Informed Consent Through 3D Virtual Reality: A Randomized Clinical Trial

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Informed Consent Through 3D Virtual Reality: A Randomized Clinical Trial
Alessandro Perin, Tommaso Francesco Galbiati, Roberta Ayadi, Enrico Gambatesa, Eleonora Francesca Orena, Nicole Irene Riker, Hagit Silberberg, Donatella Sgubin, Torstein Ragnar Meling, Francesco DiMeco
Acta Neurochirurgica, 3 April 2020
Abstract
Background
The informed consent is a defining moment that should allow patients to understand their condition, what procedure they are undergoing, and what consequences may follow. This process should foster trust and promote confidence, without increasing patients’ anxiety. New immersive 3D imaging technologies may serve as a tool to facilitate this endeavor.
Methods
In a prospective, single-center, randomized controlled clinical trial (SPLICE Study: Surgical Planning and Informed Consent Study; ClinicalTrials.gov NCT03503487), 40 patients undergoing surgery for intracranial tumors were enrolled. After undergoing a traditional surgical informed consent acquisition, 33 patients were randomized 1:1:1 to 3 groups: in 2 experimental groups, patients underwent a 3D, immersive informed consent with two different surgical planners (group 1 and group 2); in the control group, patients underwent an informed consent supported by traditional 2D radiological images.
Results
Patients in the experimental groups appreciated this communication experience, while their objective comprehension was higher ((score mean (SD)): group 1 82.65 (6.83); group 2 77.76 (10.19)), as compared with the control group (57.70 (12.49); P < 0.001). Subjective comprehension and anxiety levels did not differ between experimental groups and control group.
Conclusions
3D virtual reality can help surgeons and patients in building a better relationship before surgery; immersive 3D-supported informed consent improves patients’ comprehension of their condition without increasing anxiety. This new paradigm may foster trust between surgeons and patients, possibly restraining medical-legal acts.

Editor’s note: Acta Neurochirurgica is an Austrian journal.

Educational Video Addition to the Bariatric Surgery Informed Consent Process: a Randomized Controlled Trial

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Educational Video Addition to the Bariatric Surgery Informed Consent Process: a Randomized Controlled Trial
Original Contributions
Saglam K, Kayaalp C, Aktas A, Sumer F
Obesity Surgery, 11 Apr 2020
Abstract
Objective
Bariatric surgery is not a risk-free procedure and requires lifelong patient compliance in the postoperative period. Although the risks involved in bariatric surgery and the importance of lifelong follow-ups in the postoperative period are explained to patients in detail through verbal and written informed consent, the strong desire for weight loss can sometimes cause patients and their families to be ignorant of the mentioned issues preoperatively. The objective of this study is to evaluate the effectiveness of preoperative informational videos at improving the comprehension of informed consent content in bariatric surgery candidates.
Materials and Methods
A total of 74 bariatric surgery candidates were randomized into two groups. The first group was given a usual verbal-written informed consent. The second group got an additional informing video presentation informed consent, in addition to the usual verbal-written informed consent. Then, both groups got a questionnaire evaluating their knowledge of bariatric surgery informed consent. The correct response scores and their relationship with patient demographics were analyzed.
Results
Both groups had similar demographic features. Video-presented group had higher scores in questionnaire (11.3 ± 2.3 versus 9.4 ± 1.7, p = 0.001). Subgroup analysis showed that health care workers (12.5 ± 1.9 versus 10.3 ± 2.2, p = 0.005) and university graduates (11.6 ± 2.4 versus 10.1 ± 2.1, p = 0.03) got better results in the questionnaire. In multivariate analysis, video-assisted informing was found to be the only independent variable for high questionnaire scores (p = 0.0001).
Conclusions
This study showed that video-assisted informed consent improves patients’ comprehension prior to bariatric surgery. We recommend routine preoperative video-assisted informing for bariatric surgery candidates in addition to usual verbal-written informed consent.

Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial

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Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial
Research Article
Erin Rothwell, Erin Johnson, Bob Wong, Aaron Goldenberg, Beth A. Tarini, Naomi Riches, Louisa A. Stark, Christina Pries, Carrie Langbo, Elizabeth Langen, Jeffrey Botkin
Journal of Empirical Research on Human Research Ethics, 3 April 2020
Abstract
Obtaining informed consent for bloodspot research from newborn screening is particularly challenging due to the hectic environment of the postnatal period and the relatively abstract nature of future, unspecified research on the biospecimens. A randomized controlled trial was conducted in three Michigan hospitals to compare two different consent processes (video and interactive tablet “app”) with standard brochure-based consent in the Michigan BioTrust for Health. Results indicated higher knowledge scores for the video and app groups as well as significantly higher scores on satisfaction, amount of information, and clarity with the information provided. More research is needed to find the right amount of information for informed decision-making, and additional feasibility studies are needed to assess implementation strategies.

Assessing the stability of biobank donor preferences regarding sample use: evidence supporting the value of dynamic consent

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Assessing the stability of biobank donor preferences regarding sample use: evidence supporting the value of dynamic consent
Joel E. Pacyna, Jennifer B. McCormick, Janet E. Olson, Erin M. Winkler, Josh T. Bublitz, Matthew A. Hathcock & Richard R. Sharp
European Journal of Human Genetics, 23 April 2020
Abstract
Dynamic consent has been proposed as a strategy for addressing the limitations of traditional, broad consent for biobank participation. Although the argument for dynamic consent has been made on theoretical grounds, empirical studies evaluating the potential utility of dynamic consent are needed to enhance deliberations about the merits of dynamic consent. Few studies have assessed such considerations as whether donor preferences may change over time or if participants would use a dynamic consent mechanism to modify preferences when they change. We administered a 66-item survey to participants in a large DNA biobank. The survey sought to gauge the stability of donor preferences specified at the time of biobank enrollment, specifically the stability of donors’ preference regarding posthumous availability of biospecimens to next-of-kin. We received 1164 completed surveys for a response rate of 72%. Forty percent of respondents indicated a preference regarding sample availability on the survey (T2) that was inconsistent with the preference they had expressed when they enrolled in the biobank (T1). Most (94%) individuals with inconsistent preferences regarding sample availability had initially restricted sample availability at T1 but were comfortable with broader availability when asked at the time of the survey (T2). Our findings demonstrate that preferences regarding sample use expressed at the time of enrollment in a DNA biobank may not be reliable indicators of donor preferences over time. These findings lend empirical support to the case for a dynamic consent model in which biobank participants are approached over time to clarify their views regarding sample use.

Approaches for assessing decision-making capacity in older adults a scoping review protocol

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Approaches for assessing decision-making capacity in older adults a scoping review protocol
Systematic Review Protocols
Ruth Usher, Tadhg Stapleton
JBI Evidence Synthesis, April 2020; 18(4) pp 832-840
Open Access
Abstract
Objective
This review will identify and map existing evidence on current approaches to determining decision-making capacity in older adults. It will provide a summary of available evidence and policies and identify gaps in research.
Introduction
Assessment of decision-making capacity is emerging as an important issue in society and healthcare. It is considered an ethically challenging area of clinical practice, and issues with implementation have been identified internationally. With the aging population increasing globally, approaches to assess and support decision-making are becoming more pertinent.
Inclusion criteria
This scoping review will consider studies on assessment approaches and procedures that are used to evaluate the decision-making capacity of older adults, aged 60 years and over. It will include those with age-related cognitive impairment, dementia, and neurodegenerative conditions. Quantitative, qualitative, and mixed-methods studies along with gray literature, including expert opinions, policies reports, and practice guides, will be included.
Methods
The JBI scoping review methodological framework will be used. The review will also be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) checklist for scoping reviews. The following major healthcare databases will be searched: MEDLINE, PsycINFO, Embase, CINAHL, Cochrane Databases, Web of Science, and Scopus. The search will cover studies published in English from January 2000 to the present date. Titles and abstracts will be screened against inclusion criteria. Data will be extracted using a form developed for this review. A stakeholder consultation meeting will be held to provide feedback on the findings.

Ageism in Consent? In a decision-making capable geriatric orthopaedic trauma patient population, does increased age impact who physicians consent for surgical fixation?

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Ageism in Consent? In a decision-making capable geriatric orthopaedic trauma patient population, does increased age impact who physicians consent for surgical fixation?
Madeline M McGovern, Michael F McTague, Marilyn Heng
Jefferson Digital Commons, January 2020
Open Access
Abstract
Introduction
Persistent misconceptions of frailty and dementia in geriatric patients impact physician-patient communication and leave patients vulnerable to disempowerment. Our study examines the consenting process in an orthogeriatric trauma patient population to determine if there is a relationship between increased age at presentation and utilization of health care proxies (HCPs) for surgical procedure consent.
Methods
We retrospectively reviewed medical records of patients aged 65 and older admitted for an operative fracture between 2013 and 2016. Patients were considered decision-making capable if there was absence of history of cognitive impairment prior to surgical consent and if the patients screened negative in a pre-surgical Confusion Assessment Method (CAM) and Mini-Cog Assessment. Data was analyzed via chi-squared and t-test analysis in SPSS.
Results
510 patients were included, and 276 (54.1%) patients were deemed capable of consent. 27 (9.8%) decision-making capable patients had HCPs consent for surgery. 20 of the 27 (74.1%) were 80 years of age or older and 7 patients between 70 and 79 had HCP consent. (p=0.07). HCP consent was significant for age (p<0.001), income level (p=0.03), and HCP physically present at consult (p<0.001). Additionally, language other than English was found to be a significant predictor of HCP consent (p=0.035).
Conclusion
It is concerning that cognitively intact geriatric orthopaedic trauma patients are not always consented for their own surgical procedures. Factors including age, income, and language contribute to increased risk of HCP consent. Increased physician vigilance and adoption of institutional consenting guidelines can reinforce appropriate respect of geriatric patients’ consenting capacity.

Editor’s note: The Jefferson Digital Commons is a service of Thomas Jefferson University’s Center for Teaching and Learning (CTL). The Commons is a showcase for Jefferson books and journals, peer-reviewed scholarly publications, unique historical collections from the University archives, and teaching tools.

Reflecting on three creative approaches to informed consent with children under six

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Reflecting on three creative approaches to informed consent with children under six
Lorna Arnott, Loreain Martinez, Kate Wall, Caralyn Blaisdell, Ioanna Palaiologou
British Educational Research Journal, 10 March 2020
Abstract
In an era where children’s rights are paramount, there are still few practical examples to guide us when seeking informed consent from children. This paper therefore makes a significant contribution to the field by examining three practical approaches to negotiating informed consent with young children under 6 years old. We draw on researcher field notes, images and observations from four research projects that employed creative methods for seeking informed consent from young children. We take a reflexive approach, considering how successful the three techniques have been in facilitating young children’s decision making around research participation. Our findings suggest that innovative approaches to informed consent create spaces for children to engage in dialogue and questioning about the research project. However, in order for the approaches to be meaningful they need to be pedagogically-appropriate to the maturity and capabilities of the children. We also demonstrate that irrespective of the approach devised, researchers have a responsibility to ensure consent is continuously negotiated throughout the project through reflexive questioning.

Children’s ability to consent to medical management in South Africa

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Children’s ability to consent to medical management in South Africa
J van Heerden, R Delport, M Kruger
South African Journal of Child Health, 23 April 2020; 14(1) pp 25-29
Open Access
Abstract
Background
The South African Children’s Act No. 38 of 2005 requires paediatric medical consent from 12 years of age
Objective
To determine children’s ability to provide informed consent for medical treatment.
Methods
Assessment used hypothetical treatment storyboards and structured interviews for assessment of 100 children (aged 10 -17 years), and 25 adult controls, using a tandardized scoring tool to test understanding, ability to deliberate treatment choices, and provide rational reasons. Statistical analysis involved multivariate analyses of variance (MANOVAs) and analysis of variance (ANOVA).
Results
The female:male ratios for children and adults were 1:0.92 and 1:0.98, respectively. Children ≥12 years were competent with regard to treatment choices (p<0.001), while 10-year-olds could deliberate reasonable outcomes, similar to adults (p<0.001). However, only children 12 years and older could provide rational reasons, where abstract concepts were not involved, whereas children who were ≥14 years old were able to provide rational reasons involving abstract concepts. The actual understanding of choices, compared with adults, was only observed in children older than 14 years (p<0.001). Gender was not a statistically significant denominator.
Conclusion
Children of 12 years and older are competent to make medical decisions, but the understanding of medical treatment choices under the age of 14 years is not clear.

A Survey of Current Practices of Informed Consent by Pediatric Anesthesiologists

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A Survey of Current Practices of Informed Consent by Pediatric Anesthesiologists
Short Report
Allison M Fernandez, Scott C Watkins, David J Clendenin, Erik B Smith, Jenny E Dolan, Ernest Amankwah, Ali Jalali, Luis Ahumada, Anh Thy H Nguyen, Mohamed Rehman, Richard A Elliott
Pediatric Anesthesia, 22 April 2020
Abstract
Informed consent is fundamental to the ethical practice of medicine and carries important legal implications. Of particular relevance to pediatric anesthesia is the Food and Drug Administration’s Drug Safety Communication (DSC), which highlights potential yet theoretical adverse effects on brain development of repeated or prolonged anesthesia administration to children younger than 3 years of age.

Risk disclosure and informed consent: practice caveats in the post‐Montgomery era

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Risk disclosure and informed consent: practice caveats in the post‐Montgomery era
Original Article
Danny WH Lee, Paul BS Lai
Surgical Practice, 1 April 2020
Abstract
The UK Supreme Court decision in Montgomery v Lanarkshire Health Board has overturned the use of the “accepted practice test” (Bolam) in deciding breach of duty cases related to risk disclosure and informed consent. Following Montgomery, a doctor is under a legal duty to take reasonable care to ensure his patient is aware of any material risks involved in the recommended treatment, and of any reasonable alternative or variant treatments. Based on Montgomery and a number of relevant published cases, this article highlighted some practice caveats for surgeons to take note of when they participate in the consent process with the following headings: the objective and subjective elements of the legal test of materiality of risks; postoperative risks, follow‐up and management; timing and adequacy of risk disclosure; withholding information and therapeutic exception; and the incorporation of Montgomery into local professional code and case law. In order to minimize legal risks, surgeons are also encouraged to keep abreast of the medico‐legal development in this area, to reflect on their own practices, and to take proactive steps to enhance their interactions with patients.