Clinical research informatics and electronic health record data.

OBJECTIVES: The goal of this survey is to discuss the impact of the growing availability of electronic health record (EHR) data on the evolving field of Clinical Research Informatics (CRI), which is the union of biomedical research and informatics. RESULTS: Major challenges for the use of EHR-derived data for research include the lack of standard methods for ensuring that data quality, completeness, and provenance are sufficient to assess the appropriateness of its use for research. Areas that need continued emphasis include methods for integrating data from heterogeneous sources, guidelines (including explicit phenotype definitions) for using these data in both pragmatic clinical trials and observational investigations, strong data governance to better understand and control quality of enterprise data, and promotion of national standards for representing and using clinical data. CONCLUSIONS: The use of EHR data has become a priority in CRI. Awareness of underlying clinical data collection processes will be essential in order to leverage these data for clinical research and patient care, and will require multi-disciplinary teams representing clinical research, informatics, and healthcare operations. Considerations for the use of EHR data provide a starting point for practical applications and a CRI research agenda, which will be facilitated by CRI's key role in the infrastructure of a learning healthcare system.

An automated communication system in a contact registry for persons with rare diseases: scalable tools for identifying and recruiting clinical research participants.

OBJECTIVES: Strategies for study recruitment are useful in clinical research network settings. We describe a registry of individuals who have self-identified with one of a multiplicity of rare diseases, and who express a willingness to be contacted regarding possible enrollment in clinical research studies. We evaluate this registry and supporting tools in terms of registry enrollment and impact on participation rates in advertised clinical research studies. METHODS: A web-based automated system generates periodic and customized communications to notify registrants of relevant studies in the NIH Rare Diseases Clinical Research Network (RDCRN). The majority of these communications are sent by email. We compare the characteristics of those enrolled in the registry to the characteristics of participants enrolled in sampled RDCRN studies in order to estimate the impact of the registry on study participation in the network. RESULTS: The registry currently contains over 4000 registrants, representing 40 rare diseases. Estimates of study participation range from 6-27% for all enrollees. Study participation rates for some disease areas are over 40% when considering only contact registry enrollees who live within 100 mi of a clinical research study site. CONCLUSIONS: Automated notifications can facilitate consistent, customized, and timely communication of relevant protocol information to potential research subjects. Our registry and supporting communication tools demonstrate a significant positive impact on study participation rates in our network. The use of the internet and automated notifications make the system scalable to support many protocols and registrants.

Impact of the 1993 CDC surveillance definition of AIDS in Texas, 1991-1994.

In 1993, the Centers for Disease Control and Prevention (CDC) expanded the surveillance case definition of AIDS to include all individuals showing immune suppression, measured by absolute CD4 lymphocyte count or CD4/CD8 ratio, as well as those presenting with the 23 clinical conditions from previous case definitions or with three new indicator conditions (pulmonary tuberculosis, recurrent pneumonia, and invasive cervical cancer). The greatest impact of the expanded definition is the dramatic increase in cases reported in 1993, largely due to a backlog of 1992-diagnosed cases that meet the new criteria. Texas reported a 136% increase in cases in 1993 compared with 1992. Despite a drop between 1993 and 1994, the number of reported cases increased 75% overall between 1992 and 1994. Most cases reported in 1993 and 1994 fall under the 1993 expanded surveillance case definition (59% and 60%, respectively). More than 90% of all cases reported under the new definition are classified under immunologic criteria. The Department of Health and Human Services (DHHS) Public Health Region 4 was the most affected, with a 213% increase in reported cases between 1992 and 1993, and a 163% increase between years 1992 and 1994. In Texas, the new definition shows the greatest impact among women, blacks, and "other" ethnic groups, persons 20 through 29 years of age, and cases attributable to heterosexual contact. From 1992 to 1993, cases reported in Texas increased 161% among females, 171% among blacks, 219% among persons 15 through 19 years old, and 189% among cases citing heterosexual contact. The new definition has successfully identified population subgroups affected most recently by the epidemic. The inflated growth in cases caused by the expanded case definition carries implications for program administrators and health care providers in both allocating resources and targeting prevention efforts.