Publications

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Displaying 51 through 100 of 136 publications.

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.

Francois C, Danchenko N, Williams V, Nelson L, Williams NJ, Yarr S, DiBenedetti DB, Lancon C. Validation of the depression and family functioning scale (DFFS). Poster presented at the 2015 ISPOR 20th Annual International Meeting; May 2015. Philadelphia, PA. [abstract] Value Health. 2015 May; 18(3):A24.

Petrillo J, Cano S, McLeod LD, Coon C. Using classical test theory, item response theory, and rasch measurement theory to evaluate patient-reported outcome measures: a comparison of worked examples. Value Health. 2015 Jan;18(1):25-34. doi: 10.1016/j.jval.2014.10.005

Doward L, Højbjerre L, Hogue S, Fernandez M, Barrett A, Crawford R, Kragh N, Aagren M. Influence of patient-reported outcomes on regulatory, HTA, and market access decisions: obesity and diabetes case examples. Poster presented at the 2015 ISPOR 20th Annual International Meeting; May 2015. Philadelphia, PA. [abstract] Value Health. 2015; 18:A1-A333.

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

McLeod L. Review of the Task Force Report on PRO data collection in clinical trials using mixed modes. Value Health. 2014 Jul;17(5):491-2. doi: 10.1016/j.jval.2014.06.003

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

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

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

Wilburn J, McKenna S, Twiss J, Kemp K, Campbell S. Validation of the Crohn's Life Impact Questionnaire (CLIQ), the first patient-reported outcome measure specific to adults with Crohn's disease. Poster presented at the 2013 ISPOR 16th Annual European Congress; November 2013. Dublin, Ireland. [abstract] Value Health. 2013 Nov; 16(7):A499-500. doi: 10.1016/j.jval.2013.08.1129

Wilburn J, McKenna S, Twiss J, Kemp K, Campbell S. Validating the Unidimensional Fatigue Impact Scale (U-FIS) for use in Crohn's disease. Poster presented at the 2013 ISPOR 16th Annual European Congress; November 2013. Dublin, Ireland. [abstract] Value Health. 2013 Nov; 16(7):A499. doi: 10.1016/j.jval.2013.08.1128

Twiss J, McKenna S, Graham JE, Swetz KM, Sloan J, Gomberg-Matiland M. Assessing measurement equivalence of different forms of administration of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) using Rasch analysis. Poster presented at the 2013 ISPOR 16th Annual European Congress; November 2013. Dublin, Ireland. [abstract] Value Health. 2013 Nov; 16(7):A606. doi: 10.1016/j.jval.2013.08.1731

Twiss J, McKenna S, Rouse M. Using Rasch analysis to co-calibrate scores from outcome measures specific to asthma (ALIS), chronic obstructive pulmonary disease (LCOPD) and pulmonary hypertension (CAMPHOR). Poster presented at the 2013 ISPOR 16th Annual European Congress; November 2013. Dublin, Ireland. [abstract] Value Health. 2013 Nov; 16(7):A605. doi: 10.1016/j.jval.2013.08.1724

Rouse M, McKenna S, Twiss J, Graham JE, Wilburn J. Quality of life outcomes in multiple sclerosis: a review of the literature. Poster presented at the 2013 ISPOR 16th Annual European Congress; November 2013. Dublin, Ireland. [abstract] Value Health. 2013 Nov; 16(7):A626. doi: 10.1016/j.jval.2013.08.1843

Graham JE, McKenna S, Wilburn J, Twiss J. Assessing quality of life in adult growth hormone deficiency: further development of the QoL-AGHDA. Poster presented at the 2013 ISPOR 16th Annual European Congress; November 2013. Dublin, Ireland. [abstract] Value Health. 2013 Nov; 16(7):A446-7. doi: 10.1016/j.jval.2013.08.710

DiBenedetti D, Coles T, Sharma T. Recruiting patients with a rare blood disorder and their caregivers through social media. Poster presented at the 2013 ISPOR 18th Annual International Meeting; April 23, 2013. [abstract] Value Health. 2013 May; 16(3):A51.

DiBenedetti D, Coles T, Ling CS, Sharma T, Pericleous L. Web-based study of patients and caregivers in the United States and Canada: perspectives on improvements in stability of factor viii products for hemophilia a. Poster presented at the 2013 ISPOR 18th Annual International Meeting; April 30, 2013. [abstract] Value Health. 2013 May; 16(3):A121.

Barrett A, DiBenedetti D, Phatak H, lloeje U. Structured review of patient-reported outcome instruments for assessing atrial fibrillation. Poster presented at the 2013 ISPOR 18th Annual International Meeting; April 23, 2013. [abstract] Value Health. 2013 May; 16(3):A293.

Twiss J, Ganderton L, Jenkins S, Ben-L'amri M, Gain K, Fowler R, Gabbay E, McKenna S. Comparison of the psychometric properties of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) and the SF-36 in patients with pulmonary hypertension. Poster presented at the 2012 ISPOR 15th Annual European Congress; November 2012. Berlin, Germany. [abstract] Value Health. 2012 Nov; 15(7):A378-9.

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.

Forsyth B, Fehnel SE, Danchenko N, Franois C, Brevig T. Assessing impacts of major depressive disorder (MDD) on cognitive function. Value Health. 2012 Nov 1;15(7):A341.

Badia X, Forsythe A, Nelson LM, Coles TM, McLeod LD, Webb SM. Improvements in health-related quality of life in acromegaly with pasireotide LAR and octreotide LAR: results from a large, randomized, double-blind phase III trial. Poster presented at the 2012 ISPOR 15th Annual European Congress; November 2012. Berlin, Germany. [abstract] Value Health. 2012 Nov; 15(7):A505.

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

Brown TM, Olanrewaju B, Deal L, Katz EC, Chiou C, Martin S, Fehnel S. Assessing pruritus among patients with atopic dermatitis: targeted literature and instrument review. Poster presented at the 2012 ISPOR 17th Annual International Meeting; June 6, 2012. [abstract] Value Health. 2012 Jun; 15(4):A253.

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

McKenna SP, Wilburn J, Crawford SR, Aryamanesh M, Twiss J. New developments in the Ankylosing Spondylitis Quality of Life (ASQOL) scale. Poster presented at the 2011 ISPOR 14th Annual European Congress; November 2011. Madrid, Spain. [abstract] Value Health. 2011 Nov; 14(7):A314.

Wilburn J, McKenna S, Crawford SR, Perry-Hinsley D, Bayat A. Determining the true impact of dupuytren's disease: a qualitative study. Poster presented at the 2011 ISPOR 14th Annual European Congress; November 2011. Madrid, Spain. [abstract] Value Health. 2011 Nov; 14(7):A314-5.

Twiss J, McKenna SP, Bloch M, Bonney M. Patient and clinician perceived benefit of early consumption of famciclovir for the treatment of herpes outbreaks. Poster presented at the 2011 ISPOR 14th Annual European Congress; November 2011. Madrid, Spain. [abstract] Value Health. 2011 Nov; 14(7):A266. doi: 10.1016/j.jval.2011.08.193

Clark M, Hofmann A, Tabberer M, Martin S. Development and content validity of the COPD device preference questionnaire. Poster presented at the 2011 ISPOR 14th Annual European Congress; November 9, 2011. [abstract] Value Health. 2011 Nov; 14(7):A255.

Crawford SR, McKenna SP, Twiss J, Tammaru M, Oprandi NC. Further developments of the Asthma Life Impact Scale (ALIS). Poster presented at the 2011 ISPOR 14th Annual European Congress; November 2011. [abstract] Value Health. 2011 Nov; 14(7):A497. doi: 10.1016/j.jval.2011.08.1440

Crawford SR, McKenna SP, Twiss J, Tammaru M, Oprandi NC. Further developments of the Living with Chronic Obstructive Pulmonary Disease (LCOPD). Poster presented at the 2011 ISPOR 14th Annual European Congress; November 2011. [abstract] Value Health. 2011 Nov; 14(7):A497.

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.

Gilligan TM, Nelson L, Dalal AA, McLeod LD. Visually evaluating the measurement comparability between paper-based and alternate versions of administration of the lung function questionnaire. Poster presented at the 2011 ISPOR 16th Annual International Meeting; May 25, 2011. [abstract] Value Health. 2011 May; 14(3):A153.

Coon CD, McLeod LD, Arnold LM, Chandran A, Martin S. Evaluating the screening ability of patient-reported outcome instruments. Poster presented at the 2011 ISPOR 16th Annual International Meeting; May 25, 2011. [abstract] Value Health. 2011 May; 14(3):A151.

DeMuro C, Mordin M, Evans ED, Copley-Merriman K, Fehnel S, Gnanasakthy A. Reasons for rejection of PRO label claims: an analysis based on a review of PRO use 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.

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.

McKenna SP, Doward LC, Twiss J, Hagell P, Oprandi NC, Fisk J, Grand'Maison F, Bhan V, Arbizu T, Brassat D, Kohlmann T, Meads DM, Eckert BJ. International development of the Patient-Reported Outcome Indices for Multiple Sclerosis (PRIMUS). Value Health. 2010 Dec 1;13(8):946-51.

Twiss J, McKenna S, Doward LC, Hana V, Karbownik-Lewinksa M, Popovic V. Further developments of the Quality of Life Assessment of Growth Hormone Deficiency in Adults (QOL-AGHDA). Poster presented at the 13th Annual European Congress; November 2010. Prague, Czech Republic. [abstract] Value Health. 2010 Nov; 13(7):A297.

Twiss J, McKenna S, Crawford SR, Doward LC. Scaling properties of two commonly used outcome measures in dermatology – the Dermatology Life Quality Index (DLQI) and the Psoriasis Quality of Life Scale (PSORIQoL). Presented at the 13th Annual European Congress; November 2010. Prague, Czech Republic. [abstract] Value Health. 2010 Nov; 13(7):A244.

Fehnel S, Ervin CM, Lewis B, Carson RT, Johnston JM. Identifying endpoints for irritable bowel syndrome (IBS) clinical trials: incorporating the patient's voice. Poster presented at the 2010 ISPOR 13th Annual European Congress; November 15, 2010. [abstract] Value Health. 2010 Nov; 13(7):A372.

Ervin CM, Fehnel S, Carson R, Kurtz C, Shiff S, Johnston J. Selecting chronic constipation (CC) clinical trial endpoints: incorporating the patient's voice. Poster presented at the 2010 ISPOR 15th Annual International Meeting; May 28, 2010. [abstract] Value Health. 2010 May; 13(3):A74.

Nelson L, Coon C, Williams V, Price M. Determining missing data rules for pros: alpha-if-item-deleted. Poster presented at the 2010 ISPOR 15th Annual International Meeting; May 2010. Atlanta, GA. [abstract] Value Health. 2010 May; 13(3):A21.

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

Doward LC, Meads DM, Fisk J, Twiss J, Hagell P, Opra N, Grand'Maison F, Bhan V, Arbizu T, Kohlmann T, Brassat D, Eckert B, McKenna S. International development of the Unidimensional Fatigue Impact Scale (U-FIS). Value Health. 2010;13(4):463-8.

Fehnel S. Establishing optimal requirements for content validity: a work in progress. Value Health. 2009 Nov 1;12(8):1074.

Wilburn J, McKenna SP, Twiss J. Further developments of the rheumatoid arthritis quality of life scale (RAQoL). Poster presented at the 2009 ISPOR 12th Annual European Congress; October 2009. Paris, Spain. [abstract] Value Health. 2009 Oct; 12(7):A447-8. doi: 10.1016/S1098-3015(10)75215-3