Abstract
BackgroundThe lack of a consensus definition of neonatal sepsis and a core outcome set (COS) proves a substantial impediment to research that influences policy and practice relevant to key stakeholders, patients and parents.MethodsA systematic review of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. In the included studies, the described outcomes were extracted in accordance with the provisions of the Core Outcome Measures in Effectiveness Trials (COMET) handbook and registered.ResultsAmong 884 abstracts identified, 90 randomised controlled trials (RCTs) were included in this review. Only 30 manuscripts explicitly stated the primary and/or secondary outcomes. A total of 88 distinct outcomes were recorded across all 90 studies included. These were then assigned to seven different domains in line with the taxonomy for classification proposed by the COMET initiative. The most frequently reported outcome was survival with 74% (n = 67) of the studies reporting an outcome within this domain.ConclusionsThis systematic review constitutes one of the initial phases in the protocol for developing a COS in neonatal sepsis. The paucity of standardised outcome reporting in neonatal sepsis hinders comparison and synthesis of data. The final phase will involve a Delphi Survey to generate a COS in neonatal sepsis by consensus recommendation.ImpactThis systematic review identified a wide variation of outcomes reported among published RCTs on the management of neonatal sepsis.The paucity of standardised outcome reporting hinders comparison and synthesis of data and future meta-analyses with conclusive recommendations on the management of neonatal sepsis are unlikely.The final phase will involve a Delphi Survey to determine a COS by consensus recommendation with input from all relevant stakeholders.
Highlights
Neonatal sepsis is estimated to be responsible for 15% of all neonatal deaths globally.[1]
MATERIALS AND METHODS We prospectively registered the study on the Core Outcome Measures in Effectiveness Trials (COMET) database for core outcome set (COS)
There is a wide variation of outcomes among published randomised controlled trials (RCTs) on the management of neonatal sepsis
Summary
The lack of a consensus definition of neonatal sepsis and a core outcome set (COS) proves a substantial impediment to research that influences policy and practice relevant to key stakeholders, patients and parents. A total of 88 distinct outcomes were recorded across all 90 studies included These were assigned to seven different domains in line with the taxonomy for classification proposed by the COMET initiative. The paucity of standardised outcome reporting in neonatal sepsis hinders comparison and synthesis of data. The final phase will involve a Delphi Survey to generate a COS in neonatal sepsis by consensus recommendation. ● This systematic review identified a wide variation of outcomes reported among published RCTs on the management of neonatal sepsis. ● The paucity of standardised outcome reporting hinders comparison and synthesis of data and future meta-analyses with conclusive recommendations on the management of neonatal sepsis are unlikely. ● The final phase will involve a Delphi Survey to determine a COS by consensus recommendation with input from all relevant stakeholders
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