Optimising adverse event analysis in clinical trials when dichotomising continuous harm outcomes

Session

Introduction: Well-designed visualisations are a powerful way to communicate information to a range of audiences. In randomised controlled trials (RCT) where there is an abundance of complex data on harms (known as adverse events) visualisations can be a highly effective means to summarise harm profiles and identify potential adverse reactions. Trial reporting guidelines such as the CONSORT extension for harms encourage the use of visualisations for exploring harm outcomes, but research has demonstrated that their uptake is extremely low.

Methods: To improve the communication of adverse event data collected in RCTs we developed recommendations to help trialists decide which visualisations to use to present this data. We developed Stata commands (aedot and aevolcano) to produce two of the visualisations, the volcano and dot plot, to present adverse event data with the aim of easing implementation and promoting increased uptake.

Results: In this talk, using clinical examples, we will introduce and demonstrate application of these commands. We will contrast the produced visual summaries from the volcano and dot plot with traditional non-graphical presentations of adverse data with examples in the published literature, with the aim of demonstrating the benefits of graphical displays.

Discussion: Visualisations offer an efficient means to summarise large amounts of adverse event data from RCTs and statistical software eases the implementation of such displays. We hope that development of bespoke Stata commands to create visual summaries of adverse events will increase uptake of visualisations in this area by the applied clinical trial statistician.