Is there an impact of a video-based patient informed consent in elective hand surgery?
Justus Osterloh, Wibke Müller-Seubert, Aijia Cai, Andreas Arkudas, Raymund R. E. Horch
Archives of Orthopaedic and Trauma Surgery, 8 June 2024
Open access
Abstract
Background
Patient informed consent is a crucial subject in preoperative care of patients before elective hand surgery, ensuring that patients have the necessary information and a comprehensive understanding to make autonomous decisions. The use of video-based informed consent systems is an innovative concept to enhance the consent process with multimedia tools. In addition to the conventional process, mostly relying on verbal communication and written documents, the video-based approach aims to present information in a standardized and visually appealing format.
Methods
In this study, 33 patients were asked to watch a video on a tablet about the planned elective hand surgery after a conventional pre-treatment consultation including informed consent throughout verbal explanations and paper forms by an attending physician or resident. All patients were asked to complete a questionnaire after watching the video.
Results
An overwhelming majority of participants, specifically 97.0%, stated that the video improved their understanding of the upcoming surgery. 90.9% of the participant would refer the video to other patients undergoing elective hand surgery, while 72.7% of participants indicated that they would have appreciated the opportunity to view an informational video before undergoing different types of surgeries in the past.
Conclusion
The use of a video-based patient information system in elective hand surgery had a positive impact on patient education and satisfaction with the informed consent process. Therefore, it is a powerful tool in preoperative management to guarantee a standardized and educative informed consent.

Video-Assisted informed consent in endoscopic urology: a randomized trial on ureterorenoscopy
Research Article
Dr. Guglielmo Mantica, Dr. Francesco Esperto, Dr. Rafaela Malinaric, Dr. Francesca Ambrosini, Dr. Loris Cacciatore, Prof. Rocco Papalia, Dr. Daniele Panarello, Prof. Roberto Mario Scarpa, Prof. Carlo Terron
Journal of Endourology, 17 May 2024
Abstract
Purpose
The aim of this study is to evaluate the possible beneficial effect of using the video – consent in the preoperative URS consent giving process.
Material and Methods
Prospective randomized trial took place at two Italian tertiary-care centers from March 2022 to September 2022. Patients were randomly assigned to two groups: Group A (standard verbal/written informed consent) and Group B (informed consent supported by video). We investigated the impact of both types of the informed consent on the level of patients’ anxiety assessed with the STAI questionnaire pre- and postoperatively. Additionally, we evaluated the effect of informed consents on the postoperative pain, measured with the VAS scale, and the number of assistances calls during hospitalization as secondary outcomes. To assess the satisfaction level related to the whole process, we asked patients to rate their experience on a scale of 1-10, with 1 indicating “not satisfied” and 10 indicating “completely satisfied.”
Results
Overall, 166 patients were randomized 1:1 in each group. According to the multivariable regression model, the video-assisted informed consent significantly increased the difference between postoperative and preoperative STAI, reducing the level of anxiety. The video-assisted informed consent significantly predicted the number of assistance calls during the hospitalization.
Conclusions
Video-consent for ureteroscopies are a valid tool to improve patients’ satisfaction and awareness of the procedure. Video-consent is able to reduce patients’ anxiety related to the procedure and assistance calls during the postoperative period, resulting in a useful tool to administer a better-informed consent for endourological procedures.

The Impact of a Computer-Based Interactive Informed Consent for Surgery on Decision Conflict
Scientific Article
Sina Ramtin, Floor Davids, Amir Reza Farhoud, Raul Tejada, David Ring
The Journal of Hand Surgery, 12 May 2024
Abstract
Purpose
Informed consent for surgery can address the legal aspects of care while also being simple, informative, and empathic. We developed interactive informed consents and compared them with standard printed informed consents asking: (1) are there any factors associated with lower decision conflict or greater patient-rated clinician empathy including consent format? (2) Are there any factors associated with rating the consent process as informative, comfortable, and satisfying including consent format?
Methods
Ninety-four adult patients accepted an offer of surgery from one of three hand surgeons to address one of six common hand surgery diagnoses: carpal tunnel release, cubital tunnel release, trigger finger release, plate and screw fixation of a distal radius fracture, removal of a benign mass, including a ganglion cyst, and Dupuytren contracture release. Fifty-three patients were randomized to complete an interactive consent, and 41, a standard written consent. Symptoms of anxiety, depression, and unhelpful thoughts were measured. Patients completed the Decision Conflict Scale and the Jefferson Scale of Patient’s Perceptions of Physician Empathy and rated the consent as informative, comfortable, and satisfactory on a scale of 0–10.
Results
Greater decisional conflict was slightly associated with greater patient unhelpful thoughts about symptoms and was not associated with consent format. A higher rating of comfort with the consent process was slightly associated with patient choice to proceed with surgical treatment, but not with consent format. Accounting for potential confounding in multivariable analysis, a higher rating of the consent process as informative was slightly associated with patient preference for surgical over nonsurgical treatment,
Conclusions
The observation that an interactive consent form was not related to decision conflict or other aspects of patient experience suggests that such tools may not have much weight relative to the interaction between patient and clinician.
Clinical relevance
Efforts to improve informed consent may need to focus on the dialog between patient and surgeon rather than how information is presented.

Power to the people? Time to improve and implement patient decision aids to strengthen shared decision-making
Invited Commentary
Sandra B Lauck, Krystina B Lewis, Michelle Carter, Catriona Jennings
European Journal of Cardiovascular Nursing, 26 April 2024
Excerpt
    For many people living with heart disease, the journey from their diagnosis to their consent for treatment and beyond is rarely a straight path. Barriers along the way include the maze of diagnostic testing and consultations, the steep learning curve to grasp what options might be appropriate and feasible, the evolving emotions accompanying the diagnosis and the need for treatment, and the diverse power dynamics that might be at play with health care providers. These challenges are often compounded by the need to manage their increasing burden of symptoms. In this complex context of care, patients must make decisions about their treatment, decisions that can have implications for their current and future health and quality of life.

Recognizing the importance of engaging and supporting patients to achieve a high-quality treatment decision in partnership with their providers, multiple cardiovascular guidelines have endorsed shared decision-making (SDM) as a core principle of patient-centred communication in multidisciplinary team best practices. This bi-directional exchange of information is a mechanism to promote patient empowerment, consideration of patients’ preferences, values and priorities, and ultimately, the provision of true informed consent. Patient decision aids (PtDAs) are evidence-based, patient-facing interventions developed according to international standards and designed to facilitate SDM. Patient decision aids explicitly state the decision to be made, provide information about options (inclusive of the option of not actively intervening and choosing watchful waiting/active surveillance) and outcomes associated with each option, while helping patients clarify their values and preferences…

Improving Patient Information and Enhanced Consent in Urology: The Impact of Simulation and Multimedia Tools. A Systematic Literature Review from the European Association of Urology Patient Office
Review – Education
Carlotta Nedbal, Patrick Juliebø-Jones, Eamonn Rogers, James N’Dow, Maria Ribal, Jens Rassweiler, Evangelos Liatsikos, Hein Van Poppel, Bhaskar
European Urology, 25 April 2024
Abstract
Background and objective
Discussions surrounding urological diagnoses and planned procedures can be challenging, and patients might experience difficulty in understanding the medical language, even when shown radiological imaging or drawings. With the introduction of virtual reality and simulation, informed consent could be enhanced by audiovisual content and interactive platforms. Our aim was to assess the role of enhanced consent in the field of urology.
Methods
A systematic review of the literature was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, using informed consent, simulation, and virtual reality in urology as the search terms. All original articles were screened.
Key findings and limitations
Thirteen original studies were included in the review. The overall quality of these studies was deemed good according to the Newcastle-Ottawa Scale. The studies analysed the application of different modalities for enhanced consent: 3D printed or digital models, audio visual multimedia contents, virtual simulation of procedures and interactive navigable apps. Published studies agreed upon a significantly improved effect on patient understanding of the diagnosis, including basic anatomical details, and surgery-related issues such as the aim, steps and the risks connected to the planned intervention. Patient satisfaction was unanimously reported as improved as a result of enhanced consent.
Conclusions and clinical implications
Simulation and multimedia tools are extremely valuable for improving patients’ understanding of and satisfaction with urological procedures. Widespread application of enhanced consent would represent a milestone for patient-urologist communication.
Patient summary
Several multimedia tools can be used to improve patients’ understanding of urological conditions and procedures, such as simulation and models. Use of these tools for preoperative discussion enhances knowledge and patient satisfaction, resulting in more realistic patient expectations and better informed consent.

Enhancing comprehension of online informed consent: the impact of interactive elements and presentation formats
Research Article
Bree Holtz, Katharine Mitchell, Robyn Adams, Caitlin Grier, Jason Wright
Ethics & Behavior, 29 March 2024
Abstract
Informed consent, a cornerstone of research ethics, ensures participant protection and informed participation, particularly in online settings. Despite its significance, engagement with online consent forms remains low, underscoring the need for improved presentation strategies. This study investigates the impact of interactive elements and diverse presentation formats on the comprehension and engagement of online informed consent documents among a broad demographic beyond the commonly studied student populations. Employing a between-subjects experimental design, we explored six versions of online consent forms varying in interactivity, readability, and visual formatting to identify optimal strategies for enhancing participant comprehension and engagement. Our findings reveal that interactive formats significantly improve comprehension and perceived readability, highlighting the pivotal role of design in facilitating informed consent. The study also examines the influence of individual differences, such as self-efficacy and trust in science, on the effectiveness of consent forms, providing insights into the nuanced dynamics between participant characteristics and consent form engagement. These results advocate for integrating interactive elements and thoughtful design in consent forms to foster a more informed and engaged participant base. Implications for research ethics, best practices in consent form development, and future research directions are also discussed, emphasizing the need for ongoing innovation in the consent process to adapt to the evolving landscape of online research. This study contributes to the body of knowledge on research ethics by offering evidence-based recommendations for enhancing the informed consent process, ultimately promoting participant-centered research practices.

Optimizing the consent process for emergent laparoscopic cholecystectomy using an interactive digital education platform: a randomized control trial
Anood Alqaydi, Erin Williams, Sulaiman Nanji, Boris Zevin
Surgical Endoscopy, 18 March 2024
Abstract
Background
Informed consent is essential for any surgery. The use of digital education platforms (DEPs) can enhance patient understanding of the consent discussion and is a method to standardize the consent process in elective, ambulatory settings. The use of DEP as an adjunct to standard verbal consent (SVC) has not been studied in an acute care setting.
Methods
We conducted a prospective randomized control trial with patients presenting to the emergency department of a tertiary care hospital with acute biliary pathology requiring a laparoscopic cholecystectomy (LC) between August 2021 and April 2023. Participants were randomized 1:1 to receive either a DEP module with SVC or SVC alone. Baseline procedure-specific knowledge and self-reported understanding of risks and benefits of LC were collected using a questionnaire. Primary outcome was immediate post-intervention knowledge assessed using a 21-question multiple choice questionnaire. Secondary outcomes were delayed procedure-specific knowledge and participants’ satisfaction with the consent discussion.
Results
We recruited 79 participants and randomized them 1:1 into the intervention group (DEP + SVC, n = 40) and the control group (SVC, n = 39). Baseline demographics and baseline procedure-specific knowledge were similar between groups. The immediate post-intervention knowledge was significantly higher for participants in the intervention versus the control group with a Cohen’s d effect size of 0.68 (85.2(10.6)% vs. 78.2(9.9)%; p = 0.004). Similarly, self-reported understanding of risks and benefits of LC was significantly greater for participants in the intervention versus the control group with a Cohen’s effect size of 0.76 (68.5(16.4)% vs. 55.1(18.8)%; p = 0.001). For participants who completed the delayed post-intervention assessment (n = 29), there continued to be significantly higher retention of acquired knowledge in the intervention group with a Cohen’s effect size of 0.61 (86.5(8.5)% vs. 79.8 (13.1)%; p = 0.024). There was no difference in participants’ self-reported satisfaction with the consent discussion between groups (69.5(6.7)% vs. 67.2(7.7)%; p = 0.149).
Conclusion
The addition of digital education platform to standard verbal consent significantly improves patient’s early and delayed understanding of risks and benefits of LC in an acute care setting.

Assessing the impact of mixed reality-assisted informed consent: A study protocol
Gianluca Scalia, Stefano Maria Priola, Sruthi Ranganathan, Tejas Venkataram, Valeria Orestano, Salvatore Marrone, Bipin Chaurasia, Rosario Maugeri, Domenico Gerardo Iacopino, Lidia Strigari, Maurizio Salvati, Giuseppe Emmanuele Umana
Surgical Neurology International, March 2024
Abstract
Background Informed consent is a crucial aspect of modern medicine, but it can be challenging due to the complexity of the information involved. Mixed reality (MR) has emerged as a promising technology to improve communication. However, there is a lack of comprehensive research on the impact of MR on medical informed consent. The proposed research protocol provides a solid foundation for conducting future investigations and developing MR-based protocols that can enhance patients’ understanding and engagement in the decision-making process.
Methods
This study will employ a randomized controlled trial design. Two arms will be defined: MR-assisted informed consent (MRaIC) as the experimental arm and conventional informed consent (CIC) as the control arm consent, with 52 patients in each group. The protocol includes the use of questionnaires to analyze the anxiety levels and the awareness of the procedure that the patient is going to perform to study the impact of MRaIC versus CIC before medical procedures.
Results
The study will evaluate the impact of MR on patients’ information comprehension, engagement during the process of obtaining informed consent, emotional reactions, and consent decisions. Ethical concerns will be addressed.
Conclusion
This study protocol provides a comprehensive approach to investigate the impact of MR on medical informed consent. The findings may contribute to a better understanding of the effects of MR on information comprehension, engagement during the process of obtaining informed consent, psychological experience, consent decisions, and ethical considerations. The integration of MR technology has the potential to enhance surgical communication practices and improve the informed consent process.

Trust-Building: Why Virtual Formats Threaten the Moral Ends of Surgical Informed Consent
John H. Lee, Katherine E. Neff, Christian J. Vercler
Annals of Surgery, Surgical Perspectives, 26 February 2024
Abstract
The COVID-19 pandemic forced a wide range of medical practices to virtual formats, including the preoperative informed consent practice. However, virtual informed consent persists despite the pandemic largely considered resolved. The continued use of virtual formats relies on a problematic “information-transfer” model of informed consent. We suggest that a “trust-building” model of consent as a better conceptualization of what is occurring during the consent process. Highlighting how virtual formats might fail to fulfill this fuller understanding of consent on both interpersonal and systemic levels, we offer up an ethical structure for physicians to navigate this novel virtual space.

Effect of enhanced informed consent on veteran hesitancy to disclose suicidal ideation and related risk factors
Original Article
Brock C. Tucker, Vivian M. Gonzalez
Suicide and Life-Threatening Behavior, 12 February 2024
Abstract
Introduction
The concealment of suicidal ideation (SI) constitutes a significant barrier to reducing veteran deaths by suicide and is associated with fear of negative consequences (e.g., involuntary hospitalization). This study examined whether augmenting informed consent with psychoeducation aimed to help patients achieve a more realistic risk appraisal of consequences associated with disclosure of SI, decreased hesitancy to disclose SI, and related risk behaviors among U.S. veterans.
Method
Participants (N = 133) were recruited from combat veteran social media groups and were randomly assigned to a video simulated treatment-as-usual informed consent (control) or to one of two psychoeducation-enhanced informed consent conditions (psychoed, psychoed + trust).
Results
Compared with the control group, participants in both psychoeducation and enhanced informed consent conditions reported lower hesitancy to disclose SI, firearm access, and problems with drugs/thoughts of harming others, as well as greater trust and respect for the simulated clinician.
Conclusions
These findings suggest that brief psychoeducation regarding common factors that affect hesitancy to disclose SI may be beneficial for increasing trust in providers during the informed consent process and decreasing concealment of SI and firearm access among veterans.