Publications

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Displaying 1 through 50 of 138 publications.

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 presented at the ISPOR Europe 2024; November 17, 2024. Barcelona, Spain. [abstract] Value Health. 2024 Dec; 27(12 Supplement):S506. doi: 10.1016/j.jval.2024.10.3260

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. [abstract] Value Health. 2024 Dec; 27(12 Supplement):S516-7. doi: 10.1016/j.jval.2024.10.3307

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 presented at the ISPOR Europe 2024; November 20, 2024. Barcelona, Spain. [abstract] Value Health. 2024 Dec; 27(12 Supplement):S568. doi: 10.1016/j.jval.2024.10.3550

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

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

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

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

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

Doma R, Suminski N, Gold A. Landscape analysis of Alzheimer's disease-specific caregiver outcome assessments. Poster presented at the ISPOR Europe 2023; November 12, 2023. Copenhagen, Denmark. [abstract] Value Health. 2023 Dec; 26(12 Supplement):S227. doi: 10.1016/j.jval.2023.09.1173

Gold A, Brouwer E, Hakkarainen KM, Brown D. A review of patient-reported outcomes and external control arms in regulatory submissions of novel oncology drugs. Poster presented at the ISPOR Europe 2023; November 12, 2023. Copenhagen, Denmark. [abstract] Value Health. 2023 Dec; 26(12 Supplement):S216-7. doi: 10.1016/j.jval.2023.09.1120

Gnanasakthy A, Norcross L, Fitzgerald K. Editorial - Assessment of patient-reported outcomes in industry-sponsored phase 1 oncology studies: considerations for translating theory into practice. Value Health. 2023 Jun 21;26(10):1440-3. doi: 10.1016/j.jval.2023.06.006

Grant S, Gold A, Pavisic I, Doma R, Rudell K. Using qualitative methods to develop grounded relevant content for preference surveys in a Specific Rare Bleeding Disorder (SRBD). Poster presented at the ISPOR 2023; May 7, 2023. Boston, MA. [abstract] Value Health. 2023 Jun; 26(6 Supplement):S327. doi: 10.1016/j.jval.2023.03.1864

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. [abstract] Value Health. 2023 Jun; 26(6 supplement):S352. doi: 10.1016/j.jval.2023.03.2395

Doma R, Gold A, Gregg M, Brouwer ES, Rudell K. A secondary analysis of the cross-cultural validation of multi-dimensional postpartum health PROMs, and suggestions for improving their validity and administration. Poster presented at the ISPOR 2023; May 7, 2023. Boston, MA. [abstract] Value Health. 2023 Jun; 26(6 Supplement):S189. doi: 10.1016/j.jval.2023.03.1021

Gnanasakthy A, Levy C, Norcross L, Doward L, Winnette R. A review of labeling based on patient reported outcome endpoints for new oncology drugs approved by the European Medicines Agency (2017-2021). Value Health. 2023 Jun;26(6):893-901. doi: 10.1016/j.jval.2023.01.017

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. [abstract] Value Health. 2023 Jun; 26(6 supplement):S315. doi: 10.1016/j.jval.2023.03.1800

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

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

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

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

Whalley D, Belongie K, Frangiosa T, Krasa H, Mladsi DM, Twiss J, Wolowacz S. Understanding the patient experience of erythropoietic protoporphyria and x-linked protoporphyria: a qualitative study. Poster presented at the ISPOR 2022 Conference; May 15, 2022. Washington, DC. [abstract] Value Health. 2022 Jun; 25(6 S1).

Gnanasakthy A, Norcross L, (DeMuro) Romano C, Carson RT. A review of patient-reported outcome labeling of FDA-approved new drugs (2016-2020): counts, categories, and comprehensibility. Value Health. 2022 Apr;25(4):647-55. doi: 10.1016/j.jval.2021.10.006

Williams V, DeMuro C, Finelli L, Qin S, Saretsky TL, Ma J, Lewis S, Phillips M, Osborne RH. Preliminary psychometric evaluation of the respiratory syncytial virus infection intensity impact questionnaire (RSV-IIIQ) in adults. Poster presented at the Virtual ISPOR EUR 2021; November 30, 2021. [abstract] Value Health. 2022 Jan 1; 25(1 Supplement):S234. doi: 10.1016/j.jval.2021.11.1144

Martin SA, Meckley LM, Harris NI, Chen KS, Leffler DA. Symptom assessment in adolescents and adults with celiac disease. Poster presented at the Virtual ISPOR Europe 2021; December 1, 2021. [abstract] Value Health. 2021 Dec; 24(12):S2.

DeMuro C. Two years of COVID-19: what has been the global impact on HRQoL and clinical outcomes? Presented at the Virtual ISPOR Europe 2021; November 2021. [abstract] Value Health. 2021 Dec; 24(12):S2.

Gnanasakthy A, Barrett A, Norcross L, D’Alessio D, Romano (DeMuro) C. Use of patient and investigator global impression scales: a review of Food and Drug Administration–approved labeling, 2009 to 2019. Value Health. 2021 Jul;24(7):1016-23. doi: 10.1016/j.jval.2021.01.005

Shah SN, Hepp Z, Martin S, Harris N, Morgans A. Qualitative analysis of pain in patients with locally advanced or metastatic urothelial cancer. Poster presented at the Virtual ISPOR Europe 2020 Conference; November 2020. [abstract] Value Health. 2020 Dec; 23(S2).

VanderPluym JH, Ramirez-Campos V, Cortez A, Cohen J, Gandhi S, Lewis S, Sweeney C, DeMuro C, Lipton R. Patient-reported outcomes to assess symptoms and effects across all 5 phases of migraine. Poster presented at the 2020 ISPOR Conference (Conference cancelled); May 2020. [abstract] Value Health. 2020 May; 23(Supplement 1):S280.

Saretsky T, Finelli L, Phillips M, DeMuro C, Lewis S, Norquist J, Monto A, Martin ET, Osborne RH. Measuring Respiratory Syncytial Virus (RSV) symptom intensity and impact in adults: content validity assessment of a Patient-Reported Outcome (PRO) measure: the RSV Infection Intensity and Impact Questionnaire (RSV-IIIQ). Poster presented at the 2020 ISPOR Virtual Conference; May 2020. [abstract] Value Health. 2020 May 1; 23(Supplement 1):S360. doi: 10.1016/j.jval.2020.04.1380

Gnanasakthy A, Barrett A, D'Alessio D, Norcross L. Review of patient and clinician global assessments in PRO labeling (2017-2019). Poster presented at the ISPOR Virtual 2020 Conference; May 2020. [abstract] Value Health. 2020 May 1; 23(Suppl 1):S299. doi: 10.1016/j.jval.2020.04.094

Reed SD, McLeod L. Moving beyond the tip of the iceberg to incorporate patients' perspectives and outcomes in the medical device regulatory process. Value Health. 2020 Mar;23(3):298-9. doi: 10.1016/j.jval.2020.01.008

Twiss J, Whalley D, Doward L, Balp MM, Brass C, Lopez P, Loeffler J, Cai J, Cryer D, Sanyal AJ, Anstee QM. Psychometric evaluation of NASH-CHECK, a patient-reported outcome measure for Nonalcoholic Steatohepatitis. Poster presented at the ISPOR 2019 European Conference; November 6, 2019. Copenhagen, Denmark. [abstract] Value Health. 2019 Dec; 22(S3).

Barrett A, Hahn-Pedersen J, Kragh N, Evans E, Gnanasakthy A. Patient-reported outcome measures in atopic dermatitis and chronic hand eczema in adults. Poster presented at the ISPOR 2019 European Conference; November 4, 2019. Copenhagen, Denmark. [abstract] Value Health. 2019 Dec; 22(S3).

Crawford SR, Morrison R, Doward L. The rise of the social media machine - a review of patient-centered research utilizing social media research methods presented at ISPOR (2010 -2018). Poster presented at the ISPOR 2019 European Conference; November 4, 2019. Copenhagen, Denmark. [abstract] Value Health. 2019 Dec; 22(S3). doi: 10.1016/j.jval.2019.09.2281

Ervin C, Thach A, Lee A, Navia B, Evans E, Doward L. Refinement of the treatment preference questionnaire in adults with Parkinson's Disease and off-episodes. Poster presented at the ISPOR 2019 European Conference; November 6, 2019. Copenhagen, Denmark. [abstract] Value Health. 2019 Nov; 22(S3):S756. doi: 10.1016/j.jval.2019.09.1870

Gnanasakthy A, Barrett A, Evans E, D'Alessio D, Romano (DeMuro) C. A review of patient-reported outcomes labeling for oncology drugs approved by the FDA and the EMA (2012-2016). Value Health. 2019 Feb;22(2):203-9. doi: 10.1016/j.jval.2018.09.2842

Coles T, Williams V, Dwyer K, Mordin M. Psychometric evaluation of the patient's knee implant performance questionnaire. Value Health. 2018 Nov;21(11):1305-12. doi: 10.1016/j.jval.2018.05.006

DeMuro C, Lewis S, Barrett A, Andersson FL. Assessing sleep impact in patients with nocturia disorder. Poster presented at the 2018 ISPOR 23rd Annual International Meeting; May 22, 2018. Baltimore, MD. [abstract] Value Health. 2018 May; 21(Suppl 1):S267. doi: 10.1016/j.jval.2018.04.1816

Qin S, Coles T, Nelson L, McLeod L, Williams V, Williams N, Reaney M. CDFs and PDFs: comparing visual methods supporting responder thresholds in clinical trials. Poster presented at the 2018 ISPOR 23rd Annual International Meeting; May 21, 2018. Baltimore, MD. [abstract] Value Health. 2018 May; 21(Suppl):S53. doi: 10.1016/j.jval.2018.04.442

Svedsater H, Doward L, Whalley D, Crawford R, Leather D, Lay-Flurrie J, Bosanquet N. Salford Lung Study in Chronic Obstructive Pulmonary Disease (SLS COPD): follow-up interviews on patient-centered outcomes. Poster presented at the 2017 ISPOR 22nd Annual International Meeting; May 23, 2017. Boston, MA. [abstract] Value Health. 2017 May; 20(5):A205.

McLeod L, Sikirica MV, Qin S, Joshi AV, Sweeney CT, Blum SI. Psychometric evaluation of the nausea and vomiting questionnaire in patients with type 2 diabetes mellitus receiving a glucagon-like peptide-1 receptor agonist. Poster presented at the 2017 ISPOR 22nd Annual International Meeting; May 23, 2017. Boston, MA. [abstract] Value Health. 2017 May; 20(5):A175.

McLeod L, Sikirica MV, Davenport E, Sweeney CT, Joshi AV. The impact of GLP-1 induced nausea and vomiting on work productivity and health-related quality of life in patients with T2DM. Poster presented at the 2017 ISPOR 22nd Annual International Meeting; May 23, 2017. Boston, MA. [abstract] Value Health. 2017 May; 20(5):A172.

DeMuro C, Gnanasakthy A, Price M, Winnette R, Desphande A. Development of a daily diary to assess signs and symptoms of genital herpes. Poster presented at the 2017 ISPOR 22nd Annual International Meeting; May 22, 2017. Boston, MA. [abstract] Value Health. 2017 May; 20(5):A80.

Park J, Covert D, Fairchild C, Brubaker M, Martin SA, Lewis S, DeMuro C. Development of an eye drop comfort measure for topical ocular drop application. Poster presented at the 2017 ISPOR 22nd Annual International Meeting; May 24, 2017. Boston, MA. [abstract] Value Health. 2017 May; 20(5):A364.

Fehnel SE, Ervin CM, Carson RT, Rigoni G, Lackner JM, Coons SJ. Development of the diary for irritable bowel syndrome symptoms to assess treatment benefit in clinical trials: foundational qualitative research. Value Health. 2017 Apr;20(4):618-26.

Gnanasakthy A, Mordin M, Evans E, Doward L, DeMuro C. A review of patient-reported outcome labeling in the United States (2011-2015). Value Health. 2017;20(3):420-9. doi: 10.1016/j.jval.2016.10.006

Martin SA, Chen K, Harris NI, Vera-Llonch M. Development of a patient-reported outcome measure for chronic hypoparathyroidism. Poster presented at the 2016 ISPOR 19th Annual European Congress; November 1, 2016. Vienna, Austria. [abstract] Value Health. 2016 Nov; 19(7):A679.