Regenstrief researchers have published more randomized controlled trial studies of the effect of computers than any other U.S. center.

Electronic Medical Records Development

The Regenstrief Institute developed the Regenstrief Medical Record System (RMRS), one of the first and now one of the oldest and largest [3] (300 million on-line clinical results) electronic medical record systems. The operational electronic medical record system for Wishard Health Services and Clarian Health Partners (IU, Riley and Methodist hospitals and outpatient facilities), the RMRS includes EKG tracings, radiology images (CTs, MRIs), digital radiography, laboratory results, pathology reports, diagnostic studies, operative notes and discharge summaries used as the source of clinical data for day-to-day patient care.

McDonald CJ, Overhage JM, Tierney WM, et al., "The Regenstrief Medical Record System: a quarter century experience" International Journal of Medical Informatics 1999; 54:225-253.

Operational Enterprise Clinical Information Systems

The RMRS operates in real settings, interfaces with many operational computer systems and is part of the care process at Wishard Hospital and Clarian Health Partners. Regenstrief research scientists and fellows interact at many levels with the healthcare institutions and are involved with numerous details of enterprise integration, including the selection of computer systems, integration of the features and functions into workflow and policy, the use of standards, and the physical location and ergonomics of clinical devices for clinicians and other health care professionals providing outstanding opportunities to fellows interested in institutional information system management.

A document delivery system known as DOCS4DOCS distributes clinical medical information from various source systems to provider practices via a global computer network for documentation, charting, and informational purposes.

Biondich PG, Overhage JM, Dexter PR, Downs SM, Lemmon L, McDonald CJ. A modern optical character recognition system in a real world clinical setting: some accuracy and feasibility observations. JAMIA (Symposium Supplement) Proceedings of the American Medical Informatics Association Annual Symposium, Fall 2002; 56-60.

Mamlin B, Blevins L, Warvel J, McDonald CJ. “An Open-Source XML-Based Java Implementation of the Medical Gopher Order and Note Writing Tool”. JAMIA (Symposium Supplement) Proceedings of the American Medical Informatics Association Annual Symposium, Fall 2001; 826.

Kroth PJ, Belsito A, Overhage JM, McDonald CJ. “Bedside Vital Signs Capture for the non-ICU Setting – An Open Source, PC-Based Solution”. JAMIA (Symposium Supplement) Proceedings of the American Medical Informatics Association Annual Symposium, Fall 2001; 344-348.

Indianapolis Network for Patient Care (INPC) - a Community-based Electronic Medical Records

Regenstrief faculty, staff and fellows manage and continually enrich a large clinical information system and have set up one of the few city-wide information repositories in the nation. This unique operational role provides opportunities available at few fellowship programs.

With support from the National Library of Medicine, the Regenstrief informaticists have created a citywide electronic medical record system, the Indianapolis Network for Patient Care, to improve the care of patients presenting to the emergency departments at all five major Indianapolis hospital systems which together operate a total of 11 geographically separated hospitals. The hospitals send real-time registration messages to the RMRS as patients check into the emergency room. Each hospital pre-stores laboratory results in its own standardized computer vault. At the time of the emergency room visit, with a patient's permission, the information from the separate hospital vaults can be presented to the attending emergency department physicians as a single virtual record. Regenstrief research scientists are studying the effect of access to this information on the care process. This database provides a unique resource for medical informatics fellows’ research projects.

Public Health Extension of INPC

The Indiana State Department of Health has entered into an agreement with Regenstrief Institute and the five major Indianapolis hospitals to permit automated review of laboratory reports in search of reportable communicable diseases. Early trials of this system organized by Regenstrief Research Scientist J. Marc Overhage, MD, PhD suggest that automated reporting delivers signals about new outbreaks faster and more completely at very low marginal cost. Many research opportunities are available here.

Overhage JM, Suico J, McDonald CJ. “Electronic Laboratory Reporting: Barriers, Solutions and Findings”, J Public Health Manag Pract. 2001 Nov; 7(6):60-6.

Shared Pathology Informatics Network (SPIN)

With the goal of allowing cancer researchers to query standardized and de-identified electronic clinical record information to identify tissue blocks that could be used to test specific biologic hypotheses, the Institute has received NCI funding to extend the data collecting approach used in the INPC project and direct it toward cancer research. The five Indianapolis hospital systems have agreed to add de-identified pathology reports, discharge summaries, operative notes, radiology reports and inpatient medication records to the data set they are storing in their INPC vaults. The Indiana Public Health Department provides tumor registry data available under appropriate privacy constraints.

Grannis SJ, Overhage JM, McDonald CJ. “Analysis of Identifier Performance using a Deterministic Linkage Algorithm”, Proc AMIA Symp. 2002 (accepted). First author Sean Grannis, MD is a current medical informatics fellow.

Thomas SM, Mamlin B, Schadow G, McDonald CJ. “A Successful Technique for De-Identifying Pathology Reports Using an Augmented Search and Replace Method.” Proc AMIA Symp. 2002 (accepted).

Physician Order Entry Systems

The Medical Gopher is a continually updated physician order entry system that is used throughout Wishard Memorial Hospital, a number of specialty clinics and in most of IU Medical Group's primary care practices. This system provides a rich platform for studying interventions designed to influence patient care and was the subject of the first randomized controlled trial of physician order entry.

"Physician Inpatient Order Writing on Microcomputer Workstations: Effects on Resource Utilization." Journal of the American Medical Association 1993; 269(3): 379-383.

Randomized Trials of Electronic Medical Records and Medical Informatics System

Regenstrief investigators published the first Randomized Controlled Trial of the effect of computer-based reminders on physician decision processes in 1976[4], and have published more randomized controlled trial studies of the effect of computers than any other U.S. center [5][6]. Ongoing studies include a randomized trial of emergency room access to multi-hospital laboratory and encounter data, on call physicians' access to nursing home patients via video conferencing technology, and a study to detect and reduce adverse events through a computer order entry system.

Efforts are made to test each major RMRS innovation in a randomized, controlled trial and successful innovations have then always been incorporated into the RMRS and used as part of routine care. The reminder system was studied in 1974 and published in 1976 [7][8]. It evolved through a series of further studies[9][10][11] and continues to operate as a routine part of care in all of Wishard Hospital's clinics today. The enhanced RMRS tends to become the control for subsequent studies of newer informatics innovations.

Wishard and IU physicians have maintained a nearly 30-year commitment to the RMRS and use of their sites as "laboratories" for clinical investigation for informatics and health services researchers [12].

The RMRS now carries huge amounts of imaging data ranging from CTs to digital plain files and from motion cardiac echoes to MPEG-1stored patient-to-doctor televideo sessions. Major opportunities exist for clinical and systems research related to the use of those imaging technologies and clinical and systems research in imaging data in diagnosis.

Medical Informatics Standards

The Regenstrief Institute has long been a leader and active participant in medical informatics standards development. Regenstrief investigators organized the first medical informatics effort in 1984, wrote the ASTM and HL7 chapters for orders and observation reporting, and were the lead authors of the unified (USAMP) data HL7 data model, the HL7 version 3 data types, and the proposed HIPAA claims attachments documents. IU/Regenstrief Institute initiated the LOINC® vocabulary standard for observations which has been adopted by the largest commercial laboratories and most Federal agencies (CDC, DOD, HCFA). Fellows will have opportunities to develop research projects related to medical informatics standards.

Russler DC, Schadow G, Mead C, et al. “Influences of the Unifed Service Action Model on the HL7 Reference Information Model.” Proc AMIA Symp. 1999;930-934.

Schadow G, McDonald CJ, Suico JG, et al. “Units of Measure in Clinical Information Systems.” JAMIA 1999 6(2):151-162.

Vreeman DJ, McDonald CJ. Automated Mapping of Local Radiology Terms to LOINC. AMIA Annu Symp Proc. 2005:769-73.

• More information about Health Level Seven (HL7)
• More information about LOINC® and RELMA®

Public Use Tools and Open Source Software for Electronic Medical Record Systems

Since the mid-1990’s Regenstrief research scientists have been building and distributing special purpose public use software tools including RELMA - the LOINC browser and access routines for DICOM databases. A long-term goal is to extend this activity to tools and modules for a reference electronic medical record system and to encourage an Open Source movement among academic and industrial medical informatics groups. The third generation RMRS electronic medical record system is under development in a standard SQL database and JAVA, with the intention of providing this as open source software. Fellows will have the opportunity to participate in the design, implementation and conversion of data between the current system and the new third generation RMRS.

McDonald CJ, Schadow G, Barnes M, McCoy JM. “Open Source Software in Medical Informatics – Why, How and What”, Int J Med Inf (2002 IMIA Conference Special Issue) (accepted).

Privacy and Security Issues

Researcher Gunther Schadow, MD is developing security authentication and security standards for version 3 HL7 messaging based on web security standards, and implementing the Next Generation Internet (NGI) security standards (IPSec) using very low cost network attached devices and LINUX. These devices have been developed and deployed to nursing home televideo projects.

Schadow G, McDonald CJ, Suico JG, et al. Units of Measure in Clinical Information Systems. JAMIA 1999 6(2):151-162.

Large Scale Clinical Databases, Database Mining

Fellows will have the opportunity to participate in the design, implementation and conversion of data between the current system and the new third generation Regenstrief Medical Records System.

The RMRS and the Indianapolis citywide-extension provide an unusually large community-wide clinical database that now carries 300 million results and will grow by 50-70 million results per year under the NCI-funded Shared Pathology Informatics Network (SPIN).

Regenstrief research scientists with interest in geriatrics are engaged in an ongoing collaborative project with the Indiana Peer Review Organization to analyze Medicare administrative data for the entire state.

A number of Regenstrief investigators have special interests in large clinical databases and these systems provide especially rich research opportunities for them and for medical informatics fellows. All medical informatics fellows are required to complete at least one database/epidemiology research project.

See: Mahon BE, Rosenman MB, Kleiman MB. “Maternal and Infant Use of Erythromycin and or\Other Macrolide Antibiotics as Risk Factors for Infantile Hypertrophic Pyloric Stenosis.” J Pediatrics, 2001 Sep;139(3):380-4. Co-author Marc Rosenman is a recent Institute fellow.

Murray MD, Aguirre B, McDonald CJ. “Inhaled Corticosteroids and Adverse Gastrointestinal Effects”, Abstract. Pharmacoepidemiology and Drug Safety, 9: S1-S70 (2000).

Kroenke K, Stump T, Clark DO, Callahan CM, McDonald CJ. “Symptoms in Hospitalized Patients: Outcome and Satisfaction with Care”, Am J Med 1999 Nov;107(5):425-31.

Clark DO, Kroenke K, Callahan CM, McDonald CJ. “Validity and Utility of Patient-reported Health Measures on Hospital Admission”, J Clin Epidemiol. 1999 Jan; 52(1):65-71.

Overhage JM, Tierney WM, Zhou XH, McDonald CJ. “A Randomized Trial of “Corollary Orders” to Prevent Errors of Omission”, J Am Med Inform Assoc. 1997 Sep-Oct; 4(5):364-75.

Tierney WM, Fitzgerald JF, Miller ME, James MK, McDonald CJ. “ Predicting Inpatient Costs with Admitting Clinical Data,” Med Care. 1995 Jan; 33(1):1-14.

Bowman L, Carlstedt BC, Miller ME, McDonald CJ. “Evaluation of ACE-Inhibitor (ACE-I) Associated Cough Using Modified Prescription Sequence analysis (PSA).” Pharmacoepidemiol Drug Saf 1995; 4:17-22.

Telemedicine

The Institute has NLM High Performance Computing and Communications grant support for Next Generation Internet MPEG-1 real time telemedicine imaging (video-conferencing). Institute researchers have developed high speed (cable-based), full-motion video (340x280 x 30 frames per second) modest cost Internet telemedicine links between a 250-bed skilled nursing home and the residences of on-call geriatricians. These links will allow much improved communication between patients and their physicians during on-call hours. This effort requires use of H.323 and MPEG-1 video conferencing, storage and streaming (to see old examinations) and uses IPSec to encrypt the dialogue, both requiring NGI technologies. Fellows can develop research projects related to many aspects of this project.

Weiner M, Shadow G, Lindbergh D, Warvel J, Abernathy G, Perkins SM, Dexter PR, McDonald, CJ. “Conducting a Study of Internet-based Video Conferencing for Assessing Acute Medical Problems in a Nursing Facility”, Proc AMIA Symp. 2002 (accepted).

Improving Patient Safety

With grant support for the Agency for Healthcare Research and Quality Institute researchers are using computerized outpatient prescribing to reduce preventable ADE rates in a diverse array of outpatient setting. They are also employing advanced decision-support within computerized prescribing to reduce the frequency of preventable adverse drug events, medication errors and potential adverse drug events.

A new project to improve patient safety with technology, also funded by AHRQ, will measure “indicators” of medical errors of omission or commission and provide feedback and decision support to clinicians to determine errors.

Technology evaluation

Since the early 1970’s the Institute has been a leader in evaluation and application of evolving technologies to health care. Speech recognition, personal digital assistants and wireless networking are among the technologies actively being explored.

Although the majority of the Institute’s informatics research scientists and fellows focus on medical informatics, other concentrations are available to informatics fellows.

Bioinformatics

This is one of the new areas of interest to our medical informatics group. We have a special interest in linking our computer database to patient biologic samples on a large sale. Fellows can take special course work in bioinformatics.

The Lilly Foundation has awarded a $105 million grant to Indiana University for the Indiana Genomics Initiative. A significant portion of these dollars has been earmarked for a bioinformatics center and recruitment of a center director is underway.

Indiana University has also been awarded a 3-year NIH planning grant (Institute Director and Informatics Fellowship Director Clement McDonald, MD, is co-principal investigator) for the Indiana Program of Excellence in Biomedical Computing which increases opportunities for bioinformatics research as part of the medical informatics training program.

McDonald CJ. “Hickam 2000: The Maturation of, and Linkages Between, Medical Informatics and Bioinformatics”, J Lab Clin Med 2001 Dec; 138(6):359-66.

Lang Li, PhD, a biostatistics researcher and Institute affiliated scientist, has a special interest in bioinformatics and offers a special workshop in the analysis of array data. The first bioinformatics fellow within the Regenstrief NLM training program, had completed a medical residency in pediatric oncology and received a doctoral degree in molecular genetics. Her fellowship project focused on statistical and programming techniques for analyzing array data to predict outcomes of pediatric hematologic tumors. Following her fellowship she joined the Department of Pediatrics at the IU School of Medicine.

Imaging Informatics

Indiana University School of Medicine and Institute researchers, affiliated scientists, and staff have heavy experience with many kinds of clinical images. The RMRS carries over 8 million radiology images as moderately compressed JPEGs and provides access to motion JPEG cardiac echoes. (See also Telemedicine MPEG-1 and H.323 videos above.)

The IUSM radiology department has a very successful imaging research program and equipment to study biological processes in humans and small animals. The IUSM division of nephrology is an international leader in confocal and two photon microscopy imaging, which permits the imaging of cells and organs while they are living and metabolizing. The IUPUI Department of Computer Science has special expertise on processing of 3-dimensional visualization. Medical informatics fellows may focus on clinical and biologic imaging informatics in collaboration with these groups.

Since the early 1970’s the Institute has been a leader in evaluation and application of evolving technologies to health care.