FeBRILe3: Safety Evaluation of Febrile Infant Guidelines Through Prospective Bayesian Monitoring

Abstract

OBJECTIVES Despite evidence supporting earlier discharge of well-appearing febrile infants at low risk of serious bacterial infection (SBI), admissions for ≥48 hours remain common. Prospective safety monitoring may support broader guideline implementation. METHODS A sequential Bayesian safety monitoring framework was used to evaluate a new hospital guideline recommending early discharge of low-risk infants. Hospital readmissions within 7 days of discharge were regularly assessed against safety thresholds, derived from historic rates and expert opinion, and specified a priori (8 per 100 infants). Infants aged under 3 months admitted to 2 Western Australian metropolitan hospitals for management of fever without source were enrolled (August 2019–December 2021), to a prespecified maximum 500 enrolments. RESULTS Readmission rates remained below the prespecified threshold at all scheduled analyses. Median corrected age was 34 days, and 14% met low-risk criteria (n = 71). SBI was diagnosed in 159 infants (32%), including urinary tract infection (n = 140) and bacteraemia (n = 18). Discharge occurred before 48 hours for 192 infants (38%), including 52% deemed low-risk. At study completion, 1 of 37 low-risk infants discharged before 48 hours had been readmitted (3%), for issues unrelated to SBI diagnosis. In total, 20 readmissions were identified (4 per 100 infants; 95% credible interval 3, 6), with >0.99 posterior probability of being below the prespecified noninferiority threshold, indicating acceptable safety. CONCLUSIONS A Bayesian monitoring approach supported safe early discharge for many infants, without increased risk of readmission. This framework may be used to embed safety evaluations within future guideline implementation programs to further reduce low-value care.