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The PRO-CTCAE Measurement System
The NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Measurement System was developed to evaluate symptomatic toxicities by self-report in adults, adolescents and children participating in cancer clinical trials. It was designed to be used as a companion to the Common Terminology Criteria for Adverse Events (CTCAE), the standard lexicon for adverse event reporting in cancer trials.
The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities that include pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective. The PRO-CTCAE Item Library includes 124 items representing 78 symptomatic toxicities drawn from the CTCAE. A pediatric module permits self-reporting by children and adolescents ages 7-17 years (Ped-PRO-CTCAE®). A version for caregiver reporting is available for use when children or adolescents ages 7-17 are unable to self-report (Ped-PRO-CTCAE®[Caregiver]). The pediatric module includes 130 items representing 62 symptomatic toxicities drawn from the CTCAE.
All components of the PRO-CTCAE Measurement System are developed and validated in accordance with well-established measurement principles, as well as guidelines for patient-reported outcomes instrument development and validation articulated by the International Society of Quality of Life Research (ISOQOL), ISPOR - The Professional Society for Health Economics and Outcomes Research, the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA). The development and testing of PRO-CTCAE Measurement System components include patients undergoing cancer treatment, as well as professionals from the U.S. and Europe with expertise in oncology, instrument development, clinical research and the regulatory aspects of cancer therapy development.
The PRO-CTCAE Measurement System is intended to enhance the precision and reproducibility of adverse event reporting in cancer clinical trials, to provide data that complements and extends the information provided by clinician- reporting using CTCAE, and to represent the patient perspective of the experience of symptomatic adverse events.