Multinational randomized trial of inter-rater reliabiliby of CTCAE assessments with or without patient-reported outcome data

The CTCAE is the standard for provider-based rating of adverse events in oncology, but its reliability for symptomatic adverse events is low. A randomized trial at 11 centers in ten countries investigated whether providers’ access to patient-reported outcome (PRO) data would enhance the inter-rater reliability of CTCAE ratings and the detection of symptomatic adverse events. A total of 1067 patients receiving therapy for cancer were randomized to an intervention group, in which providers saw patients’ PRO data as they were doing CTCAE assessments (n=529) or a control group, in which providers did not have access to PRO data (n=538). Inter-rater reliability was significantly higher in the intervention group for 13 of 17 symptomatic adverse events, with the largest differences for memory impairment, irritability, concentration impairment, depression, and anxiety. There was no significant difference for pain, rash, and peripheral sensory neuropathy, whereas the reliability was significantly higher in the control group than in de intervention group for diarrhea. The authors conclude that availability of PRO data to providers for CTCAE rating improves the consistency of provider-based symptomatic adverse event detection in patient with cancer.