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Items: 1 to 20 of 145


A reference standard for evaluation of methods for drug safety signal detection using electronic healthcare record databases.

Coloma PM, Avillach P, Salvo F, Schuemie MJ, Ferrajolo C, Pariente A, Fourrier-Réglat A, Molokhia M, Patadia V, van der Lei J, Sturkenboom M, Trifirò G.

Drug Saf. 2013 Jan;36(1):13-23. doi: 10.1007/s40264-012-0002-x.


Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection.

Pacurariu AC, Straus SM, Trifirò G, Schuemie MJ, Gini R, Herings R, Mazzaglia G, Picelli G, Scotti L, Pedersen L, Arlett P, van der Lei J, Sturkenboom MC, Coloma PM.

Drug Saf. 2015 Dec;38(12):1201-10. doi: 10.1007/s40264-015-0341-5.


Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor?

Trifirò G, Pariente A, Coloma PM, Kors JA, Polimeni G, Miremont-Salamé G, Catania MA, Salvo F, David A, Moore N, Caputi AP, Sturkenboom M, Molokhia M, Hippisley-Cox J, Acedo CD, van der Lei J, Fourrier-Reglat A; EU-ADR group.

Pharmacoepidemiol Drug Saf. 2009 Dec;18(12):1176-84. doi: 10.1002/pds.1836.


Postmarketing safety surveillance : where does signal detection using electronic healthcare records fit into the big picture?

Coloma PM, Trifirò G, Patadia V, Sturkenboom M.

Drug Saf. 2013 Mar;36(3):183-97. doi: 10.1007/s40264-013-0018-x. Review.


The role of electronic healthcare record databases in paediatric drug safety surveillance: a retrospective cohort study.

de Bie S, Coloma PM, Ferrajolo C, Verhamme KM, Trifirò G, Schuemie MJ, Straus SM, Gini R, Herings R, Mazzaglia G, Picelli G, Ghirardi A, Pedersen L, Stricker BH, van der Lei J, Sturkenboom MC; EU-ADR consortium.

Br J Clin Pharmacol. 2015 Aug;80(2):304-14. doi: 10.1111/bcp.12610. Epub 2015 May 20.


EU-ADR healthcare database network vs. spontaneous reporting system database: preliminary comparison of signal detection.

Trifirò G, Patadia V, Schuemie MJ, Coloma PM, Gini R, Herings R, Hippisley-Cox J, Mazzaglia G, Giaquinto C, Scotti L, Pedersen L, Avillach P, Sturkenboom MC, van der Lei J, Eu-Adr Group.

Stud Health Technol Inform. 2011;166:25-30.


Signal detection of potentially drug-induced acute liver injury in children using a multi-country healthcare database network.

Ferrajolo C, Coloma PM, Verhamme KM, Schuemie MJ, de Bie S, Gini R, Herings R, Mazzaglia G, Picelli G, Giaquinto C, Scotti L, Avillach P, Pedersen L, Rossi F, Capuano A, van der Lei J, Trifiró G, Sturkenboom MC; EU-ADR consortium.

Drug Saf. 2014 Feb;37(2):99-108. doi: 10.1007/s40264-013-0132-9.


Electronic healthcare databases for active drug safety surveillance: is there enough leverage?

Coloma PM, Trifirò G, Schuemie MJ, Gini R, Herings R, Hippisley-Cox J, Mazzaglia G, Picelli G, Corrao G, Pedersen L, van der Lei J, Sturkenboom M; EU-ADR Consortium.

Pharmacoepidemiol Drug Saf. 2012 Jun;21(6):611-21. doi: 10.1002/pds.3197. Epub 2012 Feb 8.


Pediatric drug safety signal detection: a new drug-event reference set for performance testing of data-mining methods and systems.

Osokogu OU, Fregonese F, Ferrajolo C, Verhamme K, de Bie S, 't Jong G, Catapano M, Weibel D, Kaguelidou F, Bramer WM, Hsia Y, Wong IC, Gazarian M, Bonhoeffer J, Sturkenboom M.

Drug Saf. 2015 Feb;38(2):207-17. doi: 10.1007/s40264-015-0265-0.


The EU-ADR project: preliminary results and perspective.

Trifiro G, Fourrier-Reglat A, Sturkenboom MC, Díaz Acedo C, Van Der Lei J; EU-ADR Group.

Stud Health Technol Inform. 2009;148:43-9.


Using real-world healthcare data for pharmacovigilance signal detection - the experience of the EU-ADR project.

Patadia VK, Coloma P, Schuemie MJ, Herings R, Gini R, Mazzaglia G, Picelli G, Fornari C, Pedersen L, van der Lei J, Sturkenboom M, Trifirò G; EU-ADR consortium.

Expert Rev Clin Pharmacol. 2015 Jan;8(1):95-102. doi: 10.1586/17512433.2015.992878. Review.


Longitudinal medical records as a complement to routine drug safety signal analysis.

Star K, Watson S, Sandberg L, Johansson J, Edwards IR.

Pharmacoepidemiol Drug Saf. 2015 May;24(5):486-94. doi: 10.1002/pds.3739. Epub 2015 Jan 27.


Harmonization process for the identification of medical events in eight European healthcare databases: the experience from the EU-ADR project.

Avillach P, Coloma PM, Gini R, Schuemie M, Mougin F, Dufour JC, Mazzaglia G, Giaquinto C, Fornari C, Herings R, Molokhia M, Pedersen L, Fourrier-Réglat A, Fieschi M, Sturkenboom M, van der Lei J, Pariente A, Trifirò G; EU-ADR consortium.

J Am Med Inform Assoc. 2013 Jan 1;20(1):184-92. doi: 10.1136/amiajnl-2012-000933. Epub 2012 Sep 6.


Drug safety data mining with a tree-based scan statistic.

Kulldorff M, Dashevsky I, Avery TR, Chan AK, Davis RL, Graham D, Platt R, Andrade SE, Boudreau D, Gunter MJ, Herrinton LJ, Pawloski PA, Raebel MA, Roblin D, Brown JS.

Pharmacoepidemiol Drug Saf. 2013 May;22(5):517-23. doi: 10.1002/pds.3423. Epub 2013 Mar 20.


Evaluating performance of electronic healthcare records and spontaneous reporting data in drug safety signal detection.

Patadia VK, Schuemie MJ, Coloma P, Herings R, van der Lei J, Straus S, Sturkenboom M, Trifirò G.

Int J Clin Pharm. 2015 Feb;37(1):94-104. doi: 10.1007/s11096-014-0044-5. Epub 2014 Dec 9.


Signal Detection of Imipenem Compared to Other Drugs from Korea Adverse Event Reporting System Database.

Park K, Soukavong M, Kim J, Kwon KE, Jin XM, Lee J, Yang BR, Park BJ.

Yonsei Med J. 2017 May;58(3):564-569. doi: 10.3349/ymj.2017.58.3.564.


Validation of statistical signal detection procedures in eudravigilance post-authorization data: a retrospective evaluation of the potential for earlier signalling.

Alvarez Y, Hidalgo A, Maignen F, Slattery J.

Drug Saf. 2010 Jun 1;33(6):475-87. doi: 10.2165/11534410-000000000-00000.


A Method to Combine Signals from Spontaneous Reporting Systems and Observational Healthcare Data to Detect Adverse Drug Reactions.

Li Y, Ryan PB, Wei Y, Friedman C.

Drug Saf. 2015 Oct;38(10):895-908. doi: 10.1007/s40264-015-0314-8.


Combing signals from spontaneous reports and electronic health records for detection of adverse drug reactions.

Harpaz R, Vilar S, Dumouchel W, Salmasian H, Haerian K, Shah NH, Chase HS, Friedman C.

J Am Med Inform Assoc. 2013 May 1;20(3):413-9. doi: 10.1136/amiajnl-2012-000930. Epub 2012 Oct 31.


Structured assessment for prospective identification of safety signals in electronic medical records: evaluation in the health improvement network.

Cederholm S, Hill G, Asiimwe A, Bate A, Bhayat F, Persson Brobert G, Bergvall T, Ansell D, Star K, Norén GN.

Drug Saf. 2015 Jan;38(1):87-100. doi: 10.1007/s40264-014-0251-y.

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