Evidence map›Paper›PMID 29967521›Full record

ArticlePediatric research2018

Assessment of a shortened informed consent form for pediatric research: a pilot study.

Peter D Murray, Barbara E Bierer, Steven Hirschfeld, Andreas K Klein, Jonathan M Davis

Abstract read
PubMed Publisher
In one paragraph

Article in Pediatric research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Minimal Effect of Messaging on Engagement in a Digital Anxiety Intervention.Professional psychology, research and practice · 2023
    Article
  3. Article
  4. Article
  5. 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

5 authors.

Peter D MurrayThe Department of Pediatrics, Floating Hospital for Children at Tufts Medical Center, Boston, MA, USA. PM7DN@hscmail.mcc.virginia.edu.
Barbara E BiererHarvard Catalyst, The Harvard Clinical and Translational Science Center, Boston, MA, USA.
Steven HirschfeldDepartment of Defense, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.
Andreas K KleinThe Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA.
Jonathan M DavisThe Department of Pediatrics, Floating Hospital for Children at Tufts Medical Center, Boston, MA, USA.

Funding

Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
Tufts Clinical and Translational Research InstituteUL1TR001064 · NCATS · TUFTS UNIVERSITY BOSTON · PI SELKER, HARRY P. · 2013 to 2017
$26.4M
Phase 2 Study of rhCC10 to Prevent Neonatal Bronchopulmonary DysplasiaR01FD003899 · FDA · TUFTS MEDICAL CENTER · PI DAVIS, JONATHAN M. · 2013 to 2016
$1.6M
FDA HHS R01 FD003899NCATS NIH HHS UL1 TR001064
6 · The paper itself

Abstract

backgroundInherent to clinical research is the informed consent process, with the informed consent form (ICF), a key component of human participant protections. We wished to examine whether a shortened and simplified ICF, accompanied by an appendix, improved participant understanding of a study compared with a conventional ICF.

methodsA shortened ICF was developed from an existing conventional ICF for a neonatal study. Either the shortened or conventional ICF was randomly distributed to members of two parental advocacy groups. Participants answered survey questions about the form they received.

resultsThirty-one out of forty-one (76%) parents in the shortened ICF and 28/41 (68%) in the conventional ICF group responded. Significantly more parents in the shortened ICF group found their form "short and to the point". Although they also stated that the shortened ICF did not provide enough information, there were no significant differences between groups measuring the understanding of key study components.

conclusionA shortened ICF did not impact the understanding of the clinical trial. It will be important to compare the shortened and conventional forms in actual clinical trials.

Indexed as

Informed ConsentBiomedical ResearchChildClinical Trials as TopicComprehensionConsent FormsDecision MakingHumansInfant, NewbornLanguageLiteracyParentsPediatricsPilot ProjectsSurveys and Questionnaires

Identifiers

PMID29967521

What OpenQuestion holds

Textmetadata
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.