The Tendril Plot—a novel visual summary of the incidence, significance and temporal aspects of adverse events in clinical trials. (21st March 2018)

• Record Type: Journal Article
• Authors: Karpefors, Martin; Weatherall, James
• Is Part Of: Journal of the American Medical Informatics Association. Volume 25:Number 8(2018)
• Page Start: 1069
• Page End: 1073
• Publication Date: 2018-03-21
• Subjects: Patient safety -- Visualization -- Adverse event -- Safety assessment -- Clinical -- Respiratory; Medical informatics -- Periodicals; Information Services -- Periodicals; Medical Informatics -- Periodicals; Médecine -- Informatique -- Périodiques; Informatica; Geneeskunde; Informatique médicale; Computer network resources; Electronic journals; 610.285
• DOI: 10.1093/jamia/ocy016
• Languages: English
• ISSNs: 1067-5027

Abstract

Abstract: Background: In contrast to efficacy, safety hypotheses of clinical trials are not always pre-specified, and therefore, the safety interpretation work of a trial tends to be more exploratory, often reactive, and the analysis more statistically and graphically challenging. Methods: We introduce a new means of visualizing the adverse event data across an entire clinical trial. Results: The approach overcomes some of the current limitations of adverse event analysis and streamlines the way safety data can be explored, interpreted and analyzed. Using a phase II study, we describe and exemplify how the tendril plot effectively summarizes the time-resolved safety profile of two treatment arms in a single plot and how that can provide scientists with a trial safety overview that can support medical decision making. Conclusion: To our knowledge, the tendril plot is the only way to graphically show important treatment differences with preserved temporal information, across an entire clinical trial, in a single view.