Evidence map›Paper›PMID 38401783›Full record

ArticleThe Journal of pediatrics2024

Measuring Clinical Benefit in Neonatal Randomized Clinical Trials: Challenges and Opportunities.

An N Massaro, Beth Boyer, Mira Gill, Dure Kim, Matthew Laughon, Michele Walsh, Monica E Lemmon, Betsy Pilon, Gerri Baer, Duke-Margolis/FDA Measuring Clinical Benefit in Neonatal RCTs Workshop Participants

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Journal of pediatrics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Observational
  3. 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

10 authors.

An N MassaroOffice of Pediatric Therapeutics, Office of the Commisioner, US FDA, Silver Spring, MD. Electronic address: an.massaro@fda.hhs.gov.
Beth BoyerDuke-Margolis Center for Health Policy, Washington, DC.
Mira GillDuke-Margolis Center for Health Policy, Washington, DC.
Dure KimDuke-Margolis Center for Health Policy, Washington, DC.
Matthew LaughonDepartment of Pediatrics, The University of North Carolina at Chapel Hill, Chapel Hill, NC.
Michele WalshEunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, Bethesda, MD.
Monica E LemmonDuke-Margolis Center for Health Policy, Washington, DC; Departments of Pediatrics and Population Health Sciences, Duke University School of Medicine, Durham, NC.
Betsy PilonHope for HIE, West Bloomfield, MI.
Gerri BaerOffice of Pediatric Therapeutics, Office of the Commisioner, US FDA, Silver Spring, MD.
Duke-Margolis/FDA Measuring Clinical Benefit in Neonatal RCTs Workshop Participants

Funding

Cooperative Agreement to Support Regulatory Research Related to the 2022 Prescription Drug User Fee Act and Biosimilar User Fee Act (U19)U19FD006602 · FDA · DUKE UNIVERSITY · PI Marianne Hamilton Lopez · 2018 to 2026
$8.2M
FDA HHS U19 FD006602
6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Indexed as

Randomized Controlled Trials as TopicHumansInfant, NewbornResearch Design

Identifiers

PMID38401783
PMCPMC11181158

What OpenQuestion holds

Textmetadata
LicenceTDM
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.