COHESION: Core Outcomes in Neonatal Encephalopathy

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

Contributors

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: Ongoing
Date: September 2018 - September 2022
Funding source(s): Health Research Board (HRB)


Health Area

Disease Category: Neonatal care

Disease Name: Neonatal Encephalopathy

Target Population

Age Range: 0 - 0

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

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

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- 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 Neonatal Encephalopathy;
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 Neonatal Encephalopathy;
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 Neonatal Encephalopathy COS;
Phase 5: Implementation of a dissemination and implementation strategy for the final COS.