Evidence map›Paper›PMID 33557892›Full record

ArticleTrials2021

COHESION: core outcomes in neonatal encephalopathy (protocol).

Fiona A Quirke, Patricia Healy, Elaine Ní Bhraonáin, Mandy Daly, Linda Biesty, Tim Hurley, Karen Walker, Shireen Meher, David M Haas, Frank H Bloomfield and 3 more

Open access · goldAbstract read
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 3 pooled it
4.3field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Melatonin treatment for neonatal encephalopathy.The Cochrane database of systematic reviews · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 5 countries.

Fiona A QuirkeHealth Research Board Neonatal Encephalopathy PhD Training Network (NEPTuNE), Galway, Ireland. f.quirke1@nuigalway.ie.ORCID http://orcid.org/0000-0001-9155-5543
Patricia HealyCollege of Medicine, Nursing and Health Sciences, National University of Ireland Galway, Galway, Ireland.
Elaine Ní BhraonáinFamily Support Liaison, Irish Neonatal Health Alliance, Wicklow, Ireland.
Mandy DalyAdvocacy and Policymaking, Irish Neonatal Health Alliance, Wicklow, Ireland.
Linda BiestyCollege of Medicine, Nursing and Health Sciences, National University of Ireland Galway, Galway, Ireland.
Tim HurleyHealth Research Board Neonatal Encephalopathy PhD Training Network (NEPTuNE), Galway, Ireland.
Karen WalkerRPA Newborn Care, Sydney Local Health District, Sydney, Australia.
Shireen MeherBirmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.
David M HaasDepartment of Obstetrics and Gynaecology, Indiana University School of Medicine, Indianapolis, USA.
Frank H BloomfieldLiggins Institute, University of Auckland, Auckland, New Zealand.
Jamie J KirkhamCentre for Biostatistics, University of Manchester, Manchester, UK.
Eleanor J MolloyPaediatrics and Child Health, Trinity College Dublin, Dublin, Ireland.
Declan DevaneHealth Research Board - Trials Methodology Research Network (HRB-TMRN), Galway, Ireland.
Ollscoil na Gaillimhe – University of Galway · IETrinity College Dublin · IEBirmingham Women’s and Children’s NHS Foundation Trust · GBIndiana University School of MedicineSydney Local Health District · AUUniversity of Auckland · NZUniversity of Manchester · GB

Funding

Health Research Board HRB-NEPTuNE
6 · The paper itself

Abstract

backgroundNeonatal encephalopathy is a complex syndrome in infants that predominantly affects the brain and other organs. The leading cause is a lack of oxygen in the blood reaching the brain. Neonatal encephalopathy can result in mortality or complications later in life, including seizures, movement disorders and cerebral palsy. Treatment options for neonatal encephalopathy are limited mainly to therapeutic hypothermia, although other potential treatments are emerging. However, evaluations of the effectiveness of treatments are challenging because of heterogeneity and inconsistency in outcomes measured and reported between trials. In this paper, we detail how we will develop a core outcome set to standardise outcomes measured and reported upon for interventions for the treatment of neonatal encephalopathy.

methodsWe will systematically review the literature to identify outcomes reported previously in randomised trials and systematic reviews of randomised trials. We will identify outcomes important to parents or caregivers of infants diagnosed with and who have received treatment for neonatal encephalopathy. We will do this by conducting in person or by video teleconferencing interviews with parents or caregivers in high-income and low- to middle-income countries. Stakeholders with expertise in neonatal encephalopathy (parents/caregivers, healthcare providers and researchers) will rate the importance of identified outcomes in an online Delphi survey using either a three-round Delphi survey or a "Real-Time" Delphi survey to which stakeholders will be allocated at random. Consensus meetings will take place by video conference to allow for an international group of stakeholder representatives to discuss and vote on the outcomes to include in the final core outcome set (COS). DISCUSSION: More research is needed on treatments for neonatal encephalopathy. Standardising outcomes measured and reported in evaluations of the effectiveness of interventions for the treatment of neonatal encephalopathy will improve evidence synthesis and improve results reported in systematic reviews and meta-analysis in this area. Overall, this COS will allow for improved treatments to be identified, heterogeneity in research to be reduced, and overall patient care to be enhanced.

trial registrationThis study is registered in the Core Outcome Measures for Effectiveness (COMET) database http://www.comet-initiative.org/Studies/Details/1270 .

Indexed as

Brain DiseasesResearch DesignDelphi TechniqueHumansInfant, NewbornMeta-Analysis as TopicOutcome Assessment, Health CareSystematic Reviews as TopicTreatment OutcomeCore outcome setDelphiHigh-income countriesLow- to middle-income countriesNeonatal encephalopathyOutcomesPPIReal-time Delphi

Identifiers

PMID33557892
PMCPMC7871638
OpenAlexW3128899558

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.