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
Carrigan G, Bradbury BD, Brookhart MA, Capra WB, Chia V, Rothman KJ, Sarsour K, Taylor MD, Brown JS. External comparator groups derived from real-world data used in support of regulatory decision making: use cases and challenges. Curr Epidemiol Rep. 2022 Dec;9:326-37. doi: 10.1007/s40471-022-00305-9
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
Margulis AV, Anthony M, Rivero-Ferrer E. Drug safety in pregnancy: review of study approaches requested by regulatory agencies. Curr Epidemiol Rep. 2019 Sep;6(3):380-9. doi: 10.1007/s40471-019-00212-6
Danysh HE, Navai SA, Scheurer ME, Hunt R, Venkatramani R. Malignant melanoma incidence among children and adolescents in Texas and SEER 13, 1995-2013. Pediatr Blood Cancer. 2019 Jun;66(6):e27648. doi: 10.1002/pbc.27648
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
Peckham-Gregory EC, Danysh HE, Brown AL, Eckstein O, Grimes A, Chakraborty R, Lubega J, McClain KL, Allen CE, Scheurer ME, Lupo PJ. Evaluation of maternal and perinatal characteristics on childhood lymphoma risk: a population-based case-control study. Pediatr Blood Cancer. 2017 May;64(5). doi: 10.1002/pbc.26321
Sankaran H, Danysh HE, Scheurer ME, Okcu MF, Skapek SX, Hawkins DS, Spector LG, Erhardt EB, Grufferman S, Lupo PJ. The role of childhood infections and immunizations on childhood rhabdomyosarcoma: a report from the children's oncology group. Pediatr Blood Cancer. 2016 Sep;63(9):1557-62. doi: 10.1002/pbc.26065
Rees CA, Keating EM, Lukolyo H, Danysh HE, Scheurer ME, Mehta PS, Lubega J, Slone JS, Baylor Pediatric HIV-Related Malignancy Consortium. Mapping the epidemiology of Kaposi sarcoma and non-Hodgkin lymphoma among children in sub-Saharan Africa: a review. Pediatr Blood Cancer. 2016 Aug;63(8):1325-31. doi: 10.1002/pbc.26021
Danysh H, Zhang K, Mitchell LE, Scheurer ME, Lupo PL. Maternal residential proximity to roadways during pregnancy and childhood central nervous system tumors: a population-based assessment in Texas, 2003-2009. Presented at the 47th Congress of the International Society of Paediatric Oncology; October 10, 2015. Cape Town, South Africa. [abstract] Pediatr Blood Cancer. 2015 Nov; 62(S4). Previously presented at the Brain Tumor Epidemiology Consortium 2015 Annual Conference.
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
Danysh HE, Mitchell LE, Zhang K, Scheurer ME, Lupo PJ. Traffic-related air pollution and the incidence of childhood central nervous system tumors: Texas, 2001-2009. Pediatr Blood Cancer. 2015 Sep;62(9):1572-8. doi: 10.1002/pbc.25549
Danysh HE, Mitchell LE, Zhang K, Scheurer ME, Lupo PL. A statewide assessment of childhood central nervous system tumors and traffic-related air pollution. Presented at the 46th Congress of the International Society of Paediatric Oncology (SIOP); October 2014. Toronto, Canada. [abstract] Pediatr Blood Cancer. 2014 Dec; 61(S2). Previously presented at the Brain Tumor Epidemiology Consortium 2014 Annual Conference. doi: 10.1002/pbc.25314
Andrews EB, Margulis AV, Tennis PS, West SL. Opportunities and challenges in using epidemiologic methods to monitor drug safety in the era of large automated health databases. Curr Epidemiol Rep. 2014 Oct 12;1(4):194-205.
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.
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.