Feasibility of Patient Reporting of Adverse Events in Cancer Clinical Trials
In a study reported in JAMA Oncology, Basch et al found that use of patient-reported outcome questionnaires to report symptomatic adverse events was feasible in the setting of multicenter cancer treatment trials.
Study Details
In the study, 361 consecutive patients enrolled in 1 of 9 U.S. multicenter cancer treatment trials were invited to self-report 13 common symptomatic adverse events using a patient-reported outcome adaptation of the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) using tablet computers at 5 successive clinic visits. The study was conducted from March 2007 to August 2011. Agreement of patient self-reports with clinician reports was analyzed using weighted κ statistics.
Patient Adherence
Of the 361 patients invited, 285 (78.9%) enrolled; these patients had a median age of 57 years (range = 24–88 years), 74.3% were female, 85.5% were white, 26.8% had a high school education or less, and 64.7% reported regular Internet use. Self-reports were completed at 1,202 of a total of 1,280 visits (93.9%), with adherence decreasing from 100% at visit 1 to 96%, 95%, 91%, and 85% at visits 2 to 5.
Factors in missing patient reports included institutional error, such as staff neglecting to provide tablet computers, in 56.3% of cases; patient feeling “too ill” in 16.7%; patient refusal in 16.7%; and Internet connection problems in 10.4%.
Patient-Investigator Agreement
Among the 13 adverse events on the patient instrument, agreement between patient and investigator was slight (κ value = 0.01–0.20) for hand or foot rash; fair (κ value = 0.21–0.40) for anorexia, constipation, cough, dyspnea, fatigue, and watery eyes; moderate (κ value = 0.41–0.60) for mouth sores and neuropathy; and substantial (κ value ≥ 0.61) for diarrhea, nausea, pain, and vomiting. Investigators reported fewer adverse events than did patients, with the greatest discrepancies in this regard being observed for anorexia, fatigue, nausea, and pain.
Among patients, 93.2% indicated that the reporting system was easy to use, and 93.1% indicated that it was useful. Among investigators, 94.3% indicated that patient-reported adverse events were useful, and 83.2% thought the reporting was accurate.
The investigators concluded: “Participants in multicenter cancer trials are willing and able to report their own symptomatic [adverse events] at most clinic visits and report more [adverse events] than investigators. This approach may improve the precision of [adverse event] reporting in cancer trials.”
The study was supported by grants from the National Cancer Institute.
Ethan Basch, MD, of Lineberger Comprehensive Cancer Center, University of North Carolina, is the corresponding author of the JAMA Oncology article.
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®.
