The ESINEA Study: A Novel Screening Tool for Identifying Patient Safety Incidents and Adverse Events in Hospitalized Patients-An Index-Date Cohort Evaluation.

Abstract

Background: This study, ESINEA, investigated the period prevalence and characteristics of Patient Safety Incidents (PSIs) at La Paz University Hospital. PSIs were operationally defined as healthcare-related events with the potential to cause patient harm, including near misses, incidents, and adverse events (AEs) resulting in actual injury. Recognizing the critical importance of patient safety and the limitations of existing AE detection methods, the study aimed to improve identification and understanding of these incidents.

Methodology: An index-date inpatient cohort study was conducted, including all patients hospitalized at La Paz University Hospital on April 23^rd, 2023 (n=870 episodes), with follow-up from admission to discharge. The methodology involved two phases: (i) electronic health records screening using a novel trigger-based tool, and (II) expert adjudication to confirm the PSIs and AEs, serving as the reference standard for tool validation.

Results: The population showed a high rate of urgent admissions (79%) and a predominance of older patients (75-85 years old, 19.5%). Phase I identified at least one positive screening trigger in 58% of patients. Following expert adjudication, the period prevalence of PSI was 47.9% (95%CI: 45.16-50.72), and AEs were confirmed in 27% (95% CI: 24.17-30.06). Phase II confirmed that PSI accounted for 92.35% of the positive screening. The most frequent incidents occurred during "patient care and follow-up" (29.95%), followed by "Healthcare-Associated Infections" (17.21%). Vulnerability to PSI was significantly higher among older patients, those with longer hospital stays, and those with higher comorbidity burdens. Although 34.17% of PSIs were deemed preventable, slightly lower than the expected 40%;the analysis identified 88 distinct types of improvement actions to enhance patient safety.

Conclusion: The ESINEA study identified a high period prevalence of AEs (27%) in hospitalized patients, which is higher than the estimated 10% prevalence often cited. Although direct comparisons require caution due to differences in detection sensitivity and study design, these findings underscore the need for enhanced care coordination, infection prevention, and stricter protocol adherence, particularly among vulnerable populations.