Digital technology in informed consent for surgery: systematic review

Digital technology in informed consent for surgery: systematic review
Aoife Kiernan, Brian Fahey, Shaista S Guraya, Fiona Boland, Daragh Moneley, Frank Doyle, Denis W Harkin
British Journal of Surgery, 24 January 2023
Open Access
Abstract
Background
Informed consent is an ethical and legal requirement in healthcare and supports patient autonomy to make informed choices about their own care. This review explores the impact of digital technology for informed consent in surgery.
Methods
A systematic search of EBSCOhost (MEDLINE/CINAHL), Embase, Cochrane Central Register of Controlled Trials and Web of Science was performed in November 2021. All RCTs comparing outcomes of both digital and non-digital (standard) consent in surgery were included. Each included study underwent an evaluation of methodological quality using the Cochrane risk of bias (2.0) tool. Outcomes assessed included comprehension, level of satisfaction and anxiety, and feasibility of digital interventions in practice.
Results
A total of 40 studies, across 13 countries and 15 surgical specialties were included in this analysis. Digital consent interventions used active patient participation and passive patient participation in 15 and 25 studies respectively. Digital consent had a positive effect on early comprehension in 21 of 30 (70 per cent) studies and delayed comprehension in 9 of 20 (45 per cent) studies. Only 16 of 38 (42 per cent) studies assessed all four elements of informed consent: general information, risks, benefits, and alternatives. Most studies showed no difference in satisfaction or anxiety. A minority of studies reported on feasibility of digital technology in practice.
Conclusion
Digital technologies in informed consent for surgery were found to have a positive effect on early comprehension, without any negative effect on satisfaction or anxiety. It is recommended that future studies explore the feasibility of these applications for vulnerable patient groups and busy surgical practice.

Electronic Consent at US Cancer Centers: A Survey of Practices, Challenges, and Opportunities

Electronic Consent at US Cancer Centers: A Survey of Practices, Challenges, and Opportunities
Applied Research
Susan Chimonas, Allison Lipitz-Snyderman, Kemi Gaffney, Gilad J. Kuperman
JCO Clinical Cancer Informatics, 3 January 2023
Abstract
Purpose
Digital technologies create opportunities for improving consenting processes in cancer care and research. Yet, little is known about the prevalence of electronic consenting, or e-consent, at US cancer care institutions.
Methods
We surveyed institutions in the National Comprehensive Cancer Network about their capabilities for clinical, research, and administrative e-consents; technologies used; telemedicine consents; multilingual support; evaluations; and opportunities and challenges in moving from paper-based to electronic processes. Responses were summarized across responding institutions.
Results
Twenty-five institutions completed the survey (81% response rate). Respondents were from all census regions and included freestanding and matrix cancer centers. Twenty (80%) had e-consent capabilities, with variability in the extent of adoption: One (5%) had implemented e-consent for all clinical, research, and administrative needs while 19 (95%) had a mix of paper and electronic consenting. Among those with e-consent capabilities, the majority (14 of 20, 70%) were using features embedded in their electronic health record. Most had a combination of paper and e-consenting for clinical purposes (18, 72%). About two-thirds relied entirely on paper for research consents (16, 64%) but had at least some electronic processes for administrative consents (15, 60%). Obstacles to e-consenting included challenges with procuring or maintaining hardware, content management, workflow integration, and digital literacy of patients. Successes included positive user experiences, workflow improvements, and better record-keeping. Only two of 20 (10%) respondents with e-consent capabilities had evaluated the impact of automating consent processes.
Conclusion
E-consent was prevalent in our sample, with 80% of institutions reporting at least some capabilities. Further progress is needed for the benefits of e-consenting to be realized broadly.

Comparison of Spanish-Speaking Parental Understanding Using Two Alternative Consent Pathways

Comparison of Spanish-Speaking Parental Understanding Using Two Alternative Consent Pathways
Homa Amini, Andrew Carranco, Paul S. Casamassimo, Dennis McTigue, Jin Peng
Pediatric Dentistry, November-December 2022; 44(6) pp 400-403
Abstract
Purpose
The purpose of this study was to assess the understanding of Spanish-speaking caregivers consenting to dental core using general anesthesia (GA) utilizing two consent-delivery pathways.
Methods
Seventy-eight parents of children who never had GA were randomly assigned to one of two groups: (0) interpreter; or (2) video: they completed o survey to evaluate comfort level with GA and comprehension of areas of informed consent.
Results
Most parents in both groups understood the risks associated with GA (89 percent in the interpreter group and 90 percent in the video group). The majority of families had difficulty understanding indications for GA (64 percent in the interpreter group versus 60 percent in the video group). Overall, 97 percent of participants believed they sufficiently understood the information presented about GA. The mean score for comfort level with GA was 7.03 for the interpreter group and 6.82 for the video group.
Conclusion
Consent pathways used in this study were not significantly different for risk understanding and acquisition of consent-related knowledge.

Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With Traditional Paper-Based Methods

Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With Traditional Paper-Based Methods
Michael T. Buckley, Molly R. O’Shea, Sangeeta Kundu, Allison Lipitz-Snyderman, Gilad Kuperman, Suken Shah, Alexia Iasonos, Collette Houston, Stephanie L. Terzulli, Joseph M. Lengfellner, Paul Sabbatini
JCO Oncology Practice, 19 December 2022
Abstract
Purpose
Consent processes are critical for clinical care and research and may benefit from incorporating digital strategies. We compared an electronic informed consent (eIC) option to paper consent across four outcomes: (1) technology burden, (2) protocol comprehension, (3) participant agency (ability to self-advocate), and (4) completion of required document fields.
Methods
We assessed participant experience with eIC processes compared with traditional paper-based consenting using surveys and compared completeness of required fields, over 3 years (2019-2021). Participants who consented to a clinical trial at a large academic cancer center via paper or eIC were invited to either pre-COVID-19 pandemic survey 1 (technology burden) or intrapandemic survey 2 (comprehension and agency). Consent document completeness was assessed via electronic health records.
Results
On survey 1, 83% of participants (n = 777) indicated eIC was easy or very easy to use; discomfort with technology overall was not correlated with discomfort using eIC. For survey 2, eIC (n = 262) and paper consenters (n = 193) had similar comprehension scores. All participants responded favorably to at least five of six agency statements; however, eIC generated a higher proportion of positive free-text comments (P < .05), with themes such as thoroughness of the discussion and consenter professionalism. eIC use yielded no completeness errors across 235 consents versus 6.4% for paper (P < .001).
Conclusion
Our findings suggest that eIC when compared with paper (1) did not increase technology burden, (2) supported comparable comprehension, (3) upheld key elements of participant agency, and (4) increased completion of mandatory consent fields. The results support a broader call for organizations to offer eIC for clinical research discussions to enhance the overall participant experience and increase the completeness of the consent process.

Animation supported consent before elective laparoscopic cholecystectomy

Animation supported consent before elective laparoscopic cholecystectomy
Emre Doganay, David Wald, Sam Parker, Frances Hughes
British Journal of Surgery, 7 December 2022
Abstract
Background
Patient understanding of surgical procedures is often incomplete at the time they are performed, invalidating consent, and exposing healthcare providers to complaints and claims of failure to inform. Remote consultations, language barriers and patient factors can hinder an effective consent pathway. New approaches are needed to support communication and shared decision-making.
Methods
Multi-language digital animations explaining laparoscopic cholecystectomy were introduced at The Royal London Hospital for patients who attended for elective surgery (www.explainmyprocedure.com). Patients completed questionnaires on the day of their procedure both before and after introduction of the animations. We assessed patient-reported understanding of the procedure, its intended benefits, the possible risks, and alternatives to treatment in 72 consecutive patients, 37 before (no animation group) and after 35 after introducing the animations into the consent pathway (animation group). Patient understanding in the two groups was compared.
Results
The two groups were well matched in respect of age, sex and whether English was their first spoken language. The proportions of patients who reported they completely understood the procedure, its benefits, risks, and alternatives in the no animation group were 54%, 57%, 38% and 24% and in the animation group, 91%, 91%, 74% and 77% respectively; p<0.01 for each comparison.
Conclusions
The integration of multi-language laparoscopic cholecystectomy video animations into the patient consent pathway was associated with substantial improvement in reported understanding of the procedure, benefits, risks, and alternatives to treatment. This approach can be applied across all surgical disciplines in a standardised manner in an era of accelerated elective work and remote consultations.

Digital Informed Consent: Modernising Information Sharing in Surgery to Empower Patients

Digital Informed Consent: Modernising Information Sharing in Surgery to Empower Patients
Original Scientific Report
Simon L. Parsons, Prita Daliya, Phil Evans, Dileep N. Lobo
World Journal of Surgery, 3 December 2022
Open Access
Abstract
Background
Despite the 2015 Montgomery Ruling highlighting key requisites for informed consent, little has changed to modernise data-sharing and documentation of the consent process. It can be difficult to gauge patient understanding and address all patient concerns in time-limited appointments. We aimed to assess the feasibility of a digital information-sharing platform to support a move towards a digital informed consent process.
Methods
All adult patients referred to a single centre with symptomatic gallstones were invited to use a digital information-sharing platform to support the informed consent process prior to their first surgical clinic appointment. The platform provided patients with multimedia information on gallstones and available treatment options. It recorded the time spent accessing information, asked patients multiple choice questions (MCQs) to allow a self-test of understanding, documented a summary medical history, and allowed free text for patient questions. This information was summarised into a clinical report to support outpatient clinic consultations.
Results
Of the 349 patients registered to use the digital platform, 203 (58.2%) [165 (81.3%) female, mean age 47.6 years (range 19–84 years)] completed all modules necessary to generate a clinical report. Some 130 patients (64.0%) answered all 10 MCQs correctly and spent a mean of 18.7 min (range 3–88 min) reading the consent information. Most patient-reported medical histories were deemed to be accurate.
Conclusion
Despite difficulties with access, resulting in drop-outs, patients welcomed the opportunity to receive information digitally, prior to their consultation. Patients described feeling empowered and better informed to be involved in decision-making.

A Video-Based Consent Tool: Development and Effect of Risk–Benefit Framing on Intention to Randomize

A Video-Based Consent Tool: Development and Effect of Risk–Benefit Framing on Intention to Randomize
Alex Lois, Jonathan E. Kohler, Sarah E. Monsell, Kelsey M. Pullar, Jesse Victory, Stephen R. Odom, Katherine Fischkoff, Amy H. Kaji, Heather L. Evans, Vance Sohn, Lillian S. Kao, Shah-Jahan Dodwad, Anne P. Ehlers, Hasan B. Alam, Pauline K. Park, Anusha Krishnadasan, David A. Talan, Nicole Siparsky, Thea P. Price, Patricia Ayoung-Chee, William Chiang, Matthew Salzberg, Alan Jones, Matthew E. Kutcher, Mike K. Liang, Callie M. Thompson, Wesley H. Self, Bonnie Bizzell, Bryan A. Comstock, Danielle C. Lavallee, David R. Flum, Erin Fannon, Larry G. Kessler, Patrick J. Heagerty, Sarah O. Lawrence, Tam N. Pham, Giana H. Davidson
Journal of Surgical Research, March 2023; 283 pp 357-367
Abstract
Introduction
Nearly 75% of clinical trials fail to enroll enough participants, and cohorts often fail to reflect the clinical and demographic diversity of at-risk populations. Effective recruitment strategies are critically important for successful clinical trials. Framing treatment risks are known to affect medical decision-making for both physicians and patients but has not been rigorously studied in surgical trials. We sought to examine the impact of a high-quality video-based consent tool and the effect of risk–benefit framing on patient willingness to participate in a surgical clinical trial.
Methods
A standardized video consent was shown to all potential participants in the Comparison of Outcomes of antibiotic Drugs and Appendectomy (CODA) trial, a randomized controlled trial comparing antibiotics and surgery for acute appendicitis. We report (1) differences in recruitment between two versions of a video-based tool that differed in production quality and (2) the impact of risk–benefit framing on participant randomization rates. The reasons for declining randomization were also assessed.
Results
Of 4697 eligible patients approached to participate in the CODA trial, 1535 (33% [95% confidence interval (CI): 31%-34%]) agreed to randomization; this did not change from video version 1 to version 2. There was no difference in participation between positively framed videos (32% [95% CI: 30%-34%]) versus negatively framed videos (33.0% [95% CI: 30.8-35.2]). The most common reason for declining participation was treatment preference (72% for surgery and 18% for antibiotics).
Conclusions
Neither the change from video 1 to video 2 nor the positive versus negative framing affected participant willingness to randomize. The stakeholder-informed video-based consenting tool used in CODA was an effective strategy for the recruitment of a heterogeneous patient population within the proposed study period.

Electronic informed consent criteria for research ethics review: a scoping review

Electronic informed consent criteria for research ethics review: a scoping review
Research
Mohd Yusmiaidil Putera Mohd Yusof, Chin Hai Teo, Chirk Jenn Ng
BMC Medical Ethics, 21 November 2022; 23 (117)
Open Access
Abstract
Background
The research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent (eConsent) may be used to assess the research subject’s comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.
Methods
The search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation guideline was used to report this work.
Results
Of 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs (27%, n = 65) followed by accessibility (24%, n = 56), comprehension engagement (18%, n = 43), autonomy (14%, n = 34), confidentiality (11%, n = 25), language (5%, n = 13), and parental consent (1%, n = 2). Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.
Conclusion
The current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/REC members during a review process on electronic informed consent and useful to the future preparation of a checklist.

Learning to listen: A complementary approach to informed consent for patients with visual impairments

Learning to listen: A complementary approach to informed consent for patients with visual impairments
Forum
Kayo Takashima, Takeshi Soma, Kaori Muto, Kohji Nishida, Jusaku Minari
Stem Cell Reports, 10 November 2022
Open Access
Excerpt
This forum describes an exploratory approach for assisting individuals with visual impairment during the informed consent (IC) process to participate in a cutting-edge trial. Our approach has been developed to focus on potential participants’ preparedness to give IC, along with the creation of supporting audio material…

A cost–consequence analysis of eLearning videos designed to supplement the consent process in lower limb arthroplasty

A cost–consequence analysis of eLearning videos designed to supplement the consent process in lower limb arthroplasty
J Brock, A Sale, U Jayaraju, A Chandetreya, P Lee
Royal College of Surgeons of England Annals, 19 October 2022
Abstract
Introduction
Since the Montgomery ruling in 2015 surgeons have been tasked with identifying material risk when taking informed consent. Despite this, there has been limited uptake of technological aids to supplement the consent process although such aids are shown to improve patient knowledge and satisfaction. ConsentPLUS is a free-to-access website with bite-sized educational videos designed to clearly explain lower limb arthroplasty procedures to patients and aid their consent.
Methods
We performed a prospective cost–consequence analysis, outlining any costs associated with the intervention and any quantitative or qualitative impacts the intervention may have on patients.
Results
A total of 3,143 consecutive patients were identified who were undergoing total knee or hip replacement in 25 elective NHS orthopaedic units. The total cost of development and projected 10-year running fees for ConsentPLUS total £75,000. Health Foundation support means the service is free-to-access for centres throughout the UK. Mean exposure time per patient was 10min 29s, equivalent to £185,437 of additional contact time according to the National Tariff. Mean clinic time was reduced by 17min owing to the earlier identification of material risk. Patient knowledge on pre- and post-video quizzes increased from 7.01 to 9.08 following eLearning (paired t-test = 0.998). The process had an overall satisfaction rate of 97%.
Conclusion
Educational eLearning videos are an accessible and digestible way to supplement the consent process. This enables earlier identification of material risk in clinics owing to improved patient knowledge, leading to increased patient satisfaction with arthroplasty consenting.