Skip to main content
Publications
Girardi A, Limoncella G, Hyeraci G, Roberto G, Bartolini C, Paoletti O, Messina D, Villalobos F, Bissacco C, Van den Burg J, Houben E, Santaca k, Lentile V, Ingrasciotta Y, Trifiro G, Hoxhaj V, Duran C, Riera-Arnau J, Garcia P, Martin-Perez M, Huerta-Alvarez C, Llorente-Garcia A, Sanchez-Saez F, Rodriguez-Bernal C, Lassalle R, Jove J, Bernard M, Thurin N, Jordan S, Thayer D, Evans H, Coldea A, Manfrini M, Van Gelder M, Hayati S, Schink T, Tari M, Pajouheshnia R , Afonso A, Noan-Laine M, Molgaard-Nielsen D, Cunnington M, Dodd C, Sturkenboom M, Nordeng H, Gini R. Impact of data source diversity on the distribution of key variables in pregnancy cohorts based on the ConcePTION pregnancy algorithm leveraging a random forest imputation model . Presentation to be given at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Mayer SE, Kawai A , Fuller CC, Agan AA, Rao S , Koram N, Calingaert B , Marshall J, Connolly JG, Moyneur E, Jamal-allial A, Brown J, Burk J, Chomistek A, Daniels K, Dea K, DeFor TA, Diessner B, Djibo DA, Ezzy S, Hawrusik R, Johannes CB , Kendrick K, Layton JB , Ma Q, Mai X, Mack M, Pawloski PA, Reynolds JS, Selvan M, Sharma V, Vetter J, McMahill-Walraven CN, Platt R, Gilsenan A . Interim utilization results from a post-approval safety study of Pfizer-BioNTech monovalent COVID-19 vaccine in the United States . Poster to be given at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Danysh HE , Gilsenan A , Kaye JA, Garcia de Albeniz Martinez X , Schmid R, Bartsch J , Calingaert B , Rahman S, Layton JB , Gutierrez L . Validation of algorithms to identify breast cancer and bladder cancer among patients with type 2 diabetes mellitus in United States medicare administrative claims . Poster to be given at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Layton JB , Muthuri S, Lindaas A, Lloyd PC, Richey MM, Gruber JF, Clarke TC, Kowarski LS, McKillop M, Fisher S, Lyu H, Cheng A, Bui CL , Duenas PF, Chen Y, Forshee RA, Anderson SA, Beers JB, Burrell T, Chillarige Y, Anthony MS , Shoaibi A. Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States . Presentation to be given at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Layton JB , Lindaas A, Muthuri S, Lloyd PC, Richey MM, Gruber JF, Clarke TC, Kowarski L, McKillop M, Fisher S, Lyu H, Cheng A, Bui C , Duenas PF, Chen Y, Beers JB, Forshee RA, Anderson SA, Burrell T, Chillarige Y, Anthony MS , Shoaibi A. Risk of cardiovascular adverse events after COVID-19 diagnosis in the United States . Poster to be given at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Domenech E, Fortuny J , Martinez D , Tormos A , Huang Z, Hill D, Weinstein C, Esslinger S, Krumme A, Mines D, Gisbert J. A post-authorization safety study of golimumab in ulcerative colitis using the Spanish ENEIDA registry (MK8259-042) . Poster to be given at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Ahmadizar F, Fortuny J , Royo AC, Plana E , Weinrib R , Garcia Esteban R , Boric K , Yefimenko N, Haugh M, Carreras JJ, Urchueguia-Fornes A, Correcher E, van den Berg JM, Lysen T, Villalobos F, Bissacco CA, Newbern EC, Willame C, Praet N, Sturkenboom MCJM. Safety of the Janssen COVID-19 vaccine (JCOVDEN) using VAC4EU European healthcare data sources: methods and results of the second study feasibility assessment . Poster to be given at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Jacobson MH, Sabido M, Afonso AS, Ajao A, Alghamdi EA, Andrade S, Bennett D, Kharat V, Kurzinger ML, Le Noan-Laine M, Molgaard-Nielsen D, Murray G, Rivero-Ferrer E , Lopez-Leon S. Algorithms to identify major congenital malformations in routinely collected healthcare databases: a systematic literature review . Poster to be given at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Peetluk LS, Djibo DA, Layton JB , Deng J, Deshazo J, Richey MM, Ogilvie RP, Parambi RJ, Miller M, Song J, Tarazi W, Weatherby LB, Bell EJ, Anthony MS , McMahill-Walraven CN, Yang GW, Seeger JD, Amend KL. Considerations for negative control outcome analyses in vaccine effectiveness studies: post-hoc analyses from an adult vaccine effectiveness study conducted within the FDA BEST initiative . Presentation to be given at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Broe A, Willis SK, Dareng E, Haviland M, van Gelder MMHJ, Nordeng HME, Wood ME, Sahin L, Margulis AV , Rivero-Ferrer E . Building global consensus on definitions for drug safety studies in pregnancy to improve harmonized evaluation of real-world data . Presentation to be given at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Layton JB , Peetluk LS, Lloyd PC, Jiao Y, Djibo DA, Deng J, Gruber JF, Ogilvie RP, Parambi R, Miller M, Song J, Weatherby LB, Bell EJ, Lo AC, Hervol JR, Wernecke M, Cho S, Wong H-L, Clarke TC, Bui CL , Stone A, Tarazi W, Deshazo J, Forshee RA, Anderson SA, Seeger JD, Amend KL, MaMahill-Walraven CN, Chillarige Y, Yang GW, Anthony MS , Shoaibi A. Effectiveness over time of a complete primary series of the original, monovalent COVID-19 vaccines among adults aged 18-64 years in the United States . Poster to be given at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Layton JB , Richey M, Lindaas A, Muthuri S, Lloyd PC, Gruber JF, Bui C , McKillop M, Kowarski L, Lyu H, Cheng A, Wan Z, Clarke TC, Kawai AT , Beers J, Forshee RA, Anderson SA, Burrell T, Chillarige Y, Anthony MS , Shoaibi A. Events on day zero of follow-up: considerations for cohort studies of adverse events after COVID-19 diagnosis . Presentation to be given at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Johannes CB , Ziemiecki R , Pladevall-Vila M , Kosvesdy CP, Ebert N, Thomsen RWW, Christiansen CF, Baak B, Cabaninas CR, Kashihara N, Yano Y, Kanegae H, Coleman CI, Okami S, Li u F, Layton JB , Vizcaya D, Oberprieler NG. Use of SGLT2 inhibitors in patients with type 2 diabetes and chronic kidney disease – a multi-country report from the FOUNTAIN platform . Poster to be given at the 2024 ISPE Annual Meeting; August 26, 2024. Berlin, Germany.
Pajouheshnia R , Gini R, Gardarsdottir H, Bennett D, Li L, Gulea C, Wientzek-Fleischmann A, Bazelier M, Burcu M, Dodd C, Duran C, Kaplan S, Lanes S, Marinier K, Roberto G, Soman KV, Platt R, Setoguchi S, Hall G, Zhou X. Towards a framework to describe diversity of real-world data sources: findings from the DIVERSE initiative scoping review . Poster to be given at the 2024 ISPE Annual Meeting; August 26, 2024. Berlin, Germany.
Weinrib R , Fortuny J , Martinez D , Kollhorst B, Haug U, Kousholt A, Ehrenstein V, Iversen P, Mortensen J, Bosch D, Kuppen M, Pisa F, Vassiley Z. Drug utilisation study of radium-223 under routine clinical practice (DIRECT) in Europe: a post-authorisation safety study . Poster to be given at the 2024 ISPE Annual Meeting; August 26, 2024. Berlin, Germany.
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
Ogilvie RP, Layton JB , Lloyd PC, Jiao Y, Djibo DA, Wong HL, Gruber JF, Parambi R, Deng J, Miller M, Song J, Weatherby LB, Peetluk L, Lo A, Matuska K, Wernecke M, Bui CL , Clarke TC, Cho S, Bell EJ, Yang G, Amend KL, Forshee RA, Anderson SA, McMahill-Walraven CN, Chillarige Y, Anthony MS , Seeger JD, Shoaibi A. Effectiveness of BNT162b2 COVID-19 primary series vaccination in children aged 5–17 years in the United States: a cohort study . BMC Pediatr. 2024 Apr 26;24(1):276. doi: 10.1186/s12887-024-04756-5
Gannon PR, MacKay RE , Love KL, Weaver BW, Burke KB, Dotto VR, Garcia JM, Luciano A, Berryhill BA, Mumma JM. Connecting pathogen transmission and performance of the WHO's 'my 5 moments of hand hygiene' in a high-fidelity simulation . Poster presented at the Society for Healthcare Epidemiology of America (SHEA) Spring Conference; April 19, 2024. Houston, TX.
Melen E, Faner R, Allinson JP, Bui D, Bush A, Custovic A, Garcia-Aymerich J, Guerra S, Breyer-Kohansal R, Hallberg J, Lahousse L, Martinez FD, Merid SK, Powell P, Pinnock H, Stanojevic S, Vanfleteren LEGW, Wang G, Dharmage SC, Wedzicha J, Agusti Alvar, Abellan A , CADSET Investigators. Lung-function trajectories: relevance and implementation in clinical practice . Lancet. 2024 Apr 13;403(10435):1494-503. doi: 10.1016/S0140-6736(24)00016-3
Josa-Cullere A, Basagana X, Koch S, Arbillaga-Etxarri A, Balcells E, Bosch de Basea M, Celorrio N, Foraster M , Rodriguez-Roisin R, Marin A, Peralta GP, Rodriguez-Chiaradia DA, Simonet P, Toran-Monserrat P, Vall-Casas P, Garcia-Aymerich J. Short-term effects of air pollution and weather on physical activity in patients with chronic obstructive pulmonary disease (COPD) . Environ Res. 2024 Apr;247:118195. doi: 10.1016/j.envres.2024.118195.
Rebordosa C , Thomsen RW, Tave AK, Madsen M, Beachler DC, Martinez D , Garcia-Esteban R , Plana E , Tormos A , Farsani SF, Perez-Gutthann S , Pladevall-Vila M . Liver, renal, genitourinary, and diabetic ketoacidosis risks among new users of empagliflozin versus DPP-4 inhibitors in patients with type 2 diabetes: post-authorisation safety study based on multinational cohorts . Diabetes Obes Metab. 2024 Apr;26(4):1291-304. doi: 10.1111/dom.15429
Anthony MS , Aroda VR, Parlett LE, Djebarri L, Berreghis S, Calingaert B , Beachler DC, Crowe CL, Johannes CB , Juhaeri J, Lanes S, Pan C, Rothman KJ , Saltus CW , Walsh KE. Risk of anaphylaxis among new users of glp-1 receptor agonists: a cohort study . Diabetes Care. 2024 Apr 1;47(4):712-9. doi: 10.2337/dc23-1911
Keens T, Hoffman V , Topuria I, Elder K, Cerf S, Mulder K, Roberts J, Lysinger J, Del Carmen Reyes M, Berdella M, Cairns AM, Jain M, Ganapathy V, Lou Y, Morcos B, Wu C, Sass L, VX19-CFD-003 Study Group. Real-world effectiveness of elexacaftor/tezacaftor/ivacaftor on the burden of illness in adolescents and adults with cystic fibrosis . Heliyon. 2024 Mar 26;10(7):e28508. doi: 10.1016/j.heliyon.2024.e28508
Rao S , Forns J , Danysh HE , Calingaert B , Dempsey C, Aquilina T, Pathak S, Anthony MS , Layton JB . Natural history and clinical outcomes in patients with Alzheimer's disease-related psychosis in the United States . Presented at the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) 2024; March 5, 2024. Lisbon, Portugal.
Abellan A , Warembourg C, Mensink-Bout SM, Ambros A, de Castro M, Fossati S, Guxens M, Jaddoe VW, Nieuwenhuijsen MJ, Vrijheid M, Santos S, Casas M, Duijts L. Urban environment during pregnancy and lung function, wheezing, and asthma in school-age children. The generation R study . Environ Pollut. 2024 Mar 1;344:123345. doi: 10.1016/j.envpol.2024.123345
Simon TA, Suissa S, Skovron ML, Frisell T, Askling J, Michaud K, Pedro S, Strangfeld A, Meissner Y, Boers M, Hoffman V , Dominique A, Gomez A, Hochberg MC. Infection outcomes in patients with rheumatoid arthritis treated with abatacept and other disease-modifying antirheumatic drugs: results from a 10-year international post-marketing study . Semin Arthritis Rheum. 2024 Feb;64:152313. doi: 10.1016/j.semarthrit.2023.152313
Layton JB , Peetluk L, Wong HL, Jiao Y, Djibo DA, Bui C , Lloyd PC, Gruber JF, Miller M, Ogilvie RP, Deng J, Parambi R, Song J, Weatherby LB, Lo AC, Matuska K, Wernecke M, Clarke TC, Cho S, Bell EJ, Seeger JD, Yang GW, Illei D, Forshee RA, Anderson SA, McMahill-Walraven CN, Chillarige Y, Amend KL, Anthony M , Shoaibi A. Effectiveness of monovalent COVID-19 booster/additional vaccine doses in the United States . Vaccine-X. 2024 Jan;16:100447. doi: 10.1016/j.jvacx.2024.100447
Persson Waye K, Love J, Lercher P, Dzhambov AM, Klatte M, Schreckenberg D, Belke C, Leist L, Ristovska G, Jeram S, Kanninen KM, Selander J, Arat A, Lachmann T, Clark C, Botteldooren D, White K, Julvez J, Foraster M , Kaprio J, Bolte G, Psyllidis A, Gulliver J, Boshuizen H, Bozzon A, Fels J, Hornikx M, van den Hazel P, Weber M, Brambilla M, Braat-Eggen E, van Kamp I, Vincens N, Equal-life Scientific Team. Adopting a child perspective for exposome research on mental health and cognitive development - conceptualisation and opportunities . Environ Res. 2023 Dec 15;239 (Pt 1):117279. doi: 10.1016/j.envres.2023.117279
Pesantez D, Hoorn ST, Machado I, Garcia-Albeniz X , Rodriguez-Salas N, Heredia-Soto V, Vinal D, Pericay C, Garcia-Carbonero R, Losa F, Alonso V, Vera R, Batlle JF, Gallego J, Salud A, Nogue M, Layos L, Montagut C, Capdevila J, Vermeulen L, Maurel J, Fernandez-Martos C. Total neoadjuvant therapy with or without aflibercept in rectal cancer: three-year results of GEMCAD-1402 . J Natl Cancer Inst. 2023 Dec 6;115(12):1497-505. doi: 10.1093/jnci/djad120