Design, Biostatistics, and Ethics

Projects

Research Collaborations
Cerebral Autoregulation Project. Biostatisticians Keith Williams, PhD, and Heath Gauss, MS, are engaged in a long-term collaboration with Jeffrey R. Kaiser, MD, MA, a neonatologist at UAMS and Arkansas Children’s Hospital, to investigate cerebral autoregulation in very low birth weight (VLBW) infants (1K23NS43185, 5/2002–4/2007). This team was the first in the world to show that increasing carbon dioxide during the first week of life is associated with progressively impaired cerebral autoregulation in VLBW infants. The team is conducting a randomized, controlled trial comparing a permissive hypercapnia ventilatory strategy to normal carbon dioxide during the first week of life, with development of intraventricular hemorrhage (the most common acute brain injury in premature infants) as the primary outcome (1R01NS060674-01A1, 6/2008–5/2013). Developing predictive models and translating study results to the community have the potential to lead to important changes in the care of VLBW infants around the world and promote survival without brain injury.

Winthrop P. Rockefeller Cancer Institute. Biostatistical collaboration in the design and analysis of cancer-related research projects has been available to researchers in the Winthrop P. Rockefeller Cancer Institute since 1995 when the Biostatistics Shared Resource (BSR) was established there. BSR personnel have access to other department members for troubleshooting and expertise in specialized statistical methods. This shared resource is currently staffed by Dr. Jeannette Y. Lee and research associates Horace Spencer, MS, and Eric Siegel, MS. Collaborations have led to successful grant applications to the NCI, DOD, and private foundations such as Komen and Armstrong.

Telemedicine. In 2003, the UAMS Division of Maternal–Fetal Medicine launched a unique collaboration with the Arkansas Department of Human Services, Arkansas Medical Society, and Arkansas’ rural physicians to enhance the quality of care for high-risk obstetrics through a telemedicine program entitled Antenatal & Neonatal Guidelines, Education, and Learning System (ANGELS). This program employs telemedicine to increase statewide access to maternal–fetal medicine consult services for high-risk pregnancies. The biostatisticians’ role is key to evaluating the clinical-effectiveness and cost-effectiveness of ANGELS. Biostatisticians are currently using regression trees to examine the risk profile of Medicaid-covered pregnant women to identify factors associated with a greater likelihood of a completed referral to maternal-fetal medicine consult services in 2001–2003 (pre-ANGELS).

Tailored Biobehavioral Interventions Research Center (TCBIRC). The mission of this UAMS College of Nursing Center is to bring together scientists to facilitate and enhance the science of tailored biobehavioral interventions and inform clinical practice. This exploratory center is funded by the National Institute of Nursing Research (P20 NR009006). As the center’s statistician and member of its Executive Committee, Dr. Roberson works with junior investigators to design and analyze pilot studies supported by the center and works with investigators to develop grant proposals related to its mission.

Childhood Obesity in Arkansas. Biostatisticians Zoran Bursac, PhD, and Heath Gauss, MS have been collaborating with a group of College of Public Health investigators since 2004 to evaluate Arkansas Act 1220, a legislative bill targeting childhood obesity in Arkansas. In the multi-component evaluation, the biostatisticians’ involvement includes design and analysis of complex longitudinal surveys of parents and adolescents in the state to measure changes in behavior, knowledge, attitude, and perception regarding obesity.

Wart Immunotherapy Clinical Trials. Dr. Roberson worked with faculty in the UAMS Department of Dermatology to design and analyze clinical trials evaluating the use of FDA-approved skin-test antigens, singly and in combination, to treat the common wart caused by the Human Papilloma Virus (HPV). A series of pilot studies and a blinded, randomized, controlled clinical trial demonstrated that intralesional injection of a skin antigen can induce an immunological response that, in many individuals, leads to clearing of the injected wart as well as distant untreated warts.

Potential herb–drug interactions of Dietary Supplements. Dr. Williams' 7-year collaboration with Bill Gurley, PhD, of the UAMS Department of Pharmaceutical Sciences, focuses on popular over-the-counter herbal supplements (including St. John’s wort) and their effects on prescription drugs.

Disparities Research. Dr. Bursac is a co-investigator on a novel behavioral intervention study funded by the Susan G. Komen Foundation and American Cancer Society, targeting rural Latina women in Arkansas with the goal of increasing breast and cervical cancer screening. He and Mr. Gauss are working on this study via the NIH-funded Exploratory National Center for Minority Health and Disparity (NCMHD) Research Center of Excellence in Arkansas. In this role, they are supporting one core research project and six pilot research projects that focus on various minority health and health-disparity problems.

HIV Prevention in Substance Abusers.The Jes'Us (Joining Everyone Spiritually, United in Strength) Help Program is a direct collaborative venture with the UAMS College of Public Health’s Department of Health Behavior and Health Education (R01 DA024575-01, 09/20/07–08/31/12, PI: K. Stewart, PhD). The primary objective is to test the efficacy of culturally appropriate, theory-based sexual-risk intervention for rural African-American cocaine users.

Arkansas Injury and Prevention Research Center (AIPRC). The overall mission of the AIPRC, led by Mary Aitken, MD, in the Department of Pediatrics, is to reduce injury and the sequelae of injury in high-risk, vulnerable populations, specifically rural, poor children and families. The broad AIPRC mission will be achieved through a combination of core and educational functions and multidisciplinary research needed to focus, organize, and refine the injury prevention activities of the state and the region, consistent with the Centers for Disease Control and Prevention’s (CDC) Injury Research Agenda and Healthy People 2010.

Community-Partnered Walking Program in Rural Worksites. Dr. Moore is a co-investigator on a novel study to examine the effects of a worksite walking intervention designed to increase physical activity and improve cardiorespiratory fitness in multiple rural demographic regions in Arkansas using an ecological model.
Protein–Energy Undernutrition in Elderly. Dr. Hackler serves as an ethics consultant and Dr. Roberson as study statistician on a 5-year, $2.4 million grant (VA HSR&D Project #: IIR 04-298-2) studying the manifestations, causes, and consequences of protein–energy undernutrition in elderly nursing home patients residing in a transitional care unit. Patients’ nutritional intakes are carefully monitored to better understand the relationships among nutrient intake, weight loss, serum concentration of albumins, health status, illness severity, and mortality. Residents will be identified who are receiving an inadequate nutrient intake; thus, ethical concerns are expected to arise about the extent of researchers’ obligations to intervene to protect patients’ welfare. To minimize ethical conflicts, Dr. Hackler assisted in the study design. He also conducts workshops for research staff, monitors results, and consults with study personnel about questionable cases.

UAMS Translational Research Institute
4301 W. Markham #Slot 577, Little Rock, AR 72205, 501-614-2287


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