Statistical Analysis
toxicity, toxicities
ADVERSE EVENT
All patients who provided PRO-CTCAE data at baseline were included in the analysis of symptom burden at the initiation of the regimen, and those who also provided data for at least one postbaseline assessment were included in the analysis of symptomatic toxicity during treatment (Fig CONSORT flow diagram for symptomatic toxicity as measured by PRO-CTCAE. GA, geriatric assessment; PRO-CTCAE, Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events; UC, usual care.Descriptive statistics, means, standard deviation, range for continuous measures, and n (%) for categorical measures were used to characterize the sample. To appraise baseline severity, the distribution of each symptom was visualized according to study arm. The balance in distribution of symptom severity across the two study arms was assessed using the Wilcoxon rank test. To characterize symptom burden at baseline, the overall proportion of patients who reported any symptom with moderate or higher severity were evaluated as well as proportions of patients who reported severe/very severe symptoms. The same proportions were evaluated for cores symptoms. Additionally, differences between patients who provided only baseline PRO-CTCAE data and those who provided at least one additional time point were compared by chi-square test.To evaluate the effects of the GA intervention on the outcomes of patient-reported symptomatic toxicity, a two-step process was followed. First, following the baseline-adjusted method developed by Basch et alBetween-arm differences in symptomatic toxicities were compared using the chi-square test. To account for correlations between patients from the same practice cluster, we further assessed the effect of the intervention on symptomatic toxicity using a generalized estimating equation