Addressing the Need for Standardized Adverse Event (AE) Documentation within the Electronic Medical Record (EMR): Part 2

Abstract

Accurate reporting of adverse events (AEs) facilitates analyses of new and approved therapies and is a federal requirement for clinical research. Healthcare professionals utilize the Common Terminology Criteria for Adverse Events (CTCAE) for this reporting. Our group reviewed the documentation within our hospital's EMR Epic® for a subset of over 100 transplants performed in 2012-2013 and collected data for toxicities meeting grades 3 or higher into a shared project-specific Access® database which is tied to the program BMT database. We then imported the CTCAE from a spreadsheet into drop down menus to decrease the likelihood of entry errors and to standardize the data at the time of first entry. As we reviewed the documentation in Epic®, it became clear that a lack of standardized terminology made it difficult for the consistent and accurate documentation of this data within the medical records. Since our project began in the spring of 2014, our Senior Application Developer worked with Epic® to integrate the CTCAE within our hospital's EMR. The University of Iowa imported from Epic® the CTCAE Toxicity Assessment V4.03 into our EMR. This charting was made available for physicians to document. Our program now has the ability to document toxicities into a dynamic and user-friendly template. This discrete data is able to display to our physicians and staff in real time and able to export out for data analysis. The BMT program also has the ability to run reports on documented toxicities with ease and save as a XML file, thereby saving staff time and resources by eliminating the requirement for other team members to re-enter each record and search to abstract this important data. Since starting with V4.03 we have created charting options for V4.01 and V4.02 by request of staff. All this charting will be available to document by BMT and all our oncology physicians. After an extensive analysis by our team, it was determined that an additional tool could further support clinician documentation when they are away from the hospital EMR system. Our Clinical Trials Research Specialist came up with an idea for the capture of toxicities by which clinicians would answer a series of yes or no questions that would produce the appropriate toxicity via smartphone or tablet. As a result of our experience with our data project, current efforts are underway to enhance and support the documentation of toxicities related to transplantation. By making the entry of this data efficient and available in multiple platforms, we are confident that clinicians and program staff will find the documentation and analysis of this critical data more accessible and usable than ever before.