Publications

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Displaying 1 through 50 of 131 publications.

Qin S, Nelson L, Williams N, Williams V, Bender R, McLeod L. Comparison of anchor-based methods for estimating thresholds of meaningful within-patient change using simulated PROMIS PF 20a data under various joint distribution characteristic conditions. Qual Life Res. 2022 Nov 13. doi: 10.1007/s11136-022-03285-x

Williams V, Romano (DeMuro) C, Clark M, Goss D, Naujoks C, Marvel J. Psychometric evaluation of a new electronic pediatric asthma symptom diary. Poster presented at the ISPOR Europe 2022; November 8, 2022. Vienna, Austria.

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

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

Amato AA, Hanna MG, Machado PM, Badrising UA, Chinoy H, Benveniste O, Karanam AK, Wu M, Tanko LB, Schubert-Tennigkeit AA, Papanicolaou DA, Lloyd TE, Needham M, Liang C, Reardon KA, de Visser M, Ascherman DP, Barohn RJ, Dimachkie MM, Miller JAL, Kissel JT, Oskarsson B, Joyce NC, Van den Bergh P, Baets J, De Bleecker JL, Karam C, David WS, Mirabella M, Nations SP, Jung HH, Pegoraro E, Maggi L, Rodolico C, Filosto M, Shaibani AI, Sivakumar K, Goyal NA, Mori-Yoshimura M, Yamashita S, Suzuki N, Aoki M, Katsuno M, Morihata H, Murata K, Nodera H, Nishino I, Romano (DeMuro) C, Williams VSL, Vissing J, Auberson LZ, RESILIENT Study Extension Group . Efficacy and safety of Bimagrumab in sporadic inclusion body Myositis: long-term extension of RESILIENT. Neurology. 2021 Mar 23;96(12):e1595-607. doi: 10.1212/WNL.0000000000011626

Hanna MG, Badrising UA, Benveniste O, Lloyd TE, Needham M, Chinoy H, Aoki M, Machado PM, Liang C, Reardon KA, de Visser M, Ascherman DP, Barohn RJ, Dimachkie MM, Miller JAL, Kissel JT, Joyce NC, Van den Bergh P, Baets J, De Bleecker JL, Karam C, David WS, Mirabella M, Nations SP, Jung HH, Pegoraro E, Maggi L, Rodolico C, Filosto M, Shaibani AL, Sivakumar K, Goyal NA, Mori-Yoshimura M, Yamashita S, Suzuki N, Katsuno M, Murata K, Nodera H, Nishino I, Romano C, Williams VSL, Vissing J, Zhang Auberson L, Wu M, de Vera A, Papanicolaou DA, Amato AA, RESILIENT Study Group. Safety and efficacy of intravenous bimagrumab in inclusion body myositis: a phase 2b, randomised, double-blind, placebo-controlled study (RESILIENT). Lancet Neurol. 2019 Sep;18(9):834-44.

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

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

Williams V, Stull D, Houghton K, Williams N, Teynor M. Minimal clinically important differences of the expanded hammersmith functional motor scale in later-onset spinal muscular atrophy: results from the Phase 3 CHERISH trial. Poster presented at the 2019 AMCP Managed Care & Specialty Pharmacy Annual Meeting; March 25, 2019. San Diego, CA. [abstract] J Manag Care Spec Pharm. 2019 Mar; 25(3-a Suppl):S54.

Stull D, Williams V, Houghton K, Williams N, Teynor M. Minimal clinically important differences in motor function in patients with infantile-onset spinal muscular atrophy: results from the Phase 3 ENDEAR trial. Poster presented at the 2019 AMCP Managed Care & Specialty Pharmacy Annual Meeting; March 25, 2019. San Diego, CA. [abstract] J Manag Care Spec Pharm. 2019 Mar; 25(3-a Suppl):S55.

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

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

Coles T, Williams V, Dwyer K, Mordin M. Psychometric evaluation of the patient's knee implant performance questionnaire. Value Health. 2018 Nov;21(11):1305-12. doi: 10.1016/j.jval.2018.05.006

Qin S, Coles T, Nelson L, McLeod L, Williams V, Williams N, Reaney M. CDFs and PDFs: comparing visual methods supporting responder thresholds in clinical trials. Poster presented at the 2018 ISPOR 23rd Annual International Meeting; May 21, 2018. Baltimore, MD. [abstract] Value Health. 2018 May; 21(Suppl):S53. doi: 10.1016/j.jval.2018.04.442

Williams VSL, Soliman AM, Barrett AM, Klein KO. Review and evaluation of patient-centered psychosocial assessments for children with central precocious puberty or early puberty. J Pediatr Endocrinol Metab. 2018 Apr 25;31(5):485-95.

Donohue IF, Bollu VK, Stull DE, Nelson LM, Williams VS, Stensland MD, Hanania NA. Long-term health-related quality-of-life and symptom response profiles with arformoterol in COPD: results from a 52-week trial. Int J Chron Obstruct Pulmon Dis. 2018 Feb 5;13:499-508.

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

Qin S, Coles T, Nelson L, Williams V, Williams N, McLeod L. What impacts the stability of anchor-based responder definitions? Presented at the ISOQOL 24th Annual Conference; October 19, 2017. Philadelphia, PA.

Francois C, Nielsen R, Danchenko N, Williams V, Lancon C. The impact of antidepressant treatments on family functioning in adults with major depressive disorder: a post hoc comparison of vortioxetine and agomelatine. Curr Med Res Opin. 2017 Jun;33(6):1057-66. doi: 10.1080/03007995.2017.1299701

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

Williams V, Francois C, Danchenko N, Nelson L, Williams N, Yarr S, DiBenedetti D, Lancon C. Psychometric validation of the depression and family functioning scale. Curr Med Res Opin. 2016 Apr;32(4):639-50. doi: 10.1185/03007995.2015.1135111

Williams V, McLeod L, Nelson L. Advances in the evaluation of longitudinal construct validity of clinical outcome assessments. Ther Innov Regul Sci. 2015 Nov;49(6):805-12. doi: 10.1177/2168479015609103

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 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.

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.

François C, Danchenko N, Williams V, Nelson L, Williams NJ, Yarr S, DiBenedetti DB, Lançon C. Psychometric evaluation of the Depression and Family Functioning Scale (DFFS). Poster presented at the 2015 ISPOR 20th Annual International Meeting; May 2015. Philadelphia, PA.

François C, Nielsen R, Danchenko N, Williams V, Lançon C. The effect of vortioxetine on family functioning in adults with major depressive disorder. Poster presented at the 2015 ISPOR 20th Annual International Meeting; May 2015. Philadelphia, PA.

Camilleri M, Lembo AJ, Lavins BJ, Macdougall JE, Carson RT, Williams VSL, Nelson LM, Shiff SJ, Currie MG, Kurtz CB, Johnston JM. Comparison of adequate relief with symptom, global, and responder endpoints in linaclotide phase 3 trials in IBS-C. United European Gastroenterol J. 2015 Feb 3;3(1):53-62. doi: 10.1177/2050640614555946

Hartman EE, Pawaskar M, Williams V, McLeod L, Dubois D, Benninga MA, Joseph A. Psychometric properties of PedsQL generic core scales for children with functional constipation in the Netherlands. J Pediatr Gastroenterol Nutr. 2014 Dec;59(6):739-47. doi: 10.1097/MPG.0000000000000527

Coles TM, Dwyer K, Mordin MM, Williams VS, Clatworthy M, Yates P, Hamilton B. Psychometric evaluation of the patients's Knee Implant Performance (PKIP) questionaire for the assessment of primary total knee arthroplasty. Poster presented at the 2014 ISPOR 17th Annual European Congress; November 2014. Amsterdam, The Netherlands.

Coles TM, Chen W, Nelson LM, Williams VS, Williams NJ, McLeod LD. Current sample size practices in the psychometric evaluation of patient-reported outcome measures for use in clinical trials. Poster presented at the 2014 ISPOR 17th Annual European Congress; November 2014. Amsterdam.

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.

Francois C, Danchenko N, Williams VS, Nelson LM, Williams NJ, Yarr SR, DiBenedetti DB, Lancon C. Psychometric evaluation of the depression and family functioning scale (DFFS). Poster presented at the Second Meeting on Patient Reported Outcomes and Person Centered Care in Mental Health – Diagnosis, Prevention and Treatment in Mental Health: Effectiveness and Comparative Effectiveness; September 26, 2014. Washington, DC. [abstract] J Ment Health Policy Econ. 2014 Sep; 17(Suppl 1):S5-6.

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.

Bollu V, Nelson LM, Williams VS, Stensland MD, Stull DE. Symptom response profiles for patients with chronic obstructive pulmonary disease initiating nebulized arformoterol tartrate or placebo. Poster presented at the 2014 ISPOR 19th Annual International Meeting; June 3, 2014.

Macdougall JE, Johnston JM, Lavins BJ, Nelson LM, Williams VS, Carson RT, Shiff SJ, Shi K, Kurtz CB, Baird MJ, Currie MG, Lembo AJ. An evaluation of the FDA Responder Endpoint for IBS-C clinical trials: analysis of data from linaclotide Phase 3 clinical trials. Neurogastroenterol Motil. 2013 Jun;25(6):481-6. doi: 10.1111/nmo.12089

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.

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.

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.

Spiegel BMR, Locke G, Kurtz CM, Williams VSL, Nelson LM, Carson RT, Currie MG, Schneier HA, Johnston JM. Clinically meaningful change benchmarks for IBS-C symptoms developed using data from two phase 3 trials of linaclotide. Presented at the Joint International Neurogastroenterology and Motility Meeting; September 2012. Bologna, Italy. [abstract] Neurogastroenterol Motil. 2012 Sep; 24(s2):35.

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.

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

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.

Williams V, Rousculp MD, Price M, Coles T, Therrien MA, Griffin J, Hollis K, Toback S. Elementary school-located influenza vaccine programs: key stakeholder experiences from initiation to continuation. J Sch Nurs. 2012 Aug 1;28(4):256-67.

Spiegel BMR, Locke GR, Kurtz C, Williams VS, Nelson LM, Carson RT. Developing benchmarks for clinically meaningful change for ibs-c symptoms using data from two phase 3 trials of linaclotide. Poster presented at the 2012 Digestive Disease Week; May 2012.

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.