Electronic Toxicity Monitoring and Patient-Reported Outcomes

Understanding the potential profile of adverse events associated with cancer treatment is essential in balancing safety vs. benefits. Multiple stakeholders make use of this information towards decision-making, including patients, clinicians, researchers, regulators, and payors. Currently, adverse events are reported by clinical research staff, yet evidence suggests that this may contribute to under-reporting of symptom events. Direct patient reporting via electronic interfaces offers a promising mechanism to enhance the efficiency and precision of our current approach, and may complement clinician reports of adverse events. The National Cancer Institute has contracted to develop and test an item bank and software system for directly eliciting adverse symptom event information from patients in cancer clinical research, called the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The validity, usability, and scalability of the PRO-CTCAE prototype are currently being examined in academic and community-based settings