Autonomous patient consent for anaesthesia without preoperative consultation: a qualitative feasibility study including low-risk procedures

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

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

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

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

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

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.

Implementation of Surgical Education Video to Burn Patients Before the Informed Consent Process

Implementation of Surgical Education Video to Burn Patients Before the Informed Consent Process
Theses and Dissertations
Brian Piatkowski
Doctor of Nursing Practice, 28 May 2022
Open Access
Abstract
Purpose
Before the initiation of this evidence-based Doctor of Nursing Practice (DNP) project, a systematic review of literature set forth by other researchers regarding the informed consent process was done. The literature showed patient satisfaction scores increased, while anxiety decreased regarding surgical procedures after using a multimedia educational tool. The first goal of the project was to determine any gaps in knowledge of the burn surgical patient population. The second goal of the project was to determine gaps in knowledge and comfort levels with providers obtaining informed consent. The third goal was to determine the efficacy of implementing a surgical education video for patients and providers.
Background
The informed consent process is a daily task for providers with a surgical patient population. In the burn population, informed consent is often presented by an intern or resident physician. Consent is comprised of surgical debridement with a multitude of options for coverage of their wounds. The current state of practice is a verbal overview of all the possible procedures that may be done to the patient’s wound(s). Patients often verbalize feeling overwhelmed with the amount of information on the consent and often have questions related to their procedure just before the brief of the operative case.
Methods
An educational video was developed that detailed the surgical procedure and the potential burn wound coverings. A 3-question survey was given to patients who have already been through the informed consent process. Survey metrics examined knowledge of consent when signed, the satisfaction of verbal explanation, and if a video would increase understanding. The video was given to the same patients to watch. After the video was viewed, those patients were then again surveyed. Providers were also given a 3-question survey before viewing the video. Survey metrics examined comfort of consent, knowledge of procedures, and if the video would increase patient understanding of consent topics. The providers were then surveyed after watching the video.
Results
Initial post-implementation data shows that patients and providers have increased comfort and knowledge in the informed consent process. Patients show an 80% increase in understanding of consent, a 72% increase in satisfaction with video vs verbal overview, and a 97% increase in satisfaction with material viewed. Provider data shows a 65% increase in the comfort of consent, a 64% increase in knowledge of procedures, and a 97% increase that the video will help patients understand their consent. This shows that this evidence-based project is an improvement from the current standard of practice.
Evaluation
Implementation of a standardized audio/video teaching method for burn surgical patients is an effective way to increase patient and provider satisfaction regarding the informed consent process. This tool can easily be modified with practice changes for sustainability. Implementing this educational tool is a cost-effective and simple way to educate burn patients before their surgical procedures. There is an overall improvement in patient satisfaction and increased satisfaction in the providers who obtain the consent.

Participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent: A parallel-group pilot study among Danish citizens

Participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent: A parallel-group pilot study among Danish citizens
Anne Nyholm Gaarskjær, Meg Duroux, Rasmus Hogreffe
Contemporary Clinical Trials Communications, 27 May 2022
Abstract
Background
Teleconsent via video conferencing enables decentralized trials with remote consent and has the additional benefit of allowing a real-time reaction to potential misunderstandings. However, participant acceptance of and satisfaction with teleconsent versus in-person consent processes are unknown.
Methods
We conducted a parallel-group pilot study to evaluate participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent among Danish citizens for a hypothetical research study.
Results
There were no statistically significant differences in perceptions of security or satisfaction between teleconsent and in-person consent arms. However, participants viewed teleconsent as more convenient than in-person consent, as no transportation was needed and the process was less time-consuming. Recruitment was also faster in the teleconsent arm, and more people dropped out of the in-person arm, citing difficulties with transportation and time.
Conclusion
Decentralized clinical trials have been demonstrated to increase recruitment and enrollment rates, improve trial efficiency, and decrease dropout rates and trial delays. We add to this literature by suggesting that patients perceive teleconsent as similar to in-person consent, suggesting this is a feasible and acceptable substitution for in-person consent in multisite, decentralized trials. Future work should include patient perspectives from a larger, more diverse group of participants.

Video-assisted informed consent in a clinical trial of resuscitation of extremely preterm infants: Lessons learned

Video-assisted informed consent in a clinical trial of resuscitation of extremely preterm infants: Lessons learned
Namrita Jain Odackal, Catherine Grace Caruso, Melissa Klitzman, Mónica Rincón, Bobbi Byrne, Jameel Justin Winter, Gina Petroni, Karen D Fairchild, Jamie B Warren
American Journal of Perinatology, 26 May 2022
Abstract
Objective
Obtaining informed consent for clinical trials is challenging in acute clinical settings. For the VentFirst randomized clinical trial (assisting ventilation during delayed cord clamping for infants <29 weeks’ gestation), we created an informational video that sites could choose to use to supplement the standard in-person verbal and written consent. Using a post-consent survey, we sought to describe the impact of the video on subject recruitment, satisfaction with the consent process, and knowledge about the study.
Study design
Descriptive survey-based sub-study.
Results
Of the sites participating in the VentFirst trial that obtained IRB approval to allow use of the video to supplement the standard informed consent process, three elected to participate in the survey substudy. From February 2018 to January 2021, 82 women at these three sites were offered the video and completed the post-consent survey. Overall, 73 of these 82 women (89%) consented to participate in the primary study, 78 (95%) indicated the study was explained to them very well or extremely well, and the range of correct answers on 5 knowledge questions about the study was 63%-98%. Forty-six (56%) of the 82 women offered the video chose to watch it. There were no major differences in study participation, satisfaction with the consent process, or knowledge about the study between the women who chose to watch or not watch the video.
Conclusion
Watching an optional video to supplement the standard informed consent process did not have a major impact on outcomes in this small sub-study. The ways in which audiovisual tools might modify the traditional informed consent process deserve further study.

Improving comprehension, recall and attention using multimedia-informed assent among pediatric oncology patients: A comparative randomized controlled trial

Improving comprehension, recall and attention using multimedia-informed assent among pediatric oncology patients: A comparative randomized controlled trial
Psychosocial and Supportive Care: Research Article
Passara Wongthai, Apichat Photia, Chanchai Traivaree, Chalinee Monsereenusorn, Nawachai Lertvivatpong, Khemika Khemakanok Sudnawa, Piya Rujkijyanont
Pediatric Blood & Cancer, 25 May 2022
Abstract
Background
Assent should be obtained in all children involved in research in keeping with their level of maturity. Traditional assent forms contain too much information and are difficult to read. The study aimed to identify an effective tool to enhance children’s comprehension during the assent process and focused on those with cancer who are likely more engaged in research involving greater than minimal risk.
Methods
In all, 116 children with cancer were randomized to receive either a paper-based assent document or a multimedia-based assent document. Open-ended and multiple-choice questions were used to assess comprehension and recall. Time spent on the documents and children’s behavior during the assent process was recorded to determine their attention and satisfaction.
Results
Children randomized to a multimedia-based assent document achieved significant higher comprehension and recall assessment scores (p-values <.001). The high score achievement significantly correlated with the child’s age with adjusted odds ratio (OR) of 1.90 (p-value <.001; 95% confidence interval [CI]: 1.35–2.66) for comprehension assessment and 1.59 (p-value .001; 95% CI: 1.20–2.12) for recall assessment. Children randomized to a multimedia-based assent document had significant longer time spent on the document (p-value .001) with less numbers of inattention (p-value <.001) and expressed more signs of enjoyment during the assent process (p-values <.001).
Conclusion
Multimedia-based assent document successfully enhanced comprehension, recall, and attention with more satisfaction compared with a traditional paper-based document among children with cancer. This approach may be considered as an alternative format for children engaging in research involving greater than minimal risk.