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
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
Mordin M, Castro C, Gnanasakthy A. Trends in the inclusion of patient reported outcomes in oncology clinical trials: analysis of clinicaltrials.gov (2013-2022). Poster presented at the ISPOR 2023 Conference; May 8, 2023. Boston, MA. [abstract] Value Health. 2023 Jun; 26(6 supplement):S325. doi: 10.1016/j.jval.2023.03.1852
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
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
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
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
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).
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
Zhou X, Eid D, Gnanasakthy A. Methods for reporting the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) data in cancer clinical trials. Poster presented at the 2018 ISPOR 23rd Annual International Meeting; May 21, 2018. Baltimore, MD. [abstract] Value Health. 2018 May; 21(Suppl 1):S226. doi: 10.1016/j.jval.2018.04.1528
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.
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
Mordin M, Haydysch E, Graham-Clarke CP, Gnanasakthy A, Nikai E. Patient perceptions of psoriasis: a review of the survey literature by geography. Poster presented at the 2016 ISPOR 21st Annual International Meeting; May 23, 2016. Washington, DC. [abstract] Value Health. 2016 May; 19(3):A126-7.
Gnanasakthy A, Mordin M, Haydysch E, DeMuro C. FDA patient-reported outcome labeling of novel therapies (2011-2015). Poster presented at the 2016 ISPOR 21st Annual International Meeting; May 25, 2016. Washington, DC. [abstract] Value Health. 2016 May; 19(3):A285-6.
Gnanasakthy A, DeMuro C. Outcome assessments of primary endpoints of new drugs approved by the FDA (2011-2015). Poster presented at the 2016 ISPOR 21st Annual International Meeting; May 25, 2016. Washington, DC. [abstract] Value Health. 2016 May; 19(3):A275.
Rothman M, Gnanasakthy A, Wicks P, Papadopoulos EJ. Can we use social media to support content validity of patient-reported outcome instruments in medical product development? Value Health. 2015 Jan;18(1):1-4. doi: 10.1016/j.jval.2014.10.001
Strober B, Zhao Y, Tran MH, Gnanasakthy A, Nelson LM, McLeod LD, Mordin M, Gottlieb A, Elewski B, Lebwohl MG. Psychometric evaluation of the Psoriasis Symptom Diary using phase 3 trial data. Poster presented at the 2014 ISPOR 19th Annual International Meeting; May 2014. Montreal, Canada. [abstract] Value Health. 2014 Jun; 17(3):A288. doi: 10.1016/j.jval.2014.03.1676
Stull DE, McBride D, Gnanasakthy A, Balp M. Correlations between changes in the urticaria activity score (UAS7) and the dermatology life quality index (DLQI) from baseline to 28 or 40 weeks: comparisons of trajectories of change in patients with chronic spontaneous/idiopathic urticaria (CSU/CIU). Poster presented at the 2013 ISPOR 16th Annual European Congress; November 2013. [abstract] Value Health. 2013 Nov; 16(7):A509.
DeMuro C, Clark M, Coon C, Evans E, Mordin M, Gnanasakthy A. Assessment of PRO labels claims granted by the FDA as compared to the EMA. 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.2012.03.1085
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
Gnanasakthy A, Lewis S, Clark M, Evans E, Mordin M, DeMuro C. Reported outcomes as primary endpoints in confirmatory clinical trials. Poster presented at the 2012 ISPOR 17th Annual International Meeting; June 2012. Washington, DC. [abstract] Value Health. 2012 Jun; 15(4):A200.
Gnanasakthy A, Mordin M, Clark M, DeMuro C, Fehnel S, Copley-Merriman C. A review of patient-reported outcome labels in the United States: 2006 to 2010. Value Health. 2012 May;15(3):437-42. doi: 10.1016/j.jval.2011.11.032
Gnanasakthy A, DeMuro C, Mordin M, Copley-Merriman K, Mauskopf J. The role of the patient voice in health technology assessment. Poster presented at the 2010 ISPOR 15th Annual International Meeting; May 2010. Atlanta, GA. [abstract] Value Health. 2010 May; 13(3):A19. doi: 10.1016/S1098-3015(10)72074-X
Yost KJ, Sorenson MV, Hahn EA, Glendenning GA, Gnanasakthy A, Cella D. Using multiple anchor- and distribution-based estimates to evaluate clinically meaningful change on the Functional Assessment of Cancer Therapy-Biologic Response Modifiers (FACT-BRM) instrument. Value Health. 2005 Mar;8(2):117-27.