Patient self-report tool on side effects in cancer clinical trials validated by landmark study
the ONA take:
A landmark study has validated the National Cancer Institute’s Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) as an accurate, reliable, and responsive measure of side effects experienced by patients participating in clinical trials. This study compared the PRO-CTCAE with other patient-reported and clinical measures.
More than 1,000 patients from clinical practices across the United States, including seven cancer centers, were recruited to participate in the study.
They were asked to complete the PRO-CTCAE before appointments. Their reports were compared against other established measures of symptoms such as case and quality of life reports and prescription information.
The researchers validated 119 of 125 PRO-CTCAE questions against the established measurement tools usually based on information from providers. Underrepresentation in the study population prohibited evaluation of the five questions that could not be validated.
This study was unique in that more than 100 distinct questions about symptomatic adverse events were validated simultaneously.
The Common Terminology Criteria for Adverse Events (PRO-CTCAE) is accurate, reliable.
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