Evidence map›Paper›PMID 38259600›Full record

ArticleFrontiers in pediatrics2023

The neonatal adverse event severity scale: current status, a stakeholders' assessment, and future perspectives.

Karel Allegaert, Thomas Salaets, Kelly Wade, Mary A Short, Robert Ward, Kanwaljit Singh, Mark A Turner, Jonathan M Davis, Tamorah Lewis

Open access · goldAbstract read
In one paragraph

Article in Frontiers in pediatrics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
5.5field-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

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
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

9 authors at 7 institutions in 5 countries.

Karel AllegaertDepartment of Development and Regeneration, KU Leuven, Leuven, Belgium.
Thomas SalaetsDepartment of Development and Regeneration, KU Leuven, Leuven, Belgium.
Kelly WadeDepartment of Pediatrics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.
Mary A ShortInternational Neonatal Consortium, Communications Workgroup, Tucson, AZ, United States.
Robert WardDepartment of Pediatrics, University of Utah, Salt Lake City, UT, United States.
Kanwaljit SinghInternational Neonatal Consortium, Critical Path Institute, Tucson, AZ, United States.
Mark A TurnerInstitute of Lifecourse and Medical Sciences, University of Liverpool, Liverpool Health Partners, Liverpool, United Kingdom.
Jonathan M DavisDepartment of Pediatrics, Tufts Children's Hospital, Tufts University School of Medicine, Boston, MA, United States.
Tamorah LewisDepartment of Pediatrics, City School of Medicine, Kansas Children's Mercy Hospital, University of Missouri Kansas, Kansas City, MO, United States.
KU Leuven · BEChildren's Mercy Hospital · USCritical Path Institute · USTufts Children's Hospital · USUniversity of Liverpool · GBUniversity of Pennsylvania · USUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To support informed decisions on drug registration and prescription, clinical trials need tools to assess the efficacy and safety signals related to a given therapeutic intervention. Standardized assessment facilitates reproducibility of results. Furthermore, it enables weighted comparison between different interventions, instrumental to facilitate shared decisions. When focused on adverse events in clinical trials, tools are needed to assess seriousness, causality and severity. As part of such a toolbox, the international Neonatal Consortium (INC) developed a first version of the neonatal adverse event severity scale (NAESS). This version underwent subsequent validation in retro-and prospective trials to assess its applicability and impact on the inter-observer variability. Regulators, sponsors and academic researchers also reported on the use of the NAESS in regulatory documents, trial protocols and study reports. In this paper, we aim to report on the trajectory, current status and impact of the NAESS score, on how stakeholders within INC assess its relevance, and on perspectives to further develop this tool.

Indexed as

adverse eventclinical trialsdata standardsdrug developmentdrug safetyinfantnewborn

Identifiers

PMID38259600
PMCPMC10800487
OpenAlexW4390665485

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.