Evidence map›Paper›PMID 37259112›Full record

ArticleTrials2023

Development of an international core outcome set for treatment trials in necrotizing enterocolitis-a study protocol.

Daphne H Klerk, Otis C van Varsseveld, Martin Offringa, Neena Modi, Martin Lacher, Augusto Zani, Mikko P Pakarinen, Antti Koivusalo, Ingo Jester, Marie Spruce and 6 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
6.4field-weighted citation impact, top 4% 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

5 citing papers in PubMed, 11 citations in OpenAlex.

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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

16 authors at 9 institutions in 6 countries.

Daphne H KlerkDivision of Neonatology, Beatrix Children's Hospital, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands. d.h.klerk@umcg.nl.ORCID http://orcid.org/0000-0002-0994-2120
Otis C van VarsseveldDepartment of Surgery, Division of Paediatric Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Martin OffringaDivision of Neonatology, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
Neena ModiSection of Neonatal Medicine, School of Public Health, Chelsea and Westminster Hospital campus, Imperial College London, London, UK.
Martin LacherDepartment of Paediatric Surgery, University Hospital Leipzig, University of Leipzig, Leipzig, Germany.
Augusto ZaniDepartment of General and Thoracic Surgery, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
Mikko P PakarinenDepartment of Paediatric Surgery, Children's Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.
Antti KoivusaloDepartment of Paediatric Surgery, Children's Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.
Ingo JesterDepartments of Paediatric Surgery, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK.
Marie SpruceNEC UK Charity, Nottingham, UK.
Joep P M DerikxDepartment of Paediatric Surgery, UMC, Emma Children's Hospital, Amsterdam, University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
Roel BakxDepartment of Paediatric Surgery, UMC, Emma Children's Hospital, Amsterdam, University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
Amine KsiaDepartment of Surgery, Department of Paediatric Surgery, Monastir Medical School, Fattouma Bourguiba Hospital, Monastir University, Monastir, Tunisia.
Marijn J VermeulenCare4Neo, Neonatal Patient and Parent Organization, Rotterdam, the Netherlands.
Elisabeth M W KooiDivision of Neonatology, Beatrix Children's Hospital, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Jan B F HulscherDepartment of Surgery, Division of Paediatric Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
University Medical Center Groningen · NLEmma Kinderziekenhuis · NLUniversity of Helsinki · FIUniversity of Toronto · CABirmingham Women’s and Children’s NHS Foundation Trust · GBChelsea and Westminster Hospital · GBErasmus MC · NLHospital Fatuma Bourguiba Monastir · TNUniversity Hospital Leipzig · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimNecrotizing enterocolitis (NEC) is the most lethal disease of the gastrointestinal tract of preterm infants. New and existing management strategies need clinical evaluation. Large heterogeneity exists in the selection, measurement, and reporting of outcome measures in NEC intervention studies. This hampers meta-analyses and the development of evidence-based management guidelines. We aim to develop a Core Outcome Set (COS) for NEC that includes the most relevant outcomes for patients and physicians, from moment of diagnosis into adulthood. This COS is designed for use in NEC treatment trials, in infants with confirmed NEC.

methodsThis study is designed according to COS-STAD (Core Outcome Set-STAndards for Development) recommendations and the COMET (Core Outcome Measures in Effectiveness Trials) Initiative Handbook. We obtained a waiver from the Ethics Review Board and prospectively registered this study with COMET (Study 1920). We will approach 125 clinicians and/or researchers from low-middle and high-income countries based on their scientific output (using SCIVAL, a bibliometric tool). Patients and parents will be approached through local patient organisations. Participants will be separated into three panels, to assess differences in priorities between former patients and parents (1. lay panel), clinicians and researchers involved in the neonatal period (2. neonatal panel) and after the neonatal period (3. post-neonatal panel). They will be presented with outcomes currently used in NEC research, identified through a systematic review, in a Delphi process. Eligible outcome domains are also identified from the patients and parents' perspectives. Using a consensus process, including three online Delphi rounds and a final face-to-face consensus meeting, the COS will be finalised and include outcomes deemed essential to all stakeholders: health care professionals, parents and patients' representatives. The final COS will be reported in accordance with the COS-Standards for reporting (COS-STAR) statement.

conclusionsDevelopment of an international COS will help to improve homogeneity of outcome measure reporting in NEC, will enable adequate and efficient comparison of treatment strategies, and will help the interpretation and implementation of clinical trial results. This will contribute to high-quality evidence regarding the best treatment strategy for NEC in preterm infants.

Indexed as

Enterocolitis, NecrotizingInfant, Newborn, DiseasesDelphi TechniqueEndpoint DeterminationHumansInfant, NewbornInfant, PrematureOutcome Assessment, Health CareResearch DesignSystematic Reviews as TopicTreatment OutcomeChildrenConsensus meetingCore OutcomesCore Outcome SetDelphiNecrotizing enterocolitisPreterm

Identifiers

PMID37259112
PMCPMC10230797
OpenAlexW4378904737

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.