Reliability of adverse symptom event reporting by clinicians

• DOI: 10.1007/s11136-011-0031-4
• Publication Date: 2011-10-07T19:42:13Z
• Authors: Thomas M. Atkinson; Yuelin Li; Charles W. Coffey; Laura Sit; Mary Shaw; Dawn Lavene; Antonia V. Bennett; Mike Fruscione; Lauren Rogak; Jennifer Hay; Mithat Gönen; Deborah Schrag; Ethan Basch
• Keywords: Male; Clinical Trials as Topic; Drug-Related Side Effects and Adverse Reactions; Data Collection; Reproducibility of Results; Middle Aged; Risk Assessment; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Neoplasms; Physicians; Humans; Female; Retrospective Studies

Purpose 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. Methods 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. Results 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%). Conclusion 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.