Department of Urology and Pediatric Urology, University Medical Center, Mainz, Germany.
Department of Urology and Pediatric Urology, University Medical Center, Brandenburg an der Havel, Germany.
Prostate Cancer Prostatic Dis. 2024 Dec;27(4):715-719. doi: 10.1038/s41391-023-00737-4. Epub 2023 Nov 4.
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. Aim of this study is to evaluate the effectiveness of multimedia-supported compared to traditional paper-based IC.
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).
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.
Multimedia-supported IC prior to consultation 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.
由于时间和人员的限制，临床实践中的知情同意（IC）往往缺乏清晰度、可理解性和信息范围。数字媒体在增强 IC 方面具有巨大潜力。本研究的目的是评估多媒体支持与传统纸质 IC 相比的效果。
在这项随机、对照、三臂 DICon（泌尿外科手术数字知情同意）研究中，70 名接受前列腺活检的患者被随机分为 1:1:1 组，分别接受传统纸质 IC、IC 前多媒体支持信息和 IC 期间多媒体支持信息。通过验证的问卷在 2 周和直接在手术前测量患者满意度、焦虑和信息获取情况，并记录时间效率。使用 Kruskal-Wallis 和 Dunn 检验（单向 ANOVA）和双向 ANOVA（带 Bonferroni 后检验）进行统计分析。
与纸质信息（5.3 分钟对 9.5 分钟；p<0.05）和共享多媒体信息（5.3 分钟对 13.9 分钟；p<0.001）相比，咨询前的多媒体信息节省了 32.9%的时间，而患者满意度（62.6 对 62.7 对 80 的最大 80；p=0.07）、焦虑（8 对 8.1 对 16 的最大 16；p=0.35）或信息获取（6.5 对 5.7 对 10 的最大 10；p=0.23）没有差异。满意度（56.6 对 62.6 对 66；p=0.06）、焦虑（7.2 对 7.2 对 6.8；p=0.84）和信息获取（7 对 6.4 对 5.9；p=0.43）的结果在时间上保持稳定。
与传统纸质 IC 相比，咨询前的多媒体支持 IC 提供了更高的时间效率（提高了 33%），同时具有相似的满意度、焦虑和信息获取。因此，应更频繁地在患者教育中使用多媒体支持信息材料。
