1. Across 26 cancer clinical trials, researchers detected fewer baseline symptoms than those reported by patients, suggesting that adjustments to baseline determinations in clinical trials should consider patient reports as reliable data points.
Evidence Rating Level: 2 (Good)
Baseline symptoms are an important consideration in oncologic clinical trials. Currently, the standard process of determining adverse events (AEs) is the Common Terminology Criteria for Adverse Events (CTCAE), however, this does not account, in a clear manner, events attributable to baseline symptoms and those arising during clinical trials. As such, it is important to account for patient-reported baseline symptoms to adjust analyses of adverse events that are specific to the trials themselves. This retrospective study of legacy clinical trials supported by the National Cancer Institute aimed to analyze clinician CTCAE as well as patient-reported outcome (PRO) questionnaires both at baseline and throughout the clinical trials. A total of 26 cancer clinical trials between 1996 and 2015 were identified, with 24 unique AEs captured with the PRO questionnaires and other specific symptom scales. Baseline scores were significantly higher on patient reports compared to clinicians (83% of symptoms differed). Worst-case postbaseline symptom rates, independent of baseline adjustments, were different between patients and clinicians in 88% of reported symptoms, 76% of which were higher according to the patients. Importantly, approximately 67% of reported symptoms were significantly different between patients and clinicians when accounting for baseline symptoms, only 56% of which were rated higher by patients. This study highlights that nearly 75% of patients report a higher number of baseline symptoms than clinicians, such that misattribution of symptoms to trial effects may be overestimated. However, if sufficient patient reports are obtained and adjustment methods are utilized in accordance with this study, this discrepancy is reduced to roughly 50% disagreement and may reduce error in determining trial effects and AEs.
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