Jon D. Duke

Chapter 5 – Regenstrief Medical Informatics: Experiences with Clinical Decision Support Systems

The discipline of clinical informatics endeavors to improve the process and outcomes of health care by enabling efficient access to information. Care providers can then use this information, both in the form of medical knowledge and in the form of patient data collected during clinical practice, to make decisions and comply with appropriate standards of care. The Regenstrief Institute began work on clinical information systems in 1972, when Dr. Clement McDonald and colleagues conceptualized and began construction of a computerized patient management system for outpatient diabetes care, developed to meet three primary goals: first, it was built to eliminate the problems inherent in paper records by making clinical data available to authorized users “just-in-time” as medical decisions are made; second, it was designed to aid in the recognition of diagnoses and adoption of pertinent care practices by assisting clinicians during their record-keeping activities; third, the system was designed to aggregate and analyze clinical information to be used in health care support systems, such as those for public health, health services research, and quality improvement. The first installation of the Regenstrief Medical Record System (RMRS) at Wishard Memorial Hospital occurred in 1974 and, over the next few years, the use of this system expanded outside of the diabetic clinic into a few of the hospital’s many general medicine clinics. From early in its history, the Regenstrief system has included mechanisms for tailoring rules based on the data, to generate reminders and alerts to care providers. This chapter provides a history of the development and growth of the RMRS into a region-wide source of clinical data, the Indiana Network for Patient Care (INPC), and a summary of the research on the decision support interventions themselves, made possible by this infrastructure. Additionally, lessons learned throughout the more than 30 years of experience in both building and maintaining this system are detailed, alongside some reflections that may be useful for future system builders.

Risk of angioedema associated with levetiracetam compared with phenytoin: Findings of the observational health data sciences and informatics research network.

Recent adverse event reports have raised the question of increased angioedema risk associated with exposure to levetiracetam. To help address this question, the Observational Health Data Sciences and Informatics research network conducted a retrospective observational new‐user cohort study of seizure patients exposed to levetiracetam (n = 276,665) across 10 databases. With phenytoin users (n = 74,682) as a comparator group, propensity score‐matching was conducted and hazard ratios computed for angioedema events by per‐protocol and intent‐to‐treat analyses. Angioedema events were rare in both the levetiracetam and phenytoin groups (54 vs. 71 in per‐protocol and 248 vs. 435 in intent‐to‐treat). No significant increase in angioedema risk with levetiracetam was seen in any individual database (hazard ratios ranging from 0.43 to 1.31). Meta‐analysis showed a summary hazard ratio of 0.72 (95% confidence interval [CI] 0.39–1.31) and 0.64 (95% CI 0.52–0.79) for the per‐protocol and intent‐to‐treat analyses, respectively. The results suggest that levetiracetam has the same or lower risk for angioedema than phenytoin, which does not currently carry a labeled warning for angioedema. Further studies are warranted to evaluate angioedema risk across all antiepileptic drugs.