Development of a core outcome set for neonatal septic shock management: a study protocol

Area of Science:

• Neonatal Medicine
• Clinical Trial Methodology
• Evidence Synthesis

Background:

• Neonatal septic shock is a critical condition requiring prompt, individualized treatment.
• Current research on neonatal septic shock management lacks outcome consistency, hindering evidence synthesis.
• A standardized Core Outcome Set for Neonatal Septic Shock Management (COS-NSS) is needed for research and clinical practice.

Purpose of the Study:

• To develop a consensus-driven Core Outcome Set for Neonatal Septic Shock Management (COS-NSS).
• To establish standardized outcomes for neonatal septic shock research and clinical care.
• To improve the comparability and synthesis of evidence in neonatal septic shock trials.

Main Methods:

• A four-stage methodology will be employed.
• Stage 1: Scoping review of reported outcomes.
• Stage 2: Expert stakeholder meeting for outcome elucidation.
• Stage 3: Two-round e-Delphi survey for outcome prioritization.
• Stage 4: Consensus meeting to finalize the Core Outcome Set.

Main Results:

• The study protocol details a comprehensive plan for developing the COS-NSS.
• The methodology integrates existing research with multi-stakeholder input.
• The process aims to identify and agree upon essential outcomes for neonatal septic shock.

Conclusions:

• The developed COS-NSS will standardize outcome measurement in neonatal septic shock research.
• This standardization will enhance study comparability and facilitate high-quality evidence generation.
• Ultimately, the COS-NSS aims to improve the medical care provided to neonates with septic shock.