Alcohol Abuse Treatment Outcomes in Managed Care

Personnel: Robert Kane (Health Services Research & Policy), Principal Investigator

Melanie M. Wall, Biostatistician

Agency: NIAAA

Total Grant: $800,425

This project collects follow-up data on alcohol and substance abuse cases to determine outcomes and related costs. This project ended 8/31/2002.

Ancillary Study Data Analysis

Personnel: Robert Margolis, Principal Investigator

Chap T. Le, Co-Investigator

Agency: National Institutes of Health (NIDCD)

Total Grant: $109,360

In this Phase II project, the prototype developed in Phase I will be tested on a wide range of normal and hearing-impaired subjects in three clinical settings.

Ancillary Study Data Analysis in VA-HIT

Personnel: Hanna Rubins, Principal Investigator

David B. Nelson, Biostatistician

Agency: National Institutes of Health

Total Grant: $109,360

The VA HDL Intervention Trial was a multicenter, placebo controlled randomized trial that showed that gemfibrozil significantly reduced major cardiovascular events in 2531 men with coronary heart disease, low levels of low density lipoprotein cholesterol and levels of high density lipoprotein cholesterol. We propose to undertake the following further analyses of the VA-HIT data. 1) An analysis of the association between levels of glucose tolerance, insulin resistance and other features of the metabolic syndrome, occurrence of major cardiovascular outcomes, and gemfibrozil efficacy. 2) An analysis of the effect of gemfibrozil on progression of carotid atherosclerosis, as measured by B-mode ultrasound. 3) An analysis of the association between LDL particle size distribution and lipoprotein subclass distribution, homocysteine; lipoprotein(a); C-reactive protein, tissue plasminogen activator (tPA); fibrinogen; and factor VII, major cardiovascular outcomes, and gemfibrozil efficacy.

Blood and Marrow Transplant Program, Biostatistics Support Group

Personnel: Anne I. Goldman, Senior Statistician of Biostatistics Support Group

Total Budget: $777,000

The Biostatistics Support Group provides biostatistical help for research in blood and bone marrow transplantation and has designed and maintains the BMT database for all patients who have received transplants at the University of Minnesota. The Biostatistics Support Group is supported by a variety of sources including the University of Minnesota Comprehensive Cancer Center Grant, the Stem Cell Program Project, Fairview University Medical Center, and several pharmaceutical company contracts.

Division of Biostatistics 2003 Annual Report

Grants and Contracts, continued

University of Minnesota Comprehensive Cancer Center

Personnel: John H. Kersey, Director

Chap T. Le, Director of the Biostatistics Core

Anne I. Goldman, Co-Investigator

Collaborative with Medical School, University of Minnesota

Agency: National Institutes of Health (NCI)

Total Grant: $5,455,791

The mission of the University's Comprehensive Cancer Center is to create a collaborative environment that advances knowledge about the causes, prevention, detection, and treatment of cancer and to apply that knowledge to patient treatment. The Comprehensive Cancer Center consists of 8 research programs and several core units. The Biostatistics Core supports all aspects of cancer studies, from study design, randomization, registration, data collection, processing, quality control, data storage and retrieval to data analysis. Major activities are in statistical consulting and protocol reviews.

Chemoprevention of Lung and Esophageal Cancers

Personnel: Steve S. Hecht (Cancer Center), Program Director

Chap T. Le, Co-Investigator and Biostatistician

Agency: National Institutes of Health (NCI)

Total Grant: $4,532,150

This project is a joint effort between the University of Minnesota, the Ohio State University, and the New York Health Foundation. The overall goal is to discover and develop effective chemopreventive agents against lung and esophageal cancers: the approach is based on an understanding of mechanisms by which these agents prevent tumor development and decrease DNA damage by tobacco related carcinogens. This project ended 1/31/2003.

Clinical Coordinating Center for Feasibility Study of Retinoid Therapy for Emphysema

Personnel: John E. Connett, Principal Investigator

Agency: National Institutes of Health (NHLBI)

Total Grant: $1,390,285

The purpose of this project is to establish and operate a clinical coordinating center for feasibility studies of retinoic acid as a possible treatment for emphysema. The clinical coordinating center participates in design, data processing and management, statistical analysis of data, and authorship of recommendations, evaluations and publications.

Clinical Research Curriculum Award

Personnel: Stephen P. Glasser (Epidemiology), Principal Investigator

William Thomas, Co-Investigator

Agency: National Institutes of Health

Total Grant: $1,000,000

This grant funds the establishment of a MS-degree program in Clinical Research in the Division of Epidemiology.

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Community Programs for Clinical Research on AIDS (Statistical Center)

Personnel: James D. Neaton, Principal Investigator

Agency: National Institutes of Health (NIAID)

Total Grant: $41,061,714

The Community Programs for Clinical Research on AIDS (CPCRA) is a 15 year program that evaluates AIDS treatments nationwide in primary care clinics. There are 15 affiliated units and approximately 150 participating clinical sites in the United States. Several large studies are ongoing and several have been completed. The Statistical Center includes staff from the School of Statistics as well as the School of Public Health. The Statistical Center provides biostatistical, epidemiologic and data management expertise for the project.

Data Coordinating Center for Controlled Onset Verapamil Investigation of Cardiovascular Endpoints

Personnel: James D. Neaton, Principal Investigator

Patricia M. Grambsch, Co-Principal Investigator

Greg Grandits, Co-Investigator

Agency: Pharmacia Corp.

Total Grant: $1,707,269

The CONVINCE project is a multi-center clinical trial comparing two regimens for controlling blood pressure (standard of care and verapamil) on significant clinical endpoints: stroke, myocardial infarction, and cardiovascular disease death. The primary results of the trial were published in April, 2003. Several secondary data analysis projects are in progress.

Data and Coordinating Center for Early Intervention for Chronic Obstructive Pulmonary Disease (COPD): The Lung Health Study

Personnel: John E. Connett, Principal Investigator

Agency: National Institutes of Health (NHLBI)

Total Grant: $8,006,057

In May of 1994, the multi-center clinical trial known as the Lung Health Study, which was coordinated by the Division of Biostatistics, completed follow-up of its 5,887 participants. This was a randomized trial to test the efficacy of a combination of bronchodilator therapy and smoking cessation among a group of cigarette smokers aged 35 to 60 who had mildly impaired lung function. The trial was sponsored by the Lung Division of the National Heart, Lung and Blood Institute. Analysis of data and preparation of papers on the study is continuing, and studies of genetic and biochemical markers of lung disease are ongoing.

Effect of Minnesota State and Local Programs on Youth Tobacco Use

Personnel: Jean L. Forster (Epidemiology), Principal Investigator

Lynn E. Eberly, Co-Investigator (through April 30, 2003)

Patricia M. Grambsch, Co-Investigator

Agency: National Institutes of Health

Total Grant: $4,622,974

This longitudinal study is using a combination of cohort, cross-sectional, and time series designs to measure adolescent tobacco-use patterns and tobacco-related attitudes and perceptions over time at the community and individual level in Minnesota and the Upper Midwest.

Division of Biostatistics 2003 Annual Report

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Effectiveness of a Machine Guarding Intervention

Personnel: Wei Pan, Principal Investigator

Agency: National Institutes of Health (Subcontract to Park Nicollet)

Total Grant: $7,837

The purpose of this study is to assess the effectiveness of interventions designed to lower the risk of amputation and related injuries by increasing the availability and use of machine guards in small manufacturing shops (4-50

employees). The effectiveness of interventions will be evaluated at two levels: 1) minimal (control) and 2) intervention directed at both owners and employees. Individual machine guarding assessments will be used to measure availability and adequacy of guards and to develop prioritized recommendations. Shops will be recruited from the St Paul/Minneapolis metropolitan area. In intervention shops, peer trainers will deliver education and technical assistance to owners and employees.

Epidemiology of Otitis Media in Native American Children

Personnel: Kathleen A. Daly (Otolaryngology), Principal Investigator

Cynthia S. Davey, Research Fellow

Agency: National Institutes of Health (NIDCD)

Total Grant: $2,220,384

The purpose of this prospective study is to understand more about the pattern of ear infections (OM) in Native American infants and children, to assess knowledge and attitudes about ear infections and health care beliefs and practices, and evaluate factors that increase risk of getting ear infections. Native American women who are pregnant will be recruited from three reservations in northern Minnesota, and from one urban health clinic with a high proportion of Native Americans clients. Participants will provide information about themselves, their families, and their infants. A research nurse will examine the infants regularly from birth to age 2 years to determine their middle ear status.

Epilepsy Clinical Research Program

Personnel: Ilo E. Leppik (College of Pharmacy), Principal Investigator

Judith M. Garrard (Health Services Research and Policy), Principal Investigator

Lynn E. Eberly, Co-Investigator

Agency: National Institutes of Health

Total Grant: $6,406,739

The elderly are the fastest growing demographic group in the U.S., and recent research has shown that use of drugs for epilepsy is very common in this age group (10% of 45,000 nursing home residents). We will study antiepileptic drug metabolsim using liver biopsy tissue from elderly with stable (non-radioactive) and labelled tracer drugs. A sophisticated computer system will be used to investigate patterns of antiepileptic drug metabolism and use from over 6,000 nursing home patients in the U.S. Also, we will be studying the risk factors for developing epilepsy in 16,000 African-Americans and Caucasians.

Division of Biostatistics 2003 Annual Report

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Gene Polymorphism and Kidney Transplant Outcome

Personnel: William S Oetting (Medicine Genetics), Principal Investigator

John E. Connett, Co-Investigator

Wei Pan, Co-Investigator

Agency: National Institutes of Health

Total Grant: $1,037,075

The major goal of this proposal is to determine if common polymorphic alleles in biologically relevant genes, in either the recipient or the donor genome, influence kidney transplant outcome.

General Clinical Research Center

Personnel: David M. Brown (Pediatrics), Director

William Thomas, Director of Statistics and Computing

Agency: National Institutes of Health

Total Grant: $16,004,985

The General Clinical Research Center (CRC) offers opportunities for health science faculty, fellows and students to conduct clinical studies in a setting specifically designed for research. Nursing, dietary, statistics, and computer science personnel are available to provide support and consultation to investigators, from study design and meal planning through data collection and analysis.

Genetic Epidemiology of Chronic/Recurrent Otitis Media

Personnel: Katherine A. Daly (Otolaryngology), Principal Investigator

Bruce R. Lindgren, Co-Investigator

Agency: National Institutes of Health

Total Grant: $1,745,374

The goal of this project is to demonstrate linkage between chronic/recurrent otitis media and genetic markers among families with two or more affected children, and families with one affected and one unaffected child. Families previously participated in a study of the genetic epidemiology of otitis media. The search for linkage will take place across the entire human genome. Analysis will focus on concordant (both affected) and discordant (one affected, one unaffected) sibling pairs.

Graduate Training in Biostatistics

Personnel: John E. Connett, Program Director

Agency: National Institutes of Health

National Research Service Award

Total Grant: $618,801

This program is designed to prepare pre- and post-doctoral students for research careers in biostatistics, with emphasis on clinical trials and observational studies in AIDS. Trainees work closely with investigators in the Community Programs for Clinical Research on an AIDS project (CPCRA), and have the opportunity to do original analytic studies on large, well-documented data sets from completed clinical trials and epidemiological studies.

Division of Biostatistics 2003 Annual Report

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International Phase III IL-2 Study (ESPRIT)

Personnel: James D. Neaton, Principal Investigator

Agency: National Institutes of Health (NIAID)

Total Grant: $43,311,870

ESPRIT is an international randomized clinical trial to determine whether subcutaneous interleukin-2 (rIL-2, Proleukin ®) delays progression of AIDS and extends survival among HIV-infected patients with CD4+ cell counts of at least 300 cells/mm³. The study involves over 248 clinical sites in 25 countries. A total of 4,150 patients have enrolled and these patients will be followed for at least 4 years.

Lung Health Study: Long Term Follow-Up Data Coordinating Center (LHS III)

Personnel: John E. Connett, Principal Investigator

Agency: National Institutes of Health (NHLBI)

Total Grant: $3,158,399

This study has collected information on former participants in the Lung Health Study (LHSI), including data on mortality and morbidity, documented by hospital and other health records, and data from a 12-year clinic visit. The objective is to see whether the LHS smoking intervention program had a beneficial effect on long-term survival, cardiovascular and respiratory health of the participants, and on their health-related quality of life. The participants are contacted by personnel at the 10 LHS clinical centers which are funded by separate grants from the NHLBI. Analyses of LHSIII data are continuing.

Maternal Immunization to Prevent Infant Otitis Media

Personnel: G. Scott Giebink (Pediatrics), Principal Investigator

Chap T. Le, Co-Investigator

Bruce R. Lindgren, Database Administrator

Agency: National Institutes of Health (NIDCD)

Total Grant: $3,241,588

This Phase 1-2 clinical trial will determine if infants of women immunized with 9-valent PCV (PCV9) and infants of control women who receive placebo during the third trimester of pregnancy have equivalent anti-capsular polysaccharide (PS) IgG antibody responses to PCV7 measured one month after the third vaccine injection at 6 months of age, to compare local and systemic adverse events among women immunized with PCV9 or placebo, and to investigate the hypotheses that (1) maternal immunization does not interfere with the infant's antibody subclass and pneumococcal opsonic responses to the primary PCV7 vaccine series or to booster PCV7 dose at 12 months, (2) pregnant women have a significant antibody response to PCV9 vaccine compared to placebo vaccine and increased antibody persists 13 months after delivery, (3) anti-PS IgG and secretory IgA antibodies are present in the milk of immunized lactating women, and (4) maternal immunization does not interfere with the infants' antibody response to H influenzae type b conjugate and diphtheria toxoid vaccines.

Division of Biostatistics 2003 Annual Report

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MedDRA Conversion and Implementation

Personnel: James D. Neaton, Principal Investigator

Agency: National Institutes of Heath (NIAID) Subcontract to Social and Scientific Systems

Total Grant: $490,196

The first year will be devoted to developing systems for coding new events using MedDRA as well as converting existing data for ongoing studies from the ICD9 coding scheme to MedDRA. This legacy data for ongoing studies dates back to 1998.

Medication Use by Residents of Assisted Living Facilities

Personnel: Judith M. Garrard (Health Services Research and Policy), Principal Investigator

Lynn E. Eberly, Statistician

Agency: Retirement Research Foundation

Total Grant: $394,348

This is a two year project with three research objectives: Methodology Development - to develop and standardize a methodology for interviewing elderly residents in assisted living facilities (ALF) about their use of all medications, whether self selected or prescribed by their physicians. Prevalence of Medication Use - to apply that methodology in a cross-sectional study of botanical and dietary supplements, prescriptions and over-the-counter drugs used singly or in combination by residents in ALF. Factors Associated with Use - to examine demographic and clinical factors associated with each medicinal category and with different combinations of medicinal categories in a multivariate analysis. This project ended 9/30/2002.

Microvascular Complications of CFRD

Personnel: Antoinette M. Moran (Pediatrics), Principal Investigator

William Thomas, Statistical Consultant

Agency: Cystic Fibrosis Foundation Therapeutics, Inc.

Total Grant: $256,807

The general aim of this project is to determine the prevalence of diabetic microvascular complications in CFRD patients with and without fasting hyperglycemia, and to explore whether the presence of these complications is related to diabetes or CF factors. This cross-sectional study will provide pilot data for a longitudinal study of diabetes complications in CFRD.

Minnesota Center for Excellence in Health Statistics

Personnel: Melanie M. Wall, Principal Investigator

Agency: Subcontract to the Minnesota Department of Health

Total Grant: $915,562

This project will create a long term partnership between the Minnesota Department of Health and the University of Minnesota School of Public Health to develop more advanced statistical methods for assessing smoking and racial disparities in health status and outcomes. The project will develop new methods in tobacco use cessation and prevention, and for investigating racial/ethnic disparities in health outcomes.

Division of Biostatistics 2003 Annual Report

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Minnesota TMJ Implant Registry and Repository

Personnel: James Fricton (Diagnostic/Surgical Science), Principal Investigator

Bruce R. Lindgren, Statistician

Agency: National Institutes of Health

Total Grant: $5,155,157

The overall purpose of this proposal is to develop a national TMJ registry and repository to conduct intramural research and facilitate extramural research to enhance our understanding of the biological and behavioral outcomes of patients with TMJ implants and improve the design of TMJ implants and the care and outcome of patients who require them.

Model Building in Marginal Regression with Dependent Data

Personnel: Wei Pan, Principal Investigator

Agency: National Institutes of Health

Total Grant: $321, 624

The goal of this research is to develop useful methods for building marginal regression models for generalized estimating equations (GEE).

Modeling Multivariate Survival Data with Spatial Associations and Competing

Risks

Personnel: Sudipto Banerjee, Principal Investigator

Agency: Minnesota Medical Foundation, Academic Health Center

Total Grant: $24,376

With the last decade witnessing major advances in medical science and health care, medical databases today offer much more information on patients with multiple cancers than were available some years ago. This grant investigates data where progression of multiple cancers has been systematically recorded for each patient - from diagnosis of the first primary cancer to possible subsequent cancers. Analysis of such data helps in comparing treatment and therapeutic strategies for dealing with these diseases at advanced stages, for evaluating possible associations between the diseases and for detecting their progression patterns in the patients. Of particular interest is the analysis of spatial variation in such data, thereby revealing spatial patterns in survival data that help identify problem areas in maps. Used conjunctively with statistical software, sophisticated GIS (Geographical Information Systems) programs enable easy production of maps for raw data and interesting estimates that help discern spatial patterns and interactions among the cancers.

Mortality Follow-up and Analysis: Multiple Risk Factor Intervention Trial (MRFIT)

Personnel: James D. Neaton, Principal Investigator

Lynn Eberly, Co-Principal Investigator

Greg Grandits, Co-Investigator

Agency: National Institutes of Health

Total Grant: $2,609,680

Faculty and staff of the Division of Biostatistics continue analysis of data collected during, and since the conclusion of, the Multiple Risk Factor Intervention Trial (MRFIT), one of the largest randomized trials ever conducted. Mortality follow-up through 1999 of both of the men randomized and of all 361,662 men screened is now available and being analyzed.

Division of Biostatistics 2003 Annual Report

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MRS and MRI of Breast Cancer at Very High Magnetic Field

Personnel: Michael Garwood (Radiology), Principal Investigator

Chap T. Le, Biostatistician

Agency: National Institutes of Health

Total Grant: $1,652,065

The general goal of this research is to develop and test improved magnetic resonance spectroscopy (MRS) methods optimized for diagnosing breast lesions noninvasively with very high magnetic field (3 and 4 Tesla) MR systems.

NDS-R Fluoride Component

Personnel: John H. Himes (Epidemiology), Principal Investigator

Sudipto Banerjee, Co-Investigator

Agency: National Institutes of Health

Total Grant: $74,024

The purpose of the study is to document the nature and extent of variation in fluoride concentration within chief brands and types of commercial beverages at community, regional and national levels. Categories of commercial beverages contributing a large proportion of the dietary fluoride intake in the United States will be identified. A sampling design will be developed on a national scale and geographical as well as nutritional factors will be investigated through classes of mixed hierarchical models.

Neurophysiologic Assessment of the At-Risk Newborn

Personnel: Charles A. Nelson (Institute of Child Development), Principal Investigator

William Thomas, Statistical Consultant

Agency: National Institutes of Health

Total Grant: $2,029,716

The objective of this proposal is to identify differences in brain development in high risk infants using a benign electrophysiologic test, event-related potential (ERP), that assesses memory in the newborn of diabetic mothers and intrauterine growth retarded infants, who can then be targeted for early developmental intervention.

Occupation and COPD Project

Personnel: John E. Connett, Principal Investigator

Agency: Center for Disease Control

Subcontract to University of California, Los Angeles

Total Grant: $19,091

The purpose of this project is to relate decline in lung function to occupational exposures to dust, fumes, and other respiratory irritants. Lung Health Study (LHS) Coordinating Center staff will key text related to occupations from baseline forms for all LHS participants. This portion of the work is expected to be complete within 3 months. Dr. Connett will be responsible for the ongoing analysis and reporting of data for the entire 12-month period. This project ended 9/30/2003.

Division of Biostatistics 2003 Annual Report

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Organ Transplantation in Animals and Man

Personnel: Arthur J. Matas (Surgery), Principal Investigator

Thomas E. Nevins (Pediatrics), Co-investigator

William Thomas, Statistician

Collaborative with Department of Surgery, University of Minnesota

Agency: National Institutes of Health

Total Grant: $4,865,119

This study, part of a large program project, seeks to relate long-term electronic records of prescription-drug bottle-cap opening, specifically evidence of non-compliance, to adverse outcomes after kidney transplantation. A clinical trial of intervention to improve compliance is underway.

Otitis Media Core Center

Personnel: G. Scott Giebink (Pediatrics), Principal Investigator

Chap T. Le, Biostatistics Core Director

Bruce R. Lindgren, Core Database Manager

Agency: National Institutes of Health

Total Grant: $2,058,203

The Otitis Media Core Center will support sixteen currently NIH-funded base research projects and an additional two recently submitted projects. The research is focused on basic molecular, cellular, microbial, immunological, animal modeling, population science, and clinical studies. The Biostatistics Core is responsible for study design, data collection and processing, quality control, data storage and retrieval, and data analysis, to provide investigators with a high level and broad range of expertise in data management and analysis.

Otitis Media Vaccine Trial

Personnel: G. Scott Giebink (Pediatrics), Principal Investigator

Chap T. Le, Statistician

Bruce R. Lindgren, Co-Investigator

Agency: National Institutes of Health

Total Grant: $1,353,003

This application is an extension of the vaccine project, one of the four current projects. This project ended

2/28/2003.

Pharmacologic Induction of Weight Loss in Diabetes Mellitus

Personnel: John Bantle (Medicine) and Bruce Redmon (Medicine), Principal Investigators

William Thomas, Statistician

Collaborative with Department of Medicine, University of Minnesota

Agency: American Diabetes Association

Total Grant: $210, 000

A clinical trial of the long-term effect of drug-promoted weight loss in patients with diabetes.

Division of Biostatistics 2003 Annual Report

Grants and Contracts, continued

A Phase III Multicenter Randomized Study of the Biological and Clinical Efficacy of Subcutaneous Recombinant, Human Interleukin-2 in HIV-Infected Patients with Low CD4+ Counts Under Active Antiretroviral Therapy

Personnel: James D. Neaton, Principal Investigator

Agency: Chiron Corporation

Total Grant: $18,000,000

SILCAAT is an international randomized trial to determine whether subcutaneous interleuken-2 (~IL-2 Proleuken) delays progression of AIDS and extends survival among HIV-infected patients with CD4+ cell count < 300 cells/mm³. The study involves 139 clinical sites in 11 countries. A total of 1970 patients have been enrolled and these patients will be followed for at least 4 years.

Preparation of Limited Access Data Set from the MRFIT

Personnel: James D. Neaton, Principal Investigator

Greg Grandits, Co-Investigator

Agency: National Institutes of Health (NHLBI)

Total Grant: $68,556

By the completion of the 12-month funding period, the purpose of this project is to prepare and provide NHLBI with a limited access dataset and useful documentation for data collected from the Multiple Risk Factor Intervention Trial (MRFIT).

Project EAT II: A Longitudinal Study

Personnel: Dianne Neumark-Sztainer (Epidemiology), Principal Investigator

Melanie M. Wall, Co-Investigator

Agency: Maternal and Child Health Bureau

Total Award: $1,376,689

This project will examine adolescent eating patterns and weight status in a longitudinal study. Adolescents who participated in the first phase of Project EAT will be surveyed to examine changes in their eating patterns and weight status as they progress from early adolescence (ages 11-14) to middle adolescence (15-17), and from middle to late adolescence/young adulthood (ages 18-21).

Quality of Life in Children Who Survived Neuroblastoma

Personnel: James G. Gurney (Pediatrics), Principal Investigator

Melanie M. Wall, Co-Investigator

Agency: American Cancer Society

Total Award: $432,000

This is a follow-up study among neuroblastoma survivors of a Children's Cancer Group randomized clinical trial that compared a treatment protocol of intensive chemotherapy to that of intensive chemotherapy with total body irradiation and autologous bone marrow transplantation.

Division of Biostatistics 2003 Annual Report

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Regional Coordinators for ALLHAT

Personnel: Richard H. Grimm (Medicine), Principal Investigator

Leslie Ann Holland, Coordinator

Agency: Subcontract to Minneapolis Medical Research Foundation

Prime is National Institutes of Health

Total Grant: $862,232

The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) is a practice-based, randomized, clinical trial of antihypertensive pharmacologic treatment and, in a specific subset, cholesterol-lowering treatment. This trial involves over 42,000 patients in the US, Canada, Puerto Rico, and the US Virgin Islands. The purpose of the antihypertensive trial component is to determine whether the combined incidence of fatal CHD and non-fatal MI differs between diuretic treatment and three alternative antihypertensive pharmacologic treatments - a calcium channel antagonist, an ACE inhibitor, and an alpha adrenergic blocker. The purpose of the cholesterol-lowering trial component is to determine whether lowering serum cholesterol in moderately hypercholesterolemic men and women using the coenzyme A (HMG CoA) reductase inhibitor pravastatin will reduce all-cause mortality as compared to a control group receiving "usual care." This project ended 9/30/2002.

Research Diagnostic Criteria: Reliability and Validity

Personnel: Eric Schiffman (TMJ and Orofacial Pain), Principal Investigator

Wei Pan, Co-Investigator

Agency: National Institutes of Health

Total Grant: $3,933,302

The aim of this study is to determine the reliability and validity of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC for TMD). The RDC for TMD includes Axis I biomedical diagnoses of TMD and Axis II biobehavioral assessment procedures. In addition, this study will assess several biological markers for their role as potential mediators underlying the biomedical diagnoses.

Retrospective Assessment of Mixed Chemical Exposure

Personnel: Gurumurthy Ramachandran (Environmental and Occupational Health), Principal Investigator

Sudipto Banerjee, Co-Investigator

Agency: National Institutes of Health, National Cancer Institute

Total Grant: $551,664

The purpose of this study is to obtain the quantitative dose-response relationship between crystalline silica and silicosis in a manner that addresses the following issues: 1) Exposure reconstructions are typically based on sparse data with significant uncertainty. 2) Dose reconstructions that obtain the cumulative long burden of the worker do not account for retention and clearance of inhaled dusts. 3) Exposure reconstructions for silica, a highly toxic dust, do not account for simultaneous exposures to less toxic dusts.

Statistical Analysis of Microarray Data

Personnel: Wei Pan, Principal Investigator

Agency: Minnesota Medical Foundation, Academic Health Center

Total Grant:: $24,774

The goal of the study is to develop new methods and compare existing methods in detecting differential gene expression with microarray data.

Division of Biostatistics 2003 Annual Report

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Statistical Core for the Center for AIDS Research (Developmental Funds)

Personnel: Cavan S. Reilly, Principal Investigator

Agency: National Institute of Health (Subcontract to Northwestern University)

Total Grant: $77,477

This research seeks to understand microarray normalization for experiments that attempt to measure the half life of mRNA for many genes in parallel.

Statistical Core for the Center for AIDS Research

Personnel: James D. Neaton, Principal Investigator

Cavan Reilly, Co-Investigator

(Subcontract to Northwestern University)

Agency: National Institutes of Health

Total Grant: $606,895

The Statistical Core staff in Biostatistics assists in designing studies and collecting data on the basic science of HIV. The overall objective of the Center is to support systematic HIV/AIDS patient sampling and detailed, intensive and interrelated laboratory studies providing comprehensive analysis of HIV infection.

Statistical Methods to Assess Environmental Justice II

Personnel: Bradley P. Carlin, Principal Investigator

Subcontract to Emory University

Agency: National Institutes of Health

Total Grant: $517,000

The proposed research will develop and evaluate statistical methods for the analysis of environmental exposure and disease incidence data with special emphasis on identifying differences in exposure and risk among demographic groups. Such differences may constitute social inequity. Methods will be designed to analyze data in Geographic Information Systems. Federal data will be used to illustrate the new methods.

Statistical Methods in Cancer Control and Epidemiology

Personnel: Bradley P. Carlin, Principal Investigator

Agency: National Institutes of Health (NCI)

Total Grant: $1,244,941

This project will develop and evaluate statistical methods that, when coupled with geographic informations systems software, will enable a much more accurate and complete analysis of cancer-related mortality, incidence, screening, staging, and exposure data. Special emphasis will be on developing methods that accommodate the multivariate, longitudinal, and often spatially misaligned nature of data relevant for cancer control efforts. Publicly available state and federal datasets will be used to illustrate the new methods.

Division of Biostatistics 2003 Annual Report

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Statistical Methods for Environmental Social Sciences

Personnel: Bradley P. Carlin, Principal Investigator

Sudipto Banerjee, Co-Principal Investigator

Alan E. Gelfand (Statistics, Duke University), Co-Principal Investigator

Agency: National Science Foundation (NSF)

Environmental Protection Agency (EPA)

Total Grant: $383,994

Sophisticated computer programs known as geographic information systems (GISs) have revolutionized the analysis of environmental social science datasets through their ability to "layer" multiple data sources over a common study area. However, methods for statistical inference on these complex and often spatially and temporally misaligned datasets have been slow to develop. This three-year project seeks to develop statistical methodology for improved environmental justice assessments, a systematic approach for handling data at different scales, and practical strategies for resolving conflicting analytic priorities and goals. In addition, these benefits will be made available to non-experts in advanced statistical methods through the software tools developed.

Stem Cell Program Project

Personnel: Phillip McGlave (Medicine), Principal Investigator

Anne I. Goldman, Leader of the Biostatistics Core

Collaborative with Medical School, University of Minnesota

Agency: National Institutes of Health (NCI)

Total Grant: $4,929,176

This project is a focused, integrated effort to characterize the hematopoietic stem cell and to develop methods for ex vivo selection and expansion of stem cells suitable for human clinical transplantation therapy. The Biostatistics Core is an integral part of the Biostatistics Support Group for the University Blood and Bone Marrow Transplantation Program.

Transdisciplinary Tobacco Use Research Center

Personnel: Dorothy J. Hatsukami (Psychiatry), Director

Chap T. Le, Director of the Design and Analysis Core

Agency: National Cancer Institute

Total Grant: $9,227,445

The Transdisciplinary Tobacco Use Research Center (TTURC) has four research projects varying from animal studies to human clinical trials. The targeted populations to be studied vary across the life span including mothers who smoke and medically compromised smokers. The aim is to examine tobacco exposure reduction methods to treat smokers who have been resistant to conventional methods of intervention; reduction serves as a transitional goal toward cessation. The center grant also involves four research projects and three cores: Administration, Biomarkers, and Design and Analysis (Biostatistics).

Division of Biostatistics 2003 Annual Report

Grants and Contracts, continued

United States Renal Data Systems Coordinating Center

Personnel: Wei Pan, Principal Investigator

Agency: Subcontract to Minneapolis Medical Research Foundation; Prime is National Institutes of

Health

Total Grant: $475,716

The function of this project will be to provide biostatistical, epidemiological and clinical expertise to develop and implement innovative health policy studies using the United States Renal Data System (USRDS) database.

James R. Boen Biostatistics Consulting Laboratory

Personnel: Bruce R. Lindgren, Senior Research Fellow

Cynthia Davey, Research Fellow

Dorothee Aeppli, Research Associate

Total for year: $149,041

The Division's Biostatistics Consulting Laboratory (BCL) provides statistical consulting and analysis for many projects both within the University and at external facilities, and is a valuable biostatistical resource for researchers in the Academic Health Center. The BCL staff have provided statistical support for several grant proposals. A sample of past and present projects in which the BCL has been involved includes:

- A study of home monitoring of lung function following lung transplantation

- Otitis media clinical and basic science research

- A feasibility study for the collection, storage and transplantation of umbilical cord blood

- A randomized clinical trial of a new CPR technique following cardiac arrest

- A study of failed extubation rates and risk factors in Pediatric intensive care units

- A study of end stage renal disease patient data for quality improvement projects

Division of Biostatistics 2003 Annual Report