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A descriptive assessment of the informed consent document used by congenital cardiac surgery centres

Published online by Cambridge University Press:  04 December 2023

Kristal M. Hock*
Affiliation:
School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA Department of Pediatric Cardiology, Section of Cardiac Critical Care Medicine, University of Alabama at Birmingham, Birmingham, AL, USA
Katja Gist
Affiliation:
Department of Pediatrics, Cincinnati Children’s Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA
Pariya L. Fazeli
Affiliation:
School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA
Hayden J. Zaccagni
Affiliation:
Department of Pediatric Cardiology, Section of Cardiac Critical Care Medicine, University of Alabama at Birmingham, Birmingham, AL, USA
Robert A. Sorabella
Affiliation:
Department of Cardiovascular Surgery, University of Alabama at Birmingham, Birmingham, AL, USA
Patricia A. Patrician
Affiliation:
School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA
*
Corresponding author: Kristal M. Hock; Email: kristalhock@uabmc.edu

Abstract

Background:

Informed consent for surgery is a complex process particularly in paediatrics. Complexity increases with procedures such as CHD surgery. Regulatory agencies outline informed consent contents for surgery. We assessed and described CHD surgical informed consent contents through survey dissemination to paediatric CHD centres across United States of America.

Methods:

Publicly available email addresses for 125 paediatric cardiac clinicians at 70 CHD surgical centres were obtained. Nine-item de-identified survey assessing adherence to The Joint Commission informed consent standards was created and distributed via RedCap® 14 March, 2023. A follow-up email was sent 29 March, 2023. Survey link was closed 18 April, 2023.

Results:

Thirty-seven surveys were completed. Results showed informed consent documents were available in both paper (25, 68%) and electronic (3, 8%) format. When both (9, 24%) formats were available, decision on which format to use was based on centre protocols (1, 11%), clinician personal preference (3, 33%), procedure being performed (1, 11%), or other (4, 45%). Five (13%) centres’ informed consent documents were available only in English, with 32 (87%) centres also having a Spanish version. Review of informed consent documents demonstrated missing The Joint Commission elements including procedure specific risks, benefits, treatment alternatives, and expected outcomes.

Conclusions:

Informed consent for CHD surgery is a complex process with multiple factors involved. Majority of paediatric CHD surgical centres in the United States of America used a generic informed consent document which did not uniformly contain The Joint Commission specified information nor reflect time spent in discussion with families. Further research is needed on parental comprehension during the informed consent process.

Type
Original Article
Copyright
© The Author(s), 2023. Published by Cambridge University Press

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Footnotes

University of Alabama at Birmingham Institutional Review Board (IRB-3000010833 date 08 March 2023) waived informed consent.

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