Advertisement

Study Validates Method for Patient Reporting of Cancer Drug–Related Adverse Events

Advertisement

Key Points

  • Previous research has shown doctors underreport patient side effects during cancer clinical trials.
  • Researchers tested 124 of the measures that had been developed for the National Cancer Institute to question patients about 78 potential adverse events. The study involved nearly 1,000 patients who were undergoing outpatient chemotherapy, radiation therapy, or both.
  • Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures performed extremely well, demonstrating validity and reliability across items.

In cancer clinical trials, doctors typically report side effects that patients experience—not patients themselves. Previous research has shown that doctors underreport these symptoms.

Ethan Basch, MD, MSc, Director of the UNC Lineberger Cancer Outcomes Research Program and Associate Professor of Medicine and Public Health at the UNC School of Medicine, has led studies and national initiatives to enable patients to directly report their own symptoms during cancer drug development. In an article published by Dueck et al in JAMA Oncology, a study led by Dr. Basch and colleagues for the National Cancer Institute (NCI) showed that a system they developed accurately and reliably captures the patient experience with cancer drug side effects.

“This is a landmark study because patient-reported information has not been used for measuring side effects in cancer research,” said Dr. Basch. “This study shows that these patient-reported measures perform well and are ready for implementation in cancer research.”

Study Findings

The study tested the reliability and validity of a group of measures previously developed by Dr. Basch and colleagues for the NCI to test patient-reported adverse events. Dr. Basch, as well as other authors, were contracted to develop the measures, which 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 and/or radiation therapy at one of nine U.S. cancer cancers 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,” Dr. Basch said.

The study found that the PRO-CTCAE measures performed extremely well, demonstrating validity and reliability across items.

Dr. Basch said that the study is important, as it validates measures developed to obtain reports of adverse events directly from patients. He noted a study by Di Maio et al published earlier this year in the Journal of Clinical Oncology, which found doctors underreported 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,” Dr. Basch said. “This is important because in risk-benefit balancing for drugs, we need to have comprehensive and valid information about risk.”

Dr. Basch is the corresponding author of the JAMA Oncology article.

The study was supported by the National Cancer Institute.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


Advertisement

Advertisement



Advertisement