Use of multimedia during informed consent: novelty or necessity
Henry H. Chill, Uri Dior, David Shveiky
International Urogynecology Journal, 13 July 2019; pp 1–3 
Abstract
The process of informed consent is an integral part of the preoperative encounter. In theory, it has the potential to educate patients, enabling them to reach a true autonomous decision regarding the treatment offered. Unfortunately, in recent years informed consent has become overly complicated for the average patient. Questions have been raised regarding the ability of the process, as practiced nowadays, to actually increase knowledge and achieve its goals. In search of new ways to increase patient comprehension, researchers have suggested use of multimedia during the process of informed consent. Visualization of complex ideas, interactive learning and tailoring the procedure to fit patient needs are all advantages presented by use of multimedia during the process. Several randomized prospective trials have looked into this topic and have presented promising data in favor of multimedia use. Informed consent is a process with unfulfilled potential, and use of multimedia may be part of the solution. In our opinion, it is time to change the way we educate patients.

Electronic informed consent: the need to redesign the consent process for the digital age
Personal Viewpoint
Helen Lunt, Saxon Connor, Helen Skinner, Greg Brogden
International Medicine Journal, 11 July 2019
Abstract
The delivery of healthcare, which includes the informed consent process, is moving to a digital environment. This change in informed consent delivery will be associated with opportunities, risks and also unintentional consequences. Physicians are well placed to contribute to the ongoing dialogue about what is needed to make the informed consent process fit for purpose, in the digital age.

Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study
Research Article 
Linda Brubaker, J Eric Jelovsek, Emily S Lukacz, Sunil Balgobin, Alicia Ballard, Alison C Weidner, Marie G Gantz, Ryan Whitworth, Donna Mazloomdoost
Clinical Trials, 26 July 2019
Abstract
Background/aims
In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone.
Methods
Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5 years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student’s t-test (continuous) and chi-square or Fisher’s exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p < 0.05.
Results
Of the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p = 0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p = 0.47) or in any secondary outcomes. Being “very satisfied” overall with study information (97.7% vs 88.5%, p = 0.01); “strong agreement” for feeling informed about the study (81.3% vs 70.8%, p = 0.06), understanding the study purpose (83.6% vs 71.0%, p = 0.02), nature and extent (82.8% vs 70.2%, p = 0.02), and potential societal benefits (82.8% vs 67.9%, p = 0.01); and research coordinator/study nurse relationship being “very important” (72.7% vs 63.4%, p = 0.03) were better in the video compared to the no video consent group.
Conclusion
The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.

Oxford Video Informed Consent Tool (OxVIC): a pilot study of informed video consent in spinal surgery and preoperative patient satisfaction
Research
Gerard Mawhinney, Chrishan Thakar, Victoria Williamson, Dominique A Rothenfluh, Jeremy Reynolds
BMJ Open, 24 July 2019; 9(7)
Open Access
Abstract
Objectives 
The British Association of Spinal Surgeons recently called for updates in consenting practice. This study investigates the utility and acceptability of a personalised video consent tool to enhance patient satisfaction in the preoperative consent giving process.
Design 
A single-centre, prospective pilot study using questionnaires to assess acceptability of video consent and its impacts on preoperative patient satisfaction.
Setting 
A single National Health Service centre with individuals undergoing surgery at a regional spinal centre in the UK.
Outcome measure 
As part of preoperative planning, study participants completed a self-administered questionnaire (CSQ-8), which measured their satisfaction with the use of a video consent tool as an adjunct to traditional consenting methods.
Participants 
20 participants with a mean age of 56 years (SD=16.26) undergoing spinal surgery.
Results 
Mean patient satisfaction (CSQ-8) score was 30.2/32. Median number of video views were 2–3 times. Eighty-five per cent of patients watched the video with family and friends. Eighty per cent of participants reported that the video consent tool helped to their address preoperative concerns. All participants stated they would use the video consent service again. All would recommend the service to others requiring surgery. Implementing the video consent tool did not endure any significant time or costs.
Conclusions 
Introduction of a video consent tool was found to be a positive adjunct to traditional consenting methods. Patient–clinician consent dialogue can now be documented. A randomised controlled study to further evaluate the effects of video consent on patients’ retention of information, preoperative and postoperative anxiety, patient reported outcome measures as well as length of stay may be beneficial.

Obtaining Informed Consent Using Patient Specific 3D Printing Cerebral Aneurysm Model
Pil Soo Kim, Chang Hwa Choi, In Ho Han, Jung Hwan Lee, Hyuk Jin Choi, Jae Il Lee
Journal of Korean Neurosurgical Society, 1 July 2019; 62(4) pp 398-404
Open Access
Abstract
Objective
Recently, three-dimensional (3D) printed models of the intracranial vascular have served as useful tools in simulation and training for cerebral aneurysm clipping surgery. Precise and realistic 3D printed aneurysm models may improve patients’ understanding of the 3D cerebral aneurysm structure. Therefore, we created patient-specific 3D printed aneurysm models as an educational and clinical tool for patients undergoing aneurysm clipping surgery. Herein, we describe how these 3D models can be created and the effects of applying them for patient education purpose.
Methods
Twenty patients with unruptured intracranial aneurysm were randomly divided into two groups. We explained and received informed consent from patients in whom 3D printed models-(group I) or computed tomography angiography-(group II) was used to explain aneurysm clipping surgery. The 3D printed intracranial aneurysm models were created based on time-offlight magnetic resonance angiography using a 3D printer with acrylonitrile-butadiene-styrene resin as the model material. After describing the model to the patients, they completed a questionnaire about their understanding and satisfaction with aneurysm clipping surgery.
Results
The 3D printed models were successfully made, and they precisely replicated the actual intracranial aneurysm structure of the corresponding patients. The use of the 3D model was associated with a higher understanding and satisfaction of preoperative patient education and consultation. On a 5-point Likert scale, the average level of understanding was scored as 4.7 (range, 3.0–5.0) in group I. In group II, the average response was 2.5 (range, 2.0–3.0).
Conclusion
The 3D printed models were accurate and useful for understanding the intracranial aneurysm structure. In this study, 3D printed intracranial aneurysm models were proven to be helpful in preoperative patient consultation.

Ethical Tensions Resulting from Interpreter Involvement in the Consent Process
Amelia Barwise, Richard Sharp, and Jessica Hirsch
Ethics & Human Research, July 2019; 41(4) pp 31-35
Open Access
Abstract
We describe how our institution responded when an interpreter who participated in the consent process involving an individual with limited English proficiency refused to cosign consent documents attesting that the individual enrolling in the study understood the consent information and that her consent to enroll was voluntary. In developing our approach, our institution took into account ethical tensions between the Belmont principles of respect for persons, beneficence, and justice that apply to the protection of research participants and the professional principles of beneficence, fidelity, and respect for the importance of culture that are outlined in ethical guidelines for medical interpreters.

Editor’s note: The Belmont principles referred to above can be found in the Belmont Report here.

Evaluation of a REDCap-based Workflow for Supporting Federal Guidance for Electronic Informed Consent
Cindy Chen, Scott P. Turner, Evan T. Sholle, Scott W. Brown, Vanessa L.I. Blau, Julianna P. Brouwer, Alicia N. Lewis, Curtis L. Cole, David M. Nanus, Manish A. Shah, John P. Leonard, Thomas R. Campion, Jr.
AMIA Joint Summits on Translational Science Proceedings, 6 May 2019; pp 163–172
Open Access
Abstract
Adoption of electronic informed consent (eConsent) for research remains low despite evidence of improved patient comprehension, usability, and workflow processes compared to paper. At our institution, we implemented an eConsent workflow using REDCap, a widely used electronic data capture system. The goal of this study was to evaluate the extent to which the REDCap eConsent solution adhered to federal guidance for eConsent. Of 29 requirements derived from sixteen recommendations from the United States Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA), the REDCap eConsent solution supported 24 (86%). To the best of our knowledge, this is among the first studies to evaluate an eConsent approach’s support for federal guidance. Findings suggest use of REDCap may help other institutions overcome barriers to eConsent adoption, and that OHRP and FDA expand guidance to recommend eConsent solutions integrate with enterprise clinical and research information systems.

Research ethics for mobile sensing device use by vulnerable populations
Samantha Breslin, Martine Shareck, Daniel Fuller
Social Science & Medicine, July 2019; 232 pp 50-57
Abstract
Devices equipped with sensors to track mobility, such as through Global Position Systems (GPS) and accelerometery, are increasingly being used for research. Following Canadian, US, and International guidelines there is a need to give special consideration when conducting research with vulnerable populations. This paper examines specific ethical concerns for conducting research with mobile sensing devices for use by vulnerable populations, considering aspects of both research design and research process. Drawing on insights from feminist design and aligned fields, such as participatory design and action research, we contend that any research design and process for working with vulnerable populations must be developed in collaboration with the particular groups and communities who are part of the research. As part of this process of collaborative research, we discuss risks in terms of the lack of control over data associated with choosing commercial devices, as well as practicality and obtrusiveness of devices for the wearer. We also discuss the significance of informed consent and refusal and issues relating to security and safety during research. As part of the collaborative research design and process, we argue that participants should be given as much control over their data as possible. Based on this discussion, we provide recommendations for researchers to consider, which are broadly relevant for research using mobile sensing devices but particularly significant in relation to vulnerable populations.

A randomized, controlled trial of video supplementation on the cataract surgery informed consent process
Journal Article 
Zhang MH, Haq ZU, Braithwaite EM, Simon NC, Riaz KM
Graefe’s Archive for Clinical and Experimental Ophthalmology, 30 May 2019; pp 1-10
Abstract
Purpose
To assess the effects of the American Academy of Ophthalmology’s 2015 patient education video on patient information retention and anxiety preoperatively, on the day of surgery and postoperatively.
Methods
This is a prospective, surgeon-blinded randomized controlled trial at the University of Chicago Medical Center. Ninety-one patients with a diagnosis of first-eye cataract were randomized into either a video or control group. Subjects in both groups received face-to-face discussion with the surgeon and an informational brochure at the preoperative evaluation. Participants in the video group then viewed a four-minute educational video at the preoperative evaluation and on the day of surgery. Both groups completed an information retention quiz and a state anxiety assessment at the preoperative visit, on the day of surgery, and on the postoperative week one visit. Subject understanding of cataract surgery was measured using a twelve-question multiple choice quiz. State anxiety was measured by State Trait Anxiety Inventory-Y1 survey score.
Results
Participants in the video group did not score significantly higher on the information retention quiz compared with the control group at the preoperative evaluation (8.7 ± 2.4 vs 7.7 ± 2.5, P = 0.07), but did so on the day of surgery (11.2 ± 0.8 vs 8.4 ± 1.7, P < 0.001) and postoperative week 1 visit (10.8 ± 1.5 vs 9.0 ± 2.0, P < 0.001). Subjects in the video group were significantly less anxious on the day of surgery (26.4 ± 5.1 vs 41.1 ± 10.3, P < 0.001).
Conclusions
Video supplementation to the traditional informed consent process demonstrated an improvement in patient understanding of cataract surgery at multiple timepoints and decreased anxiety on the day of surgery.

An Educational Video Improves Consent in Pediatric Lumbar Puncture: A Randomized Control Trial
Research Paper
MaryDunbar, GillianPaton, AshutoshSinghal
Pediatric Neurology, 13 May 2019
Abstract
Background
Lumbar puncture is a low-risk procedure performed on pediatric patients for a variety of indications. Parents are consented to this procedure but are often left with concerns. There are no published studies on the nature of the concerns of parents in North America, and no studies examining a process to improve pediatric lumbar puncture consent.
Objective
Identify parent concerns with lumbar puncture and determine the utility of an adjunctive educational video.
Methods
Seventy-two patient-parent dyads were enrolled in a randomized control trial to receive standard consent with or without an educational video. A survey was provided to determine parent self-rated understanding of the procedure, their perception of its safety, their perception of the painfulness and their overall comfort with their child undergoing lumbar puncture. In addition, demographic characteristics and qualitative information about parent concerns were collected.
Results
The video resulted in significantly greater parent understanding of the procedure (p=0.015) and perception of its safety (p=0.021) compared to controls. Parent comfort with the procedure increased after viewing the video (p = 0.002). Parents’ top three concerns were pain, infection, and neurologic injury.
Conclusions
Parent concerns in pediatric lumbar puncture include pain, infection and neurologic injury, and viewing an educational video improved parent perception of understanding and safety compared to controls. In addition, there was reduced variability of responses in those who viewed the video. Thus, a short educational video on a handheld device is an effective means to address parent concerns and standardize the process of pediatric lumbar puncture consent.