Patient safety incidents reported by patients and witnesses in prehospital emergency medical services: a multicentre prospective study.

BACKGROUND AND IMPORTANCE: Patient safety incidents - events or circumstances that could have resulted, or did result, in unnecessary harm to a patient, and referred to hereafter as incidents - fall into four categories: reportable circumstances, near misses, no-harm incidents, and harmful incidents ('adverse events'). In prehospital emergency medical services (EMS), most research has addressed only harmful incidents, leaving the other three categories poorly characterized. OBJECTIVES: The primary objective was to determine the frequency of incidents reported by patients and witnesses after prehospital EMS care. DESIGN: Multicenter prospective study, following the Strengthening the Reporting of Observational Studies in Epidemiology statement. SETTINGS AND PARTICIPANTS: The eight provincial EMS services of Andalusia, Spain (April 2021-March 2022). Recruitment was consecutive. Eligible participants were patients transported to the hospital by EMS teams, or a witness if not possible, interviewed by telephone 15-20 days after the episode (the EMS attendance and hospital transport). OUTCOME MEASURES AND ANALYSIS: The primary outcome was incident reporting frequency; secondary outcomes were reported harm, sociodemographic characteristics, and a single-item safety self-rating (a four-point scale: 'very safe', 'safe', 'fairly safe', or 'unsafe'). Rather than relying on spontaneous or passive reporting, data were collected through a systematic, structured telephone interview in which participants were explicitly asked whether four specific incidents - error, fall, harm or injury, or another incident described in their own words - had occurred. Frequencies were reported with confidence intervals (CIs); secondary associations used bivariable analyses and, for sociodemographic characteristics, binary logistic regression, with CIs unadjusted for multiplicity. MAIN RESULTS: Among 3156 episodes (1756 patients and 1400 witness respondents; response rate 40.4%), an incident was reported in 166 (5.3%; 95% CI = 4.55-6.08). Reported harm was identified in 58 of these incidents (34.9%), leaving two-thirds without reported harm. During the same interview, incident reporting rose from 2.8% among respondents who felt 'very safe' to 26.3% among those who felt 'unsafe'. CONCLUSIONS: In this prospective study, systematic follow-up of patients and witnesses of EMS transportation identified a declared safety incident in 5.3% of episodes, most of them without reported harm.