Picturing informed consent: Exploring participatory visual methods to enhance meaningful consent conversations with young people

Research article

Jennifer A. Thompson, Emilia Gonzalez, Mónica Ruiz-Casares

Research Ethics, 20 May 2025

Open access

Abstract

Informed consent (IC) is a cornerstone of ethical research, ensuring participants are informed and provide voluntary agreement to participate. Yet IC remains complex, especially in research with young people, and practical examples for engaging youth meaningfully in IC processes are limited. Participatory visual methodologies engage youth as knowledge producers to think creatively, express diverse perspectives, and engage in dialog. This study explores how participatory visual methodologies can involve youth in IC by inviting them to create and discuss visual representations of its key concepts. Grounded in literature on research ethics with young people, we ask: How do young people in Cameroon represent some of the core concepts within IC visually, and what kinds of conversations emerge around these representations? To address these questions, we conducted workshops with 56 young people (10–16 years old) in Cameroon’s Southwest and Northwest Regions. Participants took photos to represent and discuss the benefits and risks of research, voluntary participation, and confidentiality as key elements of IC, and created visual representations of IC forms. Findings show that incorporating visual elements in IC prompted participants to critically engage with IC, facilitating a deeper contextualized and nuanced understanding and meaningful dialog about both the notion of consent and the study they are potentially consenting to. This study presents a case on adolescents and IC in an African context, emphasizing the importance of social and cultural factors in IC and contributing to literature that largely focuses on younger children in Western settings. Integrating participatory visual methods reframed IC as a collaborative, group-centered process rather than a researcher-driven, one-time event. These findings highlight the potential of participatory visual approaches to deepen youth engagement in research ethics, contributing to more equitable and locally relevant research practices.

Video-assisted education for informed consent in percutaneous nephrolithotomy: a prospective study on patient comprehension

Research

Mucahit Gelmis, Yasar Pazir, Ufuk Caglar, Ahmet Halis, Caglar Dizdaroglu, Furkan Gunay, Sedat Cakmak, Faruk Ozgor

World Journal of Urology, 15 May 2025

Abstract

Purpose

The prevalence of urinary stone disease is increasing due to climate change, dietary habits, and obesity. Percutaneous nephrolithotomy (PCNL) remains the preferred treatment for large kidney stones. The informed consent process is essential for patient understanding; however, conventional verbal and written methods may be inadequate. This study aimed to evaluate the effectiveness of video-assisted education in improving informed consent for PCNL.

Methods

This randomized controlled study was conducted from January to July 2023. Eighty patients scheduled for PCNL were randomly assigned to either a written-consent-only group or a video-assisted consent group that received both written consent and a seven-minute 3D-animated video. Comprehension was assessed using a 17-question knowledge assessment questionnaire before and after the consent process. Improvements in knowledge and differences in comprehension were compared.

Results

The video-assisted consent group showed significantly greater comprehension improvement than the written-only group, benefiting patients across all education levels. Multivariate analysis confirmed the strong association between video education and knowledge gain, though older age was linked to lower improvement. Despite its effectiveness, two patients withdrew due to increased anxiety, underscoring the need to balance understanding with emotional reassurance.

Conclusion

Video-assisted informed consent significantly improves comprehension in PCNL patients, particularly in those with lower education levels. However, an increased awareness of surgical risks may contribute to preoperative anxiety. Future research should refine video content, assess long-term outcomes, and explore strategies to balance comprehension with emotional reassurance.

Uses of augmented reality in surgical consent and patient education – A systematic review

Research Article

Thomas Evans, Adam Turna, Thomas D. Stringfellow, Gareth G. Jones

PLOS Digital Health, 28 April 2025

Open Access

Abstract

Augmented reality (AR) allows the real environment to be altered with superimposed graphics using a head-mounted-display (HMD), smartphone or tablet. AR in surgery is being explored as a potential disruptive technology and could be used to improve patient understanding of treatment and as an adjunct for surgery. The aim was to explore this use of AR and assess potential benefits for consent and patient education. A systematic review was conducted using PRISMA-SCR guidelines. 4 major bibliographic databases were searched using the terms: ‘(augmented reality OR mixed reality) AND surgery AND (consent OR patient education)’. Included papers evaluated an AR intervention on consenting patients for enhancing surgical consent or education about a procedure. Non-English language papers and studies which did evaluate an intervention were excluded. Three reviewers screened all abstracts and full text papers for inclusion. The review protocol was prospectively registered with PROSPERO (ID: CRD42020207360). 52 records were identified. Following removal of 13 duplicates, 21 were removed after abstract screening leaving 17 articles for full assessment. One article was a letter and 8 did not evaluate interventions, leaving 8 articles published between 2019 and 2023. 3 papers were randomised controlled trials comparing AR enhanced processes to standard consent, 2 cohort studies evaluated patient satisfaction with AR interventions and there was one randomised crossover trial of AR against traditional consent consultation. The Cochrane risk of bias tool was used most studies were deemed as high risk of bias. Patient satisfaction and understanding were improved using AR. However, advantages over other enhanced techniques are less clear. Using AR to enhance written literature was shown to require less mental effort from patients and was preferred to standard resources to understand complex surgery. The few randomised trials are limited by bias and lack of power calculation, highlighting the need for further research.

How Making Consent Procedures More Interactive can Improve Informed Consent: An Experimental Study and Replication

Marije Aan Het Rot, Ineke Wessel

Journal of Empirical Research on Human Research Ethics, February-April 2025

Abstract

Prospective research participants do not always retain information provided during consent procedures. This may be relatively common in online research and is considered particularly problematic when the research carries risks. Clinical psychology studies using the trauma film paradigm, which aims to elicit an emotional response, provide an example. In the two studies presented here, 112-126 participants were informed they would be taking part in an online study using a variant of this paradigm. The information was provided across five digital pages using either a standard or an interactive format. In both studies, compared to the control condition, participants in the interactive condition showed more retention of information. However, this was only found for information about which they had been previously asked via the interactive format. Therefore, the impact of adding interactivity to digital study information was limited. True informed consent for an online study may require additional measures.

Co-designing and pilot-testing an infographic to support the consent process in an adaptive platform trial for adults in ICU with community-acquired pneumonia or COVID-19: a mixed methods study within a trial (SWAT)
Research
Heather K. O’Grady, Kathy Smith, Sandra Dalziel, Barbara Dolanjski, Gyan Sandhu, Marlene Santos, Jackie Bosch, Lyn S. Turkstra, Srinivas Murthy, John C. Marshall, Michelle E. Kho
Research Involvement and Engagement, 25 April 2025
Open Access
Abstract
Background
Informed consent documents educate patients and families about research participation and alternatives. However, given their length and complexity, consent documents can be challenging to understand, particularly in high-stress environments such as the Intensive Care Unit (ICU) and for complex study designs such as platform trials.
Methods
This is an exploratory sequential mixed methods study-within-a-trial (SWAT) of REMAP-CAP (Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia). Phase 1: We conducted focus groups with individuals with lived experience, including ICU survivors, substitute decision makers (SDMs) and research coordinators (RCs) to refine an infographic to augment a priori REMAP-CAP consent encounters. We analyzed data using inductive content analysis. Phase 2: We piloted the infographic with patients/SDMs approached a priori to participate in REMAP-CAP, who could communicate in English, at five sites in Ontario, Canada. We assessed implementation according to 1) eligible consent encounters (number of patients/SDMs eligible for SWAT / approached for REMAP-CAP), 2) receipt of infographic (number of patients/SDMs who received the infographic / eligible consent encounters), 3) consent to participation in this SWAT by patients/SDMs (number of patients/SDMs who consented / those approached), and 4) feedback questionnaire completion (number of patients/SDMs who completed the questionnaire / those who received it).
Results
Phase 1: We conducted two, two-hour focus groups with 5 participants (10 participants total). Participants identified important infographic design considerations (visual presentation, language) and content (study details, participation in research).
Integration: Results from Phase 1 were used to develop a final consent infographic.
Phase 2: Sixty-three patients were eligible for REMAP-CAP during the study period; 21 were eligible (33%) for the SWAT. Of these, 18 patients/SDMs (86%) received the infographic, 17 consented to the SWAT (94%) and 15 (88%) completed questionnaires. RCs completed case report forms for each consent encounter (n = 18, 100%).
Conclusions
We engaged individuals with lived experience to co-design a consent infographic. We achieved three of four pre-specified feasibility objectives during pilot testing of the infographic for a priori REMAP-CAP consent encounters. Although there were fewer eligible consent encounters than anticipated, we identified acceptable rates of infographic delivery, consent to SWAT participation and questionnaire completion.

A Randomized Controlled Trial of Video-Assisted Electronic Consent Versus Standard Consent for Percutaneous Kidney Biopsy
Pedro H Franca Gois,  Vera Y Miao, Rebecca B Saunderson, Marina Wainstein, Julia Jefferis, Rebecca Hudson, Shaun Chandler, Kylie-Ann Mallitt, Martin Wolley, Belinda Elford, Ann Bonner, Helen G Healy
Clinical Journal of the American Society of Nephrology, 9 April 2025
Abstract
Background
Informed consent is crucial in healthcare, as it respects and honors patient autonomy. However, the process of consenting a patient to a procedure or intervention is often unstandardized, leading to gaps in comprehension, which in turn affects decision-making. This study aimed to assess the patient-reported benefits of video-assisted electronic consent (eConsent) compared with the usual consent practices for percutaneous kidney biopsies (PKB).
Methods
In this single-center, open-label, randomized controlled trial, consecutive patients undergoing PKB between July 2021 and January 2024 were randomized (1:1) to either video-assisted eConsent (intervention) or usual practice of consent (control). The intervention group accessed an eight-minute explanatory animation on an online platform covering the procedure, its risks, and pre- and post-biopsy care before providing digital consent. The control group was consented to by clinicians in the usual manner and signed a paper form. The primary outcome was questionnaire-based patient comprehension, with secondary outcomes including patient-reported experience, anxiety, and satisfaction with the consent process.
Results
Of 178 eligible patients, 120 were enrolled (60 in each group), with a median age of 52 (IQR 34-65) years, 56% were female, and 59% had less than 12 years of education. Comprehension scores were significantly higher in the eConsent group, with participants answering on average three more questions correctly out of nine compared to the control group (p<0.001). Comprehension did not differ significantly by sex or education level, but younger patients scored higher. The eConsent group also had better comprehension of pre- and post-PKB care. No significant differences were observed in patient-reported experience, anxiety, or satisfaction between groups.
Conclusions
Video-assisted eConsent improves patient comprehension of PKB compared to usual consent practice without affecting patient experience, anxiety, or satisfaction.

An informational video for informed consent improves patient comprehension before total hip replacement- a randomized controlled trial
Research
Sebastian von Hertzberg-Boelch, Konrad Fuchs, Johanna Schubring, Dominik Rak, Kilian List, Konstantin Horas, Axel Jakuscheit, Maximilian Rudert
International Orthopaedics, 2 April 2025
Open Access
Abstract
Purpose
Effective patient comprehension is critical for informed consent, particularly in Total Hip Arthroplasty (THA), a globally prevalent procedure. This study evaluates the efficacy of an informational video to improve the patients’ understanding, self-perceived knowledge, and emotional comfort in the context of THA informed consent. This randomized controlled trial investigates the impact of an additional informational video on (I) the patients’ understanding, (II) self-precepted knowledge and (III) emotional comfort during the informed consent process for THA.
Methods
Participants were randomized to receive either the standard informed consent procedure or the standard procedure supplemented with an informational video. The effect of the video was tested with post-consent questionnaires.
Results
The informational video significantly (p = 0.014) improved the patients’ understanding from 78.6% to 86.5%. Self-precepted knowledge and Emotional comfort was not effected by the video (p = 0.986; p = 0.333).
Conclusions
The informational video significantly improved patient comprehension during the informed consent process before THA.

Comprehension and Satisfaction with Informed Consent for Hip Arthroscopy Using Supplemental Online Educational Materials
Molly Piper, Kira Smith, Margaret Sinkler, Michael Salata, Jacob Calcei
Journal of Hip Preservation Surgery, 27 March 2025
Abstract
Background
Informed consent is a crucial component of building the patient-physician relationship, and it typically involves a conversation between patient and provider along with a written document. The purpose of this study was to determine whether the use of electronic educational resources in addition to paper handouts would improve patient comprehension and retention of informed consent for hip arthroscopy procedures.
Methods
Patients undergoing hip arthroscopy were enrolled prospectively, and they were randomized into two groups at their preoperative visit. The first group of patients received a handout discussing their procedure following the informed consent process with the physician, while the second group received the handout as well as access to an online educational forum. The online educational materials included information regarding the procedure, risks, benefits, and alternative options to surgery. The patient’s comprehension, retention, and satisfaction were assessed with a survey on their day of surgery prior to the hip arthroscopy procedure.
Results
There were 26 patients who completed the survey preoperatively, and 65% of those patients were females (n= 17). The average age was 30 ± 9.6 years. 13 of those patients accessed the online educational materials, and 13 patients only had a paper copy of the information. There was no significant difference in the proportion of patients who were very or extremely informed of their procedure (p > 0.99). Additionally, there was not a significant difference in the awareness of the risks, benefits, and alternatives to hip arthroscopy between patient groups (p > 0.99). Over 75% of patients in each group were very or extremely satisfied with the information and teaching they received during the informed consent, but there was not a significant difference between groups (p= 0.59). Of the patients who utilized the online educational materials, 62% agreed that the materials helped improve their understanding of the surgery (n= 8).
Conclusion
Despite an additional online educational forum, there was not a difference in patients’ comprehension of information from the informed consent process for those undergoing hip arthroscopy. There was also not a difference in patient satisfaction between patients receiving only a paper handout versus the additional online educational forum.

Accelerating implementation of visual key information to improve informed consent in research: a single-institution feasibility study and implementation testing
Angela Hill, Ashley J Housten, Krista Cooksey, Eliana Goldstein, Jessica Mozersky, Mary C Politi
BMJ Open, 18 March 2025
Abstract
Objective
Current consent processes often fail to communicate study information effectively and may lead to disparities in study participation. The 2018 Common Rule introduced a mandatory key information (KI) section as a means of improving consents; however, it frequently remains lengthy and prohibitively complex. We conducted a feasibility study of an accessible visual KI template for use in routine studies.
Design
Parallel feasibility study and implementation testing.
Setting
Single Midwestern US academic centre, between July 2023 and July 2024.
Participants
To develop and implement the visual KI template, we used rapid implementation science methods and recruited decision-making and clinical experts, patients and community partners to iteratively adapt the KI template. To assess its efficacy, we surveyed patient participants eligible to enrol in one of four clinical trials that used the visual KI template as part of informed consent.
Primary and secondary outcome measures
The primary outcome was participant knowledge about clinical trial details. Secondary outcomes included decisional conflict about joining the trial (validated SURE measure), KI template acceptability (validated Acceptability of Intervention Measure) and perceived self-efficacy communicating about trial details with researchers/clinicians (items adapted from the Perceived Efficacy in Patient/Physician Interaction measure). Feasibility was evaluated based on reach, number of modifications needed to tailor the intervention to each pilot trial, and time required for ethics reviews.
Results
Of 85 study participants across the four clinical trials using the visual KI page, the weighted mean knowledge score about trial details was 87.4% correct (range 77.8%-88.9%). Few (n=9; 10.6%) reported decisional conflict about whether to participate. Almost all (n=82; 96.5%) participants stated they approve using the visual KI template. 79 (92.9%) participants reported feeling confident asking clinicians or researchers questions about the trial.
Conclusions
Visual KI templates can improve potential participant comprehension and in doing so, may reduce barriers to participation in research. Parallel feasibility studies and implementation science methods can facilitate the rapid development and evaluation of evidence-based interventions, such as improved informed consent templates.

The Effects of Written Versus Video Aids on Informed Consent Across Different Types of Surgeries: A Randomized Controlled Study
Ziyao Liu, Li Yuan, Wei Rong, Pei Wang
Current Problems in Surgery, 17 March 2025
Open Access
Abstract
Background
Previous studies have demonstrated the effectiveness of written and video aids in improving surgical informed consent; however, the relative effectiveness of these two aid formats remains unclear.
Objective
To compare the effects of written and video aids on informed consent across different types of surgeries.
Methods
270 participants (193 inpatients and 77 college students) were randomly allocated to a hypothetical informed consent procedure of hemorrhoidectomy, laparoscopic cholecystectomy, or arthroscopic knee meniscus repair. Within each informed consent procedure, participants randomly received either traditional verbal informed consent, verbal informed consent plus written aids, or verbal informed consent plus video aids. Participants’ understanding of their disease and surgery, satisfaction with the consent process, and anxiety levels were assessed.
Results
Providing written aids, but not video aids, in addition to conventional verbal consent significantly improved patient understanding compared to verbal consent alone (P = 0.037). Neither aid affected patient satisfaction or anxiety (P > 0.05). No significant differences emerged in understanding, satisfaction, or anxiety scores between written and video aid groups across surgery types (P > 0.05).
Conclusions
Providing written aids can improve patient understanding but have no effect on satisfaction or anxiety during surgical informed consent process. There are no differences in the effects of written and video aids on informed consent across different surgery types. Their relative effectiveness needs to be further determined.