Permission form synopses to improve parents’ understanding of research: a randomized trial
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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. Access through your institution Buy or subscribe This is a
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PERSPECTIVES ON A TRIAL USING WAIVED INFORMED CONSENT AT BIRTH Article 21 December 2023 EXPERIENCES AND PREFERENCES FOR LEARNING ABOUT NEONATAL RESEARCH: INSIGHTS FROM PARENT INTERVIEWS
Article 25 November 2023 INTEGRATING PARENT VOICES INTO RESEARCH AT THE EXTREMES OF PREMATURITY: WHAT ARE WE DOING AND WHERE SHOULD WE GO? Article Open access 15 November 2024 REFERENCES *
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ACKNOWLEDGEMENTS This research was supported in part by NICHD Bioethics Supplement 3U10HD068263-01S1, and is listed on clinicaltrials.gov, NCT01704560. We wish to thank the study
coordinators, Elizabeth Werner, MPH, Tanya Scalise, RN, BSN, and Deanna Maffett, RN, the neonatal faculty and fellows and Christine Trahms, BS for their help. We thank the ‘Randomized
Controlled Trial of the Effect Of Hydrocortisone on Survival Without Bronchopulmonary Dysplasia and on Neurodevelopmental Outcomes at 22–26 Months of Age in Intubated Infants <30 Weeks
Gestation Age’ (‘Hydrocortisone’) subcommittee of the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s Neonatal Research Network (NRN), which agreed to the
use of the modified consent forms. We similarly thank the Rochester center investigators of the National Heart Lung and Blood Institute’s Prematurity and Respiratory Outcome Program (PROP)
for allowing modified consent forms. We also thank the families who agreed to participate, without whom the work would not have been possible. AUTHOR INFORMATION AUTHORS AND AFFILIATIONS *
Department of Pediatrics, University of Rochester Medical Center, Golisano Children’s Hospital, Rochester, NY, USA C T D’Angio, J E Hunn, G S Pryhuber & P R Chess * Department of
Biostatistics, University of Rochester, Rochester, NY, USA H Wang * St Francis Hospital and Medical Center, University of Connecticut, Hartford, CT, USA J E Hunn * Department of Pediatrics,
University at Buffalo, Buffalo, NY, USA S Lakshminrusimha Authors * C T D’Angio View author publications You can also search for this author inPubMed Google Scholar * H Wang View author
publications You can also search for this author inPubMed Google Scholar * J E Hunn View author publications You can also search for this author inPubMed Google Scholar * G S Pryhuber View
author publications You can also search for this author inPubMed Google Scholar * P R Chess View author publications You can also search for this author inPubMed Google Scholar * S
Lakshminrusimha View author publications You can also search for this author inPubMed Google Scholar CORRESPONDING AUTHOR Correspondence to C T D’Angio. ETHICS DECLARATIONS COMPETING
INTERESTS The authors declare no conflict of interest. ADDITIONAL INFORMATION Supplementary Information accompanies the paper on the _Journal of Perinatology_ website SUPPLEMENTARY
INFORMATION SUPPLEMENTARY FIGURE 1 (PDF 140 KB) SUPPLEMENTARY FIGURE 2 (PDF 92 KB) SUPPLEMENTARY FIGURE 3 (PDF 174 KB) SUPPLEMENTARY FIGURE 4 (PDF 201 KB) RIGHTS AND PERMISSIONS Reprints and
permissions ABOUT THIS ARTICLE CITE THIS ARTICLE D’Angio, C., Wang, H., Hunn, J. _et al._ Permission form synopses to improve parents’ understanding of research: a randomized trial. _J
Perinatol_ 37, 735–739 (2017). https://doi.org/10.1038/jp.2017.26 Download citation * Received: 22 August 2016 * Revised: 17 January 2017 * Accepted: 19 January 2017 * Published: 30 March
2017 * Issue Date: June 2017 * DOI: https://doi.org/10.1038/jp.2017.26 SHARE THIS ARTICLE Anyone you share the following link with will be able to read this content: Get shareable link
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