Identifying Factors and Root Causes Associated With Near-Miss or Safety Incidents in Patients Treated With Radiotherapy: A Case-Control Analysis.

Abstract

To identify factors associated with a near-miss or safety incident (NMSI) in patients undergoing radiotherapy and identify common root causes of NMSIs and their relationship with incident severity. We retrospectively studied NMSIs filed between October 2014 and April 2016. We extracted patient-, treatment-, and disease-specific data from patients with an NMSI (n = 200; incident group) and a similar group of control patients (n = 200) matched in time, without an NMSI. A root cause and incident severity were determined for each NMSI. Univariable and multivariable analyses were performed to determine which specific factors were contributing to NMSIs. Multivariable logistic regression was used to determine root causes of NMSIs and their relationship with incident severity. NMSIs were associated with the following factors: head and neck sites (odds ratio [OR], 5.2; P = .01), image-guided intensity-modulated radiotherapy (OR, 3; P = .009), daily imaging (OR, 7; P < .001), and tumors staged as T2 (OR, 3.3; P = .004). Documentation and scheduling errors were the most common root causes (29%). Communication errors were more likely to affect patients ( P < .001), and technical treatment delivery errors were most associated with a higher severity score ( P = .005). Several treatment- and disease-specific factors were found to be associated with an NMSI. Overall, our results suggest that complexity (eg, head and neck, image-guided intensity-modulated radiotherapy, and daily imaging) might be a contributing factor for an NMSI. This promotes an idea of developing a more dedicated and robust quality assurance system for complex cases and highlights the importance of a strong reporting system to support a safety culture.