RATIONALE, AIMS AND OBJECTIVES: To gain insight into the incidence of paediatric adverse events (AEs); to assess if there are significant differences among study results and to what extent methodological issues can explain them. METHODS: From November 2012 to January 2013, systematic literature searches were conducted on PubMed, Scopus and the Cochrane Library. We selected studies from 1970 onwards that evaluated the incidence of AEs in hospitalized paediatric patients and included a minimum of 1000 patient records with the same definition of AE. Studies that reported only specific AEs or only a specific ward were not considered. Data were extracted on the method of data collection, study design, type of hospital, and the timing of the AE in relation to its discovery and the index admission (time frame). AE incidence and preventability were considered. RESULTS: The pooled incidence of AEs was 2.0% (95% CI: 1.3-3.0%). Five methodological differences among studies were taken into account. Only the time frame of detected events had a statistically significant effect on the incidence of AEs (P<0.0001). The pooled incidence of preventable AEs was 46.2% (95% CI: 35.3-57.5%) with a high variability among studies. CONCLUSIONS: Our meta-analysis confirms that AEs are a major public health issue. Although studies use the same definition of AE, the reported incidence of AEs and preventable AEs varied considerably. To direct prevention efforts properly, studies methodologically more homogeneous and more detailed about the standard of health care provided and the health system organization are needed.
RATIONALE, AIMS AND OBJECTIVES: To gain insight into the incidence of paediatric adverse events (AEs); to assess if there are significant differences among study results and to what extent methodological issues can explain them. METHODS: From November 2012 to January 2013, systematic literature searches were conducted on PubMed, Scopus and the Cochrane Library. We selected studies from 1970 onwards that evaluated the incidence of AEs in hospitalized paediatric patients and included a minimum of 1000 patient records with the same definition of AE. Studies that reported only specific AEs or only a specific ward were not considered. Data were extracted on the method of data collection, study design, type of hospital, and the timing of the AE in relation to its discovery and the index admission (time frame). AE incidence and preventability were considered. RESULTS: The pooled incidence of AEs was 2.0% (95% CI: 1.3-3.0%). Five methodological differences among studies were taken into account. Only the time frame of detected events had a statistically significant effect on the incidence of AEs (P<0.0001). The pooled incidence of preventable AEs was 46.2% (95% CI: 35.3-57.5%) with a high variability among studies. CONCLUSIONS: Our meta-analysis confirms that AEs are a major public health issue. Although studies use the same definition of AE, the reported incidence of AEs and preventable AEs varied considerably. To direct prevention efforts properly, studies methodologically more homogeneous and more detailed about the standard of health care provided and the health system organization are needed.