INPC Clinical Data Repository

For more than 40 years researchers at the Regenstrief Institute have developed and operated a massive clinical informatics infrastructure in the INPC that has been the object of more than 1000 publications and reports. Involving more than 70 hospitals and 19,000 physicians, the INPC has accumulated more than 4 billion clinical results--mostly numeric and coded data that are most useful for research and interventions to enhance quality improvement and patient safety--from more than 12 million unique patients. The INPC is well known nationally and internationally and has been the model for a number of commercial and academic medical record systems.

The INPC, especially its implementation as the RMRS in Wishard Health Services, is one of the nation's first electronic medical record systems and the keystone of many Institute activities for the Regenstrief Institute and, through the Indiana Clinical and Translational Sciences Institute, academic researchers in Indiana University, Purdue University, and the University of Notre Dame. The data in the INPC are used heavily for both research and clinical management purposes. The Regenstrief Institute employs eight full-time data analysts to answer research and management requests related to this data for a large number of research and clinical projects.

Architecturally, the system standardizes all clinical data as it arrives: laboratory test results are mapped to a set of common test codes (LOINC) with standard units of measure for patient care, public health and research purposes. Patient and provider matching are achieved through a probabilistic global patient and provider index.  Data are provided in both identified and de-identified formats for prospective and retrospective research.

An open source query tool provides investigators with easily navigable access to summary patient data for planning research projects. A more sophisticated query system provides data for in-depth clinical epidemiologic research and healthcare management activities.  Using these tools, researchers can query more than 19,000 standardized variables arranged in a tree-structure and combine them using Boolean logic and numeric operators. Cohorts can be distilled into datasets that are loaded into any existing database and statistical programming software for analysis.

Observational Medical Outcomes Partnership (OMOP)

Regenstrief serves as a partner, and data contributor, for the Observational Medical Outcomes Partnership (OMOP), a public-private partnership designed to help improve the monitoring of drugs for safety. The partnership is conducting a two-year initiative to research methods that are feasible and useful to analyze existing healthcare databases to identify and evaluate adverse event, safety and benefit issues of drugs already on the market. This process is often referred to as pharmacosurveillance, and is similar to public health surveillance activities.  In addition to commercially available databases, the project relies on five distributed data partners, including the Regenstrief Institute, to build a cohort in excess of 300 million lives.

Indiana Biorepository

The Regenstrief Institute has been the leading force in biorepository software development and integration at Indiana University.  Leading the Indiana CTSI's Biomedical Informatics Program, Regenstrief investigators developed software tools for tissue banking to enable high throughput studies for researchers throughout the State of Indiana.  To accomplish this, they developed an open-source intelligent barcode-based automatic data capture system (caTrack), an innovated XML-based data import and export software program (xCaCORE), and scalable globally unique specimen identification that is now being used by the CTSA community nationally.  To enable faster and lower cost tracking of consent forms and collecting data, Regenstrief developers have integrated form scanning and optical recognition technology into the Indiana Biobank and implemented a method for importing data generated from scanning into the dynamic extension tables of caTissue Suite.  At Indiana University, these tools have been used to support 165 studies and store data for more than 250,000 biospecimens.  These data can be linked to phenotypic data in patients' INPC records.

Practice-Based Research Networks and Clinical Trial Support

Regenstrief Institute investigators have been among the nation's leaders in developing practice-based research networks and using them to perform prospective research.  Established originally in the early 1980s, ResNet is based in the primary care services of Wishard Health Services and IU Health-Primary Care and has supported hundreds of research projects supported by more than $150 million in extramural funding and resulting in more than 400 peer-reviewed articles.  Regenstrief was the founding home of Agency for Healthcare Research and Quality (AHRQ's) National Resource Center for Practice-Based Research Networks, supporting more than 100 such networks containing more than 24 million patients.  ResNet uses INPC data to provide research assistants with lists of potential research subjects with upcoming appointments.  Using an open-source SQL database, Regenstrief developers have created a Web-based recruitment management program that ResNet has used over the past ten years to screen 45,000 patients for eligibility to 70+ active protocols, recruiting more than 16,000 (63% of those eligible).  With support from the Indiana CTSI, ResNet has been combined with other primary care and specialty practice-based networks into the Central Indiana Innovation Network (CI-Net) that is leveraging Regenstrief's research and development resources and the INPC to enhance research opportunities statewide, especially in therapeutics.