Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial

Background The traditional informed consent (IC) process rarely emphasizes research participants’ comprehension of medical information, leaving them vulnerable to unknown risks and consequences associated with procedures or studies. Objective This paper explores how we evaluated the feasibility of a digital health tool called Virtual Multimedia Interactive Informed Consent (VIC) for advancing the IC process and compared the results with traditional paper-based methods of IC. Methods Using digital health and web-based coaching, we developed the VIC tool that uses multimedia and other digital features to improve the current IC process. The tool was developed on the basis of the user-centered design process and Mayer’s cognitive theory of multimedia learning. This study is a randomized controlled trial that compares the feasibility of VIC with standard paper consent to understand the impact of interactive digital consent. Participants were recruited from the Winchester Chest Clinic at Yale New Haven Hospital in New Haven, Connecticut, and healthy individuals were recruited from the community using fliers. In this coordinator-assisted trial, participants were randomized to complete the IC process using VIC on the iPad or with traditional paper consent. The study was conducted at the Winchester Chest Clinic, and the outcomes were self-assessed through coordinator-administered questionnaires. Results A total of 50 participants were recruited in the study (VIC, n=25; paper, n=25). The participants in both groups had high comprehension. VIC participants reported higher satisfaction, higher perceived ease of use, higher ability to complete the consent independently, and shorter perceived time to complete the consent process. Conclusions The use of dynamic, interactive audiovisual elements in VIC may improve participants’ satisfaction and facilitate the IC process. We believe that using VIC in an ongoing, real-world study rather than a hypothetical study improved the reliability of our findings, which demonstrates VIC’s potential to improve research participants’ comprehension and the overall process of IC. Trial Registration ClinicalTrials.gov NCT02537886; https://clinicaltrials.gov/ct2/show/NCT02537886


1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.

Does your paper address subitem 1a-i? *
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Comparing a Multimedia Web-based Informed Consent Tool to Traditional Paperbased Methods Among GenEx Trial Participants: Randomized Control Trial"

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
subitem not at all important 1 2 3 4 5 essential 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.

Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Comparing a Multimedia Web-based Informed Consent Tool to Traditional Paperbased Methods Among GenEx Trial Participants: Randomized Control Trial" 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT
Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This paper explores how we evaluated the feasibility of a digital health tool called 'VIC' for advancing the informed consent process and compared results to traditional paper-based methods of informed consent." 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The trial was coordinator-assisted" 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The trial was coordinator-assisted, and either primarily web-based for VIC participants (with face-to-face components for intervention assessment) as well as primarily faceto-face for paper participants." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Overall 50 participants were recruited in the study (VIC: n=25; Paper: n=25). VIC participants reported higher satisfaction, higher perceived ease of use, higher ability to complete the consent independently, and a shorter perceived time for completing the consent process."

INTRODUCTION 2a) In INTRODUCTION: Scientific background and explanation of rationale
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "The use of dynamic, interactive audiovisual elements in VIC may improve patient recall and facilitate the informed consent process as well as allow for remote consent. We believe that using VIC in an ongoing, real-world study rather than a hypothetical study improved the reliability of our findings which demonstrate VIC's potential to improve patients' comprehension as well as the overall process of the 2a-i) Problem and the type of system/solution Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in " Methods" under 5) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Despite the implications and magnitude of the informed consent process, the Joint Commission for Transforming Healthcare has reported that an estimated 60-70% of individuals do not read or understand the information contained in the consent form and 44% of patients signing informed consent documents do not understand the nature of the proposed procedure.
[5] While many providers have opted for electronic IC in an attempt to mitigate these issues, this method usually results in a mere electronic version of the standard paper-based form and does little to address patient comprehension. This lack of sufficient information and patient comprehension in the IC process negatively impacts patient safety and quality of care." "Existing research suggests that the use of Digital Health interventions-such as virtual coaching and mobile apps-and interactive audio and visual elements in a patient-centered IC can increase the patient's interest and retention.
[3] [8][9][10][11]. We applied these principles in the development of our patient-centered, tablet-based tool, "Virtual multimedia interactive Informed Consent" (VIC), which uses virtual coaching to conduct a brief and virtual interview with patients using tablet computers. VIC greatly advances the existing IC process by featuring a comprehensive multimedia library, including videos, narrative audio functionality, and quizzes to better explain for patients the risks, benefits, and alternatives of a treatment or clinical study." 2a-ii) Scientific background, rationale: What is known about the (type of) system

2b) In INTRODUCTION: Specific objectives or hypotheses
Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Existing research suggests that the use of Digital Health interventions-such as virtual coaching and mobile apps-and interactive audio and visual elements in a patient-centered IC can increase the patient's interest and retention.
[3] [8][9][10][11]. We applied these principles in the development of our patient-centered, tablet-based tool, "Virtual multimedia interactive Informed Consent" (VIC), which uses virtual coaching to conduct a brief and virtual interview with patients using tablet computers. VIC greatly advances the existing IC process by featuring a comprehensive multimedia library, including videos, narrative audio functionality, and quizzes to better explain for patients the risks, benefits, and alternatives of a treatment or clinical study.
While more than half of feasibility studies in the existing literature use hypothetical scenarios to test enhanced IC, we believe the use of an actual research study improves the validity, accuracy, and reliability of the results. [12,13] In this paper, we used a randomized control trial to test VIC with participants involved in a real-world study and evaluated the tool's feasibility and utility compared to standard, paper-based IC." Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "While more than half of feasibility studies in the existing literature use hypothetical scenarios to test enhanced IC, we believe the use of an actual research study improves the validity, accuracy, and reliability of the results. [12,13] In this paper, we used a randomized control trial to test VIC with participants involved in a real-world study and evaluated the tool's feasibility and utility compared to standard, paper-based IC." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Our study was a randomized controlled trial to test the feasibility of VIC in an ongoing, real-world research study titled "Yale Center for Asthma and Airway Disease Mechanisms and Mediators of Chronic Lung Disease Study" (GenEx 2.0)." "Utilizing the parent study's existing infrastructure and participants, the VIC trial recruited individuals and randomly assigned them to receive either the existing GenEx 2.0 paper consent document (control arm) or consent on the tablet through the VIC tool (intervention arm). Of the eligible participants, the allocation ratio for each group was 1:1." Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There were no changes to methods after trial commencement.
subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants

3b-i) Bug fixes, Downtimes, Content Changes
Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].
Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study During the duration of the study, there were no changes/downtime/bug fixes required.
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were eligible for both GenEx 2.0 and the VIC trial if they: (1) spoke English, (2) were over 21 years old, (3) provided an email address, and (4) were willing to use an iPad. Computer literacy was not required for eligibility. Participants were excluded from the GenEx 2.0 study for: (1) having a smoking history of over 10 packs a year, (2) being active smokers within the past year, or (3) having other chronic lung disease or asthma variant. Additionally, GenEx 2.0 participants were excluded from participation in VIC if they were (1) not able to safely undergo the studies required for participation, (2) not able to read or understand English, (3) refused to participate, or (4) had participated in the GenEx 2.0 trial in the past."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Computer literacy was not required for eligibility." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "For VIC participants, the trial would include web-based with face-to-face components, or be conducted primarily face-to-face depending on the arm they were assigned."

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

4b) Settings and locations where the data were collected
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The GenEx 2.0 study recruited patients with lung disease from Winchester Chest Clinic (WCC) at Yale New Haven Hospital in New haven, CT as well as healthy individuals from the community using fliers. We approached participants who were considered for the parent study and asked if they were interested in participating in the VIC trial in addition to their participation in GenEx 2.0."

Does your paper address CONSORT subitem 4b? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "GenEx 2.0, the parent study for VIC, evaluated the pathophysiology and heterogenicity of airway disease in participants using several procedures, including: a coordinatoradministered, self-assessed questionnaire, lung function testing, blood draw, and hypertonic saline-induced sputum induction at the Winchester Chest Clinic." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.

Does your paper address subitem 4b-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Outcomes were self-assessed through coordinator-administrated questionnaires at the GenEx 2.0 trial location."

4b-ii) Report how institutional affiliations are displayed
Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Affiliation was mentioned on flyers local to New Haven, CT, area, and did not seem to have an effect on results.

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).

Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.

Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This is addressed in an earlier paper regarding the development process of the tool: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5977640/

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We had no relevant revisions, updates or changes to content during the trial period.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.

Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Since VIC is a web-based application that provides access to the consent before, during, and after the study visit, the individuals who were assigned to VIC received an email with a link to the remote online version of the VIC consent session. This remote "review" link allowed VIC participants to preview what would be seen on the iPad during the study visit but did not give access to the final signature needed to complete the consent process. Only VIC-assigned participants received access to the application itself during this time." "During the GenEx 2.0 study visit, individuals completed the consent process according to the arm they were assigned to." "Individuals assigned to the intervention arm (VIC tablet-based consent) completed the visit with a study coordinator who provided the individual with an iPad along with disposable headphones so that the individual could listen to the audio 5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "The VIC tool was developed by Thi Nguyen, presently lead software engineer at Michigan State University for the purpose of this trial. Secure severe hosting was handled by the Yale University ITS team, along with database security maintenance." "Since VIC is a web-based application that provides access to the consent before, during, and after the study visit, the individuals who were assigned to VIC received an email with a link to the remote online version of the VIC consent session. This remote "review" link allowed VIC participants to preview what would be seen on the iPad during the study visit but did not give access to the final signature needed to complete the consent process." "Individuals assigned to the intervention arm (VIC tablet-based consent) completed the visit with a study coordinator who provided the individual with an iPad along with disposable headphones so that the individual could listen to the audio instructions comfortably. The individual would then go through the consent process alone on the iPad and sign the consent on the iPad at the end if interested in participating in the GenEx 2.0 study. The format of the VIC process on the iPad allowed for the presentation of content to be displayed one section at a time with a "Continue" and "Back" button that participants could press to move forward or backward. For text-only sections, no more than approximately 90 words at a time were displayed. Some sections were transformed into interactive multimedia components, including animated videos that explained study procedures (videos specific to the GenEx 2.0 trial included demonstrations of blood draw and sputum collection) as well as videos specific to Privacy and Withdrawal information. These multimedia components also allowed interactivity with a simple menu that could pause, play, rewind, mute and enable closed captioning if needed. Some sections were followed by interactive quizzes that emphasized key information to enhance patient comprehension, which would give automatic feedback to the participant on the answer and allow them to go back to the key section and revisit the material or move forward, regardless of their answer. This method was not to inhibit the participant, but rather encourage active retention of the material.

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.

Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not relevant to our study.

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Individuals assigned to the intervention arm (VIC tablet-based consent) completed the visit with a study coordinator who provided the individual with an iPad along with disposable headphones so that the individual could listen to the audio instructions comfortably. " "For both arms, the study coordinator was available to respond to any participant questions regarding the IC process. After the consenting process, participants from both groups started the GenEx 2.0 study procedures, which took on average two hours to complete. Outcomes were self-assessed through coordinator-administrated questionnaires at the GenEx 2.0 trial location."

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
subitem not at all important 1 2 3 4 5 essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Since VIC is a web-based application that provides access to the consent before, during, and after the study visit, the individuals who were assigned to VIC received an email with a link to the remote online version of the VIC consent session. This remote "review" link allowed VIC participants to preview what would be seen on the iPad during the study visit but did not give access to the final signature needed to

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Our study did not include any co-interventions.
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "We measured six outcomes to assess the feasibility of VIC compared to standard paper consent in a real-world clinical research study, which were recorded through a paper survey after completing the IC process. Study outcomes included each participant's:

6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored
Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text Your answer 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text   "We measured six outcomes to assess the feasibility of VIC compared to standard paper consent in a real-world clinical research study, which were recorded through a paper survey after completing the IC process. Study outcomes included each participant's: (1) Comprehension of the GenEx 2.0 study IC content, measured through a 13question comprehension quiz (2) Satisfaction with the IC process, ranked on a 7-point Likert scale (3) Perceived time required to complete the IC process (4) Perceived ease of the IC process (5) Perceived likelihood of participating in future clinical trials (6) Perception of the importance of the IC process in the decision to participate in Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There were no changes made to trial outcomes after the trial commenced.
subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.

Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable to our current study.
8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Eligible and consenting participants were randomized to receive IC through the standard paper consent or VIC tool. Given the small sample size, the method of minimization [13] was used first to achieve balance on the following demographic characteristics: gender, race, education, employment type, marital status, household income, and technology confidence (see Table 1 for categorization). A computer algorithm belonging to the VIC back-end system maintained a record of all enrolled participants and automatically generated the randomization sequence after Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Eligible and consenting participants were randomized to receive IC through the standard paper consent or VIC tool. Given the small sample size, the method of minimization [13] was used first to achieve balance on the following demographic characteristics: gender, race, education, employment type, marital status, household income, and technology confidence (see Table 1 for categorization). A computer algorithm belonging to the VIC back-end system maintained a record of all enrolled participants and automatically generated the randomization sequence after 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Eligible and consenting participants were randomized to receive IC through the standard paper consent or VIC tool. Given the small sample size, the method of minimization [13] was used first to achieve balance on the following demographic characteristics: gender, race, education, employment type, marital status, household income, and technology confidence (see Table 1 for categorization). A computer algorithm belonging to the VIC back-end system maintained a record of all enrolled participants and automatically generated the randomization sequence after Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A computer algorithm belonging to the VIC back-end system maintained a record of all enrolled participants and automatically generated the randomization sequence after minimization. The study coordinator who handled enrollment would select a button in the administrator portal for a particular participant to prompt the randomization process from the VIC tool, which would then display which arm (VIC or Paper) the participant was randomized to. " subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

Does your paper address subitem 11a-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were not blinded, as it was not possible for the purposes of this study, and the study coordinator was aware of which group each participant belonged to as they oversaw both groups separately. " 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were also aware that VIC was the comparator of interest for this trial." Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Both groups (digital consent and paper consent) described in full in Methods section.
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "All analyses were according to intent-to-treat (i.e., all participants were analyzed as randomized). Baseline data are reported as means and standard deviations (SD) for continuous data and as counts and percent of total for discrete data. The 13 comprehension questions were summarized as means (SD) and proportions [standard errors (SE)]. Differences in mean number of correct answers between VIC and paper consent are presented with 95% confidence intervals. The proportion of correct answers for each of the 13 individual questions was analyzed by risk ratios (VIC relative to paper) with 95% confidence intervals. Likert data for each treatment group were summarized as means (SD), as well as the perceived time to complete the IC process. There was one participant in each treatment group who reported 120 minutes as the perceived time, which were likely outliers and were removed from mean calculations. Analyses were performed using SAS v9.4 (SAS Institute, Cary, NC)."

12a-i) Imputation techniques to deal with attrition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4] Not applicable as all eligible participants participated fully in the study.

Does your paper address CONSORT subitem 12b? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There were no additional analyses involved in the study.

X26-i) Comment on ethics committee approval
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The VIC trial protocol was approved by the Yale University Institutional Review Board."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.

Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline)

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The VIC trial protocol was approved by the Yale University Institutional Review Board. The VIC tool was hosted on a secure server located on the Yale University network, and only accessible to those with explicit administrator access via the Yale University network through Yale's Central Authentication System. Databases storing participant data were also maintained on the Yale University network, and hosted on separate servers from the tool itself to increase security measures." Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A total of 50 individuals were ultimately enrolled in the VIC trial, and 25 were randomized to the VIC intervention arm and 25 to the paper IC control arm (Figure 1)." subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Ninety-one individuals were approached for the study, of whom 25 were ineligible because they had already participated in GenEx 2.0. The remaining 66 individuals completed the initial screening questionnaire, and of them, sixteen participants were deemed ineligible due to either not providing an email address (n = 4), refusing to participate (n = 5), or other unknown reasons (n = 7). A total of 50 individuals were ultimately enrolled in the VIC trial, and 25 were randomized to the VIC intervention arm and 25 to the paper IC control arm (Figure 1)."

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other figures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable for our trial as the use of the program was only during the trial period.
subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No critical secular events occurred during the study period.
14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Our trial was not stopped early.
Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, this is outlined in table 1.

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See table 1. subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, see Table 2 for full outline.
"Participant comprehension overall was high in both IC process groups. For the comprehension outcome (Table 2), VIC participants scored a mean of 11.0 correct answers out of 13 compared to the paper IC group mean of 10.6 correct answers; the mean difference in the number of correct answers between VIC and paper was 0.4 (95% CI: -0.5, 1.3). For each of the 13 individual comprehension survey questions, the proportion with correct responses was generally comparable for VIC and paper with risk ratios not different from one (Table 2). However, VIC participants appeared to have better knowledge about use of their personal health information and study withdrawal (risk ratios > 1.20), which were sections in the tablet-based tool formatted uniquely as animated videos rather than plain text. Participants were also asked questions to ascertain their level of satisfaction and perception with the two consent processes (Figure 2). Overall, mean levels of satisfaction and perception on a 7-point Likert Scale were higher with the VIC tool for every category except for the "Clinical Trial Recommendation" category. When participants were asked how well they understood who to contact with any questions or concerns related to the research study, VIC participants had a higher mean score (7.0) compared to paper consent participants (6.4).
Furthermore, on average, VIC participants had a slightly better understanding of who in the study had access to their personal health information and what would happen if they chose to participate in the study (mean scores of 7 for both), while paper consent participants scored a mean of 6.6 and 6.7, respectively. When asked about their level of understanding on how to withdraw from the study, VIC participants had a mean score of 7.0 vs. 6.7 for paper participants. Furthermore, VIC participants reported a lower mean perceived time to complete the consent process, 12.9 min (SD: 7.6) vs. 16.6 min (SD: 9.7) for paper; mean difference of -3.7 min (95% CI: -9.0, 1.5)." subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Other analyses were not performed from our pre-specified ones.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There were no unintended effects/harms during the period of this trial.

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].

Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There were no privacy breaches or technical problems during this trial.
subitem not at all important 1 2 3 4 5 essential DISCUSSION 22) Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group

19-ii) Include qualitative feedback from participants or observations from staff/researchers
Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.

Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer subitem not at all important 1 2 3 4 5 essential 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).

Does your paper address subitem 22-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "The study was conducted to test the feasibility of the VIC tool that enhances the IC process with interactive, digital content on tablets. We built VIC with a reusable infrastructure that allows for integration into the IC process for future research studies and may improve the clinical workflow through a more efficient IC process. VIC can assess participant comprehension through automated quizzes and selftests, emphasize topics using multimedia, and allow individuals to view demos and presentations. Participants can also listen to comments and explanations, get customized information, click on links to drill down for more information, ask questions, receive answers and rewind and replay audio and visual components as needed." "These innovative, dynamic features enhanced the overall participant experience in the ongoing research study, GenEx 2.0 in comparison to the standard paper IC process. In our study, VIC trial participants reported higher levels of satisfaction and comprehension than participants receiving the paper consent. Prior systematic reviews have suggested that enhanced consent forms and extended discussions were most effective in improving participant understanding, and our findings confirm this claim [3,[14][15][16][17][18]  Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Potential future research topics that would be important to consider and explore with the VIC tool would be expanding future research utilizing VIC to include participants of alternate languages other than English, as well as populations with various hearing and vision impairments. VIC's integrated text-to-speech and other audiovisual components feature innovative language integration tools that would make switching languages for other consent forms a feasible task. VIC's tabletbased methods also offer various accessibility tools that can be considered for integration to reach a more inclusive target population-with VIC's primary feature prioritizing a customized level of information, we feel that there is a great potential subitem not at all important 1 2 3 4 5 essential 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "There are some limitations to the nature of this study, which may have affected certain findings. One limitation of our study is that we did not have masked research staff administering the survey with patients after the IC process. The study coordinator for GenEx 2.0 was the same person who administered the paper-based and VIC IC processes, as well as collected study surveys, which limits our control over observer bias. Another limitation was that we did not directly and independently measure the time to complete the IC, and instead relied on the participant-reported perceived time to complete the IC. Also, we limited participation in this study to individuals who spoke English, had an e-mail address, and were willing to use the iPad. Although most participants were confident in using technology, we believe that these conditions could have potentially limited the generalizability of findings since 6% (n=7) of the screened individuals did not provide an email address. While the GenEx 2.0 study topic difficulty could be described as moderate with very few study procedures involved, VIC may perform significantly better with more complicated topics with the use of multimedia and subitem not at all important

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

OTHER INFORMATION
23) Registration number and name of trial registry 24) Where the full trial protocol can be accessed, if available Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study ClinicalTrials.gov NCT02537886; https://clinicaltrials.gov/ct2/show/NCT02537886.

Does your paper address CONSORT subitem 24? *
Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 25) Sources of funding and other support (such as supply of drugs), role of funders

X27) Conflicts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This publication was made possible by the Yale CTSA grant UL1TR000142 from the National Center for Advancing Translational Sci. (NCATS), NIH. This study was funded by grant number R21HS023987 from the Agency for Healthcare Research and Quality (AHRQ)."

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.