Publications

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Displaying 51 through 100 of 183 publications.

Williams VS, Nelson LM, Fehnel SE, MacDougall J, Carson RT, Tourkodimitris S, Kurtz C, Baird MJ, Johnston JM. Psychometric validation of symptom severity measures in irritable bowel syndrome with constipation. Aliment Pharmacol Ther. 2014 Aug;40(3):298-308. doi: 10.1111/apt.12830

Chen WH, McLeod L, Nelson LM, Williams VS, Fehnel SE. Quantitative challenges facing patient-centered outcomes research. Expert Rev Pharmacoecon Outcomes Res. 2014 Jun 14;14(3):379-86.

Ervin CM, Fehnel SE, Baird MJ, Carson RT, Johnston JM, Shiff SJ, Kurtz CB, Mangel AW. Assessment of treatment response in chronic constipation clinical trials. Clin Exp Gastroenterol. 2014 Jun 3;7:191-8. doi: 10.2147/CEG.S58321. 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.

Baird MJ, Carson RT, Ervin CM, Chang L, Spiegel B, Norton NJ, Lackner J, Lasch K, Fehnel SE. Qualitative assessment of symptom experience in patients with irritable bowel syndrome for the development of patient reported outcome instruments. Poster presented at the 2013 Digestive Disease Week; May 2013.

Lenderking WR, Coon C, Fehnel SE, Burke L. The utility of mixed-method approaches to evaluate the content validity of patient-reported outcome measures. Presented at the International Society for Pharmacoeconomics and Outcomes Research; May 1, 2013.

Fehnel SE. Choice of recall period in patient-reported outcome measurement. Presented at the 4th Annual Patient-Reported Outcome Consortium Workshop; April 1, 2013.

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.

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.

Forsyth B, Fehnel SE, Danchenko N, François C, Brevig T. Assessing impacts of major depressive disorder on depression. Poster presented at the 2012 ISPOR 15th Annual European Congress; November 1, 2012. Berlin, Germany.

Carson R, Nelson LM, Williams VS, Fehnel SE, Tourkodimitris S, Baird M, et al a. Psychometric evaluation of patient-reported outcome measures for assessing ibs-c symptom severity and change: results from 2 randomized, double-blind, placebo-controlled phase 3 trials of linaclotide. Poster presented at the Annual Scientific Meeting of the American College of Gastroenterology; October 1, 2012.

Carson R, Baird M, Coon C, Fehnel SE, MacDougall J, Nelson LM. Psychometric evaluation of patient-reported outcome measures assessing IBS-C symptom severity and change: results from two randomized, double-blind, placebo-controlled phase 3 trials of linaclotide. Presented at the ISOQOL 19th Annual Conference; October 1, 2012.

Nelson LM, Williams VS, Carson R, Baird M, Coon C, Fehnel SE. Factor analyses of chronic constipation patient-reported outcome measures: results from phase 2b and phase 3 trials of linaclotide. Poster presented at the Annual Scientific Meeting of the American College of Gastroenterology; October 1, 2012. Previously presented at the Joint International Neurogastroenterology and Motility Meeting.

Forsyth B, Fehnel SE, Danchenko N, François C, Brevig T. Patient-reported cognitive symptoms and a patient-reported outcome measure of cognitive function in depression. Poster presented at the Annual European College of Neuropsychopharmacology Congress; October 1, 2012.

Baird M, Carson R, Coon CD, Fehnel SE, MacDougall J, Nelson LM, Williams VS. Psychometric validation of patient-reported outcome measures assessing chronic constipation symptom severity: results from phase 2b and phase 3 trials of linaclotide. Poster presented at the ISOQOL 19th Annual Conference; October 2012.

Nelson LM, Williams VSL, Fehnel SE, Tourkodimitris S, Baird MJ, Carson RT, Johnston JM. Psychometric evaluation of patient-reported outcome measures for assessing chronic constipation symptom severity and change: results from phase 2b and phase 3 trials of linaclotide. Presented at the Joint International Neurogastroenterology and Motility Meeting; September 2012. [abstract] Neurogastroenterol Motil. 2012 Sep 6; 24(Suppl. s2):180.

Williams VSL, Nelson LM, Carson RT, Baird MJ, Coon CD, Fehnel SE, Johnston JM. Factor analyses of patient-reported outcome measures in Irritable Bowel Syndrome with Constipation (IBS-C): results from two randomized, double-blind, placebo-controlled phase 3 trials of linaclotide. Presented at the 2012 ACG Annual Meeting and Postgraduate Course; September 1, 2012. Previously presented at the Joint International Neurogastroenterology and Motility Meeting.

Williams VS, Nelson LM, Carson RT, Baird MJ, Coon CD, Fehnel SE. Factor analyses of patient-reported outcome measures in irritable bowel syndrome with constipation (IBS-C): results from two randomized, double-blind, placebo-controlled phase 3 trials of linaclotide. Poster presented at the Joint International Neurogastroenterology and Motility Meeting; September 1, 2012.

Nelson LM, Williams VSL, Carson RT, Baird MJ, Fehnel SE, Johnston JM. Factor analyses of patient-reported outcome measures in Irritable Bowel Syndrome with Constipation (IBSC): results from two randomized, double-blind, placebo-controlled phase 3 trials of linaclotide. Poster presented at the Joint International Neurogastroenterology and Motility Meeting; September 2012. Bologna, Italy. [abstract] Neurogastroenterol Motil. 2012 Sep 1; 24(Suppl. 2):106. doi: 10.1111/j.1365-2982.2012.01997.x

Nelson LM, Williams VS, Carson RT, Baird MJ, Coon CD, Fehnel SE. Factor analyses of chronic constipation patient-reported outcome measures: results from phase 2b and phase 3 trials of linaclotide. Presented at the Joint International Neurogastroenterology and Motility Meeting; September 1, 2012.

Carson RT, Nelson LM, Williams VSL, Fehnel SE, Tourkodimitris S, Baird MJ, Johnston JM. Psychometric evaluation of patient-reported outcome measures for assessing IBS-C symptom severity and change: results from two randomized, double-blind, placebo-controlled phase 3 trials of linaclotide. Poster presented at the Joint International Neurogastroenterology and Motility Meeting; September 2012. [abstract] Neurogastroenterol Motil. 2012 Sep 1; 24(Suppl. 2):179.

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.

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.

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

Coon CD, Fehnel SE, Davis KH, Runken MC, Beach ME, Cady RK. The development of a survey to measure completeness of response to migraine therapy. Headache. 2012 Apr 1;52(4):550-72.

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.

Bell C, McLeod LD, Nelson LM, Fehnel SE, Zografos LJ, Bowers B. Development and psychometric evaluation of a new patient-reported outcome instrument measuring the functional impact of insomnia. Qual Life Res. 2011 Nov 1;20(9):1457-68.

Williams VS, Nelson LM, Gilligan TM, Fehnel SE, Baird MJ, Carson RT. The relationship between changes in PRO measures of IBS-C symptoms and the IBS-QOL: results from two phase 3 trials of linaclotide. Poster presented at the 18th Annual Conference of the International Society for Quality of Life Research; October 1, 2011.

Nelson LM, Williams VS, Gilligan TN, Fehnel SE, Baird MJ, Carson RT. Examining the relationship between changes in pro measures of chronic constipation symptoms and the pac-qol: results from two phase 3 trials of linaclotide. Poster presented at the 18th Annual Conference of the International Society for Quality of Life Research; October 1, 2011.

Mangel AW, Fehnel SE. End points in irritable bowel syndrome. Expert Rev Gastroenterol Hepatol. 2011 Jun 1;5(3):293-5.

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.

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.

McLeod LD, Coon CD, Martin SA, Fehnel SE, Hays RD. Interpreting patient-reported outcome results: uS FDA guidance and emerging methods. Expert Rev Pharmacoecon Outcomes Res. 2011 Apr 1;11(2):163-9.

Mangel AW, Wang J, Sherrill B, Gnanasakthy A, Ervin C, Fehnel SE. Urgency as an endpoint in irritable bowel syndrome. Gastroenterology Research. 2011 Feb 1;4(1):9-12.

Deal LS, Williams VSL, Fehnel SE. Development of an electronic daily uterine fibroid symptom diary. Patient. 2011 Jan 1;4(1):31-44.

Fehnel SE, Manjunath R, Ervin CM, French JA, Vanlandingham K, Sweeney CT. Developing a functional status diary for epilepsy. Poster presented at the 64th Annual Meeting of the American Epilepsy Society; December 1, 2010.

Williams VSL, Carson RT, Nelson LM, MacDougall J, Fehnel SE, Lewis B, Johnston JM. Application of exploratory factor analysis to support the conceptual framework of PRO measures: results from a phase 2 study of irritable bowel syndrome with constipation. Poster presented at the International Society for Quality of Life Research (ISOQOL) 2010 Annual Meeting; November 18, 2010.

Norquist JM, Girman CJ, Fehnel S, DeMuro C, Santanello N. Choice of recall period for patient-reported outcome measures: criteria for consideration. Poster presented at the International Society for Quality of Life Research (ISOQOL) 2010 Annual Meeting; November 18, 2010.

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.

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.

Fehnel SE, Coon CD, Davis KH, Runken MC, Cady RK. Development and Psychometric Evaluation of the Migraine Completeness of Response Survey (CORS). Poster presented at the 52nd Annual Scientific Meeting of the American Headache Society; June 2010. [abstract] Headache. 2010 Aug; 50(s1):S49-50.

Deal LS, Williams VSL, DiBenedetti DB, Fehnel SE. Development and psychometric evaluation of the endometriosis treatment satisfaction questionnaire. Qual Life Res. 2010 Aug 1;19(6):899-905.

Deal LS, DiBenedetti DB, Williams VSL, Fehnel SE. The development and validation of the daily electronic endometriosis pain and bleeding diary. Health Qual Life Outcomes. 2010 Jul 2;8:64.

Fehnel SE, Ervin CM, Shiff SJ, Johnston JM, Kurtz CB, Carson RT. Assessing treatment response in chronic constipation clinical trials: concepts elicited through qualitative interviews with patients. Poster presented at the 2010 Digestive Disease Week; May 1, 2010.

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.

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.

Mordin M, Lewis SE, Gnanasakthy A, Demuro-Mercon C, Copley-Merriman K, Fehnel S. Patient-reported outcomes as mentioned in product development guidance. Poster presented at the 2010 ISPOR 15th Annual International Meeting; May 4, 2010. [abstract] Value Health. 2010 May; 13(3):A17-8.

Williams VS, Edin HM, Hogue SL, Fehnel SE, Baldwin DS. Prevalence and impact of antidepressant-associated sexual dysfunction in three European countries: replication in a cross-sectional patient survey. J Psychopharmacol. 2010 Apr 1;24(4):489-96.