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
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
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.
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.
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
Krege JH, Gilsenan AW, Komacko JL, Kellier-Steele N. Teriparatide and osteosarcoma risk: history, science, elimination of boxed warning, and other label updates. J Bone Miner Res. 2022 Aug 14;6(9):e10665. doi: 10.1002/jbm4.10665
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
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
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.
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
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.
Hallas J, Margulis AV, Pottegard A, Kaye JA, Kristiansen N, Bui CL, Atsma WJ, Appenteng K, Franks B, de Vogel S, D'Silva M, Perez-Gutthann S, Arana A. Elevated bladder and prostate cancer rates following initiation of OAB medication: findings from the Danish Registries. 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):533.
Linder M, Margulis AV, Anveden-Berglind I, Bahmanyar S, Bui CL, Atsma WJ, Appenteng K, Franks B, de Vogel S, D'Silva M, Perez-Gutthann S, Arana A. Cardiovascular risk in users of antimuscarinic drugs for overactive bladder: a cohort study in the Swedish National Registers. 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):491-2.
Linder M, Margulis AV, Anveden-Berglind I, Bahmanyar S, Bui CL, Atsma WJ, Appenteng K, Franks B, de Vogel S, D'Silva M, Perez-Gutthann S, Arana A. Cancer risk in users of antimuscarinic drugs for overactive bladder: a cohort study in the Swedish National Registers. 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):533-4.
Williams V, Coles T, DeMuro C, Lewis S, Williams N, Yarr S, Barghout V, Lowes L, Alfano L, Goldberg B, Gnanasakthy A, Tseng B. Psychometric evaluation of the Sporadic Inclusion Body Myositis (sIBM) Physical Functioning Assessment (sIFA). Poster presented at the 1st Annual International Conference on Myositis; May 2015. Stockholm, Sweden.
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
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.
Wheeler SB, Kohler RE, Goyal RK, Lich KH, Lin CC, Moore A, Smith TW, Melvin CL, Reeder-Hayes K, Domino ME. Is medical home enrollment associated with receipt of guideline-concordant follow-up care among low-income breast cancer survivors? Med Care. 2013 Jun;51(6):494-502.
Lenderking WR, Coon C, Fehnel SE, Burke L. The utility of mixed-method approaches to evaluate the content validity of patient-reported outcome measures. Presented at the International Society for Pharmacoeconomics and Outcomes Research; May 1, 2013.
Gnanasakthy A, DeMuro-Mercon CJ, Clark MJ, Mordin MM, Thomas S. Role of patient-reported outcome measures in the assessment of central nervous system agents. Ther Innov Regul Sci. 2013;47(5):613-8.
Chandran AB, Coon CD, Martin SA, McLeod LD, Coles TM, Arnold LM. Sphygmomanometry-evoked allodynia in chronic pain patients with and without fibromyalgia. Nurs Res. 2012 Sep 1;61(5):363-8.
Gilsenan AW, Kellier N, Harris DH, Andrews EB, Masica DN. Linking a voluntary patient registry with US state cancer registries for possible signal detection. Poster presented at the 28th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 23, 2012. Barcelona, Spain. [abstract] Pharmacoepidemiol Drug Saf. 2012 Aug 27; 21(suppl 3):464. doi: 10.1002/pds.3324
Norquist JM, Girman C, Fehnel S, Demuro-Mercon C, Santanello N. Choice of recall period for patient-reported outcome (PRO) measures: criteria for consideration. Qual Life Res. 2012 Aug 1;21(6):1016-20.
Gnanasakthy A, Sadrick A, DeMuro C, Rahul R. Promotion of patient reported outcomes (PRO) label claims based on non-primary endpoints. Poster presented at the 2012 ISPOR 17th Annual International Meeting; June 2012. Washington, DC. [abstract] Value Health. 2012 Jun; 15(4):A201. doi: 10.1016/j.jval.2012.03.1086
Davis KL, Wei W, Kilpatrick BS, Meyers JL, Pandya N. Use of basal insulins in elderly nursing home residents with type 2 diabetes mellitus: a retrospective chart review study. Poster presented at the Annual Scientific Meeting of the American Geriatric Society; May 2012.
Swartz RJ, Schwartz C, Basch E, Cai l, Fairclough DL, McLeod L, Mendoza TR, Rapkin B. The king's foot of patient-reported outcomes: current practices and new developments for the measurement of change. Qual Life Res. 2011 Oct 1;20(8):1159-67.
Mordin M, Clark M, DeMuro C, Evans ED, Copley-Merriman K, Fehnel S, Gnanasakthy A. Pro label claims: an analysis based on a review of pros among new molecular entities and biologic license applications 2006-2010. Poster presented at the 2011 ISPOR 16th Annual International Meeting; June 3, 2011. [abstract] Value Health. 2011 May; 14(3):A29.
Mordin MM, Lewis SA, Gnanasakthy A, DeMuro-Mercon CJ, Copley-Merriman K, Fehnel SE. Patient-reported outcomes in product development guidance. Poster presented at the 2010 ISPOR 15th Annual International Meeting; May 1, 2010. Atlanta, GA. [abstract] Value Health. 2010 May; 13(3):A-17-8.
Mordin M, Lewis SE, Gnanasakthy A, Demuro-Mercon C, Copley-Merriman K, Fehnel S. Patient-reported outcomes as mentioned in product development guidance. Poster presented at the 2010 ISPOR 15th Annual International Meeting; May 4, 2010. [abstract] Value Health. 2010 May; 13(3):A17-8.
Pattanayak SK, Poulos C, Yang JC, Patil SR, Wendland KJ. Of taps and toilets: quasi-experimental protocol for evaluating community-demand-driven projects. J Water Health. 2009 Sep 1;7(3):434-51.
Martin S, Chandran A, Zografos L, Zlateva G. Evaluation of the impact of fibromyalgia on patients' sleep and the content validity of two sleep scales. Health Qual Life Outcomes. 2009 Jul 1;7:64.
Mordin MM, Clark M, Siersma CA, Copley-Merriman K, Gnanasakthy A. Impact of the FDA draft guidance on patient reported outcomes (PRO) label claims for approved drug products in the US: has it made a difference? Poster presented at the International Society for Pharmacoeconomics and Outcomes Research 14th Annual International Meeting; May 19, 2009. Orlando, FL. [abstract] Value Health. 2009 May; 12(3):A29.
Harness J, Mamolo C, Olsen E, Price V, DeMuro-Mercon CJ, Fehnel SE, Barrows SM. The women's hair growth questionnaire (WHGQ): development and validation of a patient-reported measure for treatment efficacy in female pattern alopecia. Poster presented at the 67th Annual Meeting of the American Academy of Dermatology; March 2009.
Martin S, Chandran A, Zografos L, Zlateva G, Sadosky A. Content validity of the sleep quality numeric rating scale (NRS) and the medical outcomes study sleep scale (MOS-sleep) in patients with fibromyalgia (Fm). Sleep. 2009 Jan 1;32(Suppl. S):A327.
De Bellis MD, Van Voorhees E, Hooper SR, Gibler N, Nelson LM, Hege SG, Payne ME, MacFall J. Diffusion tensor measures of the corpus callosum in adolescents with adolescent onset alcohol use disorders. Alcohol Clin Exp Res. 2008 Mar;32(3):395-404.
Harris DH, Pulliam P, Kropp N. A comparison of national cancer registries in India and the United States of America. Poster presented at the International Conference on Survey Methods in Multinational, Multiregional, and Multicultural Contexts; 2008. Berlin, Germany.