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PRO-CTCAE for Patient Reporting of Toxicities

By Lisa Schulmeister, RN, MN, APRN-BC, OCN, FAAN
Dr. Ethan Basch at Memorial Sloan-Kettering Cancer Center and a team of researchers recognized that many symptoms and toxicities experienced by patients during cancer treatment are very subjective in nature. They also recognized that the more subjective a symptom is, the less likely a healthcare provider is to detect it or accurately grade it.

In 2008, the National Cancer Institute (NCI) began a program, led by Dr. Basch and his team, to create a patient version of the Common Terminology Criteria for Adverse Events (CTCAE), which is the standard system for toxicity reporting in oncology. The Patient-Reported Outcomes version  or PRO-CTCAE was created to develop an electronic system that would enable patients to more accurately self-report toxicities listed in the CTCAE.

Out of the approximately 800 toxicities in the CTCAE, 78 were identified as being appropriate for patient reporting in the PRO-CTCAE. Items to rate each of these toxicities were developed, tested through in-depth patient cognitive interviews, and assessed for validity and reliability in a large U.S. national trial.

It is envisioned that not all 78 PRO-CTCAE toxicities will be assessed in any given clinical trial or in practice, but rather the most relevant ones would be included in a patient form or checklist, along with a mechanism for patients to self-report additional unlisted toxicities. Software has been created for administering the items via the internet or an automated telephone system, which is hosted at the NCI. Multiple cooperative group and industry clinical trials are now piloting use of the PRO-CTCAE to evaluate feasibility and value of information. A Spanish language version is also being validated. Further information about the PRO-CTCAE is available at
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