Affiliation:
1. Department of Urology and Pediatric Urology, Mainz University Medical Center
2. Department of Urology, Faculty of Health Sciences Brandenburg, Brandenburg Medical School Theodor Fontane, Germany
Abstract
Abstract
Introduction: Due to a lack of time and staff, informed consent (IC) in clinical practice often lacks clarity, comprehensibility and scope of information. Digital media offer great potential to enhance IC, but are still too rarely used. Aim of this study is to evaluate the effectiveness of multimedia-supported compared to traditional paper-based IC.
Methods: In the randomized, controlled, three-arm DICon (Digital Informed Consent for urological surgery) study 70 patients with an indication for prostate biopsy were randomized 1:1:1 to receive traditional paper-based IC vs. multimedia-supported information before IC vs. multimedia-supported information during IC. Patient satisfaction, anxiety and information gain were measured by validated questionnaires 2 weeks and directly before the procedure and time efficiency was recorded. Statistical analysis was performed using Kruskal-Wallis and Dunn's test (one-way ANOVA) and two-way ANOVA (with bonferroni post-test).
Results: Multimedia information prior to the consultation saved 32.9% time compared to paper-based (5.3 min. vs. 9.5 min; p<0.05) and 60.4% time compared to shared multimedia information (5.3 min. vs. 13.9 min.; p<0.001), with no difference in satisfaction (62.6 vs. 62.7 vs. 68.6 of max. 80; p=0.07), anxiety (8 vs. 8.1 vs. 7 of max. 16; p=0.35), or information gain (6.5 vs. 5.7 vs. 6.7 of max. 10; p=0.23). Results on satisfaction (56.6 vs. 62.6 vs. 66; p=0.06), anxiety (7.2 vs. 7.2 vs. 6.8; p=0.84), and information gain (7 vs. 6.4 vs. 5.9; p=0.43) remained stable over time.
Conclusions: Multimedia-supported IC provided improved time efficiency (33% gain) compared to traditional paper-based IC, with comparable satisfaction, anxiety and information gain. Multimedia-supported information materials should therefore be used more frequently in patient education.
Publisher
Research Square Platform LLC
Reference32 articles.
1. Aufklärungspflichten. Bürgerliches Gesetzbuch. Sect. Buch 2 - Recht der Schuldverhältnisse (§§ 241–853), Abschnitt 8 - Einzelne Schuldverhältnisse (§§ 433–853), Titel 8 - Dienstvertrag und ähnliche Verträge (§§ 611–630h), Untertitel 2 - Behandlungsvertrag (§§ 630a – 630h).
2. Improving informed consent of surgical patients using a multimedia-based program? Results of a prospective randomized multicenter study of patients before cholecystectomy;Bollschweiler E;Ann Surg,2008
3. Paterick TJ, Carson GV, Allen MC, Paterick TE. Medical Informed Consent: General Considerations for Physicians. Mayo Clin Proc. 2008 Mar 1;83(3):313–9.
4. Dokumentation der Behandlung. Bürgerliches Gesetzbuch. Sect. Buch 2 - Recht der Schuldverhältnisse (§§ 241–853), Abschnitt 8 - Einzelne Schuldverhältnisse (§§ 433–853), Titel 8 - Dienstvertrag und ähnliche Verträge (§§ 611–630h), Untertitel 2 - Behandlungsvertrag (§§ 630a – 630h).
5. Strategies for improving physician documentation in the emergency department: a systematic review;Lorenzetti DL;BMC Emerg Med,2018