In 1997, UK advanced a strategic and business plan to reach the rank of one of the top 20 public research universities by the year 2020.7
The transformation of the institution’s clinical and translational research enterprise along the lines of the NIH CTSA program became an important element in UK’s top 20 quest. While CTSA programs include multiple components deemed necessary for the establishment of the discipline of clinical and translational science, a comprehensive and functional bioinformatics program () was a key element. The required development of biomedical informatics infrastructure stimulated a series of dialogues between senior university and medical center leadership and key faculty involved with research, clinical care, and information systems. This dialogue identified university-wide needs, which stimulated the creation of a university-wide biomedical informatics roadmap. A consultant, IBM (Armonk, NY), was engaged to assist in the development of the roadmap that defined the personnel, strategic architecture, implementation strategies, and timeline necessary to achieve UK’s informatics objectives.
Clinical and Translation Science Award (CTSA) Application
An early objective of the informatics roadmap was to establish the mission, implementation strategy, and guiding principles with key informatics stakeholders. The CBI’s mission centers on providing UK investigators and community health care researchers and providers with the informatics tools and support necessary to promote the translation of scientific breakthroughs to advance the health and well being of the people of the Commonwealth of Kentucky and beyond. This ambitious goal required UK to evolve beyond locally implemented IT-based activities to an institutionally integrated and comprehensive informatics infrastructure and processes. Consequently, the CBI was developed using the guiding principle of providing an accessible, high-quality biomedical informatics infrastructure to the entire University community. One potential impediment to this goal was the barriers between the academic departments of UK’s colleges and the business operations groups of UK HealthCare. The academic units possessed intellectual property focused on theoretical informatics, while the business and operations staff possessed the applied knowledge and infrastructure to operate informatics tools. The business operations group consisted of UK HealthCare IT resources, while the research resources consisted of faculty and staff from academic departments in computer science; the Colleges of Business, Medicine, and Pharmacy; and the Office of the Provost. The vision for the CBI was to pool these resources together and create an environment that encouraged collaborative projects that focused on both informatics research and informatics tool development. Remarkably, the resulting CBI supported the development of resources to support clinical care, education, and research within and outside of the NIH CTSA. ( and ).
UK assessed the demand for high-level informatics infrastructure using a multi-faceted approach. In 2006–2007, IBM conducted an institutional assessment of current UK informatics capacity and unmet needs and developed the UK biomedical informatics roadmap. The resulting recommendations spanned six categories of activity: 1) operational planning, 2) governance, 3) change management, 4) reporting, analytics, and data mining requirements; 5) data analytics environment; and 6) technical infrastructure. Based on the IBM recommendations, formation of the CBI coalesced faculty from across UK in support of biomedical informatics development. Using SWOT (strengths, weaknesses, opportunities, and threats) and gap analyses at CBI leadership meetings, the CBI faculty formulated project plans based on institutional needs and the needs of their specific research.
Ten principles were formulated that articulate ideas about UK’s informatics vision, roles, governance, standardization, access, priorities, and funding:
- Facilitating clinical and translational research by collaborating around a shared biomedical informatics platform,
- Establishing a UK-wide, multi-tiered governance structure,
- Using informatics to accelerate excellence in research, patient care and education,
- Driving toward University-wide standards of data, and infrastructure, without impairing collaboration,
- Developing guidelines that protect research integrity and recognizing data as a university asset,
- Providing funds and resources to the functions determined by biomedical informatics governance,
- Balancing organizational priorities when deploying the roadmap and addressing early value for all constituents,
- Implementing the roadmap through a series of progressive leaps,
- Defining a multi-channel, stakeholder-specific communication plan,
- Adopting a comprehensive and systematic change management program.
The CBI, working with UK academic, clinical, external partners, and members of the National CTSA Consortium, is in its third year of implementing the UK biomedical informatics roadmap. The CBI supports translational research by allowing CCTS investigators to access existing data technologies to readily store, mine, and retrieve data from a variety of sources. This allows for linkage of individual research data sources from biomedical studies, health services, and epidemiologic research, and genomic, proteomic, and sequencing data integrated with clinical information. Specifically, CBI faculty and staff collaborate and provide technical assistance across three critical areas: (1) research and service: support innovative storage, retrieval, and dissemination technologies to apply and advance biomedical knowledge to support clinical care, translational research, education, and administration; (2) education: provide education and training to undergraduate, graduate, professional, and postgraduate students, as well as practitioners in the theory and practice of biomedical informatics as it pertains to translational science; (3) professional and ethical standards: develop and maintain collaborative ties with local, national, and international colleagues to develop and disseminate biomedical informatics research ethical and professional standards.
In addition to technical infrastructure recommendations, the roadmap outlines a governance structure, a comprehensive change management program, and a detailed communication plan. We focused on several highly effective, nationally recognized informatics programs as models of an integrated and expanded CBI infrastructure.
Based on roadmap recommendations, a CBI governance structure linking separate resources and expertise was established. This governance structure includes a senior leadership team; oversight and governance committees; an operations group; and an external advisory board. The senior leadership team meets at least quarterly and includes the Provost, the executive vice president for health affairs, the vice president for research, and selected Deans from the Colleges of Medicine, Public Health, Nursing, and Pharmacy. This team approves high-level informatics recommendations including capital expenditures and funding. It has approved and funded the proposed governance structure, granted authority to the CBI and recruited its new director. The Biomedical Informatics Oversight Committee has responsibility for policy and budget allocation as they pertain to biomedical informatics in the context of overall IT decision-making and prioritization. During its monthly meetings, it establishes policy and allocates budget with the UK HealthCare IT Governance Committee. The UK HealthCare IT Governance Committee focuses on enterprise wide IT decisions and investment prioritization; it advises and provides recommendations to the executive vice president for health affairs on enterprise-wide IT strategy and resource deployment. The Biomedical Informatics Operations Group, led by the CBI director, meets weekly and sets, organizes, establishes standards and priorities, and assigns specific tasks to work groups. This group works with the Regulatory Knowledge and Research Integrity Core, a key function of a CTSA (), to establish guidelines and policies addressing the Health Insurance Portability and Accountability Act (HIPAA), privacy, and Institutional Review Board issues related to establishing the data warehouse. Work groups are formed on an ad hoc basis to assess and advise specific proposed initiatives (e.g., data integrity, security standards). One example of a created BIC work group is the Center for Enterprise Quality and Safety (CEQS) Data Oversight Committee, which meets monthly. Current members represent clinical practice, quality and safety, finance, administration, IT, and computer science. The group has inventoried UK’s databases and data resources throughout the university and UKHealthCare for inclusion into the data warehouse and has developed a standard procedure for requesting existing clinical and administrative data for quality improvement, research, administration, and health care delivery.
The External Advisory Board, which reports to the CBI director, includes a group of interdisciplinary advisors external to the CBI from well-established informatics programs and CTSA programs. The Board meets biannually to discuss CBI initiatives, grants and strategies and to address both issues raised by UK informatics thought leaders and issues deemed of significance by the Advisory Board members themselves. To date, this group has proved critical in discussions related to: location of biomedical Informatics within the institution, director appointment, shaping informatics aims, and curriculum development planning. In 2010, the External Advisory Board reviewed a CBI self-assessment report and copies of grant proposals submitted by CBI faculty as part of the biomedical informatics development and participated in workshops with CBI leadership, informatics investigators, and UK and UK HealthCare senior leaders. The resulting report findings provided significant impetus for moving forward.
The CBI provides CCTS researchers with the resources to fulfill the objectives of the NIH CTSA program by (1) providing opportunities and informatics resources to study methods and approaches to clinical and translational science; (2) collaborating between departments and schools at UK and with corporate partners [Eclipsys (Eclipsys Corporation, Atlanta, GA), IBM]; (3) providing portals for partnerships with community physicians, industry, and foundations; and (4) providing research education, training and career development in biomedical informatics for clinical and translational researchers (including physicians, nurses, dentists, pharmacists, and other health professionals). The CBI also participates in activities with other established CTSA programs at Vanderbilt University, the University of Pittsburgh, and Harvard University.
To leverage resources, an inventory of relevant clinical, administrative, and health-related databases located at or affiliated with UK was performed. To assess the needs of community based health professionals qualitative methods were used (focus groups, surveys). UK’s four practice-based research networks in ambulatory care, oral health, rehabilitative medicine, and public health, which link academic clinicians with their counterparts in community settings and which form a vital link in the health communication network were evaluated. Biomedical informatics infrastructure and sharing were identified in both workshop sessions and a conference evaluation as priorities.
Several existing databases were integrated and federated and a university-wide data warehouse was developed to leverage resources. The current data warehouse infrastructure consists of an Oracle 11g database using SAN Storage for both the Development and Production Environment along with our Extract, Transform and Load Environment. Informatics is our chosen Extract, Transform and Load tool from which the central database is loaded and operated.
The data warehouse is designed to support two general user systems within the University community, research and operations/business. The research user environment uses a trusted agent model for de-identification and access via the CCTS e-Workbench (see below). Operationally, the data warehouse allows researchers to easily and quickly find subjects across disparate systems, including complex multi-criteria selection and “refocus” the database to concentrate on key areas such as patient, disease state, provider, diagnosis, procedure, protocol, biomarker, tissue sample, clinical trial or grant, intervention, or other user-defined area. Design features include mapping to recognized standards and extension to multiple disease states in an integrated manner. A high priority is compliance with governmental and organizational privacy requirements.
An operations/business user environment provides with tools for dashboards, multi-dimensional analysis, data mining, and ad-hoc queries. UK users and authorized UK collaborators can extract data from internal and external sources with tools and applications available via an innovative web portal, eWorkBench. Accessed through the CCTS web site, this portal allows UK users including CCTS faculty and staff as well as collaborators flexible, efficient and effective means of collaboration and interaction with data. Large patient or disease state datasets can be analyzed using a concise, flexible, easy-to-use unit focused on reporting, analysis, and data mining. This knowledge portal provides research data mining, public health-related applications access to various public databases, presentation tools to interact with data, and a UK research portal to facilitate research and allow collaboration with UK and other researchers via the web. The eWorkBench has access to other operational systems, which include the electronic medical record (EMR) and financial data. This approach provides an enhanced collaborative working environment reducing dependency on other communication systems (electronic or postal services mail, fax) while enhancing other means of communication including online discussion forums, interactive multimedia-rich online meetings, and continuing medical educational learning.
The creation of this data model has proceeded through four primary activities: (1) data discovery and analysis to identify data sources and analyze content and source standard common to multiple sources; (2) establishing a common data model to ensure individual fields within the same domain are consistent and data structures compatible; (3) data integration to either load data into the data warehouse or associate data from larger information sources; and (4) establish a presentation format through which users interact with data.
Access to the data warehouse () is granted to UK CCTS staff, researchers and collaborators and/or UK faculty or staff with appropriate certification and Institutional Review Board approval for any research use. CCTS researchers are granted access to data through a process requiring certification and completion of a data use agreement consistent with requirements of their work or research. As a condition of CCTS membership, a researcher must sign a commitment, which is reviewed and approved by the CCTS to maintain the security and confidentiality of all CBI information systems. Detailed user guides for accessing the inpatient and outpatient datasets, data security and other relevant topics are maintained by the CBI. Maintaining data in a central location that is specifically designed for research purposes facilitates compliance with HIPAA privacy and security rule requirements. The CBI and the appropriate CCTS key functions () ensure that appropriate members of the workforce with access to protected health information follow HIPAA rules regarding use or disclosure of information. Our approach to HIPAA compliance in research includes use of subjective de-identification methodologies, limited data sets and data use agreements, and certifications for reviews conducted preparatory to research. The public portion of data in the central warehouse is made anonymous. Any links to non-anonymized sources are under strict HIPAA and Institutional Review Board control. To ensure patient confidentiality, we implemented a Trusted Agent, both automated and manual, that fully meets HIPAA requirements and use-reporting tools that enforce rules returning only properly aggregated data.
Functional Relationships of University of Kentucky High Performance Analytical Data Warehouse (HPADW)