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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
Ogilvie RP, Layton JB , Wong HL, Jiao Y, Parambi RJ, Deng J, Miller M, Song J, Lloyd PC, Weatherby L, Peetluk LS, Bell EJ, Yang G, Amend KL, Kawai A , Lo AC, Matuska K, Wernecke M, Gruber JF, Clarke TC, Forshee RA, Anderson SA, Anthony MS , Chillarige Y, Seeger JD, Shoaibi A. Effectiveness of BNT162b2 COVID-19 vaccine in US children aged 5-17 years . Presented at the 39th ICPE Annual Conference; August 26, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):78. doi: 10.1002/pds.5687
Layton JB , Peetluk LS, Wong H, Jiao Y, Ogilvie RP, Miller M, Glazier-Essalmi A, Parambi RJ, Song J, Garcia de Albeniz Martinez X , Lloyd PC, Lo A, Kawai A , Weatherby L, Bell EJ, Yang G, Amend KL, Gruber JF, Clarke TC, Forshee RA, Anderson SA, Wernecke M, Matuska K, Chillarige Y, Anthony M , Seeger JD, Shoaibi A. Effectiveness of monovalent COVID-19 booster/additional vaccine doses in the United States . Presented at the 39th ICPE Annual Conference; August 27, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):608. doi: 10.1002/pds.5687
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
Gilsenan A , Fortuny J , Cainzos-Achirica M, Cantero OF, Flynn RW, Garcia-Rodriguez L, Harding A , Kollhorst B, Karlsson P, Linner L, MacDonald TM, Odsbu I, Plana E , Ruigomez A, Schink T, Ziemiecki R , Andrews EB. Cardiovascular safety of prucalopride for chronic constipation: a multinational population-based cohort study . Presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2019. Philadelphia, PA. [abstract] Pharmacoepidemiol Drug Saf. 2019 Aug 20; 28(S2):33. doi: 10.1002/pds.4864
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
Forns J , Cainzos-Achirica M, Hellfritzsch M, Giner-Soriano M, Poblador-Plou B, Hallas J, Morros R, Prados-Torres A, Pottegard A, Cortes J, Aguado J , Castellsague J, Jacquot E, Deltour N, Perez-Gutthann S , Pladevall M . How valid are the codes used to identify acute liver injury (ALI)? A study in 3 European data sources . Presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2018. Prague, Czech Republic. [abstract] Pharmacoepidemiol Drug Saf. 2018 Aug 17; 27(S2):371-2. doi: 10.1002/pds.4629
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
Setoguchi S, Kayo-Yang YH, Strom B, Stang P, Horton D, Gerhard T, Perez-Gutthann S , Leufkens B, Pinheiro S. It takes a village: raising a global community of pharmacoepidemiologists through high-quality education . Presented at the 33rd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 28, 2017. Montreal, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2017 Aug; 26(Suppl 2):5. doi: 10.1002/pds
Rebordosa C , Castellsague J, Kristiansen N, Pottegard A, Plana E , Aguado J , Garcia-Gil E, Hallas J, Perez-Gutthann S . Severity of COPD in new users of aclidinium bromide and other COPD medications: a population-based study in the United Kingdom and Denmark . Presented at the 33rd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 28, 2017. Montreal, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2017 Aug; 26(Suppl 2):45-6. doi: 10.1002/pds