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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, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfelix-Gimeno G, Hurtado I, Acosta MB, 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 (MINERVA): 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, Acosta MB, 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
Gini R, Messina D, Aarts W, Paoletti O, Bartolini CC, Weibel D, Choi J, Cid-Royo A, Elbers RJK, Vaz TA, Belitser SV, Bots SH, Riefolo F, Plana E , Sturkenboom MC. Representation of study scripts to improve transparency and efficiency in multidatabase distributed vaccine studies . Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):600-1. doi: 10.1002/pds.5687
Kawai A , Fuller CC, Koram N, Agan A, Brown J, Burk J, Cai B, Daniels K, Fearrington J, Franklin JM, Hague C, Jamal-allial A, Johannes CB , Kempner M, Layton JB , Ma Q, Mai X, Mayer SE, Pawloski PA, Reynolds JS, Seals RM, Selvan M, Smith S, McMahill-Walraven CN, Gilsenan A , Platt R. Monitoring results from a postapproval safety study of Pfizer-BioNTech COVID-19 vaccine in the United States: vaccine utilization and incidence rates of myocarditis/pericarditis . Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):182. doi: 10.1002/pds.5687
Tormos A , Thomsen RW, Tave AK, Madsen M, Beachler DC, Martinez D , Garcia Esteban R , Plana E , Farsani SF, Perez-Gutthann S , Pladevall-Vila M , Rebordosa C . Post-authorisation safety study (PASS) assessing the risk of liver, renal, genitourinary, and diabetic ketoacidosis outcomes among users of empagliflozin versus DPP-4 inhibitors in patients with type 2 diabetes mellitus (T2D) . Poster presented at the 39th ICPE Annual Conference; August 27, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):585. doi: 10.1002/pds.5687
Mayer SE, Fuller CC, Haynes K, Alam S, Brown JS, Daniels K, Hawrusik R, Horgan C, Jamal-allial A, Johannes CB , Kawai AT , Layton JB , Mai X, Marshall J, McMahill-Walraven CN, Reynolds JS, Seals R, Selvan M, Stemkowski S, Wang FT, Yost E, Gilsenan A , Platt R. Use of Janssen Ad26.COV2.S COVID-19 Vaccine (JCOVDEN) and mRNA COVID-19 vaccines in four large US national insurers . Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):186. doi: 10.1002/pds.5687
Weibel D, De Luise C, Elbers R, van den Bor R, Martin I, Cid-Royo A, Plana E , Garcia de Albeniz Martinez X , Weinrib R , Yefimenko N, Poblador-Plou B, Marconi E, Barbieri E, Stona L, Swart KMA, Roy D, Hyeraci G, Bartolini C, Lupattelli A, Villalobos F, Kendrick K, Garg R, Rubino H, Eijkemans R, Sturkenboom M, Arana A . Utilisation patterns of the COVID-19 mRNA vaccine (Comirnaty®) from the VAC4EU active safety surveillance study in five European countries . Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):173-4. doi: 10.1002/pds.5687
Saltus C , Djibo DA, Peetluk L, Kaye J, McMahill-Walraven C, Johannes C , Bernick B, Calingaert B , Franklin J, Graham S, Pigoga J, Shuminski P, Margulis AV . Use of very low-dose vaginal estrogens among postmenopausal women in the US . Poster presented at the 39th ICPE Annual Conference; August 26, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):352-3. doi: 10.1002/pds.5687
Levesque L, Johannes CB , Lecciones JA, Giamberardino H, Marcelon L, Cohen C, Rojas A, Bennett L , Khromava A. Post-authorization safety study: cohort event monitoring for CYD-TDV dengue vaccine (DNG15) . Poster presented at the 39th ICPE Annual Conference; August 27, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):592. doi: 10.1002/pds.5687
Ahmadizar F, Fortuny J , Cid-Royo A, Plana E , Weinrib R , Garcia Esteban R , Boric K , Yefimenko N, Carreras JJ, Urcheguia A, Correcher-Martinez E, Mira-Iglesias A, Swart KMA, van den Berg JM, Overbeek JA, Villalonos F, Bissacco CA, Newbern C, Praet N, Willame C, Sturkenboom M. Safety of the Janssen COVID-19 vaccine (JCOVDEN) using VAC4EU European healthcare data: methods and results of the first study feasibility assessment . Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):189-90. doi: 10.1002/pds.5687
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
Simon MA, Lapane K, Khan AM , Spevack SC, Murray CR, Burns DR, Gifford D, Mor VW, Dore DD. Novel data and lag-times within the EHR provided by the long-term care data cooperative (LTCDC) . Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):421. 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
Chomistek AK, Hoffman V , Gill K, Urman R, Ezzy SM, Zhou L, Park A, Loop B, Lopez-Leon S, McAllister P, Wang F. Inpatient constipation among migraine patients treated with preventive medications in a United States electronic health record database . Poster presented at the 2022 ICPE Conference; August 26, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 25; 31(S2):132. doi: 10.1002/pds.5518
Gini R, Pajouheshnia R , Hall G, Platt R, Setoguchi S, Bazelier M, Kaplan S, Zhou X, Lanes S, Man K, Li L, Burcu M, Roberto G, Dodd C, Duran C, Wientzek-Fleischmann A, Soman K, Lai E, Marinier K, Bennett D, Gardarsdottir H. Data source heterogeneity in multi-data base Pharmacoepidemiologic studies: an ISPE-sponsored scoping review . Poster presented at the 2022 ICPE Conference; August 26, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):216. doi: 10.1002/pds.5518
Gini R, Paoletti O, Pajouheshnia R , Souverein PC, Thurin NH, Ehrenstein V, Barreiro-De Acosta M, Sturkenboom M, Gutierrez L , Perez-Gutthann S . Study scripts supporting multiple common data models . Poster presented at the 2022 ICPE Conference; August 28, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):550. doi: 10.1002/pds.5518Pharmacoepidemiol Drug Saf.2022;31(Suppl. 2):3–628.wileyonlinelibrary.com/journal/pds© 2022 John Wiley & Sons Ltd.3
Weibel D, Sturkenboom M, Eijkemans R, van den Bor R, Elbers R, Plana E , Garcia de Albeniz X , Weinrib R , Yefimenko N, Bianchini E, Stona L, Poblador-Plou B, Swart-Polinder K, Bartolini C, Hyeraci RG, Roy D, Lupattelli A, Villalobos F, Barbieri E, Garg RK, Rubino H, De Luise C, Arana A . VAC4EU active safety surveillance study of the BNT162b2 COVID-19 vaccine in five European countries: study design and first results . Poster presented at the 2022 ICPE Conference; August 30, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):627-8. doi: 10.1002/pds.5518
Pajouheshnia R , Gini R, Hyde E, Swertz MA, Sturkenboom M, Margulis AV , Franzoni C , Arana A , Ehrenstein V, Gembert K, Jansen E, Herings RMC, Thurin NH, Locatelli I, Jazbar J, Zerovnik S, Kos M, Smit S, Lind S, Metspalu A, Zaccagnino S, Busto MP, Middelkoop B, Barreiro-De Acosta M, Saez FS, Rodriguez-Bernal C, Sanfelix-Gimeno G, Poblador-Plou B, Carmona-Pirez J, Gimeno-Miguel A, Gil M, Schafer W, Haug U, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Gutierrez L , Perez-Gutthann S . MINERVA: Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies . Poster presented at the 2022 ICPE Conference; August 28, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):564. doi: 10:1002/pds.5518
Limoncella G, Bartolini CC, Duran C, Girardi A, Hyeraci G, Arnau JR, Llorente A, Soriano LC, Martin-Perez M, Garcia-Poza P, Sanchez-Saez F, Sanfelix-Gimeno G, Nordeng H, Hurley E, Maglanoc LA, Holthuis E, Swart K, Lentile V, Tanaglia M, Brown J, Wing K, Schink T, Pajouheshnia R , Cunnington M, Sturkenboom M, Gini R. Extracting pregnancies from heterogeneous data sources in Europe: a novel algorithm in the conception project . Poster presented at the 2022 ICPE Conference; August 26, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):236-7. doi: 10.1002/pds.5518
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
Cruz Rivera S, Aiyegbusi OL, Ives J, Draper H, Mercieca-Bebber R, Ells C, Hunn A, Scott JA, Fernandez CV, Dickens AP, Anderson N, Bhatnagar V, Bottomley A, Campbell L, Collett C, Collis P, Craig K, Davies H, Golub R, Gosden L, Gnanasakthy A , Haf Davies E, von Hildebrand M, Lord JM, Mahendraratnam N, Miyaji T, Morel T, Monteiro J, Zwisler AO, Peipert JD, Roydhouse J, Stover AM, Wilson R, Yap C, Calvert MJ. Ethical considerations for the inclusion of patient-reported outcomes in clinical research: the PRO ethics guidelines . JAMA. 2022 May 17;327(19):1910-9. doi: 10.1001/jama.2022.6421
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