Table 2

Inclusion criteria

Population
  • Human neonates (aged <28 days of life or hospitalised to a neonatal unit) being evaluated for neonatal sepsis (as defined by the individual studies).

  • Studies examining a range of patient ages will be included, providing sufficient data are available to examine findings for neonates in isolation.

Concept
  • Studies that develop, validate or assess the impact of a clinical prediction model to diagnose neonatal sepsis.

  • Studies that report any of:

  •    modelling methods (including participants, predictors, outcomes and type of model).

  •    model performance (including sensitivity and specificity).

  •    success of implementation (including acceptability and any changes to practice or outcomes).

  • Only internally and/or externally validated models will be included.

  • Management algorithms, decision rules or prediction models based on expert opinion will not be included unless validated in a subsequent study.

  • Studies evaluating prognostic models (eg, to predict neonatal sepsis-related mortality or morbidity) will be excluded.

Context
  • Studies from any country.

  • Studies from any healthcare setting (including neonatal unit, emergency department, outpatient or community setting).

Types of studies
  • Randomised and quasi-randomised controlled trials, cohort studies, cross-sectional studies, case-control studies and guidelines.

  • Letters, comments and conference proceedings will be included if sufficient details are provided.

  • Studies published in English or Spanish.

  • Systematic reviews, meta-analyses and editorials will be excluded, but will be used to identify relevant primary literature.