Reliability of adverse symptom event reporting by clinicians

Adverse symptom event reporting is vital as part of clinical trials and drug labeling to ensure patient safety and inform
risk–benefit decision making. The purpose of this study was to assess the reliability of adverse event reporting of different
clinicians for the same patient for the same visit.

A retrospective reliability analysis was completed for a sample of 393 cancer patients (42.8% men; age 26–91, M = 62.39) from lung (n = 134), prostate (n = 113), and Ob/Gyn (n = 146) clinics. These patients were each seen by two clinicians who independently rated seven Common Terminology Criteria
for Adverse Events (CTCAE) symptoms. Twenty-three percent of patients were enrolled in therapeutic clinical trials.

The average time between rater evaluations was 68 min. Intraclass correlation coefficients were moderate for constipation
(0.50), diarrhea (0.58), dyspnea (0.69), fatigue (0.50), nausea (0.52), neuropathy (0.71), and vomiting (0.46). These values
demonstrated stability over follow-up visits. Two-point differences, which would likely affect treatment decisions, were most
frequently seen among symptomatic patients for constipation (18%), vomiting (15%), and nausea (8%).

Agreement between different clinicians when reporting adverse symptom events is moderate at best. Modification of approaches
to adverse symptom reporting, such as patient self-reporting, should be considered.