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Standardising outcomes in paediatric bloodstream infection antibiotic trials: a scoping review
Sophie C H Wen1, Sabrina de Souza2, Elizabeth T Thomas3
1Children's Health Queensland Hospital and Health Service, Brisbane, Queensland, Australia; Children's Health Research Centre (CHRC), University of Queensland, Brisbane, Queensland, Australia.
Background:
The lack of a standardised framework for outcome measures in paediatric antimicrobial trials for bloodstream infections (BSIs) limits comparability and evidence synthesis.
Objectives:
To identify and categorise the outcome measures reported in paediatric antibiotic trials for Staphylococcus aureus, Streptococcus pyogenes, and gram-negative BSIs to inform future paediatric BSI trial design and core outcome set development, and to identify patient-reported outcome measures (PROMs).
Methods:
DATA SOURCES: MEDLINE, Embase, CENTRAL, and grey literature (2010 to December 2024).
Study Eligibility Criteria:
Interventional antibiotic trials, clinical guidelines and consensus statements for paediatric BSI, and qualitative studies on PROMs.
Participants:
Children aged 0-18years, including neonates.
Interventions:
Antibiotic therapy for BSIs, including systemic antibiotic therapy and antibiotic lock therapy. Assessment of risk of bias: Not performed, consistent with scoping review methodology.
Methods:
of data synthesis: Two reviewers independently screened and extracted data. Outcomes were categorised thematically.
Results:
Of 22,622 records (15,960 peer-reviewed; 6,662 grey literature), 58 studies met inclusion criteria, comprising 14,424 paediatric and neonatal patients. Neonatal sepsis was the most frequently studied condition (n= 28, 51%). Clinical and microbiological outcomes were reported in 50 (86%) and 48 (83%) studies respectively. Combined outcomes in 34 (59%). Safety outcomes were reported in 35 (60%) studies, surrogate outcomes in 22 (38%), pharmacokinetic measures in 12 (21%), cost-related outcomes in 2 (3%), and acceptability in 1 (2%). Subjective clinical outcomes were reported in 2 studies (3%). A total of 514 distinct outcome subcategories were identified. No studies reported PROMs.
Conclusions:
Outcome reporting in paediatric BSI trials is highly variable, and PROMs were not reported. Developing a core outcome set incorporating standardised and patient-centred outcomes is needed to improve comparability and support evidence-based decision-making.
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