Publications
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Johannes CB, Beachler DC, Layton JB, Danysh HE, 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 study of hospitalization for acute kidney injury in patients with type 2 diabetes exposed to dapagliflozin in a real-world setting. Drug Saf. 2023 Feb 1;46(2):157-74. doi: 10.1007/s40264-022-01263-3
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
Danysh HE, Gilsenan A, Arana A, Pladevall-Vila M, Layton JB, Ziemiecki R, Chen H, Hunt PR, Johannes C. Validation of acute outcomes among patients with type 2 diabetes mellitus in the clinical practice research datalink. Poster presented at the Virtual ICPE 2021 Conference; August 23, 2021.
Layton JB, Ziemiecki R, Danysh HE, Gaber C, Gilsenan A, Johannes CB. Graphical representation of an array of quantitative bias analysis scenarios for differential outcome misclassification. Presented at the Virtual ICPE 2021 Conference; August 23, 2021.
Layton JB, Ziemiecki R, Danysh H, Gilsenan A, Johannes C. Graphical representation of multiple quantitative bias analysis scenarios for unmeasured confounding. Poster presented at the Virtual ICPE 2021 Conference; August 23, 2021.
Johannes C, Layton JB, Beachler DM, Ziemiecki RM, Li L, Danysh HE, Dinh J, Hunt PR, Karlsson C, Chen H, Gilsenan A. Risk of acute kidney injury in real-world use of dapagliflozin. Presented at the 2021 Virtual American Diabetes Association 81st Scientific Session; June 25, 2021.
Johannes C, Layton JB, Beachler DC, Ziemiecki RM, Li L, Danysh HE, Dinh J, Hunt PR, Karlsson C, Chen H, Gilsenan A. Risk of severe complications of urinary tract infection in real-world use of dapagliflozin. Poster presented at the 2021 Virtual American Diabetes Association 81st Scientific Session; June 25, 2021.
Layton JB, Zhou CK, Danysh HE, Bleachler DC, Ziemiecki R, Dinah J, Yin R, Calingaert B, Hunt PR, Gilsenan AW, Johannes CW. Identifying cohorts of patients with type 2 diabetes mellitus initiating dapagliflozin in three data sources. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Dinh J, Danysh HE, Johannes C, Gutierrez L, Schmid R, Arana A, Kaye JA, Pladevall-Vila M, Garcia de Albeniz X, Hunt PR, Gilsenan A, Beachler DC, Ke Zhou C. Description of acute kidney injury and breast cancer outcome validation processes across three databases. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Danysh HE, Layton B, Beachler DC, Arana A, Pladevall-Vila M, Schmid R, Calingaert B, Ziemiecki R, Hunt PR, Gilsenan A, Johannes C. Validation of acute outcomes among patients with type 2 diabetes mellitus in Medicare: a pilot study. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 2020.
Gilsenan AW, Brainsky A, Colilla S. Applying CIRS-BRAT framework in a regulatory setting: updated benefit risk assessment for fibrinogen concentrate in the setting of complex cardiac surgery. Poster presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 28, 2019. Philadelphia, PA. [abstract] Pharmacoepidemiol Drug Saf. 2019 Aug 20; 28(S2):964. doi: 10.1002/pds.4864
Ritchey ME, Hollis KA, Hauber AB, Gilsenan A, Krueger WS. Reporting of "Benefit-Risk" studies for medical devices in published literature. Poster presented at the 2018 ISPOR 23rd Annual International Meeting; May 23, 2018. Baltimore, MD. [abstract] Value Health. 2018 May; 21(Suppl 1):S175. doi: 10.1016/j.jval.2018.04.1167
Gilsenan A, Smith M, Wise L, Mouchantat R, Dal Pan G, Morrato E. Introduction to therapeutic risk management. Presented at the 33rd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2017. Montreal, Canada.
Johannes C, Beachler D, Ziemiecki R, Yin R, McGrath L, Jemison J, Lanes S, Gilsenan A. Characteristics of new users of dapagliflozin and other antidiabetic drugs: United States and United Kingdom. Poster presented at the 33rd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 28, 2017. Montreal, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2017 Aug; 26(Suppl 2):129. doi: 10.1002/pds
Dal Pan G, Spooner A, Morrato E, Smith M, Jones J, Wise L, Gilsenan A. Introduction to the evaluation of therapeutic risk management programs. Presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 24, 2016. Dublin, Ireland. Previously presented at the 31st International Conference on Pharmacoepidemiology and Therapeutic Risk Management.
Andrews E, Sturmer T, McGrath LJ, Johnson Funk M, Lund JL, Johannes CB, Gilsenan AW, Powers C. Exploring innovative methods to conduct validation using United States Medicare administrative claims data. Presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2016. Dublin, Ireland. [abstract] Pharmacoepidemiol Drug Saf. 2016 Aug; 25(S3):50.
Ritchey ME, Jalbert J, Gilsenan A, Lystig T, Peng M, Kou TD, Blumentals W. The epidemiological approach to rare disease research: challenges and opportunities. Presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 27, 2016. Dublin, Ireland. [abstract] Pharmacoepidemiol Drug Saf. 2016 Aug; 25(S3):S479.
Hauber AB, Gilsenan A, Juhaeri J, Zhong Y, Noel B. Benefit risk assessment: understanding and using patient preference methodologies. Presented at the 31st ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 2015. Boston, MA.
Gilsenan AW. European guideline on Good Pharmacovigilance Practices (GVP) – Module XVI – risk minimization measures. Presented at the SCOPE Summit for Clinical Ops Executives; February 25, 2015. Orlando, FL.
Gilsenan AW. Observational data collection studies: considerations to minimize bias. Presented at the SCOPE Summit for Clinical Ops Executives; February 24, 2015. Orlando, FL.
Freeman E, Gilsenan AW. Assess the European guideline on good pharmacovigilance practices (GVP) – module XVI – risk minimization measures. Presented at the 7th Risk Evaluation and Mitigation Strategies Summit (REMS Summit); January 22, 2015. Arlington, VA.
Andrews EB, Davis KH, DiBenedetti DB, Forsyth B, Gilsenan AW, Hollis KA, Lewis SA, Price MA, Tennis P, Zografos LJ. Risk evaluation and mitigation strategy assessments: social science methodologies to assess goals related to knowledge. 2014. Research Triangle Park: RTI Press.
Gilsenan AW, Andrews EB. Considerations and strategies for benefit-risk assessment in the real-world setting. In: Sashegyi A, Felli J, Noel R, editors. Benefit-risk assessment in pharmaceutical research and development. 1st ed. Boca Raton: United States. CRC Press; 2013. p.153-64.
Gilsenan AW, Harris DH, Midkiff KD, Andrews EB, Massica D. Seeing the big picture in long-term surveillance for rare events. Presented at the North American Association of Central Cancer Registries Annual Conference; 2013.
Chirila C, Gilligan TM, Gilsenan A, Price M, Hollis K, Calingaert B, Zografos L, Andrews E. A comparison of factors influencing patient knowledge: results across selected REMS surveys. Poster presented at the 27th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 18, 2011. Chicago, IL.
Gilsenan A, Hollis K, Zografos L, Calingaert B, Andrews E. Examination of respondent bias and patient characteristics in multiple REMS assessment surveys. Poster presented at the 27th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 18, 2011. Chicago, IL.
Levitan BS, Andrews EB, Gilsenan A, Ferguson J, Noel RA, Coplan PM, Mussen F. Application of the BRAT framework to case studies: observations and insights. Clin Pharmacol Ther. 2011 Feb 1;89(2):217-24. doi: 10.1038/clpt.2010.280
Gilsenan A, Andrews E, Hollis KA. Characterization of current risk evaluation and mitigation strategies. Poster presented at the 26th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25, 2010. Brighton, United Kingdom. [abstract] Pharmacoepidemiol Drug Saf. 2010 Aug; 19(S1):S100. doi: 10.1002/pds.2019
Gilsenan A, Andrews EB, Calingaert B, Crozier DA, Vanderpuije A. Evaluation of current risk evaluation and mitigation strategies. Poster presented at the 25th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 16, 2009. Providence, RI.
Andrews EB, Irish WD, Gilsenan AW, Campbell WH. Evaluation of therapeutic risk management programs. In: Hartzema AG, Tilson HH, Arnold Chan K, editors. Pharmacoepidemiology and therapeutic risk management. 1st ed. Cincinnati: United States. Harvey Whitney Books; 2008. p.637-52.
Andrews EB, Gilsenan AW, Cook SF. Therapeutic risk management interventions: feasibility and effectiveness. In: Pharmacoepidemiology and therapeutic risk management. Cincinnati: United States. Harvey Whitney Books; 2008. p.613-33.
Martin RD, Gilsenan AW, Wu Y, Midkiff KD, Masica DN. Long-term post-marketing studies: flexibility, perseverance and patience. Presented at the North American Association of Central Cancer Registries Annual Meeting; 2007.
West R, Gilsenan A, Coste F, Zhou X, Brouard R, Nonnemaker J, Curry SJ, Sullivan SD. The ATTEMPT cohort: a multi-national longitudinal study of predictors, patterns and consequences of smoking cessation; introduction and evaluation of internet recruitment and data collection methods. Addiction. 2006 Sep 1;101(9):1352-61.
Gilsenan A, Tennis P, Andrews EA, Zhou X, Coste F, Radigue C. Is it feasible to conduct a cohort study via the internet? Poster presented at the 21st ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 24, 2005. Nashville, TN.
Gilsenan A, Zhou X, Tennis P, Andrews EA, Coste F, Radigue C. Should we believe results obtained from an internet-based cohort study? Presented at the 21st ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 24, 2005. Nashville, TN.
Gilsenan AW, Andrews EB, Burdett AN, Martin R. Post-marketing safety surveillance studies requiring access to patients and charts: does persistence yield results? Poster presented at the 21st ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 24, 2005. Nashville, TN.
Lopez R, Gilsenan AW, Zhou X, Myrie L. Attempt – Assessment methodology and study population description. Poster presented at the Sanofi-Aventis Recherche et Développement's Expert Meeting; May 2004.
West R, Curry SJ, Fiore MC, Sullivan SD, Neighbors D, Gilsenan AW, Smadja E, Lavaud V. Attempt cohort: weight gain concern of smokers intending to quit. Poster presented at the 10th Annual Scientific Sessions of the Society for Research on Nicotine and Tobacco; February 2004. Scottsdale, AZ.
Andrews EB, Gilsenan A, Cook SF. Therapeutic Risk Management Interventions: feasibility and Effectiveness. J Am Pharm Assoc. 2004 Jan 1;44(4):491-500.
Andrews EB, Mitchell AA, Seligman P, Cook SF, Gilsenan AW. Risk management: what are we driving, where are we going, and how will we know when we get there? Presented at the 18th International Conference on Pharmacoepidemiology; August 2002.
Gilsenan AW. Development of a minimum dataset (MDS)-based comorbidity index for a nursing home population. Poster presented at the Fourth International Society for Pharmacoeconomics and Outcomes Research Congress; 2001. [abstract] Value Health. 2001 Sep; 4(6):417-8.
Sloan FA, Whetten-Goldstien K, Gilsenan AW. Hospital pharmacy decisions: cost-containment, and use of cost-effectiveness analysis. Soc Sci Med. 1997 Aug;45(4):523-33.
Sloan FS, Whetten-Goldstein K, Gilsenan AW. Use of cost-effectiveness analysis in US hospitals. Presented at the Cost-Effectiveness Analysis in Decision-Making Conference; 1995. Durham, NC.