Exploring differences in symptomatic adverse events assessment between nurses and physicians in the clinical trial setting

Abstract

A cross-sectional study was performed at Hebei Medical University Fourth Affiliated Hospital from April to July 2020 to explore the difference and consistency between nurses and physicians in terms of symptomatic adverse event (AE) assessment. The Common Terminology Criteria for Adverse Events (CTCAE) was utilized by nurses and physicians to assess patients’ symptomatic AEs. Patients self-reported their AEs utilizing the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Four nurses and three physicians were enrolled to assess patients’ symptomatic AEs. Given the same AEs, nurses tended to detect more AEs than physicians, and the differences were statistically significant (P < 0.001). The toxicity grade reported by nurses and physicians showed no difference for all AEs, except for fatigue (χ2 = 5.083, P = 0.024). The agreement between nurses and patients was highest compared to the agreement between nurses versus physicians and physicians versus patients. The differences in symptomatic AE assessment can lead to different symptom management. Thus, it is important to establish a collaborative approach between nurses and physicians to ensure continuity in care delivery.