Presentation (CTI)

OBJECTIVES: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) data is now widely collected in oncology trials to evaluate patients’ perspectives of symptomatic toxicity over time and support risk-benefit assessment. Methods to operationalise and visualise PRO-CTCAE data are broadly established, but there remains limited guidance on the relevant questions best suited to address through PRO-CTCAE data, acknowledging that this may provide richer, more direct patient insight beyond clinician adverse event (AE) information. Our aim was to identify the key research questions that may follow from the collection of PRO-CTCAE data, and how effective visualisation can facilitate interpretation.
METHODS: We identified five research questions and R Shiny was utilised to develop an interactive visualisation tool to help address these key questions through categorical summaries. Data was obtained from a simulated dataset reflecting typical PRO-CTCAE symptom patterns seen in oncology to illustrate interpretation.
RESULTS: We defined five research questions of interest: 1) When do symptoms occur? What is the proportion of patients with symptoms and the pattern over time? 2) What is the relationship over time between symptom frequency, severity and interference? 3) What are the most common, severe or impactful symptoms (baseline-adjusted worst score)? 4) What symptoms display the most grade 3/4 reports? 5) How does the proportion of patients with levels of improvement or deterioration in symptoms change over time?
We used an interactive tool to visualise the data descriptively. To address these questions and enable efficient treatment comparisons, we presented interactive stacked bar charts, butterfly plots, and tornado plots.
CONCLUSIONS: A barrier to interpretation of the rich and extensive symptom AE data collected from patients using PRO-CTCAE is developing and prioritising the research questions of interest. We developed key research questions along with an interactive tool that enables efficient interpretation of patient experiences with symptomatic toxicity, as captured by PRO-CTCAE data.