Use of Structured Electronic Health Records Data Elements for the Development of Computable Phenotypes to Identify Potential Adverse Events Associated with Intravenous Immunoglobulin Infusion.

Introduction: Detection of adverse reactions to drugs and biologic agents is an important component of regulatory approval and post-market safety evaluation. Real-world data, including insurance claims and electronic health records data, are increasingly used for the evaluation of potential safety outcomes; however, there are different types of data elements available within these data resources, impacting the development and performance of computable phenotypes for the identification of adverse events (AEs) associated with a given therapy.

Objective: To evaluate the utility of different types of data elements to the performance of computable phenotypes for AEs.

Understanding Immunotherapy Terminology: An Analysis of Provider-Patient Conversations.

Background: Immunotherapy terminology is complex and can be difficult for patients to understand, threatening informed consent. The aims of this exploratory study are to determine whether patients understand immunotherapy terminology and if the provider defining the term improves patient understanding.

Methods: Conversations between oncology providers and patients discussing immunotherapy were observed(n=39), and technical terms used were noted.