Leveraging a Statewide Clinical Data Warehouse to Expand Boundaries of the Learning Health System.

Learning Health Systems (LHS) require accessible, usable health data and a culture of collaboration-a challenge for any single system, let alone disparate organizations, with macro- and micro-systems. Recently, the National Science Foundation described this important setting as a cyber-social ecosystem. In 2004, in an effort to create a platform for transforming health in South Carolina, Health Sciences South Carolina (HSSC) was established as a research collaboration of the largest health systems, academic medical centers and research intensive universities in South Carolina. With work beginning in 2010, HSSC unveiled an integrated Clinical Data Warehouse (CDW) in 2013 as a crucial anchor to a statewide LHS. This CDW integrates data from independent health systems in near-real time, and harmonizes the data for aggregation and use in research. With records from over 2.7 million unique patients spanning 9 years, this multi-institutional statewide clinical research repository allows integrated individualized patient-level data to be used for multiple population health and biomedical research purposes. In the first 21 months of operation, more than 2,800 de-identified queries occurred through i2b2, with 116 users. HSSC has developed and implemented solutions to complex issues emphasizing anti-competitiveness and participatory governance, and serves as a recognized model to organizations working to improve healthcare quality by extending the traditional borders of learning health systems.

Development of an electronic research permissions management system to enhance informed consents and capture research authorizations data.

Informed consents are a critical and essential component of the clinical research process. Currently, most consents and research privacy authorizations are being captured on paper. In this paper we describe a novel method of capturing this information electronically. The objective is to allow easier tracking of research participants' intent for current and future research involvement, enhance consent comprehension and facilitate the research workflow. After multidisciplinary analysis in key hospital registration areas and research participant enrollment, an open source software product was designed to capture this data through a user-friendly touch screen interface. The data may then be fed into a clinical data warehouse for use in cohort discovery or consent tracking. Despite ethical, legal and informatics challenges in clinical and research environments, we propose that this technology opens new avenues for significantly enhancing the consent process and positively impacting recruitment.

An investigation of the efficacy of electronic consenting interfaces of research permissions management system in a hospital setting.

PURPOSE: Ethical and legal requirements for healthcare providers in the United States, stipulate that patients sign a consent form prior to undergoing medical treatment or participating in a research study. Currently, the majority of the hospitals obtain these consents using paper-based forms, which makes patient preference data cumbersome to store, search and retrieve. To address these issues, Health Sciences of South Carolina (HSSC), a collaborative of academic medical institutions and research universities in South Carolina, is developing an electronic consenting system, the Research Permissions Management System (RPMS). This article reports the findings of a study conducted to investigate the efficacy of the two proposed interfaces for this system - an iPad-based and touchscreen-based by comparing them to the paper-based and Topaz-based systems currently in use. METHODS: This study involved 50 participants: 10 hospital admission staff and 40 patients. The four systems were compared with respect to the time taken to complete the consenting process, the number of errors made by the patients, the workload experienced by the hospital staff and the subjective ratings of both patients and staff on post-test questionnaires. RESULTS: The results from the empirical study indicated no significant differences in the time taken to complete the tasks. More importantly, the participants found the new systems more usable than the conventional methods with the registration staff experiencing the least workload in the iPad and touchscreen-based conditions and the patients experiencing more privacy and control during the consenting process with the proposed electronic systems. In addition, they indicated better comprehension and awareness of what they were signing using the new interfaces. DISCUSSION: The results indicate the two methods proposed for capturing patient consents are at least as effective as the conventional methods, and superior in several important respects. While more research is needed, these findings suggest the viability of cautious adoption of electronic consenting systems, especially because these new systems appear to address the challenge of identifying the participants required for the complex research being conducted as the result of advances in the biomedical sciences.

Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents.

BACKGROUND: One mechanism to increase participation in research is to solicit potential research participants' general willingness to be recruited into clinical trials. Such research permissions and consents typically are collected on paper upon patient registration. We describe a novel method of capturing this information electronically. PURPOSE: The objective is to enable the collection of research permissions and informed consent data electronically to permit tracking of potential research participants' interest in current and future research involvement and to provide a foundation for facilitating the research workflow. METHODS: The project involved systematic analysis focused on key areas, including existing business practices, registration processes, and permission collection workflows, and ascertaining best practices for presenting consent information to users via tablet technology and capturing permissions data. Analysis was followed by an iterative software development cycle with feedback from subject matter experts and users. RESULTS: An initial version of the software was piloted at one institution in South Carolina for a period of 1 year, during which consents and permission were collected during 2524 registrations of patients. The captured research permission data were transmitted to a clinical data warehouse. The software was later released as an open-source package that can be adopted for use by other institutions. LIMITATIONS: There are significant ethical, legal, and informatics challenges that must be addressed at an institution to deploy such a system. We have not yet assessed the long-term impact of the system on recruitment of patients to clinical trials. CONCLUSIONS: We propose that by improving the ability to track willing potential research participants, we can improve recruitment into clinical trials and, in the process, improve patient education by introducing multimedia to informed consent documents.

The Clinical Research Forum and Association of American Physicians disagree with criticism of the NIH Roadmap.

As representatives of 50 leading academic medical centers focusing on clinical research and many of academic medicine's scientific leaders, the Clinical Research Forum and Association of American Physicians disagree with the JCI's recent editorials on the NIH Roadmap, Elias Zerhouni's leadership, and the future directions of biomedical research.

Reinventing the academic health center.

Academic health centers have faced well-documented internal and external challenges over the last decade, putting pressure on organizational leaders to develop new strategies to improve performance while simultaneously addressing employee morale, patient satisfaction, educational outcomes, and research growth. In the aftermath of a failed merger, new leaders of The Pennsylvania State University College of Medicine and Milton S. Hershey Medical Center encountered a climate of readiness for a transformational change. In a case study of this process, nine critical success factors are described that contributed to significant performance improvement: performing a campus-wide cultural assessment and acting decisively on the results; making values explicit and active in everyday decisions; aligning corporate structure and governance to unify the academic enterprise and health system; aligning the next tier of administrative structure and function; fostering collaboration and accountability-the creation of unified campus teams; articulating a succinct, highly focused, and compelling vision and strategic plan; using the tools of mission-based management to realign resources; focusing leadership recruitment on organizational fit; and "growing your own" through broad-based leadership development. Outcomes assessment data for academic, research, and clinical performance showed significant gains between 2000 and 2004. Organizational transformation as a result of the nine factors is possible in other institutional settings and can facilitate a focus on crucial quality initiatives.

Basic science faculty in surgical departments: advantages, disadvantages and opportunities.

The number of Ph.D. faculty in clinical departments now exceeds the number of Ph.D. faculty in basic science departments. Given the escalating pressures on academic surgeons to produce in the clinical arena, the recruitment and retention of high-quality Ph.D.s will become critical to the success of an academic surgical department. This success will be as dependent on the surgical faculty understanding the importance of the partnership as the success of the Ph.D. investigator. Tighter alignment among the various clinical and research programs and between surgeons and basic scientists will facilitate the generation of new knowledge that can be translated into useful products and services (thus improving care). To capitalize on what Ph.D.s bring to the table, surgery departments may need to establish a more formal research infrastructure that encourages the ongoing exchange of ideas and resources. Physically removing barriers between the research groups, encouraging the open exchange of techniques and observations and sharing core laboratories is characteristic of successful research teams. These strategies can meaningfully contribute to developing successful training program grants, program projects and bringing greater research recognition to the department of surgery.