# Outcomes for trials

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self
design_other
neo_out_chorio
our_dag
our_target_trial_protocol
fetal_risk_factors
parental_outcomes
research_groups
routine_data
key_papers
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`````{admonition} Executive summary
:class: info

* Trials of NE have not used consistent outcome measures
* The Cohesion group was a collaborative study that defined a core outcome set for trials of NE treatments - these were (a) survival, (b) brain injury on imaging, (c) neurological status at discharge, (d) cerebral palsy, (e) general cognitive ability, (f) quality of life of the child, and (g) adverse events
`````

## What is the problem?

'A significant obstacle in determining the effectiveness of new treatments for neonatal encephalopathy is the lack of standardisation in the outcomes measured and reported in randomised trials.' 'This heterogeneity in outcome reporting can be minimised by developing a core outcome set (COS). A COS is an agreed standardised set of outcomes that should be measured and reported as a minimum in all studies related to a particular health condition. Other outcomes may be measured and reported by trialists, but the COS is the minimum number of outcomes that should be measured and reported in all studies.'[[COHESION - Quirke et al. 2013]](https://doi.org/10.1038/s41390-023-02938-y)

Standardising outcome reporting across studies, irrespective of underlying aetiology or type of treatment being investigated - faciliating evidence synthesis through systematic review and meta-analysis, enhancing our understanding of intervention effects[[Devane et al. 2024]](https://doi.org/10.1038/s41390-023-03006-1)

## COHESION

'The COHESION Steering Group was formed in January 2019. It included neonatologists, obstetricians, midwives, a neonatal nurse practitioner, parent (i.e. public and patient involvement (PPI) representatives), experts in COS development and researchers with expertise in neonatal encephalopathy. The collective knowledge of this group informed the planning, design, and development of this COS.'

They performed a systematic review, identifying 66 unique outcomes. They delivered Delphi surveys with 269 participants (parents of infants with NE or HIE, and relevant healthcare providers) who were asked to rate the outcomes. They then conducted a series of consensus review meetings. The final core outcome set was:
* **Survival**
* **Brain injury on imaging**
* **Neurological status at discharge**
* **Cerebral palsy**
* **General cognitive ability**
* **Quality of life of the child**
* **Adverse events**

They recommend that these outcomes are used in future studies evaluating NE treatments. Note that this study focussed on definiting outcomes for NE (not specifically HIE).

[[COHESION - Quirke et al. 2013]](https://doi.org/10.1038/s41390-023-02938-y)

## Is this relevant to our project?

The focus of this project is on prevention of HIE, rather than treatment of NE, so this is not directly relevant - but potentially might be.