Medical School Hotline

Introduction

Strong research design and biostatistical support play a critical role in the long-term success of clinical and translational research and education enterprises.¹ Current research studies involve complex study design and generate complicated multivariate data which require statistical expertise. In addition, extramural funding has become increasingly competitive. Funding agencies and study sessions are focusing more on whether the research design of a proposal is efficient and whether the data analysis plan is statistically appropriate. Understanding and applying statistical research design and analysis principles can benefit biomedical researchers in expanding their research effectiveness and efficiency.²

Recognizing the importance of biostatistics as a critical research infrastructure resource, John A. Burns School of Medicine (JABSOM) established the Biostatistics and Data Management Core (BDMC) in September 2011 to centralize and expand its biostatistical support and collaboration. The BDMC started with very limited staff (1.75 FTE). To meet the needs of the investigators and their research studies, the group has since grown to the current five PhD biostatisticians, one PhD bioinformatician, one senior PhD epidemiologist, and several analysts and database specialists (See photo). The BDMC funding model uses an “all funds budgeting” approach by leveraging its support from various sources to include institutional funds (eg, general, research training, and revolving funds), department and school funds (collaboration model), infrastructure grants, center grants, research grants, contracts, non-University of Hawai‘i (UH) funds, and fee-for-service income.

The BDMC's vision is to strive for excellence in research, education, and service through collaboration and innovation in quantitative health sciences. Its mission is to enhance JABSOM's research, education and service mission by fostering the understanding and implementing biostatistical principles from study design to dissemination; catalyzing collaborative research through institutional and community partnerships; providing quality education and training in quantitative health sciences; and developing novel methods and generating new knowledge to improve quantitative health research and practice. The BDMC promotes core values into its daily operations that are high quality, efficient, and reliable.

BDMC Contributions

Biostatistics is the science of applying statistical reasoning and modeling to the solution of problems from a wide range of topics in biological and health sciences and encompasses all phases of a biomedical research project. Biostatisticians provide statistical education, conduct methodological research, and participate in collaborative research.

Education: BDMC provides biostatistical related training and education to students, researchers, and clinicians through structured courses and degree programs, seminars, workshops, and individual mentoring. BDMC supports the masters and doctoral Clinical Research Programs by teaching biostatistics courses to graduate students as well as supports the students with their individual research projects. Also, BDMC has provided graduate biostatistics courses for the JABSOM Department of Tropical Medicine, Medical Microbiology and Pharmacology, UH School of Nursing, and Office of Public Health Studies. Additional quantitative health science courses are currently being developed and will be offered in the near future. Ongoing are a multitude of biostatistical related lectures, seminars, and workshops that have been offered. BDMC will continue to develop and offer similar and related types of training.

Research: Biostatisticians conduct methodological research which involves the development of novel approaches to model biological and clinical phenomena, and helps to enhance the existing bodies of knowledge in theoretical and applied biostatistics. BDMC has statistical expertise in Bayesian statistics, clinical trials, longitudinal data analysis, statistical genetics, and survival analysis.

In collaborative research studies, biostatisticians contribute expertise in the planning and conducting of the study to ensure consistency with good statistical practice. They participate in the research design of studies and perform data analyses and interpretation of the findings. BDMC provides grant proposal development support to include research design and statistical analysis plans. The involvement of an experienced biostatistician from the early stages in the development of a research project tends to significantly increase the quality of the study, and could significantly impact the success of extramural funding.³

Since its formation, the BDMC has supported 118 grant proposals, of which 30 were funded with total budgets exceeding $50 million. In addition, BDMC provided over 300 consultations and supported more than 400 projects which have resulted in 85 publications in peer-reviewed journals. Also, BDMC has supported over 120 abstracts for presentations at conferences. Research support has been provided to researchers, clinicians, students, clinical trainees (eg, fellows and residents). UH units that have sought BDMC collaboration include UH School of Nursing; JABSOM Departments of Medicine, Obstetrics and Gynecology, Surgery; and Center for Native and Pacific Health Disparities Research. External collaborators include Hawai‘i Health Information Corporation (HHIC); Queen's Medical Center, Shriners Hospitals for Children; and Hawai‘i Pacific Health. Examples of projects are:

• RCMI Multidisciplinary and Translational Research Infrastructure Expansion (RMATRIX) (PI: Hedges)

• Bioscience Research Infrastructure Development for Grant Enhancement and Success (BRIDGES) (PI: Berry)

• INBRE III: Hawai‘i Statewide Research and Education Partnership (HISREP) (PI: Nichols)

• Center for Native and Pacific Health Disparities Research (CNPHDR) (PI: Mau)

• Hospital Quality Reports For Expectant Mothers: Considering Race and Language (PI: Sentell)

• Cardio-Pulmonary Stethoscope: A Novel Radio Frequency Sensor for Non-Invasive Measurement of the Changes in Lung Water Content and Cardiac Parameters. (PI: Iskander)

• Partnerships to Improve Lifestyle Interventions (PILI) ‘Ohana Dissemination Project (PI: Kaholokula)

• Enhancing Hawai‘i Hospital Information Content (PI: Seto)

• Hawai‘i Pacific Health Summer Student Research Program (Co-Directors: Brady & Kamida)

• The Hawai‘i Trauma Research Program (Director: Walton)

In addition to collaborative and methodological research, BDMC provides services and support in database design and management by assisting researchers in developing database structures to ensure that the data is collected and stored appropriately and can be easily exported into statistical analysis software for efficient and accurate analysis. BDMC faculty and staff contribute their quantitative health sciences expertise to their profession as well as to the community by serving as reviewers on basic sciences and clinical journals as well as various funding programs. BDMC, as the designated statistical review consulting unit, has reviewed over 30 manuscripts for the Hawai‘i Journal of Medicine & Public Health since 2012.

BDMC into the Future

Biostatistics plays a critical and central role in multidisciplinary clinical, basic science, and translational research. The BDMC core faculty and staff with their diverse skills and expertise collaborate with researchers on research projects and continue to gain new knowledge and develop their skills to meet the future biomedical research needs.

Currently BDMC is expanding its knowledge and expertise in the area of big data analysis. This includes the analysis of large healthcare databases, such as HHIC hospitalization and emergency room data, Centers for Medicare and Medicaid Services (CMS) data, National Health And Nutrition Examination Survey (NHANES), Behavioral Risk Factor Surveillance System (BRFSS), National Health Interview Study, Medical Expenditure Panel Study, and Health and Retirement Study. The BDMC biostatisticians are prepared to work with researchers by using these large databases to generate data-driven research hypotheses and conduct data analyses. Another expansion in the big data analysis is in bioinformatical analysis of “omics”-scale data (eg, next generation sequencing data). The need for these types of big data analytics is increasing rapidly and the BDMC has the skills and expertise to meet these demands.

In recognition of the importance and contribution of the BDMC and to further streamline quantitative support and collaboration, UH JABSOM will establish an Office of Biostatistics & Quantitative Health Sciences (BQHS), effective July 1, 2015. The faculty and staff at the new BQHS will continue to pursue its mission of providing high quality, efficient, and reliable collaborations and support to improve the overall biomedical research quality and productivity in Hawai‘i.

UH JABSOM BDMC faculty and staff at their UH Kaka‘ako campus facility.