Publications

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Displaying 1 through 50 of 2295 publications.

Forns J, Dudukina E, Hagg D, Szentkuti P, Gembert K, Plana E, Gilsenan A, Horvath-Puho E, Ehrenstein V, Reutfors J, Rebordosa C. Risk of major cardiovascular and cerebrovascular events in users of lisdexamfetamine and other medications for attention-deficit/hyperactivity disorder in Denmark and Sweden: a population-based cohort study. Neurol Ther. 2022 Dec 1;11(4):1659-76. doi: 10.1007/s40120-022-00396-y

Ysander M, Caplanusi I, Arana A. True adverse reaction or not: that's the question. Presented at the Global Forum for Qualified Persons for Pharmacovigilance; November 9, 2022. Amsterdam, Netherlands.

Gilsenan A, Kawai A. Considerations for planning safety surveillance studies of COVID-19 vaccine. Presented at the North American Chapter of the International Society of Pharmacovigilance (NASoP); November 8, 2022.

Garcia de AlbenizMartinez X. Target trial emulation and pharmacovigilance. Presented at the North American Chapter of the International Society of Pharmacovigilance (NASoP); November 7, 2022.

Anthony MS, Zhou X, Schoendorf J, Reed SD, Getahun D, Armstrong MA, Gatz J, Peipert JF, Raine-Bennett T, Fassett MJ, Saltus CW, Ritchey ME, Ichikawa L, Shi JM, Alabaster A, Wahdan Y, Wang J, Xie F, Merchant M, Hunter S, Chiu VY, Postlethwaite D, Rothman KJ, Im TM, Chillemi G, Takhar HS, Asiimwe A, Pisa F. Demographic, reproductive, and medical risk factors for intrauterine device explusion. Obstet Gynecol. 2022 Nov 3;140(6):1017-30. doi: 10.1097/AOG.0000000000005000

Braitmaier M, Kollhorst B, Heinig M, Langner I, Czwikla J, Heinze F, Buschmann L, Minnerup H, Garcia-Albeniz X, Hense HW, Karch A, Zeeb H, Haug U, Didelez V. Effectiveness of mammography screening on breast cancer mortality - a study protocol for emulation of target trials using German health claims data. Clin Epidemiol. 2022 Nov 2;14:1293-303. doi: 10.2147/CLEP.S376107

Bond JC, Abrams J, Wesselink AK, White KO, Rothman KJ, Wise LA. Predictors of non-response to a sexual health survey in a North American preconception cohort study. J Sex Med. 2022 Nov;19(11):1707-15. doi: 10.1016/j.jsxm.2022.08.199

Aparicio J, Virgili Manrique AC, Capdevila J, Munoz Boza F, Galvan P, Richart P, Oliveres H, Paez D, Hernando J, Serrano S, Vera R, Hernandez‑Yague X, Gallego RA, Riesco‑Martinez MC, Garcia de Albeniz Martinez X, Maurel J. Randomized phase II trial of FOLFIRI‑panitumumab compared with FOLFIRI alone in patients with RAS wild‑type circulating tumor DNA metastatic colorectal cancer beyond progression to first‑line FOLFOX‑panitumumab: the BEYOND study (GEMCAD 17‑01). Clin Trans Oncol. 2022 Nov 1;24(11):2155-65. doi: 10.1007/s12094-022-02868-x

Smith LH, Garcia-Albeniz X, Chan JM, Zhao S, Cowan JE, Broering JM, Cooperberg MR, Carroll PR, Hernan MA. Emulation of a target trial with sustained treatment strategies: an application to prostate cancer using both inverse probability weighting and the g-formula. Eur J Epidemiol. 2022 Oct 26. doi: 10.1007/s10654-022-00929-7

Djibo DA, Margulis AV, McMahill-Walraven CN, Saltus C, Shuminski P, Kaye JA, Johannes C, Caligaert B, Libertin M, Graham S. Performance of endometrial cancer case finding algorithms among women with select comorbidities in US claims data. Poster presented at the 2022 North American Menopause Society Meeting; October 13, 2022. Atlanta, GA.

Beier L, Lu S, Franca LR, Marler S, Lip GYH, Huisman MV, Teutsch C, Halperin JL, Zint K, Diener HC, Baker L, Ma CS, Paquette M, Bartels DB, Dubner SJ, Lyrer P, Senges J, Rothman KJ. Evolution of antithrombotic therapy for patients with atrial fibrillation: the prospective global GLORIA-AF registry program. PLoS One. 2022 Oct 6;17(10):e0274237. doi: 10.1371/journal.pone.0274237

Forns J, Danysh HE, McQuay LJ, Turner ME, Dempsey C, Anthony MS, Demos G, Layton JB. Clinical outcomes and treatment patterns of older adults with dementia‑related psychosis by dementia type in the United States. BMC geriatr. 2022 Oct 6;22(1):784. doi: 10.1186/s12877-022-03489-3.

Willis SK, Hatch EE, Laursen ASD, Wesselink AK, Mikkelsen EM, Tucker KL, Rothman KJ, Mumford SL, Wise LA. Dietary patterns and fecundability in 2 prospective preconception cohorts. Am J Clin Nutr. 2022 Oct 3;116(5):1441-51. doi: 10.1093/ajcn/nqac213

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. Value Health. 2022 Oct 1;25(10):1663-72.

Quinn KL, Abdel-Qadir H, Barrett K, Bartsch E, Beaman A, Biering-Sorensen T, Colacci M, Cressman A, Detsky A, Gosset A, Lassen MH, Kandel C, Khaykin Y, Lapointe-Shaw L, Lovblom E, MacFadden DR, Perkins B, Rothman KJ, Skaarup KG, Stall N, Tang T, Yarnell C, Zipursky J, Warkentin MT, Fralick M, COVID-ACE Group. Variation in the risk of death due to COVID-19: an international multicenter cohort study of hospitalized adults. J Hosp Med. 2022 Oct 1;17(10):739-802. doi: 10.1002/jhm.12946

Neumann ML, Allen JY, Kakani S, Ladner A, Rauen MH, Weaver MS, Mercer DF. Taking care of the caregiver: exploring the impacts of pediatric short bowel syndrome on parent wellbeing using a disease-specific pilot survey. Poster presented at the 12th International Pediatric Intestinal Failure and Rehabilitation Symposium (PIFRS); September 30, 2022. Toronto, Canada.

Lund KH, Laursen ASD, Gronborg TK, Toft G, Jacobsen BH, Wang TR, Wesselink AK, Hatch EE, Sommer GJ, Eisenberg ML, Rothman KJ, Sorensen HT, Wise LA, Mikkelsen EM. Perceived stress and semen quality. Andrology. 2022 Sep 24. doi: 10.1111/andr.13301

Stattin P, Westerberg M, Franck Lissbrant I, Hjalm-Eriksson M, Kjellman A, Ullen A, Vassilev Z, Sandstrom P, Weinrib R, Martinez D, Garcia de Albeniz Martinez X. Real world outcomes in patients with metastatic, castration-resistant prostate cancer treated with radium-223 in routine clinical practice in Sweden. Clin Genitourin Cancer. 2022 Sep 9;S1558-7673(22):00194-X. doi: 10.1016/j.clgc.2022.09.002

Weissert S, Mikkelsen EM, Jacobsen BH, Hatch EE, Wesselink AK, Wise LA, Rothman KJ, Sorensen HT, Laursen ASD. Organic food consumption and fecundability in a preconception cohort study of Danish couples trying to conceive. Paediatr Perinat Epidemiol. 2022 Sep 7. doi: 10.1111/ppe.12924

Willis SK, Wise LA, Laursen ASD, Wesselink AK, Mikkelsen EM, Tucker KL, Rothman KJ, Hatch EE. Glycemic load, dietary fiber, added sugar and spontaneous abortion in two preconception cohorts. J Nutr. 2022 Sep 4. doi: 10.1093/jn/nxac202

Laursen ASD, Johannesen BR, Willis SK, Hatch EE, Wise LA, Wesselink AK, Rothman KJ, Sorensen HT, Mikkelsen EM. Adherence to Nordic dietary patterns and risk of first-trimester spontaneous abortion. Eur J Nutr. 2022 Sep;61(6):3255-65. doi: 10.1007/s00394-022-02886-z

Vinceti M, Balboni E, Rothman KJ, Teggi S, Bellino S, Pezzotti P, Ferrari F, Orsini N, Filippini T. Substantial impact of mobility restrictions on reducing COVID-19 incidence in Italy in 2020. J Travel Med. 2022 Sep;29(6):taac081. doi: 10.1093/jtm/taac081

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.

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. Presented at the 2022 ICPE Conference; August 28, 2022. Copenhagen, Denmark.

Kawai AT, Fuller CC, de Luise C, Layton JB, Johannes CB, Brown J, Platt R, Gilsenan AW. Adapting to the dynamic landscape of the COVID-19 pandemic: proposed study design approaches for a postauthorization safety study for Pfizer-BioNTech COVID-19 vaccine in the United States. Presented at the 2022 ICPE Conference; August 28, 2022. Copenhagen, Denmark.

Bradley Layton J, McQuay L, Forns J, Danysh H, Dempsey C, Anthony MS, Turner ME. Risk of mortality associated with pimavanserin compared with atypical antipsychotics in patients with Parkinson's disease–related psychosis. Presented at the 2022 ICPE Conference; August 27, 2022. Copenhagen, Denmark. Previously presented at the 2022 American Society of Clinical Psychopharmacology (ASCP).

Gilsenan AW, Sturkenboom MC, de Luise C, Cohet C, Anderson SA, Brown J, Foskett N, Perez-Gutthann S. COVID-19 vaccine safety monitoring: opportunities, challenges and lessons learned for pharmacoepidemiology. Presented at the 2022 ICPE Conference; August 27, 2022. Copenhagen, Denmark.

Pottegard A, Prieto-Alhambra D, Bradley Layton J, Sturkenboom MC, Cohet C. Updates from the COVID-19 pharmacoepidemiological battlefield: recent victories and battles ahead [Plenary]. Presented at the 2022 ICPE Conference; August 27, 2022.

Lund JL, Garcia de Albeniz X, Maringe C, Gaber C, Wyss R, Salas M, Ghazarian A. Cloning, censoring, and weighting – oh my! Applications of target trial emulation for evaluating cancer interventions when study eligibility, intervention initiation, and start of follow-up are not aligned. Presented at the 2022 ICPE Conference; August 27, 2022. Copenhagen, Denmark.

Gini R, Pajouheshnia R, Hall GC, Platt RW, Setoguchi S, Perez-Gutthann S, Willame C. Representing and leveraging heterogeneity between data sources in multi-database pharmacoepidemiologic studies. Presented at the 2022 ICPE Conference; August 26, 2022. Copenhagen, Denmark.

Gardarsdottir H, Wang SV, Perez-Gutthann S, Rodriguez-Watson CV, Klungel OH, Rivera DR. It takes a village: strategic global collaborations to advance RWE within ISPE. Presented at the 2022 ICPE Conference; August 26, 2022. Copenhagen, Denmark.

Seeger JD, Jonsson Funk M, Bradley Layton J, Lloyd P. Considerations of misclassification and confounding on COVID-19 vaccines effectiveness studies - a Vaccine SIG endorsed symposium. Presented at the 2022 ICPE Conference; August 26, 2022. Copenhagen, Denmark.

Mayer SE, Hallas J, Edwards J, Henderson L, Sturmer T. Successful implementation of inverse-probability-of-screening weights to address differential outcome screening: effects of statin persistence on breast cancer risk in Denmark. Presented at the 2022 ICPE Conference; August 26, 2022. Copenhagen, Denmark.

Hernandez Diaz S, Sahin L, Chambers C, Margulis AV, Huybrechts KF, de Vries C. Post-authorization regulatory strategies to evaluate drug safety in pregnancy: how to optimize the design of registries & database studies. Presented at the 2022 ICPE Conference; August 26, 2022. Copenhagen, Denmark.

Margulis AV, Calingaert B, Kawai AT, Rivero-Ferrer E, Anthony MS. Distribution of gestational age by maternal and infant characteristics in US birth certificate data: toward informing gestational age assumptions when clinical estimates are not available. Poster presented at the 2022 ICPE Conference; August 26, 2022. Copenhagen, Denmark.

Bratton E, Izem R, Garcia de Albeniz X, Li J. Real-World Evidence (RWE) generation for rare disease drug development and orphan drug approvals. Presented at the 2022 ICPE Conference; August 25, 2022. Copenhagen, Denmark.

Gilsenan A, Juhaeri J, Poulos C, Levitan B. Weighting the benefits & risks: the science and methods of benefit-risk assessment in drug development. Presented at the 2022 ICPE Conference; August 25, 2022. Copenhagen, Denmark.

Margulis AV, Huybrechts KF, Bateman BT, Hernandez-Diaz S. Modern pregnancy pharmacoepidemiology: emulating target trials. Presented at the 2022 ICPE Conference; August 25, 2022. Copenagen, Denmark.

Margulis AV, Huybrechts K. Identification of pregnancies in healthcare data: a changing landscape. Pharmacoepidemiol Drug Saf. 2022 Aug 17. doi: 10.1002/pds.5526

Krege JH, Gilsenan AW, Komacko JL, Kellier-Steele N. Teriparatide and osteosarcoma risk: history, science, elimination of boxed warning, and other label updates. J Bone Miner Res. 2022 Aug 14;6(9):e10665. doi: 10.1002/jbm4.10665

Garcia-Albeniz X, Del Amo J, Polo R, Morales-Asencio JM, Hernan MA. Systematic review and meta-analysis of randomized trials of hydroxychloroquine for the prevention of COVID-19. Eur J Epidemiol. 2022 Aug 9;37(8):789-96. doi: 10.1007/s10654-022-00891-4

Polo R, Garcia-Albeniz X, Teran C, Morales M, Rial-Crestelo D, Garcinuno MA, Garcia del Toro M, Hita C, Gomez-Sirvent JL, Buzon L, Diaz de Santiago A, Perez Arellano JL, Sanz J, Bachiller P, Martinez Alfaro E, Diaz-Brito V, Masia M, Hernandez-Torres A, Guerra J, Santos J, Arazo P, Munoz L, Arribas JR, Martinez de Salazar P, Moreno S, Hernan MA, Del Amo J. Daily tenofovir disoproxil fumarate/emtricitabine and hydroxychloroquine for pre-exposure prophylaxis of COVID-19: a double-blind placebo controlled randomized trial in healthcare workers. Clin Microbiol Infect. 2022 Aug 5;1198-743X(22):00370-6. doi: 10.1016/j.cmi.2022.07.006.

Rebordosa C, Plana E, Rubino A, Aguado J, Martinez D, Lei A, Daoud S, Saigi-Morgui N, Perez-Gutthann S, Rivero-Ferrer E. Risk assessment of acute myocardial infarction and stroke associated with long-acting muscarinic antagonists, alone or in combination, versus long-acting beta2-agonists. Int J Chron Obstruct Pulmon Dis. 2022 Aug 2;17:1715-33. doi: 10.2147/COPD.S363997

Fuller CC, Kawai AT, Haynes K, Coughlin K, Reynolds JS, Hawrusik R, Horgan C, Calingaert B, Johannes CB, Bradley Layton J, Peterson A, Praet N, Willame C, Yost E, Brannan C, McMahill-Walraven CNN, Guzman M, Jamal-allial A, Nair V, Seals RM, Wang FT, Selvan M, Ma Q, Platt R, Gilsenan AW, Brown J. Capacity for identifying Janssen Ad26.COV2.S COVID-19 vaccination in four US health insurance and state Immunization Information System databases: preparation for a post authorization safety study. Presented at the 2022 ICPE Conference; August 2022. Copenhagen, Denmark.

Djibo DA, Margulis AV, McMahill-Walraven CNN, Saltus C, Shuminski P, Kaye JA, Johannes CB, Calingaert B, Libertin M, Graham S. Validation of a case-finding algorithm for endometrial cancer using ICD10 diagnostic codes in insurance claims. Poster presented at the 2022 ICPE Conference; August 2022.

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

Saigi-Morgui N, Rebordosa C, Plana E, Rubino A, Aguado J, Martinez D, Lei A, Daoud SZ, McMahon P, Perez-Gutthann S, Rivero-Ferrer E. Acute myocardial infarction, stroke, and MACE in COPD patients treated with aclidinium and other inhaled bronchodilators. Poster presented at the 2022 ICPE Conference; August 2022. Copenhagen, Denmark.

Garcia de Albeniz X, Del Amo J, Polo R, Morales-Asencio JM, Hernan MA. Drug repurposing in a pandemic: systematic review and meta-analysis of randomized trials of hydroxychloroquine for the prevention of COVID-19. What have we learned? Poster presented at the 2022 ICPE Conference; August 2022. Copenhagen, Denmark.

Garcia de Albeniz X, Polo R, Teran C, Morales M, Rial-Crestelo D, Garcinuno MA, Garcia del Toro M, Hita C, Gomez-Sirvent JL, Buzon L, Diaz de Santiago A, Perez JL, Sanz J, Bachiller P, Martinez E, Diaz-Brito V, Masia M, Hernandez-Torres A, Guerra J, Arazo P, Arribas J, Martinez de Salazar P, Moreno S, Hernan MA, Del Amo J. Daily tenofovir disoproxil fumarate/emtricitabine and hydroxychloroquine for pre-exposure prophylaxis of COVID-19: a double-blind placebo controlled randomized trial in healthcare workers. A randomized clinical trial. Poster presented at the 2022 ICPE Conference; August 2022. Copenhagen, Denmark.

Wesselink AK, Willis SK, Laursen ASD, Mikkelsen EM, Wang TR, Trolle E, Tucker KL, Rothman KJ, Wise LA, Hatch EE. Protein-rich food intake and risk of spontaneous abortion: a prospective cohort study. Eur J Nutr. 2022 Aug;61(5):2737-48. doi: 10.1007/s00394-022-02849-4