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.
KeywordsDrug toxicity Reproducibility of results Risk assessment Statistical data interpretation
Common Terminology Criteria for Adverse Events
Intraclass correlation coefficient(s)
Medical dictionary of regulatory activities
Medical record number(s)
National Cancer Institute
Patient-reported outcomes version of the Common Terminology Criteria for Adverse Events
This project was supported by a National Institutes of Health Research Training Grant (T32 CA009461-25); a National Institutes of Health Support Grant (P30-CA-008748). The findings in this manuscript were partially reported at the 31st Annual Meeting and Scientific Sessions of the Society of Behavioral Medicine, Seattle, WA, April 7–10, 2010.
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