Core Outcome Measures in Effectiveness Trials

COHESION: Core Outcome set for Hypoxic ischemic Encephalopathy to StandardIse Outcomes for treatmeNt

General Information

The aim of COHESION is to develop a COS for use in clinical trials, and other studies, for the treatment of HIE.

Ms Fiona Quirke1, Dr Patricia Healy2,3,4, Elaine Ní Bhraoináin5, Dr Linda Biesty2,4, Mr Tim Hurley1, Prof Karen Walker6 Dr Shireen Meher7, Prof David Haas8, Prof Frank Bloomfield9, Prof Eleanor Molloy1,10, Prof Declan Devane1,2,3,4,11.

1HRB Neonatal Encephalopathy PhD Training Network (NEPTuNE), NUI Galway
2Health Research Board – Trials Methodology Research Network, Ireland
3Evidence Synthesis Ireland, NUI Galway
4School of Nursing and Midwifery, NUI Galway, Galway, Ireland
5PPI partner and board member of the Irish Neonatal Health Alliance (INHA)
6Grace Centre for Newborn Intensive Care, Australian College of Neonatal Nurses, Council of International Neonatal Nurses
7Department of Women's and Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom
8Indiana University-Purdue University Indianapolis, USA
9Liggins Institute, University of Auckland, Auckland, New Zealand
10Trinity College, the University of Dublin, Trinity Translational Medicine Institute, Dublin
11Cochrane Ireland, NUI Galway

Further Study Information

Current Stage:
September 2018 - September 2022
Funding source(s):
Health Research Board (HRB)

Health Area

Disease Category
Neonatal care

Disease Name
Hypoxic ischemic encephalopathy (HIE)

Target Population

Age Range


Nature / type of Intervention


Consensus meeting
Delphi process
Focus group(s)
Systematic review

We will develop the COS through five discrete, yet complimentary, phases (see Figure 1):
Phase 1: A systematic review of the literature to identify outcomes that have been reported in trials and systematic reviews of trials of interventions for the treatment of HIE;
Phase 2: Interviews to obtain the views of women, their partners, other family members who may care for the infant and healthcare providers on critical outcomes they feel should be measured to determine the effect of treatment for HIE;
Phase 3: Development of a preliminary COS (informed by Phases 1 & 2) through a three-round web-based Delphi survey with key stakeholders;
Phase 4: Consensus meeting to discuss and agree on the final HIE COS;
Phase 5: Implementation of a dissemination and implementation strategy for the final COS.

Stakeholders Involved

Clinical experts
Consumers (caregivers)
Patient/ support group representatives
Policy makers
Service providers
Service users

Study Type

COS for clinical trials or clinical research

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