In cancer clinical trials, adverse events (AEs) are collected and reported using the U.S. National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) . To improve precision and patient-centeredness in the capture of symptomatic AEs, the NCI developed a library of patient-reported outcome (PRO) items to supplement the CTCAE, called the PRO-CTCAE [2,3] Of the 790 AEs in the CTCAE, 78 were identified as amenable to patient self-report. For each of these AEs, PRO items were created reflecting the attributes of frequency, severity, interference with usual or daily activities, amount, or presence/absence. One to three attributes were selected for any given AE depending on the content of the CTCAE criteria for that AE and the nature of that particular AE.
The PRO-CTCAE flow contains the PRO-CTCAE questionnaire and associated calculation. After form submission, the PRO-CTCAE calculation is executed automatically. It's easy to extend this flow with conditional logic based on the interpretation of the PRO-CTCAE calculation.
Questions and Scoring
124 individual items represent the 78 symptomatic AEs currently in the PRO-CTCAE item library. There are scored from 0 to 4 (or 0/1 for absent/present) and the PRO-CTCAE yields up to three patient-reported scores per symptomatic toxicity.
The full PRO-CTCAE Symptom Term list can be found here.
 National Cancer Institute, National Institutes of Health, U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. [last accessed March 16, 2015];NIH publication # 09-7473. Published May 29, 2009; Revised Version 4.03 June 14, 2010. Available at http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5×7.pdf. \
 Basch EM, Reeve BB, Mitchell SA, et al. Electronic toxicity monitoring and patient-reported outcomes. Cancer J. 2011;17(4):231-234. doi:10.1097/PPO.0b013e31822c28b3\
 Basch E, Reeve BB, Mitchell SA, et al. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst. 2014;106(9):dju244. Published 2014 Sep 29. doi:10.1093/jnci/dju244