The Institute of Translational Health Sciences at the University of Washington

The Institute of Translational Health Sciences (ITHS), based at the University of Washington (UW), has sought resources outside the health science arena to enhance translational research. For example, the Biomedical Informatics Core is partnering with Microsoft to evaluate using the Amalga tool to improve research access to medical record data.

To help investigators translate concepts to the clinic, the ITHS Preclinical Research Development Network partnered with academic business and law groups. For example, the UW School of Business provides fellowships for MBA students to work with researchers to develop a business plan or market assessment for a putative therapy or device. Three fellowships have been awarded so far, and one project has already achieved funding from NIH’s Small Business Innovation Research program. The ITHS also teamed up with the UW Entrepreneurial Law Clinic, which helps investigator-inventors analyze the commercial potential of their therapy or device. Participants receive assistance with business plans and legal/regulatory strategy.

Another business practice, Toyota Lean, provides a model for the ITHS’s strategic development. Lean is a data-driven, collaborative approach to continuous improvement. It has been used for several years by one of the ITHS’s key partners, Seattle Children’s Hospital, to increase efficiency, such as by reducing the average turnaround time for full review by an institutional review board by 55 percent. With support from Seattle Children’s, Lean was used at the UW Clinical Research Center to increase access for researchers and to replace outdated systems. The new tools helped management reduce overtime and per diems by more than 50 percent. Learn more about the new, streamlined process.

The ITHS is also producing adaptable research tools. To facilitate research with community partners, the Community Outreach and Research Translation (CORT) Core will publish a collaboration toolkit; a guide on best recruitment practices for multi-site studies; a data use agreement toolkit; and a data query, extraction, and standardization tool (Data QUEST). The CORT team also uses the Project to Review and Improve Study Materials (PRISM) readability toolkit (developed prior to ITHS funding)—a publicly available resource useful to anyone who wants to develop more participant-centered, reader-friendly research materials, such as consent forms, invitation letters, and HIPAA authorization language.

The Treuman Katz Center for Pediatric Bioethics at Seattle Children’s developed the Bioethics Consult Application (BECA), a Web-based system to enhance the efficiency and quality of clinical and research bioethics consultation and improve communication with consult requestors. The BECA manages information about each consultation, including documents such as protocols, consent forms, and manuscripts. The results of the consultations are searchable. A new evaluation module will solicit feedback from consult requestors and generate metric reports. Just as the BECA may be used by multiple consultants in one organization, multiple institutions could use the BECA to share data between institutions and as a platform for research.

Biostatistics, Epidemiology, and Research Design Vital to Translational Science

The Biostatistics/Epidemiology/Research Design (BERD) Key Function Committee is a forum for CTSA consortium members to exchange information on current approaches to integrating BERD into clinical and translational science research programs, within and across CTSA institutions. The committee seeks to identify best practices as well as barriers to major gains in efficiency in the national clinical research effort.

At its November 2008 meeting, the BERD KFC highlighted four priority areas. First, promoting statistical research and serving as an incubator for methodological research; second, expanding access to reproducible research methods and tools, by consolidating existing tools, developing new tools, test-driving them, and sharing them more widely; third, promoting best statistical practice; and, finally, supporting graduate students and recent graduates pursuing quantitative science by providing them the tools and techniques to succeed in translational science.

Towards these goals, several subgroups have been and will be created, as needed.

The BERD Evaluation Group focuses on developing process and outcome measures. It is creating a set of evaluation guidelines (available on the CTSA wiki) that institutions can use to assess their BERD activities and, ideally, to document improvement over time. These metrics will help institutions justify and manage their BERD resources. The guidelines currently address six areas: consultative/collaborative activities, grants submitted and funded, protocols developed and reviewed, abstracts and manuscripts submitted and accepted, new methodology developed, and educational activities. The guidelines also include a survey that can be used to gather feedback from users of BERD resources and a time log for individuals to track their productivity in providing BERD resources.

The Online Resources and Education Group seeks to develop an online repository of teaching materials as well as online access to other tools and resources. It recently received an administrative supplement award from NCRR to expand CTSpedia, an online collection of tools, educational materials, and other items that is largely focused on biostatistical and epidemiological issues and written for clinical and translational researchers. The University of California, San Francisco, hosts CTSpedia. To communicate the results of these efforts, the feasibility and value of a new online journal of statistical and epidemiological methodology for translational science is being considered.

To ensure that BERD expertise is fully integrated with CTSA activities, the committee evaluated the CTSA consortium’s recent draft strategic plan and related the various BERD activities to the four strategic goal areas.

The resulting document notes, “BERD members have a long history of creating and applying quantitative methods across the entire range of biomedical disciplines by designing effective clinical and epidemiological studies, assisting in their conduct, and synthesizing meaningful and reproducible results from the data collected.” It identifies the specific roles that BERD plays in each of the consortium’s strategic goals. The document also points out, “The need for BERD expertise and educational efforts in transformative research is particularly urgent to counterbalance the widespread misconception that technological advances in biomedical informatics (e.g., computationally efficient data-mining techniques for large databases of hospital records, ontology development tools) will be sufficient to derive valid conclusions and translate them into improved clinical care and public health.”

What Should CTSAs Achieve?

That was the fundamental question the four Strategic Goal Committees (SGCs) tackled when they met on January 26–27 in Bethesda, Md. In the few months following the October 2008 Steering Committee meeting, the SGCs developed a range of goals and objectives within their committees, which they presented on the first day of this month’s meeting. With this broad perspective, the SGCs identified potential areas of project overlap, short- and long-term deliverables, and the Key Function Committees (KFCs) that would be essential for goal implementation. On the second day, each SGC was asked to present only a single goal that best matched the consortium’s priorities with an emphasis on priorities and deliverables that are achievable within a 12–18 month timeframe. In preliminary form (that the relevant committees may further refine), the SGCs will:

• Improve the study process by reducing the time taken to achieve the protocol and contract approval needed to initiate a clinical study. Steps to develop a data-driven process improvement include pilot studies to validate metrics at 8 CTSAs, a workshop to be held in June 2009, a cross-consortium study, and standardized metrics. In 2–3 years time, all sites are expected to develop data on the actual change in study initiation times.
• Open access to training resources across the CTSA Consortium. Core competencies and curricula will be mapped and posted to a portal that will also allow educational material created by CTSAs and their CDC, NIH Clinical Center and other partners to be downloaded into portable media devices. The Web site will be available in a year and 3–5 years later, it will be possible to determine whether these resources are increasing the number of trained clinical researchers.
• Create a research networking capability that focuses on people. The intent here is to help basic and clinical junior researchers identify sources of knowledge and advice from both local and distant research communities. The process will require the dissemination of informatics tools that already exist or are in development.
• Link and facilitate collaboration among community-based research networks to implement research and best practices. Additionally, CTSAs have the capacity and methods that translate clinical research results into practice across the healthcare system, to include health services and health policy research, comparative effectiveness research, and research into the generation and implementation of evidence-based medicine.

Two additional goals are likely to be added. The first will focus on T1 translation and will be developed with input from the Translation KFC. The second will extend and enhance the research networking goal to include physical resources such as cores. This is already a focus of effort by several funded administrative supplements and has been identified as an area of interest to NCRR and the NIH.

Identifying CTSA goals is important because they will constitute demonstrable achievements to the public, our elected representatives, and our NIH partners. Achieving the goals will show how the CTSA Program is improving the efficiency and quality of medical research, bringing better treatments faster to the people who need them. Given the importance of the goals, the next step will be discussions with the KFCs to establish which goals are already adequately covered and how they relate to last year’s administrative supplements. Watch this newsletter for updates.

The West Coast Consortium Meets for the Third Time

Members of the West Coast Consortium, an informal regional network of CTSA sites, met for the third time in December at the University of Washington in Seattle. The consortium’s meetings serve as a forum for sharing best practices and spreading new ideas across institutions and program areas. The West Coast Consortium is taking steps to create a formal structure of governance and a mission statement to guide its future efforts.

Collaborations are developing and increasing as members find areas and themes of common interest. In Seattle, for example, leaders in informatics explored methods for effective electronic data capture (EDC) and evaluated clinical trial management systems. As a result, an online matrix of approaches and assessment tools of EDC products and systems will be presented to the consortium members in the coming weeks. In particular, the Web site will encourage users to share their experiences with using specific evaluation tools—something akin to Amazon.com’s customer reviews.
 
In presentations to the group, Havivah Schwartz of the University of Washington’s Institute of Translational Health Sciences (ITHS) and Mike Neal of the Oregon Clinical and Translational Research Institute described their organizations’ experiences in process improvement using the principles of “Lean” production (the basis of the Toyota Production System) and Six Sigma. Lean and Six Sigma define value from the perspective of the customer and seek to eliminate waste—i.e., anything that does not provide value to the customer. Meeting participants were extremely enthusiastic about exploring management tools and methodologies, including Lean, to better manage and streamline clinical research management, ensure cost-effectiveness, and improve core resource utilization.

Eric Larson of the ITHS Community Outreach and Research Translation Core and the Group Health Center for Health Studies described lessons learned on how to pave the way for better participatory community-based research. For example, he described how the Coordinated Clinical Studies Network (an NIH-funded precursor to the CTSAs) focused on health literacy by making its consent forms and other research information more readable. Its Project to Review and Improve Study Materials (PRISM) developed a modular guide to improve readability and also provides editing services and training workshops.

The group held several breakout sessions. In one, participants discussed how to enhance interactions between the region’s National Primate Research Centers and CTSAs. They agreed to facilitate a Web site and resource database for investigators and to develop more educational and training opportunities for trainees in nonhuman primate research. As a result of continued coordination and collaboration, a joint call for proposals is near completion that leverages the resources at Oregon Health & Science University; the University of California, Davis; and the University of Washington.

Participants in a breakout session on mentoring emphasized the need for an effective evaluation tool to better identify and address the challenges of mentoring, noting that the CTSA consortium is working on such an evaluation tool at the national level. Participants also discussed creating an online space for West Coast Consortium members to exchange information and tools for mentoring.

In a breakout session on administrative best practices, participants shared the communication strategies and information technology tools they had used at their institutions to enhance communication and participation. The group suggested organizing future West Coast Consortium meetings around specific areas of interest.

Chicago CTSA Sites Combine Forces to Enhance Community Engagement

Northwestern University, the University of Chicago, and the University of Illinois at Chicago (UIC) have joined forces to expand community engagement in clinical research. These universities participate in the national consortium of universities funded by the National Institutes of Health under its CTSA mechanism or are awaiting funding.

The Chicago CTSA Consortium for Community Engagement (C4) seeks to knit together Chicago CTSA research efforts that involve community partners in every stage, from project design through data collection and analysis, to results interpretation. In December 2008, the Otho S. A. Sprague Memorial Institute awarded a grant to support development of C4, which is committed to finding new ways to disseminate information about research findings. In 2009, C4 will co-sponsor three half-day seminars addressing topics important to network members and others interested in improving health in Chicago.

Each partner brings a unique contribution to C4. The Northwestern University Community-Engaged Research Center includes the Alliance for Research in Chicagoland Communities (ARCC). Its mission is to cultivate equitable and collaborative partnerships between Chicago area communities and Northwestern University for research that leads to measurable improvements in community health. ARCC is led by a steering committee comprising representatives from local community-based organizations and Northwestern faculty and staff. ARCC’s initial activities included awarding seed grants for partnership building and pilot research to four community-academic partnership teams, facilitating free capacity-building workshops for community and academic partners, and fostering the development of academic-community partnerships by hosting networking events and brokering individual connections.

University of Chicago investigators and community partners are working to expand their experience in community-based participatory research for health care and disease prevention and management in concert with the research component of the emerging Urban Health Initiative. Current research includes the Reach-Out Chicago Children’s Diabetes Prevention Program, in which lay leaders from within the African American community on Chicago’s South Side conduct group nutrition and exercise sessions for families at risk for diabetes. Other pilot projects include working with churches on Chicago’s South Side to develop their health ministry programs, collaborative efforts with a community group to assess smoking cessation among residents of a local housing project, and after-school programming promoting healthy nutrition and physical activity among Chicago schoolchildren.

The UIC Community Engagement and Research Core is home to the Great Cities Institute Healthy City Collaborative (HCC), a multidisciplinary workgroup that engages university researchers, external partners, and community leaders in conversations and research to benefit the health of Chicago residents. UIC is the recipient of a CTSA planning grant. In collaboration with UIC research centers and institutes and city and community partners, the HCC focuses on developing and promoting a responsive, mutually accepted research agenda. The HCC’s recent activities include hosting a community summit and community focus groups to engage stakeholders in identifying relevant determinants of the quality of life in Chicago.

C4’s seminars and activities will involve a broad and emerging network of Chicago academic institutions in dialogue and collaborative research involving community engagement. The Chicago Community-Based Participatory Research Network meets regularly to discuss issues of common interest and to coordinate technical assistance provided to community-based organizations, practitioners, and faculty engaging in community research in Chicago.

For more information about C4, please contact Jen Kauper-Brown at Northwestern University (312-503-2942, j-kauper-brown@northwestern.edu), Deborah Burnet at the University of Chicago (773-702-4582, dburnet@medicine.bsd.uchicago.edu), or Cynthia Barnes-Boyd at UIC (312-996-7963, cboyd@uic.edu).