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The ICTS Administrative Core provides support for programmatic initiatives, including the Barnes-Jewish Hospital Foundation (BJHF) BJHF/ICTS Clinical and Translational Pilot Program, Just-In-Time (JIT) voucher program, Sharing Partnership for Innovative Research in Translation (SPIRiT) and Strategic Pharma-Academic Research Consortium (SPARC) initiatives, the Research Forum (RF) Program, and coordinates the structure that supports day-to-day operations to achieve the overall goals of the ICTS. The Administrative Core provides budgetary oversight for the CTSA program and coordinates institutional funds allocated to the ICTS; manages tracking procedures and processes for internal monitoring and NCATS required reporting, and provides marketing and communication between WUSM and the NCATS, ICTS partner institutions and internally with other WU centers and institutes. The Administrative Core has dedicated space (1,500 SF), near the Clinical Research Training Center (CRTC) in the Wohl Complex and staff to support these functions. Small and mid-size conference rooms that accommodate between 8-15 participants are contiguous with this space.
The Biostatistics Epidemiology and Research Design( BERD) group offers expertise in the statistical and computational aspects of conducting clinical research. Support from this core includes the determination of overall experimental designs, hypothesis generation, interim analysis, data management, quality control of research data and final statistical analysis. The BERD team also assists investigators in exploring new approaches and methods of research design in order to better understand outcomes of laboratory experiments, new treatments, and the significance of interventions when exploring preventive measures for disease. Main BERD activities are housed within the Division of Biostatistics, a WUSM-wide facility that engages in research, biostatistical consultation, teaching and training. A multi-disciplinary graduate program in biostatistics, launched in 2011 with a Master of Science (MS) degree in Biostatistics (MSIBS), provides training in biostatistics, genetic epidemiology, statistical genetics, and bioinformatics. The division leads a post-doctoral training program in genetic epidemiology and a PRIDE summer institute program (Program to Increase Diversity among Individuals Engaged in Health-Related Research).
The BERD group provides regular consultation office hours to ICTS investigators and scholars for research design advice through their Biostats Clinic (Tuesdays 9am-12pm, Thursdays 1-4pm). The clinic has full computer and software resources in a dedicated conference room within the hospital setting and is staffed by faculty- and staff-level biostatisticians that will assess the needs of the investigator and refer to appropriate personnel as necessary. BERD also maintains an Methodologist Database of ~50 experts drawn from our CTSA in a range of research design areas (clinical trials, adaptive designs, observational studies, epidemiology, econometrics, patient reported outcomes, qualitative research, and statistical genetics). These individuals are available for consultation and discussions segue into formal collaborations.
The WUBIOS Computing Resource is an organized activity within the Division of Biostatistics that provides computing and networking services for BERD and ICTS members. The resource is organized around 100 multiprocessor Intel and AMD architecture servers running Linux. Compute servers provide access to statistical analysis resources like SAS, R and S+, as well as specialized genetic epidemiology software. Web servers provide access to both static content web pages and dynamic resources. These are utilized for the display of information contained within databases and for the web-based data entry systems. REDCap runs within this environment in order to provide investigators with a mechanism for building and manipulating study data. REDCap, supported through BERD, now services almost 800 projects, representing a 33% increase compared to YR8, and provides resource guidance for over 5,000 users. Notably, nearly 2,000 users are drawn from outside of the medical center representing the strong use of REDCap to support multi-institutional studies.
The Biotechnology and Life Science Advising (BALSA) Group is a non-profit organization founded and led by WU graduate students and post-doctoral fellows. The BALSA group provides short-term consulting services to companies ranging from small start-ups to large corporations and to the ICTS during the scientific and commercialization merit review of proposals the BJHF/ICTS Clinical and Translational Pilot Program. The goals of the BALSA group are to 1) facilitate closer collaboration between the local business community and WU researchers and students, 2) assist local biotechnology firms in overcoming obstacles, exploring opportunities, achieving growth and maximizing profits and 3) provide opportunities for group members to obtain real. Although the St. Louis biotechnology and life science community is vibrant and growing, many early stage companies lack the human and financial resources needed to develop their ideas into viable commercial products at the invention/entrepreneur interface, so the BALSA group addresses this challenge, and provides education and insight to apply diverse, analytical skills to facilitate the translation of science within the local biotech marketplace. These opportunities allow students to gain practical experience and make valuable interdisciplinary connections, on and off campus.
The Bernard Becker Medical Library serves WUSM, BJH, and SLCH on the Medical School Campus. The mission of the Becker Medical Library is to provide information resources and technology in support of the educational, research, and patient care objectives of WUSM. The eight-level, 114,000 SF structure has capacity for more than 300,000 volumes. The Research Pod is located on the main floor of the library and contains customized iMacs and PCs equipped with a core set of statistical, research, and presentation software packages. The current biomedical resource collection includes 33 subscribed databases, 4,615 full-text electronic journals, and 42,000 electronic books. The Library is organized into several departments which play unique roles in serving the WUSM community, including: Archives and Rare Books, Collection Management Services, Health Information Resources (Reference), and Translational Research Support. Dedicated scholarly publishing specialists provide services, education, and resources to assist faculty, investigators and students on public access policies for publication and evaluation needs. An early Becker Medical Library Model for Assessment of Research Impact provided a list of key indicators to document evidence of biomedical research impact, including pathways such as advancement of knowledge, clinical implementation, community benefit, legislation and policy and economic benefit. Through additional resources, the Library offers the Communicating for Health program, a service that provides customizable presentations, tailored trainings, and consultations in the areas of health information, health literacy, and health communication. The Library has a staff of 50, including librarians and information technology specialists and two specialist-librarians serve as members of the ICTS Tracking and Evaluation (T&E) Team and support evaluation and continuous improvement for the CTSA.

Center for Administrative Data for Research (CADR): CADR assists ICTS investigators interested in using existing administrative data for clinical epidemiologic, health services, and comparative effectiveness research. Led by researchers with a background in medicine, epidemiology and health policy, CADR assists ICTS members with study design and selection of appropriate administrative databases; storing data securely and in accordance with data use agreements; using the data; and providing collaboration tools, programs and resources.

  • The CADR repository currently holds 12 types of databases including Medicare, Medicaid, Truven Health Analytics MarketScan® Commercial Claims and Encounters database, Claritas, American Hospital Association Annual Survey data, Health Resources and Service Administration (HRSA) Area Resource File (ARF) and multiple sources of billing data from the AHRQ Healthcare Cost and Utilization Project (HCUP). The HCUP data sources cover inpatient, emergency department, and some ambulatory surgery services. The Medicare, Medicaid and MarketScan data also include outpatient (provider and facility) and pharmacy services. CADR has published data access and services rates: dedicated Linex server fees ($40/GB/yr), statistical software ($600-850/user); data use ($200-$2000/year, depending on selected database) and programing and analysis consultation (hourly faculty or programmer rates), and many projects are supported through the JIT voucher scheme. On an annual basis, 50 investigators receive CADR services.

  • Through CADR, a database of information for approximately 4 million veterans is available through the Clinical Epidemiology Center (CEC) at the Saint Louis VA Health Care System. Established in July 2013, the CEC serves as a core resource available to VA investigators to support the growth of clinical epidemiology research through weekly seminar programs and lectures on novel concepts in biostatistics, epidemiology, data visualization, presentations of current research results, and hands-on seminars in statistics, grant writing, and proposal preparation. The CEC provides support to investigators in study design, data management, statistical analyses, preparation of grant proposals, and preparation of manuscripts, posters and scholarly presentations.

CADR houses and maintains numerous large administrative datasets, and provides data management expertise to users in the ICTS community and provides training to program scholars in the use of health services administrative data in clinical epidemiologic, health services and outcomes research. The table below outlines the data sets that can be used by the ICTS investigators and Clinical Research Training Center (CRTC) scholars and trainees:



Database

Setting/Types of Files

Years

Population

NCI Surveillance Epidemiology and End Results (SEER) – Medicare (breast CA )

MEDPAR, Outpt, Carrier Claims, Home Health, Hospice, DME

1995-2002 (SEER) /

1995-2004 (Medicare claims files)



76,199 breast cancer Medicare patients

CMS Medicaid eXtract (MAX) files – MO, IL, CA, FL, GA, TX

Inpt, Other Therapy, Personal summary, Prescription Drug

1999-2005

~2.2-3.0 Medicaid enrollees

CMS Chronic Condition Warehouse

Inpt, Outpt, Carrier Claims, SNF, DME, Beneficiary Summary, Chronic Condition

1999-2010

3.9 million Medicare enrollees

CMS Medicare 100% Inpatient SAF

Inpatient

2003

38.2 million Medicare patients

AHRQ HCUP Nationwide Inpatient Sample (NIS)

Inpatient

1998-2011

~7.1-8.2M (unweighted); ~34.8-39.5M (weighted) hospital discharges

AHRQ HCUP Nationwide Emergency Department Sample (NEDS)

Emergency department

2006-2010

~25.7-28.6M (unweighted); ~120-129M (weighted) ED visits

AHRQ HCUP Kids’ Inpatient Database (KIDS)

Inpatient

1997, 2000, 2003, 2006, 2009

~1.9M-3.4M (unweighted); ~6.3-6.6M (weighted) hospital discharges

AHRQ HCUP State Inpatient Databases (SID) – AZ, AR, CA, CO, FL, HI, IA, KY, MD, MA, MI, NE, NJ, NM, NY, NC, SC, UT, VT, WA, WI

Inpatient

Varies by state;

~2000-2011



129K-3.9M hospital discharges per year per state

AHRQ HCUP State Emergency Department Databases (SEDD) – AZ, CA, FL, HI, IA, MD, MA, NE, NJ, NY, NC, UT, VT

Emergency department

Varies by state;

~2000-2011



223K-9.9M ED visits per year per state

AHRQ HCUP State Ambulatory Surgery Databases (SASD) – CA, FL, MD, MI, NE, NJ, NY, NC

Ambulatory surgery

Varies by state;

~2003-2011



180K-3.0M ambulatory surgery visits per year per state

American Hospital Association (AHA) Annual Survey Database

Hospital facility

2000, 2004, 2006, 2008, 2009, 2010

n/a

Nielson Claritas

Demographic data

2004, 2005, 2006, 2008

n/a

Truven Health Analytics MarketScan® Commercial Claims Database

Inpatient, outpatient, outpatient drugs

2006-2010

~31-49 million enrollees/year


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