First use of a video to assist the informed consent process in a randomized controlled trial in Japan

1997 ◽  
Vol 2 (3) ◽  
pp. 156-160 ◽  
Author(s):  
Nobuyuki Hamajima ◽  
Keyword(s):  
Randomized Controlled Trial ◽  
Informed Consent ◽  
Controlled Trial ◽  
Informed Consent Process ◽  
Consent Process ◽  
Randomized Controlled

scholarly journals A Randomized Controlled Trial of an Electronic Informed Consent Process

2014 ◽  
Vol 9 (5) ◽  
pp. 1-7 ◽  
Author(s):  
Erin Rothwell ◽  
Bob Wong ◽  
Nancy C. Rose ◽  
Rebecca Anderson ◽  
Beth Fedor ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Informed Consent ◽  
Controlled Trial ◽  
Informed Consent Process ◽  
Consent Process ◽  
Randomized Controlled

scholarly journals A parental educational intervention to facilitate informed consent for pediatric procedural sedation in the emergency department: a parallel group randomized controlled trial

2020 ◽  
Author(s):  
Yen-Ko Lin ◽  
Yung-Sung Yeh ◽  
Chao-Wen Chen ◽  
Wei-Che Lee ◽  
Chia-Ju Lin ◽  
...  
Keyword(s):  
Emergency Department ◽  
Informed Consent ◽  
Controlled Trial ◽  
Intervention Group ◽  
Informed Consent Process ◽  
Consent Process ◽  
Procedural Sedation ◽  
Control Group ◽  
Randomized Controlled ◽  
Video Assisted

Abstract Background Obtaining valid parental informed consent for pediatric procedures in the emergency department (ED) is challenging. This study compared a video-assisted informed consent intervention with conventional consent discussion to inform parents about pediatric procedural sedation in the ED. Methods A video-assisted informed consent intervention was developed to explain the process, benefits, risks, and alternatives of pediatric procedural sedation. A prospective randomized controlled trial was conducted with a convenience sample of parents of children recommended for procedural sedation for facial laceration in the ED. Intervention group participants watched the video. Control group participants received information from physicians during conventional discussion. Participants completed pre- and post-education knowledge tests and rated their satisfaction with the informed consent process. The primary outcome was efficacy of the video intervention compared with conventional discussion. Secondary outcomes were parental satisfaction and consent refusal. A covariate-controlled multivariable regression model was used to analyze between-group differences in knowledge and satisfaction. Results There were 32 participants in the intervention group and 30 in the control group. Mean knowledge scores were higher in the intervention group (91.67 ± [standard deviation] 12.70) than in the control group (73.33 ± 19.86). The intervention group showed significantly greater knowledge score differences (coefficient: 18.931, 95% confidence interval: 11.146–26.716). Intervention group participants showed greater satisfaction than control group participants. Conclusions Video-assisted informed consent was superior to conventional discussion for informing parents during an ED informed consent process. Video-assisted informed consent may improve parents’ understanding of pediatric procedural sedation and satisfaction with the informed consent process in the ED. Institutions should develop structured methods and strategies to better inform parents, facilitate treatment decisions, and improve parent satisfaction in the ED. Trial registration: The ClinicalTrials.gov Identifier is NCT01850329. Registered 9 May, 2013 - Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/study/NCT01850329

scholarly journals Using media to improve the informed consent process for youth undergoing pediatric endoscopy and their parents

2017 ◽  
Vol 05 (01) ◽  
pp. E41-E46 ◽  
Author(s):  
Debra Yeh ◽  
Stanford Chun ◽  
Laura Terrones ◽  
Jeannie Huang
Keyword(s):  
Randomized Controlled Trial ◽  
Informed Consent ◽  
Controlled Trial ◽  
Informed Consent Process ◽  
Structured Interviews ◽  
Endoscopic Procedures ◽  
Video Intervention ◽  
Randomized Controlled ◽  
Pediatric Endoscopy ◽  
Media Intervention

Abstract Background and study aims Youth undergoing pediatric endoscopic procedures and their parents demonstrate suboptimal comprehension of the informed consent (IC) process. We developed informational videos discussing key IC elements for pediatric endoscopy and evaluated their effects on youth and parental comprehension of the IC process. Patients and methods A randomized controlled trial of the video intervention was performed among youth undergoing endoscopy and their parents at an academic children’s hospital. Randomization occurred at the time of enrollment using permutated blocks. Following the IC process with the proceduralist, subjects underwent structured interviews to assess IC comprehension. An Informed Consent Overall Score (ICOS: range 0 – 4) for comprehension was calculated. Results Seventy-seven pairs of children and their parents participated. Intervention recipients (N = 37 pairs) demonstrated higher ICOS scores as compared to control counterparts (mean (standard deviation): 3.6 (0.7) v. 2.9 (0.9), intervention v. control parents, P < 0.0001 and 2.7 (1.1) v. 1.7 (1.1), intervention v. control youth, P < 0.0001). Conclusions A media intervention addressing key elements of the IC process for pediatric endoscopy was effective in improving comprehension of IC for youth undergoing endoscopic procedures and their parents.

scholarly journals A randomized controlled trial comparing video-assisted informed consent with standard consent for Mohs micrographic surgery

2020 ◽  
Vol 1 (1) ◽  
pp. 13-20
Author(s):  
Yueyue Miao ◽  
Victoria L. Venning ◽  
Kylie-Ann Mallitt ◽  
Julia E.J. Rhodes ◽  
Noah J. Isserman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Informed Consent ◽  
Controlled Trial ◽  
Mohs Micrographic Surgery ◽  
Micrographic Surgery ◽  
Randomized Controlled ◽  
Video Assisted
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