Publications

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Displaying 1 through 50 of 1477 publications.

Sauchelli Toran S, Whalley D, Orfanos P, Kohli R, Balp MM. Clinical relevance of disease activity scores from the patient perspective in chronic spontaneous urticaria. Poster to be given at the ISPOR Europe 2024; November 20, 2024. Barcelona, Spain.

Whalley D, Balp MM, Yarr S, Korver D, Sauchelli Toran S, Kohli R, Orfanos P. Psychometric evaluation of the urticaria activity score in chronic spontaneous urticaria. Poster to be given at the ISPOR Europe 2024; November 17, 2024. Barcelona, Spain.

Gnanasakthy A, Crawford R, Qin S, Doward L, Rockwood NJ. Advanced patient-reported outcomes. Presentation to be given at the ISPOR Europe 2024; November 17, 2024. Barcelona, Spain. Previously presented at the ISPOR 2024.

Sauchelli Toran S, Whalley D, Balp MM, Kohli R, Orfanos P. Content validity of the angioedema activity score from the perspective of adults with chronic spontaneous urticaria. Poster presented at the ISPOR Europe 2024; November 2024. Barcelona, Spain.

Bratlee-Whitaker E, Hill NL, Mogle J, Bhargava S, DeMuro Romano C. Older adults' dementia worry, self-reported cognition, and control beliefs about cognitive aging: a mixed methods study. Presented at the 31st Annual Conference of the International Society for Quality of Life Research (ISOQOL); October 15, 2024. Cologne, Germany. [abstract] Qual Life Res. 2024 Oct 14; 33(Suppl 1).

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.

Yap C, Aiyegbusi OL, Alger E, Basch E, Bell J, Bhatnagar V, Cella D, Collis P, Dueck AC, Gilbert A, Gnanasakthy A, Greystoke A, Hansen AR, Kamudoni P, Kholmanskikh O, King-Kallimanis BL, Krumbolz H, Minchom A, O'Connor D, Petrie J, Piccinin C, Rantell KR, Rauz S, Retzer A, Rizk S, Wagner L, Sasseville M, Seymour LK, Weber HA, Wilson R, Calvert M, Peipert JD. Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable. EClinicalMedicine. 2024 Oct;76:102838. doi: 10.1016/j.eclinm.2024.102838

Bhushan NL, DeMuro Romano C, Gras-Najjar J, Reno J, Rockwood N, Quattrone W, Adams ET, Kelly B, McLeod L, Bhavnani SP, Bocell FD, Campbell M, Kontson K, Reasner D, Zhang C, Retzky S. Remote-use applications of the amyotrophic lateral sclerosis functional rating scale-revised clinical outcome assessment tool: a scoping review. Value Health. 2024 Oct;27(10):1454-65. doi: 10.1016/j.jval.2024.05.005

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

Hill NL, Bhargava S, Do J, Bratlee-Whitaker EM, Brown MJ, Komalasari R, Wu R, Mogle J. Just as expected? Older adults' aging expectations are associated with subjective cognition. Aging Ment Health. 2024 Sep 6. doi: 10.1080/13607863.2024.2399080

Pandya AG, Amoloja T, Bibeau K, DiBenedetti D, Kosa K, Butler K, Kornacki D, Ezzedine K. Assessing participants' experiences with vitiligo from patient interviews. Dermatol Ther. 2024 Sep;14(9):2467-78. doi: 10.1007/s13555-024-01241-w

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

Romano (DeMuro) C, Bratlee-Whhitaker E, Hartry A, Mearns E, Taylor J, Taylor G, Callahan L, Monks D, Kremer I, Lappin D, Frangiosa T, Sangodkar S, Herring WL, Gnanasakthy K, Goss D, McLeod L, Edwards T, Poulos C, DiBenedetti D, Paulsen R. Measuring what matters most to people living with Alzheimer's disease and care partners: what matters most quantitative research development. Poster presented at the Alzheimer's Association International Conference (AAIC) 2024; July 31, 2024. Philadelphia, PA.

Clevenger C, Brubaker M, Jackson WC, Stroud J, Peschin S, Fehnel S, Brown TM, Bratlee-Whitaker E, Bucior I, Patel M, Grossberg G. Study protocol: quantitative evaluation of the Agitation in Alzheimer's screener for caregivers (AASC™), a novel tool for improving recognition of agitation in Alzheimer's dementia. Poster presented at the Alzheimer's Association International Conference (AAIC) 2024; July 28, 2024. Philadelphia, PA.

Kamudoni P, Amtmann D, Johns J, Cook KF, Salem R, Salek S, Raab J, Middleton R, Repovic P, Alschuler KN, Geldern GV, Wundes A, Barrett A, Olayinka-Amao O, Henke C. People with multiple sclerosis help design a tool to measure physical functioning and how it affects their daily lives: a plain language summary. Neurodegener Dis Manag. 2024 Jul 26;1-7. doi: 10.1080/17582024.2024.2357002

Kessler AS, Brown TM, Bratleey-Whitaker E, Arca M, Baass A, Baum SJ, Bergeron J, Gauget D, Grijalvo OM, Alexander VJ, Llonch MV, Fehnel S, Tsimikas S. Patient experience with familial chylomicronemia syndrome before and after olezarsen treatment: qualitative interviews with clinical trial participants. Poster presented at the PancreasFest 2024; July 25, 2024. Cincinnati, OH. Previously presented at the National Lipid Association Scientific Sessions 2024.

Norman KS, Brookhart MA, Anakwenze OA, Bolognesi MP, Horn ME, Goode AP, George SZ. Can patient reported outcomes measurement information system (PROMIS) estimate high-impact chronic pain after total shoulder arthroplasty? JSES Int. 2024 Jul 22. doi: 10.1016/j.jseint.2024.07.005

Percy AK, Neul JL, Benke TA, Berry-Kravis EM, Glaze DG, Marsh ED, Barrett AM, An D, Bishop KM, Youakim JM. Trofinetide for the treatment of Rett syndrome: long-term safety and efficacy results of the 32-month, open-label LILAC-2 study. Med. 2024 Oct 11;5(10):1275-1281. doi: 10.1016/j.medj.2024.06.007

McCann E, Peterson KA, Whalley D, Qin S, Tilton ST, Kamat S, Sun X, Dellon ES. Psychometric evaluation of the Dysphagia Symptom Questionnaire for adults and adolescents with eosinophilic esophagitis. J Allergy Clin Immunol Glob. 2024 Jul 16;3(4):100302. doi: 10.1016/j.jacig.2024.100302

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

Norman K, Bettger J, Dong C, French A, Lake A, Tchuisseu YP, Repka S, Vasudeva K, Whitaker R. Perspectives of telehealth and the impact on equity in access to health care from community members and healthcare providers: a multimethod analysis. Poster presented at the Academy Health 2024 Annual Research Meeting; June 30, 2024. Baltimore, MD.

Norman K, Barton K, Boucher H, Collyar D, Doemberg S, King H, Lydon E, Miller J, Oakes M, Radar A, Ruffin F, Skalla L, Wang T-W. A systematic review of patient-reported health-related quality of life measurement in patients with acute bacterial skin and skin structure infection. Poster presented at the Academy Health 2024 Annual Research Meeting; June 30, 2024. Baltimore, MD.

Paller AS, Siegfried EC, Marron SE, Clark M, Harris N, Kosa K, Qin S, Whalley D, Chao J, Bansal A, Chuang CC, Wang Z. Skin pain and sleep quality numeric rating scales for children aged 6 months to 5 years with atopic dermatitis. J Eur Acad Dermatol Venereol. 2024 Jun 29. doi: 10.1111/jdv.20199

Ridley M, Strauss RP, Drake AF, Miller MQ. Narrative study of resilience in facial paralysis: Similarities and differences in the resilience profiles and psychosocial responses of patients with congenital and acquired types. Presented at the Appearance Matters 10 Conference (UWE Bristol); June 11, 2024. Bristol, UK.

Jain M, Girardi A, Ridley M, Rudell K, Gold A. Impact of caring for persons with schizophrenia: review of burden assessment measures. Poster presented at the ISPOR 2024; May 5, 2024. Atlanta, GA. [abstract] Value Health. 2024 Jun; 27(6 Supplement):S34. doi: 10.1016/j.jval.2024.03.181

Martin S, Kosa K, Podgrabinska S, Garg A, Oral EA, Yildirim Simsir I, Brown RJ, Ozen S, Pagovich O, Srinivasan D, Sanchez RJ. Qualitative interviews describing the patient experience of individuals with generalized lipodystrophy enrolled in a clinical trial of mibavademab. Poster presented at the Endocrine Society (ENDO) 2024; June 1, 2024. Boston, MA.

Girardi A, Ridley M, Suminski N, Gold A, Rudell K. Saturation reporting in COA development and validation studies: a scoping overview. Poster presented at the ISPOR 2024; May 5, 2024. Atlanta, GA. [abstract] Value Health. 2024 Jun; 27(6 Supplement):S54. doi: 10.1016/j.jval.2024.03.2199

Roth CL, Shoemaker AH, Ervin C, Norcross L, Fehnel S, Huber C, Scimia C, Abuzzahab MJ. Patient- and caregiver-reported experiences of hunger, weight, and energy in acquired yypothalamic obesity before and during setmelanotide treatment. Poster presented at the Endocrine Society (ENDO) 2024; June 1, 2024. Boston, MA.

Gaudiani L, Sikirica S, Hardin MB, Ervin CM, Goss DS, Kosa KM, Gopinathan S. Patient-reported burden of disease in diabetic peripheral neuropathic pain: learnings from in-depth patient interviews, sub-study of RELIEF-DPN 1. Poster presented at the American Diabetes Association's 84th Scientific Sessions; June 21, 2024. Orlando, FL. [abstract] Diabetes. 2024 Jun; 73(Suppl 1):484.

Potashman MH, Rudell K, Abetz-Webb L, Suminski N, Gold A, Doma R, Jarodia K, Buckley C, Ridley M, Lerner J, Mather J, Millichap J, Berg AT, L'Italien G. Understanding lived experiences with KCNQ2-development and epileptic encephalopathy (KCNQ2-DEE) - parent interviews. Poster presented at the Congress of the European Academy of Neurology (EAN); June 29, 2024. Helsinki, Finland. [abstract] Eur J Neurol. 2024 Jun; 31(Suppl 1):363.

Slota C, Norcross L, Comerford E, Sasane M, Zheng Y, Gnanasakthy A. Critical comments by Food and Drug Administration Reviewers on patient-reported outcomes in Food and Drug Administration Regulatory Submissions (2018-2021) [Editor's Choice]. Value Health. 2024 Jun;27(6):755-66. doi: 10.1016/j.jval.2024.02.011

Kessler AS, Brown TM, Bratlee-Whitaker E, Arca M, Baass A, Baum SJ, Bergeron J, Gaudet D, Grijalvo OM, Alexander VJ, Llonch MV, Fehnel S, Tsimikas S. Patient experience with familial chylomicronemia syndrome before and after olezarsen treatment: qualitative interviews with clinical trial participants. Poster presented at the National Lipid Association Scientific Sessions 2024; May 30, 2024. Las Vegas, NV.

Simpson EL, Eckert L, Gadkari A, Brown TM, Lio PA, Lockshin B, Nelson L, Fehnel SE, Mahajan P, Chao J, Nygardas M, Guillemin I. Evaluating the clinical utility of the Atopic Dermatitis Control Tool: measurement properties and agreement between patients' responses and clinicians' impressions of atopic dermatitis control. Br J Dermatol. 2024 May 17;190(6):917-9. doi: 10.1093/bjd/ljae056

Jang H, Hill NL, Turner J, Bratlee-Whitaker E, Jeong M, Mogle J. Poor-quality daily social encounters, daily stress, and subjective cognitive decline among older adults. Innov Aging. 2024 May 8. doi: 10.1093/geroni/igae038

Gnanasakthy A, Crawford R, Qin S, Rockwood N, Doward L. Advanced patient-reported outcomes. Presented at the ISPOR 2024; May 5, 2024.

McLeod L, Ervin C, Fehnel SE, Eremenco S, Carson RT, Hanlon J, Coons SJ. Psychometric evaluation of the diary for irritable bowel syndrome symptoms-constipation in a prospective observational study. Value Health. 2024 May;27(5):614-22. doi: 10.1016/j.jval.2024.01.013

Kimpel CC, Myer EA, Cupples A, Roman Jones J, Seidler KJ, Rick CK, Brown R, Rawlins C, Hadler R, Tsivitse E, Lawlor MAC, Ratcliff A, Holt NR, Callaway-Lane C, Godwin K, Ecker AH. Identifying barriers and facilitators to veterans affairs whole health integration using the updated consolidated framework for implementation research. J Healthc Qual. 2024 May;43(6):137-49. doi: 10.1097/JHQ.0000000000000419

Gnanasakthy A, Romano DeMuro C. Editorial - The limitations of EQ‑5D as a clinical outcome assessment tool. Patient. 2024 May;17(3):215-7. doi: 10.1007/s40271-024-00683-w

Yee KS, Alexanderian D, Martin S, Olayinka-Amao B, Whiteman DAH. Clinical investigator perspectives on patient outcomes in children with neuronopathic mucopolysaccharidosis II during intrathecal idursulfase-IT treatment. Orphanet J Rare Dis. 2024 Apr 12;19(1):148. doi: 10.1186/s13023-024-03147-4

Comerford E, Norcross L, Sasane M, Zheng Y, Gnanasakthy A. Patient-reported outcome (PRO) data in oncology NDAs approved by the FDA (2018–2021): a review of criticism and concerns in comments from regulators. Poster presented at the National Comprehensive Cancer Network (NCCN) 2024 Annual Conference; April 5, 2024. Orlando, FL. [abstract] J Natl Compr Canc Netw. 2024 Apr 5; 22(2.5). doi: 10.6004/jnccn.2023.7146

Reuteman-Fowler C, Tulliez S, Ridley M, Rudell K, Girardi A, Correll C, Keefe R, Goldring A. Objective burden among primary and secondary caregivers from cognitive impairment symptoms of patients with schizophrenia. Poster presented at the 2024 Annual Congress of the Schizophrenia International Research Society; April 3, 2024. Florence, Italy.

DeWaters AL, Miller EL, Haidet P, Gonzalo JD. Systems-based practice: expert perspectives on the origin and evolution of an ambiguous competency. Acad Med. 2024 Apr 1;99(4):424-9. doi: 10.1097/ACM.0000000000005478

Barrett A, Olayinka-Amao O, Ziemssen T, Bharadia T, Henke C, Kamudoni P. Understanding the symptoms and impacts experienced by people with relapsing-remitting MS: a qualitative investigation using semi-structured interviews. Neurol Ther. 2024 Apr;13(2):449-64. doi: 10.1007/s40120-024-00584-y

Bali V, Schelfhout J, Sher MR, Tripathi Peters A, Patel GB, Mayorga M, Goss D, Romano (DeMuro) C. Patient-reported experiences with refractory or unexplained chronic cough: a qualitative analysis. Ther Adv Respir Dis. 2024 Mar 19;18:175346662. doi: 10.1177/17534666241236025

Yee KS, Lewis S, Evans E, Romano (DeMuro) C, Alexanderian D. Caregiver experiences and observations of intrathecal idursulfase-IT treatment in a phase 2/3 trial in pediatric patients with neuronopathic mucopolysaccharidosis II. Orphanet J Rare Dis. 2024 Mar 10;19(1):100. doi: 10.1186/s13023-024-03034-y

Aiyegbusi OL, Cruz Rivera S, Roydhouse J, Kamudoni P, Alder Y, Anderson N, Baldwin RM, Bhatnagar V, Black J, Bottomley A, Brundage M, Cella D, Collis P, Davies EH, Denniston AK, Efficace F, Gardner A, Gnanasakthy A, Golub RM, Hughes SE, Jeyes F, Kern S, King-Kallimanis BL, Martin A, McMullan C, Mercieca-Bebber R, Monteiro J, Peipert JD, Quijano-Campos JC, Quinten C, Rantell KR, Regnault A, Sasseville M, Schougaard LMV, Sherafat-Kazemzadeh R, Snyder C, Stover AM, Verdi R, Wilson R, Calvert MJ. Recommendations to address respondent burden associated with patient-reported outcome assessment. Nat Med. 2024 Mar;30(3):650-9. doi: 10.1038/s41591-024-02827-9

Paller AS, Marron SE, Whalley D, Nelson L, Qin S, Chao J, Bansal A, Chuang C, Wang Z. Clinically meaningful change threshold in health‐related quality of life among patients aged 6 months to 5 years with atopic dermatitis and their caregiver(s)/family. JEACP. 2024 Mar;3(1):253-7. doi: 10.1002/jvc2.290

Williams V, DeMuro Romano C, Finelli L, Qin S, Saretsky TL, Ma J, Lewis S, Phillips M, Osborne RH, Norquist JM. Psychometric evaluation of the respiratory syncytial virus infection, intensity and impact questionnaire (RSV-iiiQ) in adults. Health Qual Life Outcomes. 2024 Feb 20;22(1):19. doi: 10.1186/s12955-023-02174-2

Brown TM, Vera-Llonch M, Kanu C, Sikora Kessler A, Yarlas A, Fehnel SE. Cross-sectional quantitative evaluation of a novel patient-reported outcome measure in familial chylomicronemia syndrome. Patient Relat Outcome Meas. 2024 Feb 15;15:45-59. doi: 10.2147/PROM.S441583

Do J, Fishman C, Bhargava S, Bratlee-Whitaker E, Turner JR, Mogle J, Hill NL. Aging expectations predict subjective cognitive decline among community-dwelling older adults. Poster presented at the Alpha Omega Alpha (AOA) Research Symposium; February 9, 2024. Philadelphia, PA.