Publications

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Displaying 51 through 100 of 148 publications.

Lewis S, DeMuro C. Use of exit interviews with participants in randomized controlled trials: value of understanding the patient experience. Poster presented at the 9th Annual SCOPE Summit Conference; February 14, 2018. Orlando, FL.

Williams V, DeMuro C, Lewis S, Williams N, Wolynn T, Wisman P, Block SL, Senders S, Toback S, Chien JW. Psychometric evaluation of a caregiver diary for the assessment of symptoms of respiratory syncytial virus. J Patient Rep Outcomes. 2018;2(10). doi: 10.1186/s41687-018-0036-7

Deal LS, DeMuro C, DiBenedetti D, Lewis S. Development of the observable behaviors of autism spectrum disorder scale. Ther Innov Regul Sci. 2017 May 1;51(3):372-9. doi: 10.1177/2168479016680258

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.

Brogan AP, DeMuro C, Barrett AM, D’Alessio D, Bal V, Hogue SL. Payer perspectives on patient-reported outcomes in health care decision making: oncology examples. J Manag Care Spec Pharm. 2017 Feb;23(2):124-34. doi: 10.18553/jmcp.2017.23.2.125.

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

Williams V, Coles T, Gnanasakthy A, DeMuro C, Yarr S, Williams NJ, Lowes L, Alfano L, Tseng B. Psychometric validation of a patient-reported measure of physical functioning in sporadic inclusion body myositis. Muscle Nerve. 2016 Oct 13;54(4):658-65. doi: 10.1002/mus.25080

DeMuro C, Lewis S, Lowes L, Alfano L, Tseng B, Gnanasakthy A. Development of the sporadic inclusion body myositis physical functioning assessment (sIFA). Muscle Nerve. 2016 Oct;54(4):653-7. doi: 10.1002/mus.25079

Gnanasakthy A, DeMuro C, Clark M, Haydysch E, Ma E, Bonthapally V. Patient-reported outcomes labeling for products approved by the office of hematology and oncology products of the US Food and Drug Administration (2010-2014). J Clin Oncol. 2016 Jun 1;34(16):1928-34. doi: 10.1200/JCO.2015.63.6480

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.

Winnette R, Zárate V, Machnicki G, Demuro-Mercon C, Gawlicki M, Gnanasakthy A. Patient-reported outcomes in Latin America: implementation in research and role in emerging HTA systems. Value in Health Regional Issues. 2015 Dec;8:49-55. doi: 10.1016/j.vhri.2015.03.008

Hogue S, Brogan AP, DeMuro C, Barrett A, D'Alessio D, Bal V. Influence of Patient-Reported Outcomes (PRO) on market access decisions in markets with centralized healthcare systems. Poster presented at the 2015 ISPOR 18th Annual European Congress; November 2015. Milan, Italy.

Hogue S, Brogan AP, DeMuro C, D'Alessio D, Bal V. Patient Reported Outcomes (PRO) in post-progression oncology: implications in health technology assessments (HTA) & payer decision making. Poster presented at the 2015 ISPOR 18th Annual European Congress; November 2015. Milan, Italy.

Hogue SL, Brogan AP, DeMuro C, Barrett A, McLeod LD, D'Alessio D, Bal V. Payer perspectives of patient reported outcomes data: an online assessment. Poster presented at the ISOQOL 22nd Annual Conference; October 24, 2015. Vancouver, Canada.

Toback S, Lewis SA, DeMuro-Mercon CJ, Chien J, Schwartz R, Wolynn T, Wisman P, Block SL, Andrews W, Senders S, Williams NJ, Williams VS. Psychometric evaluation of a novel observer-reported outcome tool for the assessment of respiratory syncytial virus infection symptoms in infants. Poster presented at the IDWeek 2015; October 7, 2015. San Diego, CA.

Gnanasakthy A, DeMuro C. Overcoming organizational challenges of integrating patient-reported outcomes in oncology clinical trials. Ther Innov Regul Sci. 2015 Oct;49(6):822-30. doi: 10.1177/2168479015608413

Williams V, Coles T, DeMuro C, Lewis S, Williams N, Yarr S, Barghout V, Lowes L, Alfano L, Goldberg B, Gnanasakthy A, Tseng B. Psychometric evaluation of the Sporadic Inclusion Body Myositis (sIBM) Physical Functioning Assessment (sIFA). Poster presented at the 1st Annual International Conference on Myositis; May 2015. Stockholm, Sweden.

Hogue S, Brogan AP, DeMuro C, Barrett A, D'Alessio D, Bal V. Influence of patient-reported outcomes on market access decisions in decentralized markets (Brazil, Italy, Spain, and the United States). Poster presented at the 2015 ISPOR 20th Annual International Meeting; May 2015. Philadelphia, PA. [abstract] Value Health. 2015 May; 18(3):A212.

Mordin M, Brown TM, McLeod L, DeMuro C, Gnanasakthy A. Two companies following the FDA pro guidance leads to similar but different measures: a case study in psoriasis. Poster presented at the 2015 ISPOR 20th Annual International Meeting; May 2015. Philadelphia, PA.

DeMuro C, Lewis S, Lowes L, Tseng B, Gnanasakthy A. A novel measure to assess self-reported physical functioning in patients with sporadic inclusion body myositis. Poster presented at the 2015 ISPOR 20th Annual International Meeting; May 2015. Philadelphia, PA.

Barghout V, DeMuro C, Price M, Lewis S, Tseng B. Skeletal muscle activity and resource tool for sporadic inclusion body myositis: characterization of resource utilization and financial burden experienced by sIBM patients. Poster presented at the 2015 ISPOR 20th Annual International Meeting; May 2015. Philadelphia, PA.

Gnanasakthy A, DeMuro C, Lewis S, Tseng B. Development of a disease model for sporadic inclusion body myositis. Poster presented at the 2015 ISPOR 20th Annual International Meeting; May 2015. Philadelphia, PA.

Gnanasakthy A, DeMuro-Mercon CJ. Logistical considerations for intergrating patient-reported outcomes in multiregional clinical trials. Clinical Researcher. 2015 Apr;45-8.

Barrett AM, Harris NI, DeMuro-Mercon CJ, Phatak H. Literature review of patient-reported outcome measures assessing anticoagulant therapy. Poster presented at the 2014 ISPOR 17th Annual European Congress; November 2014. Amsterdam.

Gnanasakthy A, Sadrick A, Eghbal-Ahmadi M, DeMuro C. Promotion of patient-reported outcome label claims based on nonprimary endpoints. Ther Innov Regul Sci. 2014 Sep;48(5):557-63.

Clark MJ, Simons C, Haydysch EE, DeMuro-Mercon CJ, Gnanasakthy A. A review of patient-reported outcome orphan drug labels in the United States from January 2006-September 2013: analysis of evidence for orphan drug PRO label claims. Poster presented at the 2014 ISPOR 19th Annual International Meeting; June 3, 2014.

Coles T, Coon C, DeMuro C, McLeod LD, Gnanasakthy A. Psychometric evaluation of the Sheehan Disability Scale in adult patients with attention-deficit/hyperactivity disorder. Neuropsychiatr Dis Treat. 2014 May 19;10:887-95. doi: 10.2147/NDT.S55220. eCollection 2014

DeMuro CJ, McLeod LD, Fehnel SE, Meyer T. Determining clinically meaningful change in subjective tinnitus loudness. Presented at the 2014 International Tinnitus Seminar; May 2014. Berlin, Germany.

DeMuro C, Clark M, Doward L, Evans E, Mordin M, Gnanasakthy A. Assessment of PRO label claims granted by the FDA as compared to the EMA (2006–2010). Value Health. 2013 Dec;16(8):1150-5. doi: 10.1016/j.jval.2013.08.2293

Deal L, Lewis SA, DiBenedetti DB, DeMuro-Mercon CJ. Development of a clinical outcome assessment for autism spectrum disorder. Presented at the 20th Annual Conference of the International Society for Quality of Life Research; October 2013.

Barrett AM, Clark MJ, DeMuro C, Esser D. Proxy-reported questionnaires for young children with asthma: a structured review. Eur Respir J. 2013 Aug 1;42(2):513-26.

Gnanasakthy A, Lewis S, Clark M, Mordin M, DeMuro C. Potential of patient-reported outcomes as nonprimary endpoints in clinical trials. Health Qual Life Outcomes. 2013 May 15;11:83.

Gnanasakthy A, DeMuro C, Boulton C. Integration of patient-reported outcomes in multiregional confirmatory clinical trials. Contemp Clin Trials. 2013 May 1;35(1):62-9.

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.

Fehnel S, DeMuro C, McLeod L, Coon C, Gnanasakthy A. FDA patient-reported outcome guidance: great expectations and unintended consequences. Expert Rev Pharmacoecon Outcomes Res. 2013;13(4):441-6.

Gnanasakthy A, Doward L, Clark M, Mordin M, DeMuro C. Concordance of pro labeling claims between the FDA and EMA. Poster presented at the 2012 ISPOR 15th Annual European Congress; November 9, 2012. Berlin, Germany. [abstract] Value Health. 2012 Nov; 15(7):A321.

Engelhart L, Nelson L, Lewis S, Mordin M, Demuro-Mercon C, Uddin S, McLeod L, Cole B, Farr J. Knee injury and osteoarthritis outcome score subscales for patients with articular cartilage lesions of the knee. Am J Sports Med. 2012 Oct 1;40(10):2264-72.

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, Lewis SA, Clark MJ, Mordin MM, Evans E, DeMuro-Mercon CJ. The impact of primary endpoints on patient-reported outcome label claims. Poster presented at the 2012 ISPOR 17th Annual International Meeting; June 2012.

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.

DeMuro C, Clark M, Mordin M, Fehnel S, Copley-Merriman C, Gnanasakthy A. Reasons for rejection of patient-reported outcome label claims: a compilation based on a review of patient-reported outcome use among new molecular entities and niologic license applications, 2006-2010. Value Health. 2012 May 1;15(3):443-8.

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

DeMuro CJ, Lewis SA, DiBenedetti DB, Price MA, Fehnel SE. Successful implementation of cognitive interviews in special populations. Expert Rev Pharmacoecon Outcomes Res. 2012 Apr 1;12(2):181-7.

Dalal AA, Nelson L, Gilligan T, McLeod L, Lewis S, Demuro-Mercon C. Evaluating patient-reported outcome measurement comparability between paper and alternate versions, using the lung function questionnaire as an example. Value Health. 2011 Jul 1;14(5):712-20.

Dalal AA, Nelson L, Gilligan TM, McLeod LD, Lewis SE, DeMuro C. Measurement comparability between paper and alternate versions: recommended assessment steps using the lung function questionnaire as an example. Poster presented at the 2011 ISPOR 16th Annual International Meeting; May 25, 2011. [abstract] Value Health. 2011 May; 14(3):A145.

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.