The focused Sankey ( Bii) highlights the proportions of patients for whom interference got worse. Observing panel Bi, the arcs demonstrate frequent movement for patients at each time point to both lower and higher levels of interference. For example, following the yellow color, about a fifth (22%) of patients reported that they had diarrhea rarely at the baseline (yellow node) following the arcs to 4–6 weeks, 33% of these individuals improved and reported no diarrhea, 28% stayed the same at rarely, and 27% reported the frequency had increased, while 12% discontinued. Figure Aii: Focus on the arcs as they flow from left to right. PRO-CTCAE Symptom Data Display with Sankey Flow Diagramsįigure Ai: Both prevalence and frequency appear to be quite stable over time. Three important symptomatic toxicities (diarrhea frequency, fatigue interference with usual/daily activities, and pain severity) were selected, and two graphs are provided for each symptom to illustrate specific aspects. In these diagrams, responses of three and four represent the most severe, most frequent, or highest interference and are collapsed into one category to simplify interpretation by decreasing the number of nodes. In GAP70+, Sankey diagrams were used to visualize the trajectories of symptoms during six months of treatment ( Figure 2) in 692 patients at four time points. Questions include the symptom attributes of presence/absence, frequency, severity, and interference from the symptom with usual/daily activities, scored 0–4. 9 A library of 78 symptom terms is available investigators select items that are relevant to the population and treatment under investigation. The National Cancer Institute developed PRO-CTCAEs to evaluate symptomatic toxicity in patients participating in cancer clinical trials. 8 Patients’ perspectives about symptoms were assessed with Patient- Reported Outcomes (PRO)-CTCAEs. Geriatric Assessment for Patients 70+ (GAP 70+, NCT:02054741) was a nationwide cluster randomized trial evaluating the effect of a geriatric assessment intervention on treatment- related toxicity reported by clinicians via the Common Terminology Criteria for Adverse Events (CTCAEs). Sankey example: Patient-reported symptomatic toxicities
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