Publications

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Displaying 51 through 100 of 185 publications.

Fortuny J, Gilsenan AW, Cainzos-Achirica M, Cantero OF, Flynn RW, Garcia-Rodriguez L, Kollhorst B, Karlsson P, Linner L, MacDonald TM, Plana E, Ruigomez A, Schink T, Ziemiecki R, Andrews EB. Cohort study of the relative incidence of major cardiovascular events among patients initiating prucalopride versus a matched comparator cohort in a multinational study: study design and comparability of cohorts. Poster presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 27, 2019. Philadelphia, PA. [abstract] Pharmacoepidemiol Drug Saf. 2019 Aug 20; 28(S2):627. doi: 10.1002/pds.4864

Cainzos-Achirica M, Ruigomez A, MacDonald T, Garcia-Rodriguez L, Fortuny J, Flynn RW, Plana E, Ziemiecki R, Andrews EB, Gilsenan A. Validation of major cardiovascular events in a multi-database post-authorization safety study of prucalopride. Poster presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2019. Philadelphia, PA. [abstract] Pharmacoepidemiol Drug Saf. 2019 Aug 20; 28(S2):331. doi: 10.1002/pds.4864

Gilsenan A. Challenges with methods used to synthesize findings from observational studies. Presented at the DIA 2019 Global Annual Meeting; June 24, 2019. San Diego, CA.

Gilsenan A, Midkiff K, Harris D, Kellier-Steele N, Andrews E. Results from a fifteen-year postmarketing drug safety study of adult osteosarcoma and teriparatide in the US. Poster presented at the 2019 NAACCR / IACR Combined Annual Conference; June 11, 2019. Vancouver, Canada.

Harris D, Casso D, Midkiff K, Anderson A, Gilsenan A, Oliveria A, Andrews E, Kellier-Steele N. Methods, results, and lessons learned from two postmarketing drug safety surveillance studies linking state cancer registry data to large pharmacy databases. Presented at the 2019 NAACCR / IACR Combined Annual Conference; June 11, 2019. Vancouver, Canada.

Millar M, Kinney AY, Camp N, Cannon-Albright L, Hashibe M, Penson D, Kirchhoff A, Neklason D, Gilsenan A, Dieck GS, Stroup AM, Edwards SL, Bateman C, Carter ME, Sweeney C. Predictors of response outcomes for research recruitment through a central cancer registry: evidence from 17 population-based studies. Am J Epidemiol. 2019 May 1;188(5):928-39. doi: 10.1093/aje/kwz011

Gilsenan A, Harding A, Kellier-Steele N, Harris D, Midkiff K, Andrews E. The Forteo patient registry linkage to multiple state cancer registries: study design and results from the first 8 years. Osteoporos Int. 2018 Oct;29(10):2335-43. doi: 10.1007/s00198-018-4604-8

Auth D, Gilsenan A, Morrato E, Smith M, Wise L. Effective risk management: best practices for designing, implementing and evaluating risk minimization programs. Presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 22, 2018. Prague, Czech Republic.

Krueger WS, Young JC, Hollis K, Hauber AB, Gilsenan A, Ritchey ME. Limitations in reporting "benefit-risk" across therapeutic areas in medical device literature. Poster presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2018. Prague, Czech Republic. [abstract] Pharmacoepidemiol Drug Saf. 2018 Aug; 27(S2):515. doi: 10.1002/pds.4629

Harris D, Midkiff K, Gilsenan A, Andrews E. Linking big (federal) data to state cancer registry data for a post-marketing drug safety surveillance study: challenges and lessons learned. Presented at the 2018 Annual Conference of the North American Association of Central Cancer Registries (NAACCR); June 12, 2018. Pittsburgh, PA.

Gilsenan A, Fortuny J, Plana E, Ruigomez A, Karlsson P, Flynn RWV, Cantero OF, Garcia-Rodriguez L, Linner L, Cainzos-Achirica M, Bartsch J, MacDonald T, Kieler H, Andrews EB. Non-interventional cohort study of the relative incidence of major cardiovascular events among patients initiating prucalopride versus a matched comparator cohort initiating polyethylene glycol 3350 (PEG). Poster presented at the 2018 Digestive Disease Week; June 3, 2018. Washington, DC.

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

Midkiff K, Andrews EB, Gilsenan A, Harris D. Comparing strategies to monitor for a potential association between teriparatide and adult osteosarcoma. Poster presented at the 10th Asian Conference on Pharmacoepidemiology (ACPE); October 31, 2017. Brisbane, Australia.

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.

Gutierrez L, Beachler DC, Overbeek J, McQuay L, Yin R, Kuiper J, McGrath L, Jemison J, Houben E, Lanes S, Gilsenan A, Herrings R. Characteristics of new users of dapagliflozin and other antidiabetic drugs: United States, United Kingdom, and the Netherlands. 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):128.

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

Harris D, Midkiff K, Gilsenan A, Kellier-Steele N, McSorley D, Andrews EB. Study update for a postmarketing case series study of adult osteosarcoma and teriparatide in the US. Poster presented at the 33rd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 29, 2017. Montreal, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2017 Aug; 26(Suppl 2):314. Previously presented at the 32nd International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE). doi: 10.1002/pds

Harris D, Midkiff K, Gilsenan A, Andrews E. Twelve-year study update for a postmarketing case series study of adult osteosarcoma and teriparatide in the U.S. Poster presented at the North American Association of Central Cancer Registries (NAACCR) 2017 Annual Conference; June 21, 2017. Albuquerque, NM.

Andrews EB, Gilsenan A, Midkiff K, Harris D. Challenges in studying very rare cancer outcomes and infrequent exposures: example of teriparatide and osteosarcoma - Editorial. Ann Epidemiol. 2016 Nov;26(11):751-3. doi: 10.1016/j.annepidem.2016.08.011

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.

Arana A, Varas-Lorenzo C, McQuay LJ, Ziemiecki R, Bui CL, Gilsenan AW, Rothman KJ, Atsma WJ, Appenteng K, Franks B, de Vogel S, D'Silva M, Margulis AV, Perez Gutthann S. Do individual antimuscarinic drugs to treat overactive bladder have different cardiovascular risks? A UK CPRD cohort study. Poster presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 28, 2016. Dublin, Ireland. [abstract] Pharmacoepidemiol Drug Saf. 2016 Aug; 25(Suppl 3):534-5.

Midkiff KD, Andrews EB, Gilsenan AW, Deapen M, Harris DH, Schymura MJ, Hornicek FJ. The experience of accommodating privacy restrictions during implementation of a large-scale surveillance study of an osteoporosis medication. Pharmacoepidemiol Drug Saf. 2016 Aug;25(8):960-8. doi: 10.1002/pds.4008

McGrath LJ, Rulgomez A, Plana E, Fortuny J, Garcia-Rodriguez L, Rebordosa C, Varas-Lorenzo C, Ziemiecki R, Gilsenan AW, Andrews E. Characteristics of patients prescribed prucalopride versus an active comparator in England, Wales, and Northern Ireland. Poster presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 28, 2016. Dublin, Ireland. [abstract] Pharmacoepidemiol Drug Saf. 2016 Aug; 25(Suppl 3):634.

Plana E, McGrath LJ, Fortuny J, Ruigomez A, Fernandez-Cantero O, Garcia-Rodriguez LA, Gilsenan AW, Andrews E, Rebordosa C, Ziemiecki R. An algorithm to identify duplicate patients when pooling aggregate data from two primary care databases in the United Kingdom. Poster presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2016. Dublin, Ireland. [abstract] Pharmacoepidemiol Drug Saf. 2016 Aug; 25(Suppl 3):58-9. doi: 10.1002/pds

Harris D, Midkiff K, Gilsenan A, Kellier-Steele N, McSorley D, Andrews EB. Study update for a postmarketing case series study of adult osteosarcoma and teriparatide in the United States. Poster presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 27, 2016. Dublin, Ireland. [abstract] Pharmacoepidemiol Drug Saf. 2016 Aug; 25(Suppl 3):437-8.

Kellier-Steele N, Gilsenan A, Midkiff K, Harris D, Andrews E. Complementary observational studies assessing the incidence of a rare cancer outcome by linking state cancer registry data to large pharmacy claims databases in the United States. Poster presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2016. Dublin, Ireland. [abstract] Pharmacoepidemiol Drug Saf. 2016 Aug; 25(Suppl 3):152.

Fortuny J, Kaye JA, Bui CL, Gilsenan AW, Bartsch J, Plana E, McQuay LJ, Calingaert B, Atsma WJ, Appenteng K, Franks B, de Vogel S, D'Silva M, Perez Gutthan S, Arana A, Margulis AV. Evaluation of free-text comments to validate common cancer diagnoses in the UK CPRD. Poster presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2016. Dublin, Ireland. [abstract] Pharmacoepidemiol Drug Saf. 2016 Aug; 25(Suppl 3):58.

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.

Kellier-Steele N, Gilsenan A, Midkiff K, Harris D, Andrews E, Acquavella J. Parallel observational studies in a post-marketing setting assessing the incidence of osteosarcoma among teriparatide users versus a comparator group of nonusers by linking state cancer registry data to data from two large pharmacy claims databases. Poster presented at the North American Association of Central Cancer Registries (NAACCR) 2016 Annual Conference; June 14, 2016. St. Louis, MO.

Krohn K, Kellier-Steele N, Gilsenan A, Harding A, Andrews E. Forteo voluntary patient registry: 6-year progress on a prospective osteosarcoma surveillance study. Poster presented at the 22nd Annual Meeting of the International Society of Clinical Densitometry (ISCD); June 2016. Dublin, Ireland.

Midkiff K, Harris D, Gilsenan A, Andrews E. Studying cancer as an adverse outcome from nononcological therapies: review of the Food and Drug Administration's postmarketing commitment database. Poster presented at the 31st ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 2015. Boston, MA.

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.

Harris D, Gilsenan A, Harding A, Andrews E, Kellier N, Masica D. Long-term cancer surveillance: five-year update for the Forteo Patient Registry Surveillance Study. Poster presented at the 31st International Conference on Pharmacoepidemiology and Therapeutic Risk Management; August 2015. Boston, MA.

Harris DH, Gilsenan AW, Harding AA, DeGuire B, Andrews EB. Long-term cancer surveillance: five-year update for the Forteo Patient Registry data linkage study. Presented at the NAACCR 2015 Annual Conference; June 2015. Charlotte, NC. Previously presented at the 31st International Conference on Pharmacoepidemiology and Therapeutic Risk Management.

Midkiff KD, Andrews EB, Gilsenan AW, Harris DH. "First in Flight" or "When Pigs Fly" – Can cancer registries play a critical role at the national level in studying cancer as an adverse outcome from drug treatments? Presented at the NAACCR 2015 Annual Conference; June 2015. Charlotte, NC.

Midkiff KD, Gilsenan AW, Andrews EB, Masica D, Ceberg J, Alvegard T. Findings from the postmarketing adult osteosarcoma surveillance study in the Nordic countries. Poster presented at the 37th Meeting of the Scandinavian Sarcoma Group; May 20, 2015. Stockholm, Sweden.

Andrews EB, Gilsenan AW, Midkiff KD, Harris DH. Comments on Bang et al.: the impact of recombinant parathyroid hormone on malignancies and mortality: 7 years of experience based on nationwide Danish registers. Osteoporos Int. 2015 May;26(5):1663-4. doi: 10.1007/s00198-014-3003-z

Kruse-Jarres R, Gilsenan AW, Spears J, Kaye JA. Prospective, observational study of plasma-derived factor VIII/von Willebrand factor in immune tolerance induction: the PRISM registry. Haemophilia. 2015 Mar;21(2):e122-4. doi: 10.1111/hae.12590

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.

Hollis K, Gilsenan A. Design and implementation of surveys to assess patient and health care provider understanding of risks and safe use conditions. In: Andrews EB, Moore M, editors. Mann's pharmacovigilance. 3rd ed. Hoboken: NJ. John Wiley & Sons; 2014.

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.

Kellier N, Krohn K, Gilsenan AW, Harris DH, Andrews EB, Massica D. Forteo voluntary patient registry: 3-Year progress on a prospective osteosarcoma surveillance study. Poster presented at the American Society for Bone and Mineral Research Annual Meeting; October 6, 2013.

Gilsenan AW, Midkiff KD, Andrews EB, Von Scheele BG, Masica D, Ceberg J. Multinational collaboration: a long-term surveillance program for osteosarcoma and potential exposure to teriparatide. Presented at the 36th meeting of the Scandinavian Sarcoma Group; October 2013.

Midkiff KD, Von Scheele BG, Gilsenan AW, Ceberg J, Alvegård T. Progress update for the postmarketing adult osteosarcoma surveillance study in five Nordic countries. Poster presented at the 36th meeting of the Scandinavian Sarcoma Group; October 2013.

Kruse-Jarres R, Gilsenan AW, Spears J, Kaye JA. Prospective study of plasma-derived factor VIII/vWF in immune tolerance induction therapy: the SPIRIT registry. Poster presented at the Annual Meeting of the National Hemophilia Foundation; October 2013.

Harris DH, Midkiff K, Gilsenan A, Kellier N, Masica D, Andrews E. Eight-year results from the US osteosarcoma surveillance study. Poster presented at the 29th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 2013. Montreal.

Gilsenan AW, Harris DH, Midkiff KD, Andrews EB, Kellier N, Masica D. Approaches to long-term surveillance for rare cancer events. Poster presented at the 29th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25, 2013. Montreal, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2013 Aug; 22(Suppl 1):218-9.