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
Brockbank J, Hancock H, Khare A, Joshi P, Risson V. Cost-effectiveness of [177Lu]Lu-PSMA-617 in progressive PSMA-positive metastatic castration-resistant prostate cancer. Poster presented at the ISPOR Europe 2024; November 17, 2024. Barcelona, Spain. [abstract] Value Health. 2024 Dec; 27(12 Supplement):S121. doi: 10.1016/j.jval.2024.10.619
Adelakun A, Dolph M, Matthews E, Oglebsy A, Campbell K, Davis A, Xu J, Hardy I, Danchenko N, Anderson SJ. Cost-effectiveness and public-health impact of cabotegravir long-acting injectable for HIV pre-exposure prophylaxis in Canada. Poster presented at the HIV Drug Therapy Glasgow 2024; November 10, 2024. Glasgow, Scotland. [abstract] J Int AIDS Soc. 2024 Nov; 27:234-5.
Yousif Z, Nangia A, Abeysinghe S, Jiang J, Sanchirico M, Fan T. Comparative efficacy of biologics for the induction of clinical remission and response in biologic-naïve patients with moderate-to-severe crohn's disease: outcomes from frequentist and bayesian network meta-analyses. Poster presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting 2024; October 29, 2024. Philadelphia, PA.
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
O'Brien P, Campbell K, Anderson SJ, Cornic L, Davis A, Schroeder M. Cost-effectiveness of every two month Cabotegravir Long-Acting (CAB-LA) for Pre-exposure Prophylaxis (PrEP) compared with daily oral Tenofovir Disoproxil Fumarate (TDF)/ emtricitabine (FTC) as PrEP to prevent HIV-1 UK. Poster presented at the ISPOR 2024; May 7, 2024. Atlanta, GA. [abstract] Value Health. 2024 Jun; 27(6 Supplement):S109. doi: 10.1016/j.jval.2024.03.580
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.
Niyazov A, Simou E, Kirker M, Houghton K, Le Moine JG, Chang J, Yarr S, Barnett C, Mladsi D. Pre-progression health state utility values from the TALAPRO-2 clinical trial in patients with metastatic castration-resistant prostate cancer unselected for DDR mutations. Poster presented at the ISPOR Europe 2023; November 14, 2023. Copenhagen, Denmark. [abstract] Value Health. 2023 Dec; 26(12 Supplement):S149. doi: 10.1016/j.jval.2023.09.772
Niyazov A, Simou E, Kirker M, Houghton K, Le Moine JG, Chang J, Yarr S, Barnett C, Mladsi D. Pre-progression health state utility values from the TALAPRO-2 clinical trial in patients with metastatic castration-resistant prostate cancer with HRR mutations. Poster presented at the ISPOR Europe 2023; November 14, 2023. Copenhagen, Denmark. [abstract] Value Health. 2023 Dec; 26(12 Supplement):S119. doi: 10.1016/j.jval.2023.09.772
Morris MJ, Armstrong AJ, Chi K, de Bono J, Herrmann K, Krause B, Rahbar K, Sartor O, Tagawa ST, Nagarajah J, Wei XX, Nordquist LT, Koshkin VS, Saad F, Vickers A, Ghouse R, Wu J, Mirante O, Fizazi K. Association of health-related quality of life with efficacy outcomes in the VISION study of patients with metastatic castration-resistant prostate cancer. Poster presented at the ESMO Congress 2023; October 22, 2023. Madrid, Spain.
Njue A, Nuabor W, Lyall M, Margulis A, Mauskopf J, Curcio D, Kurosky S, Gessner BD, Begier E. Systematic literature review of risk factors for poor outcomes among adults with respiratory syncytial virus infection in high-income countries. Open Forum Infect Dis. 2023 Oct 20;10(11):ofad513. doi: 10.1093/ofid/ofad513
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.
Fan Q, Hawe E, Yang J, Burgess B, Bullano M, Mokdad A. Cost outcomes of noninhibitor patients with hemophilia A switching from prophylaxis with factor VIII to emicizumab: a meta-analysis of real-world evidence studies in the United States. Poster presented at the AMCP Nexus 2023; October 16, 2023. Orlando, FL. [abstract] J Manag Care Pharm. 2023 Oct; 29(10-a Suppl):S35.
Nangia A, Simou E, Abeysinghe S, Colosia A, Bektas M, Workman J, Gao S, Bello N. Incidence rate of infections and association between lupus nephritis and serious infections in patients with systemic lupus erythematosus: systematic literature review and meta-analyses. Poster presented at the ISPOR 2023 Conference; May 7, 2023. Boston, MA. [abstract] Value Health. 2023 Jun; 26(6 supplement):S180. doi: 10.1016/j.jval.2023.03.972
Yousif Z, Schultz BG, Candela N, Harold S, Bell J, Turpin R, Hartley L. Systematic literature review to evaluate randomized clinical trials of advanced therapies for moderate to severe crohn's disease. Poster presented at the ISPOR 2023 Conference; May 6, 2023. Boston, MA. [abstract] Value Health. 2023 Jun; 26(6 supplement):S15. doi: 10.1016/j.jval.2023.03.085
Bello N, Meyers KJ, Workman J, Hartley L, McMahon M. Cardiovascular events and risk in patients with systemic lupus erythematosus: systematic literature review and meta-analysis. Lupus. 2023 Mar;32(3):325-41. doi: 10.1177/09612033221147471
Bello N, Meyers KJ, Workman J, Marcano Belisario J, Cervera R. Systematic literature review and meta-analysis of venous thromboembolism events in systemic lupus erythematosus. Rheum Ther. 2023 Feb 1;10(1):7-34. doi: 10.1007/s40744-022-00513-1
Ainsworth C, Higuchi K, Simou E, Guyot P, Araujo L, Greene N. Relative differences in brain volume loss with teriflunomide vs other disease-modifying therapies in relapsing multiple sclerosis: a systematic review and network meta-analysis. Poster presented at the AMCP Nexus 2022; October 11, 2022. National Harbor, MD. [abstract] J Manag Care Spec Pharm. 2022 Oct; 28(10-a):S73-4. Previously presented at the ACTRIMS Forum 2022.
Hawe E, Castro CV, Johannesen J, Belisario JM, Mordin M, Sawant R, Petrillo Billet J. Driving outcomes in mild cognitive impairment/Alzheimer's disease - a review of association between driving simulator measures and clinical outcomes assessments. Poster presented at the ISPOR 2022 Conference; May 15, 2022. Washington, DC. [abstract] Value Health. 2022 Jun; 25(6 S1).
Hawe E, Castro CV, Johannesen J, Belisario JM, Mordin M, Sawant R, Billet JP. Impact of Huntington's disease on driving: a review of driving simulator measures and association with clinical outcomes assessments. Poster presented at the ISPOR 2022 Conference; May 15, 2022. Washington, DC. [abstract] Value Health. 2022 Jun; 25(6 S1).
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
Ainsworth C, Higuchi K, Simou E, Guyot P, Greene N. Relative differences in brain volume loss with teriflunomide versus other disease-modifying therapies in relapsing multiple sclerosis: a systematic review and network meta-analysis. Poster presented at the ACTRIMS Forum 2022; February 24, 2022. West Palm Beach, FL.
Zhou X, Davenport E, Ouyang J, Hoke ME, Garbinsky D, Agarwal I, Krasa HB, Oberdhan D. Pooled data analysis of the long-term treatment effects of tolvaptan in ADPKD. Kidney Int Rep. 2022 Feb 19;7(5):1037-48. doi: 10.1016/j.ekir.2022.02.009
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
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
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
Njue A, Coyne C, Margulis AV, Wang D, Marks MA, Russell K, Das R, Sinha A. The role of congenital cytomegalovirus infection in adverse birth outcomes: a review of the potential mechanisms. Viruses. 2020 Dec 24;13(1):E20. doi: 10.3390/v13010020
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.
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.
Zhou X, Garbinsky D, Ouyang J, Davenport E, Agarwal I, Oberdhan D. Longitudinal data on treatment duration and compliance from autosomal dominant polycystic kidney disease clinical trials with tolvaptan. Nephrol Dial Transplant. 2020 Jun;35(Supplement_3):gfaa139.S. doi: 10.1093/ndt/gfaa139.SO093
Zhou X, Davenport E, Ouyang J, Hoke M, Garbinsky D, Agarwal I, Oberdhan D. Population characteristics across an expanded pooled database of multiple autosomal dominant polycystic kidney disease clinical studies. Nephrol Dial Transplant. 2020 Jun;35(Supplement_3):gfaa142.P. doi: 10.1093/ndt/gfaa142.P0037
Zhou X, Davenport EK, Ouyang J, Krasa H, Garbinsky D, Agarwal I, Oberdhan D. Population characteristics across a pooled database of multiple Autosomal Dominant Polycystic Kidney Disease (ADPKD) clinical studies. Poster presented at the 2020 National Kidney Foundation Spring Clinical Meeting; March 2020. New Orleans, LA. [abstract] Am J Kidney Dis. 2020 Apr; 75(4):663.
Njue A, Margulis AV, Lyall M, Nuabor W, Marks M, Russell K, Sinha A. Congenital cytomegalovirus: what are the rates of maternal screening, diagnostic amniocentesis, and elective termination? Poster presented at the ID Week 2019; October 4, 2019. Washington, DC.
Vickers AD, Winfree KB, Cuyun Carter G, Kiiskinen U, Jen MH, Stull D, Kaye JA, Carbone DP. Relative efficacy of interventions in the treatment of second-line non-small cell lung cancer: a systematic review and network meta-analysis. BMC Cancer. 2019 Apr 15;19(1):353. doi: 10.1186/s12885-019-5569-5.
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
Stebbins KL, Herring WL, Grant TJ, Mladsi DM, Witkowski C, Garg S. Cost savings associated with teleretinal imaging in primary care. Poster presented at the 2018 American Telemedicine Association (ATA) Annual Conference; April 30, 2018. Chicago, IL.
Nance R, Vannappagari V, Johannes C, Calingaert B, Saltus C, Boswell S, Rodriguez B, Moore R, Eron J, Geng E, Mathews WC, Saag MS, Kitahata M, Delaney JAC, Crane HM, Centers For AIDS Research Network of Integrated Clinical Systems (CNICS). Viral failure among persons living with HIV initiating dolutegravir-based vs. other recommended regimens in real-world clinical care settings. Poster presented at the IDWeek 2017 Conference; October 2017. San Diego, CA. [abstract] Open Forum Infect Dis. 2017 Oct 4; 4((Suppl 1)):S39. doi: 10.1093/ofid/ofx162.095
Chirila C, Mitra D, Colosia A, Ling C, Odom D, Iyer S, Kaye JA. Comparison of palbociclib in combination with letrozole or fulvestrant with endocrine therapies for advanced/metastatic breast cancer: network meta-analysis. Curr Med Res Opin. 2017 Aug;33(8):1457-66. doi: 10.1080/03007995.2017.1325730
Glaser DA, Hebert AA, Fehnel S, DiBenedetti D, Nelson L, Drew J, Pariser DM. The axillary sweating daily diary: a validated patient-reported outcome measure to assess axillary hyperhidrosis symptom severity. Poster presented at the 2017 Maui Derm for Dermatologists; March 2017. Maui, HI.
Gnanasakthy A, Hochhaus A, Giles FJ, Radich JP, Brandt P, Saglio G. ENESTfreedom trial of treatment-free remission: patient-reported quality of life before and after stopping treatment in patients with chronic myeloid leukemia in chronic phase. Poster presented at the 2017 AMCP Managed Care & Specialty Pharmacy Annual Meeting; March 27, 2017. Denver, CO. [abstract] J Manag Care Spec Pharm. 2017 Mar; 23(3a):S4.
Gnanasakthy A, Brandt P, Hughes TP. ENESTop trial of treatment-free remission: patient-reported quality of life before and after stopping treatment in patients with chronic myeloid leukemia in chronic phase. Poster presented at the 2017 AMCP Managed Care & Specialty Pharmacy Annual Meeting; March 27, 2017. Denver, CO. [abstract] J Manag Care Spec Pharm. 2017 Mar; 23(3a):S3.
Chirila C, Mitra D, Colosia A, Ling C, Odom D, Iyer S, Kaye JA. Efficacy of palbociclib combinations versus endocrine therapies in advanced/ metastatic breast cancer: network meta-analysis. Poster presented at the 2016 ISPOR 19th Annual European Congress; November 2, 2016. Vienna, Austria. [abstract] Value Health. 2016 Nov; 19(7):A710.
Colosia A, Khan S, Hackshaw MD, Oglesby A, Kaye JA, Skolnik JM. A systematic literature review of adverse events associated with systemic treatments used in advanced soft tissue sarcoma. Sarcoma. 2016 Jul 19;2016:3597609. doi: 10.1155/2016/3597609