Evaluating a Web-Based Coaching Program Using Electronic Health Records for Patients With Chronic Obstructive Pulmonary Disease in China: Randomized Controlled Trial

Background Chronic obstructive pulmonary disease (COPD) is now the fourth leading cause of death in the world, and it continues to increase in developing countries. The World Health Organization expects COPD to be the third most common cause of death in the world by 2020. Effective and continuous postdischarge care can help patients to maintain good health. The use of electronic health records (EHRs) as an element of community health care is new technology in China. Objective The aim of this study was to develop and evaluate a Web-based coaching program using EHRs for physical function and health-related quality of life for patients with COPD in China. Methods A randomized controlled trial was conducted from 2008 to 2015 at two hospitals. The control group received routine care and the intervention group received routine care with the addition of the Web-based coaching program using EHRs. These were used to manage patients’ demographic and clinical variables, publish relevant information, and have communication between patients and health care providers. Participants were not blinded to group assignment. The effects of the intervention were evaluated by lung function, including percent of forced expiratory volume in 1 second (FEV1%), percent of forced vital capacity (FVC%), peak expiratory flow (PEF), maximum midexpiratory flow; St George’s Respiratory Questionnaire (SGRQ); Modified Medical Research Council Dyspnea Scale (MMRC); and 6-Minute Walk Test (6MWT). Data were collected before the program, and at 1, 3, 6, and 12 months after the program. Results Of the 130 participants, 120 (92.3%) completed the 12-month follow-up program. There were statistically significant differences in lung function (FEV1%: F1,4=5.47, P=.002; FVC%: F1,4=3.06, P=.02; PEF: F1,4=12.49, P<.001), the total score of SGRQ (F1,4=23.30, P<.001), symptoms of SGRQ (F1,4=12.38, P<.001), the activity of SGRQ (F1,4=8.35, P<.001), the impact of SGRQ (F1,4=12.26, P<.001), MMRC (F1,4=47.94, P<.001), and 6MWT (F1,4=35.54, P<.001) between the two groups with the variation of time tendency. Conclusions The Web-based coaching program using EHRs in China appears to be useful for patients with COPD when they are discharged from hospital into the community. It promotes the sharing of patients’ medical information by hospital and community nurses, and achieves dynamic management and follow-up analysis for patients’ disease. In addition, this program can postpone the decreasing rate of lung function, improve quality of life, decrease dyspnea, and increase physical capacity.

file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 3/35 I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") yes 其他: 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 of 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.
1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study The title included the word "Webbased" to indicate the nature of the interventions.

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").
1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study No, there are no nonwebbased components.
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 1 2 3 4 5 file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 4/35 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 brie y explain why the item is not applicable/relevant for your study Yes, the title included "Patients with Chronic Obstructive Pulmonary Disease in China" to indicate the target group of the study.
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) 1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study Yes. "The aim of this study is to develop and evaluate Webbased Electronic Health Records Coaching Programme on physical function and health related quality of life for patients with COPD in China." 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) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-ii?
file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 5/35 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 Yes. "Webbased Electronic Health Records Coaching Programme was provided by researcher team with clinical nurses and researchers." 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. of 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 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 brie y explain why the item is not applicable/relevant for your study Yes. "Participants were recruited facetoface in clinics and the effects of the intervention were evaluated by lung function, SGRQ, MMRC and 6MWT. Data were collected at preprogram, and at postprogram in 1month, 3month, 6month and 12month".
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) 1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study 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 file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 7/35 routine care, which involve healthcare providers' and patients' enrollment in the use of their own health records, health information exchange achieving referral between tertiary and primary care. The first aim of present study is to develop EHRs as a hospitalcommunity referral platform, to accomplish seamless nursing and transitional care. Secondary aim is to describe a prospective design to assess the feasibility and effective of implementing EHRs among patients with COPD, in order to inform larger studies of EHRs application in China and management of COPD in primary care." 2a-ii) Scientiǳc background, rationale: What is known about the (type of) system Scientiǳc 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 speciǳc study, from which stakeholder viewpoint is the study performed, potential impact of ǳndings [2]. Brie y justify the choice of the comparator.
1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study Yes. "EHRs include personal medical records that consist of information related to the individual and family health history, results of physical examinations, immunization status, health care service use and demographic data. It has been hypothesized that placing the technology in the patients' homes may have an impact on patient involvement in self monitoring, decisionmaking and selfcare [27]. However, to our knowledge, no research has been published about the clinical outcomes using EHRs in a COPD setting.."

2b) In INTRODUCTION: Speciǳc 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 brie y explain why the item is not applicable/relevant for your study exchange achieving referral between tertiary and primary care. The first aim of present study is to develop EHRs as a hospitalcommunity referral platform, to accomplish seamless nursing and transitional care. We hypothesized that this programme with EHRs has positive effect in physical function and health related quality of life for patients with COPD in China. Secondary aim is to describe a prospective design to assess the feasibility and effective of implementing EHRs among patients with COPD, in order to inform larger studies of EHRs application in China and management of COPD in primary care." 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 file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 8/35 not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "This study was a randomized control trail involving Webbased Electronic Health Records Coaching Programme intervention and routine care".
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 brie y explain why the item is not applicable/relevant for your study No. There is no change on methods after trial commencement 3b-i) Bug ǳxes, Downtimes, Content Changes Bug ǳxes, 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 ǳxes 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].
1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study No. There was no system change after trial commenced.

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 brie y explain why the item is not applicable/relevant for your study file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 9/35 COPD based on the Chinese Medical Association Diagnostic criteria. The Chinese Medical Association diagnostic criteria of COPD are: FEV1%≤80%, FEV1/FVC≤70%. 2) clear consciousness, be mandarin speaking and able to communicate. 3) be discharged to home where internet and computer have been installed. 4) be able to be reached by telephone postdischarge. The exclusion criteria were: 1) Presence of comorbidities, such as allergic rhinitis, myocardial infarction, severe heart failure, malignant tumor. 2) not live in Tianjin. 3) no computer and internet at home."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clariǳed.
1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study 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. of 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 quasianonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email conǳrmation, phone calls) were used to detect/prevent these.
1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study Yes. The study targeted participants and recruitment was done through facetoface from two tertiary hospitals in Tianjin. To prevent multiple identities, it has also been mentioned in the manuscripts that "Participants in intervention group received an activation link via email every month regularly" 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.
1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study Yes. "Eligible individuals were given detailed information about the study aims, length of the program, participant involvement, and the assignment of intervention through randomization. They were also informed that the study was conducted by the Tianjin Medical University, General Hospital of Tianjin Medical University, Tianjin first center Hospital." 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 brie y explain why the item is not applicable/relevant for your study No. "Participants filled in the pre post , and follow up assessments faceto face by research assistant." 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.
1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study No. "Participants filled in the pre post , and follow up assessments faceto face by research assistant." 4b-ii) Report how institutional afǳliations are displayed Report how institutional afǳliations are displayed to potential participants [on ehealth media], as afǳliations 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) 1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study Yes. "They were also informed that the study was conducted by the Tianjin Medical University, General Hospital of Tianjin Medical University, Tianjin first center Hospital." 5) The interventions for each group with sufǳcient details to allow replication, including how and when they were actually administered

5-i) Mention names, credential, afǳliations of the developers, sponsors, and owners
Mention names, credential, afǳliations 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).
1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study were clinical nurses and teacher in University." "The study was supported National Natural Science Foundation of China (71473175; 71673199) , the Key Project Scientific of Tianjin Science, Technology Commission of China (15ZCZDSY00500) and Social Sciences projects of Tianjin in China (Grant No. TJSR13006). The first, second and corresponding authors of the study are developers of the content of the trails and website. There is no conflict of interest.

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.
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 Yes. "EHRs has been widely adopted in US health care system [8] and it is a combination of diagnostic and therapy codes for COPD in UK Primary Care [9]. EHRs, as a reminder, plays beneficial roles in care of patients with chronic illness [10] and it has been proved to improve quality and efficiency of healthcare globally [11].)."

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).
1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study No major change was made after the website was launched.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study Yes. "Data was collected facetoface by research assistant who were blindness of the participants." file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 13/35 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screencapture 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 scientiǳc reporting.
1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study Yes, flowcharts were provided in Figure 1.

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.
1 2 3 4 5 subitem not at all important 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 brie y explain why the item is not applicable/relevant for your study Yes, There are several funding to support is available for the website to keep running and digital preservation.

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 speciǳc 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). 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 participant accessed the content with an URL for free. subitem not at all important essential 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 brie y explain why the item is not applicable/relevant for your study the progress of the disease. Tailored contents which matching the users' preference would be more useful in order to motivate to change their behaviors [28].EHRs can store all of the patients' health information from hospital to community care. In this particular project, the person also had control of their own record and managed their files. The record could be packaged to send over the internet. As the person had control of the record they could supply their own health information to their treating health practitioners."

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.
1 2 3 4 5 subitem not at all important essential 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 file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 15/35

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).
1 2 3 4 5 subitem not at all important 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 brie y explain why the item is not applicable/relevant for your study 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).
1 2 3 4 5 subitem not at all important 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 brie y explain why the item is not applicable/relevant for your study Yes. "The researcher team also sent email to trigger the participants every month in the programme to maintain contact ." 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.
1 2 3 4 5 subitem not at all important 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 brie y explain why the item is not applicable/relevant for your study No co intervention was provided.
6a) Completely deǳned pre-speciǳed 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 brie y explain why the item is not applicable/relevant for your study Only primary outcomes were applicable. "The questionnaires and clinical variables were collected the day before patients' discharge from the hospital (T0) and at one (T1), three(T2), six(T3) and twelve months(T4) post discharge at home or outpatient department facetoface by research assistant.". The primary outcomes are lung function, quality of life, MMRC and 6MWT. All of the questionnaires were validated and have good validity and reliability. Reliable and valid measures were used and described in the "measures" section.
6a-ii) Describe whether and how "use" (including intensity of use/dosage) was deǳned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was deǳned/measured/monitored (logins, logǳle analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 6a-ii?

Copy and paste relevant sections from manuscript text
Yes. "Participants were guided to call or send email to our research team for consultation in case of questions or problems during the course of the intervention, and research team will be feedback immediately." 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).

2 3 4 5
subitem not at all important essential Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text 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 brie y explain why the item is not applicable/relevant for your study file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 18/35 No change to trial outcomes after the trial commenced.
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.
1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study Expecting a difference between the groups at followup equivalent of an effect size of approximately 0.8, with a power of 0.80 and alpha at P=0.05, the number of participants needed in each group was estimated to be 33. Therefore, a sample of 130 participants at pre program would be enough.

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 brie y explain why the item is not applicable/relevant for your study Not applicable 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 19/35 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 Yes. "The Participants who consented to participate were assigned to the intervention or control group using a computergenerated randomized table, with a computer number '0' belonged to the control group and '1' the study group." 8b) Type of randomisation; details of any restriction (such as blocking and block size) 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 True randomization was used 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? * 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 Randomization was performed automatically by computer after participants gave consent to participating in the study. No one had prior knowledge regarding which condition a participant got assigned to till the assignment was completed.
10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 10? * file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 20/35 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 allocation was performed programmatically by the computer.
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).

2 3 4 5
subitem not at all important essential 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 It is not possible to blind the participants in webbased trials. However, the research assistants who collected data were blindness to the participants. Researchers were not blinded to the conditions as well.
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".
1 2 3 4 5 subitem not at all important essential 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 file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 21/35 Participants were told that they would be assigned to either one of the two groups. It is not possible to blind the participants in webbased trials.
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? * 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 guided to call or send email to our research team for consultation in case of questions or problems during the course of the intervention, and research team will be feedback immediately." 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? * 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 "Data were analyzed using SPSS for Windows Version 19.0 software (SPSS Inc., Chicago, IL, USA), with the level of statistical significance set at p<0.05. Descriptive statistics was used to analyze the participants' characteristics. Repeated variant analysis was performed to test the data of predischarge, one, three, six, twelve months after discharge between two groups. Differences between two groups were evaluated by ttest." 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]).
1 2 3 4 5 subitem not at all important essential file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 22/35 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 Yes. Missing data were excluded.

12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
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 There is no additional analyses. subitem not at all important essential Does your paper address subitem X26-i?

X26) REB/IRB Approval and Ethical Considerations
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 Yes. "Permission to carry out the study was granted by Tianjin Medical University Ethics Committee. The study was conducted in accordance with the Declaration of Helsinki. All participants completed informed consent form with aims, length of the program, participant involvement, and the assignment of intervention before entering the study." subitem not at all important essential 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 Yes. "Permission to carry out the study was granted by Tianjin Medical University Ethics Committee. The study was conducted in accordance with the Declaration of Helsinki. All participants completed informed consent form with aims, length of the program, participant involvement, and the assignment of intervention before entering the study."

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) 1 2 3 4 5 subitem not at all important essential 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 Each participant was monitored through one, three, six, twelve months selfreport measures as well as sending email to participants by email using EHRs.

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? * 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 file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 24/35 Yes. Figure 1 showed all the details.
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 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 Yes. Figure 1 one showed the attrition over the study

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 ǳgures or tables demonstrating usage/dose/engagement.

2 3 4 5
subitem not at all important essential Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the ǳgure 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 Yes. Figure 1 one showed the attrition over the study 14a) Dates deǳning the periods of recruitment and followup 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 file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 25/35 Yes. "Participants were recruited from September 2008 to November 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., signiǳcant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 1 2 3 4 5 subitem not at all important essential 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 No critical "secular events" fell into the study period.
14b) Why the trial ended or was stopped (early) 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 The trial was ended because the proposal of funding plan it.

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.
1 2 3 4 5 subitem not at all important essential 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 Yes. Table 1 reported demographics associated with digital divide issues.
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 deǳnitions Report multiple "denominators" and provide deǳnitions: 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 speciǳc pre-deǳned time points of interest (in absolute and relative numbers per group). Always clearly deǳne "use" of the intervention.
1 2 3 4 5 subitem not at all important essential 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 file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 27/35 Yes. ". In the year of intervention 7 out of 62 participants (11.1%) of the study group dropped out, because three of them changed addresses, two got cerebral infarction, one had fracture and one declined ongoing participation. 3 out of 68 participants (4.4%) in the control group were lost to followup. Reasons for not continuing participation were that one had a cerebral infarction, one had myocardial infarction and one declined ongoing participation. Therefore, at the end of the study, 120 participants completed. The number of intervention group was 55 and the control group was 65."

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).
1 2 3 4 5 subitem not at all important essential 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 All analyses were conducted using Repeated variant analysis. There is no additional analyses.".
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% conǳdence interval) 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 All relevant results were reported in the result section and in Table 2, Table  3 and Table 4.

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 deǳnitions 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 deǳned (e.g., timeout after idle time) [1] (report under item 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 All of the data were reported exact t, F and P.
17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Binary outcomes are not applicable in the present study.
18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-speciǳed from exploratory 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 "All analyses were conducted using Repeated variant analysis."

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).
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 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 qualitative feedback gathered in the study.

22) Interpretation consistent with results, balancing beneǳts 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). 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 months and the quality of life had also gone down as identified on SGRQ. The rate of decline in FEV1% is representative of the natural history of COPD [39]. With the aggravation of airway obstruction, FEV1% had a descending trend and an irreversible pathological process. Although declining of FEV1% could not change, a study by Garcia demonstrated that respiratory muscle exercise could increase FVC% which was a kind of simple mean to judge airway obstruction and had a relationship with trachea resistance and conformance of pulmonary tissue [40].

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.
1 2 3 4 5 subitem not at all important essential 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 participants who enrolled versus those who declined participation. Second, a lot of participants were too old to use EHRs by themselves, who could only get help from their family members. This condition may limit the participants to navigate the EHRs at any time when their families were not around. Third, we could not control the frequency of navigation on line of participants and coaching compliance which influence the effect of intervention. Finally, our studied setting was only in Tianjin and not having mild severity (GOLDⅠ) limiting the generalizability of our results in all the patients with COPD in China." 21) Generalisability (external validity, applicability) of the trial ǳndings NPT: External validity of the trial ǳndings 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 1 2 3 4 5 subitem not at all important essential 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 file:///G:/JMIR/revised%202/CONSORTEHEALTH%20(V%201.6.1)%20%20Submission_Publication%20Form.html 32/35 not in the ms, or brie y explain why the item is not applicable/relevant for your study Generalizability to other populations. " Finally, our studied setting was only in Tianjin and not having mild severity (GOLDⅠ) limiting the generalizability of our results in all the patients with COPD in China." 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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study " The intervention group had a statistically significant better pulmonary function measured by FVC% and PEF, physical capacity measured by 6MWT, health related quality of life measured by SGRQ and lower dyspnea degree measured by MMRC during the one year follow up. '

23) Registration number and name of trial registry
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 Any other comments or questions on CONSORT EHEALTH STOP -Save this form as PDF before you click submit To generate a record that you ǳlled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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