Evidence map›Paper›PMID 28358380›Full record

Trial reportJournal of perinatology : official journal of the California Perinatal Association2017

Permission form synopses to improve parents' understanding of research: a randomized trial.

C T D'Angio, H Wang, J E Hunn, G S Pryhuber, P R Chess, S Lakshminrusimha

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. Can we make informed consent forms more informative?Archives of disease in childhood. Fetal and neonatal edition · 2018
    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

6 authors.

C T D'AngioDepartment of Pediatrics, University of Rochester Medical Center, Golisano Children's Hospital, Rochester, NY, USA.
H WangDepartment of Biostatistics, University of Rochester, Rochester, NY, USA.
J E HunnDepartment of Pediatrics, University of Rochester Medical Center, Golisano Children's Hospital, Rochester, NY, USA.
G S PryhuberDepartment of Pediatrics, University of Rochester Medical Center, Golisano Children's Hospital, Rochester, NY, USA.
P R ChessDepartment of Pediatrics, University of Rochester Medical Center, Golisano Children's Hospital, Rochester, NY, USA.
S LakshminrusimhaDepartment of Pediatrics, University at Buffalo, Buffalo, NY, USA.

Funding

NICHD Neonatal Research NetworkUG1HD027851 · NICHD · EMORY UNIVERSITY · PI Ravi Mangal Patel · 2016 to 2026
$3.0M
Rochester-Buffalo Neonatal Research GroupUG1HD068263 · NICHD · UNIVERSITY OF ROCHESTER · PI BLISS, JOSEPH MARK · 2016 to 2024
$1.6M
Rochester-Buffalo Neonatal Research GroupU10HD068263 · NICHD · UNIVERSITY OF ROCHESTER · PI D'ANGIO, CARL T. · 2011 to 2015
$1.4M
NICHD NIH HHS U10 HD068263NICHD NIH HHS UG1 HD027851NICHD NIH HHS UG1 HD068263
6 · The paper itself

Abstract

objectiveWe hypothesized that, among parents of potential neonatal research subjects, an accompanying cover sheet added to the permission form (intervention) would increase understanding of the research, when compared to a standard form (control). STUDY

designThis pilot study enrolled parents approached for one of two index studies: one randomized trial and one observational study. A one-page cover sheet described critical study information. Families were randomized 1:1 to receive the cover sheet or not. Objective and subjective understanding and satisfaction were measured.

resultsThirty-two parents completed all measures (17 control, 15 intervention). There were no differences in comprehension score (16.8±5.7 vs 16.3±3.5), subjective understanding (median 6 vs 6.5), or overall satisfaction with consent (median 7 vs 6.5) between control and intervention groups (all P>0.50).

conclusionA simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited.

Indexed as

ComprehensionHealth Knowledge, Attitudes, PracticeAdultFemaleHumansInfant, NewbornLinear ModelsMaleMultivariate AnalysisNew YorkParental ConsentPilot ProjectsResearchSingle-Blind MethodYoung Adult

Identifiers

PMID28358380
PMCPMC5446277

What OpenQuestion holds

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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.