Core Outcome Measures in Effectiveness Trials

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

General Information

Summary:
COHESION aims to develop a core outcome set for use in clinical trials, and other studies, for (a) the prevention and (b) the treatment of Hypoxic Ischaemic Encephalopathy.

Contributors:
Health Research Board (HRB), Neonatal Brain Consortium Ireland, Clinical Research Development Ireland (CRDI), HRB Neonatal Encephalopathy PhD Training Network (NEPTuNE, HRB Trials Methodology Research Network (HRB-TMRN)

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
Hypoxic ischemic encephalopathy (HIE)

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Interview
Literature review

We will develop the COSs through five discrete, yet complimentary, phases:
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 prevention and treatment of Hypoxic Ischaemic Encephalopathy (HIE);
Phase 2: Semi-structured interviews to obtain women’s, their partner’s, and carers’ attitudes and views on interventions used for the prevention and treatment of HIE. This will then be followed by a consultation exercise to decide which of the patient-guided outcomes should be brought forward to the Delphi Survey phase of the study;
Phase 3: Development of a preliminary COS (informed by Phase 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 core outcome sets;
Phase 5: Implementation of a dissemination and implementation strategy for the final core outcome set.


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

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