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

Objective: We 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 Design: This pilot study enrolled parents ap...

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Published inJournal of perinatology Vol. 37; no. 6; pp. 735 - 739
Main Authors D’Angio, C T, Wang, H, Hunn, J E, Pryhuber, G S, Chess, P R, Lakshminrusimha, S
Format Journal Article
LanguageEnglish
Published New York Nature Publishing Group US 01.06.2017
Nature Publishing Group
Subjects
692/308/409
706/648/179
Adult
Comprehension
Confidentiality
Design standards
Female
Health Knowledge, Attitudes, Practice
Humans
Infant, Newborn
Informed consent
Informed consent (Medical law)
Intervention
Legal documents
Linear Models
Male
Medicine
Medicine & Public Health
Multivariate Analysis
Neonatal intensive care
Neonates
New York
Observational studies
original-article
Parental Consent - psychology
Parents
Parents & parenting
Participation
Pediatric research
Pediatric Surgery
Pediatrics
Pilot Projects
Premature babies
Premature birth
Psychological aspects
Single-Blind Method
Young Adult
United States
Online AccessGet full text

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Abstract Objective: We 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 Design: This 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. Results: Thirty-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). Conclusion: A simplified permission form cover sheet had no effect on parents’ understanding of studies for which their newborns were being recruited.
AbstractList Objective: We 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 Design: This 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. Results: Thirty-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). Conclusion: A simplified permission form cover sheet had no effect on parents’ understanding of studies for which their newborns were being recruited.
Objective: We 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 Design:This 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. Results: Thirty-two parents completed all measures (17 control, 15 intervention). There were no differences in comprehension score (16.8 plus or minus 5.7 vs 16.3 plus or minus 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). Conclusion: A simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited.
Objective:We 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 Design:This 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.Results:Thirty-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).Conclusion:A simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited.
We 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).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).This 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.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.Thirty-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).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).A simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited.CONCLUSIONA simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited.
We 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). This 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. Thirty-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). A simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited.
We 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). This 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. Thirty-two parents completed all measures (17 control, 15 intervention). There were no differences in comprehension score (16.8[plus or minus]5.7 vs 16.3[plus or minus]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). A simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited.
Audience Academic
Author Wang, H
Hunn, J E
Lakshminrusimha, S
Pryhuber, G S
Chess, P R
D’Angio, C T
AuthorAffiliation 3 St. Francis Hospital and Medical Center, University of Connecticut, Hartford, CT, United States
1 Department of Pediatrics, University of Rochester, Rochester, NY, United States
4 Pediatrics, University at Buffalo, Buffalo, NY, United States
2 Department of Biostatistics, University of Rochester, Rochester, NY, United States
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/28358380$$D View this record in MEDLINE/PubMed
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CitedBy_id crossref_primary_10_1136_archdischild_2017_314126
crossref_primary_10_1080_03630242_2018_1553816
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SSID ssj0014767
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Snippet Objective: We hypothesized that, among parents of potential neonatal research subjects, an accompanying cover sheet added to the permission form (intervention)...
We hypothesized that, among parents of potential neonatal research subjects, an accompanying cover sheet added to the permission form (intervention) would...
Objective: We hypothesized that, among parents of potential neonatal research subjects, an accompanying cover sheet added to the permission form (intervention)...
Objective:We hypothesized that, among parents of potential neonatal research subjects, an accompanying cover sheet added to the permission form (intervention)...
SourceID pubmedcentral
proquest
gale
pubmed
crossref
springer
SourceType Open Access Repository
Aggregation Database
Index Database
Enrichment Source
Publisher
StartPage 735
SubjectTerms 692/308/409
706/648/179
Adult
Comprehension
Confidentiality
Design standards
Female
Health Knowledge, Attitudes, Practice
Humans
Infant, Newborn
Informed consent
Informed consent (Medical law)
Intervention
Legal documents
Linear Models
Male
Medicine
Medicine & Public Health
Multivariate Analysis
Neonatal intensive care
Neonates
New York
Observational studies
original-article
Parental Consent - psychology
Parents
Parents & parenting
Participation
Pediatric research
Pediatric Surgery
Pediatrics
Pilot Projects
Premature babies
Premature birth
Psychological aspects
Single-Blind Method
Young Adult
Title Permission form synopses to improve parents’ understanding of research: a randomized trial
URI https://link.springer.com/article/10.1038/jp.2017.26
https://www.ncbi.nlm.nih.gov/pubmed/28358380
https://www.proquest.com/docview/1902452716
https://www.proquest.com/docview/2615529838
https://www.proquest.com/docview/1882501317
https://www.proquest.com/docview/1906454498
https://pubmed.ncbi.nlm.nih.gov/PMC5446277
Volume 37
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