Incidence and risk factors of adverse events in pediatric hemato-oncological patients: A cohort study.

BACKGROUND: Pediatric hemato-oncological (HO) patients are highly susceptible to the occurrence of adverse events (AE), nevertheless few research has been done in this field. Our aim was to describe the incidence, type, severity and preventability of AE in these patients, including bone marrow transplant (BMT) patients, and to identify patient's risk factors for having an AE.

METHODS: Retrospective cohort study. Children under 18yo hospitalized at the HO or BMT ward in 2016 were eligible for the study. Type of AE, severity and preventability were described as absolute and relative frequencies. Cumulative incidence of patients with at least one AE (CI_AE) and the rate of occurrence of all AE were calculated. Risk factors (sex, recovery probability, comorbidities and being a BMT patient) were analyzed using logistic regression.

RESULTS: 114 patients were included, 58% were male, average age was 8.7yo and 25 were BMT patients. 44 had at least one AE, with CI_AE of 38.6% (95%CI 29.7-47.5). Overall rate of occurrence of AE was 2.5 cases per 100 patients-day (95%CI 2.15-2.98). For BMT and non-BMT patients they were 2.8 (95%CI 2.2-3.6) and 2.5 (95%CI 1.98-3.1) respectively. Healthcare related infection was the most frequent AE. Most AE were moderate and with high preventability. Being a BMT patient was the only independent factor associated with the occurrence of at least one AE (OR=11.5, p<0.001).

CONCLUSIONS: Our findings suggest that AE tend to be moderate and preventable in HO pediatric patients. BMT patients seem to be at greater risk of having an AE. Strategies focused on patient safety need to account for their specific characteristics.