Stothers Rosenberg S, Ng X, Mansfield C, Poulos C, Peay H, Lee TH, Irony T, Ho M. Adaptation of the WOMAC for use in a patient preference study. Ther Innov Regul Sci. 2023 Jul;57(4):702-11. doi: 10.1007/s43441-023-00510-8
Greene A, Elmer M, Ludlam S, Shay K, Bentley S, Trennery C, Grimes R, Gater A. Evaluation of the content validity and cross-cultural validity of the Study Participant Feedback Questionnaire (SPFQ). Ther Innov Regul Sci. 2020 Nov;54(6):1522-33. doi: 10.1007/s43441-020-00179-3
Hackshaw MD, Bui CL, Ladner A, Tu N, Zahidu I, Ritchey ME, Salas M. Review of survival, safety, and clinical outcomes in HER2+ metastatic gastric cancer following the administration of trastuzumab post-trastuzumab gastric cancer. Cancer Treat Res Commun. 2020;24(2020). doi: 10.1016/j.ctarc.2020.100189
Byrom B, Gwaltney C, Slagle A, Gnanasakthy A, Muehlhausen W. Measurement equivalence of patient-reported outcome measures migrated to electronic formats: a review of evidence and recommendations for clinical trials and bring your own device. Expert commentary. Ther Innov Regul Sci. 2018 Aug 29. doi: 10.1177/2168479018793369
Odom D, McLeod L, Sherif B, Nelson L, McSorley D. Longitudinal modeling approaches to assess the association between changes in 2 clinical outcome assessments. Ther Innov Regul Sci. 2018 May;52(3):306-12. doi: 10.1177/2168479017731584
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
Beillat M, Brown TM, DiBenedetti DB, Naber D. Patient and caregiver perspectives on the Heinrichs-Carpenter Quality of Life Scale and the Subjective Well-being Under Neuroleptics-Short Form. J Psychiatry Psychiatric Disord. 2017 May;1(3):109-26.
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
O'Donohoe P, Lundy JJ, Gnanasakthy A, Greene A. Considerations for requiring subjects to provide a response to electronic patient-reported outcome instruments. Ther Innov Regul Sci. 2015 Nov;49(6):792-6. doi: 10.1177/2168479015609647
Gnanasakthy A, DeMuro C. Overcoming organizational challenges of integrating patient-reported outcomes in oncology clinical trials. Ther Innov Regul Sci. 2015 Oct;49(6):822-30. doi: 10.1177/2168479015608413
Gnanasakthy A, Sadrick A, Eghbal-Ahmadi M, DeMuro C. Promotion of patient-reported outcome label claims based on nonprimary endpoints. Ther Innov Regul Sci. 2014 Sep;48(5):557-63.
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
Gnanasakthy A, DeMuro-Mercon CJ, Clark MJ, Mordin MM, Thomas S. Role of patient-reported outcome measures in the assessment of central nervous system agents. Ther Innov Regul Sci. 2013;47(5):613-8.
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.
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 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.
Sharp L, Foll P, Deady S, O'Ceilleachair A, Buicke C, Carsin AE. Where do people with lung cancer die and how is this changing? A population-based study. Irish Med J. 2010 Oct;103(9):262-6.
Mangel AW, Fehnel SE. Design of treatment trials in irritable bowel syndrome: opioid agonists and atypical benzodiazepine antagonists. Neurogastroenterol Motil. 2008 Oct 1;20(10):1086-93.