Skip to main content
Publications
Gini R, Pajouheshnia R , Gutierrez L , Swertz MA, Hyde E, Sturkenboom M, Arana A , Franzoni C , Ehrenstein V, Roberto G, Gil M, Macia MA, Schafer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembrt K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfelix-Gimeno G, Hurtado I, Barreiro-de Acosta M, Poblador-Plou B, Carmona-Pirez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Zerovnik S, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Perez-Gutthann S . Commentary - Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies: lessons learnt from the MINERVA project in Europe . Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5884. doi: 10.1002/pds.5884
Pajouheshnia R , Gini R, Gutierrez L , Swertz MA, Hyde E, Sturkenboom M, Arana A , Franzoni C , Ehrenstein V, Roberto G, Gil M, Macia MA, Schafer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfelix-Gimeno G, Hurtado I, Barreiro-de Acosta M, Poblador-Plou B, Carmona-Pirez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Zerovnik S, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Perez-Gutthann S . Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA): development and pilot of a metadata list and catalogue in Europe . Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5871. doi: 10.1002/pds.5871
Gini R, Pajouheshnia R , Gardarsdottir H, Bennett D, Li L, Gulea C, Wientzek-Fleischmann A, Bazelier MT, Burcu M, Dodd C, Duran CE, Kaplan S, Lanes S, Marinier K, Roberto G, Soman K, Zhou X, Platt R, Setoguchi S, Hall GC. Describing diversity of real world data sources in pharmacoepidemiologic studies: the DIVERSE scoping review . Pharmacoepidemiol Drug Saf. 2024 May;33(5):e5787. doi: 10.1002/pds.5787
de Vogel S, Seeger JD, Arana A , Margulis AV , McQuay LJ, Perez-Gutthann S , Hallas J, Kristiansen NS, Linder M, Odsbu I, Suehs B, Xu Y, Uribe C, Appenteng K, Robinson NJ. Lessons learned from a multi-data source research collaboration: the mirabegron post-authorization safety study program . Pharmacoepidemiol Drug Saf. 2024 May;33(5):e5799. doi: 10.1002/pds.5799
Muntner P, Hernandez RK, Kent ST, Browning JE, Gilbertson DT, Hurwitz KE, Jick SS, Lai EC, Lash TL, Monda KL, Rothman KJ , Bradbury BD, Brookhart MA. Staging and clean room: constructs designed to facilitate transparency and reduce bias in comparative analyses of real-world data . Pharmacoepidemiol Drug Saf. 2024 Mar;33(3):1-10. doi: 10.1002/pds.5770
Levintow SN, Nielson CM, Hernandez RK, Breskin A, Pritchard D, Lash TL, Rothman KJ , Gilbertson D, Muntner P, Critchlow C, Brookhart MA, Bradbury BD. Pragmatic considerations for negative control outcome studies to guide non-randomized comparative analyses: a narrative review . Pharmacoepidemiol Drug Saf. 2023 Jun;32(6):599-606. doi: 10.1002/pds.5623
Wang SV, Pottegard A, Crown W, Arlett P, Ashcroft DM, Benchimol EI, Berger ML, Crane G, Goettsch W, Hua W, Kabadi S, Kern DM, Kurz X, Langan S, Nonaka T, Orsini L, Perez-Gutthann S , Pinheiro S, Pratt N, Schneeweiss S, Toussi M, Williams RJ. HARmonized protocol template to enhance reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: a good practices report of a joint ISPE/ISPOR task force . Pharmacoepidemiol Drug Saf. 2023 Jan;32(1):44-55. doi: 10.1002/pds.5507
Rebordosa C , Farkas DK, Montonen J, Laugesen K, Voss F, Aguado J , Bothner U, Rothman KJ , Zint K, Mines DI , Ehrenstein V. Cardiovascular events and all-cause mortality in patients with chronic obstructive pulmonary disease using olodaterol and other long-acting beta2-agonists . Pharmacoepidemiol Drug Saf. 2022 Aug;31(8):827-39. doi: 10.1002/pds.5432
Sultana J, Crisafulli S, Almas M, Antonazzo IC, Baan E, Bartolini C, Bertuccio MP, Bonifazi F, Capuano A, Didio A, Ehrenstein V, Felisi M, Ferrajolo C, Fontana A, Francisca R, Fourrier-Reglat A, Fortuny J , Gini R, Hyeraci G, Hoeve C, Kontogiorgis C, Isgrò V, Lalagkas P, L'Abbate L, Layton D, Landi A, Narduzzi S, Pereira LR, Poulentzas G, Rafaniello C, Roberto G, Scondotto G, Sportiello L, Toma M, Toussi M, Verhamme K, Volpe E, Trifirò G. Overview of the European post-authorisation study register post-authorization studies performed in Europe from September 2010 to December 2018 . Pharmacoepidemiol Drug Saf. 2022 Jun;31(6):689-705. doi: 10.1002/pds.5413
Beachler DC, Taylor DH, Anthony MS , Yin R, Li L, Saltus CW , Li Lin, Shaunik A, Walsh KE, Rothman KJ , Johannes CB , Aroda VR, Carr W, Goldberg P, Accardi A, O'Shura JS, Sharma K, Juhaeri J, Lanes S, Wu C. Response to letter to the editor regarding “Development and validation of a predictive model algorithm to identify anaphylaxis in adults with type 2 diabetes in U.S. administrative claims data” . Pharmacoepidemiol Drug Saf. 2022 Jan;31(1):110-1. doi: 10.1002/pds.5376
Fortuny J , von Gersdorff G, Lassalle R, Linder M, Overbeek J, Reinold J, Toft G, Timmer A, Dress J, Blin P, Droz-Perroteau C, Ehrenstein V, Franzoni C , Herings R, Kollhorst B, Moore N, Odsbu I, Perez-Gutthann S , Schink T, Rascher K, Rasouliyan L, Rothman KJ , Saigi-Morgui N , Schaller M, Smits E, Forstner M, Intravenous Iron Consortium, Benichou J, Bircher AJ, Garbe E, Rampton DS, Gutierrez L . Use of intravenous iron and risk of anaphylaxis: a multinational observational post-authorisation safety study in Europe . Pharmacoepidemiol Drug Saf. 2021 Oct;30(10):1447-57. doi: 10.1002/pds.5319
Beachler DC, Taylor DH, Anthony MS , Yin R, Li L, Saltus CW , Li Lin, Shaunik A, Walsh KE, Rothman KJ , Johannes CB , Aroda VR, Carr W, Goldberg P, Accardi A, O'Shura JS, Sharma K, Juhaeri J, Lanes S, Wu C. Development and validation of a predictive model algorithm to identify anaphylaxis in adults with type 2 diabetes in U.S. administrative claims data . Pharmacoepidemiol Drug Saf. 2021 Jul;30(7):918-26. doi: 10.1002/pds.5257
Arana A , Margulis AV , Varas-Lorenzo C, Bui CL , Gilsenan A , McQuay LJ, Reynolds M , Rebordosa C , Franks B, de Vogel S, Appenteng K, Perez-Gutthann S . Validation of cardiovascular outcomes and risk factors in the Clinical Practice Research Datalink in the United Kingdom . Pharmacoepidemiol Drug Saf. 2021 Feb;30(2):237-47. doi: 10.1002/pds.5150
Forns J , Cainzos-Achirica M, Hellfritzsch M, Morros R, Poblador-Plou B, Hallas J, Giner-Soriano M, Prados-Torres A, Pottegard A, Cortes J, Castellsague J, Jacquot E, Deltour N, Perez-Gutthann S , Pladevall M . Validity of ICD-9 and ICD-10 codes used to identify acute liver injury: a study in three European data sources . Pharmacoepidemiol Drug Saf. 2019 Jul;28(7):965-75. doi: 10.1002/pds.4803
Castellsague J, Poblador-Plou B, Giner-Soriano M, Linder M, Scholle O, Calingaert B , Bui C , Arana A , Laguna C, Gonzalez-Rubio F, Roso-Llorach A, Prados-Torres A, Perez-Gutthann S . Effectiveness of risk minimization measures for the use of cilostazol in United Kingdom, Spain, Sweden, and Germany . Pharmacoepidemiol Drug Saf. 2018 Sep;27(9):953-61. doi: 10.1002/pds.4584
Cainzos-Achirica M, Varas-Lorenzo C, Pottegard A, Asmar J, Plana E , Rasmussen L, Bizouard G, Forns J , Hellfritzsch M, Zint K, Perez-Gutthann S , Pladevall-Vila M . Methodological challenges when evaluating potential off-label prescribing of drugs using electronic health care databases: a case study of dabigatran etexilate in Europe . Pharmacoepidemiol Drug Saf. 2018 Jul;27(7):713-23. doi: 10.1002/pds.4416
Castellsague J, Perez-Gutthann S , Calingaert B , Bui C , Varas-Lorenzo C, Arana A , Prados-Torres A, Poblador-Plou B, Gonzalez-Rubio F, Giner-Soriano M, Roso-Llorach A, Linder M, Citarella A, Scholle O, Blenk T, Garbe E. Characterization of new users of cilostazol in the UK, Spain, Sweden, and Germany . Pharmacoepidemiol Drug Saf. 2017 Jun;26(6):615-24. doi: 10.1002/pds.4167
Johannes CB , McQuay LJ, Midkiff KD , Calingaert B , Andrews EB, Tennis P, Brown JS, Camargo, Jr CA, DiSantostefano R, Rothman KJ , Sturmer T, Lanes S, Davis KJ. The feasibility of using multiple databases to study rare outcomes: the potential effect of long-acting beta agonists with inhaled corticosteroid therapy on asthma mortality . Pharmacoepidemiol Drug Saf. 2017 Apr;26(4):446-58. doi: 10.1002/pds.4151
Yih WK, Kulldorff M, Sandhu SK, Zichittella L, Maro JC, Cole DV, Jin R, Kawai AT , Baker MA, Liu C, McMahill-Walraven CN, Selvan MS, Platt R, Nguyen MD, Lee GM. Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System . Pharmacoepidemiol Drug Saf. 2016 May;25(5):481-92. doi: 10.1002/pds.3908
Gilbertson DT, Bradbury BD, Wetmore JB, Weinhandl ED, Monda KL, Liu J, Brookhart MA, Gustafson SK, Roberts T, Collins AJ, Rothman KJ . Controlling confounding of treatment effects in administrative data in the presence of time-varying baseline confounders . Pharmacoepidemiol Drug Saf. 2016 Mar;25(3):269-77. doi: 10.1002/pds.3922
Mines D , Tennis P, Curkendall SM, Li DK, Peterson C, Andrews EB, Calingaert B , Chen H, Deshpande G, Esposito DB, Everage N, Holick CN, Meyer NM, Nkhoma ET, Quinn S, Rothman KJ , Chan KA. Topiramate use in pregnancy and the birth prevalence of oral clefts . Pharmacoepidemiol Drug Saf. 2014 Oct 1;23(10):1017-25. doi: 10.1002/pds.3612
Kawai AT , Li L, Kulldorff M, Vellozzi C, Weintraub E, Baxter R, Belongia EA, Daley MF, Jacobsen SJ, Naleway A, Nordin JD, Lee GM. Absence of associations between influenza vaccines and increased risks of seizures, Guillain-Barré syndrome, encephalitis, or anaphylaxis in the 2012-2013 season . Pharmacoepidemiol Drug Saf. 2014 May;23(5):548-53. doi: 10.1002/pds.3575
Pisa F, Castellsague J, Drigo D, Riera Guardia N , Giangreco M, Rosolen V, Clagnan E, Zanier L, Perez-Gutthann S , Barbone F. Accuracy of ICD-9-CM codes for upper gastrointestinal complications vaired by position and age: a validation study in a cohort of NSAID users in Friuli Venezia Giulia, Italy . Pharmacoepidemiol Drug Saf. 2013 Nov 22;22(11):1195-204. doi: 10.1002/pds.3504
Toh S, Avorn J, D'Agostino RB, Gurwitz JH, Psaty BM, Rothman KJ , Saag KG, Sturkenboom MCJM, Vandenbroucke JP, Winterstein AG, Strom BL. Re-using Mini-Sentinel data following rapid assessments of potential safety signals via modular analytic programs . Pharmacoepidemiol Drug Saf. 2013 Oct;22(10):1036-45.
Pisa F, Castellsague J, Drigo D, Riera-Guardia N , Giangreco M, Rosolen V, Clagnan E, Zanier L, Perez-Gutthann S , Barbone F. Accuracy of International Classification of Diseases, 9th Revision, Clinical Modification codes for upper gastrointestinal complications varied by position and age: a validation study in a cohort of nonsteroidal anti-inflammatory drugs users in Friuli Venezia Giulia, Italy . Pharmacoepidemiol Drug Saf. 2013 Aug 20;22(11):1195-204.