Publications
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Sauchelli S, Levy C, Gnanasakthy A, Dave V, Doward L, Fitzgerald KA, Carson R. From clinical trials to informing clinical decision-making: a review of patient-reported outcomes in nononcology medicines approved by the European Medicines Agency (2018-2022). Front Pharmacol. 2025 Apr 11;16:1536401. doi: 10.3389/fphar.2025.1536401
Law EH, Hanson KA, Harries M, Korver D, Sherif B, Chirila C. Patient-reported outcome improvements following scalp hair regrowth among patients with alopecia areata: analysis of the ALLEGRO-2b/3 trial. J Dermatolog Trea. 2025 Feb 3;36(1):2460577. doi: 10.1080/09546634.2025.2460577
Neofytos D, Pagliuca A, Houghton K, Broughton E, de Figueiredo Valente MLN, Jiang L, Enoch DA, Gruener B, Herbrecht R, Lahmer T, Lortholary O, Melenotte C, De Rosa FG, Garcia-Vidal C, Jimenez M, Fernandez M, Cornely O. Effectiveness, safety, and patterns of real-world isavuconazole use in Europe (2015-2019). Infect Dis Ther. 2024 Dec;13(12):2527-43. doi: 10.1007/s40121-024-01064-4
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.
Shore S, Ervin C, Kosa K, Fehnel S, Salberg L, Butzner M, Heitner SB, Jacoby D, Saberi S. Qualitative interview study of patient-reported symptoms, impacts and treatment goals of patients with obstructive hypertrophic cardiomyopathy. BMJ Open. 2024 Sep 17;14(9):e081323. doi: 10.1136/bmjopen-2023-081323
Law E, Williams N, Korver D, Bender R, Mitra D, Schaefer G, Nelson LM. Determining meaningful thresholds for evaluating treatment efficacy in patients with alopecia areata. JEACP. 2024 Sep;3(4):1119-31. doi: 10.1002/jvc2.441
Morga A, Zimmermann L, Valluri U, Siddiqui E, McLeod L, Bender RH. Validation and application of thresholds to define meaningful change in vasomotor symptoms frequency: analysis of pooled SKYLIGHT 1 and 2 data. Adv Ther. 2024 Jul;41(7):2845-58. doi: 10.1007/s12325-024-02849-2
Grivas P, Barata P, Moon H, Gupta S, Hutson T, Sternberg C, Brown J, Dave V, Downey C, Shillington A, Katzenstein H, Kirker M, Hanson S, Liu F, Morris V, Bhanegaonkar A, Sonpavde G. Avelumab first-line maintenance (1LM) therapy for locally advanced/metastatic urothelial carcinoma (la/mUC): results from the realworld US PATRIOT-II study. Poster presented at the Academy of Managed Care Pharmacy (AMCP) 2024; April 15, 2024. New Orleans, LA. [abstract] J Manag Care Spec Pharm. 2024 Apr; 30(4-a):S123.
Law EH, Sherif B, Mostaghimi A, King B, Sinclair R, Mesinkovshka N, Hanson KA, Korver D, Chirila C. Patients with alopecia areata treated with ritlecitinib have improved patient-reported emotional symptoms and activity limitations due to hair loss: post hoc analyses of ALLEGRO-2b/3. Poster presented at the Maui Derm Hawaii 2024; January 22, 2024. Wailea, HI.
Zografos LJ, Andrews E, Wolin DL, Calingaert B, Davenport EK, Michel A, Latocha M, Schmidt-Ott UM, Lovic N, Brunck LR, Johnson KT, Suzart-Woischnik K. Evaluation of physician knowledge of safety and safe use information for intravitreal aflibercept injection in Europe: a second survey of physicians following dissemination of updated risk-minimization materials. Pharmaceut Med. 2024 Jan;38(1):63-73. doi: 10.1007/s40290-023-00506-7
Sinclair G, Sension M, Dretler A, Schneider S, Schubert C, Merrill D, Richardson D, Sherif B, Zografos L, Garris C. Clinical outcomes at month 6 after initiation of cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world study (BEYOND). Poster presented at the IDWeek 2023; October 13, 2023. Boston, MA.
Dandachi D, Cunningham D, Valenti W, Phoenix J, Nguyen K, Teichner P, Jean-Louis A, Reynolds M, Richardson D, Garris C. Perspectives of people with HIV (PWH) 6 months following a switch to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND). Poster presented at the IDWeek 2023; October 13, 2023. Boston, MA.
Whalley D, Balp M, Yarr S, Porter M, Barve A. Patient-reported symptom burden in chronic inducible urticaria: post hoc analysis of baseline data from a phase 3 clinical trial. Poster presented at the 2023 EADV Congress; October 11, 2023. Berlin, Germany.
Sinclair G, Cunningham D, Gupta SK, Richardson D, Reynolds M, Nelson K, Puga A, Garris C. US Healthcare Provider Perspectives on the initiation of cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world study (BEYOND). Poster presented at the 17th Annual ACTHIV 2023 Conference; May 4, 2023. Phoenix, AZ.
Sung A, Houghton K, Cornely OA, Neofytos D, Pagliuca A, Capparella MR, Aguado J, Jimenez M, Gheorghe M. Effectiveness, safety, and patterns of real-world isavuconazole use—a retrospective medical record review study of patients with invasive aspergillosis. Poster presented at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2023; April 15, 2023. Copenhagen, Denmark.
Herrera-Restrepo O, Davis K, Sweeney C, Davenport E, Ghaswalla P, Buck PO. Hepatitis A and B vaccination in adults at risk: a survey of US healthcare providers' attitudes and practices. Hum Vaccin Immunother. 2022 Nov 30;18(6):2123180. doi: 10.1080/21645515.2022.2123180
Hsu RK, Phoenix J, Sinclair GI, Gupta SK, Puga A, Nguyen K, Schubert CK, Merrill D, Richardson D, Nelson K, Reynolds M, Zografos L, Jean-Louis A, Garris C. US Healthcare Provider Perspectives on the initiation of cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world study (BEYOND). Poster presented at the IDWeek 2022 Conference; October 21, 2022. Washington, DC.
Li D, Darden C, Osman N, Sayeed S, Jackson L, Garbinsky D, Chauhan A. Real-world clinical and patient-reported outcomes from the longitudinal telotristat ethyl treatment registry of patients with neuroendocrine tumors. Cancer Manag Res. 2022 Oct 17;14:3009-20. doi: 10.2147/CMAR.S386419
Kamudoni P, Amtmann D, Johns J, Cook KF, Salem R, Salek S, Raab J, Middleton R, Repovic P, Alschuler KN, von Geldern G, Wundes A, Barrett A, Olayinka-Amao B, Henke C. The validity, responsiveness, and score interpretation of the PROMISnq Physical Function - Multiple Sclerosis 15a short form in multiple sclerosis. Mult Scler Relat Disord. 2022 Jun;62:103753. doi: 10.1016/j.msard.2022.103753
Layton JB, Forns J, Turner ME, Dempsey C, Bartsch JL, Anthony MS, Danysh HE, Ritchey ME, Demos G. Falls and fractures in patients with Parkinson's Disease–related psychosis treated with Pimavanserin vs atypical antipsychotics: a cohort study. Drugs Real World Outcomes. 2022 Mar;9(1):9-22. doi: 10.1007/s40801-021-00284-1
Ghaswalla P, Davis K, Sweeney C, Davenport E, Trofa A, Herrera-Restrepo O, Buck PO. Health care providers' knowledge, practices, and barriers to hepatitis vaccination guidelines. J Nurse Pract. 2022 Feb 16;18:403-10.
Wyrwich KW, Winnette R, Bender R, Gandhi K, Williams N, Harris N, Nelson L. Validation of the alopecia areata patient priority outcomes (AAPPO) questionnaire in adults and adolescents with alopecia areata. Dermatol Ther. 2022 Jan;12(1):149-66. doi: 10.1007/s13555-021-00648-z
Herrera-Restrepo O, Ghaswalla P, Davis K, Sweeney C, Davenport E, Andani A, Buck PO. What can Europe learn from HCP knowledge and attitudes towards hepatitis A vaccination in the US? Poster presented at the 14th European Public Health Virtual Conference 2021 (EPH); November 10, 2021.
Li D, Darden C, Sayeed S, Jackson L, Garbinsky D, Osman N. Patient-reported clinical and productivity outcomes from the longitudinal telotristat ethyl treatment registry. Poster presented at the 2021 Virtual Annual Symposium of the North American Neuroendocrine Tumor Society (NANETS); November 3, 2021.
Kolotkin RL, Williams VSL, von Huth Smith L, Meincke HH, Qin S, Williams N, Fehnel SE. Confirmatory psychometric evaluations of the impact of weight on quality of life-lite clinical trials version (IWQOL-Lite-CT). Clin Obes. 2021 Oct;11(5):e12477. doi: 10.1111/cob.12477
Brandt T, Frangiosa T, Biggar V, Taylor A, Valentine J, Keller B, Price M, DeMuro C, Abler V. Symptoms and treatment needs of people with dementia-related psychosis: a mixed-methods study of the patient experience. Clin Gerontol. 2021 Aug 9;45(3):681-95. doi: 10.1080/07317115.2021.1957050
Ghaswalla P, Davis K, Sweeney C, Davenport E, Trofa A, Herrera-Restrepo O, Buck P. Knowledge, attitudes, practices and barriers regarding Hepatitis A and Hepatitis B vaccination: a survey of healthcare providers. Poster presented at the American Association of Nurse Practitioners (AANP) National Conference; June 15, 2021.
Husni ME, Bozyczko M, Wolin D, Sweeney C, Davenport E, Hass S, Yi E, Hur P, Grinnell-Merrick L. A prospective, longitudinal study to evaluate real-world patient experiences and treatment satisfaction with secukinumab for psoriatic arthritis. Poster presented at the Virtual EULAR 2021 Congress; June 2, 2021. [abstract] Ann Rheum Dis. 2021 Jun; 80(Suppl 1):808-9.
Winnette R, Wyrwich K, Bender R, Gandhi K, Williams N, Harris N, Nelson L. Validation of AAPPO Questionnaire in adults and adolescents with alopecia areata. Poster presented at the Virtual ISPOR 2021 Conference; May 2021.
English M, Stoykova B, Slota C, Doward L, Siddiqui E, Crawford R, DiBenedetti D. Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS sleep disturbance and sleep-related impairment measures for assessment of VMS impact on sleep. J Patient Rep Outcomes. 2021 Apr 26;5(1):37. doi: 10.1186/s41687-021-00289-y
Oppenheimer J, Slade DJ, Hahn BA, Zografos L, Gilsenan A, Richardson D, McSorley D, Lima R, Molfino NA, Averell CM. Real-world evidence: patient views on asthma in respiratory specialist clinics in America. Ann Allergy Asthma Immunol. 2021 Apr;126(4):385-93. doi: 10.1016/j.anai.2020.12.015
Williams V, Qin S, Romano CD, Lewis S, Williams N, Yarr S, Juul KV, Andersson FL. Psychometric evaluation of the Nocturia Sleep Quality Scale based on data from a prospective observational study. J Clin Sleep Med. 2021 Apr 1;17(4):691-701. doi: 10.5664/jcsm.9010
English M, Stoykova M, Slota C, Doward L, Siddiqui E, Crawford R, DiBenedetti D. Qualitative study of the burden of vasomotor symptoms associated with menopause and content validity of two PROMIS sleep measures in menopausal women. Presented at the 2021 IMS Conference (Conference cancelled); February 4, 2021. Previously presented at the NAMS 2020 Virtual Meeting.
Forns J, Layton JB, Bartsch J, Turner ME, Dempsey C, Anthony M, Ritchey ME, Demos G. Increased risk of falls and fractures in patients with psychosis and Parkinson disease. PLoS One. 2021 Jan 27. doi: 10.1371/journal.pone.0246121
Darden C, Joish VN, Price MA, Garbinsky D, Schwartz S, Warner C, Wason S, Lapuerta P. Patient-reported activity impairment, work productivity loss, and carcinoid syndrome outcomes: interim analyses of the XERMELO patient registry. Poster presented at the NANETS 2020 Multidisciplinary Net Medical Virtual Symposium; October 2, 2020.
Magrey M, Yi E, Wolin D, Price M, Chirila C, Davenport E, Park Y. Understanding barriers in the pathway to diagnosis of ankylosing spondylitis: results from a US survey of 1690 physicians from 10 specialties. ACR Open Rheumatol. 2020 Oct;2(10):616-26. doi: 10.1002/acr2.11179
English M, Stoykova B, Slota C, Doward L, Siddiqui E, Crawford R, DiBenedetti D. Qualitative study of the burden of vasomotor symptoms associated with menopause and content validity of two PROMIS sleep measures in menopausal women. Poster presented at the NAMS 2020 Virtual Meeting; September 30, 2020.
Zografos L, Rivero-Ferrer E, Abramsky S, Lou J, Davenport E, Wolin D. Evaluation of the physician education component of the ozurdex risk management plan. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Forns J, Layton JB, Bartsch J, Turner ME, Dempsey C, Anthony M, Ritchey ME, Demos G. Increased risk of falls and fractures in patients with psychosis and Parkinson disease. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Shah S, Sacco P, Jackson L, Price M, Bensink M, Bernstein C. Beyond frequency alone - exploring what meaningful improvement means in the treatment of migraine: focus groups in patients and health care providers. Poster presented at the 2020 American Headache Society 62nd Virtual Annual Scientific Meeting; June 15, 2020. San Diego, CA.
Molfino NA, Averell CM, Hahn B, Zografos L, Gilsenan A, Richardson D, McSorley D, Slade DJ. Real world evidence in asthma: pulmonary function and asthma control in respiratory specialty clinics in the US. Poster presented at the 2020 American Thoracic Society (ATS) International Conference; May 20, 2020. Philadelphia, PA.
Molfino NA, Averell CM, Hahn BA, Zografos L, Gilsenan A, Richardson D, McSorley D, Slade DJ. Patients with uncontrolled asthma eligible for a biologic. Poster presented at the 2020 American Thoracic Society (ATS) International Conference; May 20, 2020. Philadelphia, PA.
Averell CM, Hahn B, Zografos L, Gilsenan A, Richardson D, McSorley D, Molfino NA, Slade DJ. Assessment of asthma control in respiratory specialist offices in the US. Poster presented at the 2020 American Thoracic Society (ATS) International Conference; May 17, 2020. Philadelphia, PA.
Margrey M, Yi E, Wolin D, Price M, Chirila C, Davenport E, Park Y. Recognition of inflammatory back pain by US healthcare providers and barriers to specialist referral. Poster presented at the 2019 ACR/ARP Annual Meeting; November 10, 2019. Atlanta, GA.
Price MA, Joish VN, Schwartz S, Fish-Steagall A, Bennett L, Darden C, Tesfaye E, Arnold K, Wason S, Lapuerta P. Xermelo patient registry: improvements in clinical outcomes, patients satisfaction, and weight with telotristat ethyl in the real-world. Poster presented at the 2019 North American Neuroendocrine Tumor Society (NANETS) Conference; October 3, 2019. Boston, MA.
Zografos LJ, Andrews E, Wolin DL, Calingaert B, Davenport EK, Hollis KA, Schmidt-Ott UM, Petraro P, Vassilev ZP. Physician and patient knowledge of safety and safe use information for aflibercept in Europe: evaluation of risk-minimization measures. Pharmaceut Med. 2019 Jun;33(3):219-33. doi: 10.1007/s40290-019-00279-y
Magrey M, Bozyczko M, Wolin D, Mordin M, McLeod L, Davenport E, Chirila C, Park Y. A pilot study to assess the feasibility of a web-based survey to examine patient-reported symptoms and satisfaction in patients with ankylosing spondylitis receiving secukinumab. Drugs Real World Outcomes. 2019 Jun;6(2):83-91. doi: 10.1007/S40801-019-0154-4
Kreher N, Phillips D, Fehnel S, Brown M. Evaluating the content validity of the Diary of Irritable Bowel Syndrome Symptoms – Mixed (DIBSS-M) to assess gastrointestinal symptoms associated with Fabry disease. Poster presented at the 16th Annual WORLDSymposium; February 11, 2019. Orlando, FL. [abstract] Mol Genet Metab. 2019 Feb; 126(2):S87. doi: 10.1016/j.ymgme.2018.12.215
De Laurentiis M, Davis KL, Ajmera M, Mitra D, Nuzzo CMA, Harbeck N. Health related quality of life in women with HR+/HER2- advanced or metastatic breast cancer treated in real world settings in Italy and Germany. Poster presented at the European Society for Medical Oncology (ESMO) 43rd Congress 2018; October 22, 2018. Munich, Germany.
Joish VN, Price MA, Schwartz S, Stanley S, Bennett L, Darden C, Tesfaye E, Mobley Q, Arnold K, Wason S, Lapuerta P. Xermelo patient registry: a real-world evidence study evaluating patient-reported outcomes with Xermelo. Poster presented at the 2018 NANETS Annual Multidisciplinary NET Disease Symposium; October 4, 2018. Seattle, WA.