoepidemiology and Pharmacovigilance) Research Network which is a public academic partnership coordinated by the Utrecht University, the Netherlands. The project has received support from the European Medicines Agency under the Framework service contract nr EMA/2018/28/PE. The content of this paper expresses the opinion of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.

Published
2022
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21. From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

Author

Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, Gini, Rosa, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, and Gini, Rosa

Abstract

In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project-Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation-with the vision that there is a societal obligation to rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding. The present paper introduces the set of concepts used to describe the European data sources involved in the ConcePTION project and illustrates the ConcePTION Common Data Model (CDM), which serves as the keystone of the federated ConcePTION network. Based on data availability and content analysis of 21 European data sources, the ConcePTION CDM has been structured with six tables designed to capture data from routine healthcare, three tables for data from public health surveillance activities, three curated tables for derived data on population (e.g., observation time and mother-child linkage), plus four metadata tables. By its first anniversary, the ConcePTION CDM has enabled 13 data sources to run common scripts to contribute to major European projects, demonstrating its capacity to facilitate effective and transparent deployment of distributed analytics, and its potential to address questions about utilization, effectiveness, and safety of medicines in special populations, including during pregnancy and breastfeeding, and, more broadly, in the general population.

Published
2022

22. From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, Gini, Rosa, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, and Gini, Rosa

Published
2022

23. Development of a clinical prediction model for perinatal deaths in low resource settings

Author

MS Verloskunde, Epi Infectieziekten Team 2, Epi Methoden Team 2, Circulatory Health, JC onderzoeksprogramma Methodologie, Global Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Child Health, Housseine, Natasha, Rijken, Marcus J, Weller, Katinka, Nassor, Nassra Haroub, Gbenga, Kayode, Dodd, Caitlin, Debray, Thomas, Meguid, Tarek, Franx, Arie, Grobbee, Diederick E, Browne, Joyce L, MS Verloskunde, Epi Infectieziekten Team 2, Epi Methoden Team 2, Circulatory Health, JC onderzoeksprogramma Methodologie, Global Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Child Health, Housseine, Natasha, Rijken, Marcus J, Weller, Katinka, Nassor, Nassra Haroub, Gbenga, Kayode, Dodd, Caitlin, Debray, Thomas, Meguid, Tarek, Franx, Arie, Grobbee, Diederick E, and Browne, Joyce L

Published
2022

24. From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

Author

Data Science & Biostatistiek, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, Gini, Rosa, Data Science & Biostatistiek, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, and Gini, Rosa

Published
2022

26. Background Rates of 41 Adverse Events of Special Interest for COVID-19 Vaccines in 10 European Healthcare Databases - An ACCESS Cohort Study

Author

Willame, Corinne, primary, Dodd, Caitlin, additional, Carlos, Durán, additional, Roel, Elbers, additional, Gini, Rosa, additional, Bartolini, Claudia, additional, Paoletti, Olga, additional, Wang, Lei, additional, Ehrenstein, Vera, additional, Kahlert, Johnny, additional, Haug, Ulrike, additional, Schink, Tania, additional, Diez-Domingo, Javier, additional, Mira-Iglesias, Ainara, additional, Vergara-Hernández, Carlos, additional, Giaquinto, Carlo, additional, Barbieri, Elisa, additional, Stona, Luca, additional, Huerta, Consuelo, additional, Martín-Pérez, Mar, additional, García-Poza, Patricia, additional, de Burgos González, Airam, additional, Martínez-González, María, additional, Bryant, Verónica, additional, Villalobos, Felipe, additional, Pallejà-Millán, Meritxell, additional, Aragón, Maria, additional, Juan Jose, Carreras, additional, Souverein, Patrick, additional, Nicolas, Thurin, additional, Weibel, Daniel, additional, Olaf, Klungel, additional, and Miriam, Sturkenboom, additional

Published
2022
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27. From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

Author

Thurin, Nicolas H., primary, Pajouheshnia, Romin, additional, Roberto, Giuseppe, additional, Dodd, Caitlin, additional, Hyeraci, Giulia, additional, Bartolini, Claudia, additional, Paoletti, Olga, additional, Nordeng, Hedvig, additional, Wallach‐Kildemoes, Helle, additional, Ehrenstein, Vera, additional, Dudukina, Elena, additional, MacDonald, Thomas, additional, De Paoli, Giorgia, additional, Loane, Maria, additional, Damase‐Michel, Christine, additional, Beau, Anna‐Belle, additional, Droz‐Perroteau, Cécile, additional, Lassalle, Régis, additional, Bergman, Jorieke, additional, Swart, Karin, additional, Schink, Tania, additional, Cavero‐Carbonell, Clara, additional, Barrachina‐Bonet, Laia, additional, Gomez‐Lumbreras, Ainhoa, additional, Giner‐Soriano, Maria, additional, Aragón, María, additional, Neville, Amanda J., additional, Puccini, Aurora, additional, Pierini, Anna, additional, Ientile, Valentina, additional, Trifirò, Gianluca, additional, Rissmann, Anke, additional, Leinonen, Maarit K., additional, Martikainen, Visa, additional, Jordan, Sue, additional, Thayer, Daniel, additional, Scanlon, Ieuan, additional, Georgiou, Mary E., additional, Cunnington, Marianne, additional, Swertz, Morris, additional, Sturkenboom, Miriam, additional, and Gini, Rosa, additional

Published
2021
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29. Inception to ConcePTION: A conceptual framework for characterizing pharmacoepidemiologic data sources. A study from the ConcePTION project

Author

Pajouheshnia, Romin, Thurin, Nicolas H., Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, Macdonald, Thomas, Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cecile, Lassalle, Regis, Swart-Polinder, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragon, Maria, Neville, Amanda J., Armaroli, Annarita, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifiro, Gianluca, Gatt, Miriam, Rissmann, Anke, Leinonen, Maarit K., Martikainen, Visa, Jordan, Sue, Georgiou, Mary E., Cunnington, Marianne, Sturkenboom, Miriam, and Rosa Gini

Published
2021

30. Applicability of the GAIA Maternal and Neonatal Outcome Case Definitions for the Evaluation of Adverse Events Following Vaccination in Pregnancy in High-income Countries

Author

Epi Infectieziekten Team 2, Data Science & Biostatistiek, Child Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Watson, Gabriella, Dodd, Caitlin, Munoz, Flor M, Eckert, Linda O, Jones, Christine E, Buttery, Jim P, Yildirim, Inci B, Kachikis, Alisa, Heath, Paul T, Schlaudecker, Elizabeth P, Bond, Nanette H, Santarcangelo, Patricia L, Wilcox, Christopher R, Bellamy, Karen, Elmontser, Mohnd, Sienas, Laura, Simon, Rebecca, Khalil, Asma, Townsend, Rosemary, Sturkenboom, Miriam, Black, Steve, Epi Infectieziekten Team 2, Data Science & Biostatistiek, Child Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Watson, Gabriella, Dodd, Caitlin, Munoz, Flor M, Eckert, Linda O, Jones, Christine E, Buttery, Jim P, Yildirim, Inci B, Kachikis, Alisa, Heath, Paul T, Schlaudecker, Elizabeth P, Bond, Nanette H, Santarcangelo, Patricia L, Wilcox, Christopher R, Bellamy, Karen, Elmontser, Mohnd, Sienas, Laura, Simon, Rebecca, Khalil, Asma, Townsend, Rosemary, Sturkenboom, Miriam, and Black, Steve

Published
2021

31. Patterns of Immune Activation in HIV and Non HIV Subjects and Its Relation to Cardiovascular Disease Risk

Author

Global Health team 1, Unit Opleiding Aios, Global Health, CTI UDAIR, Infection & Immunity, CDL Patiëntenzorg MI, CTI Research, Cancer, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Vos, Alinda G., Dodd, Caitlin N., Delemarre, Eveline M., Nierkens, Stefan, Serenata, Celicia, Grobbee, Diederick E., Klipstein-Grobusch, Kerstin, Venter, W. D. Francois, Global Health team 1, Unit Opleiding Aios, Global Health, CTI UDAIR, Infection & Immunity, CDL Patiëntenzorg MI, CTI Research, Cancer, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Vos, Alinda G., Dodd, Caitlin N., Delemarre, Eveline M., Nierkens, Stefan, Serenata, Celicia, Grobbee, Diederick E., Klipstein-Grobusch, Kerstin, and Venter, W. D. Francois

Published
2021

32. Methodological frontiers in vaccine safety: qualifying available evidence for rare events, use of distributed data networks to monitor vaccine safety issues, and monitoring the safety of pregnancy interventions

Author

Epi Infectieziekten Team 2, Data Science & Biostatistiek, JC onderzoeksprogramma Cardiovascular Health, Dodd, Caitlin, Andrews, Nick, Petousis-Harris, Helen, Sturkenboom, Miriam, Omer, Saad B, Black, Steven, Epi Infectieziekten Team 2, Data Science & Biostatistiek, JC onderzoeksprogramma Cardiovascular Health, Dodd, Caitlin, Andrews, Nick, Petousis-Harris, Helen, Sturkenboom, Miriam, Omer, Saad B, and Black, Steven

Published
2021

33. Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project

Author

RWE/Causal inference, Epi Infectieziekten Team 2, Data Science & Biostatistiek, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Willame, Corinne, Dodd, Caitlin, van der Aa, Lieke, Picelli, Gino, Emborg, Hanne-Dorthe, Kahlert, Johnny, Gini, Rosa, Huerta, Consuelo, Martín-Merino, Elisa, McGee, Chris, de Lusignan, Simon, Roberto, Giuseppe, Villa, Marco, Weibel, Daniel, Titievsky, Lina, Sturkenboom, Miriam C J M, RWE/Causal inference, Epi Infectieziekten Team 2, Data Science & Biostatistiek, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Willame, Corinne, Dodd, Caitlin, van der Aa, Lieke, Picelli, Gino, Emborg, Hanne-Dorthe, Kahlert, Johnny, Gini, Rosa, Huerta, Consuelo, Martín-Merino, Elisa, McGee, Chris, de Lusignan, Simon, Roberto, Giuseppe, Villa, Marco, Weibel, Daniel, Titievsky, Lina, and Sturkenboom, Miriam C J M

Published
2021

35. Description of the operational platform for data sharing and task management system (D7.2)

Author

Sturkenboom, Miriam, Gini, Rosa, Moscatelli, Marco, Holub, Petr, Dodd, Caitlin, Lum, Kirsten, Cunnington, Marianne, Swertz, Morris, Geldhof, Anja, Dolk, Helen, Loane, Maria, Yates, Laura, Lewis, David, van Puijenbroek, Eug��ne, te Winkel, Bernke, Huys, Isabelle, Rosario-Jansen, Theresa, and Hansson, Mats

Abstract

This deliverable outlines the structure and tools planned to get incorporated in the ConcePTION ecosystem to efficiently, robustly, and transparently generate evidence from a wide variety of data sources.

Published
2020
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36. Report on existing common data models and proposals for ConcePTION (D7.5)

Author

Dodd, Caitlin, Gini, Rosa, Sturkenboom, Miriam, Hoxhaj, Vjola, Hollestelle, Marieke, Thurin, Nicolas, Bartolini, Claudia, Paoletti, Olga, Roberto, Giuseppe, Cunnington, Marianne, Georgiou, Betsy, Nordeng, Hedvig, Loane, Maria, Leinonen, Maarit, Ehrenstein, Vera, Damase-Michel, Christine, Beau, Anna-Belle, van Kammen, JEH, Swart, Karin, Houben, Eline, Duarte, Talita, Haug, Ulrike, Schink, Tania, Cavero, Clara, Neville, Amanda, and Pierini, Anna

Abstract

The goal of this deliverable is to describe the creation of the ConcePTION common data model (CDM) for secondary re-use of electronic health care and surveillance data that will be used for demonstration studies in work package 1 (WP1). In addition, it will outline the current approaches and status for WP2.

Published
2020
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37. User requirements and metadata model for the FAIR data catalogue from WP1, 2 &7 - task 7.4 (D7.1)

Author

Swertz, Morris, de Andrade, Fernanda, Loane, Maria, Given, Joanne, Coste, Florence, Dolk, Helen, Lewis, David, van Puijenbroek, Eugène, te Winkel, Bernke, Yates, Laura, Dodd, Caitlin, Cunnington, Marianne, Gini, Rosa, Holub, Petr, and Sturkenboom, Miriam

Subjects
ComputingMilieux_MANAGEMENTOFCOMPUTINGANDINFORMATIONSYSTEMS, Software_SOFTWAREENGINEERING
Abstract

This deliverable aims to summarize user requirements and metadata needs as the basis for the prototype of the FAIR data catalogue for the IMI ConcePTION project.

Published
2020
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38. Prototype of FAIR data catalogue-1st (D7.6)

Author

Swertz, Morris, de Andrade, Fernanda, Cunnington, Marianne, Dodd, Caitlin, Gini, Rosa, Holub, Petr, Sturkenboom, Miriam, Dolk, Helen, Costa, Florence, Loane, Maria, Given, Joanne, Lewis, David, Yates, Laura, van Puijenbroek, Eug��ne, and te Winkel, Bernke

Abstract

The purpose of this deliverable is to summarize the delivery of the first prototype of the FAIR data catalogue for the ConcePTION project. This prototype aims to collect summary level metadata on data sources to aid ConcePTION partners in the identification of relevant data sources for the conduct of studies to generate evidence on the safety of medicines in pregnancy (i.e. data source catalogue).

Published
2020
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39. Quantifying outcome misclassification in multi-database studies:The case study of pertussis in the ADVANCE project

Author

Gini, Rosa, Dodd, Caitlin, Bollaerts, Kaatje, Bartolini, Claudia, Roberto, Guiseppe, Huerta-Alvarez, Consuelo, Martín-Merino, Elisa, Duarte-Salles, Talita, Picelli, Gino, Tramontan, Lara, Danieli, Giorgia, Correa, Ana, McGee, Chris, Becker, Benedikt F.H., Switzer, Charlotte, Gandhi-Banga, Sonja, Bauwens, Jorgen, van der Maas, Nicoline A.T., Spiteri, Gianfranco, Sdona, Emmanouela, Weibel, Daniel, Sturkenboom, Miriam, Gini, Rosa, Dodd, Caitlin, Bollaerts, Kaatje, Bartolini, Claudia, Roberto, Guiseppe, Huerta-Alvarez, Consuelo, Martín-Merino, Elisa, Duarte-Salles, Talita, Picelli, Gino, Tramontan, Lara, Danieli, Giorgia, Correa, Ana, McGee, Chris, Becker, Benedikt F.H., Switzer, Charlotte, Gandhi-Banga, Sonja, Bauwens, Jorgen, van der Maas, Nicoline A.T., Spiteri, Gianfranco, Sdona, Emmanouela, Weibel, Daniel, and Sturkenboom, Miriam

Published
2020

41. ADVANCE database characterisation and fit for purpose assessment for multi-country studies on the coverage, benefits and risks of pertussis vaccinations

Author

Sturkenboom, M, Braeye, T, van der Aa, L, Danieli, G, Dodd, Caitlin, Duarte-Salles, T, Emborg, HD, Gheorghe, M, Kahlert, J, Gini, R, Huerta-Alvarez, C, Martín-Merino, E, McGee, C, de Lusignan, S, Picelli, G, Roberto, G, Tramontan, L, Villa, M, Weibel, Daniel, Titievsky, L, Sturkenboom, M, Braeye, T, van der Aa, L, Danieli, G, Dodd, Caitlin, Duarte-Salles, T, Emborg, HD, Gheorghe, M, Kahlert, J, Gini, R, Huerta-Alvarez, C, Martín-Merino, E, McGee, C, de Lusignan, S, Picelli, G, Roberto, G, Tramontan, L, Villa, M, Weibel, Daniel, and Titievsky, L

Published
2020

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

Author

Weibel, Daniel, Dodd, Caitlin, Mahaux, Olivia, Haguinet, Francois, De Smedt, Tom, Duarte-Salles, Talita, Picelli, Gino, Tramontan, Lara, Danieli, Giorgio, Correa, Ana, McGee, Chris, Martín-Merino, Elisa, Huerta-Alvarez, Consuelo, Berencsi, Klara, Emborg, Hanne Dorthe, Bollaerts, Kaatje, Bauchau, Vincent, Titievsky, Lina, Sturkenboom, MCJM, Weibel, Daniel, Dodd, Caitlin, Mahaux, Olivia, Haguinet, Francois, De Smedt, Tom, Duarte-Salles, Talita, Picelli, Gino, Tramontan, Lara, Danieli, Giorgio, Correa, Ana, McGee, Chris, Martín-Merino, Elisa, Huerta-Alvarez, Consuelo, Berencsi, Klara, Emborg, Hanne Dorthe, Bollaerts, Kaatje, Bauchau, Vincent, Titievsky, Lina, and Sturkenboom, MCJM

Published
2020

43. ADVANCE system testing: Estimating the incidence of adverse events following pertussis vaccination in healthcare databases with incomplete exposure data

Author

Dodd, Caitlin, de Ridder, Maria, Weibel, Daniel, Mahaux, O, Haguinet, F, De Smedt, T, de Lusignan, S, McGee, C, Duarte-Salles, T, Emborg, HD, Huerta-Alvarez, C, Martín-Merino, E, Picelli, G, Berencsi, K, Danieli, G, Sturkenboom, MCJM, Dodd, Caitlin, de Ridder, Maria, Weibel, Daniel, Mahaux, O, Haguinet, F, De Smedt, T, de Lusignan, S, McGee, C, Duarte-Salles, T, Emborg, HD, Huerta-Alvarez, C, Martín-Merino, E, Picelli, G, Berencsi, K, Danieli, G, and Sturkenboom, MCJM

Published
2020

44. ADVANCE system testing: Estimating the incidence of adverse events following pertussis vaccination in healthcare databases with incomplete exposure data

Author

Global Health, RWE/Causal inference, Data Science & Biostatistiek, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Dodd, Caitlin, de Ridder, Maria, Weibel, Daniel, Mahaux, Olivia, Haguinet, Francois, de Smedt, Tom, de Lusignan, Simon, McGee, Chris, Duarte-Salles, Talita, Emborg, Hanne-Dorthe, Huerta-Alvarez, Consuelo, Martín-Merino, Elisa, Picelli, Gino, Berencsi, Klara, Danieli, Giorgia, Sturkenboom, Miriam, Global Health, RWE/Causal inference, Data Science & Biostatistiek, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Dodd, Caitlin, de Ridder, Maria, Weibel, Daniel, Mahaux, Olivia, Haguinet, Francois, de Smedt, Tom, de Lusignan, Simon, McGee, Chris, Duarte-Salles, Talita, Emborg, Hanne-Dorthe, Huerta-Alvarez, Consuelo, Martín-Merino, Elisa, Picelli, Gino, Berencsi, Klara, Danieli, Giorgia, and Sturkenboom, Miriam

Published
2020

45. ADVANCE database characterisation and fit for purpose assessment for multi-country studies on the coverage, benefits and risks of pertussis vaccinations

Author

Global Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, 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, Consuelo, Martín-Merino, Elisa, McGee, Chris, de Lusignan, Simon, Picelli, Gino, Roberto, Giuseppe, Tramontan, Lara, Villa, Marco, Weibel, Daniel, Titievsky, Lina, Global Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, 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, Consuelo, Martín-Merino, Elisa, McGee, Chris, de Lusignan, Simon, Picelli, Gino, Roberto, Giuseppe, Tramontan, Lara, Villa, Marco, Weibel, Daniel, and Titievsky, Lina

Published
2020

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

Author

Global Health, JC onderzoeksprogramma Infectious Diseases, Weibel, Daniel, Dodd, Caitlin, Mahaux, Olivia, Haguinet, Francois, De Smedt, Tom, Duarte-Salles, Talita, Picelli, Gino, Tramontan, Lara, Danieli, Giorgia, Correa, Ana, McGee, Chris, Martín-Merino, Elisa, Huerta, Consuelo, Berencsi, Klara, Emborg, Hanne-Dorthe, Bollaerts, Kaatje, Bauchau, Vincent, Titievsky, Lina, Sturkenboom, Miriam, Global Health, JC onderzoeksprogramma Infectious Diseases, Weibel, Daniel, Dodd, Caitlin, Mahaux, Olivia, Haguinet, Francois, De Smedt, Tom, Duarte-Salles, Talita, Picelli, Gino, Tramontan, Lara, Danieli, Giorgia, Correa, Ana, McGee, Chris, Martín-Merino, Elisa, Huerta, Consuelo, Berencsi, Klara, Emborg, Hanne-Dorthe, Bollaerts, Kaatje, Bauchau, Vincent, Titievsky, Lina, and Sturkenboom, Miriam

Published
2020

47. Quantifying outcome misclassification in multi-database studies: The case study of pertussis in the ADVANCE project

Author

Global Health, JC onderzoeksprogramma Infectieziekten, Gini, Rosa, Dodd, Caitlin N, Bollaerts, Kaatje, Bartolini, Claudia, Roberto, Giuseppe, Huerta-Alvarez, Consuelo, Martín-Merino, Elisa, Duarte-Salles, Talita, Picelli, Gino, Tramontan, Lara, Danieli, Giorgia, Correa, Ana, McGee, Chris, Becker, Benedikt F H, Switzer, Charlotte, Gandhi-Banga, Sonja, Bauwens, Jorgen, van der Maas, Nicoline A T, Spiteri, Gianfranco, Sdona, Emmanouela, Weibel, Daniel, Sturkenboom, Miriam, Global Health, JC onderzoeksprogramma Infectieziekten, Gini, Rosa, Dodd, Caitlin N, Bollaerts, Kaatje, Bartolini, Claudia, Roberto, Giuseppe, Huerta-Alvarez, Consuelo, Martín-Merino, Elisa, Duarte-Salles, Talita, Picelli, Gino, Tramontan, Lara, Danieli, Giorgia, Correa, Ana, McGee, Chris, Becker, Benedikt F H, Switzer, Charlotte, Gandhi-Banga, Sonja, Bauwens, Jorgen, van der Maas, Nicoline A T, Spiteri, Gianfranco, Sdona, Emmanouela, Weibel, Daniel, and Sturkenboom, Miriam

Published
2020

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