P50: Looking for the best: Video vs written informed consent in coronary angiography procedures
Ines Testoni, Francesca Lampis, Erika Iacona, Roberto Valle, Gabriele Boscolo, Diego De Leo
Cambridge University Press, 2 February 2024
Abstract
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Background
Informed consent practices in healthcare are a fundamental element of patient-centred care; however, the traditional written description of the medical procedure for obtaining informed consent seems to have several limitations.
Aim
This research aimed to evaluate the effects of an alternative method of obtaining informed consent, based on a short informative video for patients waiting to undergo a coronary angiography procedure in Italy.
Methods
The study involved 40 participants, 28 males and 12 females (mean age: 68.55, SD = 13.03), equally divided into two groups, one that received video informed consent and the other the traditional written one. Each group was asked to fill out two questionnaires, one created ad hoc by the authors to measure the level of understanding of the information provided and the perception of usefulness of informed consent, and the other the DASS-21 scale, able to assess anxiety, depression and stress levels.
Results
Comparing the results of the two groups showed that informed consent via video enabled participants to better understand the information provided, as well as feel more confident in their subjective understanding of it, while perceiving informed consent via video as more useful than the traditional one. Video informed consent did not lead to higher levels of anxiety, depression, or stress among participants.
Conclusion
It can be hypothesized that video formats could represent a more useful and understandable alternative to traditional informed consent in the coronary angiography procedure sector.

Comparing Anxiety Levels and Pain Scores for Video-assisted and Traditional Informed Consent in Extracorporeal Shockwave Lithotripsy: A Prospective, Randomised, Controlled Study
Nurul Zubaidah Shahul Hameed, Devindran Manoharan, Lee Say Bob, Susan Woo
Asian Journal of Research and Reports in Urology, 23 January 2024
Abstract
Aims
Traditionally, informed consent involves verbal and/or written material provided to the patient by a treating clinician. Multimedia interventions improve patients’ knowledge and understanding during the informed consent process. This study aimed to compare pre-procedural anxiety levels and pain scores between educational video-assisted informed consent and traditional informed consent for extracorporeal shockwave lithotripsy (ESWL) at our centre.
Study Design
This was a prospective, randomised, controlled study conducted at two centres.
Place and Duration of Study
The study was conducted in two Urology centre Department of Urology, Penang General Hospital and Department of Urology, Hospital Kuala Lumpur between 15th May 2022 and 15th October 2022.
Methodology
The study group consisted of all adult patients undergoing ESWL in both centres. A video presentation explaining the ESWL procedure was developed in two languages, and group allocation was randomised using a computer-based random number generator. Anxiety levels were assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire, visual analogue scale, and numerical rating scale used to collect data on pain scores.
Results
A total of 54 respondents, with a predominance of male patients (57.4%) and the majority of patients having completed secondary school education (53.7%). In comparing the two groups, the video-assisted respondents exhibited significantly lower anxiety scores regarding the procedure than those in the traditional group (p< 0.05). However, there were no statistically significant differences between the groups in terms of pain scores, both pre- and post-procedural.
Conclusion
Video-assisted informed consent can reduce procedure-related patient anxiety levels before ESWL; however, there was no difference in pain scores between the two consent methods. patients.

Practicing care-full scholarship: Exploring the use of ‘visual informed consent’ in a study of motherhood, health and agroecology in Coventry, UK
Research Article
Mai Abbas, Alex Franklin, Stefanie Lemke, Chiara Tornaghi
Qualitative Research, 10 January 2024
Open Access
Abstract
The demand for alternative methods of providing informed consent is increasing, especially in research with marginalised (or illiterate) research participants. This article discusses the co-creation of a visual informed consent (VIC), in collaboration with an artist. The VIC was inspired by the experience of obtaining informed consent from a group of migrant women with limited English proficiency, in empirical research undertaken on agroecology and health in Coventry, UK. Reflecting further on its creation and wider utility, this article explores the inner values that might guide researchers and lead to the co-creation of care-full tools that meet the needs of research participants. Specifically, this includes, reflecting on the iterative process of developing a VIC and using an ethics of care as a primary conceptual framework. Findings reveal that participants’ understanding of ethical issues is facilitated using visual illustrations. It is argued that the creation of a VIC requires the researcher to be attentive to the embodied nature of research practice and guided by an ethics of care. A conceptual framework that integrates care and embodiment is presented, with the intention that it may further support the development of care-full research by others.

Digital consent in gynecology: an evaluation of patient experience
Laura Burney Ellis, Jennifer Barcroft, Edward St John, Dafydd Loughran, Maria Kyrgiou, David Phelps
Archives of Gynecology and Obstetrics, 8 December 2023
Open Access
Abstract
Introduction
The surgical consent process is a crucial discussion between patient and surgeon, which is predominantly documented utilizing hand-written forms. The exchange of individualized information allows the patient to make a truly informed decision. Digital consent (also known as electronic consent or e-consent) has been shown to improve accuracy of information provided without increasing the time taken to consent patients. We aimed to evaluate patient experience and effectiveness of digital consent in a gynecology department in a tertiary London Teaching Hospital.
Methods
A questionnaire was designed and completed by 100 patients undergoing gynecological surgery: 50 consented using paper and 50 consented digitally. The questionnaire included 8 statements, with five possible answers to select, ranging from strongly agree to strongly disagree, on a standard five-point Likert Scale. Patients were all female and categorized into age groups (deciles) and asked whether consent was taken digitally or on paper. Data were collected between January and July 2021.
Results
Most responses were positive with 87% (694/800) of responses to the questions being either strongly agree or agree. Patients who were consented using paper selected ‘strongly agree’ 43.5% (174/400) of the time in comparison to 64.8% (259/400) of the time when they were consented digitally. The majority, 86% (43/50), of digitally consented patients received a copy of the consent form in comparison to 18% (9/50) of those consented using paper. On average, the patients consented digitally were older than their paper-consented counterparts (49–58 and 59–68 respectively). The mean scores for the questions relating to the ease of reading the form, ease of understanding the form, understanding of the potential complications, and overall satisfaction were higher in those digitally consented (p < 0.05).
Discussion
Overall, patients were satisfied with both methods of consent. However, individuals who were consented digitally reported higher levels of satisfaction throughout the consent process, compared to paper consent. These data suggest that digital consent is an acceptable alternative to paper consent for patients and facilitates adherence to national consent guidance, which stipulates patients should be given the information they request.

Digital and paper consent errors
Rohin Wong, Mohammad Iqbal Hussain, Simon Toh, Christopher Rao, Edward R St John
British Journal of Surgery, 8 November 2023
Excerpt
    Over 300 million patients undergo an operation globally each year. The content (risks, benefits, alternatives) discussed with the patient is important to enable them to make the correct informed decision about their treatment options. The consent form is used to document the informed consent process. However, current consent practice and documentation are variable, and permit human errors of recall, incomplete form filling, and illegible handwriting, which can lead to inadequate shared decision-making, misunderstanding, complaints, and litigation. Expenditure on litigation owing to an inadequate consent process has increased across multiple healthcare systems. For example in England, UK, the number of claims and total annual spend related to failure to warn dealt with by NHS Resolution was 128 cases and €28 125 911 in 2011 versus 248 and €91 729 270 in 2021.
Digital consent has been proposed as a solution to address the challenges associated with standard paper-based consent because it improves shared decision-making and enables a bespoke informed consent process. It also facilitates the transition to paperless electronic health records, which is an increasing requirement of many global healthcare providers.
Previous systematic reviews have demonstrated that patient comprehension and satisfaction are improved by digital compared with paper-based consent. However, there has not been any synthesized evidence evaluating the impact of digital consent on error rates and standardization of informed consent. These factors were explored in the present analysis by comparing the error rates of standard paper-based and digital consent…

Evaluation of an audio-visual informed consent procedure in a diagnostic tuberculosis trial
Luis Gómez Paciello, Floryn Schippers, Ana Aguiar, Cecile Magis
European Respiratory Journal, January 2023
Abstract
Background
In line with the End Tuberculosis (TB) Strategy of the World Health Organization a diagnostic study, PriNose NCT0440732, has started in Paraguayan prisons. Due to high illiteracy among persons deprived of liberty (PDL) and low educational attainment, an audio-visual message was developed and incorporated in the informed consent (IC) procedure. The aim of this study is evaluating the experience and thoughts on the IC procedure in a vulnerable population from multiple viewpoints.
Objectives
Evaluation of the participants’ thoughts and experience on the IC procedure. 2. Evaluation of the user experience of the IC procedure.
Methods
Inclusion strategy: convenience sampling by face-to-face request, directly after completion of the IC procedure of the PriNose study. Separate written ICs were obtained. Semi-structured interview guides with 11 integrated true/false questions and Likert scales were used for in depth face-to-face interviews with respectively the PDL and the volunteers, lasting on average 22 minutes. Cyclic thematic inductive analysis with open and axial coding of data in ATLAS.ti v.22 followed.
Results
A total of 22 PDL and 4 volunteers, (Males; mean age: 31.8 years (Sd: 11.8)), were included from penitentiary institution ‘Emboscada’. Preliminary data analysis presented 3 main themes: improving disease knowledge, importance of selfcare in relation to health and level of information comprehension. Final analysis and interpretation will follow soon.

Evaluation of Informed Consent with Teach-Back and Audio Assistance to Improve Willingness to Participate in a Clinical Trial Among Underrepresented Minorities: A Randomized Pilot Trial
Research article
Brenda Jamerson, Barry Shuster
Journal of Empirical Research on Human Research Ethics, 12 October 2023
Abstract
The informed consent form (ICF) is intended to assure that subject participation in research studies is informed and voluntary. Yet, there is ample evidence that many subjects do not adequately understand the concepts and language in a clinical trial ICF, which may undermine their willingness to participate in a clinical trial. In a randomized setting, we compared a standard read-only ICF to an audio-assisted ICF with or without teach-back. We found that audio-assisted ICFs significantly improved willingness to participate in a mock clinical trial among our sample of primarily African-American participants.

Efficacy of informed consent process using educational videos for skin biopsy procedures
Dichitchai Mettarikanon, Tawanwongsri, Pitchaya Jaruvijitrattana, Sasipaka Sindhusen, Surinnart Charoenchitt, Patsaraporn Manunyanon
Contemporary Educational Technology, 26 September 2023; 15(4)
Open Access
Abstract
The informed consent process is integral to medical procedures, including skin biopsies, which are the definitive method for diagnosing challenging skin lesions. Educational videos are recognized for effective delivery of information for informed consent. This study aimed to evaluate the efficacy of an informed consent process using educational videos to improve patient understanding and reduce preprocedural anxiety. This multicenter, randomized controlled study was conducted during December 2021-June 2023. Participants were randomly assigned to either the video or verbal group in a 1:1 ratio. They completed knowledge and anxiety questionnaires before and after biopsy. The final analysis included 54 participants (verbal group: n=28; video group: n=26) with a mean age of 51.9 years (standard deviation [SD] 18.1), and a balanced gender distribution. Post-intervention knowledge scores (median 10.0; IQR 8.0-10.0) significantly increased compared to pre-intervention scores (median 6.0; IQR 4.0-9.0), p<0.001. Post-intervention Spielberger state-trait anxiety inventory (STAI) scores (median 5.0; interquartile range, IQR 5.0-6.0) significantly decreased compared to pre-intervention scores (median 7.0; IQR 5.0-10.0), p<0.001. Knowledge scores increased more in the video group (median, 2.5; IQR 1.0-5.0) than in the verbal group (median, 1.5; IQR 0.0-4.0), p=0.217. There was no significant difference in STAI score changes between the video group (median 1.0, IQR 0.0-4.0) and the verbal group (median 1.0, IQR 0.0-3.0), p=0.824. Despite statistical insignificance, educational videos exhibited greater effectiveness in enhancing comprehension and demonstrated comparable efficacy in reducing anxiety compared to conventional intervention.

The use of e-consent in surgery and application to neurosurgery: a systematic review and meta-analysis
Original Article
Asfand Baig Mirza, Abbas Khizar Khoja, Fizza Ali, Mustafa El-Sheikh, Ammal Bibi-Shahid, Jandira Trindade, Brett Rocos, Gordan Grahovac, Jonathan Bull, Alexander Montgomery, Babak Arvin, Ahmed-Ramadan Sadek
Acta Neurochirurgica, 11 September 2023
Open Access
Abstract
Introduction
The integration of novel electronic informed consent platforms in healthcare has undergone significant growth over the last decade. Adoption of uniform, accessible, and robust electronic online consenting applications is likely to enhance the informed consent process and improve the patient experience and has the potential to reduce medico-legal ramifications of inadequate consent. A systematic review and meta-analysis was conducted to evaluate the utility of novel electronic means of informed consent in surgical patients and discuss its application to neurosurgical cohorts.
Methods
A review of randomised controlled trials, non-randomised studies of health interventions, and single group pre-post design studies in accordance with the PRISMA statement. Random effects modelling was used to estimate pooled proportions of study outcomes. Patient satisfaction with the informed consent process and patients’ gain in knowledge were compared for electronic technologies versus non-electronic instruments. A sub-group analysis was conducted to compare the utility of electronic technologies in neurosurgical cohorts relative to other surgical patients in the context of patient satisfaction and knowledge gain.
Results
Of 1042 screened abstracts, 63 studies were included: 44 randomised controlled trials (n = 4985), 4 non-randomised studies of health interventions (n = 387), and 15 single group pre-post design studies (n = 872). Meta-analysis showed that electronic technologies significantly enhanced patient satisfaction with the informed consent process (P < 0.00001) and patients’ gain in knowledge (P < 0.00001) compared to standard non-electronic practices. Sub-group analysis demonstrated that neurosurgical patient knowledge was significantly enhanced with electronic technologies when compared to other surgical patients (P = 0.009), but there was no difference in patient satisfaction between neurosurgical cohorts and other surgical patients with respect to electronic technologies (P = 0.78).
Conclusions
Novel electronic technologies can enhance patient satisfaction and increase patients’ gain in knowledge of their surgical procedures. Electronic patient education tools can significantly enhance patient knowledge for neurosurgical patients. If used appropriately, these modalities can shorten and/or improve the consent discussion, streamlining the surgical process and improving satisfaction for neurosurgical patients.

Using a chat-based informed consent tool in large-scale genomic research
Sarah K Savage, Jonathan LoTempio, Erica D Smith, E Hallie Andrew, Gloria Mas, Amanda H Kahn-Kirby, Emmanuèle Délot, Andrea J Cohen, Georgia Pitsava, Robert Nussbaum, Vincent A Fusaro, Seth Berger, Eric Vilain
Journal of the American Medical Informatics Association, 4 September 2023
Abstract
Objective
We implemented a chatbot consent tool to shift the time burden from study staff in support of a national genomics research study.
Materials and Methods
We created an Institutional Review Board-approved script for automated chat-based consent. We compared data from prospective participants who used the tool or had traditional consent conversations with study staff.
Results
Chat-based consent, completed on a user’s schedule, was shorter than the traditional conversation. This did not lead to a significant change in affirmative consents. Within affirmative consents and declines, more prospective participants completed the chat-based process. A quiz to assess chat-based consent user understanding had a high pass rate with no reported negative experiences.
Conclusion
Our report shows that a structured script can convey important information while realizing the benefits of automation and burden shifting. Analysis suggests that it may be advantageous to use chatbots to scale this rate-limiting step in large research projects.