An adverse event capture and management system for cancer studies

• Published in: BMC bioinformatics Vol. 16 Suppl 13; no. Suppl 13; p. S6
• Main Authors: Lencioni, Alex, Hutchins, Laura, Annis, Sandy, Chen, Wanchi, Ermisoglu, Emre, Feng, Zhidan, Mack, Karen, Simpson, Kacie, Lane, Cheryl, Topaloglu, Umit
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 01.12.2015; BioMed Central
• Subjects: Cancer; Care and treatment; Data Collection - methods; Drug-Related Side Effects and Adverse Reactions - diagnosis; Humans; Information management; Methods; National Cancer Institute (U.S.); Neoplasms - complications; Neoplasms - drug therapy; Oncology, Experimental; Proceedings; Records and correspondence; United States
• ISSN: 1471-2105; 1471-2105
• DOI: 10.1186/1471-2105-16-S13-S6

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. 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. 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.