Post-pandemic patient safety: Have the characteristics of incidents with harm changed? Comparative observational study in primary care via review of medical records with a trigger tool

Background . The COVID-19 pandemic generated or accelerated healthcare changes, some of which persist thereafter (e.g., healthcare reorganisation, remote consultation). Such changes entail novel risks for patient safety. Methods . Aim . To compare the characteristics of patient safety incidents with harm (PSIH) in primary care before the pandemic and at present. Design and setting . Cross-sectional, comparative, observational study conducted within the entire Primary Care Service of the Madrid region with observations at two time points (2018 and 2021/2022). Participants . Patients >18 years of age with at least one consultation in the previous year. The necessary sample size was established at N1=2,000 for the first time point and N2=2,700 for the second. Sampling was performed by simple randomisation for the first group and by clusters followed by simple randomisation for the second. Main measurements . Age, gender, presence of PSIH in the medical record, and characteristics of the PSIH, specifically avoidability, severity, place of occurrence, nature, and contributory factors. Triggers validated in primary care were employed to screen the patients’ medical records and those containing any trigger were reviewed by three nurse-physician teams who underwent previous training. Analysis . Comparative analysis using Fisher’s exact test. Results . A total of 63 PSIHs and 25 PSIHs were found for the first and second samples, respectively. The comparison of the characteristics of PSIH before the pandemic and currently was: avoidable 62% vs. 52% (p=0.47), mild 51% vs. 48% (p=0.57), in the primary care setting 73% vs. 64% (p=0.47), respectively. Although no statistically significant differences were observed globally in the nature of the incidents (p=0.13), statistically significant differences were found for diagnostic errors, with pre-pandemic rates of 6% vs. 20% at present (p<0.05). Finally, no significant differences were found in the contributory factors. Conclusions . No differences were found in the avoidability, severity, place of occurrence, or contributory factors of PSIHs before the pandemic and currently. In terms of the nature of these incidents, the outcomes revealed an increase in diagnostic errors (excluding diagnostic tests), which could be attributed to a greater frequency of remote consultations and a decrease in the longitudinality of care resulting from the shortage of professionals.