How Making Consent Procedures More Interactive can Improve Informed Consent: An Experimental Study and Replication
Research Article
Marije aan het Rot, Ineke Wessel
Journal of Empirical Research on Human Research Ethics, 28 August 2024
Open Access
Abstract
Prospective research participants do not always retain information provided during consent procedures. This may be relatively common in online research and is considered particularly problematic when the research carries risks. Clinical psychology studies using the trauma film paradigm, which aims to elicit an emotional response, provide an example. In the two studies presented here, 112–126 participants were informed they would be taking part in an online study using a variant of this paradigm. The information was provided across five digital pages using either a standard or an interactive format. In both studies, compared to the control condition, participants in the interactive condition showed more retention of information. However, this was only found for information about which they had been previously asked via the interactive format. Therefore, the impact of adding interactivity to digital study information was limited. True informed consent for an online study may require additional measures.

Use of E-Consent in Healthcare Settings: A Scoping Review
Haris Obaidi, Youssef Elkhyatt, Mahmood Alzubaidi, Mowafa Househ
Studies In Health Technology and Informatics, 22 August 2024
Abstract
Electronic consent is a technology-driven approach that remains challenging in various healthcare settings. Transitioning from paper-based to electronic consent (e-consent) has streamlined the consent process. This scoping review explores patients’ electronic consent in different healthcare settings. We searched four databases and selected 14 studies that met our inclusion criteria. Our results show that E-consent is associated with key measures such as sufficient information, accuracy, enhanced shared decision-making, and efficiency. The majority of studies used a comparative design model to contrast paper-based consent with E-consent. Our findings provide an overview of the current state of E-consent use in healthcare settings.

Examining Introduction of E-consent in The Neurosurgical Caseload: Understanding The Barriers to Implementation
Original Article
Daniele S.C. Ramsay, Virensinh Rathod, Sami Rashed, Sohani Dassanayake, Santhosh Thavarajasingam, Nigel Mendoza, Ali R. Haddad
World Neurosurgery, 12 August 2024
Open Access
Abstract
Objective
To evaluate current usage and barriers of e-consent implementation in neurosurgical practice. Electronic consent (e-consent) forms provide an alternative method for conducting the informed consent (IC) procedure. IC requires an ability to understand, retain, weigh up and communicate decisions regarding the proposed procedure. Currently, e-consent has shown promise as a method of improving IC, yet barriers to implementation exist.
Methods
A comparative analysis regarding procedural and consent data was collected over six months in two neurosurgical centres with elective and emergency caseloads. These were evaluated for changes over time following e-consent introduction. Clinicians were surveyed for their experience using of e-consenting to understand the barriers to implementation.
Results
Over half (55.6%) of neurosurgical procedures made use of e-consent for IC. Lower rates of e-consent were used in trauma related procedures (38.38%) as compared to elective procedures. This did not increase significantly over the study period. Positive clinician survey feedback indicated e-consenting reduces the time required to perform IC, with 50% of respondents strongly agreeing. Barriers to implementation were reported on free-text entry pertaining largely to difficulties in emergency situations due to form complexity. The inability to create and edit templates for personalised e-consent delivery was a further limitation.
Conclusion
Despite the advantages conferred by e-consent for the administration of IC in neurosurgical procedures, reflected in our survey data, there remains limited use of the technology. Limitations remain relating to ease of access and complexity of use in trauma scenarios.

Enhancing patient informed consent in elective skin cancer surgeries: a comparative study of traditional and digital approaches in a German public hospital
Research
Alexandra Schulz, Sabine Bohnet-Joschko
BMC Health Services Research, 2 August 2024
Open Access
Abstract
Background
This study aims to investigate the integration of modern sources of patient information, such as videos, internet-based resources, and scientific abstracts, into the traditional patient informed consent process in outpatient elective surgeries. The goal is to optimize the informed consent experience, enhance patient satisfaction, and promote shared decision making (SDM) between patients and surgeons. By exploring different patient informed consent formats and their impact on patient satisfaction, this research seeks to improve healthcare practices and ultimately enhance patient outcomes. The findings of this study will contribute to the ongoing efforts to improve the informed consent process in public hospitals and advance patient-centred care.
Methods
Data collection occurred at the day care clinic of a prominent German public hospital, forming an integral component of a prospective clinical investigation. The study exclusively focused on individuals who had undergone surgical intervention for skin cancer. For the purpose of meticulous data examination, the statistical software SPSS version 21 was harnessed. In the course of this study, a chi-square test was aptly employed. Its purpose was to scrutinize the nuances in patient experiences pertaining to informed consent across four distinct categories, viz., oral informed consent discussion (Oral ICD), written informed consent discussion (Written ICD), video-assisted informed consent discussion (video-assisted ICD), and digitally assisted informed consent discussion (digital-assisted ICD). The primary dataset of this inquiry was diligently gathered via a structured questionnaire administered to a targeted cohort of 160 patients. Within this sample, a balanced representation of genders was observed, encompassing 82 males and 78 females. Their collective age span ranged from 18 to 92 years, with an average age of 71 years. A randomized selection methodology was employed to include participants in this study during the period spanning from July 2017 to August 2018.
Results
Significant differences were observed across the groups for all research questions, highlighting variations in patient responses. Video-assisted and digital-assisted IC were rated as superior in patient satisfaction with information compared to written and oral IC. Demographic profiles of the four study groups were found to be comparable.
Conclusion
The findings of this study indicate that the incorporation of digital technologies in the informed consent process can enhance patient understanding during outpatient elective skin cancer surgeries. These results have important implications for increasing patient satisfaction and improving the SDM process within the hospital environment.

Comparison of the Response to an Electronic Versus a Traditional Informed Consent Procedure in Terms of Clinical Patient Characteristics: Observational Study
Anna G M Zondag, Marieke J Hollestelle, Rieke van der Graaf, Hendrik M Nathoe, Wouter W van Solinge, Michiel L Bots, Robin W M Vernooij, Saskia Haitjema
Journal of Medical Internet Research, 11 July 2024
Abstract
Background
Electronic informed consent (eIC) is increasingly used in clinical research due to several benefits including increased enrollment and improved efficiency. Within a learning health care system, a pilot was conducted with an eIC for linking data from electronic health records with national registries, general practitioners, and other hospitals.
Objective
We evaluated the eIC pilot by comparing the response to the eIC with the former traditional paper-based informed consent (IC). We assessed whether the use of eIC resulted in a different study population by comparing the clinical patient characteristics between the response categories of the eIC and former face-to-face IC procedure.
Methods
All patients with increased cardiovascular risk visiting the University Medical Center Utrecht, the Netherlands, were eligible for the learning health care system. From November 2021 to August 2022, an eIC was piloted at the cardiology outpatient clinic. Prior to the pilot, a traditional face-to-face paper-based IC approach was used. Responses (ie, consent, no consent, or nonresponse) were assessed and compared between the eIC and face-to-face IC cohorts. Clinical characteristics of consenting and nonresponding patients were compared between and within the eIC and the face-to-face cohorts using multivariable regression analyses.
Results
A total of 2254 patients were included in the face-to-face IC cohort and 885 patients in the eIC cohort. Full consent was more often obtained in the eIC than in the face-to-face cohort (415/885, 46.9% vs 876/2254, 38.9%, respectively). Apart from lower mean hemoglobin in the full consent group of the eIC cohort (8.5 vs 8.8; P=.0021), the characteristics of the full consenting patients did not differ between the eIC and face-to-face IC cohorts. In the eIC cohort, only age differed between the full consent and the nonresponse group (median 60 vs 56; P=.0002, respectively), whereas in the face-to-face IC cohort, the full consent group seemed healthier (ie, higher hemoglobin, lower glycated hemoglobin [HbA1c], lower C-reactive protein levels) than the nonresponse group.
Conclusions
More patients provided full consent using an eIC. In addition, the study population remained broadly similar. The face-to-face IC approach seemed to result in a healthier study population (ie, full consenting patients) than the patients without IC, while in the eIC cohort, the characteristics between consent groups were comparable. Thus, an eIC may lead to a better representation of the target population, increasing the generalizability of results.

Protocol for a hybrid effectiveness-implementation clinical trial evaluating video-assisted electronic consent vs standard consent for patients initiating and continuing haemodialysis in Australia (eConsent HD)
Protocol
Pedro Henrique Franca Gois, Rebecca B Saunderson, Marina Wainstein, Chenlei Kelly Li, Matthew J Damasiewicz, Vera Y Miao, Martin Wolley, Kirsten Hepburn, Clyson Mutatiri, Bobby Chacko, Ann Bonner, Helen Healy
BMJ, 11 July 2024
Abstract
Introduction
Communicating complex information about haemodialysis (HD) and ensuring it is well understood remains a challenge for clinicians. Informed consent is a high-impact checkpoint in augmenting patients’ decision awareness and engagement prior to HD. The aims of this study are to (1) develop a digital information interface to better equip patients in the decision-making process to undergo HD; (2) evaluate the effectiveness of the co-designed digital information interface to improve patient outcomes; and (3) evaluate an implementation strategy.
Methods and analysis
First, a co-design process involving consumers and clinicians to develop audio-visual content for an innovative digital platform. Next a two-armed, open-label, multicentre, randomised controlled trial will compare the digital interface to the current informed consent practice among adult HD patients (n=244). Participants will be randomly assigned to either the intervention or control group. Intervention group: Participants will be coached to an online platform that delivers a simple-to-understand animation and knowledge test questions prior to signing an electronic consent form. Control group: Participants will be consented conventionally by a clinician and sign a paper consent form. Primary outcome is decision regret, with secondary outcomes including patient-reported experience, comprehension, anxiety, satisfaction, adherence to renal care, dialysis withdrawal, consent time and qualitative feedback. Implementation of eConsent for HD will be evaluated concurrently using the Consolidation Framework for Implementation Research (CFIR) methodology. Analysis: For the randomised controlled trial, data will be analysed using intention-to-treat statistical methods. Descriptive statistics and CFIR-based analyses will inform implementation evaluation.
Ethics and dissemination
Human Research Ethics approval has been secured (Metro North Health Human Research Ethics Committee B, HREC/2022/MNHB/86890), and Dissemination will occur through partnerships with stakeholder and consumer groups, scientific meetings, publications and social media releases.

Interactive Health Technology Tool for Kidney Living Donor Assessment to Standardize the Informed Consent Process: Usability and Qualitative Content Analysis
Fernanda Ortiz, Juulia Grasberger, Agneta Ekstrand, Ilkka Helanterä, Guido Giunti
JMIR Formative Research, 9 July 2024
Abstract
Background
Kidney living donation carries risks, yet standardized information provision regarding nephrectomy risks and psychological impacts for candidates remains lacking.
Objective
This study assesses the benefit of interactive health technology in improving the informed consent process for kidney living donation.
Methods
The Kidney Hub institutional open portal offers comprehensive information on kidney disease and donation. Individuals willing to start the kidney living donation process at Helsinki University Hospital (January 2019-January 2022) were invited to use the patient-tailored digital care path (Living Donor Digital Care Path) included in the Kidney Hub. This platform provides detailed donation process information and facilitates communication between health care professionals and patients. eHealth literacy was evaluated via the eHealth Literacy Scale (eHEALS), usability with the System Usability Scale (SUS), and system utility through Likert-scale surveys with scores of 1-5. Qualitative content analysis addressed an open-ended question.
Results
The Kidney Hub portal received over 8000 monthly visits, including to its sections on donation benefits (n=1629 views) and impact on donors’ lives (n=4850 views). Of 127 living kidney donation candidates, 7 did not use Living Donor Digital Care Path. Users’ ages ranged from 20 to 79 years, and they exchanged over 3500 messages. A total of 74 living donor candidates participated in the survey. Female candidates more commonly searched the internet about kidney donation (n=79 female candidates vs n=48 male candidates; P=.04). The mean eHEALS score correlated with internet use for health decisions (r=0.45; P<.001) and its importance (r=0.40; P=.01). Participants found that the Living Donor Digital Care Path was technically satisfactory (mean SUS score 4.4, SD 0.54) and useful but not pivotal in donation decision-making. Concerns focused on postsurgery coping for donors and recipients.
Conclusions
Telemedicine effectively educates living kidney donor candidates on the donation process. The Living Donor Digital Care Path serves as a valuable eHealth tool, aiding clinicians in standardizing steps toward informed consent.

Enhancing Informed Consent through Multimedia Tools in Pediatric Spinal Surgery: A Comprehensive Review
Marina Rosa Filezio, Nishan Sharma, Jennifer Thull-Freedman, Fabio Ferri, Maria Jose Santana
Frontiers in Pediatrics, 28 June 2024
Abstract
Pediatric spine surgery is a high complexity procedure that can carry risks ranging from pain to neurological damage, and even death. This comprehensive mini review explores current best practice obtaining valid and meaningful informed consent (IC) prior to pediatric spinal surgery, including modalities that support effective comprehension and understanding. An evaluation of the literature was performed to explore understanding of surgical IC by patients or their guardians and the role of multimedia tools as a possible facilitator. The evidence discussed throughout this review, based on legal and ethical perspectives, reveals challenges faced by patients and guardians in achieving comprehension and understanding, especially when facing stressful medical situations. In this context, the introduction of multimedia tools emerges as a patient-centered strategy to help improve comprehension and decrease pre-operative uncertainty. This review highlights the need for a tailored approach in obtaining IC for pediatric patients and suggests a potential role of shared decision-making (SDM) in the surgical discussion process.

Video consent significantly improves patient knowledge of general surgery procedures
Kristin Bremer, Emily Brown, Rachel Schenkel, Ryan W. Walters, Kalyana C. Nandipati
Surgical Endoscopy, 26 June 2024
Open Access
Abstract
Introduction
Informed consent is essential in ensuring patients’ understanding of their medical condition, treatment, and potential risks. The objective of this study was to investigate the impact of utilizing a video consent compared to standard consent for patient knowledge and satisfaction in selected general surgical procedures.
Methods and procedures
We included 118 patients undergoing appendectomy, cholecystectomy, inguinal hernia repair, and fundoplication at two hospitals in Omaha, NE. Patients were randomized to either a standard consent or a video consent. Outcomes included a pretest and posttest objective knowledge assessment of their procedure, as well as a satisfaction survey which was completed immediately after consent and following discharge. Given the pre-post design, a linear mixed-effect model was estimated for both outcomes. A two-way interaction effect was of primary interest to assess whether pre-to-post change in the outcome differed between patients randomized to standard or video consent.
Results
Baseline characteristics were mostly similar between groups except for patient sex, p = 0.041. Both groups showed a statistically significant increase in knowledge from pretest to posttest (standard group: 0.25, 95% CI 0.01 to 0.51, p = 0.048; video group: 0.68, 95% CI 0.36 to 1.00, p < 0.001), with the video group showing significantly greater change (interaction p = 0.043) indicating that incorporating a video into the consent process resulted in a better improvement in patient’s knowledge of the proposed procedure. Further, both groups showed a decrease in satisfaction post-discharge, but no statistically significant difference in the magnitude of decrease between the groups (interaction p = 0.309).
Conclusion

Video consent lead to a significant improvement in a patient’s knowledge of the proposed treatment. Although the patient satisfaction survey didn’t show a significant difference, it did show a trend. We propose incorporating videos into the consent process for routine general surgical procedures.

Teaching Nurse Practitioner Students Informed Consent Using Audiovisual Peer Feedback
Sabrina Dollar Kopf, Liang Shan, Somali Nguyen, Tracie White, Rebecca Suttle, Hiboombe Haamankuli
The Journal for Nurse Practitioners, July–August 2024
Abstract
Teaching informed consent is vital to the education of nurse practitioners. However, measures to improve student engagement and content comprehension are lacking. An online course module was created that included a didactic lecture followed by an audiovisual assignment with peer feedback. A pre- and post-survey to assess content comprehension and engagement was conducted. One hundred forty-four students participated in the learning activity. There was a statistical improvement in certain content comprehension-related questions. Audiovisual tools incorporating peer feedback can enhance traditional lecture-based asynchronous graduate nursing education by improving student engagement and comprehension.