Digitized and structured informed patient consent before contrast-enhanced computed tomography: feasibility and benefits in clinical routine
Original Article
Markus Kopp, Jan Peter Roth, Frederik Geisler, Sascha Daniel, Theresa Ruettinger, Christoph Treutlein, Eva L. Balbach, Rafael Heiss, Matthias Wetzl, Nouhayla El Amrani, Alexander Cavallaro, Michael Uder, Matthias S. May
Insights into Imaging, 11 October 2022; 13(164)
Open Access
Abstract
Background
To evaluate the feasibility and benefits of digitized informed patient consent (D-IPC) for contrast-enhanced CT and compare digitized documentation with paper-based, conventional patient records (C-PR).
Methods
We offered D-IPC to 2016 patients scheduled for a CT. We assessed patient history (e.g., CT examinations, malignant or cardiovascular diseases) and contraindications (red flags) for a CT (e.g., thyroid hyperfunction, allergies) using a tablet device. We evaluated the success rate of D-IPC and compared patient age between the subgroups of patients who were able or unable to complete D-IPC. We analyzed the prevalence of marked questions and red flags (RF). RF were compared with the documentation from C-PR. We estimated greenhouse gas (GHG) emissions for paperless workflow and provide a cost–benefit analysis.
Results
Overall, 84.4% of patients completed D-IPC. They were younger (median 61 years) than unsuccessful patients (65 years; p < 0.001). Patients who marked questions (21.7%) were older than patients without inquiries (median 63.9 vs 59.5 years; p < 0.001). The most prevalent RF was thyroid disease (23.8%). RF were considered critical for contrast-agent injection in 13.7%, requiring personalized preparation. The detection rate for RF documented with D-IPC was higher than for C-PR (n = 385 vs. 43). GHG emissions for tablet production are 80–90 times higher than for paper production. The estimated costs were slightly higher for D-IPC (+ 8.7%).
Conclusion
D-IPC is feasible, but patient age is a relevant factor. Marked questions and RF help personalize IPC. The availability of patient history by D-IPC was superior compared to C-PR.

Informed consent for third molar extraction; a comparison of conventional verbal consent versus video-assisted consent
Ciara Mulvihill
Trinity College Dublin, Dental Science Thesis, 2022
Abstract
Background
The goal of the informed consent process is to provide patients with the necessary educational information, defend their autonomy, and allow active involvement in treatment planning and decision-making. The informed consent process must not only describe the operation in full, but also provide information on the procedure’s rationale, alternative therapies, associated benefits, risks, and complications. However, the process of acquiring informed consent is fraught with issues.
Objective
This research aims to assess if presenting information about third molar extraction via an informative, narrated, animated video changes a patient s perception of the consent process for third molar extraction when compared to conventional verbal/written consent. The outcomes that are evaluated include patient understanding, patient satisfaction and patient anxiety.
Methods
In this post test-only control clinical trial patients scheduled for surgical removal of an impacted mandibular third molar that fulfilled the predetermined criteria were invited to participate in the study. The criterion variable was the presentation of an animated information consent video. Participants were randomly assigned into 2 equal groups receiving either verbal consent or video-assisted consent. After signing the consent form patients then filled out an electronic questionnaire rating their experience of the consent process. At the postoperative review, 7-14 days after the procedure, patients were asked to fill out a questionnaire rating their experience of the consent retrospectively. The outcome variables were patients self-reported level of understanding, patient anxiety measured on the Dental Anxiety Scale and patient satisfaction. The data were analysed with Pearson s chi-squared tests, Fisher s Exact test, and linear regression analysis.
Results
Ninety patients fulfilled the inclusion criteria and were included in the study. The video-assisted group reported higher levels of understanding of the proposed procedure (P<0.001) and the associated risks/complications (P<0.004 ). Patients were more satisfied with information delivered to them via video. 98% of patients in the video consent group felt that the video-assisted consent was beneficial. There was no statistically significant change in the reported level of anxiety when video-assisted consent was used.
Conclusion
The present study suggests that video-assisted consent may improve patients level of understanding of the potential postoperative risks and complications involved in surgical removal of an impacted mandibular third molar. This improved understanding did not increase patients dental anxiety compared with conventional verbal/written consent but improved patients level of satisfaction with the amount of information that they received.

Patient Decision Aids Before Informed Consent Conversations for Image-Guided Procedures: Controlled Trials at Two Institutions
Shanmukha Srinivas, Isabel G. Newton, Maciej Waradzyn, Nishita Kothary, Eric J. Keller
American Journal of Roentgenology, October 2022
Abstract
Background
Patient decision aids (PDAs) improve informed consent practices. Available PDAs for image-guided procedures are of limited quality.
Objective
To evaluate the impact of PDAs on understanding and satisfaction among patients undergoing informed consent conversations before outpatient image-guided procedures.
Methods
This prospective study included patients awaiting an interventional radiology clinic visit to discuss and obtain informed consent for an image-guided procedure. The study was conducted at two academic medical centers (site A: visits from August, 2020 to July, 2021; site B: January, 2021 to October, 2021). Patients were assigned systematically at site A, and randomly at site B, to electronically receive or not receive a 2-page PDA before the visit. PDAs described procedures and their benefits, risks, and alternatives at a 6th-8th grade health literacy level, and vetted by diverse patient focus groups. Patients completed a post visit survey (site A: phone; site B: online) assessing understanding of the procedure and satisfaction with the consent conversation using 5-point scales. Data were pooled between sites.
Results
The study included 105 patients (59 male, 46 female; median age, 67 years; 51 from site A, 54 from site B; 53 who received PDA, 52 who did not). Survey response rate was 100% (51/51) at site A and 67% (62/92) at site B. Patients who received, versus not received, a PDA reported greater understanding of benefits (4.5 vs 4.0, p<.001), risks (4.4 vs 3.6, p<.001), and alternatives (4.0 vs 3.3, p<.001), and of what procedures involved (4.4 vs 4.1, p=.02); and were more likely to feel that they were provided with enough time with the clinician (4.7 vs 4.5, p=.03), listened to carefully (4.8 vs 4.4, p<.001), free to choose any option including not to have the procedure (4.7 vs 4.3, p<.001), given enough time to make a decision (4.8 vs 4.3, p<.001), encouraged to ask questions (4.8 vs 4.5, p<.001), and had questions answered (4.8 vs 4.4, p=.001).
Conclusion
Well-vetted plain-language PDAs provided before image-guided procedure consent conversations improve patients’ self-perceived understanding of the procedure and satisfaction with the conversation.

Video Consent for Upper Endoscopy and Colonoscopy Improves Patient Comprehension in a Safety-net, Multi-lingual Population
Original Paper
Zoe Lawrence, Gabriel Castillo, Janice Jang, Timothy Zaki, Demetrios Tzimas, Alexandra Guttentag, Adam Goodman, Andrew Dikman, Renee Williams
Journal of Immigrant and Minority Health, 24 September 2022
Open Access
Abstract
The challenges of consenting for procedures are well documented and are compounded when patients have limited English proficiency (LEP). Standardized video consent has been studied, but research in gastroenterology is limited. We created educational videos in English and Spanish covering the elements of traditional consent for colonoscopy and upper endoscopy. All participants underwent traditional verbal consent and a subset viewed the language and procedure specific video. Participants from a multilingual, safety-net hospital patient population were then given a questionnaire to assess their comprehension and satisfaction. Participants who watched the video had higher comprehension scores than those who received traditional verbal consent alone. This difference persisted when data was stratified by language and procedure, and when controlled for educational level and prior procedure. Video consent improves comprehension and satisfaction for endoscopy and may mitigate some of the challenges encountered when consenting patients with LEP.

Autonomous patient consent for anaesthesia without preoperative consultation: a qualitative feasibility study including low-risk procedures
Original Research Article
MarijeMarsman, Wisse M.F. van den Beuken, Wilton A. van Klei, Teus H.Kappen
BJA Open, September 2022
Abstract
Background
Informed consent for anaesthesia is mandatory and requires provision of information and subsequent consent during consultation between anaesthesiologist and patient. Although information can be provided in an electronic format, it is unknown whether this a valid substitute for a consultation. We explored whether provision of digital information is equivalent to oral consultation and whether it enables patients to give electronic informed consent (e-consent) for anaesthesia.
Methods
Qualitative feasibility study using semi-structured interviews in 20 low-risk adults scheduled for minor surgery under general anaesthesia or procedural sedation at a university hospital. Data were analysed using a thematic content analysis approach. During the interviews, patients followed an application that provides information and subsequent e-consenting.
Results
The mean age was 50 yr and patients had good digital skills. Fifteen patients (75%) had previous experience of anaesthesia. The digital application provided enough information for all patients, but eight (40%) preferred consultation with an anaesthesiologist, mainly for personal contact. Patients had different information needs, with previous experiences leading to lower information needs. Nineteen patients had sufficient information to consent autonomously. Most patients considered separate anaesthesia consent superfluous to the surgical consent.
Conclusion
The digital application provided sufficient information and patients valued the information offered and the advantage of processing information at their own pace. This information made patients feel empowered to autonomously consent to anaesthesia without consultation. Remarkably, consent for anaesthesia was considered unimportant, because patients felt they had ‘no choice’ if they wanted to undergo surgery.

Animation Supported Consent Before Elective Laparoscopic Cholecystectomy
Original Scientific Report
Emre Doganay, David S. Wald, Sam Parker & Frances Hughes
World Journal of Surgery, 28 June 2022
Open Access
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/lapchole). 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.
Conclusion
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.

Enhancing informed consent through use of patient-specific 3D printing in skull base neurosurgery: 3D printing in skull base neurosurgery
Shan Yasin Mian, Shubash Jayasangaran, Aishah Qureshi, Mark Hughes
Journal of Neurological Surgery, 27 June 2022
Abstract
Objectives
Informed consent is fundamental to good practise. We hypothesised that a personalised 3D printed model of skull base pathology would enhance informed consent and reduce patient anxiety. Design Imaging (DICOM) files were 3D printed. After a standard pre-surgery consent clinic, patients completed part-1 of a structured questionnaire. They then interacted with their personalised 3D printed model. They then completed part-2 seeking to explore perceived involvement in decision-making, anxiety, concerns (emotional) and lesion anatomical location, surgical risks (factual). Descriptive statistics were used to report responses and text classification tools were used to analyse free text responses.
Setting and participants
14 patients undergoing elective skull base surgery (with pathologies including skull base meningioma, craniopharyngioma, pituitary adenoma, Rathke cleft cyst, and olfactory neuroblastoma) were prospectively identified at a single unit.
Results
After model exposure, there was a net trend towards reduced patient-reported anxiety and enhanced patient-perceived involvement in treatment. 13/14 patients (93%) felt better about their operation and 13/14 patients (93%) thought all patients should have access to personalised 3D models. After exposure, there was a net trend towards improved patient-reported understanding of surgical risks, lesion location, and degree of feeling informed. 13/14 patients (93%) felt the model helped them understand the surgical anatomy better. Analysis of free text responses, after exposure found 47% positive sentiment, 35% neutral, and 18% negative.
Conclusions
In the context of skull base neurosurgery, personalised 3D printed models of skull base pathology can improve surgical consent and reduce patient anxiety.

What is the best method to ensure informed consent is valid for orthodontic treatment? A trial to assess long-term recall and comprehension
Summary Review
Carter, H. Al-Diwani
Evidence-Based Dentistry, 24 June 2022; 23 pp 52–53
Abstract
Design
Single-blind randomised controlled trial.
Intervention
Patient and parent pairs were randomly assigned via a random number generator to Group A or B. Both groups were given ten minutes to read a modified consent document. Group A (rehearsal) were given printouts that showed images of four core and four custom risks with handwritten descriptions of each risk and consequences. Group B were given an audio-visual presentation instead (PowerPoint). Interviews of each group were completed immediately after the informed consent and at six-month follow-up to assess recall and comprehension of information provided.
Case selection
Patients aged 11-18 years old and their parents attending for comprehensive orthodontic treatment at Ohio State University graduate orthodontic clinic. All subjects needed to be able to communicate in English, have no developmental disabilities or urgent medical conditions and neither the patients or parents or subjects’ siblings were to have had orthodontic treatment in the last five years.
Data analysis
1) Exploratory analysis to test for differences in demographics and anxiety between the two groups; 2) Multiple linear regression analysis was used to assess percentage of accurate responses at baseline and six months and the change between the two different groups, with differing baseline characteristics (p <0.05 was considered statistically significant); and 3) Intra- and inter-rater reliability was assessed using intra-class correlation.
Results
There were no significant differences in information retention and understanding between the two methods at six-month follow-up. For both groups, recall was significantly lower six months following consent-taking. Specific domains whereby information recall and comprehension are poor include: treatment method, risks, resorption and discomfort.
Conclusions
There is no superior method of consent-taking to ensure patients’ and parents’ information retention in the months following commencement of treatment. However, the study highlighted that current consent practices which are considered ‘best practice’ may be deficient.

Comparing shared decision making using a paper and digital consent process. A multi-site, single centre study in a trauma and orthopaedic department
Rory Dyke, Edward St-John, Hemina Shah, Joseph Walker, Dafydd Loughran, Raymond Anakwe, Dinesh Nathwani
The Surgeon, 11 June 2022
Abstract
Introduction
The importance of shared decision making (SDM) for informed consent has been emphasised in the updated regulatory guidelines. Errors of completion, legibility and omission have been associated with paper-based consent forms. We introduced a digital consent process and compared it against a paper-based process for quality and patient reported involvement in shared decision making.
Methods
223 patients were included in this multi-site, single centre study. Patient consent documentation was by either a paper consent form or the Concentric digital consent platform. Consent forms were assessed for errors of legibility, completion and accuracy of content. Core risks for 20 orthopaedic operations were pre-defined by a Delphi round of experts and forms analysed for omission of these risks. SDM was determined via the ‘collaboRATE Top Score’, a validated measure for gold-standard SDM.
Results
72% (n = 78/109) of paper consent forms contained ≥1 error compared to 0% (n = 0/114) of digital forms (P < 0.0001). Core risks were unintentionally omitted in 63% (n = 68/109) of paper-forms compared to less than 2% (n = 2/114) of digital consent forms (P < 0.0001). 72% (n = 82/114) of patients giving consent digitally reported gold-standard SDM compared to 28% (n = 31/109) with paper consent (P < 0.001).
Conclusion
Implementation of a digital consent process has been shown to reduce both error rate and the omission of core risks on consent forms whilst increasing the quality of SDM. This novel finding suggests that using digital consent can improve both the quality of informed consent and the patient experience of SDM.

Characteristics of Electronic Informed Consent Platforms for Consenting Patients to Research Studies: A Scoping Review
Jennifer Guarino, Irena Parvanova, Joseph Finkelstein
Studies in Health Technology and Informatics, 6 June 2022; 290 pp 777-781
Abstract
Informed consent process assures that research study participants are properly informed about the study prior to their consent. Due to the increasing significance of electronic informed consent (eIC) platforms, particularly during the COVID-19 pandemic, we conducted a scoping review of eIC systems to address the following characteristics: 1) technological features of current eIC platforms, 2) eIC platforms usability and efficacy, and 3) areas for future eIC research. We performed a literature search using publicly available PubMed repository, where we included studies discussing an eIC platform or multimedia educational module given to patients prior to signing a consent form. In addition, we tracked first author, year of publication, sample size, study location, eIC procedure, methodology, and eIC’s comparison to paper consent. Our results showed that with a few noted exceptions, electronic consent improves patient usability, satisfaction, knowledge, and trust scores when compared to traditional paper consent.