Publications

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Displaying 1 through 50 of 164 publications.

Osborne R, Nelson L, Fehnel S, Williams N, Bender RH, Ziemiecki R, Gymnopoulou E, De Paepe E, Norcross L, Heijnen E, Ispas G, Cheret A, Comeaux C, Callendret B, Vandendijck Y, Chan E, Scott J. Measurement of symptoms in respiratory syncytial virus–infected adults: meaningful within-patient change thresholds for the respiratory infection intensity and impact questionnaire (RiiQ). Poster presented at the 8th ESWI Influenza Conference Scientific and SPI Virtual Programme; December 4, 2021.

Kolotkin RL, Williams VSL, von Huth Smith L, Meincke HH, Qin S, Williams N, Fehnel SE. Confirmatory psychometric evaluations of the impact of weight on quality of life-lite clinical trials version (IWQOL-Lite-CT). Clin Obes. 2021 Oct;11(5):e12477. doi: 10.1111/cob.12477

Osborne RH, Nelson L, Elsworth GR, Fehnel S, Williams N, Bender RH, Ziemiecki R, Gymnopoulou E, De Paepe E, Norcross L, Heijnen E, Ispas G, Cheret A, Comeaux C, Chan E, Scott JA. Psychometric evaluation of the Respiratory Infection Intensity and Impact Questionnaire Version 2 (RiiQÂ™v2) symptom scores for respiratory syncytial virus. Poster presented at the Virtual ISPOR 2021 Conference; May 2021.

Davidson D, Hsieh A, Vera-Llonch M, Stevenson M, Brown TM, Slota CM, Fehnel SE. Development of a novel patient-reported outcome measure for symptoms and impacts of familial chylomicronemia syndrome. Poster presented at the 2020 Virtual National Lipid Association Scientific Sessions; December 10, 2020.

Ervin CM, Whalley D, von Huth Smith L, Crawford R, Dine J, Fehnel SE. Development of the impact of weight on daily activities questionnaire: a patient-reported outcome measure. Clin Obes. 2020 Dec;10(6):e12387. doi: 10.1111/cob.12387

Martin SA, Brown TM, Fehnel S, Deal LS, Katz EG, Chiou CF. The atopic dermatitis itch scale: development of a new measure to assess pruritus in patients with atopic dermatitis. J Dermatolog Trea. 2020 Aug;31(5):484-30708. doi: 10.1080/09546634.2020.1713971

Davidson D, Stevenson M, Llonch MV, Hsieh A, Brown TM, Slota C, Fehnel S. Development of a novel patient-reported outcome measure symptoms and impacts of familial chylomicronemia syndrome. J Clin Lipidol. 2020 Jul;14(4):P571.

Nelson LM, DiBenedetti D, Pariser DM, Glaser DA, Hebert AA, Hofland H, Drew J, Ingolia D, Gillard KK, Fehnel S. Development and validation of the axillary sweating daily diary: a patient-reported outcome measure to assess axillary sweating severity. J Patient Rep Outcomes. 2019 Sep 5;3(1):59. doi: 10.1186/s41687-019-0148-8

Kolotkin RL, Williams VSL, Ervin CM, Williams N, Meincke HH, Qin S, von Huth Smith L, Fehnel SE. Validation of a new measure of quality of life in obesity trials: impact of weight on quality of life-lite clinical trials version. Clin Obes. 2019 Jun;9(3):e12310. doi: 10.1111/cob.12310

Fehnel S, Fiedorek FT, Nelson L, DiBenedetti D, Spence S, Carson RT. Development and psychometric evaluation of the Diabetic Gastroparesis Symptom Severity Diary. Clin Exp Gastroenterol. 2019 Feb 22;12:93-103. doi: 10.2147/CEG.S184016

Kreher N, Phillips D, Fehnel S, Brown M. Evaluating the content validity of the Diary of Irritable Bowel Syndrome Symptoms – Mixed (DIBSS-M) to assess gastrointestinal symptoms associated with Fabry disease. Poster presented at the 16th Annual WORLDSymposium; February 11, 2019. Orlando, FL. [abstract] Mol Genet Metab. 2019 Feb; 126(2):S87. doi: 10.1016/j.ymgme.2018.12.215

Kolotkin RL, Williams V, Ervin CM, Williams N, Meincke HH, Qin S, von Huth Smith L, Fehnel SE. Validation of a new measure of quality of life in obesity trials: IWQOL-Lite Clinical Trials Version. Poster presented at the 2018 Obesity Week Conference; November 13, 2018. Nashville, TN. doi: 10.1111/cob.12310

Fehnel S, Ervin C, McLeod L, Carson RT, Reasner D, Hanlon J, Eremenco S, Coons SJ, PRO Consortium’s Irritable Bowel Syndrome Working Group. Psychometric evaluation of the diary for irritable bowel syndrome symptoms-constipation (DIBSS-C). Poster presented at the 2018 ISPOR 21st Annual European Congress; November 13, 2018. Barcelona, Spain.

McLeod LD, Fehnel SE, Cappelleri JC. Patient-reported outcome measures: development and psychometric evaluation. In: Peace KE, Chen DG, Menon S, editors. Biopharmaceutical applied statistics symposium. Volume 1 Design of clinical trials. 1 ed. Singapore. Springer Nature Singapore Pte Ltd; 2018. p.317-46. doi: 10.1007/978-981-10-7829-3

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

Hanlon J, Ervin C, McLeod L, Butler A, Carson R, Coons S, Fehnel S, Kovacs S. Case study: the Diary of Irritable Bowel Syndrome Symptoms (DIBSS). Presented at the Ninth Annual PRO Consortium Workshop; April 25, 2018. Silver Spring, MD.

Ervin CM, Reasner DS, Hanlon JT, Fehnel SE. Exploring the diabetic gastroparesis patient experience: patient exit interviews. Adv Ther. 2017 Dec;34(12):2680-92. doi: 10.1007/s12325-017-0632-6

Kolotkin RL, Ervin CM, Meincke HH, Hojbjerre L, Fehnel SE. Development of a clinical trials version of the Impact of Weight on Quality of Life–Lite questionnaire (IWQOL-Lite Clinical Trials Version): results from two qualitative studies. Clin Obes. 2017 Oct;7(5):290-9. doi: 10.1111/cob.12197

Herman BK, Deal LS, Kando JC, DiBenedetti DB, Nelson L, Fehnel SE, Brown TM. The use and value of the 7-item binge eating disorder screener in clinical practice. Prim Care Companion CNS Disord. 2017 Jun;19(3):16m02075.

Fehnel S, Nelson L, DiBenedetti D, Carson RT, Spence S, Fiedorek F. Development and psychometric evaluation of the Diabetic Gastroparesis Symptom Severity Diary. Poster presented at the 2017 Digestive Disease Week; May 7, 2017. Chicago, IL.

Fehnel SE, Ervin CM, Carson RT, Rigoni G, Lackner JM, Coons SJ. Development of the diary for irritable bowel syndrome symptoms to assess treatment benefit in clinical trials: foundational qualitative research. Value Health. 2017 Apr;20(4):618-26.

Glaser DA, Hebert AA, Fehnel S, DiBenedetti D, Nelson L, Drew J, Pariser DM. The axillary sweating daily diary: a validated patient-reported outcome measure to assess axillary hyperhidrosis symptom severity. Poster presented at the 2017 Maui Derm for Dermatologists; March 2017. Maui, HI.

Glaser DA, Hebert AA, Fehnel S, DiBenedetti D, Nelson L, Drew J, Pariser DM. Confirmatory psychometric evaluation of the axillary sweating daily diary: a vaildated patient-reported outcome measure to assess axillary hyperhidrosis sweating severity. Poster presented at the 36th Fall Clinical Dermatology Conference; October 2017. Las Vegas, NV. [abstract] Skin: the journal of cutaneous medicine. 2017; 1(Suppl 93):s94. doi: 10.25251/skin.1.supp.93.

Brown TM, Martin S, Fehnel SE, Deal LS. Development of the impact of juvenile metachromatic leukodystrophy on physical activities scale. J Patient Rep Outcomes. 2017;2(1):15. doi: 10.1186/s41687-018-0041-x

Herman BK, Deal LS, DiBenedetti DB, Nelson L, Fehnel SE, Brown TM. Development of the 7-Item Binge Eating Disorder Screener (BEDS-7). Prim Care Companion CNS Disord. 2016 Jun;18(2). doi: 10.4088/PCC.15m01896

Herman BK, Deal LS, DiBenedetti DB, Nelson L, Fehnel SE, Brown TM. The use and value of the seven-item binge eating disorder screener in clinical practice. Poster presented at the American Psychiatric Association Annual Meeting; May 17, 2016. Atlanta, GA.

Fehnel SE, Forsyth BH, DiBenedetti DB, Danchenko N, Francios C, Brevig T. Patient-centered assessment of cognitive symptoms of depression. CNS Spectr. 2016 Feb;21(1):43-52. doi: 10.1017/S1092852913000643

Crawford SR, Brown TM, Fehnel SE, Doward L, Nelson L, Chen A, Kim T, Roof E, Dykens EM. The international development of the modified hyperphagia questionnaire. Poster presented at the 2015 ISPOR 18th Annual European Congress; November 2015. Milan, Italy.

Herman BK, Deal LS, DiBenedetti DB, Nelson LM, Fehnel SE, Brown TM. Development of the binge eating disorder screener. Poster presented at the 168th American Psychiatric Association Annual Meeting; May 16, 2015. Toronto, Canada.

Fehnel S, Brown TM, Nelson L, Chen A, Roof E, Kim DD, Dykens EM. Development of the hyperphagia questionnaire for use in prader-willi syndrome clinical trials. Poster presented at the 2015 ISPOR 20th Annual International Meeting; May 2015. Philadelphia, PA.

Nelson LM, Williams VS, Fehnel SE, Carson RT, MacDougall J, Baird MJ, Tourkodimitris S, Kurtz CB, Johnston JM. Psychometric validation of patient-reported outcome measures assessing chronic constipation. Clin Exp Gastroenterol. 2014 Sep 26;7:385-94.

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