Informed Consent for Online Research—Is Anybody Reading?: Assessing Comprehension and Individual Differences in Readings of Digital Consent Forms

Informed Consent for Online Research—Is Anybody Reading?: Assessing Comprehension and Individual Differences in Readings of Digital Consent Forms
Research Article
Caitlin Geier, Robyn B. Adams, Katharine M. Mitchell, Bree E. Holtz
Journal of Empirical Research on Human Research Ethics, 24 May 2021
Abstract
Informed consent is an important part of the research process; however, some participants either do not read or skim the consent form. When participants do not read or comprehend informed consent, then they may not understand the potential benefits, risks, or details of the study before participating. This study used previous research to develop experimentally manipulated online consent forms utilizing various presentations of the consent form and interactive elements. Participants (n = 576) were randomly exposed to one of six form variations. Results found that the highly interactive condition was significantly better for comprehension than any of the other conditions. The highly interactive condition also performed better for readability, though not significantly. Further research should explore the effects of interactive elements to combat habituation and to engage participants with the parts of the consent form unique to the study.

Evaluation of two communication tools, slideshow and theater, to improve participants’ understanding of a clinical trial in the informed consent procedure on Pemba Island, Tanzania

Evaluation of two communication tools, slideshow and theater, to improve participants’ understanding of a clinical trial in the informed consent procedure on Pemba Island, Tanzania
Research Article
Marta S. Palmeirim, Ulfat A. Mohammed, Amanda Ross, Shaali M. Ame, Said M Ali, Jennifer Keiser
PLoS Neglected Tropical Disease, 14 May 2021
Abstract
Background
Clinical trial participants are required to sign an informed consent form (ICF). However, information is lacking on the most effective methods to convey trial relevant information prior to inviting participants to sign the ICF, being particularly pertinent in low income countries. A previous study on Pemba Island, Tanzania, found that an oral information session (IS) was significantly better than providing an ICF alone. However, knowledge gaps remained. Building on these findings, we investigated the effect of adding a slideshow or a theater to the IS in the informed consent procedure of an anthelminthic clinical trial.
Methodology/principal findings
A total of 604 caregivers were randomized into the control group that only received an ICF (n = 150) or an ICF plus one of three intervention strategies: (i) verbal IS (n = 135), (ii) verbal IS with a slideshow (n = 174) or (iii) verbal IS followed by a theater (n = 145). All modes of information covered the same key messages. Participants’ understanding was assessed using a semi-structured questionnaire. The mean score of caregivers in the control group (ICF only) was 4.41 (standard deviation = 1.47). Caregivers attending the IS alone were more knowledgeable than those in the control group (estimated difference in mean scores: 2.40, 95% confidence interval (CI) 1.95 to 2.86, p < 0.01). However, there was no evidence of an improvement compared to the IS only when participants attended a slideshow (0.09, 95% CI -0.53 to 0.35, p = 0.68) or a theater (0.28, 95% CI -0.27 to 0.82, p = 0.32). Three out of 10 key messages remained largely misunderstood, regardless of the mode of information group.
Conclusions/significance
Our study confirmed that, in this setting, an ICF alone was not sufficient to convey clinical trial-related information. An IS was beneficial, however, additional theater and slideshows did not further improve understanding. Future research should explore methods to improve communication between study teams and participants for different key messages, study types and settings.

Effect of Conventional vs. Multimedia Aid Regarding Informed Consent for Central Venous Catheter Insertion on Anxiety and Satisfaction among Patients Admitted in Selected Areas of A Tertiary Care Hospital, Ludhiana, Punjab

Effect of Conventional vs. Multimedia Aid Regarding Informed Consent for Central Venous Catheter Insertion on Anxiety and Satisfaction among Patients Admitted in Selected Areas of A Tertiary Care Hospital, Ludhiana, Punjab
Ramit Sharma, Kapil Sharma
International Journal of Nursing Critical Care, 2021; 7(1)
Open Access
Abstract
Central venous catheter insertion is a very invasive procedure for prolonged administration of medication, parental fluids and blood products. Patients are involved in decision making regarding this procedure. The term Informed consent is used to discuss with patients complete, clear and easy to understand information about a medical procedure or surgical process in clinical settings or hospitals. Multimedia patient decision aid have been heavily utilized as supplemental educational tools instead of conventional method. A quasi-experimental study by using convenience sampling technique was conducted on 40 patients (control n = 20 and experimental n = 20) admitted in ICUs of DMC & Hospital, Ludhiana, Punjab. In pre-test assess the anxiety of patients for regarding central venous catheter insertion (CVC insertion) procedure done by (State-Trait Anxiety Inventory (STAI) scale.)) and in intervention (Provide multimedia aid regarding informed consent for central venous catheter insertion procedure) for each patients for 5 mints (only in experimental group) and in posttest assess and compare the anxiety and satisfaction of patients by (State-Trait Anxiety Inventory (STAI) scale.) and satisfaction by using modified Agency for Healthcare Researcher and quality (AHRQ) scale. Patient satisfaction with the consent process, Most of the subjects had severe anxiety among control and experimental group in pre-test and post-test (16 vs. 15), whereas the 15 (75%) subjects among experimental group had severe anxiety in pre-test which was decreased to moderate in post-test. The finding of the present study also revealed that mean anxiety score was decreased from pre-test and post-test among experimental group (52.00 ± 04.34 Vs. 42.10 ± 05.70) and control group (54.35 ± 05.15 Vs. 50.15 ± 05.61). The difference in finding were found to be statistically significant (p<0.05). It was also revealed that all the subjects were satisfied with the multimedia (14.5 ± 1.28). Whereas only 3 (15%) subjects were satisfied (8.3 ± 1.84) with conventional method. The present study concluded that multimedia aid regarding informed consent for CVC insertion is better than the conventional aid in reference to the anxiety and satisfaction of the patients.

073: Improving Consent with a Visual Tool for Communicating Surgical Risks

073: Improving Consent with a Visual Tool for Communicating Surgical Risks
SJ Tingle, JK Ramsingh, RD Bliss, PP Truran
British Journal of Surgery, 27 April 2021; Volume 108(Supplement 1)
Abstract
Introduction
Patients must understand the risks of a procedure to provide valid consent. Guidance from the General Medical Council and Royal College of Surgeons of England highlights that surgeons need to communicate risks in a way that patients can understand, and both institutions specifically mention the use of written information. We aimed to improve communication of surgical risks to patients undergoing thyroid surgery.
Method
Over 3 months, all patients undergoing thyroid surgery in a tertiary referral centre were included (n=51). Participants were given a 10 point questionnaire after the consent process. Each question had 4 options (very common, common, uncommon and rare) and tested participant understanding of surgical risks. Our intervention was a single page annotated graphic, which used a traffic-light system to explain surgical risks.
Result
When consented prior to our intervention (n=28), patient understanding of the magnitude of surgical risks was poor; median questionnaire score was 4.5 out of 10, and for some questions <15% of participants selected the correct answer. Following introduction of our surgical risk tool (n=23) median overall participant score increased from 4.5 (range 2-7) to 8.0 (4-10) out of 10 (P<0.0001; Mann-Whitney U test).
Conclusion
Patients must understand the risks of an operation, and the magnitude of those risks, in order to provide valid consent. Addition of a visual surgical risk tool enabled us to increase patient understanding of surgical risks, improving the consent process. This has implications not just for thyroid surgery, but for any procedure requiring consent.
Take-home message
Clear communication of surgical risks is essential to obtain valid consent. The use of a visual surgical risk tool increases patient understanding of risks, and therefore improves the consent process.

Randomized comparison of two interventions to enhance understanding during the informed consent process for research

Randomized comparison of two interventions to enhance understanding during the informed consent process for research
Research Article
Holly A Taylor, Daphne Washington, Nae-Yuh Wang, Hiten Patel, Daniel Ford, Nancy E Kass, Joseph
Clinical Trials, 23 April 2021
Abstract
Background/Aims
Many investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing clinical studies. The present study rigorously tested two simple and easily adoptable strategies for presenting key consent information to participants eligible to enroll in six actual clinical trials (i.e. six parent studies).
Methods
In collaboration with the study team from each parent study, we developed two consent interventions: a fact sheet and an interview-style video. The content of each of the intervention was based on the information shared in the consent form approved for each parent study. Participants were randomized to the standard consent process, or to one of the two interventions. Once exposed to the assigned consent mode, participants were asked to complete an assessment of understanding. The study was powered to determine whether those exposed to the fact sheet or video performed better on the consent assessment compared to those exposed to the standard consent. We also assessed participant satisfaction with the consent process.
Results
A total of 284 participants were randomized to one of the three consent arms. Assessments of understanding were completed with a total of 273 participants from July 2017 to April 2019. Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process (p value = 0.020). Participants were more satisfied with the video when compared to the standard consent. Participants who received the fact sheet did not achieve higher overall understanding or satisfaction scores when compared to the standard consent process.
Conclusion
This randomized study of two novel consent interventions across six different clinical trials demonstrated a statistically significant difference in participant understanding based on overall scores among those exposed to the video intervention compared to those exposed to the standard consent.

Multimedia for Delivering Participant Informed Consent in Cardiovascular Trials

Multimedia for Delivering Participant Informed Consent in Cardiovascular Trials
Niamh Chapman, Rebekah Mcwhirter, Matthew Armstrong, Ricardo Fonseca, Julie Campbell, Mark Nelson, Martin Schultz, James Sharman
Journal of Hypertension, April 2021; 39 pp e217-e218
Open Access
Abstract
Objective
Obtaining informed consent is a cornerstone requirement of conducting ethical research. Traditional paper-based consent is often excessively lengthy, legalistic in character, and may fail to achieve desired participant understanding of study requirements. Multimedia tools including video and audio may be a useful alternative. This study aimed to determine the efficacy, usability and acceptability of stand-alone multimedia delivery of participant consent relating to a cardiovascular trial.
Design and method
A total of 298 participants (63 ± 8 years; 51% female) were randomised to delivery of cardiovascular research study information and signed consent via multimedia (intervention; n = 146) compared with standard paper-based approach (control; n = 152) in a clinical research setting. Intervention was free of research staff and included short audio-visual explanations, with computer-based finger-signed consent. Efficacy, usability and acceptability were assessed by questionnaire.
Results
All participants successfully completed allocated interventions. Efficacy parameters were significantly higher among intervention participants, including better understanding of study requirements compared with controls (P < 0.05 all). Intervention participants were also significantly more likely to engage with the study information and spend more time on the consent process and study questionnaire (P = 0.038 and P = 0.007, respectively). Both groups reported similar levels of acceptability of the consent process, although more control participants reported that the study information was too long (24% versus 14%; P = 0.020).
Conclusions
A standalone multimedia consent process is effective for achieving participant understanding and obtaining consent on cardiovascular research in a clinical research setting free of research staff. Thus, multimedia represents a viable method to reduce the burden on researchers, meet participant needs, and achieve informed consent in clinical cardiovascular research.

Assessing Patient Satisfaction and Confidence After Use of Educational Video to Augment Surgical Consent for Thyroid Surgery

Assessing Patient Satisfaction and Confidence After Use of Educational Video to Augment Surgical Consent for Thyroid Surgery
Michelle Schafer, Katie Holland, Alexander Duffy, Kelley Yuan, Marisa Wu, Raphael Banoub, Elizabeth Cottrill
Translational Medical Research Commons, February 2021
Abstract
Introduction
Informed consent is a crucial aspect of ethical patient care, yet the increase in surgical complexity presents a challenge in achieve this properly. This study explores the use of an educational video to help standardize the consent process, increase patient retention of information, and promote patient understanding by allowing patients to replay the information remotely as often as needed.
Methods
This is a prospective, survey-based study of adult patients undergoing thyroid surgery. A novel video detailing thyroid surgery containing the standard contents of informed consent was shown to patients after traditional informed consent followed by a survey on their level of comfort of the information before and after the video. Data on patient age, education level, previous surgical experience was collected.
Results
Preliminary data shows that there is an increase in confidence, benefits, and knowledge of risk of the patients’ operation. We expect to find that with the addition of an educational video to the thyroid surgery consent process, patients will report a higher level of satisfaction as well as confidence in regards to their surgery.
Discussion
The process of informed consent has not evolved with the complexity of procedures. The use of multimedia has been demonstrated as a valuable teaching tool in addition to traditional informed. Our study reinforces that there is a place for multimedia, specifically educational videos in informed consent for thyroid surgery as it may help patients better understand their procedure. Future aims of this study include evaluating patient comprehension with the addition of an educational video to informed consent, as well as the creation of more educational videos for head and neck surgery consent.

Digital tools in the informed consent process: a systematic review

Digital tools in the informed consent process: a systematic review
Research Article
Francesco Gesualdo, Margherita Daverio, Laura Palazzani, Dimitris Dimitriou, Javier Diez-Domingo, Jaime Fons-Martinez, Sally Jackson, Pascal Vignally, Caterina Rizzo & Alberto Eugenio Tozzi
BMC Medical Ethics, 27 February 2021; 22(18)
Open Access
Abstract
Background
Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice. Understanding, satisfaction and participation were compared for digital tools versus the non-digital Informed Consent process.
Methods
We searched for studies on available electronic databases, including Pubmed, EMBASE, and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to October 2020, that focused on the use of digital Informed Consent tools for clinical research, or clinical procedures. Digital interventions were defined as interventions that used multimedia or audio–video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia.
Results
Our search yielded 19,579 publications. After title and abstract screening 100 studies were retained for full-text analysis, of which 73 publications were included. Studies examined interactive multimedia (29/73), non-interactive multimedia (13/73), and videos (31/73), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and clinical research (12/38). For research IC, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes.
Conclusions
Digital technologies for informed consent were not found to negatively affect any of the outcomes, and overall, multimedia tools seem desirable. Multimedia tools indicated a higher impact than videos only. Presence of a researcher may potentially enhance efficacy of different outcomes in research IC processes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardization is needed to conclusively assess impact.

The effect of animated consent material on participants’ willingness to enrol in a placebo-controlled surgical trial: a protocol for a randomised feasibility study

The effect of animated consent material on participants’ willingness to enrol in a placebo-controlled surgical trial: a protocol for a randomised feasibility study
Study Protocol
Elizabeth Nelson, Cade Shadbolt, Samantha Bunzli, Angela Cochrane, Peter Choong & Michelle Dowsey
Pilot and Feasibility Studies, 8 February 2021; 7(46)
Open Access
Abstract
Background
Placebo-controlled surgical trials are recognised as the gold standard way to test the efficacy of a surgical procedure. Despite a rise in arthroscopic subacromial decompression (ASD) surgeries for the treatment of shoulder pain, only two placebo-controlled surgical trials have been conducted. These trials encountered significant recruitment challenges, threatening the external validity of findings. Difficulties with recruitment are common in clinical trials and likely to be amplified in placebo-controlled surgical trials. This mixed method feasibility trial aims to address the following questions: (i) Feasibility: What proportion of patients who have consented to undergo ASD report that they would be willing to enrol in a placebo-controlled trial for this procedure? (ii) Optimisation: Can patients’ willingness to enrol in, or understanding of, such a trial be improved by supplementing written consent materials with a brief visual animation that outlines the details of the trial? And (iii) exploration: What factors influence patients stated willingness to enrol in such a trial, and how do they believe the recruitment process could be improved?
Methods
This study aims to recruit 80 patients on the waiting list for ASD. Participants will be randomised (1:1) to either view a brief video animation explaining the hypothetical placebo-controlled trial in addition to written information or to written information only. Participants in both groups will be required to state if they would be willing to opt-in to the hypothetical ASD trial after immediately being presented with the consent material and again 1 week after completion of the consent process. Patients in both groups will also be required to complete a measure of trial literacy. Twenty participants will be purposively sampled to take part in an embedded qualitative study exploring understanding of trial concepts and factors contributing to willingness to opt-in.
Discussion
This feasibility study will provide evidence for optimising participant recruitment into a placebo-controlled trial of ASD by consenting patients using animated trial information in addition to written information. This pilot and feasibility data may also be relevant to placebo-controlled surgical trials more broadly, which are characterised by recruitment challenges.

Can a Checklist Improve the Informed Consent Process?

Can a Checklist Improve the Informed Consent Process?
Original Article
Eric Shirley, Veronica H. Mai, Kevin M. Neal, Kathryn V. Blake
Cureus, 5 February 2021; 13(2)
Abstract
Informed consent often fails to provide patients and families with a full understanding of the proposed procedure. We developed an informed consent checklist for identifying specific aspects of the surgical consent that were not fully understood by families. The purpose of this study was to measure the effect of using this checklist on families’ knowledge, satisfaction, experience, and decisional conflict during the consent process. The families of pediatric patients scheduled for an orthopaedic preoperative visit were prospectively randomized into one of two groups: checklist or traditional appointment. Families in the checklist group completed the informed consent checklist which was then used by the surgeon to further discuss aspects of the surgery that needed clarification. Those in the traditional group had similar discussions about surgery without the aid of a checklist. Sixty-one families participated in the study; 27 in the checklist group and 34 in the traditional group without a checklist. The checklist group reported no difference in mean scores for all satisfaction (P = 0.37), decisional conflict (P = 0.51), and knowledge items (P = 0.31). For patient experience, the traditional group reported the visits were significantly more relaxed (mean 4.9, 95% confidence interval (CI) 4.8-5.0) than the checklist group (mean 4.5, 95% CI 4.3-4.7). Our results suggest that having a family member complete the informed consent checklist prior to meeting with the surgeon did not improve, and may worsen, the consent experience for some families. Other methods need to be evaluated to determine the optimal consent process from the family’s perspective.