Friederike Book1, Jan Goedeke1, Alicia Poplawski2, Oliver J Muensterer3. 1. Department of Pediatric Surgery, University Medicine of the Johannes Gutenberg University, Mainz, Germany. 2. IMBEI Institute of Medical Biostatistics, Epidemiology and Informatics University Medicine of the Johannes Gutenberg University, Mainz, Germany. 3. Department of Pediatric Surgery, University Medicine of the Johannes Gutenberg University, Mainz, Germany. Electronic address: oliver.muensterer@unimedizin-mainz.de.
Abstract
BACKGROUND: There is limited time within the clinical workflow of most pediatric surgeons to obtain a comprehensive, well informed consent. This study evaluates whether ad-lib access to an online video on the consent dialogue enhances the consent process for inguinal hernia repair (IHR) in children. METHODS: The study was approved by the state ethics board. A 6-min video of a consent speech on IHR was produced and uploaded to a nonpublic online channel, explaining the condition, procedure, complications, and postoperative expectations. A total of 50 families were randomized to conventional, face-to-face consenting in clinic either with (intervention) or without (control) access to the online video. During their child's IHR, the parents were asked to complete the State-Trait-Anxiety Inventory (STAI), a modified Friedlander questionnaire on assessing knowledge sufficient to provide informed consent, and a validated satisfaction survey. Scores of the intervention and control group were statistically compared. RESULTS: The intervention group demonstrated significantly decreased anxiety measured with the STAI (p = 0,026) and increased knowledge (p = 0,016) compared to controls. There was no difference in satisfaction (p = 0,557). CONCLUSION: Preoperatively providing access to an online consent video regarding IHR reduces anxiety and enhances knowledge without altering satisfaction level. Adjunct online videos are a useful tool to enhance the consent process. TYPE OF STUDY: Prospective randomized controlled trial. LEVEL OF EVIDENCE: Level I.
RCT Entities:
BACKGROUND: There is limited time within the clinical workflow of most pediatric surgeons to obtain a comprehensive, well informed consent. This study evaluates whether ad-lib access to an online video on the consent dialogue enhances the consent process for inguinal hernia repair (IHR) in children. METHODS: The study was approved by the state ethics board. A 6-min video of a consent speech on IHR was produced and uploaded to a nonpublic online channel, explaining the condition, procedure, complications, and postoperative expectations. A total of 50 families were randomized to conventional, face-to-face consenting in clinic either with (intervention) or without (control) access to the online video. During their child's IHR, the parents were asked to complete the State-Trait-Anxiety Inventory (STAI), a modified Friedlander questionnaire on assessing knowledge sufficient to provide informed consent, and a validated satisfaction survey. Scores of the intervention and control group were statistically compared. RESULTS: The intervention group demonstrated significantly decreased anxiety measured with the STAI (p = 0,026) and increased knowledge (p = 0,016) compared to controls. There was no difference in satisfaction (p = 0,557). CONCLUSION: Preoperatively providing access to an online consent video regarding IHR reduces anxiety and enhances knowledge without altering satisfaction level. Adjunct online videos are a useful tool to enhance the consent process. TYPE OF STUDY: Prospective randomized controlled trial. LEVEL OF EVIDENCE: Level I.
Authors: Fabian Lunger; Florian Frank; Georgios Peros; Alexander Lunger; Raphael Vuille-Dit-Bille; Laura Guglielmetti; Stefan Breitenstein; Felix Grieder; Jan Ehlers; Christian Gingert Journal: BMJ Open Date: 2021-01-26 Impact factor: 2.692
Authors: Andrew Hu; Audra J Reiter; Rodrigo Gerardo; Nicholas J Skertich; Ruth Lewit; Muhammad Ghani; Amanda Witte; Hae-Sung Kang; Holden Richards; Bradley Perry; Yao Tian; Steven C Mehl; Andres Gonzalez; Nathan M Novotny; Jeffrey Haynes; Arturo Aranda; Irving J Zamora; Daniel Rhee; Elizabeth Fialkowski; Bethany J Slater; Kyle Van Arendonk; Ankush Gosain; Monica E Lopez; Mehul V Raval Journal: Surgery Date: 2022-05-20 Impact factor: 4.348