Publications

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Displaying 1 through 50 of 800 publications.

Herring WL, Coon C, Lenderking W, Whittington M. Rethinking clinical meaningfulness and value assessment in the context of chronic progressive diseases. Presentation to be given at the ISPOR 2025; May 15, 2025. Montréal, Canada.

Halsby K, Dobler G, Easton A, Karelis G, Krbkova L, Kyncl J, Sellner J, Strle F, Veje M, Zajkowska J, Zavadska D, Angulo FJ, Pilz A, Erber W, Gabriel M, Russo J, Price M, Madhava H, Meyding-Lamade UK. Evaluating the need for standardised disease manifestation categories in patients infected with the tick-borne encephalitis virus: a Delphi panel. Ticks Tick Borne Dis. 2025 Jan;16(1):102431. doi: 10.1016/j.ttbdis.2024.102431

Gini R, Pajouheshnia R, Gutierrez L, Swertz MA, Hyde E, Sturkenboom M, Arana A, Franzoni C, Ehrenstein V, Roberto G, Gil M, Macia MA, Schafer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfelix-Gimeno G, Hurtado I, Acosta MB, Poblador-Plou B, Carmona-Pirez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Zerovnik S, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Perez-Gutthann S. Commentary - Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA): lessons learnt from the MINERVA project in Europe. Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5884. doi: 10.1002/pds.5884

Pajouheshnia R, Gini R, Gutierrez L, Swertz MA, Hyde E, Sturkenboom M, Arana A, Franzoni C, Ehrenstein V, Roberto G, Gil M, Macia MA, Schafer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfelix-Gimeno G, Hurtado I, Acosta MB, Poblador-Plou B, Carmona-Pirez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Zerovnik S, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Perez-Gutthann S. Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA): development and pilot of a metadata list and catalogue in Europe. Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5871. doi: 10.1002/pds.5871

Yee K, Poulos C, Bussberg C, Myers K. Patient preferences for generalized myasthenia gravis treatment profiles: results of a web-based survey. Poster presented at the 2025 Muscular Dystrophy Association Clinical & Scientific Conference; March 3, 2024. Orlando, FL.

Dong O, Manga N, Zhong Y, Zhang Y, Krause T, Griffin J, Herring WL, Wolowacz S. Use of patient-reported outcomes as key drivers in cost-effectiveness models: a review of UK National Institute for Health and Care Excellence health technology assessments. Poster presented at the ISPOR 2023 Conference; May 7, 2023. Boston, MA. [abstract] Value Health. 2023 Jun; 26(6 supplement):S78. doi: 10.1016/j.jval.2023.03.405

Levintow SN, Nielson CM, Hernandez RK, Breskin A, Pritchard D, Lash TL, Rothman KJ, Gilbertson D, Muntner P, Critchlow C, Brookhart MA, Bradbury BD. Pragmatic considerations for negative control outcome studies to guide non-randomized comparative analyses: a narrative review. Pharmacoepidemiol Drug Saf. 2023 Jun;32(6):599-606. doi: 10.1002/pds.5623

Carrigan G, Bradbury BD, Brookhart MA, Capra WB, Chia V, Rothman KJ, Sarsour K, Taylor MD, Brown JS. External comparator groups derived from real-world data used in support of regulatory decision making: use cases and challenges. Curr Epidemiol Rep. 2022 Dec;9:326-37. doi: 10.1007/s40471-022-00305-9

Gini R, Paoletti O, Pajouheshnia R, Souverein PC, Thurin NH, Ehrenstein V, Barreiro-De Acosta M, Sturkenboom M, Gutierrez L, Perez-Gutthann S. Study scripts supporting multiple common data models. Poster presented at the 2022 ICPE Conference; August 28, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):550. doi: 10.1002/pds.5518Pharmacoepidemiol Drug Saf.2022;31(Suppl. 2):3–628.wileyonlinelibrary.com/journal/pds© 2022 John Wiley & Sons Ltd.3

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

Gini R, Pajouheshnia R, Hall GC, Platt RW, Setoguchi S, Perez-Gutthann S, Willame C. Representing and leveraging heterogeneity between data sources in multi-database pharmacoepidemiologic studies. Presented at the 2022 ICPE Conference; August 26, 2022. Copenhagen, Denmark.

Herring W, Ciarametaro M, Mauskopf J, Wamble D, Sils B, Dubois R. What might have happened: the impact of interrupting entry of innovative drugs on disease outcomes in the United States. Expert Rev Pharmacoecon Outcomes Res. 2022 Jun;22(4):529-41. doi: 10.1080/14737167.2022.2035219

Earnshaw S, Beyhaghi H, McDade C, Purser M, Marriott R, Daane L, Le Coent V, Yang J, Toback S. Clinical and economic impacts of large volume delayed sampling and pathogen reduction technology platelet processing strategies in the United States. Transfusion. 2021 Oct;61(10):2885-97. doi: 10.1111/trf.16589

Kuiper JG, Franzoni C, Ehrenstein V, Gini R, Haug U, Moore N, Droz-Perroteau C, Bolibar B, Giner-Soriano M, Hallas J, MacDonald T, Sturkenboom M, Klungel OH, Perez-Gutthann S, Herings RM. The SIGMA Consortium: a new era of collaboration to study the safety and effectiveness of medical interventions. Poster presented at the Virtual ICPE 2021 Conference; August 23, 2021.

Sturmer T, Webster-Clark M, Lund JL, Wyss R, Ellis AR, Lunt M, Rothman KJ, Glynn RJ. Propensity score weighting and trimming strategies to reduce variance and bias of treatment effect estimates: a simulation study. Am J Epidemiol. 2021 Aug 1;190(8):1659-70. doi: 10.1093/aje/kwab041

Conover MM, Rothman KJ, Sturmer T, Ellis AR, Poole C, Jonsson Funk M. Propensity score trimming mitigates bias due to covariate measurement error in inverse probability of treatment weighted analyses: a plasmode simulation. Stat Med. 2021 Apr;40(9):2101-12. doi: 10.1002/sim.8887

Webster-Clark M, Sturmer T, Wang T, Man K, Marinac‐Dabic D, Rothman KJ, Ellis AR, Gokhale M, Lunt M, Girman C, Glynn RJ. Using propensity scores to estimate effects of treatment initiation decisions: state of the science. Stat Med. 2021 Mar 30;40(7):1718-35. doi: 10.1002/sim.8866

Ciarametaro M, Houghton K, Wamble D, Dubois R. The dollar or disease burden: caps on health care spending may save money, but at what “cost” to patients? Value Health. 2021 Mar;24(3):388-96. doi: 10.1016/j.jval.2020.10.024v

Lash TL, VanderWeele TJ, Haneuse S, Rothman KJ. Modern epidemiology. 4th ed. Philadelphia: PA. L Wolters Klouwer; 2020.

Bent R, Carson RT, Gnanasakthy A, Kennedy A. Multi-stakeholder perspectives on the patient experience data summary section in new product approvals: current state & future considerations. Presented at the 2020 ISPOR Virtual Conference; May 20, 2020.

Glynn RJ, Lunt M, Rothman KJ, Poole C, Schneeweiss S, Sturmer T. Comparison of alternative approaches to trim subjects in the tails of the propensity score distribution. Pharmacoepidemiol Drug Saf. 2019 Oct;28(10):1290-8. doi: 10.1002/pds.4846

Li W, Zou T, Li L, Deng Y, Sun VT, Zhang Q, Layton B, Setoguchi S. Impacts of the North Atlantic subtropical high on interannual variation of summertime heat stress over the conterminous United States. Clim Dyn. 2019 Sep;53(5-6):3345-59. doi: 10.1007/s00382-019-04708-1

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

Talbird SE, La EM. Treatment patterns, health care resource use, and financial impact of CADASIL in the United States. Poster presented at the 2019 ISPOR 24th Annual International Meeting; May 21, 2019. New Orleans, LA.

Basarir H, Brockbank J, Knight C, Wolowacz S. The inclusion of the utility values for carers and family members in HTAs: a case study of recent NICE appraisals in the UK. Poster presented at the 2019 ISPOR 24th Annual International Meeting; May 22, 2019. New Orleans, LA. [abstract] Value in Health Regional Issues. 2019 May; 22(Suppl 2):S330.

Zellner A, Jackson T, Edmondson P, Wolf K. Implementing quality management processes to assure data quality. Poster presented at the 35th Society of Quality Assurance (SQA) Annual Meeting; April 30, 2019. Atlanta, GA.

Qin S, Nelson L, McLeod L, Eremenco S, Coons SJ. Assessing test-retest reliability of patient-reported outcome measures using intraclass correlation coefficients: recommendations for selecting and documenting the analytical formula. Qual Life Res. 2019 Apr;28(4):1029-33. doi: 10.1007/s11136-018-2076-0

Schneeweiss S, Rassen JA, Brown JS, Rothman KJ, Happe L, Arlett P, Dal Pan W, Goettsch W, Murk W, Wang SV. Graphical depiction of longitudinal study designs in health care databases. Ann Intern Med. 2019 Mar 19;170(6):398-406. doi: 10.7326/M18-3079

Kinsey TL, Sturmer T, Poole C, Rothman KJ, Glynn RJ. Changing predictors of statin initiation in US women over two decades. Pharmacoepidemiol Drug Saf. 2019 Mar;28(3):305-14. doi: 10.1002/pds.4704

Wamble DE, Ciarametaro M, Houghton K, Ajmera M, Dubois RW. What's been the bang for the buck? Cost-effectiveness of health care spending across selected conditions in the US. Health Aff (Millwood). 2019 Jan;38(1):68-75. doi: 10.1377/hlthaff.2018.05158.

Stevenson A, Carter K, Millar (Gildea) L, Ling C. NICE: a multiprogram HTA organization to suit all? Poster presented at the 2018 ISPOR 21st Annual European Congress; November 13, 2018. Barcelona, Spain.

Le Moine JG, Hawe E, Abeysinghe S. Network meta-analysis in the presence of non-proportionality: a review of NICE submissions. Poster presented at the 2018 ISPOR 21st Annual European Congress; November 13, 2018. Barcelona, Spain.

Earnshaw SR, Brogan AJ, Davis AE. Budget impact analysis II: applications & design issues. Presented at the 2018 ISPOR 21st Annual European Congress; November 11, 2018. Barcelona, Spain. Previously presented at the ISPOR 20th Annual International Meeting.

Mullins CD, Earnshaw SR, Brogan AJ. Budget impact analysis I: a 6-step approach. Presented at the 2018 ISPOR 21st Annual European Congress; November 11, 2018. Barcelona, Spain. Previously presented at the ISPOR 18th Annual European Congress.

Wolowacz SE, Briggs A, Doward L, Lloyd A. Collecting health-state utility estimates for economic models in clinical studies. Presented at the 2018 ISPOR 21st Annual European Congress; November 10, 2018. Barcelona, Spain.

Nieuwenhuijsen MJ, Gascon M, Martinez D, Ponjoan A, Blanch J, Garcia-Gil MDM, Ramos R, Foraster M, Mueller N, Espinosa A, Cirach M, Khreis H, Dadvand P, Basagana X. Air pollution, noise, blue space, and green space and premature mortality in Barcelona: a mega cohort. Int J Environ Res Public Health. 2018 Oct 30;15(11):2405. doi: 10.3390/ijerph15112405.

Arana A, Perez-Gutthann S. Therapeutic risk management. Establishing and ensuring the safety of medicines. Presented at the University of Aveiro; October 18, 2018. Aveiro, Portugal.

Ling C, Nuabor W, Lyall M, Stevenson A. Review of possible causes of variation in National Institute for Health and Care Excellence (NICE) technology appraisals. Poster presented at the 2018 ISPOR 21st Annual European Congress; November 13, 2018. Barcelona, Spain. [abstract] Value Health. 2018 Oct; 21(Suppl 3):S200.

Ripollone JE, Huybrechts KF, Rothman KJ, Ferguson JM, Franklin JM. Implications of the propensity score matching paradox in pharmacoepidemiology. Am J Epidemiol. 2018 Sep;187(9):1951-61. doi: 10.1093/aje/kwy078

Byrom B, Gwaltney C, Slagle A, Gnanasakthy A, Muehlhausen W. Measurement equivalence of patient-reported outcome measures migrated to electronic formats: a review of evidence and recommendations for clinical trials and bring your own device. Expert commentary. Ther Innov Regul Sci. 2018 Aug 29. doi: 10.1177/2168479018793369

Setoguchi S, Stang P, Perez-Gutthann S, May F, Klungel O, Strom B, Sahin L, Caduff P, Zhou W, Young JC, Chou Su C, Hester L, Zhu Y, Cesta C, Ahad MZ, Horton D, Hernandez-Diaz S. It takes a village part II: workshop to reconsider core competencies for new generations in the global and rapidly changing community of pharmacoepidemiology. Presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2018. Prague, Czech Republic.

Odom D, Purser M, Rasouliyan L. An overview of matching adjusted indirect comparisons in single arm clinical trials with practical recommendations and potential challenges. Presented at the 2018 Joint Statistical Meetings; August 2, 2018. Vancouver, Canada.

Tormos A, Rebordosa C, Thomas S, Plana E, Rasouliyan L, Pladevall-Vila M, Fazeli-Farsani S, Deruaz-Luyet A, Brodovicz KG, Perez-Gutthann S. Time between laboratory tests and acute liver and kidney injury diagnosis codes in CPRD: are we doing it right? 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):452. doi: 10.1002/pds.4629

Garcia-Albeniz X, Hsu J, Hernan MA. A word of caution: all-cause mortality and residual confounding in Medicare claims data. 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):343. doi: 10.1002/pds.4629

Sturmer T, Rothman KJ, Ellis AR, Wyss R, Conover M, Lunt M, Glynn RJ. Comparison of propensity score (PS) weighting and trimming strategies to reduce variance and bias of treatment effect estimates: a simulation study. Poster presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 24, 2018. Prague, Czech Republic. [abstract] Pharmacoepidemiol Drug Saf. 2018 Aug; 27(S2):53. doi: 10.1002/pds.4629

DiBenedetti DB, Brown TM, DeMuro CJ, Ervin C, Lewis SA, Fehnel SE. Conducting patient interviews within a clinical trial setting. RTI Press. 2018 Aug. doi: 10.3768/rtipress.2018.op.0054.1808

Calderwood MS, Kawai AT, Jin R, Lee GM. Centers for medicare and medicaid services hospital-acquired conditions policy for central line-associated bloodstream infection (CLABSI) and cather-associated urinary tract infection (CAUTI) shows minimal impact on hospital reimbursement. Infect Control Hosp Epidemiol. 2018 Aug;39(8):897-901. doi: 10.1017/ice.2018.137

Perez-Gutthann S. Looking behind the code. Presented at the 7th Bordeaux Pharmacoepi Festival 2018; May 23, 2018. Bordeaux, France. Previously presented at the 10th Annual Harry Guess Memorial Lecture.

Mordin M, Fernandez M, Pearson I, Copley-Merriman K, McBride D. Similarities and differences in European HTA evidence requirements: one for all or one for none? Presented at the 2018 ISPOR 23rd Annual International Meeting; May 22, 2018. Baltimore, MD.

Earnshaw SR, Brogan AJ, Brodtkorb TH. Budget impact analysis II – applications and design issues. Presented at the 2018 ISPOR 23rd Annual International Meeting; May 20, 2018. Baltimore, MD. Previously presented at the ISPOR 20th Annual International Meeting.