Permission form synopses to improve parents' understanding of research: A randomized trial

C. T. D'Angio, H. Wang, J. E. Hunn, G. S. Pryhuber, P. R. Chess, Satyanarayana Lakshminrusimha

Research output: Contribution to journalArticle

1 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)735-739
Number of pages5
JournalJournal of Perinatology
Volume37
Issue number6
DOIs
StatePublished - Jun 1 2017
Externally publishedYes

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Obstetrics and Gynecology

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