Adverse symptom reporting by patients vs. clinicians

In cancer clinical trials, it is currently standard for clinicians rather than patients to report adverse symptoms such as nausea or fatigue. Patient self-reporting is an alternative approach that is not well studied and is of unknown scientific value.

Ethan Basch, M.D., M.Sc., of the Health Outcomes Group, Memorial Sloan-Kettering Cancer Center in New York, and colleagues gathered data from more than 160 lung cancer patients and their clinicians for six common symptoms reported via the standard adverse event reporting lexicon in oncology trials, the National Cancer institute's Common Terminology Criteria for Adverse Events (CTCAE).

Patients generally reported adverse symptoms earlier, more frequently, and with greater severity than their clinicians. Patient-reported symptoms were more highly associated with day-to-day health status, whereas clinician reports were more predictive of death and hospitalization.

"Patient and clinician perspectives of adverse symptoms appear to be complementary, together providing a more complete picture of the toxic impact of treatments compared with either perspective alone," the authors write. "Clinicians bring professional training and experience to their evaluations, whereas patients are in a better position to communicate their own subjective experiences."

In an accompanying editorial, Carolyn Gotay, Ph.D., of the School of Population and Public Health, University of British Columbia, in Vancouver, commends the study's collection of comparable data from both groups and impressive response rates, but points out some of the potential biases in reports that arise from the patient's perspective: motivation, interpretation, expectations, and personality.

Symptom ratings are therefore affected not only by the disease and treatment but also by other characteristics the patients bring to the situation, according to the editorialist. She suggests how this information may be used to define possible adverse events on label warnings.