Responding rapidly to FDA drug withdrawals: design and application of a new approach for a consumer health website.

BACKGROUND: Information about drug withdrawals may not reach patients in a timely manner, and this could result in adverse events. Increasingly, the public turns to consumer health websites for health information, but such sites may not update their content for days or weeks following important events like Food and Drug Administration (FDA) drug withdrawal actions. There is no recognized standard for how quickly consumer health websites should respond to such events, and reports addressing this issue are lacking. OBJECTIVE: The objective of this study was to develop and implement an approach to enhance the efficiency with which a consumer health website (NetWellness.org) responds to FDA drug withdrawal actions. METHODS: Evaluation of the current approach used by NetWellness staff to update content affected by FDA action revealed a slow process driven by the goal of performing thorough and comprehensive review and editing. To achieve our desired goal of accurately updating affected content within 24 hours of FDA action, we developed a strategy that included rapid updating of affected Web pages with warning boxes and hyperlinks to the information about the withdrawal. With the next FDA withdrawal event, that of valdecoxib (Bextra) on April 7, 2005, we applied this new approach, observed the time and resource requirements, and monitored the rate at which consumers viewed the updated information to gauge its potential impact. RESULTS: Application of the new approach allowed one person to modify the affected Web pages in less than 1 hour and within 18 hours of the FDA announcement. Using the old strategy, response to a similar event, the withdrawal of rofecoxib (Vioxx) 6 months earlier, had taken over 3 weeks and the efforts of several personnel. Updated valdecoxib content received 188 hits within the first month and 4285 hits within 1 year. CONCLUSIONS: Rapid updating of a consumer health website's content in response to an FDA drug withdrawal event was easily accomplished by applying the approach described. This allowed consumers to view accurate information regarding the withdrawn drug much sooner than would otherwise have been the case. Given that consumers increasingly turn to websites for their health information, adoption of a rapid response standard for important health events like FDA drug withdrawals should be considered by the consumer health informatics community.

Building research administration applications for the academic health center: a case study.

The academic health center information environment is saturated with information of varying quality and overwhelming quantity. The most significant challenge is transforming data and information into knowledge. The University of Cincinnati Medical Center's (UCMC) focus is to develop an information architecture comprising data structures, Web services, and user interfaces that enable individuals to manage the information overload so that they can create new knowledge. UCMC has accomplished much of what is reported in this article with the help of a four-year Integrated Advanced Information Management Systems (IAIMS) operation grant awarded by the National Library of Medicine in 2003. In the UCMC vision for knowledge management, individuals have reliable, secure access to information that is filtered, organized, and highly relevant for specific tasks and personal needs. Current applications and tool sets will evolve to become the next generation knowledge management applications or smart digital services. When smart digital services are implemented, silo applications will disappear. A major focus of UCMC's IAIMS grant is research administration. Testing and building out existing and new research administration applications and digital services is underway. The authors review UCMC's progress and results in developing a software architecture, tools, and services for research administration. Included are sections on the evolution to full integration, the impact of the work at UCMC to date, lessons learned during this research and development process, and future plans and needs.

NetWellness 1995 - 2005: ten years of experience and growth as a non-profit consumer health information and Ask-an-Expert service.

In the 10 years since its inception, NetWellness (NW) has grown from a regional demonstration project to service the health information needs of an international audience. We present data regarding NW's growth, usage statistics, data regarding the contributions of our volunteer faculty, representative feedback of visitors, and future plans for this successful service.

Integrated advanced information management systems: a twenty-year history at the University of Cincinnati.

The University of Cincinnati (UC) has been active in the National Library of Medicine's Integrated Advanced Information Management Systems (IAIMS) program since IAIMS' inception in 1984. UC received IAIMS planning and modeling grants in the 1980s, spent the 1990s practicing its own form of "iaims" and refining its vision, and, in May 2003, received an IAIMS operations grant in the first round of awards under "the next generation" program. This paper discusses the history of IAIMS at UC and describes the goals, methods, and strategies of the current IAIMS program. The goals of UC's IAIMS program are to: improve teaching effectiveness by improving the assessment of health professional students and residents in laboratory and clinical teaching and learning environments; improve the ability of researchers, educators, and students to acquire and apply the knowledge required to be more productive in genomic research and education; and increase the productivity of researchers and administrators in the pre-award, post-award, and compliance phases of the research lifecycle.

eGrants: University of Cincinnati's Digital grants preparation, workflow routing, and submission system.

Overabundance of largely unorganized and unfiltered information is the greatest information problem facing the faculty, staff, and students of the University of Cincinnati (UC). The goal of UC's IAIMS operations grant is to provide individuals with information that is organized, filtered, context -appropriate, and presented in personalized formats. This presentation will focus on one module, eGrants, of UC's IAIMS research administration system,which will fully digitize the pre-award, post-award, and compliance phases of the grant lifecycle . eGrants will streamline and reduce errors in the grant preparation, routing, and submittal process thus raising the overall quality of and consistency of grant submittals and greatly reducing the time and the cost of grant preparation.