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COHESION: core outcomes in neonatal encephalopathy (protocol)

Fiona A Quirke1,2,3, Patricia Healy4,5, Elaine Ní Bhraonáin6

  • 1Health Research Board Neonatal Encephalopathy PhD Training Network (NEPTuNE), Galway, Ireland. f.quirke1@nuigalway.ie.

Trials
|February 9, 2021
PubMed

Insights

Developing a standardized core outcome set (COS) for neonatal encephalopathy treatments will improve research consistency. This will enhance evidence synthesis and lead to better identification of effective interventions for affected infants.

Area of Science:

  • Neonatal medicine
  • Clinical trial methodology
  • Evidence-based practice

Background:

  • Neonatal encephalopathy (NE) is a critical condition in infants, often caused by oxygen deprivation, leading to severe neurological impairments.
  • Current treatment options for NE are limited, with therapeutic hypothermia being primary, and research evaluations are hindered by inconsistent outcome reporting.
  • Developing a standardized core outcome set (COS) is crucial for consistent evaluation of NE interventions.

Purpose of the Study:

  • To develop a core outcome set (COS) for standardizing outcome measurement and reporting in clinical trials for neonatal encephalopathy (NE) interventions.
  • To improve the quality of evidence synthesis and systematic reviews for NE treatments.

Main Methods:

  • Systematic literature review to identify previously reported outcomes in NE trials.
  • Interviews with parents/caregivers globally to identify outcomes important to them.
  • Online Delphi surveys and consensus meetings with international stakeholders (parents, healthcare providers, researchers) to determine the final COS.

Main Results:

  • The study outlines a comprehensive methodology for developing a COS for neonatal encephalopathy.
  • It involves a multi-stakeholder, international approach to ensure relevance and consensus.

Conclusions:

  • Standardizing outcome measures through a COS will reduce research heterogeneity in neonatal encephalopathy.
  • This will improve evidence synthesis, facilitate identification of effective treatments, and ultimately enhance patient care for infants with NE.
Abstract

Keywords:
Core outcome setDelphiHigh-income countriesLow- to middle-income countriesNeonatal encephalopathyOutcomesPPIReal-time Delphi

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