Evidence map›Paper›PMID 35911667›Full record

ArticleJAMIA open2022

Katherine A Sward, Rene Enriquez, Jeri Burr, Julie Ozier, Megan Roebuck, Carrie Elliott, J Michael Dean

Abstract read
In one paragraph

Article in JAMIA open, 2022. 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. 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.

Katherine A SwardDepartment of Nursing, University of Utah, Salt Lake City, Utah, USA.
Rene EnriquezDepartment of Pediatrics, University of Utah, Salt Lake City, Utah, USA.
Jeri BurrDepartment of Pediatrics, University of Utah, Salt Lake City, Utah, USA.
Julie OzierHuman Research Protection Program, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Megan RoebuckDuke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA.
Carrie ElliottDuke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA.
J Michael DeanDepartment of Pediatrics, University of Utah, Salt Lake City, Utah, USA.

Funding

Utah Trial Innovation CenterU24TR001597 · NCATS · UNIVERSITY OF UTAH · PI DEAN, JONATHAN MICHAEL · 2016 to 2022
$39.6M
Utah Center for Clinical and Translational ScienceUL1TR002538 · NCATS · UNIVERSITY OF UTAH · PI HESS, RACHEL, MAJERSIK, JENNIFER JUHL · 2018 to 2022
$26.0M
NCATS NIH HHS U24 TR001597NCATS NIH HHS UL1 TR002538
6 · The paper itself

Abstract

Objective: To describe process innovations related to research informed consent documents, and development and formative evaluation of Materials and Methods: Analysis of Institutional Review Board workflows and documents, followed by process redesign, document redesign, and software development. Locally developed software leverages REDCap and LaTeX. A small-scale usability study was conducted. Results: Process innovations were combining document types, and conceptualizing 2-part informed consent documents: part 1 standardizing the study description and part 2 with local site verbiage. Discussion: The process changes were generally well accepted. The software implementation uncovered un-accounted for assumptions, and variability in IRB review workflow across centers. Technical modifications may be needed before widespread implementation. Conclusion: We demonstrated proof-of-concept of an approach to generate research consent documents that are consistent across sites in study description, but which allow for customization of local site verbiage. The

Indexed as

informed consentIRB (ethics committeesmulticenter studiesresearch)user-centered design

Identifiers

PMID35911667
PMCPMC9329658

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.