An adverse event capture and management system for cancer studies. Issue 13 (December 2015)

• Record Type: Journal Article
• Authors: Lencioni, Alex; Hutchins, Laura; Annis, Sandy; Chen, Wanchi; Ermisoglu, Emre; Feng, Zhidan; Mack, Karen; Simpson, Kacie; Lane, Cheryl; Topaloglu, Umit
• Is Part Of: BMC bioinformatics. Volume 16:Issue 13(2015)
• Page Start: 1
• Page End: 11
• Publication Date: 2015-12
• Subjects: Bioinformatics -- Periodicals; Computational biology -- Periodicals; 570.285
• DOI: 10.1186/1471-2105-16-S13-S6
• Languages: English
• ISSNs: 1471-2105

Abstract

Abstract Background Comprehensive capture of Adverse Events (AEs) is crucial for monitoring for side effects of a therapy while assessing efficacy. For cancer studies, the National Cancer Institute has developed the Common Terminology Criteria for Adverse Events (CTCAE) as a required standard for recording attributes and grading AEs. The AE assessments should be part of the Electronic Health Record (EHR) system; yet, due to patient-centric EHR design and implementation, many EHR's don't provide straightforward functions to assess ongoing AEs to indicate a resolution or a grade change for clinical trials. Methods At UAMS, we have implemented a standards-based Adverse Event Reporting System (AERS) that is integrated with the Epic EHR and other research systems to track new and existing AEs, including automated lab result grading in a regulatory compliant manner. Within a patient's chart, providers can launch AERS, which opens the patient's ongoing AEs as default and allows providers to assess (resolution/ongoing) existing AEs. In another tab, it allows providers to create a new AE. Also, we have separated symptoms from diagnoses in the CTCAE to minimize inaccurate designation of the clinical observations. Upon completion of assessments, a physician would submit the AEs to the EHR via a Health Level 7 (HL7) message and then to other systems utilizing a Representational State Transfer Web Service. Conclusions AERS currently supports CTCAE version 3 and 4 with more than 65 cancer studies and 350 patients on those studies. This type of standard integrated into the EHR aids in research and data sharing in a compliant, efficient, and safe manner.