Research Initiatives

Data and Specimen Repository

The CSPEC-Durham Data and Specimen Repository aims to compile data and specimens across multiple CSPEC-Durham studies for the purpose of facilitating the conduct of multiple research protocols, consistent with CSPEC-Durham's areas of research. The repository will also store participants' contact information for the purpose of serving as a central source for recruiting participants into future research studies. Participants consist of Veterans who have participated in "feeder" studies affiliated with CSPEC-Durham. Most CSPEC-Durham studies are related to Gulf War or cancer outcomes research.

Investigators (VA and non-VA) are invited to submit data and specimen requests to the repository for their IRB-approved protocols. Requests will be reviewed by the repository's Scientific and Ethical Oversight Committee and the Repository Administrator. We encourage interested investigators to contact the repository biostatistician, Kellie Sims (Kellie.Sims@va.gov) to arrange a consultation during study planning to discuss the proposed study and repository requirements Investigators who are interested in analyzing data from CSP #380 or CSP #585 can also utilize the following resources:

• CSP #380 Data Dictionary
• CSP #380 Study Forms
• CSP #585 Data Dictionary
• CSP #585 Participant Survey

Quality Initiatives

The CSPECs have collectively identified 3 priority areas for quality improvement:

1) Data quality

2) Participant safety and privacy safeguards

3) Efficiency in conducting research

In addition to improving research-related processes, CSPEC-Durham is also committed to creating an effective and engaging work environment. Through the use of a variety of innovative tools and improvement strategies, CSPEC-Durham has evaluated and redesigned several processes essential to center operations including:

• Implementing a more efficient interview process and employee satisfaction dashboard
• Developing best practices for an improved abstract submission process
• Establishing an Employee Suggestion Program

A key focus point to CSPEC-Durham's continuous quality improvement efforts is the incorporation of Lean concepts and methodology into our operational and research project processes. Center personnel completed the Lean Yellow Belt Certification training through the VA Center for Applied Systems Engineering (VA-CASE) in February 2016 and Green Belt Certification training in August 2017.

For more information, contact the Quality Research Specialist at alyssa.bullard@va.gov

Hepatitis B Reactivation Prevention

The primary objective of this quality improvement project is to increase HBV testing prior to the start of anti-CD20 Ab therapy and initiate appropriate reactivation prophylaxis among those Veterans Health Administration (VHA) patients at risk. Our team of physicians, pharmacists, and public health professionals develop systems to increase awareness and prevent HBV reactivation, including:

• Medication Use Evaluation Tracker (MUET) to flag omissions in HBV testing and antiviral treatment;
• Pilot Electronic Medical Record order check that assesses pretreatment HBV testing, antiviral treatment and provides an explicit reminder only if deficiencies are detected;
• HBV screening/treatment incorporated into national criterion for anti-CD20 Ab use;
• National alert to all VHA Oncology providers detailing specific testing and HBV antiviral treatment needs;
• National formulary change to enable any provider to prescribe HBV prophylactic medication;
• National informational seminars/newsletters regarding HBV testing and treatment; and
• Provider and patient educational materials posted to VA websites and Oncology SharePoint.

For more information, contact christine.hunt@va.gov

Health Disparities Initiatives

The CSPEC-Durham Health Disparities Workgroup was established to incorporate an intentional health disparities focus into ongoing and future projects. Members of the workgroup develop presentations and attend trainings, conferences and workshops related to health disparities research.

The workgroup aims to conduct research that will assess the magnitude, determinants and consequences of health disparities among veterans, in addition to, examining disparities in the VA Healthcare System and how these compare to the non-VA healthcare system.

Additional Research Activities

Identification and Characterization of Risk Factors for the Development of Non-Alcoholic Fatty Liver Disease (NAFLD) Phenotypes Utilizing Administrative Databases

The primary objective of this study is to evaluate risk factors for different NAFLD phenotypes, and to develop and validate algorithms to identify NAFLD phenotypes from VA medical records and administrative databases.

PI and Investigators: Christine Hunt, MD; Yuval Patel, MD; Cynthia Moylan, MD; Steve Choi, MD; Christina Williams, PhD; Dawn Provenzale, MD, MS; Beth Gifford, PhD

Electronic medical record (EMR) data-mining for identifying clinical risk modifiers of drug induced liver injury (DILI)

The primary objective of this study is to develop the infrastructure for future data-mining efforts examining associations in DILI occurrence, severity and clinical phenotype.

PI: Ayako Suzuki, MD, PhD, MSc

Trajectories of Kidney Dysfunction in Older Adults with Chronic Kidney Disease (IK2CX000856)

The primary objective of this study is to inform the predictors, outcomes and significance of different longitudinal trajectories of kidney function in older Veterans, including relevant external factors.

PI:C. Barrett Bowling, MD MSPH