CONSORT-EHEALTH (V 1.6.1) - Submission/Publication Form
The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5 - description of the intervention) may also be applicable for other study designs.

The goal of the CONSORT EHEALTH checklist and guideline is to be
a) a guide for reporting for authors of RCTs,
b) to form a basis for appraisal of an ehealth trial (in terms of validity)

CONSORT-EHEALTH items/subitems are MANDATORY reporting items for studies published in the Journal of Medical Internet Research and other journals / scientific societies endorsing the checklist.

Items numbered 1., 2., 3., 4a., 4b etc are original CONSORT or CONSORT-NPT (non-pharmacologic treatment) items.
Items with Roman numerals (i., ii, iii, iv etc.) are CONSORT-EHEALTH extensions/clarifications.

As the CONSORT-EHEALTH checklist is still considered in a formative stage, we would ask that you also RATE ON A SCALE OF 1-5 how important/useful you feel each item is FOR THE PURPOSE OF THE CHECKLIST and reporting guideline (optional).

Mandatory reporting items are marked with a red *.
In the textboxes, either copy & paste the relevant sections from your manuscript into this form - please include any quotes from your manuscript in QUOTATION MARKS,
or answer directly by providing additional information not in the manuscript, or elaborating on why the item was not relevant for this study.

YOUR ANSWERS WILL BE PUBLISHED AS A SUPPLEMENTARY FILE TO YOUR PUBLICATION IN JMIR AND ARE CONSIDERED PART OF YOUR PUBLICATION (IF ACCEPTED).
Please fill in these questions diligently. Information will not be copyedited, so please use proper spelling and grammar, use correct capitalization, and avoid abbreviations.

DO NOT FORGET TO SAVE AS PDF _AND_ CLICK THE SUBMIT BUTTON SO YOUR ANSWERS ARE IN OUR DATABASE !!!

Citation Suggestion (if you append the pdf as Appendix we suggest to cite this paper in the caption):
Eysenbach G, CONSORT-EHEALTH Group
CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions
J Med Internet Res 2011;13(4):e126
URL: http://www.jmir.org/2011/4/e126/
doi: 10.2196/jmir.1923
PMID: 22209829

Your name *
First Last
Your answer
Primary Affiliation (short), City, Country *
University of Toronto, Toronto, Canada
Your answer
Your e-mail address *
Your answer
Title of your manuscript *
Provide the (draft) title of your manuscript.
Your answer
Name of your App/Software/Intervention *
If there is a short and a long/alternate name, write the short name first and add the long name in brackets.
Your answer
Evaluated Version (if any)
e.g. "V1", "Release 2017-03-01", "Version 2.0.27913"
Your answer
Language(s) *
What language is the intervention/app in? If multiple languages are available, separate by comma (e.g. "English, French")
Your answer
URL of your Intervention Website or App
e.g. a direct link to the mobile app on app in appstore (itunes, Google Play), or URL of the website. If the intervention is a DVD or hardware, you can also link to an Amazon page.
Your answer
URL of an image/screenshot (optional)
Your answer
Accessibility *
Can an enduser access the intervention presently?
Primary Medical Indication/Disease/Condition *
e.g. "Stress", "Diabetes", or define the target group in brackets after the condition, e.g. "Autism (Parents of children with)", "Alzheimers (Informal Caregivers of)"
Your answer
Primary Outcomes measured in trial *
comma-separated list of primary outcomes reported in the trial
Your answer
Secondary/other outcomes
Are there any other outcomes the intervention is expected to affect?
Your answer
Recommended "Dose" *
What do the instructions for users say on how often the app should be used?
Approx. Percentage of Users (starters) still using the app as recommended after 3 months *
Overall, was the app/intervention effective? *
Article Preparation Status/Stage *
At which stage in your article preparation are you currently (at the time you fill in this form)
Journal *
If you already know where you will submit this paper (or if it is already submitted), please provide the journal name (if it is not JMIR, provide the journal name under "other")
Is this a full powered effectiveness trial or a pilot/feasibility trial? *
Manuscript tracking number *
If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR)
TITLE AND ABSTRACT
1a) TITLE: Identification as a randomized trial in the title
1a) Does your paper address CONSORT item 1a? *
I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other")
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.
subitem not at all important
essential
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
Your answer
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
essential
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
Your answer
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
subitem not at all important
essential
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
Your answer
1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions
NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
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)
subitem not at all important
essential
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
Your answer
1b-ii) Level of human involvement in the METHODS section of the ABSTRACT
Clarify the level of human involvement in the abstract, e.g., use phrases like “fully automated” vs. “therapist/nurse/care provider/physician-assisted” (mention number and expertise of providers involved, if any). (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)
subitem not at all important
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
Your answer
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)
subitem not at all important
essential
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
Your answer
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)
subitem not at all important
essential
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
Your answer
1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials
Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome - if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (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)
subitem not at all important
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
Your answer
INTRODUCTION
2a) In INTRODUCTION: Scientific background and explanation of rationale
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
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
Your answer
2a-ii) Scientific background, rationale: What is known about the (type of) system
Scientific background, rationale: What is known about the (type of) system that is the object of the study (be sure to discuss the use of similar systems for other conditions/diagnoses, if appropiate), motivation for the study, i.e. what are the reasons for and what is the context for this specific study, from which stakeholder viewpoint is the study performed, potential impact of findings [2]. Briefly justify the choice of the comparator.
subitem not at all important
essential
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
Your answer
2b) In INTRODUCTION: Specific objectives or hypotheses
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
Your answer
METHODS
3a) Description of trial design (such as parallel, factorial) including allocation ratio
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
Your answer
3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons
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
Your answer
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].
subitem not at all important
essential
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
Your answer
4a) Eligibility criteria for participants
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
Your answer
4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit “de facto” eligibility criterion - this should be explicitly clarified.
subitem not at all important
essential
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
Your answer
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.
subitem not at all important
essential
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
Your answer
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.
subitem not at all important
essential
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
Your answer
4b) Settings and locations where the data were collected
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
Your answer
4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
subitem not at all important
essential
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
Your answer
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)
subitem not at all important
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
Your answer
5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered
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).
subitem not at all important
essential
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
Your answer
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.
subitem not at all important
essential
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
Your answer
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
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
Your answer
5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
subitem not at all important
essential
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
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.
subitem not at all important
essential
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.
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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).
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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
Your answer
5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
Describe mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework [6] used to design them (instructional strategy [1], behaviour change techniques, persuasive features, etc., see e.g., [7, 8] for terminology). This includes an in-depth description of the content (including where it is coming from and who developed it) [1],” whether [and how] it is tailored to individual circumstances and allows users to track their progress and receive feedback” [6]. This also includes a description of communication delivery channels and – if computer-mediated communication is a component – whether communication was synchronous or asynchronous [6]. It also includes information on presentation strategies [1], including page design principles, average amount of text on pages, presence of hyperlinks to other resources, etc. [1].
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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
Your answer
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.
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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
Your answer
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).
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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
Your answer
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).
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essential
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
Your answer
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.
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essential
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
Your answer
6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed
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
Your answer
6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed
If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].
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Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text
Your answer
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.
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essential
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).
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essential
Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text
Your answer
6b) Any changes to trial outcomes after the trial commenced, with reasons
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
Your answer
7a) How sample size was determined
NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed
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.
subitem not at all important
essential
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
7b) When applicable, explanation of any interim analyses and stopping guidelines
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
Your answer
8a) Method used to generate the random allocation sequence
NPT: When applicable, how care providers were allocated to each trial group
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
Your answer
8b) Type of randomisation; details of any restriction (such as blocking and block size)
Does your paper address CONSORT subitem 8b? *
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Your answer
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 9? *
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Your answer
10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions
Does your paper address CONSORT subitem 10? *
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Your answer
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
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).
subitem not at all important
essential
Does your paper address subitem 11a-i? *
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Your answer
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”.
subitem not at all important
essential
Does your paper address subitem 11a-ii?
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Your answer
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)
Does your paper address CONSORT subitem 11b? *
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Your answer
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 CONSORT subitem 12a? *
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Your answer
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]).
subitem not at all important
essential
Does your paper address subitem 12a-i? *
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Your answer
12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
Does your paper address CONSORT subitem 12b? *
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Your answer
X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
X26-i) Comment on ethics committee approval
subitem not at all important
essential
Does your paper address subitem X26-i?
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Your answer
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.
subitem not at all important
essential
Does your paper address subitem X26-ii?
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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)
subitem not at all important
essential
Does your paper address subitem X26-iii?
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Your answer
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
Does your paper address CONSORT subitem 13a? *
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Your answer
13b) For each group, losses and exclusions after randomisation, together with reasons
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) *
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Your answer
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.
subitem not at all important
essential
Does your paper address subitem 13b-i?
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Your answer
14a) Dates defining the periods of recruitment and follow-up
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Your answer
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”
subitem not at all important
essential
Does your paper address subitem 14a-i?
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Your answer
14b) Why the trial ended or was stopped (early)
Does your paper address CONSORT subitem 14b? *
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Your answer
15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group
Does your paper address CONSORT subitem 15? *
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Your answer
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.
subitem not at all important
essential
Does your paper address subitem 15-i? *
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Your answer
16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups
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.
subitem not at all important
essential
Does your paper address subitem 16-i? *
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Your answer
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).
subitem not at all important
essential
Does your paper address subitem 16-ii?
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Your answer
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)
Does your paper address CONSORT subitem 17a? *
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Your answer
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).
subitem not at all important
essential
Does your paper address subitem 17a-i?
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Your answer
17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended
Does your paper address CONSORT subitem 17b? *
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Your answer
18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory
Does your paper address CONSORT subitem 18? *
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Your answer
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).
subitem not at all important
essential
Does your paper address subitem 18-i?
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Your answer
19) All important harms or unintended effects in each group
(for specific guidance see CONSORT for harms)
Does your paper address CONSORT subitem 19? *
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Your answer
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].
subitem not at all important
essential
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Your answer
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.
subitem not at all important
essential
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Your answer
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
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).
subitem not at all important
essential
Does your paper address subitem 22-i? *
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Your answer
22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.
subitem not at all important
essential
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Your answer
20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses
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.
subitem not at all important
essential
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Your answer
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
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
subitem not at all important
essential
Does your paper address subitem 21-i?
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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.
subitem not at all important
essential
Does your paper address subitem 21-ii?
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Your answer
OTHER INFORMATION
23) Registration number and name of trial registry
Does your paper address CONSORT subitem 23? *
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Your answer
24) Where the full trial protocol can be accessed, if available
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
Your answer
25) Sources of funding and other support (such as supply of drugs), role of funders
Does your paper address CONSORT subitem 25? *
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Your answer
X27) Conflicts of Interest (not a CONSORT item)
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.
subitem not at all important
essential
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Your answer
About the CONSORT EHEALTH checklist
As a result of using this checklist, did you make changes in your manuscript? *
What were the most important changes you made as a result of using this checklist?
Your answer
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript *
Your answer
As a result of using this checklist, do you think your manuscript has improved? *
Would you like to become involved in the CONSORT EHEALTH group?
This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document
Any other comments or questions on CONSORT EHEALTH
Your answer
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