Publications

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Displaying 1 through 50 of 275 publications.

Sauchelli S, Levy C, Gnanasakthy A, Doward L, Fitzgerald K. Inclusion of patient-reported outcome endpoints in the summary of product characteristics for non-oncology drugs approved by the European Medicines Agency (2018-2022). Poster presented at the ISOQOL 31st Annual Conference; October 13, 2024. Cologne, Germany.

Martin S, Harris N, Romanus D. Evaluating meaningful changes in physical functioning and cognitive declines in metachromatic leukodystrophy: a caregiver interview study. J Patient Rep Outcomes. 2023 Jul 17;7(1):70. doi: 10.1186/s41687-023-00595-7

Gnanasakthy A, Norcross L, Fitzgerald K. Editorial - Assessment of patient-reported outcomes in industry-sponsored phase 1 oncology studies: considerations for translating theory into practice. Value Health. 2023 Jun 21;26(10):1440-3. doi: 10.1016/j.jval.2023.06.006

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

Poirrier JE, DeMartino JK, Nagar S, Carrico J, Hicks K, Meyers J, Stoddard J. Burden of opioid use for pain management among adult herpes zoster patients in the US and the potential impact of vaccination. Hum Vaccin Immunother. 2022 Nov;18(5):2040328. doi: 10.1080/21645515.2022.2040328

Gnanasakthy A, Norcross L, (DeMuro) Romano C, Carson RT. A review of patient-reported outcome labeling of FDA-approved new drugs (2016-2020): counts, categories, and comprehensibility. Value Health. 2022 Apr;25(4):647-55. doi: 10.1016/j.jval.2021.10.006

Boyett B, Wiest K, McLeod LD, Nelson LM, Bickel WK, Learned SM, Heidbreder C, Fudala PJ, Le Moigne A, Zhao Y. Assessment of craving in opioid use disorder: psychometric evaluation and predictive validity of the opioid craving VAS. Drug Alcohol Depend. 2021 Dec 1;229(Pt B):109057. doi: 10.1016/j.drugalcdep.2021.109057

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.

Gnanasakthy A, Barrett A, Norcross L, D’Alessio D, Romano (DeMuro) C. Use of patient and investigator global impression scales: a review of Food and Drug Administration–approved labeling, 2009 to 2019. Value Health. 2021 Jul;24(7):1016-23. doi: 10.1016/j.jval.2021.01.005

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.

Poirrier J-E, Carrico J, DeMartino JK, Hicks KA, Stoddard JJ, Nagar S, Meyers J. The potential for reducing opioid and analgesic prescriptions via herpes zoster vaccination. Poster presented at the IDWeek 2020 Virtual Conference; October 21, 2020.

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.

Filonenko A, Purser M, Mader G, Graham J. Impact of increased utilization of long-acting reversable contraceptive methods among young women on cost and unintended pregnancies (UP) in the United States (US). Poster presented at the 2020 ISPOR Virtual Conference; May 2020. [abstract] Value Health. 2020 May 1; 23(Suppl 1):S153. doi: 10.1016/j.jval.2020.04.371

Gnanasakthy A, Barrett A, D'Alessio D, Norcross L. Review of patient and clinician global assessments in PRO labeling (2017-2019). Poster presented at the ISPOR Virtual 2020 Conference; May 2020. [abstract] Value Health. 2020 May 1; 23(Suppl 1):S299. doi: 10.1016/j.jval.2020.04.094

Salem L, Malouvier A, Blatchford J, Rivero‐Ferrer E, Deltour N, Jacquot E. Ivabradine drug utilization study in five European countries: a multinational, retrospective, observational study to assess effectiveness of risk‐minimization measures. Pharmacoepidemiol Drug Saf. 2019 Nov;28(11):1470-9. doi: 10.1002/pds.4880

Parikh RC, Nagar SP, Ajmera M, Kurosky SK. Nationwide trends in prescription opioid use among adults- a pre-public health emergency perspective on the opioid crisis. Poster presented at the 2019 ISPOR 24th Annual International Meeting; May 21, 2019. New Orleans, LA.

Ritchey ME, Buck P, Castro C, Fernandez M, Hollis K, Mordin M. "Real-world" evidence for drugs and devices: 2017 literature reviewed. 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):410-1. doi: 10.1002/pds.4629

Young-Xu Y, Van Aalst R, Mahmud SM, Rothman KJ, Thornton Snider J, Westreich D, Mor V, Gravenstein S, Lee JKH, Thommes EW, Decker MD, Chit A. Relative vaccine effectiveness of high-dose versus standard-dose influenza vaccines among Veterans Health Administration Patients. J Infect Dis. 2018 May;217(11):1718-27. doi: 10.1093/infdis/jiy088

Sura SD, Goyal RK, Adhikari D, Mehta HB. Association of multiple chronic conditions with health-related quality of life and physical functioning. Poster presented at the 2017 ISPOR 20th Annual European Congress; November 7, 2017. Glasgow, Scotland.

Arana A, Huerta C, Prieto D, Montero D, Hermosilla E, Martin E, Mendez L, del Mar Garcia M, Comas M, Giner M, Macia MA, Morros R, Duarte T. Uso de datos basados en historia clinica informatizada ('real world data') en los estudios farmaco-epidemiologicos. Presented at en IDIAP Jordi Gol Conference; October 23, 2017. Barcelona, Spain.

Setoguchi S, Kayo-Yang YH, Strom B, Stang P, Horton D, Gerhard T, Perez-Gutthann S, Leufkens B, Pinheiro S. It takes a village: raising a global community of pharmacoepidemiologists through high-quality education. 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):5. doi: 10.1002/pds

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

Perez-Gutthann S, Ali MS. Real world data epidemiology – Oxford Summer School. Presented at the 2nd Oxford Summer School; June 21, 2017. Oxford, United Kingdom.

Garland J, Stephen J, Class B, Gruber A, Ciccone C, Poliak A, Hayes CP, Singhal V, Slota C, Perreault J, Gavrilova R, Shrader JA, Chittiboina P, Joe G, Heiss J, Gahl WA, Huizing M, Carrillo N, Malicdan MCV. Identification of an Alu element-mediated deletion in the promoter region of GNE in siblings with GNE myopathy. Mol Genet Genomic Med. 2017 Jun 14;5(4):410-7. doi: 10.1002/mgg3.300

Mercieca-Bebber R, Rouette J, Calvert M, King MT, McLeod L, Holch P, Palmer MJ, Brundage M, ISOQOL Best Practice for PROs-Reporting Task Force. Preliminary evidence on the uptake, use, and benefits of the CONSORT-PRO extension. Qual Life Res. 2017 Jun;26(6):1427-37. doi: 10.1007/s11136-017-1508-6

Goyal RK, Ajmera MR, Davis KL. Recent trends in emergency department visits resulting from unintentional overdose of non-opioid analgesics, antipyretics, and antirheumatics in the United States. Poster presented at the 2017 ISPOR 22nd Annual International Meeting; May 23, 2017. Boston, MA. [abstract] Value Health. 2017 May; 20(5):A231.

Zijlema WL, Triguero-Mas M, Smith G, Cirach M, Martinez D, Dadvand P, Gascon M, Jones M, Gidlow C, Hurst G, Masterson D, Ellis N, van den Berg M, Maas J, van Kamp I, van den Hazel P, Kruize H, Nieuwenhuijsen MJ, Julvez J. The relationship between natural outdoor environments and cognitive functioning and its mediators. Environ Res. 2017 May;155:268-75. doi: 10.1016/j.envres.2017.02.017

Layton JB, Kim Y, Alexander GC, Emery SL. Association between direct-to-consumer advertising and testosterone testing and initiation in the United States, 2009-2013. JAMA. 2017 Mar 21;317(11):1159-66. doi: 10.1001/jama.2016.21041

Christensen T, Riis AH, Hatch EE, Wise LA, Nielsen MG, Rothman KJ, Toft Sorensen H, Mikkelsen EM. Costs and efficiency of online and offline recruitment methods: a web-based cohort study. J Med Internet Res. 2017 Mar 1;19(3):e58. doi: 10.2196/jmir.6716

Cairns B, Kowolenko M, Talbird S, Britt T, Shanley L. Applying artificial intelligence to the diagnosis of rare diseases. Presented at the UNC Renaissance Computing Institute (RENCI); February 15, 2017. Chapel Hill, NC.

Price MA, Hamm L. Synergies in the operationalization of clinical and observational studies. Presented at the 8th Annual SCOPE Summit Conference; January 24, 2017. Miami, FL.

Gnanasakthy A, Mordin M, Evans E, Doward L, DeMuro C. A review of patient-reported outcome labeling in the United States (2011-2015). Value Health. 2017;20(3):420-9. doi: 10.1016/j.jval.2016.10.006

Hudgens S, Symonds T, McLeod L, Coon C. Moving the science forward: psychometric considerations and study designs for understanding meaningful change and conducting mixed methods research. Presented at the 2016 ISPOR 19th Annual European Congress; October 31, 2016. Vienna, Austria.

Copley-Merriman K. Value for money: assessing the value of a pharmaceutical product. Presented at the University of Michigan Translational Pharmacology Course 621; October 6, 2016.

Rasouliyan L, Plana E, Aguado J. Considerations in the use of propensity scores in observational studies. Poster presented at the 2016 PhUSE Annual Conference; October 2016. Barcelona, Spain.

Boscarino JA, Kirchner HL, Pitcavage JM, Nadipelli VR, Ronquest NA, Fitzpatrick MH, Han JJ. Factors associated with opioid overdose: a 10-year retrospective study of patients in a large integrated health care system. Subst Abuse Rehabil. 2016 Sep 16;7:131-41. doi: 10.2147/SAR.S108302

Rothman KJ, Glynn R, Whitaker H, Cadarette S. Advanced topics in pharmacoepidemiology. Presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25, 2016. Dublin, Ireland.

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.

Davis K, Asiimwe A, Zografos L, McSorley D. Evaluation of risk minimisation activities for cyproterone acetate 2 mg/ethinylestradiol 35 μg. 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):309-10.

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.

Zografos LJ, Andrews E, Whalley D, Petraro P, Vassilev Z. Use of cognitive testing to optimize questionnaire wording and mode of administration in the evaluation of risk minimization activities. 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):319-20.

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.

Perez-Gutthann S. Pharmacoepidemiology overview & case study. Presented at the Oxford Epidemiology Summer School; July 12, 2016. Oxford, United Kingdom.

Morgan F, Demeyin (Nuabor) W, Weightman A, Strange H, Chestnutt I, Farnell D, Johnson I, Searchfield L, Mann M. Oral health for adults in care homes. NICE. 2016 Jul 5;(NG48). Available at: https://www.nice.org.uk/guidance/ng48. Accessed July 23, 2024.