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

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.

Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study.

BACKGROUND/AIMS: In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone. METHODS: Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5 years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student's t-test (continuous) and chi-square or Fisher's exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p < 0.05. RESULTS: Of the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p = 0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p = 0.47) or in any secondary outcomes. Being "very satisfied" overall with study information (97.7% vs 88.5%, p = 0.01); "strong agreement" for feeling informed about the study (81.3% vs 70.8%, p = 0.06), understanding the study purpose (83.6% vs 71.0%, p = 0.02), nature and extent (82.8% vs 70.2%, p = 0.02), and potential societal benefits (82.8% vs 67.9%, p = 0.01); and research coordinator/study nurse relationship being "very important" (72.7% vs 63.4%, p = 0.03) were better in the video compared to the no video consent group. CONCLUSION: The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.

Video-Assisted Informed Consent in Endoscopic Urology: A Randomized Trial on Ureteroscopy.

Purpose: The aim of this study is to evaluate the possible benefits of using video consent in the preoperative ureteroscopy (URS) consent process. Material and Methods: Prospective randomized trials took place at two Italian tertiary-care centers from March 2022 to September 2022. Patients were randomly assigned to two groups: Group A (standard verbal/written informed consent) and Group B (informed consent supported by video). We investigated the impact of both types of informed consent on patient anxiety levels using the Spielberger State-Trait Anxiety Inventory (STAI) questionnaire both pre- and post-consent. In addition, using the Visual Analogue Scale, analysis of the effect of informed consent on postoperative pain and the number of calls for assistance during hospitalization as secondary outcomes was done. To assess the satisfaction level related to the whole process, patients were asked to rate their experience on a scale of 1-10, with 1 indicating "not satisfied" and 10 indicating "completely satisfied." Results: Overall, 166 patients were randomized 1:1 in each group. The multivariable regression model demonstrated that video-assisted informed consent significantly increased the difference between post- and pre-consent STAI with a reduced level of anxiety. The video-assisted informed consent significantly predicted the number of assistance calls during hospitalization. Conclusions: Video consent for ureteroscopies is a valid tool to improve procedure awareness and satisfaction. Video consent is able to reduce procedure-related patient anxiety and postoperative assistance calls, thus proving to be useful in obtaining better-informed consent for endourological procedures.

Educational video while "waiting-to-be-seen" in a cardiology outpatient clinic promotes opt-in self-consent for biobanking of remnant clinical biospecimens: A randomized-controlled trial.

Objectives: Consenting donors for remnant clinical biospecimen donation is critical for scaling research biorepositories. Opt-in, low-cost, self-consenting for donations that solely relied on clinical staff and printed materials was recently shown to yield ∼30% consent rate. We hypothesized that adding an educational video to this process would improve consent rates. Methods: Randomized patients (by clinic day) in a Cardiology clinic received either printed materials (control) or the same materials plus an educational video on donations (intervention) while waiting to be seen. Engaged patients were surveyed at the clinic checkout for an "opt-in" or "opt-out" response. The decision was documented digitally in the electronic medical record. The primary outcome of this study was the consent rate. Results: Thirty-five clinic days were randomized to intervention (18) or control (17). Three hundred and fifty-five patients were engaged, 217 in the intervention and 158 in the control. No significant demographic differences were noted between treatment groups. Following an intention-to-treat analysis, the rate of opt-in for remnant biospecimen donation was 53% for the intervention and 41% for the control group (p-value = 0.03). This represents a 62% increase in the odds of consenting (OR = 1.62, 95% CI = 1.05-2.5). Conclusion: This is the first randomized trial showing that an educational video is superior to printed materials alone when patients are self-consenting for remnant biospecimen donation. This result adds to the evidence that efficient and effective consenting processes can be integrated into clinical workflows to advance universal consenting in medical research.

Personalized video consent in Blepharoplasty: A new paradigm in the preoperative consent giving process.

BACKGROUND: Informed consent is not simply the signing of a form by the patient but more significantly, a process of an in-depth communication between the doctor and the patient. AIM: The written informed consent process typically involves reading a lengthy document involving the medical terms which at times lead to misinterpretation. Therefore, the current research envisages assessing the effectiveness and acceptability of the video consent tool athwart the traditional written consent procedure. METHODS: A retrospective questionnaire study was carried out with 30 patients posted for Blepharoplasty surgery between ages of 18-50 years. They were divided into two groups randomly. All the participants were given written consent. Video consent was taken additionally for group 2 subjects. All the participants received pre-validated questionnaire. The evaluation scale used was a 5-point Likert scale. RESULTS: People with video consent group were more satisfied with the consent process. It was noted that all the patients who received video consent were happier and understood the consent process better than patients with written consent only. CONCLUSION: The inference drawn from our study depicts that video consent is not just easy to understand and clarifies the doubts associated with the surgery but also significantly reduces the anxiety of the patient preoperatively. Also, in other 'quality of life' improving cosmetic procedures including rhinoplasty, face lift surgeries, jaw surgeries, botox, fillers, lasers etc., video consenting tool can be used to a maximum benefit. It is strongly recommended to adopt the practice of taking video consent format in all forms of cosmetic procedures.

Oxford Video Informed Consent Tool (OxVIC): a pilot study of informed video consent in spinal surgery and preoperative patient satisfaction.

OBJECTIVES: The British Association of Spinal Surgeons recently called for updates in consenting practice. This study investigates the utility and acceptability of a personalised video consent tool to enhance patient satisfaction in the preoperative consent giving process. DESIGN: A single-centre, prospective pilot study using questionnaires to assess acceptability of video consent and its impacts on preoperative patient satisfaction. SETTING: A single National Health Service centre with individuals undergoing surgery at a regional spinal centre in the UK. OUTCOME MEASURE: As part of preoperative planning, study participants completed a self-administered questionnaire (CSQ-8), which measured their satisfaction with the use of a video consent tool as an adjunct to traditional consenting methods. PARTICIPANTS: 20 participants with a mean age of 56 years (SD=16.26) undergoing spinal surgery. RESULTS: Mean patient satisfaction (CSQ-8) score was 30.2/32. Median number of video views were 2-3 times. Eighty-five per cent of patients watched the video with family and friends. Eighty per cent of participants reported that the video consent tool helped to their address preoperative concerns. All participants stated they would use the video consent service again. All would recommend the service to others requiring surgery. Implementing the video consent tool did not endure any significant time or costs. CONCLUSIONS: Introduction of a video consent tool was found to be a positive adjunct to traditional consenting methods. Patient-clinician consent dialogue can now be documented. A randomised controlled study to further evaluate the effects of video consent on patients' retention of information, preoperative and postoperative anxiety, patient reported outcome measures as well as length of stay may be beneficial.