In cancer clinical trials, doctors typically report the side effects their patients experience, such as nausea. Previous research has shown that doctors under-report these symptoms.
A new system would reliably capture the patient experience with cancer drug side effects.
Patient-reported information hasn’t been used for measuring side effects in cancer research, according to senior author Ethan Basch, director of the UNC Lineberger Cancer Outcomes Research Program and associate professor of medicine and public health at the UNC School of Medicine.
“This study shows that these patient-reported measures perform well, and are ready for implementation in cancer research,” he says.
Basch says that the study is important as it validates measures developed to obtain reports of adverse events directly from patients. He notes a study published earlier this year by European researchers in the Journal of Clinical Oncology found that doctors under-report side effects by as much as half in cancer trials.
“Patient reporting improves the quality of information that we have about how patients feel and function, and it provides a fuller picture of the impact of treatments on people’s lives,” Basch says.
“This is important because in risk-benefit balancing for drugs, we need to have comprehensive and valid information about risk.”
The study tested the reliability and validity of a group of measures previously developed by Basch and colleagues for the National Cancer Institute to test patient-reported adverse events. The measures are called the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events, or PRO-CTCAE.
The researchers tested 124 of the measures that had been developed for the NCI to question patients about 78 potential adverse events. The study involved nearly 1,000 patients who were undergoing outpatient chemotherapy, radiation therapy, or both at one of nine US cancer centers or oncology practices.
“In order to establish the validity of the 124 questions in the survey we developed using the NCI measures, we conducted statistical analyses to compare the new measurement tools to other metrics, such as to clinician reports of patient function and to data on the underlying characteristics of the patients’ cancer and their treatments,” Basch says.
The study found that the PRO-CTCAE measures performed extremely well, demonstrating validity and reliability across items.
Dueck AC, Mendoza TR, Mitchell SA, et al. Validity and Reliability of the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol. doi:10.1001/jamaoncol.2015.2639.