Publications

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Displaying 1 through 50 of 86 publications.

Riera-Guardia N, Margulis AV, Calingaert B, Fletcher MP, Patki K, Weiner E, Armstrong R, Rivero-Ferrer E. Fetal and neonatal alloimmune thrombocytopenia: systematic literature review and challenges encountered. Poster presented 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. Presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.

Forns J, Abellan A, Riera-Guardia N, Margulis AV, Rivero-Ferrer E. Identification of migraine in electronic healthcare data sources: a headache for pharmacoepidemiologists – a systematic literature review. Poster presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.

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

Margulis AV, Riera-Guardia N, Calingaert B, Armstrong R, Fletcher M, Patki K, Weiner E, Rivero-Ferrer E. Fetal and neonatal alloimmune thrombocytopenia: a systematic literature review and meta-analysis of adverse pregnancy-related outcomes to support the development of a novel prophylactic therapeutic. Poster presented at the AMCP Annual Meeting 2024; April 15, 2024. New Orleans, LA. [abstract] J Manag Care Spec Pharm. 2024 Apr; 30(4-a):S96-7. doi: 10.18553/jmcp.2024.30.4-a.s1

Djibo DA, Margulis AV, McMahill-Walraven CN, Saltus CW, Shuminski P, Kaye JA, Johannes CB, Libertin M, Graham S. Validation of an ICD-10 case-finding algorithm for endometrial cancer in US insurance claims. Pharmacoepidemiol Drug Saf. 2024 Jan;33(1):E5690. doi: 10.1002/pds.5690

Njue A, Nuabor W, Lyall M, Margulis A, Mauskopf J, Curcio D, Kurosky S, Gessner BD, Begier E. Systematic literature review of risk factors for poor outcomes among adults with respiratory syncytial virus infection in high-income countries. Open Forum Infect Dis. 2023 Oct 20;10(11):ofad513. doi: 10.1093/ofid/ofad513

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

Jacobson MH, Krumme A, Gifkins D, Margulis A, Weaver J, Davis KJ. Review of mother-infant linkage algorithms in health care databases. Poster presented at the 39th ICPE Annual Conference; August 27, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):521. doi: 10.1002/pds.5687

Margulis AV, Calingaert B, Kawai AT, Rivero-Ferrer E, Anthony MS. Distribution of gestational age at birth by maternal and infant characteristics in U.S. birth certificate data: informing gestational age assumptions when clinical estimates are not available. Pharmacoepidemiol Drug Saf. 2023 Sep;32(9):1012-20. doi: 10.1002/pds.5633

Margulis AV, Bateman BT, Hernandez-Diaz S, Huybrechts KF. Modern pregnancy pharmacoepidemiology: non-live birth outcomes. Presented at the 39th ICPE Annual Conference; August 24, 2023. Halifax, Canada.

Margulis A. Validation of events in database studies on pregnancy pharmacoepidemiology. Presented at the Bordeaux PharmacoEpi Festival 2023; May 24, 2023. Talence, France.

Margulis AV, Huybrechts K. Identification of pregnancies in healthcare data: a changing landscape. Pharmacoepidemiol Drug Saf. 2023 Jan 1;32(1):84-6. doi: 10.1002/pds.5526

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.

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

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.

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.

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.

Perez-Gutthann S, Arana A, Margulis A. ENCePP guide on methodological standards in pharmacoepidemiology, 10th edition. 2022.

Margulis A. Perinatal pharmacoepidemiology: a literature review on completeness of reporting. Presented at the University of Oslo; June 9, 2022.

Margulis AV, Kawai AT, Anthony MS, Rivero-Ferrer E. Perinatal pharmacoepidemiology: how often are key methodological elements reported in publications? Pharmacoepidemiol Drug Saf. 2022 Jan;31(1):61-71. doi: 10.1002/pds.5353

Margulis AV, Arana A. Improving the quality of observational data: registries of validated outcomes and other patient events. Epidemiology. 2021 Sep 1;32(5):661-3. doi: 10.1097/EDE.0000000000001392

Hoffman V, Hallas J, Linder M, Margulis AV, Suehs BT, Arana A, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S, Xu Y, Kristiansen NS, Appenteng K, de Vogel S, Seeger JD. Cardiovascular risk in users of mirabegron relative to users of antimuscarinic treatments for overactive bladder: findings from a non-interventional, real-world data safety study. Presented at the Virtual ICPE 2021 Conference; August 24, 2021. Previously presented at the 2020 Virtual American Heart Association’s Scientific Sessions.

Alexander K, Margulis AV, Foreman PK, Shediac R, Calingaert B, Harding A, Pladevall-Vila M, Landis S. Birth prevalence of phenylalanine hydroxylase deficiency: a systematic literature review and meta-analysis. Poster presented at the Virtual ICPE 2021 Conference; August 23, 2021.

Hoffman V, Hallas J, Linder M, Margulis AV, Suehs BT, Arana A, Phiri K, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S, Xu Y, Kristiansen NS, Appenteng K, de Vogel S, Seeger JD, mirabegron PMR-PASS study group. Cardiovascular risk in users of mirabegron compared with users of antimuscarinic treatments for overactive bladder: findings from a non-interventional, multinational, cohort study. Drug Saf. 2021 Aug;44(8):899-915. doi: 10.1007/s40264-021-01095-7

Foreman PK, Margulis AV, Alexander K, Shediac R, Calingaert B, Harding A, Pladevall-Vila M, Landis S. Birth prevalence of phenylalanine hydroxylase deficiency: a systematic literature review and meta-analysis. Orphanet J Rare Dis. 2021 Jun 3;16(1):253. doi: 10.1186/s13023-021-01874-6

Phiri K, Hallas J, Linder M, Margulis A, Suehs B, Arana A, Bahmanyar S, Hoffman V, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S, Kristiansen NS, Appenteng K, de Vogel S, Seeger J. A study of cancer occurrence in users of mirabegron and antimuscarinic treatments for overactive bladder. Curr Med Res Opin. 2021 May;37(5):867-77. doi: 10.1080/03007995.2021.1891035

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

Graham S, Constantine G, Margulis AV, Saltus CW, Johannes CB, Kaye JA, Mirkin S. A postmarketing noninterventional study evaluating the risk of endometrial cancer in women who have been prescribed Imvexxy® - study design. Poster presented at the 2021 North American Menopause Society (NAMS) Annual Meeting; September 22, 2021. [abstract] Menopause. 2021; 28(12):1462(P28). doi: 10.1097/GME.0000000000001890

Njue A, Coyne C, Margulis AV, Wang D, Marks MA, Russell K, Das R, Sinha A. The role of congenital cytomegalovirus infection in adverse birth outcomes: a review of the potential mechanisms. Viruses. 2020 Dec 24;13(1):E20. doi: 10.3390/v13010020

Hoffman V, Hallas J, Linder M, Margulis A, Suehs BT, Arana A, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S, Xu Y, Kristiansen NS, Appenteng K, de Vogel S, Seeger JD. Cardiovascular risk in users of mirabegron relative to users of antimuscarinic treatments for overactive bladder: findings from a non-interventional, real-world data safety study. Poster presented at the 2020 Virtual American Heart Association’s Scientific Sessions; November 13, 2020.

Margulis AV, Kawai AT, Anthony M, Rivero-Ferrer E. Pregnancy pharmacoepidemiology: how often are key methodological data elements reported in publications? Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.

de Vogel S, Hoffman V, Phiri K, Seeger J, Arana A, Margulis A, McQuay L, Perez-Gutthann S, Hallas J, Sahlertz Kristiansen N, Suehs B, Uribe C, Appenteng K, Robinson NJ. The Mirabegron Post-marketing Requirements (PMRs)/ Non-interventional Post-authorization Safety Study (NI-PASS) Program. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.

Forns J, Kaye JA, Lievano FA, Tyczynski JE, Margulis AV. The safety of antibody drug conjugates: a literature review. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.

Phiri K, Hallas J, Linder M, Margulis A, Suehs B, Arana A, Bahmanyar S, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S, Sahlertz Kristiansen N, Appenteng K, de Vogel S, Seeger J. A study of cancer occurrence in users of mirabegron and antimuscarinic treatments for overactive bladder. Presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 2020.

Phiri K, Hallas J, Linder M, Margulia A, Suehs B, Arana A, Bahmanyar S, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S, Sahlertz Kristiansen N, Appenteng K, de Vogel S, Seeger J. A study of cancer occurrence in users of mirabegron and antimuscarinic treatments for overactive bladder. Poster presented at the American Urological Association 2020 Conference (Conference cancelled); May 2020. Washington, DC. [abstract] J Urol. 2020 Apr; 203(Supplement 4):e910-1. doi: 10.1097/JU.0000000000000931.010

Njue A, Margulis AV, Lyall M, Nuabor W, Marks M, Russell K, Sinha A. Congenital cytomegalovirus: what are the rates of maternal screening, diagnostic amniocentesis, and elective termination? Poster presented at the ID Week 2019; October 4, 2019. Washington, DC.

Margulis AV, Anthony M, Rivero-Ferrer E. Drug safety in pregnancy: review of study approaches requested by regulatory agencies. Curr Epidemiol Rep. 2019 Sep;6(3):380-9. doi: 10.1007/s40471-019-00212-6

Bateman B, Huybrechts K, Margulis A, Rothman KJ. Modern pregnancy pharmacoepidemiology: selected analytical considerations in the study of drug safety in pregnancy. Presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25, 2019. Philadelphia, PA.

Margulis AV, Hernandez-Diaz S, McElrath T, Rothman KJ, Plana E, Almqvist C, D'Onofrio BM, Oberg AS. Relation of in-utero exposure to antiepileptic drugs to pregnancy duration and size at birth. PLoS One. 2019 Aug 5;14(8):e0214180. doi: 10.1371/journal.pone.0214180

Margulis AV, Fortuny J, Kaye JA, Calingaert B, Reynolds M, Plana E, McQuay LJ, Jan Atsma W, Franks B, de Vogel S, Perez-Gutthann S, Arana A. Proportions of cancer cases in primary care, hospital, and cancer registry data among patients treated for overactive bladder. Letter to editor. Epidemiology. 2019 Mar;30(2):e8-9. doi: 10.1097/EDE.0000000000000953

Margulis AV, Linder M, Arana A, Pottegard A, Berglind IA, Bui CL, Kristiansen NS, Bahmanyar S, McQuay LJ, Atsma WJ, Appenteng K, D'Silva M, Perez-Gutthann S, Hallas J. Patterns of use of antimuscarinic drugs to treat overactive bladder in Denmark, Sweden, and the United Kingdom. PLoS One. 2018 Sep 27;13(9):e0204456. doi: 10.1371/journal.pone.0204456

Margulis AV, Fortuny J, Kaye JA, Calingaert B, Reynolds M, Plana E, McQuy LJ, Atsma WJ, Franks B, de Vogel S, Perez-Gutthann S, Arana A. Value of free-text comments for validating cancer cases using primary-care data in the United Kingdom. Epidemiology. 2018 Sep;29(5):e41-2.

Margulis AV, D'Onofrio B, Almqvist C, McElrath T, Oberg AS, Plana E, Rothman KJ, Hernandez-Diaz S. Antiepileptic drugs in pregnancy and duration of pregnancy, birth weight, length, and head circumference. Poster presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25, 2018. Prague, Czech Republic. [abstract] Pharmacoepidemiol Drug Saf. 2018 Aug; 27(S2):234. doi: 10.1002/pds.4629

Rivero-Ferrer E, Martinez D, Rasouliyan L, Anthony MS, Margulis AV, Perez-Gutthann S. Do ICPE pregnancy abstracts make it to term? Poster presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25, 2018. Prague, Czech Republic. [abstract] Pharmacoepidemiol Drug Saf. 2018 Aug; 27(S2):241. doi: 10.1002/pds.4629

Didden E-M, Andrews EB, Hellwig K, Hernandez-Diaz S, Magyari M, Margulis AV, Rivero-Ferrer E, Bader-Weder S, Wormser D. A novel approach for active surveillance of pregnancy safety in multiple sclerosis. Poster presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25, 2018. Prague, Czech Republic. [abstract] Pharmacoepidemiol Drug Saf. 2018 Aug; 27(S2):268. doi: 10.1002/pds.4629

Arana A, Margulis AV, McQuay LJ, Ziemiecki R, Bartsch JL, Rothman KJ, Franks B, D Silva M, Appenteng K, Varas-Lorenzo C, Perez-Gutthann S. Variation in cardiovascular risk related to individual antimuscarinic drugs used to treat overactive bladder: a cohort study in the UK. Pharmacotherapy. 2018 Jun;38(6):628-37. doi: 10.1002/phar.2121.

Hallas J, Margulis AV, Pottegard A, Kristiansen NS, Atsma WJ, Appenteng K, de Vogel S, Kaye JA, Perez-Gutthann S, Arana A. Incidence of common cancers in users of antimuscarinic medications for overactive bladder: a Danish nationwide cohort study. Basic Clin Pharmacol Toxicol. 2018 Jun;122(6):612-9. doi: 10.1111/bcpt.12965

Margulis A, Andrews E, Hernandez-Diaz S, Magyari M, Rivero-Ferrer E, Bader-Weder S, Evershed J, Garas M, Wang Q, Wormser D. Design of a multi-source post-marketing study to evaluate pregnancy and infant outcomes in women with multiple sclerosis who were exposed to ocrelizumab during, or within 6 months before, pregnancy. Poster presented at the 2018 American Academy of Neurology Annual Meeting; April 25, 2018. Los Angeles, CA.