LAUSR

BACKGROUND Patient-reported outcome (PRO) measurements linked to Common Terminology Criteria for Adverse Events (CTCAE) grading may improve symptom adverse event (AE) reporting in pediatric oncology trials. We evaluated construct validity, responsiveness, and test-retest reliability of the Ped-PRO-CTCAE measurement system for children and adolescents undergoing cancer care. METHODS 482 children (7-18 years, 41.5% not non-Hispanic white) newly diagnosed with cancer and their caregivers participated from nine pediatric oncology hospitals. Surveys completed at 72 hours preceding treatment initiation (T1) and at follow-up (T2) approximately 7-17 days later for chemotherapy, and 4+ weeks for radiation. Psychometric analyses examined relationship of Ped-PRO-CTCAE items (assessing 62 symptom AEs) with Patient-Reported Outcomes Measurement Information System® (PROMIS®), Memorial Symptom Assessment Scale (MSAS), Lansky Play-Performance Scale (PPS), and medication use. A separate test-retest study included 46 children. RESULTS Ped-PRO-CTCAE and MSAS were strongly correlated across age groups at time 2 (T2): 7-12 years r=0.62-0.80, 13-15 years r=0.44-0.94, and 16-18 years r=0.65-0.98; and over time. The Ped-PRO-CTCAE was strongly correlated with PROMIS Pediatric measures at T2; e.g., pain interference r=0.70 (95%CI:0.64,0.76); fatigue severity r=0.63 (95%CI:0.56,0.69); and depression severity r=0.76 (95%CI:0.71,0.81). Ped-PRO-CTCAE items differentiated children by PPS and by medication use. Test-retest agreement ranged 54.3-93.5%. CONCLUSIONS This longitudinal study provided evidence for the construct validity and reliability of the core Ped-PRO-CTCAE symptom AE items relative to several established measures. Additional responsiveness data with clinical anchors is recommended. Incorporation of Ped-PRO-CTCAE in trials may lead to a better understanding of the cancer treatment experience.