Protocol for the development of a core outcome set for neonatal sepsis (NESCOS)

PLoS One. 2023 Dec 5;18(12):e0295325. doi: 10.1371/journal.pone.0295325. eCollection 2023.

Abstract

Neonatal sepsis is a serious public health problem; however, there is substantial heterogeneity in the outcomes measured and reported in research evaluating the effectiveness of the treatments. Therefore, we aim to develop a Core Outcome Set (COS) for studies evaluating the effectiveness of treatments for neonatal sepsis. Since a systematic review of key outcomes from randomised trials of therapeutic interventions in neonatal sepsis was published recently, we will complement this with a qualitative systematic review of the key outcomes of neonatal sepsis identified by parents, other family members, parent representatives, healthcare providers, policymakers, and researchers. We will interpret the outcomes of both studies using a previously established framework. Stakeholders across three different groups i.e., (1) researchers, (2) healthcare providers, and (3) patients' parents/family members and parent representatives will rate the importance of the outcomes in an online Real-Time Delphi Survey. Afterwards, consensus meetings will be held to agree on the final COS through online discussions with key stakeholders. This COS is expected to minimize outcome heterogeneity in measurements and publications, improve comparability and synthesis, and decrease research waste.

MeSH terms

  • Consensus
  • Delphi Technique
  • Humans
  • Infant, Newborn
  • Neonatal Sepsis* / therapy
  • Outcome Assessment, Health Care / methods
  • Research Design
  • Systematic Reviews as Topic
  • Treatment Outcome

Grants and funding

This research was funded by the Health Research Board (HRB, Ireland) through funding to the HRB Irish Network for Children’s Clinical Trials (In4Kids) [Grant number: CTN-2021-007] Funders did not play any role in the study design, data collection (when applicable) and analysis, decision to publish, or preparation of the manuscript.