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Publications
Desai RJ, Wang SV, Sreedhara SK, Zabotka L, Khosrow-Khavar F, Nelson JC, Shi X, Toh S, Wyss R, Patorno E, Dutcher S, Li J, Lee H, Ball R, Dal Pan G, Segal JB, Suissa S, Rothman KJ , Greenland S, Hernan MA, Heagerty PJ, Schneeweiss S. Process guide for inferential studies using healthcare data from routine clinical practice to evaluate causal effects of drugs (PRINCIPLED): considerations from the FDA Sentinel Innovation Center . BMJ. 2024 Feb 12;384:e076460. doi: 10.1136/bmj-2023-076460
Hansford HJ, Cashin AG, Jones MD, Swanson SA, Islam N, Douglas SRG, Rizzo RRN, Devonshire JJ, Williams SA, Dahabreh IJ, Dickerman BA, Egger M, Garcia-Albeniz X , Golub RM, Lodi S, Moreno-Betancur M, Pearson SA, Schneeweiss S, Sterne JAC, Sharp MK, Stuart EA, Hernan MA, Lee H, McAuley JH. Reporting of observational studies explicitly aiming to emulate randomized trials: a systematic review . JAMA Netw Open. 2023 Sep 5;6(9):e2336023. doi: 10.1001/jamanetworkopen.2023.36023
Danysh HE , Johannes CB , Beachler DC, Layton JB , Ziemiecki R , Arana A , Dinh J, Li L, Calingaert B , Pladevall-Vila M , Hunt PR, Chen H, Karlsson C, Johnsson K, Gilsenan A . Post-authorization safety studies of acute liver injury and severe complications of urinary tract infection in patients with type 2 diabetes exposed to dapagliflozin in a real-world setting . Drug Saf. 2023 Feb 1;46(2):175-93. doi: 10.1007/s40264-022-01262-4
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
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. doi: 10.1016/j.jval.2022.09.001
Wesselink AK, Hatch EE, Rothman KJ , Wang TR, Willis MD, Yland J, Crowe HM, Geller RJ, Willis SK, Perkins RB, Regan AK, Levinson J, Mikkelsen EM, Wise LA. A prospective cohort study of COVID-19 vaccination, SARS-CoV-2 infection, and fertility . Am J Epidemiol. 2022 Jul 23;191(8):1383-95. doi: 10.1093/aje/kwac011
Lip GYH, Kotalczyk A, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ , Marler S, Gurusamy VK, Huisman MV, GLORIA-AF Investigators. Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry . Clin Res Cardiol. 2022 May;111(5):560-73. doi: 10.1007/s00392-022-01996-2
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
Koziel M, Teutsch C, Halperin JL, Rothman KJ , Diener HC, Ma CS, Marler S, Lu S, Gurusamy VK, Huisman MV, Lip GYH, GLORIA-AF Investigators. Atrial fibrillation and comorbidities: clinical characteristics and antithrombotic treatment in GLORIA-AF . PLoS One. 2021 Apr 14;16(4):e0249524. doi: 10.1371/journal.pone.0249524
Gilsenan A , Fortuny J , Cainzos-Achirica M, Cantero OF, Flynn RWV, Garcia-Rodriguez L, Harding A , Kollhorst B, Karlsson P, Linner L, MacDonald TM, Odsbu E, Plana E , Ruigomez A, Schink T, Ziemiecki R , Andrews EB. Cardiovascular safety of prucalopride in patients with chronic constipation: a multinational population-based cohort study . Drug Saf. 2019 Oct;42(10):1179-90. doi: 10.1007/s40264-019-00835-0
Ritchey ME, Harding A , Hunter S, Peterson C, Sager PT, Kowey PR, Nguyen L, Thomas S, Cainzos-Achirica M, Rothman KJ , Andrews EB, Anthony MS . Cardiovascular safety during and after use of phentermine and topiramate . J Clin Endocrinol Metab. 2019 Feb 1;104(2):513-22. doi: 10.1210/jc.2018-01010