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.
Morrison R, Allas S, Crawford R, Tremel N, Weiss B, Robo C, Doward L. International adaptation and linguistic validation of the hypoparathyroidism daily diary of symptom experience (HPT-DD-SE) and the hypoparathyroidism life impact questionnaire (HPT-LIQ). Poster presented at the ISPOR Europe 2022; November 8, 2022. Vienna, Austria. [abstract] Value Health. 2022 Dec 1; 25(12):S418. doi: 10.1016/j.jval.2022.09.2079
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
Sarda SP, Heyes A, Bektas M, Thankur T, Chao W, Intorcia M, Wronski S, Jones DL. Humanistic and economic burden of geographic atrophy: a systematic literature review. Clin Opththa. 2021 Dec 8;2021(15):4629-44.
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
Jones DL, Bektas M, Heyes A, Wronski S, Sarda SP. Clinical & humanistic burden of geographic atrophy (GA). Poster presented at the 2021 EURETINA Virtual Congress; September 9, 2021.
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
Simpson EL, de Bruin-Weller M, Bansal A, Chen Z, Nelson L, Whalley D, Prescilla R, Guillemin I, Delevry D. Definition of clinically meaningful within-patient changes in POEM and CDLQI in children 6 to 11 years of age with severe atopic dermatitis. Dermatol Ther. 2021 Aug;11(4):1415-22. doi: 10.1007/s13555-021-00543-7
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.
Simpson EL, de Bruin-Weller M, Eckert L, Whalley D, Guillemin I, Reaney M, Chen Z, Nelson L, Qin S, Bansal A, Gadkari A. Responder threshold for Patient-Oriented Eczema Measure (POEM) and Children's Dermatology Life Quality Index (CDLQI) in adolescents with atopic dermatitis. Dermatol Ther. 2019 Dec;9(4):799-805. doi: 10.1007/s13555-019-00333-2
Nelson LM, DiBenedetti D, Pariser DM, Glaser DA, Hebert AA, Hofland H, Drew J, Ingolia D, Gillard KK, Fehnel S. Development and validation of the axillary sweating daily diary: a patient-reported outcome measure to assess axillary sweating severity. J Patient Rep Outcomes. 2019 Sep 5;3(1):59. doi: 10.1186/s41687-019-0148-8
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
Clark M, Berry P, Martin S, Harris N, Sprecher D, Olitsky S, Hoag JB. Nosebleeds in hereditary hemorrhagic telangiectasia: development of a patient-completed daily eDiary. Laryngoscope Investig Otolaryngol. 2018 Nov 14;3(6):439-45. doi: 10.1002/lio2.211
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
Yosipovitch G, Reaney M, Eckert L, Nelson L, Clark M, Ardeleanu M, Radin A, Gadkari A. Validation of the peak pruritus numerical rating scale: results from clinical studies of dupilumab in adult patients with moderate-to-severe atopic dermatitis. Poster presented at the 9th World Congress on Itch; October 2017. Wroclaw, Poland.
Yosipovitch G, Reaney M, Mastey V, Eckert L, Nelson L, Clark M, Abbe A, Ardeleanu M, Radin A, Gadkari A. Validation of the peak pruritus numerical rating scale: results from clinical studies of dupilumab in adults with moderate-to-severe atopic dermatitis. Poster presented at the 2017 American Academy of Dermatology Annual Meeting; March 4, 2017. Orlando, FL. [abstract] J Am Acad Dermatol. 2017 Jun; 76(6 Suppl 1):AB278. doi: 10.1016/j.jaad.2017.04.1082
Zuluaga S, Hess LM, Wolowacz S, Dyachkova Y, Hawe E, Vickers AD, Kaye JA, Bertwistle D. Cost-effectiveness of olaratumab in combination with doxorubicin for the treatment of locally advanced or metastatic soft tissue sarcoma in the United States. Poster presented at the 2017 ISPOR 22nd Annual International Meeting; May 22, 2017. Boston, MA. [abstract] Value Health. 2017 May; 20(5):A108.
Yosipovitch G, Reaney M, Eckert L, Nelson L, Clark M, Abbe A, Ardeleanu M, Radin A, Gadkari A. Validation of the peak pruritus numerical rating scale: results from clinical studies of dupilumab in adults with moderate-to-severe atopic dermatitis. Poster presented at the Australasian College of Dermatologists 50th Annual Scientific Meeting; May 2017. Sydney, Australia. [abstract] Australas J Dermatol. 2017 May; 58(S1):106-7. Previously presented at the 2017 American Academy of Dermatology Annual Meeting. doi: 10.1111/ajd.21_12652
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.
Glaser DA, Hebert AA, Fehnel S, DiBenedetti D, Nelson L, Drew J, Pariser DM. Confirmatory psychometric evaluation of the axillary sweating daily diary: a vaildated patient-reported outcome measure to assess axillary hyperhidrosis sweating severity. Poster presented at the 36th Fall Clinical Dermatology Conference; October 2017. Las Vegas, NV. [abstract] Skin: the journal of cutaneous medicine. 2017; 1(Suppl 93):s94. doi: 10.25251/skin.1.supp.93.
Lorenzo M, Hess L, Nicol S, Parikh R, Candrilli SD, Kaye JA. Advanced soft-tissue sarcoma-related treatment patterns and outcomes in elderly patients in the United States. Poster presented at the Connective Tissue Oncology Society Annual Meeting; November 2016. Lisbon, Portugal.
Clark M, Martin S, Svedsater H, Dale P, Jacques L. Measurement properties of an asthma symptom and rescue medication use diary. J Asthma. 2015 Feb;52(1):88-97. doi: 10.3109/02770903.2014.947430
Hogue SL, Bjoerk B, Walker A, Balp M, Fernandez MM, Quijano M, Ling CS, Heyes AE. Evidence-based market access value resource: navigating the hurdles for a biologic obtaining a license in a second indication in key European countries. Poster presented at the 2014 ISPOR 17th Annual European Congress; November 2014. Amsterdam. [abstract] Value Health. 2014 Nov; 17(7):A431-2.
Williams VS, Nelson LM, Fehnel SE, MacDougall J, Carson RT, Tourkodimitris S, Kurtz C, Baird MJ, Johnston JM. Psychometric validation of symptom severity measures in irritable bowel syndrome with constipation. Aliment Pharmacol Ther. 2014 Aug;40(3):298-308. doi: 10.1111/apt.12830
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.
Carson R, Nelson LM, Williams VS, Fehnel SE, Tourkodimitris S, Baird M, et al a. Psychometric evaluation of patient-reported outcome measures for assessing ibs-c symptom severity and change: results from 2 randomized, double-blind, placebo-controlled phase 3 trials of linaclotide. Poster presented at the Annual Scientific Meeting of the American College of Gastroenterology; October 1, 2012.
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.
Carson RT, Nelson LM, Williams VSL, Fehnel SE, Tourkodimitris S, Baird MJ, Johnston JM. Psychometric evaluation of patient-reported outcome measures for assessing IBS-C symptom severity and change: results from two randomized, double-blind, placebo-controlled phase 3 trials of linaclotide. Poster presented at the Joint International Neurogastroenterology and Motility Meeting; September 2012. [abstract] Neurogastroenterol Motil. 2012 Sep 1; 24(Suppl. 2):179.
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
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.
Khan SB, Faulkner E, Watkins J, Polkus V. Making a case for value: differences in dossier development and value communication for pharmaceuticals versus diagnostics and medical devices. Presented at the 2010 ISPOR 15th Annual International Meeting; May 2010. Atlanta, GA.