Selection from HEOR Bibliography
| Search criteria | ||||
| Drug safety |
||||
| An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy. | ||||
| Richardson JL1, Stephens S1, Thomas SH1, Jamry-Dziurla A2, de Jong-van den Berg L3, Zetstra-van der Woude P3, Laursen M4, Hliva V5, Mt-Isa S6, Bourke A7, Dreyer NA8, Blackburn SC9. | ||||
| 1The UK Teratology Information ServiceNewcastle upon Tyne Hospitals NHS Foundation TrustNewcastle upon TyneUnited Kingdom; Institute of Cellular MedicineNewcastle UniversityNewcastle upon TyneUnited Kingdom. 2Department of Medical Genetics Poznan University of Medical Sciences Poznan Poland. 3Unit of PharmacoEpidemiology and PharmacoEconomics Department of Pharmacy University of Groningen Groningen Netherlands. 4Department of Data Delivery and Medicinal Product Statistics The Danish Health Data Authority Copenhagen Denmark. 5Quintiles Real-World and Late Phase Research St. Prex Switzerland. 6Imperial Clinical Trials Unit School of Public Health Imperial College London London United Kingdom. 7Real World Evidence Solutions IMS Health London United Kingdom. 8Quintiles Real-World & Late Phase Research Cambridge, MA United States. 9Quintiles Real-World and Late Phase Research Reading United Kingdom. | ||||
| Article | ||||
| Denmark, Netherlands, Poland, UK | ||||
| Abstract: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4869218/pdf/publichealth_v2i1e13.pdf | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Womens Health | 2016 | English | direct-to-patient research | |
| Validity of ankylosing spondylitis diagnoses in The Health Improvement Network | ||||
| Dubreuil M, Peloquin C, Zhang Y, Choi HK, Inman RD, Neogi T | ||||
| Boston University School of Medicine, Section of Rheumatology; VA Boston Healthcare System; Massachusetts General Hospital, Section of Rheumatology; University of Toronto, Toronto Western Hospital | ||||
| Article | ||||
| UK | ||||
| Condition | Year | Language | Analysis type | |
| Database Validity and methodology, Drug safety, Rheumatology | 2016 | English | Retrospective database analysis | |
| Backdating of events in electronic primary health care data: should one censor at the date of last data collection | ||||
| Sammon CJ, Petersen | ||||
| Department of Primary Care and Population Health, University College London; Department of Clinical Epidemiology, Aarhus University | ||||
| Article | ||||
| UK | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety | 2016 | English | Retrospective database analysis | |
| Validation of a coding algorithm for intra-abdominal surgeries and adhesion-related complications in an electronic medical records database | ||||
| Scott FI, Mamtani R, Haynes K, Goldberg DS, Mahmoud NN, Lewis JD | ||||
| Division of Gastroenterology, Department of Medicine, University of Pennsylvania; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania; Abramson Cancer Centre, Department of Medicine, University of Pennsylvania; Department of Surgery, Perelman School of Medicine, University of Pennsylvania | ||||
| Article | ||||
| UK | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety | 2016 | English | Retrospective database analysis | |
| The Effect of Safety Warnings on Antipsychotic Drug Prescribing in Elderly Persons with Dementia in the United Kingdom and Italy: A Population-Based Study. | ||||
| Sultana J, Fontana A, Giorgianni F, Pasqua A, Cricelli C, Spina E, Gambassi G, Ivanovic J, Ferrajolo C, Molokhia M, Ballard C, Sharp S, Sturkenboom M, Trifirò G | ||||
| Department of Clinical and Experimental Medicine, University of Messina; Department of Epidemiology, Erasmus Medical Centre; Unit of Biostatistics, IRCCS Casa Sollievo della Sofferenza; Health Search, Italian College of General Practitioners; Department of Internal Medicine; Italian Drug Agency (AIFA); Department of Experimental Medicine, Pharmacology section; Department of Primary Care and Public Health Sciences; Biomedical Research Unit for Dementia; IRCCS Centro Neurolesi Bonino Pulejo | ||||
| Article | ||||
| UK | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Neurological disorders | 2016 | English | Retrospective database analysis | |
| Liver transplant associated with paracetamol overdose: results from the seven-country SALT study | ||||
| Sinem Ezgi Gulmez,1 Dominique Larrey,2 Georges- Philippe Pageaux,2 Jacques Bernuau,3 Franco Bissoli,4 Yves Horsmans,5 Douglas Thorburn,6 P. Aiden McCormick,7 Bruno Stricker,8 Massoud Toussi,9 Séverine Lignot-Maleyran,1 Sophie Micon,1 Fatima Hamoud,1 Régis Lassalle,1 Jérémy Jové,1 Patrick Blin1 & Nicholas Moore1 | ||||
| 1CIC Bordeaux CIC1401 Pharmaco-épidémiologie, Université de Bordeaux, F-33076 Bordeaux, France, 2CHU St Eloi Hospital, Liver Unit, Montpellier, France, 3Beaujon Hospital, Liver Unit, Clichy, France, 4Department of Internal Medicine, Clinica San Gaudenzio, Novara, Italy, 5Department of Gastroenterology, Louvain Catholic University, Louvain, Belgium, 6Liver Unit, Royal Free NHS Trust, London, UK, 7Liver Unit, St Vincent’s University Hospital and University College Dublin, Dublin, Ireland, 8Department of Epidemiology, Erasmus University, Rotterdam, Netherlands and 9IMSHealth, Real World Evidence Solutions, France | ||||
| British Journal of Clinical Pharmacology 2015 | ||||
| Article | ||||
| France, Greece, Ireland, Italy, Netherlands, Portugal, UK | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Public Health | 2015 | English | Epidemiological study | |
| The role of electronic healthcare record databases in paediatric drug safety surveillance: a retrospective cohort study | ||||
| de Bie S1,2, Coloma PM1, Ferrajolo C1,3, Verhamme KM1, Trifirò G1,4, Schuemie MJ1, Straus SM1,2, Gini R5, Herings R1,6, Mazzaglia G7, Picelli G8,Ghirardi A9, Pedersen L10, Stricker BH1,11,12, van der Lei J1, Sturkenboom MC1; EU-ADR consortium. | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.2Dutch Medicines Evaluation Board, Utrecht, the Netherlands. 3Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Pharmacology Section, Second University of Naples, Naples, Italy.4Department of Clinical and Experimental Medicine and Pharmacology, Section of Pharmacology, University of Messina, Messina, Italy.5Agenzia Regionale di Sanità della Toscana, Florence, Italy.6PHARMO Institute, Utrecht, the Netherlands.Società Italiana di Medicina Generale, Florence, Italy.8Pedianet-Società Servizi Telematici SRL, Padova, Italy. 9Department of Statistics, Universita di Milano-Bicocca, Milan, Italy. • 10Department of Clinical Epidemiology, Aarhus University Hospital Aarhus, Denmark.11Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands.12Inspectorate of Health Care, The Hague, the Netherlands. | ||||
| Br J Clin Pharmacol. 2015 Aug;80(2):304-14 | ||||
| Abstract | ||||
| Italy | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety | 2015 | English | Retrospective database analysis | |
| Using real-world healthcare data for pharmacovigilance signal detection - the experience of the EU-ADR project | ||||
| Patadia VK1, 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 | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands. | ||||
| Expert Rev Clin Pharmacol. 2015 Jan;8(1):95-102 | ||||
| Abstract | ||||
| Italy | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety | 2015 | English | Retrospective database analysis | |
| Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection. | ||||
| Pacurariu AC1,2, Straus SM1,2, Trifirò G1,3, Schuemie MJ1, Gini R4, Herings R5, Mazzaglia G6, Picelli G7, Scotti L8, Pedersen L9, Arlett P10, van der Lei J1, Sturkenboom MC1, Coloma PM11. | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands.2Dutch Medicines Evaluation Board, Utrecht, The Netherlands. • 3Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.4Agenzia Regionale di Sanità della Toscana, Florence, Italy.5PHARMO Institute, Utrecht, The Netherlands.6Società Italiana di Medicina Generale, Florence, Italy.7Pedianet-Società Servizi Telematici SRL, Padua, Italy. • 8Department of Statistics, Università di Milano-Bicocca, Milan, Italy.9Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.10European Medicines Agency, London, UK.11Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands | ||||
| Drug Saf. 2015 Sep 14 | ||||
| Abstract, Article | ||||
| Europe | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/26370104 | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety | 2015 | English | Retrospective database analysis, Survey research | |
| REDUCTION IN C-REACTIVE PROTEIN WITH BIOLOGIC DRUGS IN RHEUMATOID ARTHRITIS AND SPONDYLITIS PATIENTS IN GERMAN RHEUMATOLOGIST PRACTICES | ||||
| Gossen N, Kostev K | ||||
| IMS Health, Frankfurt am Main, Germany | ||||
| ISPOR 18th Annual European Congress Milan, Italy November, 2015 | ||||
| Poster | ||||
| Germany | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Rheumatology | 2015 | English | ||
| Direct-to-Patient Research: Piloting a New Approach to Understanding Drug Safety During Pregnancy | ||||
| Nancy A Dreyer1, MPH, PhD ;Stella CF Blackburn2, MBBS, MA, MSc ; Shahrul Mt-Isa3, BSc, PhD ; Jonathan L Richardson4,5, BBSc (Hons) ; Simon Thomas4,5, BSc, MD, FRCP ; Maja Laursen6, MSc, PhD ; • Priscilla Zetstra-van der Woude7, MSc ; Anna Jamry-Dziurla8, MSc ; Valerie Hliva9, PhD ; Alison Bourke10, BSc, MSc ; Lolkje de Jong-van den Berg7, PharmD, PhD | ||||
| 1Quintiles Real-World & Late Phase Research, Cambridge, MA, United States | ||||
| Article | ||||
| Denmark, Netherlands, Poland, UK | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Pregnancy | 2015 | English | direct-to-patient research, Internet or Interactive voice response system, Prospective study | |
| Direct-to-Patient Research: Piloting a New Approach to Understanding Drug Safety During Pregnancy. | ||||
| Dreyer NA1, Blackburn SC2, Mt-Isa S3, Richardson JL4, Thomas S4, Laursen M5, Zetstra-van der Woude P6, Jamry-Dziurla A7, Hliva V8, Bourke A9, de Jong-van den Berg L6. | ||||
| 1Quintiles Real-World & Late Phase Research Cambridge, MA United States. 2Quintiles Real-World & Late Phase Research Reading United Kingdom. 3Imperial College London United Kingdom. 4Institute of Cellular MedicineNewcastle UniversityNewcastle upon TyneUnited Kingdom; UK Teratology Information ServiceNewcastle HospitalsNHS Foundation TrustNewcastle upon TyneUnited Kingdom. 5Statens Serum Institut Copenhagen Denmark. 6University of Groningen Groningen Netherlands. 7Poznan University of Medical Sciences Poznan Poland. 8Quintiles Real-World & Late-Phase Research St. Prex Switzerland. 9IMS London United Kingdom. | ||||
| JMIR Public Health Surveill. 2015 Dec 22;1(2):e22. | ||||
| Article | ||||
| Denmark, Netherlands, Poland, UK | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Womens Health | 2015 | English | direct-to-patient research | |
| Direct-To-Patient Research: The Future of Pharmacovigilance | ||||
| Dreyer NA, Mt. Isa S, Richardson JL, Laursen M, Zetstravan der Woude PA, Jamry-Dziurla A, Hliva V, Bourke A | ||||
| Poster | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety | 2015 | English | RWLPR (Real-World Late Phase Research-quintiles | |
| Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection | ||||
| Pacurariu AC1,2, Straus SM1,2, Trifirò G1,3, Schuemie MJ1, Gini R4, Herings R5, Mazzaglia G6, Picelli G7, Scotti L8, Pedersen L9, Arlett P10, van der Lei J1, Sturkenboom MC1, Coloma PM11. | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands.2Dutch Medicines Evaluation Board, Utrecht, The Netherlands. 3Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.4Agenzia Regionale di Sanità della Toscana, Florence, Italy.5PHARMO Institute, Utrecht, The Netherlands.6Società Italiana di Medicina Generale, Florence, Italy.7Pedianet-Società Servizi Telematici SRL, Padua, Italy.8Department of Statistics, Università di Milano-Bicocca, Milan, Italy.9Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.10European Medicines Agency, London, UK.11Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands | ||||
| Drug Saf. 2015 Sep 14 | ||||
| Abstract | ||||
| Italy | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety | 2014 | English | Retrospective database analysis | |
| 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, Trifiro G, Sturkenboom MC, EU-ADR consortium. | ||||
| C. Ferrajolo (&) P. M. Coloma K. M. C. Verhamme M. J. Schuemie S. de Bie J. van der Lei G. Trifiro´ M. C. J. M. Sturkenboom :Department of Medical Informatics, Erasmus University Medical Center, Dr. Molewaterplein 50, 3015 GE Rotterdam, The Netherlands C. Ferrajolo F. Rossi A. Capuano :Pharmacology Section, Department of Experimental Medicine,Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, Second University of Naples, Via L. De Crecchio, 7, 80138 Naples, Italy R. Gini :Regional Health Agency of Tuscany, Florence, Italy R. Herings: PHARMO Institute, Utrecht, The Netherlands G. Mazzaglia :Italian College of General Practitioners, Florence, Italy G. Picelli :Pedianet-Societa` Servizi Telematici SRL, Padua, Italy C. Giaquinto: Department of Paediatrics, University Hospital of Padua, Padua, Italy L. Scotti :Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy P. Avillach: LESIM, ISPED, University of Bordeaux 2, Bordeaux, France L. Pedersen: Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark G. Trifiro´: Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy M. C. J. M. Sturkenboom: Epidemiology, Erasmus University Medical Center, Rotterdam,The Netherlands | ||||
| Drug Saf. 2014 Feb;37(2):99-108 | ||||
| Article | ||||
| Italy | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/24446276 | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Miscellaneous | 2014 | English | Retrospective database analysis | |
| Validation study in four health-care databases: upper gastrointestinal bleeding misclassification affects precision but not magnitude of drug-related upper gastrointestinal bleeding risk. | ||||
| Valkhoff VE1, Coloma PM2, Masclee GM1, Gini R3, Innocenti F4, Lapi F5, Molokhia M6, Mosseveld M2, Nielsson MS7, Schuemie M2, Thiessard F8, van der Lei J2, Sturkenboom MC9, Trifirò G10; EU-ADR Consortium. | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam The Netherlands.2Department of Medical Informatics, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.3Agenzi Regionali di Sanità della Toscana, Via Pietro Dazzi 1 - 50141, Firenze, Italy.4Health Search, Italian College of General Practitioners, Via del Pignoncino, 9-11,50142, Florence, Italy.5Centre for Clinical Epidemiology, Jewish General Hospital, 3755 Côte-Sainte-Catherine Road, Montréal, QC H3T 1E2, Canada; Department of Preclinical and Clinical Pharmacology, University of Florence, Piazza di San Marco, 4, 50121 Firenze, Italy.6Department of Primary Care and Public Health Sciences, Kings College London, Division of Health and Social Care Research, 7th Floor, Capital House, 42 Weston Street, London SE1 3QD, United Kingdom.7Department of Clinical Epidemiology, Aarhus University Hospital, Olof Palmes Allé 43-45 DK-8200 Aarhus N, Denmark.8LESIM, ISPED, Universite Bordeaux 2', 146 Rue Léo Saignat, 33076 Bordeaux, France.9Department of Medical Informatics, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands; Department of Epidemiology, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.10Department of Medical Informatics, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands; Department of Clinical and Experimental Medicine and Pharmacology, Via Consolare Pompea, 1, Messina, University of Messina, Italy. | ||||
| J Clin Epidemiol. 2014 Aug;67(8):921-31. doi: 10.1016/j.jclinepi.2014.02.020. Epub 2014 May 1. | ||||
| Article | ||||
| Europe | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/24794575 | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Gastrointestinal disorders | 2014 | English | Retrospective database analysis | |
| The risk of metabolic disorders in patients treated with asenapine or olanzapine: a study conducted on real-world data in Italy and Spain. | ||||
| Maina G, Ripellino C, Pegoraro V, Caresano C. | ||||
| ISPOR Annual European Congress. 2014, Amsterdam Value in health |
||||
| Poster | ||||
| Italy, Spain | ||||
| Abstract: http://www.valueinhealthjournal.com/article/S1098-3015(14)03164-7/abstract | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Neurological disorders | 2014 | English | Real World Data | |
| Emergency hospitalizations for unsupervised prescription medication ingestions by young children | ||||
| Lovegrove MC, Mathew J, Hampp C, Governale L, Wysowski DK, Budnitz DS | ||||
| Food and Drug Administration | ||||
| Pediatrics 2014;134(4):e1009-1016. | ||||
| Article | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/?term=Emergency+hospitalizations+for+unsupervised+prescription+medication+ingestions+by+young+children. | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety | 2014 | English | Real World Evidence | |
| Prescription Opioid and Heroin Abuse, April 29, 2014 | ||||
| Volkow ND, | ||||
| House Committee on Energy and Commerce Subcommittee on Oversight and Investigations | ||||
| Testimony to congress.House Committee on Energy and Commerce Subcommittee on Oversight and Investigations | ||||
| Abstract | ||||
| Abstract: https://www.drugabuse.gov/about-nida/legislative-activities/testimony-to-congress/2015/prescription-opioid-heroin-abuse | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety | 2014 | English | ||
| Replication of the OMOP experiment in Europe: evaluating methods for risk identification in electronic health record databases. | ||||
| Schuemie MJ, Gini R, Coloma PM, Straatman H, Herings RM, Pedersen L, Innocenti F, Mazzaglia G, Picelli G, Van Der Lai J, Sturkenboom MC. | ||||
| Drug Saf. 2013 Oct;36 Suppl 1:S159-69. doi: 10.1007/s40264-013-0109-8. | ||||
| Article | ||||
| Europe, Italy | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/24166232 | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Methodology | 2013 | English | Methodology, Retrospective database analysis | |
| Idiopathic acute liver injury in paediatric outpatients: incidence and signal detection in two European countries. | ||||
| Ferrajolo C1, Verhamme KM, Trifirò G, 't Jong GW, Giaquinto C, Picelli G, Oteri A, de Bie S, Valkhoff VE, Schuemie MJ, Mazzaglia G, Cricelli C, Rossi F, Capuano A, Sturkenboom MC.Capuano A, Sturkenboom MC. | ||||
| 1Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Pharmacology Section, Second University of Naples, Via L. De Crecchio, 7, 80138, Naples, Italy | ||||
| Drug Saf. 2013 Oct;36(10):1007-16. doi: 10.1007/s40264-013-0045-7. | ||||
| Article | ||||
| Italy, Netherlands | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/23591830 | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Pediatrics | 2013 | English | Retrospective database analysis | |
| 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-Reglat A, Molokhia M, Patadia V, Van Der Lei J, Sturkenboom M, Trifiro G. | ||||
| Department of Medical Informatics, Erasmus Medical Center, Postbus 2040, 3000, CA, Rotterdam, The Netherlands. | ||||
| Drug Saf. 2013 Jan;36(1):13-23. doi: 10.1007/s40264-012-0002-x | ||||
| Article | ||||
| Europe | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/23315292 | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Methodology | 2013 | English | Retrospective database analysis | |
| Population-based analysis of non-steroidal anti-inflammatory drug use among children in four European countries in the SOS project: what size of data platforms and which study designs do we need to assess safety issues? | ||||
| Valkhoff VE1, Schade R, 't Jong GW, Romio S, Schuemie MJ, Arfe A, Garbe E, Herings R, Lucchi S, Picelli G, Schink T, Straatman H, Villa M, Kuipers EJ, Sturkenboom MC; Safety of Non-steroidal Anti-inflammatory Drugs (SOS) project. | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Dr, Molewaterplein, Rotterdam, The Netherlands | ||||
| BMC Pediatr. 2013 Nov 19;13:192. doi: 10.1186/1471-2431-13-192. | ||||
| Article | ||||
| Europe, UK | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/24252465 | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Miscellaneous, Pediatrics | 2013 | English | Retrospective database analysis | |
| An inventory of European data sources for the long-term safety evaluation of methylphenidate. | ||||
| Murray ML, Insuk S, Banaschewski T, Neubert AC, McCarthy S, Buitelaar JK, Coghill D, Dittmann RW, Konrad K, Panei P, Rosenthal E, Sonuga-Barke EJ & Wong IC. | ||||
| Centre for Paediatric Pharmacy Research, University College London School of Pharmacy, London, UK | ||||
| Eur Child Adolesc Psychiatry. 2013 Oct;22(10):605-18. doi: 10.1007/s00787-013-0386-x. Epub 2013 Mar 19. | ||||
| Article | ||||
| Europe, UK | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/23508655 | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Mental health, Pediatrics | 2013 | English | Database Study, Methodology, Retrospective database analysis | |
| Harmonization process for the identification of medical events in eight European healthcare databases: the experience from the EU-ADR project. | ||||
| Avillach P1, 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.Fieschi M, Sturkenboom M, van der Lei J, Pariente A, Trifirò G; EU-ADR consortium. | ||||
| 1, LESIM, ISPED, University Bordeaux Segalen, Bordeaux,France 2,LERTIM, EA 3283, Faculté de Médecine, Université AixMarseille 2, Marseille, France 3,Department of Medical Informatics, Erasmus University Medical Center, Rotterdam,The Netherlands 4,Regional Health Agency of ARS, Florence, Italy 5,Health Search—Italian College of General Practitioners,Florence, Italy 6,Pedianet—Societa’ Servizi Telematici SRL, Padova, Italy 7,Centre on Public Health,University of Milano-Bicocca,Milano, Italy 8, PHARMO Coöperation UA,Utrecht, The Netherlands 9,Department of Primary Care and Public Health Sciences, Kings College, London,UK 10 Aarhus University Hospital,Århus Sygehus, Denmark 11 INSERM U 657, University Bordeaux Segalen, Bordeaux,France 12Department of Epidemiology,Erasmus University Medical Center, Rotterdam, The Netherlands 13, Department of Clinical and Experimental Medicine and Pharmacology, Section of Pharmacology, University of Messina, Messina, Italy | ||||
| J Am Med Inform Assoc. 2013 Jan 1;20(1):184-92. doi: 10.1136/amiajnl-2012-000933. Epub 2012 Sep 6. | ||||
| Article | ||||
| Europe, Italy | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/22955495 | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Methodology | 2013 | English | Retrospective database analysis | |
| Idiopathic acute liver injury in paediatric outpatients: incidence and signal detection in two European countries. | ||||
| Ferrajolo C1, Verhamme KM, Trifirò G, 't Jong GW, Giaquinto C, Picelli G, Oteri A, de Bie S, Valkhoff VE, Schuemie MJ, Mazzaglia G, Cricelli C, Rossi F, Capuano A, Sturkenboom MC | ||||
| 1Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Pharmacology Section, Second University of Naples, Via L. De Crecchio, 7, 80138, Naples, Ital | ||||
| Drug Saf. 2013 Oct;36(10):1007-16 | ||||
| Abstract | ||||
| Italy | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety | 2013 | English | Retrospective database analysis | |
| US-based emergency department visits for fluoroquinolone-associated hypersensitivity reactions | ||||
| Jones SC, Budnitz DS, Sorbello A, Mehta H | ||||
| Food and Drug Administration | ||||
| Pharmacoepidemiol Drug Saf 2013;22(10):1099-1106. | ||||
| Article | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/?term=US-based+emergency+department+visits+for+fluoroquinolone-associated+hypersensitivity+reactions. | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety | 2013 | English | Real World Evidence | |
| Using electronic health care records for drug safety signal detection: a comparative evaluation of statistical methods. | ||||
| Schuemie MJ1, Coloma PM, Straatman H, Herings RM, Trifirò G, Matthews JN, Prieto-Merino D, Molokhia M, Pedersen L, Gini R, Innocenti F, Mazzaglia G, Picelli G, Scotti L, van der Lei J, Sturkenboom MC. | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands | ||||
| Med Care. 2012 Oct;50(10):890-7. | ||||
| Article | ||||
| Europe, UK | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/22929992 | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Methodology | 2012 | English | Retrospective database analysis | |
| Electronic healthcare databases for active drug safety surveillance: is there enough leverage. | ||||
| Coloma PM1, 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. | ||||
| 1Department of Medical Informatics, Erasmus Medical Center, Rotterdam, The Netherlands | ||||
| Pharmacoepidemiol Drug Saf. 2012 Jun;21(6):611-21. doi: 10.1002/pds.3197. Epub 2012 Feb 8. | ||||
| Article | ||||
| Europe | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/22315152 | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety, Miscellaneous | 2012 | English | Retrospective database analysis | |
| Risk of cardiac valve regurgitation with dopamine agonist use in Parkinson's disease and hyperprolactinaemia: a multi-country, nested case-control study. | ||||
| Trifirò G1, Mokhles MM, Dieleman JP, van Soest EM, Verhamme K, Mazzaglia G, Herings R, de Luise C, Ross D, Brusselle G, Colao A, Haverkamp W, Schade R, van Camp G, Zanettini R & Sturkenboom MC. | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands. g.trifiro@erasmusmc.nl | ||||
| Drug Saf. 2012 Feb 1;35(2):159-71. doi: 10.2165/11594940-000000000-00000. | ||||
| Article | ||||
| Europe, UK | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/22204718 | ||||
| Condition | Year | Language | Analysis type | |
| Cardiovascular disease, Drug safety, Neurological disorders | 2012 | English | Retrospective database analysis | |
| The risk of new onset heart failure associated with dopamine agonist use in Parkinson's disease. | ||||
| Mokhles MM1, Trifirò G, Dieleman JP, Haag MD, van Soest EM, Verhamme KM, Mazzaglia G, Herings R, Luise Cd, Ross D, Brusselle G, Colao A, Haverkamp W, Schade R, Camp Gv, Zanettini R, Sturkenboom MC | ||||
| 1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands. | ||||
| Pharmacol Res. 2012 Mar;65(3):358-64. doi: 10.1016/j.phrs.2011.11.009. Epub 2011 Nov 23. | ||||
| Article | ||||
| Italy, Netherlands, UK | ||||
| Abstract: http://www.ncbi.nlm.nih.gov/pubmed/22123498 | ||||
| Condition | Year | Language | Analysis type | |
| Cardiovascular disease, Drug safety, Neurological disorders | 2012 | English | Retrospective database analysis | |
| DIA J 2008 | ||||
| Dreyer NA, Sheth N, Trontell A, Gliklich RE | ||||
| Good practices for handling adverse events detected through patient registries | ||||
| Abstract | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety | 2008 | English | RWLPR (Real-World Late Phase Research-quintiles | |
| The Monitor Association of Clinical Trial Professionals | ||||
| Dreyer NA, Bertagna M, and Gliklich RE | ||||
| Article | ||||
| Condition | Year | Language | Analysis type | |
| Drug safety | 2007 | English | RWLPR (Real-World Late Phase Research-quintiles | |