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A Neonatal Imaging Model of Gram-Negative Bacterial Sepsis
Published on: August 12, 2020
Outcome reporting in neonatal septic shock studies: A systematic review
Hanmei Peng1, Jing Shi2, Jun Tang2
1Department of Nursing, West China Second University Hospital, Sichuan University, Chengdu, China; Department of Neonatology, West China Second University Hospital, Sichuan University, Chengdu, China; Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, China.
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.
