Objectives
Neonatal septic shock is a critical condition requiring immediate and individualised intervention. Despite extensive research, there is a significant heterogeneity in outcome reporting across studies which may lead to incomparability of study results and limit evidence synthesis. The aim of this systematic review was to identify and analyse outcomes reported in studies focussing on interventions for neonatal septic shock to inform the development of a core outcome set to standardise outcome reporting for future research and practice.
Methods
We conducted this systematic review following the Core Outcome Measures in Effectiveness Trials initiative framework and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We systematically searched PubMed, Embase (Ovid), and the Cochrane Library, covering all records until September 2024. Four independent reviewers performed literature screening and data extraction, with disagreements resolved by consensus among two additional reviewers. Extracted outcomes and their definitions were standardised and categorised into core areas and domains using a 38-item standardised taxonomy.
Results
From 7139 records, 25 studies involving 4957 neonates were included, yielding 136 outcomes. After consolidation, 66 unique outcomes were identified and classified into four core areas based on the established taxonomy. The most frequently reported area was physiological/clinical outcomes (72%, 18 of 25 studies), encompassing 32 outcomes. This was followed by death (68%, 17/25), resource use (48%, 12/25), and adverse events (36%, 9/25). In addition, outcomes related to life impact were not measured in the included studies.
Conclusions
This review demonstrates considerable heterogeneity in outcome reporting across neonatal septic shock studies and highlights the absence of life impact measures. These findings support the need for developing a standardised core outcome set to enhance outcome reporting consistency and clinical relevance.
Hanmei Peng, Jing Shi, Jun Tang, Ying-Xin Li, Xia Li, Xuemei Guo, Meizhu Lu, Xingli Wan, Biru Luo, Mei Rosemary Fu, Yuan Li, Yanling Hu
Disease Category: Neonatal care
Disease Name: Septic shock
Age Range: 0 - 1
Sex: Either
Nature of Intervention: Any
- Systematic review of outcomes measured in trials
- Systematic review
We conducted this systematic review following the Core Outcome Measures in Effectiveness Trials initiative framework and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We systematically searched PubMed, Embase (Ovid), and the Cochrane Library, covering all records until September 2024. Four independent reviewers performed literature screening and data extraction, with disagreements resolved by consensus among two additional reviewers. Extracted outcomes and their definitions were standardised and categorised into core areas and domains using a 38-item standardised taxonomy.