Effect of an eHealth Intervention to Reduce Sickness Absence Frequency Among Employees With Frequent Sickness Absence: Randomized Controlled Trial

Background Frequent sickness absence—that is, 3 or more episodes of sickness absence in 1 year—is a problem for employers and employees. Many employees who have had frequent sickness absence in a prior year also have frequent sickness absence in subsequent years: 39% in the first follow-up year and 61% within 4 years. Moreover, 19% have long-term sickness absence (≥6 weeks) in the first follow-up year and 50% within 4 years. We developed an electronic health (eHealth) intervention, consisting of fully automated feedback and advice, to use either as a stand-alone tool (eHealth intervention–only) or combined with consultation with an occupational physician (eHealth intervention–occupational physician). Objective This study aimed to evaluate the effect of the eHealth intervention, with or without additional occupational physician consultation, to reduce sickness absence frequency for employees with frequent sickness absence, versus care as usual (CAU). Methods This study was a three-armed randomized controlled trial. Employees with frequent sickness absence received invitational letters, which were distributed by their employers. The primary outcome measure was the number of register-based sickness absence episodes 12 months after completing the baseline questionnaire. Secondary outcome measures were register-based total sickness absence days and self-assessed burnout, engagement, and work ability. In a process evaluation 3 months after baseline, we examined adherence to the intervention and additional actions such as general practitioner and occupational physician visit, communication with the manager, and lifestyle change. Results A total of 82 participants were included in the analyses, 21 in the eHealth intervention–only group, 31 in the eHealth intervention–occupational physician group, and 30 in the CAU group. We found no significant difference in sickness absence frequency between the groups at 1-year follow-up. Sickness absence frequency decreased in the eHealth intervention–only group from 3 (interquartile range, IQR 3-4) to 1 episode (IQR 0.3-2.8), in the eHealth intervention–occupational physician group from 4 (IQR 3-5) to 3 episodes (IQR 1-4), and in the CAU group from 3 (IQR 3-4) to 2 episodes (IQR 1-3). For secondary outcomes, we found no significant differences between the intervention groups and the control group. The process evaluation showed that only 3 participants from the eHealth intervention–occupational physician group visited the occupational physician on invitation. Conclusions Among employees with frequent sickness absence, we found no effect from the eHealth intervention as a stand-alone tool in reducing sickness absence frequency, nor on total sickness absence days, burnout, engagement, or work ability. This might be due to low adherence to the intervention because of insufficient urgency to act. We cannot draw any conclusion on the effect of the eHealth intervention tool combined with an occupational physician consultation (eHealth intervention–occupational physician), due to very low adherence to the occupational physician consultation. An occupational physician consultation could increase a sense of urgency and lead to more focus and appropriate support. As this was the first effectiveness study among employees with frequent sickness absence, strategies to improve recruitment and adherence in occupational eHealth are included. Trial Registration Netherlands Trial Register NTR4316; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4316 (Archived by WebCite at http://www.webcitation.org/713DHhOFU).

yes: all primary outcomes were signi cantly better in intervention group vs control partly: SOME primary outcomes were signi cantly better in intervention group vs control no statistically signi cant difference between control and intervention potentially harmful: control was signi cantly better than intervention in one or more outcomes inconclusive: more research is needed Other: Approx. Percentage of Users (starters) still using the app as recommended after 3 months * Overall, was the app/intervention effective? * no ms number (yet) / not (yet)  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 o ine 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 brie y explain why the item is not applicable/relevant for your study E-health intervention subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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").
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 brie y explain why the item is not applicable/relevant for your study The co-intervention in the second intervention arm, i.e. consultation with an occupational physician, is not included in the title as only 3 participants visited the OP upon invitation. We could not draw any conclusion on the effect of blended care (EHI-tool combined with an OP consultation) . We could only draw conclusions on the effect of the e-health intervention as a stand-alone intervention.
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 brie y explain why the item is not applicable/relevant for your study "Effect of an e-health intervention to reduce sickness absence frequency among employees with frequent sickness absence: a randomized-controlled trial." 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions 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 brie y explain why the item is not applicable/relevant for your study "We developed an e-health intervention, consisting of fully-automated feedback and advice, to use either as a stand-alone tool (EHI-only) or combined with consultation with an occupational physician (EHI-OP)." "To evaluate the effect of an e-health intervention, with or without additional OP consultation, to reduce SA frequency for employees with frequent SA, versus care as usual (CAU). " 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 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 brie y explain why the item is not applicable/relevant for your study "We developed an e-health intervention, consisting of fully-automated feedback and advice, to use either as a stand-alone tool (EHI-only) or combined with consultation with an occupational physician (EHI-OP)." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), 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 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 brie y explain why the item is not applicable/relevant for your study "Employees with frequent SA received invitational letters, which were distributed by their employers. The primary outcome measure was the number of registerbased SA episodes 12 months after completing the baseline questionnaire.
Secondary outcome measures were register-based total SA days and selfassessed burn out, engagement and work ability.
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 brie y explain why the item is not applicable/relevant for your study "A total of 82 participants were included in the analyses, 21 in the EHI-only group, 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 brie y explain why the item is not applicable/relevant for your study " Among employees with frequent SA we found no effect from the e-health intervention as a stand-alone tool in reducing SA frequency, nor on total SA days, burn out, engagement or work ability. This may be due to low adherence to the intervention because of insu cient urgency to act. We cannot draw any conclusion on the effect of blended care (EHI-OP), i.e. the EHI-tool combined with an OP consultation, due to very low adherence to the OP consultation. An OP consultation could increase a sense of urgency and lead to more focus and appropriate support. As this was the rst effectiveness study among employees with frequent SA, strategies to improve recruitment and adherence in occupational e-health are included. " 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 standalone 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 brie y explain why the item is not applicable/relevant for your study "Frequent sickness absence (SA), i.e. ≥ 3 SA episodes in a year, is common in the Dutch working population and poses a problem for both employers and employees [1]. The prevalence of frequent SA was 5.8% in 2015 and 6.1% in 2016 among more than 600,000 employees working in small-medium sized companies under contract with a Dutch national occupational health service (OHS 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 brie y explain why the item is not applicable/relevant for your study "To our knowledge, no e-health interventions have as yet been designed to reduce SA frequency among frequent absentees. We developed an E-Health Intervention (EHI) tool to advise employees with frequent SA as to how they could improve health and self-management. The theoretical framework for this EHI tool was based on the Job Demands -Resources (JD -R) model [28]. The JD -R model relates psychosocial work characteristics to outcome measures such as burn out, engagement, productivity and sickness absence [29][30][31][32], and provides keys for guidance and support [11,32]" "In the Netherlands, OPs often play a role in work-related interventions to reduce SA as they are experts in health, work, sickness absence and prevention. They can also address factors from the JD-R model, advising (temporary) accommodations to reduce job demands and/or increase job resources. The role of OPs in effective reduction of SA [12,14,15] led us to include a blendedcare study arm, combining the EHI tool with a consultation with the OP. " 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 brie y explain why the item is not applicable/relevant for your study "The main objective of this study was to evaluate the effectiveness of the EHI tool without (EHI-only) and with OP consultation (EHI-OP), compared to care as usual (CAU), on SA frequency among employees with frequent SA. Secondary outcomes were the total number of SA days, burn out, work engagement, and work ability at 1-year follow-up. We conducted a process evaluation to evaluate adherence to the intervention." 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 brie y explain why the item is not applicable/relevant for your study "The main objective of this study was to evaluate the effectiveness of the EHI tool without (EHI-only) and with OP consultation (EHI-OP), compared to care as usual (CAU), on SA frequency among employees with frequent SA. " "The study was designed as a three-armed randomized-controlled trial and registered in the Dutch trial register". "The source population (n=825) was prerandomized into three arms: intervention group 1 (EHI-only; n=270), intervention group 2 (EHI-OP; n=279) and control group (n=276)." 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 brie y explain why the item is not applicable/relevant for your study There were no changes to methods after start of the inclusion 3b-i) Bug xes, Downtimes, Content Changes Bug xes, 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 xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced 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 brie y explain why the item is not applicable/relevant for your study "After nalization of the tool, we made no changes in the contents. " 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 brie y explain why the item is not applicable/relevant for your study "Inclusion criteria were employees with frequent SA, i.e. 3 or more episodes of SA in the year prior to recruitment, irrespective of the causes or duration of sick leave. Exclusion criterion was inability to complete a questionnaire in Dutch. " 4a-i) Computer / Internet literacy Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
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 brie y explain why the item is not applicable/relevant for your study Computer/internet literacy was implicitly included: "Exclusion criterion was inability to complete a questionnaire in Dutch. " 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. o ine), 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 con rmation, phone calls) were used to detect/prevent these.
subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 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 brie y explain why the item is not applicable/relevant for your study "Study participants were recruited from 21 Dutch organizations sta ng >100 employees between December 2013 and December 2014. Of the participating organizations, 7 were in industry, 5 in commercial services and 9 in public services. The rst author (AN) had prepared a list of all frequent absentees in the participating organizations (source population), based on the occupational health service register. All employees with frequent SA received from us invitational letters combined with informed consent forms, which were distributed by their employers. The letters contained logos from both the University of Groningen and the OHS. Upon signing the informed consent form, we sent a personal URL code, that gave access to the online questionnaire at baseline (T0)." "Upon completion of the baseline questionnaire the intervention groups received fully-automated personal advice. The control group was thanked for participation upon completion of the questionnaire." "Participants in intervention group 2 received the same advices and documents as the EHI-only group, but were invited by e-mail to a preventive advisory consultation with the OP. " 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.
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 brie y explain why the item is not applicable/relevant for your study "All employees with frequent SA received from us invitational letters combined with informed consent forms, " 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 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 brie y explain why the item is not applicable/relevant for your study "Study participants were recruited from 21 Dutch organizations sta ng >100 employees between December 2013 and December 2014. Of the participating organizations, 7 were in industry, 5 in commercial services and 9 in public services. " 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 brie y explain why the item is not applicable/relevant for your study "The primary outcome measure was the number of register-based SA episodes 12 months after completing the online baseline questionnaire. Secondary outcome measures were register-based total SA days and self-assessed burn out, engagement and work ability." 4b-ii) Report how institutional a liations are displayed Report how institutional a liations are displayed to potential participants [on ehealth media], as a liations 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) 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 brie y explain why the item is not applicable/relevant for your study "The letters contained logos from both the University of Groningen and the 5) The interventions for each group with su cient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-i) Mention names, credential, a liations of the developers, sponsors, and owners Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict 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 brie y explain why the item is not applicable/relevant for your study "The authors would like to thank ArboNed for investing in the intervention as proposed. The authors would also like to thank Byelex, the software provider, who made the application to speci cation and enabled running the intervention."

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 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study "The theoretical framework for this EHI tool was based on the Job Demands -Resources (JD -R) model [28]. The JD -R model relates psychosocial work characteristics to outcome measures such as burn out, engagement, productivity and sickness absence [29][30][31][32], and provides keys for guidance and support [11,32]. We used tools from the mental health guidelines of the Netherlands Society for Occupational Physicians (NVAB) [33]. Furthermore, the EHI tool was based on the determinants of frequent SA according to focus group participants and their suggestions on how to reduce frequent SA, such as communication with management [11]. The intervention addressed these elements item-by-item." "We pilot-tested the EHI tool in 12 frequent absentees from 3 non-participating organizations. We used their feedback on technical issues and understandability to improve the EHI tool. "

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).
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 brie y explain why the item is not applicable/relevant for your study There was no revision 5-iv) Quality assurance methods Provide information on quality assurance methods to ensure accuracy and quality of information 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 brie y 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 owcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c 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 brie y explain why the item is not applicable/relevant for your study The program is owned by a private company and is not publicly accessible. A unique URL code is available to the editor and reviewers

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.
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 brie y 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 speci c 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).
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 brie y explain why the item is not applicable/relevant for your study "Upon signing the informed consent form, we sent a personal URL code, that gave access to the online questionnaire at baseline (T0). " "Participants in intervention group 2 received the same advices and documents as the EHI-only group, but were invited by e-mail to a preventive advisory consultation with the OP. "

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
"The control group received neither personalized advice nor support from the OP or researchers upon completion of the online questionnaire. Care as usual consisted of consultation with the OP at the request of the employer or control group participant. In case of long-term SA, participants were invited for a consultation with the OP to certify SA within 6 weeks of reporting sick "

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use 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 brie y explain why the item is not applicable/relevant for your study "In a process evaluation three months after baseline, adherence to the intervention was measured in the EHI groups, assessing reading the advice provided by the E-health tool and undertaking actions. "

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 21generalizability).
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 brie y explain why the item is not applicable/relevant for your study "Participants in intervention group 2 received the same advices and documents as the EHI-only group, but were invited by e-mail to a preventive advisory consultation with the OP. The e-mail contained the name of the OP and the telephone number of the OP's secretary to make an appointment. "

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 de ned pre-speci ed 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 brie y explain why the item is not applicable/relevant for your study Eligible participants received one reminder to participate when they had not yet been recruited 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 brie y explain why the item is not applicable/relevant for your study "Participants in intervention group 2 (EHI-OP) received the same advices and documents as the EHI-only group, but were invited by e-mail to a preventive advisory consultation with the OP (occupational physician). " situation. This could lead to making a joint Plan-of-Action, but it was not obligatory." 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 brie y explain why the item is not applicable/relevant for your study "The primary outcome measure was the number of register-based SA episodes 12 months after completing the online baseline questionnaire. At 1-year followup, the incident number of SA episodes was retrieved at the individual level from the occupational health service register, in which SA was recorded from the rst day of sick leave to the day of return to work. " "The number of days of all SA episodes was cumulated to a total number of SA days at 1-year follow-up. Burn out, work engagement and work ability were 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le 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 "In a process evaluation three months after baseline, adherence to the intervention was measured in the EHI groups, assessing reading the advice provided by the E-health tool and undertaking actions. 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 brie y explain why the item is not applicable/relevant for your study There were no changes 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.
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 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 brie y explain why the item is not applicable/relevant for your study " In a pilot study, we found that frequent absentees had on average 3.79 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 brie y explain why the item is not applicable/relevant for your study We performed no interim analyses. We stopped recruiting once we did not receive new informed consent forms from employees from the participating organizations and the number of participants ful lled our sample size criteria.
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 brie y explain why the item is not applicable/relevant for your study " random integers generated from www.random.org/integers. " 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 brie y explain why the item is not applicable/relevant for your study Not applicable, there were no restrictions such as blocking and block size 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 brie y explain why the item is not applicable/relevant for your study "The source population (n=825) was pre-randomized into three arms: intervention group 1 (EHI-only; n=270), intervention group 2 (EHI-OP; n=279) and control group (n=276) by random integers generated from www.random.org/integers." "Blinding. Participants were allocated to the intervention groups and control group before the study started. They were blinded for the group to which they were allocated until completion of the online questionnaire, whereupon they did (intervention groups) or did not (control group) receive a personalized advice." 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 subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "The source population (n=825) was pre-randomized into three arms: intervention group 1 (EHI-only; n=270), intervention group 2 (EHI-OP; n=279) and control group (n=276) by random integers generated from www.random.org/integers." 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 brie y explain why the item is not applicable/relevant for your study "Participants were allocated to the intervention groups and control group before the study started. They were blinded for the group to which they were allocated until completion of the online questionnaire, whereupon they did (intervention groups) or did not (control group) receive a personalized advice. The rst author (AN) knew to which group each individual belonged. SA data were retrieved and analyzed by another author (CR) who did not know to which group each individual belonged." subitem not at all important 1 2 3 4 5 essential 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 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".
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 brie y explain why the item is not applicable/relevant for your study "Participants were allocated to the intervention groups and control group before the study started. They were blinded for the group to which they were allocated until completion of the online questionnaire, whereupon they did (intervention groups) or did not (control group) receive a personalized advice." 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 brie y explain why the item is not applicable/relevant for your study "Participants in intervention group 2 received the same advices and documents as the EHI-only group, but were invited by e-mail to a preventive advisory consultation with the OP. " subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 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 brie y explain why the item is not applicable/relevant for your study "First, we investigated differences in outcomes at T1 between the EHI-only group, the EHI-OP group and the CAU group according to the intention-to-treat principle.
Because of the non-normal distribution of incident SA episodes and days, we investigated differences by using the non-parametric Kruskall-Wallis test. " 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]).
Does your paper address subitem 12a-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 brie y explain why the item is not applicable/relevant for your study Missing information from follow-up assessments was imputed using BOCF (baseline observation carried forward 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 brie y explain why the item is not applicable/relevant for your study "The intervention groups (EHI-only and EHI-OP) were merged, as all participants from these study arms had access to the same e-health intervention and only 3 (13%) participants from the EHI-OP group additionally consulted the OP upon invitation. We investigated the differences between the outcomes of the combined intervention groups and the control group by using the nonparametric Mann-Whitney U test. "

X26-i) Comment on ethics committee approval
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 brie y explain why the item is not applicable/relevant for your study "The Medical Ethics Committee of the University Medical Center Groningen approved the study (METc 2013/131).

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained o ine 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 1 2 3 4 5 essential 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 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 brie y explain why the item is not applicable/relevant for your study "Upon signing the informed consent form, we sent a personal URL code, that gave access to the online questionnaire at baseline (T0)."

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) 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 brie y explain why the item is not applicable/relevant for your study Your answer 13b) For each group, losses and exclusions after randomisation, together with reasons subitem not at all important 1 2 3 4 5 essential 14a) Dates de ning the periods of recruitment and follow-up 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 brie y explain why the item is not applicable/relevant for your study See gure 1, ow chart of participants.
"Three participants out of 30 (10%) in the EHI-OP group reported that they had consulted the OP upon study invitation. " "In total 17 participants did not ll out the last questionnaire. Included in the analysis were: n=21 in the EHI-only group, n=31 in the EHI-OP group and n=30 in the CAU group. Figure 1 provides an overview of the recruitment ow. " Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ow 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 brie y explain why the item is not applicable/relevant for your study See gure 1 owchart of participants 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 gures or tables demonstrating usage/dose/engagement. Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure 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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study "Study participants were recruited from 21 Dutch organizations sta ng >100 employees between December 2013 and December 2014. " 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant 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 brie y explain why the item is not applicable/relevant for your study To our knowledge, no critical "secular events" fell into the study period 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 brie y explain why the item is not applicable/relevant for your study We stopped recruiting once we did not receive new informed consent forms from employees from the participating organizations and the number of participants ful lled our sample size criteria as calculated before the study.
subitem not at all important Does your paper address subitem 15-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 brie y explain why the item is not applicable/relevant for your study Table 1, characteristics of analyzed participants. We did not assess the amount of digital literacy. However, participants were excluded when they consented to participation but didn't manage to nish the baseline questionnaire (possibly not having started), resulting in participants with some amount of digital literacy.
16-i) Report multiple "denominators" and provide de nitions Report multiple "denominators" and provide de nitions: 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 speci c prede ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
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% con dence interval) 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 brie y explain why the item is not applicable/relevant for your study See gure 1, ow chart. Also included in tables 2 and 3 on results.

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 brie y explain why the item is not applicable/relevant for your study table 2 shows the results for the intention-to-treat analysis on all primary and secondary outcomes 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 brie y explain why the item is not applicable/relevant for your study 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespeci ed from exploratory 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 de nitions 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 de ned (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 brie y explain why the item is not applicable/relevant for your study See 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 brie y explain why the item is not applicable/relevant for your study See table 3.Table 3 shows the results for the "combined intervention groups versus control group" as they both received the same e-health intervention and very few participants received a consultation with the occupational physician as intended in the second intervention group.

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 brie y explain why the item is not applicable/relevant for your study We performed no subgroup analysis 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 brie y explain why the item is not applicable/relevant for your study "Two reorganizing organizations withdrew from the study after receiving negative 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 brie y explain why the item is not applicable/relevant for your study "All participants who had visited the OP were satis ed with the consultation. " No qualitative feedback from participants or observations from staff/researchers on strengths and shortcomings of the application was available 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 brie y explain why the item is not applicable/relevant for your study "Future research should test the effect of blended care, possibly involving the employer or manager of the employee with frequent SA to encourage adherence to an OP consultation. This could help to increase awareness and sense of urgency, and may lead to more focus and adequate (local professional) and appropriate support." "Future intervention studies on frequent absentees should deal with possible selection bias towards participants with more severe conditions by e.g.
stratifying into groups with and without chronic disease or with and without longterm SA at baseline." Additionally we have added a chapter on learnings and implications for future research on issues relevant for future research on frequent sickness absence

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 nonuse 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 brie y explain why the item is not applicable/relevant for your study See subhead "strengths and limitations" 21) Generalisability (external validity, applicability) of the trial ndings

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 brie y explain why the item is not applicable/relevant for your study "The present study was undertaken in the Netherlands, limiting cross-country generalizability." "The low participation rate may have affected the generalizability of the results." "A higher participation rate combined with a larger source population may improve generalizability, " 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. 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 brie y explain why the item is not applicable/relevant for your study The intervention could be used as a stand-alone application in Dutch occupational health and managerial practice practice. In some organizations, employees with frequent sickness absence are stimulated by their employer to undertake action to prevent future sickness absence. Such stimulation would increase participation and adherence to the intervention (e-health intervention and consultation with occupational physician). However, this stimulation is not acceptable in a research settting in which voluntariness to participate and withdraw is important.
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 brie y explain why the item is not applicable/relevant for your study "Netherlands Trial Register NTR4316; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4316" 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 brie y explain why the item is not applicable/relevant for your study The full trial protocol is available from the authors. 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?
A few words How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * 6 hours 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?
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