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From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding
Nicolas H. Thurin,
Romin Pajouheshnia,
Giuseppe Roberto,
Caitlin Dodd,
Giulia Hyeraci,
Claudia Bartolini,
Olga Paoletti,
Hedvig Nordeng,
Helle Wallach‐Kildemoes,
Vera Ehrenstein,
Elena Dudukina,
Thomas MacDonald,
Giorgia De Paoli,
Maria Loane,
Christine Damase‐Michel,
Anna‐Belle Beau,
Cécile Droz‐Perroteau,
Régis Lassalle,
Jorieke Bergman,
Karin Swart,
Tania Schink,
Clara Cavero‐Carbonell,
Laia Barrachina‐Bonet,
Ainhoa Gomez‐Lumbreras,
Maria Giner‐Soriano,
María Aragón,
Amanda J. Neville,
Aurora Puccini,
Anna Pierini,
Valentina Ientile,
Gianluca Trifirò,
Anke Rissmann,
Maarit K. Leinonen,
Visa Martikainen,
Sue Jordan 
,
Daniel Thayer ,
Ieuan Scanlon,
Mary E. Georgiou,
Marianne Cunnington,
Morris Swertz,
Miriam Sturkenboom,
Rosa Gini
,
Daniel Thayer ,
Ieuan Scanlon,
Mary E. Georgiou,
Marianne Cunnington,
Morris Swertz,
Miriam Sturkenboom,
Rosa Gini
Clinical Pharmacology & Therapeutics, Volume: 111, Issue: 1, Pages: 321 - 331
Swansea University Authors:
Sue Jordan , Daniel Thayer , Ieuan Scanlon
-
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DOI (Published version): 10.1002/cpt.2476
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 t...
| Published in: | Clinical Pharmacology & Therapeutics |
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| ISSN: | 0009-9236 1532-6535 |
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Wiley
2022
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<?xml version="1.0"?><rfc1807><datestamp>2021-12-31T10:22:03.8622923</datestamp><bib-version>v2</bib-version><id>58921</id><entry>2021-12-06</entry><title>From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding</title><swanseaauthors><author><sid>24ce9db29b4bde1af4e83b388aae0ea1</sid><ORCID>0000-0002-5691-2987</ORCID><firstname>Sue</firstname><surname>Jordan</surname><name>Sue Jordan</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>e1a6d9b30965cc61a76371fc8a1bf232</sid><ORCID>0000-0003-1847-4362</ORCID><firstname>Daniel</firstname><surname>Thayer</surname><name>Daniel Thayer</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>9fcb224c6bd804a4d41a2a8570a71185</sid><firstname>Ieuan</firstname><surname>Scanlon</surname><name>Ieuan Scanlon</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2021-12-06</date><deptcode>HNU</deptcode><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.</abstract><type>Journal Article</type><journal>Clinical Pharmacology & Therapeutics</journal><volume>111</volume><journalNumber>1</journalNumber><paginationStart>321</paginationStart><paginationEnd>331</paginationEnd><publisher>Wiley</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>0009-9236</issnPrint><issnElectronic>1532-6535</issnElectronic><keywords>Pharmacology (medical), Pharmacology</keywords><publishedDay>1</publishedDay><publishedMonth>1</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-01-01</publishedDate><doi>10.1002/cpt.2476</doi><url/><notes/><college>COLLEGE NANME</college><department>Nursing</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HNU</DepartmentCode><institution>Swansea University</institution><apcterm/><funders>Innovative Medicines Initiative 2 Joint Undertaking. Grant Number: 821520</funders><lastEdited>2021-12-31T10:22:03.8622923</lastEdited><Created>2021-12-06T14:00:01.9128939</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Medicine</level></path><authors><author><firstname>Nicolas H.</firstname><surname>Thurin</surname><order>1</order></author><author><firstname>Romin</firstname><surname>Pajouheshnia</surname><order>2</order></author><author><firstname>Giuseppe</firstname><surname>Roberto</surname><order>3</order></author><author><firstname>Caitlin</firstname><surname>Dodd</surname><order>4</order></author><author><firstname>Giulia</firstname><surname>Hyeraci</surname><order>5</order></author><author><firstname>Claudia</firstname><surname>Bartolini</surname><order>6</order></author><author><firstname>Olga</firstname><surname>Paoletti</surname><order>7</order></author><author><firstname>Hedvig</firstname><surname>Nordeng</surname><order>8</order></author><author><firstname>Helle</firstname><surname>Wallach‐Kildemoes</surname><order>9</order></author><author><firstname>Vera</firstname><surname>Ehrenstein</surname><order>10</order></author><author><firstname>Elena</firstname><surname>Dudukina</surname><order>11</order></author><author><firstname>Thomas</firstname><surname>MacDonald</surname><order>12</order></author><author><firstname>Giorgia De</firstname><surname>Paoli</surname><order>13</order></author><author><firstname>Maria</firstname><surname>Loane</surname><order>14</order></author><author><firstname>Christine</firstname><surname>Damase‐Michel</surname><order>15</order></author><author><firstname>Anna‐Belle</firstname><surname>Beau</surname><order>16</order></author><author><firstname>Cécile</firstname><surname>Droz‐Perroteau</surname><order>17</order></author><author><firstname>Régis</firstname><surname>Lassalle</surname><order>18</order></author><author><firstname>Jorieke</firstname><surname>Bergman</surname><order>19</order></author><author><firstname>Karin</firstname><surname>Swart</surname><order>20</order></author><author><firstname>Tania</firstname><surname>Schink</surname><order>21</order></author><author><firstname>Clara</firstname><surname>Cavero‐Carbonell</surname><order>22</order></author><author><firstname>Laia</firstname><surname>Barrachina‐Bonet</surname><order>23</order></author><author><firstname>Ainhoa</firstname><surname>Gomez‐Lumbreras</surname><order>24</order></author><author><firstname>Maria</firstname><surname>Giner‐Soriano</surname><order>25</order></author><author><firstname>María</firstname><surname>Aragón</surname><order>26</order></author><author><firstname>Amanda J.</firstname><surname>Neville</surname><order>27</order></author><author><firstname>Aurora</firstname><surname>Puccini</surname><order>28</order></author><author><firstname>Anna</firstname><surname>Pierini</surname><order>29</order></author><author><firstname>Valentina</firstname><surname>Ientile</surname><order>30</order></author><author><firstname>Gianluca</firstname><surname>Trifirò</surname><order>31</order></author><author><firstname>Anke</firstname><surname>Rissmann</surname><order>32</order></author><author><firstname>Maarit K.</firstname><surname>Leinonen</surname><order>33</order></author><author><firstname>Visa</firstname><surname>Martikainen</surname><order>34</order></author><author><firstname>Sue</firstname><surname>Jordan</surname><orcid>0000-0002-5691-2987</orcid><order>35</order></author><author><firstname>Daniel</firstname><surname>Thayer</surname><orcid>0000-0003-1847-4362</orcid><order>36</order></author><author><firstname>Ieuan</firstname><surname>Scanlon</surname><order>37</order></author><author><firstname>Mary E.</firstname><surname>Georgiou</surname><order>38</order></author><author><firstname>Marianne</firstname><surname>Cunnington</surname><order>39</order></author><author><firstname>Morris</firstname><surname>Swertz</surname><order>40</order></author><author><firstname>Miriam</firstname><surname>Sturkenboom</surname><order>41</order></author><author><firstname>Rosa</firstname><surname>Gini</surname><order>42</order></author></authors><documents><document><filename>58921__21811__99068786786c4a16a3d7f88020c2edd4.pdf</filename><originalFilename>58921.pdf</originalFilename><uploaded>2021-12-06T14:04:39.3923030</uploaded><type>Output</type><contentLength>583453</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language><licence>http://creativecommons.org/licenses/by-nc/4.0/</licence></document></documents><OutputDurs/></rfc1807> |
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2021-12-31T10:22:03.8622923 v2 58921 2021-12-06 From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding 24ce9db29b4bde1af4e83b388aae0ea1 0000-0002-5691-2987 Sue Jordan Sue Jordan true false e1a6d9b30965cc61a76371fc8a1bf232 0000-0003-1847-4362 Daniel Thayer Daniel Thayer true false 9fcb224c6bd804a4d41a2a8570a71185 Ieuan Scanlon Ieuan Scanlon true false 2021-12-06 HNU 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. Journal Article Clinical Pharmacology & Therapeutics 111 1 321 331 Wiley 0009-9236 1532-6535 Pharmacology (medical), Pharmacology 1 1 2022 2022-01-01 10.1002/cpt.2476 COLLEGE NANME Nursing COLLEGE CODE HNU Swansea University Innovative Medicines Initiative 2 Joint Undertaking. Grant Number: 821520 2021-12-31T10:22:03.8622923 2021-12-06T14:00:01.9128939 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Nicolas H. Thurin 1 Romin Pajouheshnia 2 Giuseppe Roberto 3 Caitlin Dodd 4 Giulia Hyeraci 5 Claudia Bartolini 6 Olga Paoletti 7 Hedvig Nordeng 8 Helle Wallach‐Kildemoes 9 Vera Ehrenstein 10 Elena Dudukina 11 Thomas MacDonald 12 Giorgia De Paoli 13 Maria Loane 14 Christine Damase‐Michel 15 Anna‐Belle Beau 16 Cécile Droz‐Perroteau 17 Régis Lassalle 18 Jorieke Bergman 19 Karin Swart 20 Tania Schink 21 Clara Cavero‐Carbonell 22 Laia Barrachina‐Bonet 23 Ainhoa Gomez‐Lumbreras 24 Maria Giner‐Soriano 25 María Aragón 26 Amanda J. Neville 27 Aurora Puccini 28 Anna Pierini 29 Valentina Ientile 30 Gianluca Trifirò 31 Anke Rissmann 32 Maarit K. Leinonen 33 Visa Martikainen 34 Sue Jordan 0000-0002-5691-2987 35 Daniel Thayer 0000-0003-1847-4362 36 Ieuan Scanlon 37 Mary E. Georgiou 38 Marianne Cunnington 39 Morris Swertz 40 Miriam Sturkenboom 41 Rosa Gini 42 58921__21811__99068786786c4a16a3d7f88020c2edd4.pdf 58921.pdf 2021-12-06T14:04:39.3923030 Output 583453 application/pdf Version of Record true This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. true eng http://creativecommons.org/licenses/by-nc/4.0/ |
| title |
From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding |
| spellingShingle |
From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding Sue Jordan Daniel Thayer Ieuan Scanlon |
| title_short |
From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding |
| title_full |
From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding |
| title_fullStr |
From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding |
| title_full_unstemmed |
From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding |
| title_sort |
From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding |
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24ce9db29b4bde1af4e83b388aae0ea1 e1a6d9b30965cc61a76371fc8a1bf232 9fcb224c6bd804a4d41a2a8570a71185 |
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24ce9db29b4bde1af4e83b388aae0ea1_***_Sue Jordan e1a6d9b30965cc61a76371fc8a1bf232_***_Daniel Thayer 9fcb224c6bd804a4d41a2a8570a71185_***_Ieuan Scanlon |
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Sue Jordan Daniel Thayer Ieuan Scanlon |
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Nicolas H. Thurin Romin Pajouheshnia Giuseppe Roberto Caitlin Dodd Giulia Hyeraci Claudia Bartolini Olga Paoletti Hedvig Nordeng Helle Wallach‐Kildemoes Vera Ehrenstein Elena Dudukina Thomas MacDonald Giorgia De Paoli Maria Loane Christine Damase‐Michel Anna‐Belle Beau Cécile Droz‐Perroteau Régis Lassalle Jorieke Bergman Karin Swart Tania Schink Clara Cavero‐Carbonell Laia Barrachina‐Bonet Ainhoa Gomez‐Lumbreras Maria Giner‐Soriano María Aragón Amanda J. Neville Aurora Puccini Anna Pierini Valentina Ientile Gianluca Trifirò Anke Rissmann Maarit K. Leinonen Visa Martikainen Sue Jordan Daniel Thayer Ieuan Scanlon Mary E. Georgiou Marianne Cunnington Morris Swertz Miriam Sturkenboom Rosa Gini |
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Clinical Pharmacology & Therapeutics |
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111 |
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2022 |
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0009-9236 1532-6535 |
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10.1002/cpt.2476 |
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Wiley |
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Faculty of Medicine, Health and Life Sciences |
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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. |
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2022-01-01T04:15:49Z |
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11.013731 |