Digital informed consent for urological surgery - Randomized controlled study comparing multimedia-supported vs. traditional paper-based informed consent concerning satisfaction, anxiety, information gain and time e�ciency

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 e�ciency 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 e�ciency (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.


Introduction
Informed consent (IC) is mandatory before every surgical intervention and should inform the patient about expected consequences, risks, necessity, urgency, prospects of success and alternatives in a clear and comprehensive way [1][2][3][4].Furthermore, detailed documentation of the consultation is needed and information material of IC should be handed out [1,3].Structured and comprehensive documentation improves patient care and reduces treatment errors [5].However, studies have shown that 50% of physician's working time consists of documentation and other desk tasks and only 27% on direct patient consultation [6][7][8].Due to increasing documentation requirements, the high demands on IC become even more challenging.This disproportion is further exacerbated by rising patient numbers because of demographic change [9] and an aggravating shortfall of staff [10,11].Moreover, due to fast-tacked work ows in modern hospitals and multiple forms and questionnaires patients have to ll out, there often is not enough time or motivation to read the written IC-form completely and thoroughly [12].In addition, many patients have problems understanding, because of language barriers.Furthermore, patient's level of information about the respective intervention prior to the consultation can vary greatly and depends on many factors.Age, level of education, access to medical information and profession are just a few.But also, the a nity and compatibility to digital media can be a decisive limiting factor in that regard.
All the problems and obstacles listed above call for innovations in more comprehensive, descriptive, but also more time-effective educational alternatives.Digital media offer great potential in this respect and are being used more and more frequently [12,[15][16][17][18].Because digital media can appeal to several senses, information can be better internalized [13,14].In addition, multimedia-assisted education can be more standardized through recorded videos or presentations, as these are always the same.Therefore, there is more time for individual questions and concerns.Moreover, different levels of experience and motivation of the clinician or a lack of time during the patient interview become less relevant factors for a comprehensive and satisfactory education [13].
Unfortunately, high acquisition and licensing costs of software programs as well as data protection concerns are still a major obstacle to digitization.The aim of this study was to evaluate the effectiveness of an easily accessible, multimedia-supported patient education in comparison to a classical paper-based education, in terms of patient satisfaction, anxiety, information gain and time e ciency.

Study design and population
Between October 2021 and October 2022, a total of 70 patients indicated for prostate biopsy were included in this prospective, randomized, single-center study.Patients were divided into three groups.The rst group represents the control group with a classic, paper-based information (PAPER).Here, each patient received the information forms in advance of the consultation and then discussed them with the physician during the consultation.The procedure and risks were illustrated only with the help of the printed material.Patients in the second group (MMprior) received a multimedia presentation specially prepared for prostate biopsy in addition to the printed information material before the consultation.The presentation was shown to the patient alone in a separate room.Afterwards, the multimedia presentation was discussed with the physician and questions or comments were clari ed.The difference to the third group (MMtogether) was that the multimedia presentation was carried out by the physician within the framework of the consultation.In this way, questions or comments on speci c topics of the procedure could be answered directly.The patient also received the printed information forms before the consultation, as was the case in all three groups.Outcome parameters were patient satisfaction, anxiety, information gain of about disease and procedure as well as consultation time.

Multimedia-supported information
The multimedia-supported information was realized by a Microsoft® PowerPoint® presentation (Version 2301, Microsoft Corporation, Redmond, USA) specially created for the prostate biopsy with information about anatomy, basic knowledge of prostate carcinoma, risks and side effects of the intervention, further procedure after the intervention and oncological prospects.Besides some illustrations and diagrams, the presentation included a short video (45 seconds), which illustrated the anatomy and procedure even further.The PowerPoint presentation is provided in Appendix / Supplementary Material.

Data acquisition
Subsequently to the consultation, the patient was given questionnaires for the evaluation of satisfaction, anxiety, as well as information gain.A second survey took place between 1-5 days before the planned intervention and was be carried out again with the same questionnaires that were used for the rst interview.Thus, the sustainability of the information gain could be captured.To evaluate the timee ciency of each group, the time of each consultation was recorded using a stopwatch.

Questionnaires
Patient satisfaction was evaluated using a questionnaire (21 items, max.score 80) based on the standardized EORTC questionnaire "QLQ-IN-PATSAT32" for in-patient cancer care [19].Here, a high score represents a high level of satisfaction.Anxiety was surveyed by the "Perceived Stress Scale" (PSS-4; 4 items, max.score 16), also known as the "Cohens-Scale" [20].Unlike the satisfaction questionnaires, a high score in PSS-4 represents a high level of anxiety and distress.As far as the query of the information gain of disease knowledge is concerned, a multiple-choice test with 10 questions (max.score 10) was created.

Statistical analysis
Statistical analysis was performed using Kruskal-Wallis and Dunn's test (one-way ANOVA) and two-way ANOVA (with bonferroni post-test).All data were analyzed using GraphPad PRISM® 5 (Version 5.01, 2007, GraphPad Software Inc., Boston, USA).Statistical signi cance was de ned as p < 0.05.

Satisfaction
Mean patient satisfaction at rst interview did not differ signi cantly between the three groups (62.6 vs. 62.7 vs. 68.6 of max.80; p = 0.07) (Fig. 2).There was no signi cant difference in the second survey either (56.6 vs. 62.6 vs. 66; p = 0.06).Comparing the rst to second interview there was no signi cant decrease in satisfaction in all three groups (p = 0.48).
The small difference between the rst and second interview was also not statistically signi cant (p = 0.72).

Disease knowledge
In terms of disease knowledge, patients who received multimedia information did not perform worse than the traditional paper-based group (6.5 vs. 5.7 vs. 6.7 of max.10; p = 0.23) (Fig. 4).The information could be imparted in an equally sustainable way throughout all three groups, because the different scores at the second survey (7 vs. 6.4 vs. 5.9; p = 0.43) were not statistically signi cant compared to the rst interview (p = 0.33

Discussion
The process of IC is subject to high requirements, so that a patient can make a differentiated decision on a surgical intervention.However studies have shown, that patients with an oncological disease in particular, often decide on treatment options based on personal or someone else's experience as well as the physician's recommendation [21][22][23].However, these in uences can be biased because of personal interests or fear of the same bad experiences and complications someone else's had [24].Therefore, a comprehensive, detailed and empathic education from the physician is indispensable.Unfortunately, due to staff shortages, high patient volumes and documentation obligations, the modern hospital routine no longer offers su cient space to meet these requirements [6, 7, 9, 10].Digital media may not cover the empathic part of the consultation, but can greatly support with information transfer and vividness [15,25].Especially considering, that waiting times could be used more effectively with the use of digital educational materials.Digital tools for patient education have already been developed and have shown their effectiveness [15,18].However, high acquisition costs and license fees often mean that modern digital media are being cut back [26,27].These challenges gave us the reason to evaluate an easily accessible, cost-e cient, multimedia-supported patient education tool for patients indicated for prostate biopsy.
As digitalization plays a central role in societies worldwide, the use of digital media in elderly populations (> 65 years) has increased considerably over the last ten years [28].However age still shows to be a limiting factor in the use of digital media in general [29,30].Therefore, we had concerns about older patients in our study population having problems coping with the multimedia assisted IC, especially when it was shown to them alone.Thus, we created the MMtogether-group, where the physician could guide the patient through the multimedia-assisted presentation.Interestingly we could not detect a signi cant difference in test performance between the two age-categories (< 65 and > 65 years).Also, there was not difference in satisfaction (Fig. 2), anxiety (Fig. 3) and disease knowledge (Fig. 4) in comparison to the MMtogether-group.Thus, we can state that widely used multimedia software (Microsoft® PowerPoint® presentation) specially prepared for prostate biopsy is compatible with elderly patients and can safely be shown in a sole setting.Moreover, it is very cost-effective, as clinics often already have basic Software tools such as Microsoft® O ce.Before trying to implement complex, time-consuming and expensive multimedia tools for IC, we suggest using easily accessible and cost-effective software, which can be created and distributed quickly for many procedures and treatments.Putting this in relation to the time saved by using multimedia-assisted IC (Fig. 1), it shows a considerable bene t of simple digital media.
Our data show a time saving of 32,9% (Fig. 1) in consultation time while maintaining the same level of satisfaction, anxiety and disease knowledge.Therefore, our data can verify the effectiveness of digital media in terms of timesaving compared to other studies [13,15,31,32].Looking at the shortage of staff and increasing patient numbers [9,10] the demonstrated time-effectiveness of multimedia-assisted IC could become even more relevant in the near future.With increasing access to digital media and internet, multimedia information could be made available to patients online or in the waiting room so that they receive clinic-speci c specialist information in a comprehensible and vivid manner in advance of the appointment.
In summary, our study provides signi cant data that support the time-effectiveness of multimediaassisted IC tools, without compromising patient satisfaction, anxiety and information gain on disease knowledge.Our data further show that widely used digital media is compatible with elderly patients and can safely be shown in a sole setting.Through further technological developments and advancing digitalization in societies worldwide, the challenge of high demands on patient education, documentation obligations, increasing patient numbers and lack of medical staff could be managed with the little time available.
Our study also has some limitations.The study population was relatively small and patient education was carried out by several physicians.Furthermore, the multimedia-assisted presentation and questionnaires were only available in German language, which could hinder comprehensibility.In addition, we only tested the multimedia-assisted IC tool on male patients with indication for prostate biopsy.It is unclear how the outcome parameters would be affected in the context of a more complex operation or balanced gender ratios.To evaluate the gender imbalance, a follow-up study is already being conducted on patients indicated for transurethral resection of bladder tumors.Moreover, there was a problem of questionnaire completeness at second survey, because of scheduling di culties due to the COVID-19 pandemic.These patients were excluded from data analysis.Legend not included with this version Legend not included with this version