Online Program

Overview of the Development of the U.S. National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

*Amylou C. Dueck, Mayo Clinic 
Ethan Basch, University of North Carolina 
Sandra A. Mitchell, National Cancer Institute 

Keywords: Cancer, Validity, Health-related quality of life, Patient-reported outcomes, Symptoms, Adverse events, Toxicity

Current practice in U.S. National Cancer Institute (NCI)--sponsored cancer clinical trials for capturing treatment toxicity is clinician grading of adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE). PRO-CTCAE is a patient-reported outcomes version of the CTCAE developed by NCI (HHSN261200800043C, HHSN261201000063C, and HHSN261200800001E) that includes 124 items measuring 78 symptomatic AEs. For each symptomatic AE, up to three attributes (presence, frequency, severity, interference with usual or daily activities, and amount) are measured on a 0-4 Likert scale, except for presence items that are binary. The standard recall period for PRO-CTCAE items is the past 7 days. This presentation provides an overview of the measurement system and its development and testing to date. Specifically, results from the item generation, cognitive interviewing, and validation phases will be reviewed. Finally, results drawn from studies of the measurement properties of PRO-CTCAE will be summarized, including responsiveness, mode equivalence (web versus paper versus telephone), and a comparison of recall periods (daily versus 7, 14, 21, and 28 days).