An Electronic Medical Records System for Clinical Research and the EMR–EDC Interface

The electronic medical record (EMR), sometimes called electronic health record (EHR) or electronic patient record (EPR), has become one of the most important new technologies in healthcare. Electronic storage and exchange of health-care information has been of interest worldwide for years, but recent reports on medical error rates and national mandates for conversion from handwritten documents have heightened its importance. There have been many published EMR implementations in many different subspecialties. Most focus on improvements in efficiency, patient experience, and care. The Medical Records Institute has published the results of their survey of EHR usage,1 and it demonstrates that usage has been predominately in the ambulatory care sector, with a focus on clinical workflow and quality of care. Few published articles have focused on systems designed for use in ophthalmology, despite a history of the use of such systems dating back to Alcon’s IVY system in the 1990s (Alcon, Ltd., Fort Worth, TX). Published reports from users in the field of ophthalmology have all focused on custom systems, because no commercial product was suitable for their purposes.2 However, commercial systems are widely used and DeBry3 has provided a good overview of the systems available as well as the considerations that are important for individual practices. The focus of these reports is on cost savings, time savings, and quality of care. Concurrent with the increased use of EMR for clinical care, there has been an increase in the use of electronic systems for capture of data in clinical research and clinical trials.4 Many trials still require researchers to enter data manually on both a paper clinical record and a paper case report form (CRF), from which it is transcribed into an electronic database. With this process data are transcribed twice, once from the encounter note to the CRF, and again into the database, providing multiple potential sources for error. Databases tend to be developed independently for each study making cross-study research difficult and therefore infrequent. Retrospective studies require review of the paper record and recompiling the data of interest. As clinical trials have become more complicated, expensive, regulated, and increasingly monitored, clinical research organizations (CROs) and research coordinating centers have expanded and evolved, especially in terms of data collection and monitoring.5 With the advent of the internet, CROs and coordinating centers have moved to electronic data capture (EDC),6,7 which enables data entry for clinical studies to be performed on-site in real time by the researcher. This eliminates one transcription step, but still keeps data in discrete databases and provides no method for retrospective studies. With the increase in EMR implementation, there has been a subsequent increase in interest in using these systems for clinical research and clinical trials. As researchers have had to enter data into two electronic systems, EMR and EDC, speculation on the feasibility of merging these two technologies has begun.8,9 Bleicher8 and the document from the eClinical Forum (eCF)9 discuss some of the different ways that these two systems can be interfaced. In this report, we summarize a system we have built in a research environment at the National Eye Institute (NEI), National Institutes of Health (NIH). Both the eCF and Bleicher8,9 discuss the need for using the investigator as the single point of data entry and the need for electronic data transfer to a data-coordinating center to eliminate transcription errors. The data collection system would have to be highly customizable, to allow for the inclusion of elements for specific clinical trials. In addition, with all the data collected in a single system, it would allow for retrospective studies including data from all patients. We chose to build such a system based on the commercially available EMR from Next-Gen, Inc. (Horsham, PA; formerly MicroMed). In use at the NEI since 2002, the system has become the universal method of clinical research data collection in the outpatient clinic and currently contains data from almost 30,000 patient visits. Although the system has provided developmental challenges, we have implemented it as both a record of patient care and a platform for prospective and retrospective studies.