OMB No. 0925-0001 and 0925-0002 (Rev. 10/15 Approved Through 10/31/2018)

BIOGRAPHICAL SKETCHProvide the following information for the Senior/key personnel and other significant contributors.

Follow this format for each person. DO NOT EXCEED FIVE PAGES.

NAME: Shasha Bai Co-I

eRA COMMONS USER NAME (credential, e.g., agency login): SHASHA_BAI

POSITION TITLE: Assistant Professor of Pediatrics and Biostatistics

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)

INSTITUTION AND LOCATIONDEGREE

(if applicable)

Completion Date

MM/YYYYFIELD OF STUDY

Sichuan University–University of Washington Exchange Program, Chengdu, Sichuan, China, and Seattle, WA

BS 06/2004 Biology

State University of New York–College of Environmental Science and Forestry, Syracuse, NY

MS 05/2007 Molecular Biology

The Ohio State University, Columbus, OH MS 06/2011 Statistics

The Ohio State University, Columbus, OH PhD 05/2014 Biostatistics

A. Personal StatementI am an Assistant Professor of Biostatistics and Pediatrics at the University of Arkansas for Medical Sciences (UAMS). Since arriving at UAMS in 2014, I have provided biostatistical support for USDA, NIH, and industry-funded grants through the Arkansas Children’s Nutrition Center (ACNC) and Arkansas Children’s Research Institute (ACRI). My work experience as a biostatistician began at the Statistical Consulting Service of The Ohio State University in 2010. In 2011, the opportunity to work as a biostatistician intern at ACRI further enriched my research experience. From 2011 to 2014, I was jointly appointed as a research assistant by College of Medicine and College of Public Health at Ohio State. During this time, I collaborated with medical investigators and assisted with data analysis and presentation/manuscript preparation. I have a variety of statistical research interests. The main focus of my methodological research is agreement and reliability measures in complex scenarios. In addition to agreement, I am intrigued by analysis of correlated data. My statistical expertise also includes design and analysis of longitudinal studies, cluster-correlated studies, analysis of categorical outcomes, and missing data analysis.

B. Positions and HonorsPositions and Employment2010-2011 Statistical Consultant, Statistical Consulting Service, The Ohio State University, Columbus

OH2011 Biostatistician (Intern), Arkansas Children’s Hospital Research Institute, Little Rock AR2011-2014 Teaching Assistant, College of Public Health, The Ohio State University, Columbus OH2011-2013 Research Assistant, College of Public Health, The Ohio State University, Columbus OH2014-present Assistant Professor, Biostatistics Program, Department of Pediatrics, UAMS, Little Rock AR

Other Experience and Professional Memberships2004-2006 Research Assistant, Research Foundation of SUNY, Syracuse, NY2006 Research Investigator (Intern), USDA Forest Service Pacific NW Research Station2012-2013 Member, Eastern North American Region (ENAR), International Biometric Society2012-2014 Member, American Association for the Advancement of Science (AAAS)2014-present Member, American Statistical Association (ASA)2014-present Vice President, Central Arkansas Chapter (CASA), ASA

2014-present Editorial Board, Journal of Pediatrics & Child Care2015 Manuscript Reviewer for Statistics in Medicine

C. Contribution to Science1. In collaboration with researchers in neonatology, neurology, and general pediatrics, I have contributed

to several works investigating the relationship between long-term school outcomes with early childhood risk factors. In one recent publication in JAMA Pediatrics, we studied the association of transient hypoglycemia with their long-term academic performance. After controlling for myriad perinatal factors, early transient hypoglycemia was found to be associated with decreased probability of proficiency on literacy and mathematics fourth-grade achievement tests for various hypoglycemia definitive cutoffs.

a. Mulkey S, Bai S, Luo C, Cleavenger JE, Gibson N, Holland G, Mosley BS, Kaiser JR, Bhutta AT. School-age test proficiency and special education after congenital heart disease surgery in infancy. J Pediatr. 2016 Nov;178:47-54.e1. doi: 10.1016/j.jpeds.2016.06.063. PMC5295644 [Available on 2017-11-01]

b. Kaiser JR, Bai S, Gibson N, Holland G, Lin TM, Swearingen CJ, Mehl JK, El Hassan NO. Association between transient newborn hypoglycemia and fourth-grade achievement test proficiency: a population-based study. JAMA Pediatr. 2015 Oct;169(10):913-21. doi: 10.1001/jamapediatrics.2015.1631.

2. I am the lead faculty biostatistician collaborating with faculty clinicians, fellows, and residents in the fields of pediatric cardiology, pulmonary, urology, neurology, and neonatology at UAMS and ACRI. I am involved in designing, analyzing, and interpreting the results of several projects, such as prediction of aEEG on brain injuries, ATV safety for children, and early feeding on initial glucose concentration in term newborns.

a. Zhou Y, Bai S, Bornhorst JA, Elhassan NO, Kaiser JR. The effect of early feeding on initial glucose concentrations in term newborns. J Pediatr. 2017 Feb;181:112-115. doi: 10.1016/j.jpeds.2016.10.032.

b. House T, Schwebel DC, Mullins SH, Sutton AJ, Swearingen CJ, Bai S, Aitken ME. Video intervention changes parent perception of all-terrain vehicle (ATV) safety for children. Inj Prev. 2016 Oct;22 (5):328-33. doi: 10.1136/injuryprev-2015-041880.

c. Mulkey SB, Yap VL, Bai S, Ramakrishnaiah RH, Glasier CM, Bornemeier RA, Schmitz ML, Bhutta AT. Amplitude-integrated EEG in newborns with critical congenital heart disease predicts preoperative brain magnetic resonance imaging findings. Pediatr Neurol. 2015 Jun; 52(6): 599-605. doi: 10.1016/j.pediatrneurol.2015.02.026. PMC4442075

3. I have also provided assistance in several quality improvement (QI) projects with the objectives to better patient outcomes and reduce cost in a tertiary children’s hospital.

a. Linam WM, Honeycutt MD, Gilliam CH, Wisdom CM, Bai S, Deshpande JK. Successful development of a direct observation program to measure health care worker hand hygiene using multiple trained volunteers. Am J Infect Control. 2016 May 1;44(5):544-7. doi: 10.1016/j.ajic.2015.12.019.

b. Lowe GR, Willis JR, Bai S, Heulitt MJ. Implementation of a β-agonist/airway clearance protocol in a pediatric ICU. Respir Care. 2017; 62(3):259-267. doi: 10.4187/respcare.04857.

4. My methodological research interest lies in measuring agreement and reliability measures. Agreement and reliability studies are found in many applications, such as questionnaire validation, development of diagnostic tests, and assessment of rater performance. My collaborative work with a bioinformatician introduced an improved tool for assessing inter-observer reliability for meaningful clinical workflow analysis. In addition, I have written a book chapter that provides an overview of statistical tools for agreement and reliability studies, targeted at the clinical audience.

a. Bai S. Statistical Tools for Agreement and Reliability Studies. In Handbook for Clinical Research: Design, Statistics, and Implementation. Hammond FM, Malec JF, Buschbacher R, Nick TG (Eds.). Demos Medical Publishing: New York, 2014.

b. Lopetegui MA, Bai S, Yen PY, Lai A, Embi P, Payne PR. Inter-observer reliability assessments in time motion studies: the foundation for meaningful clinical workflow analysis. AMIA Annu Symp Proc. 2013;2013:889-96. PMC3900222

Complete List of Published Work in MyBibliography:http://www.ncbi.nlm.nih.gov/sites/myncbi/14IbosqI0Ov5b/bibliography/48468624/public/?sort=date&direction=descending

D. Research SupportOngoing Research SupportNIH/NIGMS (P20GM109096) Weber (PI) 08/01/16–07/31/21“Center for Childhood Obesity Prevention”The goal of the COBRE is to develop an integrated, interdisciplinary and translational Center for community-based childhood obesity prevention research. We will accomplish this through a coordinated, community-based approach targeting modifiable individual risk behaviors, environmental risk factors, and state and national risk reduction policies. We will bring together a group of four promising junior investigators (Project Leaders) whose collective research focuses on all aspects of this central theme, provide these investigators with a supportive infrastructure environment developed specifically to enhance their chances for success, and use the foundation provided by this initial group to recruit additional junior investigators with an interest in community-based approaches to childhood obesity prevention.Role: Associate Director of Biostatistics Core

USDA (3092-51000-056-04A) Weber & Børsheim (Co-PIs) 06/01/16–05/31/20“Relationship of physical activity and diet with socio-demographic, environmental, and metabolic factors in Arkansas public school children”The overarching objective of this study is to identify modifiable factors that are associated with obesity rates in Arkansas children.Role: Co-Investigator

NIH/NICHD (R01HD076702) Aitken (PI) 07/14/14–04/30/19“Generations in Families Talking Safe Sleep (GIFTSS)”The overall goal of this proposal is to use educational intervention delivered during a safety baby shower (SBS) activity and testing the impact of involving a senior caregiver (SCG) as mechanisms to improve safe sleep practices in teen mothers. Dr. Bai’s support began July 2015.Role: Co-Investigator

UAMS DOP Innovation in Pediatric Education Schellhase (PI) 08/01/16–07/31/18“AIR (Acknowledge, Investigate, Resolve) Medical Error Response Training”Role: Co-Investigator

Completed Research SupportNIH/NIEHS (R01ES021484-01A1) Gilbert (PI) 09/01/15–10/30/16“Developmental programming of TCE-induced autoimmune disease”The overall goal of this proposal is to investigate developmental exposure to TCE on autoimmune-promoting effects of adult exposure. It is expected that this effect will be mediated by changes in the DNA methylation of specific effector genes in CD4+ T cells.Role: Co-Investigator

DHHS/HRSA (R40MC23626 in NEC) Kuo (PI) 08/01/15–01/31/17“Co-management of complex neonates: Supporting the medical home”This project supports the development and evaluation of an innovative system of care integration for children with special health care needs (CSHCN), focusing on children with medical complexity (CMC).Role: Co-Investigator

USDA/ARS (6251-51000-007-00D) Adams (PI) 02/01/16–04/30/16 “Impact of early dietary factors on child development and health”The goals of this center grant are to determine the effects of diet and physical activity in humans and animal models on development and organ function, determine how early exposure to soy proteins and fruits confers resistance to chronic diseases, and evaluate multiple molecular mechanisms and identify bioactive

components for chronic disease prevention by diets on the long-term consequences of nutrition during early development in humans and animal models.Role: Faculty Biostatistician

Lyon Award Mulkey (PI) 04/01/15–03/31/16“Biomarkers of neurodevelopmental outcome in infants with congenital heart disease”This project aims to develop a predictive profile of electroencephalographic (aEEG) abnormalities and biochemical markers of neuronal injury and oxidative stress in newborns in order to predict preoperative brain injury and resultant neurodevelopmental outcomes at 2 to 3 years of age. Dr. Bai’s support began April 2015.Role: Co-Investigator

Orbis Biosciences (ORB-101-01) Kearns (PI) 10/31/15–03/31/16“A single blind, randomized, four-way crossover study examining the palatability of taste-masked oral formulation of prednisone in healthy adults”The purpose of the proposed palatability study is to determine if the Orbis microsphere formulation significantly improves palatability measures compared to prednisone solution USP (5 mg/5 mL), the most commonly prescribed formulation of prednisone to pediatric and adult patients.Role: Faculty Biostatistician

NIH/NCRR (UL1RR02988) James (PI) 07/14/09–03/31/16“Arkansas Center for Clinical and Translational Research”The Arkansas Center for Clinical and Translational Research (CCTR) unites all UAMS colleges and its graduate school behind the translational research endeavor. The overarching goal is to establish an integrative CCTR that transforms the pace, effectiveness, and quality of translational research at UAMS, resulting in better health for all Arkansans. Dr. Bai’s support began April 2014.Role: Pediatric Biostatistician

USDA/AFRI (2011-68001-30014) Nayga & Weber (Co-PIs) 02/01/11–01/31/16“Intervention for obesity prevention targeting young children in at-risk environments-an integrated approach: The Arkansas Grow Healthy Study”The goal is to improve the diets of young children, especially through improving access to fresh fruits and vegetables; to conduct a statewide foodshed assessment for the promotion and facilitation of farm-to-school initiatives; and to ensure that tomorrow’s educators, childcare providers, and other practitioners are able to make a meaningful impact on the childhood obesity crisis throughout their professional lives. Dr. Bai’s support began July 2014.Role: Co-Investigator

Arkansas Biosciences Institute Mulkey (PI) 01/01/15–12/31/15“Early factors predictive of long-term school achievement in children with a history of congenital heart disease (CHD) surgery in infancy”The overall objective of this proposal is to identify the population of infants with congenital heart disease (CHD) at the highest risk for long-term neurodevelopmental delays and poor school achievement and to evaluate the earliest detectable differences between these groups. Dr. Bai’s support began March 2015.Role: Co-Investigator

NIH/NIDDK (R42DK079387) James (PI) 09/01/12–12/30/14“Adduct dipstick for diagnosis of acetaminophen toxicity”This grant seeks to establish the clinical utility of an adduct dipstick to rapidly detect acetaminophen toxicity. Dr. Bai’s support began July 2014.Role: Co-Investigator

USDA/ARS (6251-51000-007-00D) Badger (PI) 03/31/14–08/31/14“Impact of early dietary factors on child development and health”The goals of this center grant are to determine the effects of diet and physical activity in humans and animal models on development and organ function, determine how early exposure to soy proteins and fruits confers resistance to chronic diseases, and evaluate multiple molecular mechanisms and identify bioactive components for chronic disease prevention by diets on the long-term consequences of nutrition during early development in humans and animal models.

Role: Faculty Biostatistician

USDA/ARS (6251-51000-006-00D) Badger (PI) 03/31/14–08/31/14“Dietary influences on psychological and physiological function in children”The overall goal of this center grant is to determine the influence of dietary factors on growth, psychological, physiological, and cognitive development and function in children (from infancy through childhood).Role: Faculty Biostatistician