A protocol system to satisfy research specific, disease specific, physician specific, and patient specific...

The Department of Medicine at Loyola University Medical Center Chicago (LUMC) has developed and is utilizing a Patient Information Protocol System (PIPS) to address clinical and research informational needs. PIPS, an integrated module of the department's Patient Information Management System (PIMS), enables end-users to access pre-defined informational templates or "protocols". Protocols detail pre-defined data requirements for patient management or clinical research needs. Each protocol consists of a defined collection of protocol elements. Protocol elements belong to an object group which has several defined attributes (e.g. description, acceptable ranges or inputs, units, and grouping keywords). Approximately 3,500 protocol elements have been identified to define treatments/drugs, symptoms/toxicity, clinical labs, x-rays/scans, physical findings, and lesion groups. Utilizing protocols, PIPS permits end-users to selectively review or capture clinical information. Patients may have several active protocols. PIPS interacts with a specialized database gateway to permit automatic capture of clinical laboratories information, and with reporting systems to produce one of several "chart-ready", time-oriented protocol summary reports. Data extraction programs operate in conjunction with PIPS to facilitate exporting of data for statistical analysis. PIPS has been in operation for over 24 months and has 63 defined protocols (40 clinical research and 23 patient care).