Short-Form Video Informed Consent Compared With Written Consent for Adolescents and Young Adults: Randomized Experiment
Aliyyat Afolabi, Elaine Cheung, Joanne Chen Lyu, Pamela M Ling
JMIR Formative Research, 22 November 2024
Abstract
Background
Adolescents and young adults have the highest prevalence of e-cigarette use (“vaping”), but they are difficult to enroll in health research studies. Previous studies have found that video consent can improve comprehension and make informed consent procedures more accessible, but the videos in previous studies are much longer than videos on contemporary social media platforms that are popular among young people.
Objective
This study aimed to examine the effectiveness of a short-form (90-second) video consent compared with a standard written consent for a vaping cessation study for adolescents and young adults.
Methods
We conducted a web-based experiment with 435 adolescents and young adults (aged 13-24 years) recruited by a web-based survey research provider. Each participant was randomly assigned to view either a short-form video consent or a written consent form describing a behavioral study of a social media–based vaping cessation program. Participants completed a postexposure survey measuring three outcomes: (1) comprehension of the consent information, (2) satisfaction with the consent process, and (3) willingness to participate in the described study. Independent sample 2-tailed t tests and chi-square tests were conducted to compare the outcomes between the 2 groups.
Results
In total, 435 cases comprised the final analytic sample (video: n=215, 49.4%; written: n=220, 50.6%). There was no significant difference in characteristics between the 2 groups (all P>.05). Participants who watched the short-form video completed the consent review and postconsent survey process in less time (average 4.5 minutes) than those in the written consent group (5.1 minutes). A total of 83.2% (179/215) of the participants in the video consent condition reported satisfaction with the overall consent process compared with 76.3% (168/220) in the written consent condition (P=.047). There was no difference in the ability to complete consent unassisted and satisfaction with the amount of time between study conditions. There was no difference in the composite measure of overall comprehension, although in individual measures, participants who watched the short-form video consent performed better in 4 measures of comprehension about risk, privacy, and procedures, while participants who read the written document consent had better comprehension of 2 measures of study procedures. There was no difference between the groups in willingness to participate in the described study.
Conclusions
Short-form informed consent videos had similar comprehension and satisfaction with the consent procedure among adolescents and young adults. Short-form informed consent videos may be a feasible and acceptable alternative to the standard written consent process, although video and written consent forms have different strengths with respect to comprehension. Because they match how young people consume media, short-form videos may be particularly well suited for adolescents and young adults participating in research.
Year: 2024
Virtual reality for patient informed consent in skull base tumors and intracranial vascular pathologies: A pilot study
Virtual reality for patient informed consent in skull base tumors and intracranial vascular pathologies: A pilot study
Research
Emilia Westarp, Attill Saemann, Marek Zelechovski, Balazs Faludi, Philippe Cattin, Jehuda Soleman, Raphael Guzman
Acta Neurochirurgica, 15 November 2024
Open Access
Abstract
Purpose
With the growing demand for shared decision-making and patient-centered care, optimal informed consent (IC) has gained relevance. Virtual reality (VR) has seen significant technological advancements, and its medical applications currently include surgical planning and medical education. This pilot study investigates the feasibility of VR-enhanced informed consent (VR-IC) in neurosurgery to improve preoperative IC and patient satisfaction.
Methods
We included patients aged 18 to 75 years who were scheduled for skull base meningioma or brain aneurysm surgery between May and December 2023. Exclusion criteria were visual/auditory impairments and severe cognitive/psychiatric disorders. Patients received standard IC followed by VR-IC using patient-specific VR models of their pathology. After an initial demonstration by the surgeon, the patients used the VR station independently. A questionnaire with 18 questions on a 5-point Likert scale assessed the subjective impression of VR-IC.
Results
Ten patients participated in the study, with six (60%) undergoing aneurysm clipping and four (40%) undergoing skull base meningioma resection. The mean age of the participants was 58 years (± 15, range 27 to 75 years), with four female patients (40%). Patients overall rated the VR-informed consent (VR-IC) positively with a mean of 4.22 (± 0.84). There was a better understanding of their pathology (mean 4.30 ± 0.92) and the planned procedure (mean 3.95 ± 1.04). Trust in the surgeon was rated with a mean of 3.47 (± 0.94). Only minimal side effects from the VR experience including dizziness or discomfort were noted (mean 4.60 ± 0.22). None of the participants dropped out of the study.
Conclusion
VR-enhanced informed consent is feasible and improves patient understanding and satisfaction without significant side effects. These findings will guide the planning of a randomized controlled trial to validate the benefits of VR-IC in neurosurgery further.
Demonstrating the Electronic Consent Process for Emergency Surgical Patients
Demonstrating the Electronic Consent Process for Emergency Surgical Patients
David Fellows, Giles Bond-Smith
Cureus, 25 October 2024
Abstract
Introduction
Patient consent for surgery is a vital part of the surgical pathway from both a patient safety and medicolegal point of view. Improvement in documenting the full consent process in the electronic patient record (EPR), alongside the standard completion of the paper consent form in a surgical emergency unit (SEU), to comply with the Montgomery ruling of informed consent, has become of paramount importance. The aim of this project was to improve the documentation of the full consent process by creating an electronic template that was easy for the consenting clinician to use and provided a robust record of the bespoke consent process for the individual patient.
Methods
In July 2020, clinicians in the SEU were asked to begin documenting the patient’s consent process in the EPR. The number of documented electronic consent processes (ECPs) of patients who underwent emergency general surgery during a two-week period was then captured between October and November 2020. The second cycle involved creating a single consent template, allowing the ECP to be easily documented in one template for all the common emergency surgery operations. All clinicians who were responsible for surgical consenting were asked to use the electronic template as part of the consent process. The rate of electronic consent was recorded over a second two-week period, six months later, in May 2021.
Results
From the first cycle, 78 patients were identified as undergoing emergency surgery, of which 13% (N=10) had an electronic entry regarding the consent process fully documented and personalised to the patient. From the second cycle, 64 patients were identified. The rate of documented ECPs increased to 77% (N=49).
Conclusion
This project has successfully improved the electronic demonstration of a consent process, bespoke to the individual, in accordance with the Montgomery ruling, by implementing an easy-to-use template on EPR. This is a significant step towards full digital consent in the future.
A Randomized Controlled Trial of Video-Assisted Electronic Consent vs. Standard Consent for Percutaneous Kidney Biopsy (eConsent Bx)
A Randomized Controlled Trial of Video-Assisted Electronic Consent vs. Standard Consent for Percutaneous Kidney Biopsy (eConsent Bx)
Pedro Henrique Franca Gois, Vera Y. Miao, Rebecca Saunderson, Marina Wainstein, Kylie-Ann Mallitt, Shaun Patrick Chandler, Belinda Elford, Rebecca Hudson, Julia Jefferis, Helen Healy, Ann Bonner,
Journal of the American Society of Nephrology, October 2024
Abstract
Background
Video-assisted electronic consent (eConsent) enhances understanding, reduces anxiety, and boosts satisfaction in medical procedures. Yet, its impact on percutaneous kidney biopsies (PKB) remains unexplored. We aimed to assess patient-reported benefits of eConsent versus conventional consent for PKB.
Methods
In a single-center, open-label, RCT, consecutive patients undergoing PKB were randomized (1:1) to either video-assisted eConsent (intervention) or conventional consent (control). The intervention group accessed an online platform featuring an 8-minute explanatory animation before providing eConsent, while the control group was consented by clinicians and signed a paper form. The primary outcome was questionnaire-based patient comprehension, with secondary outcomes including patient-reported experience (KidneyPREM), anxiety, and satisfaction with consent.
Results
Median participant age was 52 years (IQR [34-65]), 30.7% had ≤ year 12 education and 69.3% post-secondary qualifications. Baseline characteristics were similar between groups. PKB comprehension was significantly higher in the intervention group compared to control (3 more questions correct/9; p<0.001), regardless of education level. Moreover, the intervention group demonstrated better understanding of critical information related to pre- and post-PKB care and when to seek medical attention for complications. There were no statistically significant differences in KidneyPREM, anxiety, or satisfaction between groups.
Conclusion
Video-assisted eConsent enhances PKB comprehension without affecting KidneyPREM, anxiety or satisfaction. These benefits extend to patients with lower education levels. Its implementation could standardize and streamline consent processes in PKB, with potential application in other nephrology domains.
Patient and practice characteristics related to patient’s consent for health data exchange
Patient and practice characteristics related to patient’s consent for health data exchange
J J Keuper, K Hek, LHD van Tuyl, R S Batenburg, R A Verheij
European Journal of Public Health, 28 October 2024
Abstract
Background
Sharing patient health data electronically between healthcare providers can prevent medical errors and improve patient safety. In the Netherlands, exchange of health information is facilitated on a national level and is only allowed with patient consent. Consequently, it is important to know which factors are related to this patient consent.
Methods
Routine electronic health records data from up to 10% of Dutch general practices (sourced from the Nivel Primary Care Database) were utilized, covering the period from 2016 to 2020. We examined whether patient consent for health data exchange varied depending on patient and practice characteristics, which are expected to have a relationship with granting consent for health data exchange. Therefore, multilevel analysis was performed.
Results
The percentage of patients granting consent ranged between 40%-50% in the period 2016 to 2019, while this was 97% in 2020, due to the governmental corona opt-in regulation. Significant disparities were observed across several of the included patient and practice characteristics in relation to patient consent for all the years examined. In most years, patient consent provision varied by gender, age, socioeconomic position, location, and healthcare use. Practice characteristics showed notable differences in patient consent across information systems, patient volumes, and practice types over all years examined.
Conclusions
We observed significant variations in patient consent for health data exchange, both among the included patient (need) and practice characteristics. These differences may stem from unequal exposure to opportunities to grant consent, differences in risk of inadequate communication between healthcare providers, levels of health literacy, and practice resources. These factors should be taken into account by policymakers when further implementing and upscaling the national health data exchange system.
Parental Confirmation of a Child’s Consent to Data Processing
Parental Confirmation of a Child’s Consent to Data Processing
Paulina Klisowska
Adam Mickiewicz University Law Journal, 2024; pp 49–59
Open Access
Abstract
This article attempts to define the conditions for consenting to the processing of children’s personal data under the GDPR. The article focuses on analysing the data protection law, regarding to the most important problem, that at present, consent to data processing involves at most a few clicks or nudges, making it difficult to speak of any real control of data controllers over whether consent to the processing of a child’s personal data has been lawfully given or confirmed by an authorized person. It’s not hard to see that the young age of users, along with limited awareness of data protection and the risks associated with its use, makes this topic extremely relevant and worth addressing.
Editor’s note: Adam Mickiewicz University is based in Poznań, Poland.
Enabling Demonstrated Consent for Biobanking with Blockchain and Generative AI
Enabling Demonstrated Consent for Biobanking with Blockchain and Generative AI
Caspar Barnes, Mateo Riobo Aboy, Timo Minssen, Jemima Winifred Allen, Brian D. Earp, Julian Savulescu
The American Journal of Bioethics, 5 November 2024
Abstract
Participation in research is supposed to be voluntary and informed. Yet it is difficult to ensure people are adequately informed about the potential uses of their biological materials when they donate samples for future research. We propose a novel consent framework which we call “demonstrated consent” that leverages blockchain technology and generative AI to address this problem. In a demonstrated consent model, each donated sample is associated with a unique non-fungible token (NFT) on a blockchain, which records in its metadata information about the planned and past uses of the sample in research, and is updated with each use of the sample. This information is accessible to a large language model (LLM) customized to present this information in an understandable and interactive manner. Thus, our model uses blockchain and generative AI technologies to track, make available, and explain information regarding planned and past uses of donated samples.
Precision medicine and Friedreich ataxia: promoting equity, beneficence, and informed consent for novel gene therapies
Precision medicine and Friedreich ataxia: promoting equity, beneficence, and informed consent for novel gene therapies
International Journal for Equity in Health, 8 November 2024
Faith A. A. Kwa, Evie Kendal
Open Access
Abstract
Friedreich Ataxia (FA) is an incurable neurodegenerative disease with systemic consequences affecting vital organs including those of the central and peripheral nervous systems. This article will use FA as an example to explore some of the practical and ethical issues emerging in precision medicine for rare diseases. It will first describe the existing management strategies available for FA patients, before considering the potential impact of gene therapy trials on the prevention and treatment of disease symptoms. Finally, ethical considerations will be discussed, including equity of access and managing resource allocation dilemmas; balancing benefits, burdens and harms; and gaining informed consent for novel treatments.
Ethical issues in vaccine trial participation by adolescents: qualitative insights on family decision making from a human papillomavirus vaccine trial in Tanzania
Ethical issues in vaccine trial participation by adolescents: qualitative insights on family decision making from a human papillomavirus vaccine trial in Tanzania
Lucy Frost, Ms Tusajigwe Erio, Hilary Whitworth, Ms Graca Marwerwe, Richard Hayes, Kathy Baisley, Silvia de SanJosé, Deborah Watson-Jones, Kirstin Mitchell
BMC Medical Ethics, 20 November 2024
Open access
Abstract
Background
Research in children is essential for them to benefit from the outcomes of research but involvement must be weighed against potential harms. In many countries and circumstances, medical research legally requires parental consent until the age of 18 years, with poorly defined recommendations for assent prior to this. However, there is little research exploring how these decisions are made by families and the ethical implications of this.
Aim
To explore key ethical debates in decision-making for participation of children and adolescents in a human papillomavirus (HPV) vaccine trial.
Methods
Semi-structured interviews were undertaken with Tanzanian girls (aged 9–16 years) who had participated in an HPV vaccine trial (n = 13), their parents or guardians (n = 12), and girls together with their parents (in paired parent-child interviews) (n = 6). The interviews were analysed using thematic analysis. Interview data came from a qualitative acceptability study undertaken as part of the Dose Reduction Immunobridging and Safety Study of Two Human Papillomavirus (HPV) Vaccines in Tanzanian Girls (DoRIS) trial.
Results
Girls and parents desired collaborative decision-making, with parents ultimately making the decision to consent. However, girls wanted a larger part in decision-making. Decisions to consent involved many people, including extended social networks, the trial team, media outlets and healthcare professionals and this resulted in conflicts to be negotiated. Deciding where to place trust was central in participants and parents considering decisions to consent and overcoming rumours about trial involvement.
Conclusions
Existing models of decision-making help to understand dynamics between parents, adolescents and researchers but neglect the important wider social impacts and the fundamental nature of trust. Children’s roles in discussions can be evaluated using the principles of consent: autonomy, freedom and information. Concepts such as relational autonomy help to explain mechanisms families use to negotiate complex consent decisions. Whilst interviewees supported the maintenance of legal parental consent, researchers must design consent processes centring the child to ensure that whole family decision-making processes are supported.
Tools for effective patient education to manage outcome expectations in paediatric facial reanimation: a systematic review
Tools for effective patient education to manage outcome expectations in paediatric facial reanimation: a systematic review
Systematic Review
Dimitris Reissis, Cédric Zubler, Edel de Buitleir, Sam Brown, Jonathan Leckenby, Adriaan Grobbelaar
Plastic and Aesthetic Research, 30 October 2024
Open Access
Abstract
Aim
Informed consent for paediatric facial reanimation requires effective patient/parent education and involvement in a shared decision-making (SDM) process to help set their expectations and understanding from the outset. No article in the current literature has systematically reviewed the available tools for facilitating effective patient/parent education and the validity of informed consent in the context of paediatric facial reanimation.
Methods
A systematic literature review was undertaken, following the Preferred Reporting Items of Systematic Reviews and Meta-analyses (PRISMA) 2020 guidelines. MEDLINE via PubMed, Embase and Cochrane Library were searched and the results screened and reviewed in accordance with pre-defined inclusion and exclusion criteria.
Results
The initial search yielded 478 articles, of which only 4 fulfilled the study’s inclusion criteria. One cohort study evaluated qualitative feedback from patients and their relatives participating in a family education and support day for paediatric facial palsy, while another article from the same group reviewed the readability of online education resources. The remaining two articles represented educational reviews focusing on treatment and patient education based on expert opinion without providing original outcome data.
Conclusion
There is a paucity of evidence regarding patient/parent education to support the informed consent process for children undergoing paediatric facial reanimation. There remains a need for further resources and platforms to be developed that may support children and their parents in engaging in a SDM process, setting appropriate expectations, and providing valid informed consent for their surgery.
Center for Informed Consent Integrity 