The reporting of clinical adverse events scale (I-RoCAES): Validation and psychometric characteristics of the Italian version

Objectives Adverse event (AE) reporting is crucial to ensure patient safety and prevent future incidents, yet AEs are often underreported. Exploring healthcare professionals’ attitudes toward AE reporting is essential for addressing this gap. This study aimed to translate and validate the Italian version of the reporting of clinical adverse events scale (RoCAES), originally developed in 2008, and assess its reliability and applicability in the Italian healthcare system. Methods We developed the Italian RoCAES (I-RoCAES) through translation and back-translation. Healthcare professionals were given an electronic scale version created using Google Forms for anonymous data collection between October 2021 and October 2023. Confirmatory factor analysis (CFA) was conducted to evaluate the original scale's factor structure, followed by exploratory factor analysis (EFA) to refine the model. Internal consistency (Cronbach's alpha and Guttmann coefficient) and CFA results for the I-RoCAES were also analyzed. Results The study sample consisted of 778 healthcare professionals, including physicians, nurses, and nursing students, aged 44.2 years (SD = 15.4) on average. In total, 51.9% had been involved in AEs, but only 33.7% reported it. The data we retrieved from Italian healthcare professionals did not fit well during CFA, which led to an EFA identifying a four-factor solution that accounts for 43.9% of the variance. The I-RoCAES showed good internal consistency (Cronbach's alpha = 0.79; Guttmann coefficient = 0.77) and improved CFA fit indices. Conclusions Due to its good psychometric properties, the I-RoCAES can be utilized to study and promote AE reporting among Italian healthcare professionals.