Evidence map›Paper›PMID 35617960›Full record

Trial reportAmerican journal of perinatology2024

Video-Assisted Informed Consent in a Clinical Trial of Resuscitation of Extremely Preterm Infants: Lessons Learned.

Namrita J Odackal, Catherine G Caruso, Melissa Klitzman, Monica Rincon, Bobbi J Byrne, Jameel Winter, Gina R Petroni, Karen D Fairchild, Jamie B Warren

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in American journal of perinatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Trial
  2. Article
  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

9 authors.

Namrita J OdackalDepartment of Neonatology, North Denver Envision Group, Arvada, Colorado.ORCID 0000-0003-3680-7722
Catherine G CarusoDepartment of Pediatrics, Oregon Health and Science University, Portland, Oregon.ORCID 0000-0002-5526-0366
Melissa KlitzmanDivision of Neonatal-Perinatal Medicine, Indiana University School of Medicine, Indianapolis, Indiana.
Monica RinconDepartment of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon.
Bobbi J ByrneDivision of Neonatal-Perinatal Medicine, Indiana University School of Medicine, Indianapolis, Indiana.
Jameel WinterDivision of Neonatology, University of Minnesota Medical School, Minneapolis, Minnesota.ORCID 0000-0002-9143-8483
Gina R PetroniDepartment of Public Health Sciences, University of Virginia, Charlottesville, Virginia.
Karen D FairchildDivision of Neonatology, University of Virginia School of Medicine, Charlottesville, Virginia.
Jamie B WarrenDepartment of Pediatrics, Oregon Health and Science University, Portland, Oregon.

Funding

VentFirst: A multicenter RCT of assisted ventilation during delayed cord clamping for extremely preterm infantsR01HD087413 · NICHD · UNIVERSITY OF VIRGINIA · PI FAIRCHILD, KAREN D, KATTWINKEL, JOHN · 2016 to 2021
$3.2M
NICHD NIH HHS R01 HD087413
6 · The paper itself

Abstract

objectiveObtaining informed consent for clinical trials is challenging in acute clinical settings. For the VentFirst randomized clinical trial (assisting ventilation during delayed cord clamping for infants <29 weeks' gestation), we created an informational video that sites could choose to use to supplement the standard in-person verbal and written consent. Using a postconsent survey, we sought to describe the impact of the video on patient recruitment, satisfaction with the consent process, and knowledge about the study. STUDY

designThis is a descriptive survey-based substudy.

resultsOf the sites participating in the VentFirst trial that obtained institutional review board (IRB) approval to allow use of the video to supplement the standard informed consent process, three elected to participate in the survey substudy. From February 2018 to January 2021, 82 women at these three sites were offered the video and completed the postconsent survey. Overall, 73 of these 82 women (89%) consented to participate in the primary study, 78 (95%) indicated the study was explained to them very well or extremely well, and the range of correct answers on five knowledge questions about the study was 63 to 98%. Forty-six (56%) of the 82 women offered the video chose to watch it. There were no major differences in study participation, satisfaction with the consent process, or knowledge about the study between the women who chose to watch or not watch the video.

conclusionWatching an optional video to supplement the standard informed consent process did not have a major impact on outcomes in this small substudy. The ways in which audiovisual tools might modify the traditional informed consent process deserve further study. KEY POINTS: · Informed consent in acute clinical contexts is difficult.. · Videos offer an alternative communication tool.. · Continued research is necessary to optimize the consent process..

Indexed as

Infant, Extremely PrematureInformed ConsentResuscitationVideo RecordingAdultFemaleHumansInfant, NewbornSurveys and Questionnaires

Identifiers

PMID35617960
PMCPMC11112601

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.