PHOENIX -- A multicenter study involving Mayo Clinic researchers has found that the National Cancer Institute's Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), was accurate, reliable and responsive, compared to other, established patient-reported and clinical measures. The study is published today in the journal JAMA Oncology.
“In most cancer clinical trials, information on side effects is collected by providers who have limited time with their patients and current patient questionnaires are limited in scope and depth," says the study's lead author Amylou Dueck, Ph.D., a biostatistician on Mayo Clinic’s Arizona campus. "PRO-CTCAE is a library of items for patients to directly report on the level of each of their symptoms, to enhance the reporting of side effects in cancer clinical trials which is normally based on information from providers. The study itself is unprecedented as more than 100 distinct questions about symptomatic adverse events were validated simultaneously."
Researchers recruited more than 1,000 patients from nine clinical practices across the U.S., including seven cancer centers. These patients reflected the geographic, ethnic, racial and economic diversity in cancer clinical trials. Patients in the study also had a wide range of cancer types.
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