Biostatistics, Epidemiology, Research Design (BERD)

Assistance with biostatistical analysis and study design

Director:  Mohammad Hossein Rahbar, PhD Mohammad.H.Rahbar@uth.tmc.edu 713-500-7901

BERD provides leadership, expertise, and advice in biostatistics, epidemiology, and research design to investigators in the CCTS.  BERD’s mission is to promote (within our CCTS-affiliated institutions as well as across CTSAs nationwide) innovative, state-of-the-art clinical and translational research of maximum public health benefit and scientific impact. BERD provides the resources required to pursue the following objectives in support of the overall goals of the CCTS.

  • Contribute to the enhancement and further development of the clinical and translational research infrastructure both within the CCTS and across CTSAs nationwide.
  • Develop short term and long-term collaborations between clinical/translational investigators and members of our CCTS network of experts in biostatistics, epidemiology, and research design.
  • Contribute to the formal training of clinical and translational investigators in biostatistics, epidemiology, and research design
  • Contribute methodological advances in biostatistics, epidemiology, and study design of benefit to clinical and translational research.

To achieve these goals, BERD will seize every opportunity (e.g., through informal consultations as well as classroom instruction) to develop a collaborative relationship with clinical/translational investigators (primarily within our CCTS-affiliated institutions) to promote the rapid development of innovative research ideas and the rapid dissemination of valid research findings. Typically, this is a long-term process that begins with providing assistance with study design and epidemiological and statistical methods in the development of a research proposal, proceeding (most often iteratively) with the acquisition of funding, and, over the course of actually conducting the study, producing findings and publications (most often iteratively). The goals of BERD include collaboration with investigators to optimize the often complex trade-offs between the research innovation, its potential medical/public health impact, and the required investments of time and resources. BERD aims to reduce the number of iterations required to successfully obtain research funding and to publish research findings.

BERD faculty, staff, and trainees also conduct their own clinical and translational research and collaborate with leading statisticians in the Texas Regional CTSA Consortium and the national CTSA program. 


BERD Support Options

Research support through BERD is available in the following capacities: collaboration, consultation, or fee-for service contract. An initial BERD consultation to assess an investigator’s research needs is offered free of charge. For established, funded projects seeking an hourly “fee-for-service” arrangement, a written contract will be provided. Such projects typically require data management and statistical analysis. Whenever possible, we recommend a collaborative arrangement in which a fixed percent effort of a BERD faculty member is budgeted into the funding application. This prospective arrangement has the advantage of assuring the investigator that the necessary resources have been pre-negotiated and will be available when the application is funded.

To explore and/or request BERD services, contact Dr. Rahbar, at 713-500-7901 Mohammad.H.Rahbar@uth.tmc.edu.


BERD Faculty and Staff

The Division of Clinical and Translational Sciences (DCTS) within the Department of Internal Medicine of The University of Texas Health Science Center at Houston (UTHealth) Medical School serves as the primary academic home for faculty in BERD.  In 2012, Dr. Rahbar, the director of BERD, was appointed as the division head. Please see the division website for faculty profiles. 


Ongoing BERD Projects

Epidemiological Research on Autism Spectrum Disorders (ASD) in Jamaica: Phase 2
R01ES022165-01 (PI: Rahbar)
09/12/2013 - 04/30/2018
NIH/NIEHS

On this project, UTHealth collaborates with a team of multidisciplinary researchers in the Faculty of Medical Sciences at The University of the West Indies, Mona Campus, Kingston, Jamaica, to develop and evaluate the capacity for creating a database of genetic and phenotypic information in Jamaica among ASD cases and their family members. We are conducting population-based etiologic studies of autism in Jamaica, with a particular focus on genetic and environmental factors, including six heavy metals (lead, mercury, arsenic, cadmium, manganese, and aluminum), polychlorinated biphenyls, and organochlorine pesticides as environmental contaminants and their potential interactions with the GST genes in relation to ASD.

Statistical Methodology Development in Blood Transfusion Protocol Research
R21 HL109479 (Multiple PI: Ning/Rahbar)
07/15/2013-04/30/2015 
NIH/NHLBI   

The overall objective of this project is to address issues in blood transfusion research by developing latent class analysis and recurrent event data analysis methodology to apply to this field.

Genetics and Ankylosing Spondylitis Pathogenesis
P01AR052915  (PI: Reveille/DMSC PI: Rahbar)
09/14/2012-06/30/2017
NIH/NIAMS

The goal of this program is to further characterize the genetic basis of ankylosing spondylitis, as it affects disease susceptibility, severity, phenotype penetrance in family members and how these disease-related genetic polymorphisms relate to animal models and human disease. The Data Management and Statistical Core (DSMC) will collaborate with investigators on this project by leveraging resources to provide study design, data management, and statistical support.

Hypertrophy Regression with N-Acetylcysteine in Hypertrophic Cardiomyopathy (HALT-HCM)
R34HL105563 (PI: Marian)
12/01/2011-11/30/2015 NCE
NIH/NHLBI  

The primary objective is to perform a pilot study in patients with hypertrophic cardiomyopathy (HCM) to establish safety and gather the prerequisite data for subsequent robust randomized placebo controlled efficacy studies with N-acetylcysteine (NAC). We will gather data on the recruitment, accrual, retention, and compliance rates of HCM patients randomized to treatment with a placebo or two escalating doses of NAC. Likewise, we will determine any potential side effects and estimate the effect size of NAC on indices of cardiac hypertrophy.

Safety of L. Reuteri and Effect on Microbiota and Biomarkers of Intestinal Health in Healthy Infants with Colic
R34AT006727 (PI: Rhoads)
05/01/2012-03/31/2016 NCE
NIH/NCCAM

This project is focused on a population of healthy infants with colic to show safety of a probiotic that has been shown to reduce crying time in infants with colic. The primary aim is to demonstrate (in a 2-year trial) the safety of L. reuteri in healthy newborns with colic (n=30), by administering 5 x 108 c.f.u. by mouth once daily for 6 weeks. The secondary aims are to determine the effect of L. reuteri on (a) regulating gastrointestinal inflammation as assessed by fecal calprotectin; (b) serum cytokines; (c) circulating regulatory T-cells; and (d) fecal microbiota.

Mitral Value Dynamic Analysis and Potential Clinical Applications
R01 HL109597 (PI: Kim)
09/01/11-08/31/16
NIH/NHLBI    

Mitral valve (MV) repair is the preferred treatment in patients with MV insufficiency. The unsolved problem in MV repair surgery is predicting which repair is optimal for each patient. The principal aim of this project is to develop a novel computational technique combining 3-D echocardiography with finite element and fluid-structure interaction analyses to evaluate the effects of MV morphology (normal vs. diseased valves, and pre- vs. post-repair) on MV function.

The University of Texas Houston Regional Stroke Center
1U10N5086496-01 (PI: Savitz)
09/29/2013-07/31/2018
NIH/NINDS   

The goal of this proposal is for UTHealth to serve as a regional clinical coordinating center for the NINDS Stroke Trials Network to conduct multi-site clinical trials focusing on stroke prevention, intervention, and recovery.

Methods Training in Patient-Centered Cancer Outcomes Research
R25HS023214-01 (PI: Suarez-Almazor)
7/01/2014-06/30/2019
NIH/AHRQ

The overall goal of this application is to increase the U.S. workforce of cancer researchers conducting Comparative Effectiveness Research/Patient Centered Outcomes Research by providing a comprehensive learning and training program that will be innovative, accessible, and tailored to the needs and expertise of individual participants. CERC offers training in CER/PCOR methodology, provides guidance on promoting stakeholder involvement, assists researchers in obtaining external funding, and fosters collaborations between researchers and established CER/PCOR methodologists.

Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect – Combined pressure and Doppler FLOW velocity measurements (DEFINE-FLOW)
PI: Nils Johnson
1/1/2014- 12/31/2016
Volcano Corporation

The goal of this proposal is for the Division of Cardiology, Department of Medicine, The University of Texas Medical School at Houston, Memorial Hermann Hospital, Texas Medical Center to conduct multi-site focusing on Define independent prognostic value of coronary flow reserve and fractional flow reserve for lesions in patients undergoing physiologic assessment for percutaneous coronary intervention.

A Pilot, Phase IIb, Randomized, Multi-center Safety and Activity Trial of Argatroban in Combination with TPA Stroke Study (ARTSS-2)
PI: Barreto Andrew
9/1/2011-8/30/2015
NINDS/FARB Foundation

This project is a supplement to the study The University of Texas Specialized Program in Acute Stroke (UT SPOTRIAS), University of Texas Medical School at Houston, University of Texas Health Science Center at Houston. Dr. Rahbar serves as PI of the Data Coordinating Center.

Comprehensive Tumor Microenvironment Based Prediction Models in Prostate Cancer
5R01CA140734-04  (PI: Ayala)
06/01/2012–05/31/2015
National Cancer Institute

Prostate cancer continues to have a significant health care impact due to its high incidence and mortality. Despite advancements in understanding the clinical spectrum of this disease, there are still limits in the ability to identify the patients who present with localized disease but are likely to fail standard treatment and progress to fatal disease. The overall goal of this project is to model a rigorous quantitative and reproducible tumor microenvironment-based test. Based on the hypothesis that such a test will improve predictability of currently used algorithms, the goal is to select those patients who can benefit from combined modality treatments or adjuvant/neoadjuvant approaches, or more intense follow-up.

Predicting Prostate Cancer Aggressiveness
5U01CA151924-04 (PI: Ayala)
09/14/2011 –08/31/2015
H. Lee Moffitt Cancer Center


Text Messaging for Weight Loss
GRANT #144366  (PI: Hwang)
07/01/2011 –06/30/2015
University of Texas System

Telemedicine Guided Education on Fall Prevention and Secondary Stroke Prevention Following Inpatient Rehabilitation: A Feasibility Pilot Study
Texas Institute of Rehabilitation Research (TIRR) (PI: Mansi Jhaveri)
11/06/2014-05/31/2016

The goal of this project is to determine the feasibility of weekly telephone contact using the FaceTime application to educate and monitor stroke patients after discharge from inpatient rehabilitation to home and collect preliminary data on the use of this strategy to prevent falls, recurrent strokes, and 30-day hospital readmission.

Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
ALT113516 (PI: Hebert)
12/10/2009-12/09/2015
GlaxoSmithKline

The purpose of this study is to document the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with bacterial infections, including impetigo, folliculitis, and minor soft tissue infections including secondarily infected eczema presumed to be caused by methicillin resistant Staph aureus.

Swipe Out Stroke (SOS)
PI: Ifejika 

Feasibility of Using a Consumer Based Electronic Application to Improve Compliance with Weight Loss in Obese Minority Stroke Patients.


Completed Research Projects by BERD Faculty and Staff

PI: Rahbar
PRospective Observational Multi-center Massive Transfusion sTudy (PROMMTT-DCC)

The purpose of this project is for the Center for Clinical and Translational Sciences (CCTS) at The University of Texas Health Science Center at Houston (UTHealth) to serve as the Data Coordination Center for Prospective, Observational, Multi-center Massive Transfusion Trial (PROMMTT) which involves 10 major trauma research centers in the United States. PROMMTT-DCC will provide comprehensive administration including the establishment and management of a Consortium of at least 10 clinical sites and the coordination of data collection, data management and statistical analysis activities to achieve the overall objectives of this project. 

PI: Grotta
The University of Texas Specialized Program in Acute Stroke (UT SPOTRIAS) Data Core

This program is a renewal of The University of Texas Health Science Center at Houston Specialized Program in Translational Research in Acute Stroke. This program includes implementation of two clinical trials in stroke patients. This program also includes 3 Cores (Clinical, Data, and Tissue) to support these clinical and translational studies as well as a Career Development Program to train new investigators to carry out future translational studies. 

PI: Lindsey
Epstein-Barr Virus and Multiple Sclerosis: Correlation of Activity National Multiple Sclerosis Society

Multiple sclerosis (MS) is an immune-mediated, demyelinating disease affecting the central nervous system. The etiology of MS is currently not known, but many features of the disease are consistent with an infectious cause. There are several lines of evidence associating MS with Epstein-Barr virus (EBV). Essentially all adults with MS are infected with EBV, EBV infection occurs before the clinical manifestations of MS, and high titers of antibodies against EBV or a history of symptomatic EBV infection predict a higher risk of developing MS. Despite these associations, the relation between the virus and the disease is not clear. The specific aim is to determine whether reactivation of EBV and changes in the anti-EBV immune response correlate with disease activity in relapsing-remitting MS.

PI: Reininger
Tu Salud, ¡Si Cuenta!: Promotora Training and Community Education for Cancer Prevention  Cancer Prevention and Research Institute of Texas (CPRIT)

Tu Salud, ¡Si Cuenta! (Your Health Matters!) community-wide campaign was designed and implemented to reach adults aged 20-64 years and their families along the US/Mexico Border on the topics of physical activity and healthy food choice. It was hypothesized that individuals who reported exposure to multiple components of the CWC would also report greater physical activity and fruit and vegetable consumption. The purpose of this project is to implement community based cancer prevention using technology among the Mexican Americans. 

Transforming Texas in Cameron County: Healthy People in a Healthy Community Texas Department of State Health Services

The purpose of this project is to implement policy and environmental change strategies to promote physical activity, healthful food choices, and smoking cessation.

PI: McCormick
Collaboration with UT-Brownsville Campus:
Center of Excellence for Diabetes in Americans of Mexican Descent

This project will conduct research on the physiological progression of diabetes and its complications among Mexican Americans and develop diabetes prevention strategies and test innovative approaches to effective intervention in minorities. This Center of Excellence aims to 1) understand the changes proximal to the development of overt diabetes, 2) understand the mental health impact of diabetes and the potential for early intervention, 3) utilize the strong family unit in the Mexican American population to reduce the risk of obesity and diabetes in children through parental intervention, and 4) understand how to use the successful technique of behavioral journalism and the media to change diet and physical activity behavior at the population level.

PI: Reininger
Collaboration with UT-Brownsville Campus:
Social Cogitative Disaster Preparedness Communications for Mexican-Americans

The purpose of this grant will be to identify the special needs population within Cameron, Hidalgo and Willacy Counties in South Texas who will need assistance in being evacuated in case of emergency. The specific aims of this project include: 1) needs assessment and to determine the number of persons with special needs requiring assistance with evacuation in case of emergency; by level of need, census tract, and county based on two stage community survey; 2) needs assessment and to determine the number of persons with special needs based in institutions providing care such as nursing homes, long-term care facilities, hospice, assisted living facilities, state schools and hospitals; requiring assistance with evacuation in case of emergency by level of need, census tract and county based on a self-reported questionnaire; and 3) experimental methods will be incorporated to evaluate and improve the effectiveness of our disaster preparedness guidelines in order to enable this population to better deal with a potential disaster in future in more scientific way.

PI: Vernon
Initiation of Colorectal Cancer Screening in Veterans

This is a nationwide, randomized, controlled intervention trial to increase the initiation of colorectal cancer screening in the population of male and female U.S. veterans between 50 and 64 years of age. The stepped intervention approach will use mailed intervention materials followed by telephone reminders comparing two different approaches: automated vs. live consultations that incorporate strategies from the field of motivational interviewing. This is a collaborative project with investigators at UTHealth, Duke University School of Medicine, the Durham VAMC, and Washington University (St. Louis) School of Medicine.

PI: Cooper
Southwest Center for Agricultural Health, Injury Prevention and Education: Migrant Adolescent Health Research Study

This is an epidemiologic study of the prevalence and incidence of early indicators of chronic disease (e.g., obesity and Type II diabetes) among farm worker adolescents (13-19 years of age) to support the prevention and comprehensive policy dimensions of NIOSH’s WorkLife initiative. This project is part of the current research program of the Southwest Center for Agricultural Health, Injury Prevention, and Education at the University of Texas Health Science Center at Tyler that sponsors research, education/outreach programs.

PI: Arnett
Center for Research Translation in Scleroderma

This Center focuses on molecular approaches to understand the pathogenetic mechanisms (including genetic factors) and predictors of outcomes in systemic sclerosis. The study aims to identify the cellular pathways leading to disease and optimal targets for effective therapy and prevention. The patient population includes three major ethnic groups. There are 3 projects: 1. Functional Genomics Approach to Systemic Sclerosis Pathogenesis, 2. Gene Expression as Predictors of Outcomes in the GENISOS (Genetics versus Environment in Scleroderma Outcomes Study) Cohort, and 3. Role of TGF3 and CTGF Signaling in Transgenic Mouse Models of Scleroderma.

PIs: Sdringola/Gould
Randomized Trial of Comprehensive Lifestyle Modification, Optimal Pharmacological Treatment and PET Imaging for Detection and Management of Stable Coronary Artery Disease (The Century Trial)

The purpose of this randomized, controlled trial is to 1) evaluate the impact of stress perfusion imaging with SPECT or PET on post-test resource utilization and on risk stratification, and 2) assess whether a comprehensive program of lifestyle modification and lipid management, compared with standard therapy, reduces cardiovascular risk in patients with known disease or at high risk for coronary artery disease. Eligible patients are between 40 and 75 years of age and referred by their physicians to receive SPECT imaging. Participants are assigned randomly to receive either a comprehensive intervention program or standard follow-up care by their referring physician and are followed for five years to compare their post-intervention outcome scores on a standardized scale measuring cardiovascular risk factors and survival free of serious adverse cardiovascular disease events (e.g., myocardial infarction, stroke).

PI: Dyer
Training Excellence in Aging Studies (TEXAS)

TEXAS applies a competency-based approach to foster knowledge and skill acquisition in geriatrics at student, resident, faculty and practicing physician levels so that outcomes are realized at both organizational and individual levels. This program hopes to establish an innovative, high impact and sustainable geriatric education program for UTHealth students, residents and faculty and, ultimately, improve quality of care for the vulnerable elderly population.