Proposed Core Outcomes After Neonatal Sepsis: A Consensus Statement.

Area of Science:

• Neonatal Medicine
• Pediatric Infectious Diseases
• Clinical Trial Methodology

Background:

• Neonatal sepsis is a major contributor to infant mortality worldwide.
• Existing research on neonatal sepsis exhibits significant heterogeneity in outcome measurement and reporting.
• A standardized core outcome set is crucial for improving research consistency and comparability.

Purpose of the Study:

• To develop a consensus-based core outcome set (COS) for research evaluating treatments for neonatal sepsis.
• The Neonatal Sepsis Core Outcome Set (NESCOS) project aims to standardize outcome reporting in clinical trials.
• To enhance the comparability and reliability of research findings in neonatal sepsis.

Main Methods:

• A four-stage process including systematic reviews, a real-time Delphi (RTD) survey, and consensus meetings.
• Involved a diverse group of stakeholders: healthcare workers, researchers, academics, parents, and parent representatives.
• Utilized a 9-point Likert scale for outcome importance and an 80% agreement threshold for inclusion in the COS.

Main Results:

• The systematic review identified 19 outcomes, supplemented by previous systematic reviews.
• A total of 306 participants contributed to the RTD survey, identifying 55 potential outcomes.
• The finalized Neonatal Sepsis Core Outcome Set (NESCOS) includes 9 critical outcomes.

Conclusions:

• The developed COS provides a standardized framework for measuring and reporting outcomes in neonatal sepsis research.
• Implementation of NESCOS will enhance the comparability of research findings and facilitate evidence synthesis.
• Future research should prioritize the development of standardized measurement methods for these core outcomes.