Evidence map›Paper›PMID 36691692›Full record

Trial reportEthics & human research2023

Factors That Impact Hospital-Specific Enrollment Rates for a Neonatal Clinical Trial: An Analysis of the HEAL Study.

Katherine F Guttmann, Sijia Li, Yvonne W Wu, Sandra E Juul, Benjamin S Wilfond, Elliott Mark Weiss, HEAL Recruitment Collaborative

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Ethics & human research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.6field-weighted citation impact, top 11% 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

7 citing papers in PubMed, 13 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Experiences and preferences for learning about neonatal research: insights from parent interviews.Journal of perinatology : official journal of the California Perinatal Association · 2024
    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

7 authors at 5 institutions in 2 countries.

Katherine F GuttmannAssistant professor in the Department of Pediatrics at the Icahn School of Medicine at Mount Sinai.
Sijia LiDoctoral student in the Department of Biostatistics at the University of Washington School of Public Health.
Yvonne W WuProfessor of neurology and pediatrics in the Departments of Neurology and Pediatrics at the University of California San Francisco School of Medicine.
Sandra E JuulProfessor in the Department of Pediatrics at the University of Washington School of Medicine.
Benjamin S WilfondProfessor in the Department of Pediatrics at the University of Washington School of Medicine and Treuman Katz Center for Pediatric Bioethics at the Seattle Children's Research Institute.
Elliott Mark WeissAssociate professor at the University of Washington School of Medicine and Treuman Katz Center for Pediatric Bioethics at the Seattle Children's Research Institute.
HEAL Recruitment CollaborativeMembership of the HEAL Recruitment Collaborative consists of Kaashif Ahmad, Uchenna E. Anani, Laura Bledsoe, Taeun Chang, Leah Engelstad, John B. Feltner, Fernando F. Gonzalez, Katherine F. Guttmann, Erin M. Havrilla, John Ibrahim, Sandra E. Juul, Sijia Li, Elizabeth N. Reichert, David Riley, Elliott Mark Weiss, Benjamin S. Wilfond, Tai-Wei Wu, Yvonne W. Wu, and Toby Debra Yanowitz.
Seattle Children's Hospital · USUniversity of Washington · USAselsan (Turkey) · TRIcahn School of Medicine at Mount Sinai · USUniversity of California, San Francisco · US

Funding

Improving Diversity in Neonatal Clinical Trial EnrollmentK23HD103872 · NICHD · SEATTLE CHILDREN'S HOSPITAL · PI WEISS, ELLIOTT M · 2021 to 2025
$804k
Eunice Kennedy Shriver National Institute of Child Health and Human Development K23HD103872NICHD NIH HHS K23 HD103872Treuman Katz Incubator Fund from the Treuman Katz Center for Pediatric Bioethics at Seattle Children's Research Institute
6 · The paper itself

Abstract

Inconsistent enrollment among hospitals for neonatal clinical trials may lead to study populations that are not representative of the patient population in the neonatal intensive care unit. The High-Dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial was a multisite randomized clinical trial investigating erythropoietin as a neuroprotective treatment for term infants (those born between 37 and 42 complete weeks) with hypoxic ischemic encephalopathy. Substantial variability was noted in enrollment rate by hospital. We developed survey questions across five conceptual domains to understand systems-level issues that might contribute to variation in enrollment rate by hospital. Our study found that hospitals varied in their responses across these five domains. We propose three potential reasons that we found a lack of identifiable hospital-level factors that correlated with enrollment rates: sample-size limitations, methodological concerns, and confounding factors. Future studies with a larger sample size should be considered to evaluate contributors to hospital-level variability. This will lead to more robust recruitment strategies, improved enrollment, and decreases in the waste of research resources.

Indexed as

ErythropoietinHypoxia-Ischemia, BrainAsphyxiaEpoetin AlfaHumansInfantInfant, NewbornIntensive Care Units, NeonatalNeuroprotectionEpoetin AlfaErythropoietinclinical trialclinical trial recruitmentclinical trials enrollmentHEAL studyhuman research ethicsneonatal clinical trials

Identifiers

PMID36691692
PMCPMC9969810
OpenAlexW4317871053

What OpenQuestion holds

Textmetadata
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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.