Publications

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Displaying 1 through 50 of 1276 publications.

Chan EKH, Williams V, Romano C, Fehnel S, Slagle AF, Stoddard J, Sadoff J, Mayorga M, Lewis S, Yarr S, Ma J, Liu Y, Katz EG, McNulty P, van Dromme I, McQuarrie K. Psychometric evaluation of the symptoms of infection with coronavirus-19 (SIC): results from a cross-sectional study and a phase 3 clinical trial. J Patient Rep Outcomes. 2023 May 17;17(1):45. doi: 10.1186/s41687-023-00581-z

Kosa K, Mutebi A, Wang A, Blaedel J, Sacchi M, Martin S. Improvements in symptoms, impact of treatment, and satisfaction with treatment among patients with relapsed or refractory b-cell non-hodgkin lymphoma treated with subcutaneous epcoritamab. Poster presented at the ISPOR 2023 Conference; May 8, 2023. Boston, MA.

Frederiksen KS, Crawford R, Hahn-Pedersen JH, Morrison R, Jeppesen R, Doward L, Weidner W. Insights from social media posts on the lived experience of alzheimer's disease. Poster presented at the ISPOR 2023 Conference; May 7, 2023. Boston, MA.

Joly F, DasMahapatra P, DiBenedetti DB, Kosa K, Hill QA. Development of the cold agglutinin disease symptoms and impact questionnaire (CAD-SIQ). Eur J Haematol. 2023 May 2. doi: 10.1111/ejh.13984

Crawford R, Sikirica S, Morrison R, Cappelleri JC, Russell-Smith A, Shah R, Chadwick H, Doward L. The patient experience of acute lymphoblastic leukemia and its treatment: social media review. JMIR Cancer. 2023 May 1;9:e39852.. doi: 10.2196/39852

McLeod LD, Rockwood NJ. Editorial - Comparability among modes of data collection for patient-reported outcome measures: opening the gates for faithful migration. Value Health. 2023 May;26(5):620-2. doi: 10.1016/j.jval.2023.03.010

Ervin C, Norcross L, Mallya UG, Fehnel S, Mittleman RS, Webster M, Haqq AM, Haws RM. Interview-based patient- and caregiver-reported experiences of hunger and improved quality of life with setmelanotide treatment in bardet-biedl syndrome. Adv Ther. 2023 May;40(5):2394-411. doi: 10.1007/s12325-023-02443-y

Qin S, Nelson L, Williams N, Williams V, Bender R, McLeod L. Comparison of anchor-based methods for estimating thresholds of meaningful within-patient change using simulated PROMIS PF 20a data under various joint distribution characteristic conditions. Qual Life Res. 2023 May;32(5):1277-93. doi: 10.1007/s11136-022-03285-x

Gnanasakthy A, Norcross L, Clark M, Fitzgerald K. A review of patient-reported outcome considerations in oncologic drug advisory committee meetings (2016-2021). JCO Oncol Pract. 2023 May;19(5):e745-62. doi: 10.1200/OP.22.00774

Hauber B, Paulsen R, Krasa HB, Vradenburg G, Comer M, Callahan LF, Winfield J, Potashman M, Hartry A, Lee D, Wilson H, Hoffman DL, Weiberg D, Kremer IN, Taylor GA, Taylor JM, Lappin D, Martin AD, Frangiosa T, Biggar V, Slota C, Romano (DeMuro) C, DiBenedetti D. Assessing what matters to people affected by Alzheimer's disease: a quantitative analysis. Neurol Ther. 2023 Apr;12(2):505-27. doi: 10.1007/s40120-023-00445-0

DiBenedetti D, Menne H, Paulsen R, Krasa HB, Vradenburg G, Comer M, Callahan LF, Winfield J, Potashman M, Heithoff K, Hartry A, Oberdhan D, Wilson H, Hoffman DL, Weinberg D, Kremer IN, Taylor GA, Taylor JM, Lappin D, Martin AD, Hauber B, Romano (DeMuro) C. Technical review of clinical outcomes assessments across the continuum of Alzheimer's disease. Neurol Ther. 2023 Apr;12(2):571-95. doi: 10.1007/s40120-023-00443-2

Khan AH, Kosa K, De Prado Gomez L, Whalley D, Kamat S, Clark M. Content validation of patient-reported sleep measures and development of a conceptual model of sleep disturbance in patients with moderate-to-severe, uncontrolled asthma. Patient Relat Outcome Meas. 2023 Mar 23;14:57-71. doi: 10.2147/PROM.S392666

DeMuro C, Finelli L, Lewis S, Williams V, Martin E, Phillips M, Saretsky T, Osborne R, Norquist J. Assessing the patient experience of respiratory syncytial virus infection: development of a patient-reported outcome measure. Health Qual Life Outcomes. 2023 Feb 28;21(1):20. doi: 10.1186/s12955-022-02066-x

Sauchelli S, Pickles T, Voinescu A, Choi H, Sherlock B, Zhang J, Colyer S, Grant S, Sundari S, Lasseter G. Public attitudes towards the use of novel technologies in their future healthcare: a UK survey. BMC Med Inform Decis Mak. 2023 Feb 22;23(1):38. doi: 10.1186/s12911-023-02118-2

Martin S, Bender R, Krasner A, Marmon T, Monahan M, Nelson L. Development and evaluation of the acromegaly symptom diary. J Patient Rep Outcomes. 2023 Feb 15;7(1):15. doi: 10.1186/s41687-023-00541-7

Wilson A, Kragh N, DiBenedetti D, Pan-Petesch B, Wynn T, Neme D, Willemze A. Patient experience with efanesoctocog alfa: results from the XTEND-1 phase 3 clinical trial exit interviews in patients with severe haemophilia A. Poster presented at the 16th Annual Congress of European Association for Haemophilia and Allied Disorders 2023; February 7, 2023. Manchester, England. [abstract] Haematologica. 2023 Feb 5; 29(S1):137-8. doi: 10.1111/hae.14715

Gnanasakthy A, Levy C, Norcross L, Doward L, Winnette R. A review of labeling based on PRO endpoints for new oncology drugs approved by the European Medicines Agency (2017-2021). Value Health. 2023 Feb 4. doi: 10.1016/j.jval.2023.01.017

Cotter SP, Schwartz L, Strong TV, Bender RH, Fehnel S. The Prader-Willi syndrome anxiousness and distress behaviors questionnaire: development and psychometric validation. Value Health. 2023 Feb 1;26(2):243-50. doi: 10.1016/j.jval.2022.08.004

DeMuro (Romano) C, Mayorga M, Ruiz-Guinazu J, Trudel GC, Fehnel S, McQuarrie K, Chan EKH, Katz EG. Development of patient- and observer-reported outcome measures to assess COVID-19 signs and symptoms in children and adolescents. J Patient Rep Outcomes. 2023 Jan 26;7(1):7. doi: 10.1186/s41687-023-00542-6

Lansdall CJ, McDougall F, Butler LM, Delmar P, Pross N, Qin S, McLeod L, Zhou X, Kerchner GA, Doody RS. Establishing clinically meaningful change on outcome assessments frequently used in trials of mild cognitive impairment due to Alzheimer's disease. J Prev Alzheimers Dis. 2023;10(1):9-18. doi: 10.14283/jpad.2022.102

Browning JC, Cartwright M, Thorla, Jr. I, Martin SA, Olayinka-Amao O, Maeda-Chubachi T. A patient-centered perspective of molluscum contagiosum as reported by B-SIMPLE4 clinical trial patients and caregivers: global impression of change and exit interview substudy results. Am J Clin Dermatol. 2023 Jan;24(1):119-33. doi: 10.1007/s40257-022-00733-9

Gnanasakthy A, Qin S, Norcross L. Editorial - FDA guidance on selecting, developing, or modifying fit-for-purpose clinical outcome assessments: old wine in a new bottle? Patient. 2023 Jan. doi: 10.1007/s40271-022-00607-6

Romano C, Mayorga M, Ruiz-Guinazu J, Trudel GC, Fehnel S, McQuarrie K, Chan EKH, Katz EG. Evaluation of measures for the assessment of Covid-19 signs and symptoms in children and adolescents. Poster presented at the IDWeek 2022 Conference; October 21, 2022. Washington, DC. [abstract] Open Forum Infect Dis. 2022 Dec 15; 9(Issue Supplement_2):1061. doi: 10.1093/ofid/ofac492.902

Srivastava A, Rangarajan S, Ross C, Slota C, DiBenedetti D, Cano V, Andersson S, DasMahapatra P, Bartelt-Hofer J, Afonso M. Fitusiran reaches people's with hemophilia and their caregivers' treatment expectations: qualitative semi-structured interviews of participants of ATLAS-OLE trial (Interim analysis). Poster presented at the 64th ASH Annual Meeting and Exposition; December 11, 2022. New Orleans, LA.

Romano (DeMuro) C, Novak G, Choi J, Qin S, Henley D, Donohue M, Romano G, Raman R, Amariglio R, Aisen P, Sperling R. Assessing clinically meaningful functional outcomes in preclinical alzheimer's disease. Poster presented at the 15th Conference Clinical Trials Alzheimer's Disease 2022; November 29, 2022. San Francisco, CA. [abstract] J Prev Alzheimers Dis. 2022 Dec 3; 9(Supplement 1):S186-7.

Williams V, Romano (DeMuro) C, Clark M, Goss D, Naujoks C, Marvel J. Psychometric evaluation of a new electronic pediatric asthma symptom diary. Poster presented at the ISPOR Europe 2022; November 8, 2022. Vienna, Austria. [abstract] Value Health. 2022 Dec 1; 25(12):S428. doi: 10.1016/j.jval.2022.09.2130

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

Whalley D, Morrison R, Balp MM, Joubert Y, McKenna SJ, Christen L, Naujoks C, Gardner DD, Dery E, Lacombe A. Adaptation of the urticaria patient daily diary for caregiver completion in pediatric chronic spontaneous urticaria. 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.2022.09.2077

Crawford R, Thompson A, Chang J, Morrison R, Doward L. Patient and caregiver insight into the impact of non-muscle-invasive bladder cancer and its treatments: a social media review. Poster presented at the ISPOR Europe 2022; November 7, 2022. Vienna, Austria. [abstract] Value Health. 2022 Dec 1; 25(12):S409. doi: 10.1016/j.jval.2022.09.2032

Paller AS, Yosipovitch G, Weidinger S, DiBenedetti D, Whalley D, Gadkari A, Guillemin I, Zhang H, Eckert L, Chao J, Bansal A, Chuang CC, Delevry D. Development, psychometric validation and responder definition of worst itch scale in children with severe atopic dermatitis. Dermatol Ther. 2022 Dec;12(12):2839-50. doi: 10.1007/s13555-022-00804-z

Srivastava A, Rangarajan S, Ross C, Slota C, DiBenedetti D, Cano V, Andersson S, DasMahapatra P, Bartelt-Hofer J, Afonso M. Fitusiran reaches people's with hemophilia and their caregivers' treatment expectations: qualitative semi-structured interviews of participants of ATLAS-OLE Trial (Interim analysis). Poster presented at the American Society of Hematology (ASH) Annual Meeting 2022; December 11, 2022. New Orleans, LA. [abstract] Blood. 2022 Nov 15; 140(Suppl 1):7989-90. doi: 10.1182/blood-2022-166895

Bali V, Schelfhout J, Sher M, Peters A, Patel G, Mayorga M, (DeMuro) Romano C. Patient-reported symptoms, impacts, and treatment preferences in refractory or unexplained chronic cough: a qualitative study. Poster presented at the 2022 Advancing Allergy & Immunology Care (ACAAI) Annual Scientific Meeting; November 13, 2022. Louisville, KY.

Sauchelli S, Rogers PJ, Fry G, Hamilton-Shield JP. Preference for high carbohydrate foods does not change for children and adolescents in insulin-induced hypoglycemia. BMJ Open Diabetes Res Care. 2022 Nov 8;10(6). doi: 10.1136/bmjdrc-2022-003065

Cohen AD, Hari P, Htut M, Berdeja JG, Usmani SZ, Madduri D, Olyslager Y, Goldberg JD, Schecter JM, Jackson CC, Gries KS, Fastenau JM, Valluri S, Deraedt W, Akram M, Crawford R, Morrison R, Doward L, Morgan K, Seldam ST, Jakubowiak A, Jagannath S. Patient perceptions regarding ciltacabtagene autoleucel treatment: qualitative evidence from interviews with patients with relapsed/refractory multiple Myeloma in the CARTITUDE-1 study. Clin Lymphoma Myeloma Leuk. 2022 Nov 7;16:54. doi: /10.1016/j.clml.2022.10.001

Joly F, DasMahapatra P, Su J, DiBenedetti D, Kosa K, Hill QA. Creation of a cold agglutinin disease (CAD) specific patient-reported outcome (PRO) symptom measure. Poster presented at the 84th Annual Meeting of the Japanese Society of Hematology; October 14, 2022. Fukuoka, Japan.

Crawford R, Allas S, Tremel N, Weiss B, Robo C, Morrison R, Murphy D, Doward L. Development of the Hypoparathyroidism daily diary of symptom experience (HPT-DD-SE) and the Hypoparathyroidism life impact questionnaire (HPT-LIQ). Poster presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting 2022; September 9, 2022. Austin, TX.

Wainberg ZA, Enzinger PC, Qin S, Yamaguchi K, Gnanasakthy A, Taylor K, Jamotte A, Majer I, Kang YK. Health-related quality of life (HRQoL) in FGFR2b-overexpressing, advanced gastric or gastroesophageal junction cancer (G/GEJC): results from the FIGHT trial comparing bemarituzumab (BEMA) + modified FOLFOX6 (mFOLFOX6) to placebo (PBO) + mFOLFOX6. Poster presented at the 2022 ESMO Annual Conference; September 9, 2022. Paris, France.

Marvel J, Goransson O, Clark M, Romano (DeMuro) C, Olayinka-Amao O, Whalley D, Crawford R, Brindicci C, Garg K, Kordy K, Everhard F, Patalano F, Roesler Z, Landles R, Naujoks C, Gutzwiller FS. Interactive tablet application for self-report of asthma symptoms and impacts in young children. Poster presented at the ERS International Congress 2022; September 6, 2022. Barcelona, Spain. [abstract] Eur Respir J. 2022 Sep 4; 60(Suppl 66):2127. doi: 10.1183/13993003.congress-2022.2127

Lu E, Gnanasakthy A, Xie J, Latour A. Recognizing cultural diversity in patient-centered outcomes for healthcare decision making. Presented at the Vitrual ISPOR Asia Pacific 2022; September 2022.

Schlichting M, Hennig M, Rudell K, McLeod L, Bennett B, Shaw J, Doward L, Molsen-David E, Chassany O. Is IQWIG's 15% threshold universally applicable in assessing the clinical relevance of patient-reported outcomes changes? an ISPOR special interest group report. Value Health. 2022 Sep;25(9):1463-8. doi: 10.1016/j.jval.2022.07.010

Monsonet M, Rockwood NJ, Kwapil TR, Barrantes-Vidal N. Psychological pathways to paranoia and psychotic-like experiences in daily-life: the mediating role of distinct affective disturbances. Schizophr Bull. 2022 Sep 1;48(5):1053-65. doi: 10.1093/schbul/sbac071

Gnanasakthy A, Russo J, Gnanasakthy K, Harris N, Castro C. A review of patient-reported outcome assessments in registration trials of FDA-approved new oncology drugs (2014-2018). Contemp Clin Trials. 2022 Sep;120:106860. doi: 10.1016/j.cct.2022.106860

Dubov A, Distelberg BJ, Abdul-Mutakabbir JC, Peteet B, Roberts L, Montgomery SB, Rockwood N, Patel P, Shoptaw S, Chrissian AA. Racial/ethnic variances in COVID-19 inoculation among southern California healthcare workers. Vaccines-Basel. 2022 Aug 17;10(8):1331. doi: 10.3390/vaccines10081331

Paller A, Siegfried E, Marron SE, Clark M, Harris N, Quin S, Chao J, Bansal A, Sun Y, Chuang C, Wang Z. Development and validation of a caregiver reported numeric rating scale for measuring skin pain in children aged 6 months to 5 years with atopic dermatitis. Poster presented at the 2022 Society for Investigative Dermatology (SID) Annual Meeting; May 19, 2022. Portland, OR. doi: 10.1016/j.jid.2022.05.257

Paller A, Siegried E, Marron SE, Clark M, Kosa K, Whalley D, Chao J, Bansal A, Sun Y, Chuang C, Wang Z. Development and validation of a caregiver-reported numeric rating scale for measuring sleep quality in children aged 6 months to <6 years with atopic dermatitis. Poster presented at the 2022 Society for Investigative Dermatology (SID) Annual Meeting; May 19, 2022. Portland, OR. [abstract] J Invest Dermatol. 2022 Aug; 142(8 supplement):S42. doi: 10.1016/j.jid.2022.05.256

Paller A, Siegfried E, Marron SE, Clark M, DiBenedetti D, Nelson L, Chao J, Bansal A, Sun Y, Chuang C, Wang Z. Development and validation of a caregiver-reported numeric rating scale for measuring pruritus in children aged 6 months to <6 years with atopic dermatitis. Poster presented at the 2022 Society for Investigative Dermatology (SID) Annual Meeting; May 2022. Portland, OR. [abstract] J Invest Dermatol. 2022 Aug; 142(8 supplement):S25. doi: 10.1016/j.jid.2022.05.154

Haggerty A, Barrett A, Dine J, Martin L, Shah P, Buckingham T. Shared decision making in frontline maintenance therapy for ovarian cancer: a qualitative assessment. Poster presented at the 2022 Society of Gynecologic Oncology Annual Meeting; March 18, 2022. Phoenix, AZ. [abstract] Gynecol Oncol. 2022 Aug; 166(Supplement 1):S286. doi: 10.1016/S0090-8258(22)01810-8

Romano C, Fehnel S, Stoddard J, Sadoff J, Lewis S, McNulty P, Chan EKH, Evans E, Jamieson C, Slagle AF, Mangel A, McQuarrie K. Development of a novel patient‑reported outcome measure to assess signs and symptoms of COVID‑19. J Patient Rep Outcomes. 2022 Jul 29;6(1):85. doi: 10.1186/s41687-022-00471-w

Crawford R, Allas S, Tremel N, Weiss B, Robo C, Morrison R, Murphy D, Doward L. Living with an "invisible disease”: a qualitative study with patients with hypoparathyroidism. Poster presented at the Endocrine Society Annual Meeting (ENDO) 2022; June 11, 2022. Atlanta, GA.

Gnanasakthy A, Crawford R, Qin S, Bender R, Doward L. Advanced patient-reported outcomes. Presented at the 2022 ISPOR Virtual Short Course Program; June 8, 2022.