Publications

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Displaying 1 through 50 of 57 publications.

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

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

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

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

Gerbasi ME, Goss D, Petrillo J, Nejati M, Lewis S. Patient experiences in essential tremor: mapping functional impacts to existing measures using qualitative research. Poster presented at the 2023 International Congress of Parkinson's Disease and Movement Disorders; August 27, 2023. Copenhagen, Denmark. [abstract] Mov Disord. 2023; 38(Suppl 1).

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

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

Lewis S, Wray SE, Evans E, Romano (DeMuro) C, Bartolome L, Su W, Shah R, Russo PA. Patients' experiences in transitioning to secondary progressive multiple sclerosis: qualitative interviews. Neurol Ther. 2021 Dec;10(2):887-904. doi: 10.1007/s40120-021-00265-0

Williams V, Qin S, Romano CD, Lewis S, Williams N, Yarr S, Juul KV, Andersson FL. Psychometric evaluation of the Nocturia Sleep Quality Scale based on data from a prospective observational study. J Clin Sleep Med. 2021 Apr 1;17(4):691-701. doi: 10.5664/jcsm.9010

Starr HL, Abell J, Larish A, Lewis S, DeMuro C, Gogate J, Jamieson C, Daly E, Zaki N, Kramer M. Self-reported review of the value of esketamine in patients with treatment-resistant depression: understanding the patient experience in the STRIVE Study. Psychiatry Research. 2020 Nov;293:113376. doi: 10.1016/j.psychres.2020.113376

Saretsky T, DeMuro C, Finelli L, Phillips M, Lewis S, Martin E, Osborne R, Norquist J. Modification of an existing patient-reported outcome measure (PROM) for a new context of use in a seasonal infectious disease. Poster presented at the 27th Annual Virtual Conference of the International Society for Quality of Life Research (ISQOL); October 19, 2020. [abstract] Qual Life Res. 2020 Oct 17; 29(Suppl 1):S139. doi: 10.1007/s11136-020-02626-y

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

Lewis S, Romano C, De Bruecker G, Murrough JW, Shelton R, Singh JB, Jamieson C. Analysis of clinical trial exit interview data in patients with treatment-resistant depression. Patient. 2019 Oct;12(5):527-37. doi: 10.1007/s40271-019-00369-8

Romano (DeMuro) CD, Lewis S, Barrett A, Andersson FL, Williams V, Ancoli-Israel S, Roth T. Development of the Nocturia Sleep Quality Scale: a patient-reported outcome measure of sleep impact related to nocturia. Sleep Med. 2019 Jul;59:101-6. doi: 10.1016/j.sleep.2019.02.006

Lewis EF, Coles TM, Lewis S, Nelson LM, Barrett A, DeMuro Romano C, Stull DE, Turner SJ, Chang CG. Development, psychometric evaluation, and initial feasibility assessment of a symptom tracker for use by patients with heart failure (HFaST). J Patient Rep Outcomes. 2019 May 2;3(1):26. doi: 10.1186/s41687-019-0113-6

Lewis S, DeMuro C, Block SL, Senders S, Wisman P, Toback S, Chien JW, Williams V. Development of a novel observer-reported outcome measure for the assessment of Respiratory Syncytial Virus (RSV) infection symptoms in pediatric clinical trials. J Patient Rep Outcomes. 2018 Dec;2(9). doi: 10.1186/s41687-018-0034-9

DiBenedetti DB, Brown TM, DeMuro CJ, Ervin C, Lewis SA, Fehnel SE. Conducting patient interviews within a clinical trial setting. RTI Press. 2018 Aug. doi: 10.3768/rtipress.2018.op.0054.1808

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

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

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.

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

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.

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.

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.

Lewis S, Price M, Dwyer KA, O'Brien S, Heekin RD, Yates PJ, Beverland D, Mordin M. Development of a scale to assess performance following primary total knee arthroplasty. Value Health. 2014 Apr 21;17(4):350-9. doi: 10.1016/j.jval.2014.01.006

Andrews EB, Davis KH, DiBenedetti DB, Forsyth B, Gilsenan AW, Hollis KA, Lewis SA, Price MA, Tennis P, Zografos LJ. Risk evaluation and mitigation strategy assessments: social science methodologies to assess goals related to knowledge. 2014. Research Triangle Park: RTI Press.

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.

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.

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.

DiBenedetti DB, Lewis SA, Price MA. The role of cognitive pretesting interviews in REMS survey development. Poster presented at the Risk Evaluation and Mitigation Strategy (REMS) Assessments: Social Science Methodologies to Assess Goals Related to Knowledge Public Workshop; June 7, 2012.

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.

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 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.

DiBenedetti DB, Danchenko N, Francois C, Lewis SA, Davis KH, Fehnel SE. Development of a family functioning scale for major depressive disorder. Curr Med Res Opin. 2012 Mar 1;28(3):303-13.

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 A, DeMuro-Mercon CJ, Lewis SA, Nelson LM, Gilligan T, McLeod LD. Mixed modes of administration of the lung function questionnaire: validation in subjects with smoking history. Poster presented at the International Conference of the American Thoracic Society; May 2011.

Lançon C, DiBenedetti DB, Lewis SA, Davis KH, Danchenko N, François C. Assessing the impact of major depressive disorder (MDD) on family functioning: development of the depression and family functioning scale. Poster presented at the 2011 ISPOR 16th Annual International Meeting; May 2011. Baltimore, MD. [abstract] Value Health. 2011 May; 14(3):A195.

Dalal AA, Demuro-Mercon C, Lewis S, Nelson L, Gilligan T, McLeod L. Validation of alternate modes of administration of the lung function questionnaire (LFQ) in subjects with smoking history. Int J Chron Obstruct Pulmon Dis. 2010 Dec 1;5:425-34.

DeMuro-Mercon CJ, DiBenedetti DB, Lewis SA, Fehnel SE. Successful implementation of the cognitive interviews in special populations. Presented at the 17th Annual Conference of the International Society for Quality of Life Research; November 1, 2010. Previously presented at the 16th Annual Conference of the International Society for Quality of Life Research.

Lewis SA, DeMuro-Mercon CJ, Mordin MM, Farr J, Cole BJ, Mithoefer K, Engelhart L. Measuring pain and function in patients with articular cartilage repair. Poster presented at the 9th World Congress of the International Cartilage Repair Society; September 2010.

Mordin MM, Lewis SA, Gnanasakthy A, DeMuro-Mercon CJ, Copley-Merriman K, Fehnel SE. Patient-reported outcomes in product development guidance. Poster presented at the 2010 ISPOR 15th Annual International Meeting; May 1, 2010. Atlanta, GA. [abstract] Value Health. 2010 May; 13(3):A-17-8.

DeMuro-Mercon CJ, DiBenedetti DB, Lewis SA, Fehnel SE. Successful implementation of the cognitive interview in special populations. Presented at the 16th Annual Conference of the International Society for Quality of Life Research; October 1, 2009.

Lewis SA. The pro draft guidance and what to consider when planning for your next trial with pro endpoints. Presented at the Center for Business Intelligence conference workshop; 2007.

Lewis SA. Verify the software; Implement the process implementation of your study: the joint validation plan. Electronic patient-reported outcomes (ePRO) update: the quest to move from paper to plastic. Presented at the System Validation Workshop at the Conference of the Drug Information Association; 2006.

DeMuro-Mercon CJ, Lewis SA, Pearson JD. E-pro's: one size does not fit all critical factors in making it work. Presented at the CBINet Conference; July 2005.