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1. Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study

Author: Abtahi, Shahab, Pajouheshnia, Romin, Durán, Carlos E., Riera-Arnau, Judit, Gamba, Magdalena, Alsina, Ema, Hoxhaj, Vjola, Andersen, Morten, Bartolini, Claudia, Kristiansen, Sarah Brøgger, Brown, Jeremy, Hallgreen, Christine Erikstrup, Garcia-Poza, Patricia, Gardarsdottir, Helga, Gini, Rosa, Girardi, Anna, Holthuis, Emily, Huerta, Consuelo, Ibánez, Luisa, Limoncella, Giorgio, Martín-Pérez, Mar, Paoletti, Olga, Roberto, Giuseppe, Souverein, Patrick, Swart, Karin M. A., Wing, Kevin, Sturkenboom, Miriam, and Klungel, Olaf
Published: 2023
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2. 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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3. 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

4. Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe

Author: Infection & Immunity, Child Health, Data Science & Biostatistiek, Pajouheshnia, Romin, Gini, Rosa, Gutierrez, Lia, Swertz, Morris A, Hyde, Eleanor, Sturkenboom, Miriam, Arana, Alejandro, Franzoni, Carla, Ehrenstein, Vera, Roberto, Giuseppe, Gil, Miguel, Maciá, Miguel Angel, Schäfer, Wiebke, Haug, Ulrike, Thurin, Nicolas H, Lassalle, Régis, Droz-Perroteau, Cécile, Zaccagnino, Silvia, Busto, Maria Paula, Middelkoop, Bas, Gembert, Karin, Sanchez-Saez, Francisco, Rodriguez-Bernal, Clara, Sanfélix-Gimeno, Gabriel, Hurtado, Isabel, Acosta, Manuel Barreiro de, Poblador-Plou, Beatriz, Carmona-Pírez, Jonás, Gimeno-Miguel, Antonio, Prados-Torres, Alexandra, Schultze, Anna, Jansen, Ella, Herings, Ron, Kuiper, Josine, Locatelli, Igor, Jazbar, Janja, Žerovnik, Špela, Kos, Mitja, Smit, Steven, Lind, Sirje, Metspalu, Andres, Simou, Stefania, Hedenmalm, Karin, Cochino, Ana, Alcini, Paolo, Kurz, Xavier, Perez-Gutthann, Susana, Infection & Immunity, Child Health, Data Science & Biostatistiek, Pajouheshnia, Romin, Gini, Rosa, Gutierrez, Lia, Swertz, Morris A, Hyde, Eleanor, Sturkenboom, Miriam, Arana, Alejandro, Franzoni, Carla, Ehrenstein, Vera, Roberto, Giuseppe, Gil, Miguel, Maciá, Miguel Angel, Schäfer, Wiebke, Haug, Ulrike, Thurin, Nicolas H, Lassalle, Régis, Droz-Perroteau, Cécile, Zaccagnino, Silvia, Busto, Maria Paula, Middelkoop, Bas, Gembert, Karin, Sanchez-Saez, Francisco, Rodriguez-Bernal, Clara, Sanfélix-Gimeno, Gabriel, Hurtado, Isabel, Acosta, Manuel Barreiro de, Poblador-Plou, Beatriz, Carmona-Pírez, Jonás, Gimeno-Miguel, Antonio, Prados-Torres, Alexandra, Schultze, Anna, Jansen, Ella, Herings, Ron, Kuiper, Josine, Locatelli, Igor, Jazbar, Janja, Žerovnik, Špela, Kos, Mitja, Smit, Steven, Lind, Sirje, Metspalu, Andres, Simou, Stefania, Hedenmalm, Karin, Cochino, Ana, Alcini, Paolo, Kurz, Xavier, and Perez-Gutthann, Susana
Published: 2024

5. Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Lessons Learnt From the MINERVA Project in Europe

Author: Data Science & Biostatistiek, Child Health, Infection & Immunity, Gini, Rosa, Pajouheshnia, Romin, Gutierrez, Lia, Swertz, Morris A, Hyde, Eleanor, Sturkenboom, Miriam, Arana, Alejandro, Franzoni, Carla, Ehrenstein, Vera, Roberto, Giuseppe, Gil, Miguel, Maciá, Miguel Angel, Schäfer, Wiebke, Haug, Ulrike, Thurin, Nicolas H, Lassalle, Régis, Droz-Perroteau, Cécile, Zaccagnino, Silvia, Busto, Maria Paula, Middelkoop, Bas, Gembert, Karin, Sanchez-Saez, Francisco, Rodriguez-Bernal, Clara, Sanfélix-Gimeno, Gabriel, Hurtado, Isabel, Acosta, Manuel Barreiro de, Poblador-Plou, Beatriz, Carmona-Pírez, Jonás, Gimeno-Miguel, Antonio, Prados-Torres, Alexandra, Schultze, Anna, Jansen, Ella, Herings, Ron, Kuiper, Josine, Locatelli, Igor, Jazbar, Janja, Žerovnik, Špela, Kos, Mitja, Smit, Steven, Lind, Sirje, Metspalu, Andres, Simou, Stefania, Hedenmalm, Karin, Cochino, Ana, Alcini, Paolo, Kurz, Xavier, Perez-Gutthann, Susana, Data Science & Biostatistiek, Child Health, Infection & Immunity, Gini, Rosa, Pajouheshnia, Romin, Gutierrez, Lia, Swertz, Morris A, Hyde, Eleanor, Sturkenboom, Miriam, Arana, Alejandro, Franzoni, Carla, Ehrenstein, Vera, Roberto, Giuseppe, Gil, Miguel, Maciá, Miguel Angel, Schäfer, Wiebke, Haug, Ulrike, Thurin, Nicolas H, Lassalle, Régis, Droz-Perroteau, Cécile, Zaccagnino, Silvia, Busto, Maria Paula, Middelkoop, Bas, Gembert, Karin, Sanchez-Saez, Francisco, Rodriguez-Bernal, Clara, Sanfélix-Gimeno, Gabriel, Hurtado, Isabel, Acosta, Manuel Barreiro de, Poblador-Plou, Beatriz, Carmona-Pírez, Jonás, Gimeno-Miguel, Antonio, Prados-Torres, Alexandra, Schultze, Anna, Jansen, Ella, Herings, Ron, Kuiper, Josine, Locatelli, Igor, Jazbar, Janja, Žerovnik, Špela, Kos, Mitja, Smit, Steven, Lind, Sirje, Metspalu, Andres, Simou, Stefania, Hedenmalm, Karin, Cochino, Ana, Alcini, Paolo, Kurz, Xavier, and Perez-Gutthann, Susana
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

8. Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Lessons Learnt From the MINERVA Project in Europe.

Author: Gini, Rosa, Pajouheshnia, Romin, Gutierrez, Lia, Swertz, Morris A., Hyde, Eleanor, Sturkenboom, Miriam, Arana, Alejandro, Franzoni, Carla, Ehrenstein, Vera, Roberto, Giuseppe, Gil, Miguel, Maciá, Miguel Angel, Schäfer, Wiebke, Haug, Ulrike, Thurin, Nicolas H., Lassalle, Régis, Droz‐Perroteau, Cécile, Zaccagnino, Silvia, Busto, Maria Paula, and Middelkoop, Bas
Published: 2024
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9. Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe.

Author: Pajouheshnia, Romin, Gini, Rosa, Gutierrez, Lia, Swertz, Morris A., Hyde, Eleanor, Sturkenboom, Miriam, Arana, Alejandro, Franzoni, Carla, Ehrenstein, Vera, Roberto, Giuseppe, Gil, Miguel, Maciá, Miguel Angel, Schäfer, Wiebke, Haug, Ulrike, Thurin, Nicolas H., Lassalle, Régis, Droz‐Perroteau, Cécile, Zaccagnino, Silvia, Busto, Maria Paula, and Middelkoop, Bas
Abstract: Purpose: Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA), a European Medicines Agency–funded project (EUPAS39322), defined a set of metadata to describe real‐world data sources (RWDSs) and piloted metadata collection in a prototype catalogue to assist investigators from data source discoverability through study conduct. Methods: A list of metadata was created from a review of existing metadata catalogues and recommendations, structured interviews, a stakeholder survey, and a technical workshop. The prototype was designed to comply with the FAIR principles (findable, accessible, interoperable, reusable), using MOLGENIS software. Metadata collection was piloted by 15 data access partners (DAPs) from across Europe. Results: A total of 442 metadata variables were defined in six domains: institutions (organizations connected to a data source); data banks (data collections sustained by an organization); data sources (collections of linkable data banks covering a common underlying population); studies; networks (of institutions); and common data models (CDMs). A total of 26 institutions were recorded in the prototype. Each DAP populated the metadata of one data source and its selected data banks. The number of data banks varied by data source; the most common data banks were hospital administrative records and pharmacy dispensation records (10 data sources each). Quantitative metadata were successfully extracted from three data sources conforming to different CDMs and entered into the prototype. Conclusions: A metadata list was finalized, a prototype was successfully populated, and a good practice guide was developed. Setting up and maintaining a metadata catalogue on RWDSs will require substantial effort to support discoverability of data sources and reproducibility of studies in Europe. [ABSTRACT FROM AUTHOR]
Published: 2024
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10. Application of Healthcare ‘Big Data’ in CNS Drug Research: The Example of the Neurological and mental health Global Epidemiology Network (NeuroGEN)

Author: Ilomäki, Jenni, Bell, J. Simon, Chan, Adrienne Y. L., Tolppanen, Anna-Maija, Luo, Hao, Wei, Li, Lai, Edward Chia-Cheng, Shin, Ju-Young, De Paoli, Giorgia, Pajouheshnia, Romin, Ho, Frederick K., Reynolds, Lorenna, Lau, Kui Kai, Crystal, Stephen, Lau, Wallis C. Y., Man, Kenneth K. C., Brauer, Ruth, Chan, Esther W., Shen, Chin-Yao, Kim, Ju Hwan, Lum, Terry Y. S., Hartikainen, Sirpa, Koponen, Marjaana, Rooke, Evelien, Bazelier, Marloes, Klungel, Olaf, Setoguchi, Soko, Pell, Jill P., Cook, Sharon, and Wong, Ian C. K.
Published: 2020
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11. Impact of the 2018 revised Pregnancy Prevention Programme by the European Medicines Agency on the use of oral retinoids in females of childbearing age in Denmark, Italy, Netherlands, and Spain: an interrupted time series analysis

Author: Durán, Carlos E., primary, Riera-Arnau, Judit, additional, Abtahi, Shahab, additional, Pajouheshnia, Romin, additional, Hoxhaj, Vjola, additional, Gamba, Magdalena, additional, Alsina, Ema, additional, Martin-Perez, Mar, additional, Garcia-Poza, Patricia, additional, Llorente-Garcia, Ana, additional, Gonzalez-Bermejo, Diana, additional, Ibánez, Luisa, additional, Sabaté, Mònica, additional, Vidal, Xavier, additional, Ballarín, Elena, additional, Sanfélix-Gimeno, Gabriel, additional, Rodríguez-Bernal, Clara, additional, Peiró, Salvador, additional, García-Sempere, Aníbal, additional, Sanchez-Saez, Francisco, additional, Ientile, Valentina, additional, Ingrasciotta, Ylenia, additional, Guarneri, Claudio, additional, Tanaglia, Matilde, additional, Tari, Michele, additional, Herings, Ron, additional, Houben, Eline, additional, Swart-Polinder, Karin, additional, Holthuis, Emily, additional, Huerta, Consuelo, additional, Gini, Rosa, additional, Roberto, Giuseppe, additional, Bartolini, Claudia, additional, Paoletti, Olga, additional, Limoncella, Giorgio, additional, Girardi, Anna, additional, Hyeraci, Giulia, additional, Andersen, Morten, additional, Kristiansen, Sarah Brøgger, additional, Hallgreen, Christine Erikstrup, additional, Klungel, Olaf, additional, and Sturkenboom, Miriam, additional
Published: 2023
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12. Improving 10-year cardiovascular risk prediction in apparently healthy people: flexible addition of risk modifiers on top of SCORE2

Author: Hageman, Steven H J, primary, Petitjean, Carmen, additional, Pennells, Lisa, additional, Kaptoge, Stephen, additional, Pajouheshnia, Romin, additional, Tillmann, Taavi, additional, Blaha, Michael J, additional, McClelland, Robyn L, additional, Matsushita, Kunihiro, additional, Nambi, Vijay, additional, Klungel, Olaf H, additional, Souverein, Patrick C, additional, van der Schouw, Yvonne T, additional, Verschuren, W M Monique, additional, Lehmann, Nils, additional, Erbel, Raimund, additional, Jöckel, Karl-Heinz, additional, Di Angelantonio, Emanuele, additional, Visseren, Frank L J, additional, and Dorresteijn, Jannick A N, additional
Published: 2023
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13. Safety of off‐label dose reduction of non‐vitamin K antagonist oral anticoagulants in patients with atrial fibrillation

Author: van den Dries, Carline J., Pajouheshnia, Romin, van den Ham, Hendrika A., Souverein, Patrick, Moons, Karel G.M., Hoes, Arno W., Geersing, Geert Jan, van Doorn, Sander, Afd Pharmacoepi & Clinical Pharmacology, Sub Biomol.Mass Spectrometry & Proteom., Pharmacoepidemiology and Clinical Pharmacology, and Biomolecular Mass Spectrometry and Proteomics
Subjects: Pharmacology, Anticoagulation, non-vitamin K antagonist oral anticoagulants, Pharmacology (medical), Off-label dose reduction, Atrial fibrillation
Abstract: Aim: To investigate the effects of off-label non-vitamin K oral anticoagulant (NOAC) dose reduction compared with on-label standard dosing in atrial fibrillation (AF) patients in routine care. Methods: Population-based cohort study using data from the United Kingdom Clinical Practice Research Datalink, comparing adults with non-valvular AF receiving an off-label reduced NOAC dose to patients receiving an on-label standard dose. Outcomes were ischaemic stroke, major/non-major bleeding and mortality. Inverse probability of treatment weighting and inverse probability of censoring weighting on the propensity score were applied to adjust for confounding and informative censoring. Results: Off-label dose reduction occurred in 2466 patients (8.0%), compared with 18 108 (58.5%) on-label standard-dose users. Median age was 80 years (interquartile range [IQR] 73.0-86.0) versus 72 years (IQR 66-78), respectively. Incidence rates were higher in the off-label dose reduction group compared to the on-label standard dose group, for ischaemic stroke (0.94 vs 0.70 per 100 person years), major bleeding (1.48 vs 0.83), non-major bleeding (6.78 vs 6.16) and mortality (10.12 vs 3.72). Adjusted analyses resulted in a hazard ratio of 0.95 (95% confidence interval [CI] 0.57-1.60) for ischaemic stroke, 0.88 (95% CI 0.57-1.35) for major bleeding, 0.81 (95% CI 0.67-0.98) for non-major bleeding and 1.34 (95% CI 1.12-1.61) for mortality. Conclusion: In this large population-based study, the hazards for ischaemic stroke and major bleeding were low, and similar in AF patients receiving an off-label reduced NOAC dose compared with on-label standard dose users, while non-major bleeding risk appeared to be lower and mortality risk higher. Caution towards prescribing an off-label reduced NOAC dose is therefore required.
Published: 2022
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14. Mapping the risk of infections in patients with multiple sclerosis

Author: Leung, Melissa Wy, Bazelier, Marloes T, Souverein, Patrick C, Uitdehaag, Bernard Mj, Klungel, Olaf H, Leufkens, Hubert Gm, Pajouheshnia, Romin, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Neurology, and Amsterdam Neuroscience - Neuroinfection & -inflammation
Subjects: Multiple Sclerosis, Databases, Factual, Incidence, Clinical Neurology, United Kingdom, United Kingdom Clinical Practice Research Datalink GOLD and Aurum, Neurology, Risk Factors, Multiple sclerosis infections, Humans, Neurology (clinical), multiple outcomes multi-database study, urinary tract infection
Abstract: Background: People with multiple sclerosis (pwMS) have an increased risk of infections; risk factors include underlying disease, physical impairment and use of some disease-modifying treatments. Objective: To quantify changes in population-level infection rates among pwMS and compare these to the general population and people with rheumatoid arthritis (pwRA), and identify patient characteristics predictive of infections after MS diagnosis. Methods: We conducted a multi-database study using data on 23,226 people with MS diagnosis from the UK Clinical Practice Research Datalink Aurum and GOLD (January 2000–December 2020). PwMS were matched to MS-free controls and pwRA. We calculated infection rates, and estimated incidence rate ratios (IRR) and 95% confidence intervals (CI) of predictors for infections ⩽ 5 years after MS diagnosis using Poisson regression. Results: Among pwMS, overall infection rates remained stable – 1.51-fold (1.49–1.52) that in MS-free controls and 0.87-fold (0.86–0.88) that in pwRA – although urinary tract infection rate per 1000 person-years increased from 98.7 (96.1–101) (2000–2010) to 136 (134–138) (2011–2020). Recent infection before MS diagnosis was most predictive of infections (1 infection: IRR 1.92 (1.86–1.97); ⩾2 infections: IRR 3.00 (2.89–3.10)). Conclusion: The population-level elevated risk of infection among pwMS has remained stable despite the introduction of disease-modifying treatments.
Published: 2022
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15. Improving 10-year cardiovascular risk prediction in apparently healthy people: flexible addition of risk modifiers on top of SCORE2

Author: Hageman, Steven Hj, Petitjean, Carmen, Pennells, Lisa, Kaptoge, Stephen, Pajouheshnia, Romin, Tillmann, Taavi, Blaha, Michael J, McClelland, Robyn L, Matsushita, Kunihiro, Nambi, Vijay, Klungel, Olaf H, Souverein, Patrick C, van der Schouw, Yvonne T, Verschuren, Wm Monique, Lehmann, Nils, Erbel, Raimund, Jöckel, Karl-Heinz, Di Angelantonio, Emanuele, Visseren, Frank Lj, and Dorresteijn, Jannick An
Published: 2023

16. Prescribing of low‐dose rivaroxaban in patients with atherosclerotic cardiovascular disease in the United Kingdom and the Netherlands

Author: Hunt, Nicholas B., primary, Pajouheshnia, Romin, additional, Salih, Allan, additional, van Doorn, Sander, additional, Souverein, Patrick C., additional, Bazelier, Marloes T., additional, Klungel, Olaf H., additional, and Gardarsdottir, Helga, additional
Published: 2023
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17. Prescribing of low-dose rivaroxaban in patients with atherosclerotic cardiovascular disease in the United Kingdom and the Netherlands

Author: Hunt, Nicholas B., Pajouheshnia, Romin, Salih, Allan, van Doorn, Sander, Souverein, Patrick C., Bazelier, Marloes T., Klungel, Olaf H., Gardarsdottir, Helga, Hunt, Nicholas B., Pajouheshnia, Romin, Salih, Allan, van Doorn, Sander, Souverein, Patrick C., Bazelier, Marloes T., Klungel, Olaf H., and Gardarsdottir, Helga
Abstract: Aims Low-dose rivaroxaban has been indicated for the management of atherosclerotic cardiovascular disease (ASCVD) after recent (2019-2020) updates to European guidelines. We aimed to describe prescription trends of low-dose rivaroxaban in ASCVD patients over the period 2015-2022 in two European countries, to compare the trends before and after guideline changes, and to determine the characteristics of users. Methods In a cross-sectional interrupted time series analysis, utilization of low-dose rivaroxaban (2.5 mg, twice daily) was measured in Clinical Practice Research Datalink Aurum (United Kingdom [UK]) and the PHARMO Database Network (the Netherlands) from 1 January 2015 to 28 February 2022 in patients with an ASCVD diagnosis. Incidence rates (IRs) and incidence rate ratios (IRRs) of new use (within 182 days) compared to the reference period, 2015-2018, were calculated. Age, sex and comorbidities of users were compared to those of nonusers. Results In the UK, from 721 271 eligible subjects the IR of new use of low-dose rivaroxaban in the period 2015-2018, before guideline changes, was 12.4 per 100 000 person-years and after guideline changes in 2020-2022 was 124.0 (IRR 10.0, 95% confidence interval [CI] 8.5, 11.8). In the Netherlands from 394 851 subjects, the IR in 2015-2018 was 2.4 per 100 000 person-years and in 2020 was 16.3 (IRR 6.7, 95% CI 4.0, 11.4). Users were younger (UK mean difference [MD] −6.1 years, Netherlands −2.4 years; P < .05) and more likely to be male (UK difference 11.5%, Netherlands 13.4%; P < .001) than nonusers. Conclusions There was a statistically significant increase in the use of low-dose rivaroxaban for the management of ASCVD after guideline changes in the UK and the Netherlands. There were international differences, but low-dose rivaroxaban has not been put into widespread practice.
Published: 2023
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18. Impact of the 2018 revised Pregnancy Prevention Programme by the European Medicines Agency on the use of oral retinoids in females of childbearing age in Denmark, Italy, Netherlands, and Spain: an interrupted time series analysis

Author: Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, Sturkenboom, Miriam, Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, and Sturkenboom, Miriam
Abstract: Background: In March 2018, the European pregnancy prevention programme for oral retinoids was updated as part of risk minimisation measures (RMM), emphasising their contraindication in pregnant women. Objective: To measure the impact of the 2018 revision of the RMMs in Europe by assessing the utilisation patterns of isotretinoin, alitretinoin and acitretin, contraceptive measures, pregnancy testing, discontinuation, and pregnancy occurrence concomitantly with a retinoid prescription. Methods: An interrupted time series (ITS) analysis to compare level and trend changes after the risk minimisation measures implementation was conducted on a cohort of females of childbearing age (12-55 years of age) from January 2010 to December 2020, derived from six electronic health data sources in four countries: Denmark, Netherlands, Spain, and Italy. Monthly utilisation figures (incidence rates [IR], prevalence rates [PR] and proportions) of oral retinoids were calculated, as well as discontinuation rates, contraception coverage, pregnancy testing, and rates of exposed pregnancies to oral retinoids, before and after the 2018 RMMs. Results: From 10,714,182 females of child-bearing age, 88,992 used an oral retinoid at any point during the study period (mean age 18.9-22.2 years old). We found non-significant level and trend changes in incidence or prevalence of retinoid use in females of child-bearing age after the 2018 RMMs. The reason of discontinuation was unknown in >95% of cases. Contraception use showed a significant increase trend in Spain; for other databases this information was limited. Pregnancy testing was hardly recorded thus was not possible to model ITS analyses. After the 2018 RMM, rates of pregnancy occurrence during retinoid use, and start of a retinoid during a pregnancy varied from 0.0 to 0.4, and from 0.2 to 0.8, respectively. Conclusion: This study shows a limited impact of the 2018 RMMs on oral retinoids utilisation patterns among females of child-bearing
Published: 2023

19. Prescribing of low-dose rivaroxaban in patients with atherosclerotic cardiovascular disease in the United Kingdom and the Netherlands

Author: Hunt, Nicholas B, Pajouheshnia, Romin, Salih, Allan, van Doorn, Sander, Souverein, Patrick C, Bazelier, Marloes T, Klungel, Olaf H, Gardarsdottir, Helga, Hunt, Nicholas B, Pajouheshnia, Romin, Salih, Allan, van Doorn, Sander, Souverein, Patrick C, Bazelier, Marloes T, Klungel, Olaf H, and Gardarsdottir, Helga
Abstract: Aims: Low-dose rivaroxaban has been indicated for the management of atherosclerotic cardiovascular disease (ASCVD) after recent (2019-2020) updates to European guidelines. We aimed to describe prescription trends of low-dose rivaroxaban in ASCVD patients over the period 2015-2022 in two European countries, to compare the trends before and after guideline changes, and to determine the characteristics of users. Methods: In a cross-sectional interrupted time series analysis, utilization of low-dose rivaroxaban (2.5 mg, twice daily) was measured in Clinical Practice Research Datalink Aurum (United Kingdom [UK]) and the PHARMO Database Network (the Netherlands) from 1 January 2015 to 28 February 2022 in patients with an ASCVD diagnosis. Incidence rates (IRs) and incidence rate ratios (IRRs) of new use (within 182 days) compared to the reference period, 2015-2018, were calculated. Age, sex and comorbidities of users were compared to those of nonusers. Results: In the UK, from 721 271 eligible subjects the IR of new use of low-dose rivaroxaban in the period 2015-2018, before guideline changes, was 12.4 per 100 000 person-years and after guideline changes in 2020-2022 was 124.0 (IRR 10.0, 95% confidence interval [CI] 8.5, 11.8). In the Netherlands from 394 851 subjects, the IR in 2015-2018 was 2.4 per 100 000 person-years and in 2020 was 16.3 (IRR 6.7, 95% CI 4.0, 11.4). Users were younger (UK mean difference [MD] −6.1 years, Netherlands −2.4 years; P <.05) and more likely to be male (UK difference 11.5%, Netherlands 13.4%; P <.001) than nonusers. Conclusions: There was a statistically significant increase in the use of low-dose rivaroxaban for the management of ASCVD after guideline changes in the UK and the Netherlands. There were international differences, but low-dose rivaroxaban has not been put into widespread practice.
Published: 2023

20. Improving 10-year cardiovascular risk prediction in apparently healthy people: flexible addition of risk modifiers on top of SCORE2

Author: Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Hageman, Steven Hj, Petitjean, Carmen, Pennells, Lisa, Kaptoge, Stephen, Pajouheshnia, Romin, Tillmann, Taavi, Blaha, Michael J, McClelland, Robyn L, Matsushita, Kunihiro, Nambi, Vijay, Klungel, Olaf H, Souverein, Patrick C, van der Schouw, Yvonne T, Verschuren, Wm Monique, Lehmann, Nils, Erbel, Raimund, Jöckel, Karl-Heinz, Di Angelantonio, Emanuele, Visseren, Frank Lj, Dorresteijn, Jannick An, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Hageman, Steven Hj, Petitjean, Carmen, Pennells, Lisa, Kaptoge, Stephen, Pajouheshnia, Romin, Tillmann, Taavi, Blaha, Michael J, McClelland, Robyn L, Matsushita, Kunihiro, Nambi, Vijay, Klungel, Olaf H, Souverein, Patrick C, van der Schouw, Yvonne T, Verschuren, Wm Monique, Lehmann, Nils, Erbel, Raimund, Jöckel, Karl-Heinz, Di Angelantonio, Emanuele, Visseren, Frank Lj, and Dorresteijn, Jannick An
Published: 2023

21. Impact of the 2018 revised Pregnancy Prevention Programme by the European Medicines Agency on the use of oral retinoids in females of childbearing age in Denmark, Italy, Netherlands, and Spain: an interrupted time series analysis

Author: Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, Sturkenboom, Miriam, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, and Sturkenboom, Miriam
Published: 2023

22. Impact of the 2018 revised Pregnancy Prevention Programme by the European Medicines Agency on the use of oral retinoids in females of childbearing age in Denmark, Italy, Netherlands, and Spain:an interrupted time series analysis

Author: Durán, Carlos E., Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, Sturkenboom, Miriam, Durán, Carlos E., Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, and Sturkenboom, Miriam
Abstract: Background: In March 2018, the European pregnancy prevention programme for oral retinoids was updated as part of risk minimisation measures (RMM), emphasising their contraindication in pregnant women. Objective: To measure the impact of the 2018 revision of the RMMs in Europe by assessing the utilisation patterns of isotretinoin, alitretinoin and acitretin, contraceptive measures, pregnancy testing, discontinuation, and pregnancy occurrence concomitantly with a retinoid prescription. Methods: An interrupted time series (ITS) analysis to compare level and trend changes after the risk minimisation measures implementation was conducted on a cohort of females of childbearing age (12–55 years of age) from January 2010 to December 2020, derived from six electronic health data sources in four countries: Denmark, Netherlands, Spain, and Italy. Monthly utilisation figures (incidence rates [IR], prevalence rates [PR] and proportions) of oral retinoids were calculated, as well as discontinuation rates, contraception coverage, pregnancy testing, and rates of exposed pregnancies to oral retinoids, before and after the 2018 RMMs. Results: From 10,714,182 females of child-bearing age, 88,992 used an oral retinoid at any point during the study period (mean age 18.9–22.2 years old). We found non-significant level and trend changes in incidence or prevalence of retinoid use in females of child-bearing age after the 2018 RMMs. The reason of discontinuation was unknown in >95% of cases. Contraception use showed a significant increase trend in Spain; for other databases this information was limited. Pregnancy testing was hardly recorded thus was not possible to model ITS analyses. After the 2018 RMM, rates of pregnancy occurrence during retinoid use, and start of a retinoid during a pregnancy varied from 0.0 to 0.4, and from 0.2 to 0.8, respectively. Conclusion: This study shows a limited impact of the 2018 RMMs on oral retinoids utilisation patterns among females of child-bearing
Published: 2023

23. Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate:An Interrupted Time Series Study

Author: Abtahi, Shahab, Pajouheshnia, Romin, Durán, Carlos E., Riera-Arnau, Judit, Gamba, Magdalena, Alsina, Ema, Hoxhaj, Vjola, Andersen, Morten, Bartolini, Claudia, Kristiansen, Sarah Brøgger, Brown, Jeremy, Hallgreen, Christine Erikstrup, Garcia-Poza, Patricia, Gardarsdottir, Helga, Gini, Rosa, Girardi, Anna, Holthuis, Emily, Huerta, Consuelo, Ibánez, Luisa, Limoncella, Giorgio, Martín-Pérez, Mar, Paoletti, Olga, Roberto, Giuseppe, Souverein, Patrick, Swart, Karin M.A., Wing, Kevin, Sturkenboom, Miriam, Klungel, Olaf, Abtahi, Shahab, Pajouheshnia, Romin, Durán, Carlos E., Riera-Arnau, Judit, Gamba, Magdalena, Alsina, Ema, Hoxhaj, Vjola, Andersen, Morten, Bartolini, Claudia, Kristiansen, Sarah Brøgger, Brown, Jeremy, Hallgreen, Christine Erikstrup, Garcia-Poza, Patricia, Gardarsdottir, Helga, Gini, Rosa, Girardi, Anna, Holthuis, Emily, Huerta, Consuelo, Ibánez, Luisa, Limoncella, Giorgio, Martín-Pérez, Mar, Paoletti, Olga, Roberto, Giuseppe, Souverein, Patrick, Swart, Karin M.A., Wing, Kevin, Sturkenboom, Miriam, and Klungel, Olaf
Abstract: Introduction: Due to established teratogenicity of valproates, the EU risk minimisation measures (RMMs) with a pregnancy prevention programme (PPP) for valproate were updated in March 2018. Objectives: To investigate the effectiveness of the 2018 EU RMMs on valproate utilisation in five European countries/regions. Methods: A multi-database, times series study of females of childbearing potential (12–55 years) was conducted using electronic medical records from five countries/regions (01.01.2010–31.12.2020): Denmark, Tuscany (Italy), Spain, the Netherlands, and the UK. Clinical and demographic information from each database was transformed to the ConcePTION Common Data Model, quality checks were conducted and a distributed analysis was performed using common scripts. Incident and prevalent use of valproate, proportion of discontinuers and switchers to alternative medicine, frequency of contraception coverage during valproate use, and occurrence of pregnancies during valproate exposure were estimated per month. Interrupted time series analyses were conducted to estimate the level or trend change in the outcome measures. Results: We included 69,533 valproate users from 9,699,371 females of childbearing potential from the five participating centres. A significant decline in prevalent use of valproates was observed in Tuscany, Italy (mean difference post-intervention −7.7%), Spain (−11.3%), and UK (−5.9%) and a non-significant decline in the Netherlands (−3.3%), but no decline in incident use after the 2018 RMMs compared to the period before. The monthly proportion of compliant valproate prescriptions/dispensings with a contraceptive coverage was low (<25%), with an increase after the 2018 RMMs only in the Netherlands (mean difference post-intervention 12%). There was no significant increase in switching rates from valproates to alternative medicine after the 2018 intervention in any of the countries/regions. We observed a substantial number of concurrent pregnanci
Published: 2023

24. Prescribing of low-dose rivaroxaban in patients with atherosclerotic cardiovascular disease in the United Kingdom and the Netherlands

Author: Afd Pharmacoepi & Clinical Pharmacology, Sub Biomol.Mass Spectrometry & Proteom., Pharmacoepidemiology and Clinical Pharmacology, Biomolecular Mass Spectrometry and Proteomics, PECP - Centre for Pharmacoepidemiology, Hunt, Nicholas B, Pajouheshnia, Romin, Salih, Allan, van Doorn, Sander, Souverein, Patrick C, Bazelier, Marloes T, Klungel, Olaf H, Gardarsdottir, Helga, Afd Pharmacoepi & Clinical Pharmacology, Sub Biomol.Mass Spectrometry & Proteom., Pharmacoepidemiology and Clinical Pharmacology, Biomolecular Mass Spectrometry and Proteomics, PECP - Centre for Pharmacoepidemiology, Hunt, Nicholas B, Pajouheshnia, Romin, Salih, Allan, van Doorn, Sander, Souverein, Patrick C, Bazelier, Marloes T, Klungel, Olaf H, and Gardarsdottir, Helga
Published: 2023

25. Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study

Author: Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Abtahi, Shahab, Pajouheshnia, Romin, Durán, Carlos E, Riera-Arnau, Judit, Gamba, Magdalena, Alsina, Ema, Hoxhaj, Vjola, Andersen, Morten, Bartolini, Claudia, Kristiansen, Sarah Brøgger, Brown, Jeremy, Hallgreen, Christine Erikstrup, Garcia-Poza, Patricia, Gardarsdottir, Helga, Gini, Rosa, Girardi, Anna, Holthuis, Emily, Huerta, Consuelo, Ibánez, Luisa, Limoncella, Giorgio, Martín-Pérez, Mar, Paoletti, Olga, Roberto, Giuseppe, Souverein, Patrick, Swart, Karin M A, Wing, Kevin, Sturkenboom, Miriam, Klungel, Olaf, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Abtahi, Shahab, Pajouheshnia, Romin, Durán, Carlos E, Riera-Arnau, Judit, Gamba, Magdalena, Alsina, Ema, Hoxhaj, Vjola, Andersen, Morten, Bartolini, Claudia, Kristiansen, Sarah Brøgger, Brown, Jeremy, Hallgreen, Christine Erikstrup, Garcia-Poza, Patricia, Gardarsdottir, Helga, Gini, Rosa, Girardi, Anna, Holthuis, Emily, Huerta, Consuelo, Ibánez, Luisa, Limoncella, Giorgio, Martín-Pérez, Mar, Paoletti, Olga, Roberto, Giuseppe, Souverein, Patrick, Swart, Karin M A, Wing, Kevin, Sturkenboom, Miriam, and Klungel, Olaf
Published: 2023

26. Impact of the 2018 revised Pregnancy Prevention Programme by the European Medicines Agency on the use of oral retinoids in females of childbearing age in Denmark, Italy, Netherlands, and Spain: an interrupted time series analysis

Author: RWE/Causal inference, Epi Infectieziekten Team 2, Data Science & Biostatistiek, Child Health, Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, Sturkenboom, Miriam, RWE/Causal inference, Epi Infectieziekten Team 2, Data Science & Biostatistiek, Child Health, Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, and Sturkenboom, Miriam
Published: 2023

27. Improving 10-year cardiovascular risk prediction in apparently healthy people: flexible addition of risk modifiers on top of SCORE2

Author: Interne Geneeskunde Vasculaire, RWE/Causal inference, Cardiovasculaire Epi Team 1, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, MS Interne Geneeskunde, Hageman, Steven Hj, Petitjean, Carmen, Pennells, Lisa, Kaptoge, Stephen, Pajouheshnia, Romin, Tillmann, Taavi, Blaha, Michael J, McClelland, Robyn L, Matsushita, Kunihiro, Nambi, Vijay, Klungel, Olaf H, Souverein, Patrick C, van der Schouw, Yvonne T, Verschuren, Wm Monique, Lehmann, Nils, Erbel, Raimund, Jöckel, Karl-Heinz, Di Angelantonio, Emanuele, Visseren, Frank Lj, Dorresteijn, Jannick An, Interne Geneeskunde Vasculaire, RWE/Causal inference, Cardiovasculaire Epi Team 1, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, MS Interne Geneeskunde, Hageman, Steven Hj, Petitjean, Carmen, Pennells, Lisa, Kaptoge, Stephen, Pajouheshnia, Romin, Tillmann, Taavi, Blaha, Michael J, McClelland, Robyn L, Matsushita, Kunihiro, Nambi, Vijay, Klungel, Olaf H, Souverein, Patrick C, van der Schouw, Yvonne T, Verschuren, Wm Monique, Lehmann, Nils, Erbel, Raimund, Jöckel, Karl-Heinz, Di Angelantonio, Emanuele, Visseren, Frank Lj, and Dorresteijn, Jannick An
Published: 2023

28. Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study

Author: RWE/Causal inference, Epi Infectieziekten Team 2, Apotheek O&O&O, Child Health, Infection & Immunity, Regenerative Medicine and Stem Cells, Data Science & Biostatistiek, Abtahi, Shahab, Pajouheshnia, Romin, Durán, Carlos E, Riera-Arnau, Judit, Gamba, Magdalena, Alsina, Ema, Hoxhaj, Vjola, Andersen, Morten, Bartolini, Claudia, Kristiansen, Sarah Brøgger, Brown, Jeremy, Hallgreen, Christine Erikstrup, Garcia-Poza, Patricia, Gardarsdottir, Helga, Gini, Rosa, Girardi, Anna, Holthuis, Emily, Huerta, Consuelo, Ibánez, Luisa, Limoncella, Giorgio, Martín-Pérez, Mar, Paoletti, Olga, Roberto, Giuseppe, Souverein, Patrick, Swart, Karin M A, Wing, Kevin, Sturkenboom, Miriam, Klungel, Olaf, RWE/Causal inference, Epi Infectieziekten Team 2, Apotheek O&O&O, Child Health, Infection & Immunity, Regenerative Medicine and Stem Cells, Data Science & Biostatistiek, Abtahi, Shahab, Pajouheshnia, Romin, Durán, Carlos E, Riera-Arnau, Judit, Gamba, Magdalena, Alsina, Ema, Hoxhaj, Vjola, Andersen, Morten, Bartolini, Claudia, Kristiansen, Sarah Brøgger, Brown, Jeremy, Hallgreen, Christine Erikstrup, Garcia-Poza, Patricia, Gardarsdottir, Helga, Gini, Rosa, Girardi, Anna, Holthuis, Emily, Huerta, Consuelo, Ibánez, Luisa, Limoncella, Giorgio, Martín-Pérez, Mar, Paoletti, Olga, Roberto, Giuseppe, Souverein, Patrick, Swart, Karin M A, Wing, Kevin, Sturkenboom, Miriam, and Klungel, Olaf
Published: 2023

29. Safety of off-label dose reduction of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation

Author: Circulatory Health, HAG Trombose, Epi Methoden, Cancer, JC onderzoeksprogramma Methodology, Directie Raad van Bestuur, JC onderzoeksprogramma Cardiovascular Health, van den Dries, Carline J, Pajouheshnia, Romin, van den Ham, Hendrika A, Souverein, Patrick, Moons, Karel G M, Hoes, Arno W, Geersing, Geert-Jan, van Doorn, Sander, Circulatory Health, HAG Trombose, Epi Methoden, Cancer, JC onderzoeksprogramma Methodology, Directie Raad van Bestuur, JC onderzoeksprogramma Cardiovascular Health, van den Dries, Carline J, Pajouheshnia, Romin, van den Ham, Hendrika A, Souverein, Patrick, Moons, Karel G M, Hoes, Arno W, Geersing, Geert-Jan, and van Doorn, Sander
Published: 2023

30. Explicit inclusion of treatment in prognostic modeling was recommended in observational and randomized settings

Author: Groenwold, Rolf H.H., Moons, Karel G.M., Pajouheshnia, Romin, Altman, Doug G., Collins, Gary S., Debray, Thomas P.A., Reitsma, Johannes B., Riley, Richard D., and Peelen, Linda M.
Published: 2016
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31. Performance of the Framingham risk models and pooled cohort equations for predicting 10-year risk of cardiovascular disease: a systematic review and meta-analysis

Author: Damen, Johanna A., Pajouheshnia, Romin, Heus, Pauline, Moons, Karel G. M., Reitsma, Johannes B., Scholten, Rob J. P. M., Hooft, Lotty, and Debray, Thomas P. A.
Published: 2019
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32. 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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33. Poor reporting of multivariable prediction model studies: towards a targeted implementation strategy of the TRIPOD statement

Author: Heus, Pauline, Damen, Johanna A. A. G., Pajouheshnia, Romin, Scholten, Rob J. P. M., Reitsma, Johannes B., Collins, Gary S., Altman, Douglas G., Moons, Karel G. M., and Hooft, Lotty
Published: 2018
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34. Using pharmacy dispensing data to predict falls in older individuals

Author: Gemmeke, Marle, Koster, Ellen S., Pajouheshnia, Romin, Kruijtbosch, Martine, Taxis, Katja, Bouvy, Marcel L., Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PharmacoTherapy, -Epidemiology and -Economics, and Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET)
Subjects: RECURRENT FALLERS, drug burden index, Pharmacy, 030226 pharmacology & pharmacy, elderly, Cholinergic Antagonists, 03 medical and health sciences, dispensing records, risk prediction, 0302 clinical medicine, MEDICATION USE, BURDEN INDEX, Humans, Hypnotics and Sedatives, Medicine, Pharmacology (medical), fall risk-increasing drugs, 030212 general & internal medicine, Aged, Retrospective Studies, Polypharmacy, Pharmacology, OUTCOMES, Framingham Risk Score, business.industry, falling, Retrospective cohort study, Odds ratio, ASSOCIATION, ADULTS, NATIONAL-POPULATION, Confidence interval, COMMUNITY, Falling (accident), RISK-INCREASING DRUGS, Pharmacy practice, POLYPHARMACY, medicine.symptom, business, Demography
Abstract: Aims Associations between individual medication use and falling in older individuals are well-documented. However, a comprehensive risk score that takes into account overall medication use and that can be used in daily pharmacy practice is lacking. We, therefore, aimed to determine whether pharmacy dispensing records can be used to predict falls. Methods A retrospective cohort study was conducted using pharmacy dispensing data and self-reported falls among 3454 Dutch individuals aged >= 65 years. Two different methods were used to classify medication exposure for each person: the drug burden index (DBI) for cumulative anticholinergic and sedative medication exposure as well as exposure to fall risk-increasing drugs (FRIDs). Multinomial regression analyses, adjusted for age and sex, were conducted to investigate the association between medication exposure and falling classified as nonfalling, single falling and recurrent falling. The predictive performances of the DBI and FRIDs exposure were estimated by the polytomous discrimination index (PDI). Results There were 521 single fallers (15%) and 485 recurrent fallers (14%). We found significant associations between a DBI >= 1 and single falling (adjusted odds ratio: 1.30 [95% confidence interval {CI}: 1.02-1.66]) and recurrent falling (adjusted odds ratio: 1.60 [95%CI: 1.25-2.04]). The PDI of the DBI model was 0.41 (95%CI: 0.39-0.42) and the PDI of the FRIDs model was 0.45 (95%CI: 0.43-0.47), indicating poor discrimination between fallers and nonfallers. Conclusion The study shows significant associations between medication use and falling. However, the medication-based models were insufficient and other factors should be included to develop a risk score for pharmacy practice.
Published: 2021
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35. The Disconnect Between Development and Intended Use of Clinical Prediction Models for Covid-19: A Systematic Review and Real-World Data Illustration

Author: Prosepe, Ilaria, primary, Groenwold, Rolf H. H., additional, Knevel, Rachel, additional, Pajouheshnia, Romin, additional, and van Geloven, Nan, additional
Published: 2022
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36. 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

37. 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

38. O-007 Oral Presentation: Impact of the 2018 Pregnancy Prevention Program on the Use of Oral Retinoids in Childbearing Age Females in Europe (Abstract presented at 21st ISoP Annual Meeting 2022, Verona)

Author: Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Durán, Carlos E., Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Klungel, Olaf, Sturkenboom, Miriam, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Durán, Carlos E., Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Klungel, Olaf, and Sturkenboom, Miriam
Published: 2022

39. Safety of off-label dose reduction of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation

Author: Afd Pharmacoepi & Clinical Pharmacology, Sub Biomol.Mass Spectrometry & Proteom., Pharmacoepidemiology and Clinical Pharmacology, Biomolecular Mass Spectrometry and Proteomics, van den Dries, Carline J., Pajouheshnia, Romin, van den Ham, Hendrika A., Souverein, Patrick, Moons, Karel G.M., Hoes, Arno W., Geersing, Geert Jan, van Doorn, Sander, Afd Pharmacoepi & Clinical Pharmacology, Sub Biomol.Mass Spectrometry & Proteom., Pharmacoepidemiology and Clinical Pharmacology, Biomolecular Mass Spectrometry and Proteomics, van den Dries, Carline J., Pajouheshnia, Romin, van den Ham, Hendrika A., Souverein, Patrick, Moons, Karel G.M., Hoes, Arno W., Geersing, Geert Jan, and van Doorn, Sander
Published: 2022

40. P248 Flash presentation: Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Valproates (Abstract presented at 21st ISoP Annual Meeting 2022, Verona)

Author: Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Abtahi, Shahab, Pajouheshnia, Romin, Durán, Carlos E., Riera-Arnau, Judit, Sturkenboom, Miriam, Klungel, Olaf, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Abtahi, Shahab, Pajouheshnia, Romin, Durán, Carlos E., Riera-Arnau, Judit, Sturkenboom, Miriam, and Klungel, Olaf
Published: 2022

41. Mapping the risk of infections in patients with multiple sclerosis: A multi-database study in the United Kingdom Clinical Practice Research Datalink GOLD and Aurum

Author: Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Leung, Melissa Wy, Bazelier, Marloes T, Souverein, Patrick C, Uitdehaag, Bernard Mj, Klungel, Olaf H, Leufkens, Hubert Gm, Pajouheshnia, Romin, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Leung, Melissa Wy, Bazelier, Marloes T, Souverein, Patrick C, Uitdehaag, Bernard Mj, Klungel, Olaf H, Leufkens, Hubert Gm, and Pajouheshnia, Romin
Published: 2022

42. Flash presentation: Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Valproates

Author: Abtahi, Shahab, Pajouheshnia, Romin, Duran-Salinas, Carlos, Riera-Arnau, Judit, Gamba, Magdalena, Alsina, Ema, Hallgreen, Christine Erikstrup, Limoncella, Giorgio, Bartolini, Claudia, Holthuis, Emily, Martin-Perez, Mar, Brown, Jeremy, Sturkenboom, Miriam, Klungel, Olaf, Lot, Other, Abtahi, Shahab, Pajouheshnia, Romin, Duran-Salinas, Carlos, Riera-Arnau, Judit, Gamba, Magdalena, Alsina, Ema, Hallgreen, Christine Erikstrup, Limoncella, Giorgio, Bartolini, Claudia, Holthuis, Emily, Martin-Perez, Mar, Brown, Jeremy, Sturkenboom, Miriam, Klungel, Olaf, and Lot, Other
Published: 2022

43. 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

44. sj-docx-1-msj-10.1177_13524585221094218 – Supplemental material for Mapping the risk of infections in patients with multiple sclerosis: A multi-database study in the United Kingdom Clinical Practice Research Datalink GOLD and Aurum

Author: Leung, Melissa WY, Bazelier, Marloes T, Souverein, Patrick C, Uitdehaag, Bernard MJ, Klungel, Olaf H, Leufkens, Hubert GM, and Pajouheshnia, Romin
Subjects: FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 110904 Neurology and Neuromuscular Diseases
Abstract: Supplemental material, sj-docx-1-msj-10.1177_13524585221094218 for Mapping the risk of infections in patients with multiple sclerosis: A multi-database study in the United Kingdom Clinical Practice Research Datalink GOLD and Aurum by Melissa WY Leung, Marloes T Bazelier, Patrick C Souverein, Bernard MJ Uitdehaag, Olaf H Klungel, Hubert GM Leufkens and Romin Pajouheshnia in Multiple Sclerosis Journal
Published: 2022
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45. sj-docx-2-msj-10.1177_13524585221094218 – Supplemental material for Mapping the risk of infections in patients with multiple sclerosis: A multi-database study in the United Kingdom Clinical Practice Research Datalink GOLD and Aurum

Author: Leung, Melissa WY, Bazelier, Marloes T, Souverein, Patrick C, Uitdehaag, Bernard MJ, Klungel, Olaf H, Leufkens, Hubert GM, and Pajouheshnia, Romin
Subjects: FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 110904 Neurology and Neuromuscular Diseases
Abstract: Supplemental material, sj-docx-2-msj-10.1177_13524585221094218 for Mapping the risk of infections in patients with multiple sclerosis: A multi-database study in the United Kingdom Clinical Practice Research Datalink GOLD and Aurum by Melissa WY Leung, Marloes T Bazelier, Patrick C Souverein, Bernard MJ Uitdehaag, Olaf H Klungel, Hubert GM Leufkens and Romin Pajouheshnia in Multiple Sclerosis Journal
Published: 2022
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46. Invited Commentary: Treatment Drop-in-Making the Case for Causal Prediction

Author: Sperrin, Matthew, Diaz-Ordaz, Karla, Pajouheshnia, Romin, Afd Pharmacoepi & Clinical Pharmacology, and Pharmacoepidemiology and Clinical Pharmacology
Subjects: counterfactual causal inference, risk prediction, treatment drop-in, Epidemiology
Abstract: Clinical prediction models (CPMs) are often used to guide treatment initiation, with individuals at high risk offered treatment. This implicitly assumes that the probability quoted from a CPM represents the risk to an individual of an adverse outcome in absence of treatment. However, for a CPM to correctly target this estimand requires careful causal thinking. One problem that needs to be overcome is treatment drop-in: where individuals in the development data commence treatment after the time of prediction but before the outcome occurs. In this issue of the Journal, Xu et al. (Am J Epidemiol. 2021;190(10):2000-2014) use causal estimates from external data sources, such as clinical trials, to adjust CPMs for treatment drop-in. This represents a pragmatic and promising approach to address this issue, and it illustrates the value of utilizing causal inference in prediction. Building causality into the prediction pipeline can also bring other benefits. These include the ability to make and compare hypothetical predictions under different interventions, to make CPMs more explainable and transparent, and to improve model generalizability. Enriching CPMs with causal inference therefore has the potential to add considerable value to the role of prediction in healthcare.
Published: 2021

47. Safety of off‐label dose reduction of non‐vitamin K antagonist oral anticoagulants in patients with atrial fibrillation.

Author: van den Dries, Carline J., Pajouheshnia, Romin, van den Ham, Hendrika A., Souverein, Patrick, Moons, Karel G. M., Hoes, Arno W., Geersing, Geert‐Jan, and van Doorn, Sander
Subjects: *APIXABAN, *ATRIAL fibrillation, *ORAL medication, *ISCHEMIC stroke, *MEDICAL research, *CONFIDENCE intervals
Abstract: Aim: To investigate the effects of off‐label non‐vitamin K oral anticoagulant (NOAC) dose reduction compared with on‐label standard dosing in atrial fibrillation (AF) patients in routine care. Methods: Population‐based cohort study using data from the United Kingdom Clinical Practice Research Datalink, comparing adults with non‐valvular AF receiving an off‐label reduced NOAC dose to patients receiving an on‐label standard dose. Outcomes were ischaemic stroke, major/non‐major bleeding and mortality. Inverse probability of treatment weighting and inverse probability of censoring weighting on the propensity score were applied to adjust for confounding and informative censoring. Results: Off‐label dose reduction occurred in 2466 patients (8.0%), compared with 18 108 (58.5%) on‐label standard‐dose users. Median age was 80 years (interquartile range [IQR] 73.0‐86.0) versus 72 years (IQR 66‐78), respectively. Incidence rates were higher in the off‐label dose reduction group compared to the on‐label standard dose group, for ischaemic stroke (0.94 vs 0.70 per 100 person years), major bleeding (1.48 vs 0.83), non‐major bleeding (6.78 vs 6.16) and mortality (10.12 vs 3.72). Adjusted analyses resulted in a hazard ratio of 0.95 (95% confidence interval [CI] 0.57‐1.60) for ischaemic stroke, 0.88 (95% CI 0.57‐1.35) for major bleeding, 0.81 (95% CI 0.67‐0.98) for non‐major bleeding and 1.34 (95% CI 1.12‐1.61) for mortality. Conclusion: In this large population‐based study, the hazards for ischaemic stroke and major bleeding were low, and similar in AF patients receiving an off‐label reduced NOAC dose compared with on‐label standard dose users, while non‐major bleeding risk appeared to be lower and mortality risk higher. Caution towards prescribing an off‐label reduced NOAC dose is therefore required. [ABSTRACT FROM AUTHOR]
Published: 2023
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48. Prototype of FAIR data catalogue - 2nd (D7.7)

Author: Swertz, Morris, Hyde, Eleanor, de Andrade, Fernanda, Gini, Rosa, Pajouheshnia, Romin, Sturkenboom, Miriam, Cunnington, Marianne, Holub, Petr, Dolk, Helen, Loane, Maria, Given, Joanne, Lewis, David, Yates, Laura, van Puijenbroek, Eugène, and te Winkel, Bernke
Abstract: This deliverable focuses on summarizing the delivery of the second prototype of the FAIR data catalogue for the ConcePTION project. Such prototype aims to collect summary level metadata on the CONCEPTION common data model and map this metadata to population-based healthcare data sources and databanks to aid ConcePTION partners in the execution of analyses to generate evidence on the safety of medicines in pregnancy.
Published: 2021
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49. 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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50. 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

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