Assessing the Impact of a Novel Smartphone Application Compared With Standard Follow-Up on Mobility of Patients With Knee Osteoarthritis Following Treatment With Hylan G-F 20: A Randomized Controlled Trial

Background Osteoarthritis (OA) is a leading cause of disability in the United States. Although no disease-modifying therapies exist, patients with knee OA who increase walking may reduce risk of functional limitations. Objective The objective of the study is to evaluate the impact of a mobile app (OA GO) plus wearable activity monitor/pedometer (Jawbone UP 24) used for 90 days on the mobility of patients with knee OA treated with hylan G-F 20. Methods Patients with knee OA aged 30 to 80 years who were eligible to receive hylan G-F 20 and were familiar with smartphone technology were enrolled in this randomized, multicenter, open-label study. Patients who had a body mass index above 35 kg/m2 were excluded. All patients received a single 6-mL injection of hylan G-F 20 and wore the Jawbone monitor. The patients were then randomized 1:1 to Jawbone and OA GO (Group A; n=107) with visible feedback (unblinded) or Jawbone only (Group B; n=104) with no visible feedback (blinded). The primary endpoint was mean change from baseline in steps per day at day 90 between Groups A and B. Results Baseline characteristics were similar between groups. There were significant differences between the increases in least squares (LS) mean number of steps per day (1199 vs 467, P=.03) and the mean percentage change (35.8% vs 11.5%, P=.02) from baseline in favor of Group A over Group B. There was a greater reduction in pain from baseline during the 6-minute walk test in Group A versus Group B. (LS mean change: −55.3 vs −33.8, P=.007). Most patients (65.4%) and surveys of physicians (67.3%) reported they would be likely or very likely to use/recommend the devices. Patient Activity Measure-13 scores improved from baseline (LS mean change for Groups A and B: 5.0 vs 6.9), with no significant differences between groups. The occurrence of adverse events was similar in the 2 groups. Conclusions Use of a novel smartphone app in conjunction with a wearable activity monitor provided additional improvement on mobility parameters such as steps per day and pain with walking in the 6-minute walk test in patients with knee OA who were treated with hylan G-F 20. Results also highlight the amenability of patients and physicians to using mobile health technology in the treatment of OA and suggest further study is warranted.

Randomized study assessing the impact of a novel smartphone application compared with standard follow-up on mobility of patients with knee osteoarthritis following treatment with hylan G-F 20 Nebojsa, Skrepnik Tucson Orthopaedic Institute, Tucson, AZ NSkrepnik@tucsonortho.com 0 not submitted yet-in late draft status, just before submission 0 submitted to a journal but not reviewed yet 0 submitted to a journal and after receiving initial reviewer comments 0 submitted to a journal and accepted, but not published yet 0 published  Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially ifthe application runs on different platforms. subitem not at all important 0 0 0 0 () essential Does your paper address subltem 1 a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This is a required question

a-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 a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., Hfor children with Type I DiabetesH) Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial 1 2 3 4 5 subitem not at all important () 0 0 0 0 essential Does your paper address subitem 1 a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 1 b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
1 b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT hltps://docs.google.com/formslclle/1 FAipQLSfZBSU p1 bwOc_ OimqcS64RdfiAFvmrTSkZQL2-30809ht..5Sw/viewform?hl=en _ US&form key=dGI Kd2Z2Q11NSGQOTH 11 azM 5MS 1aWWc6MA&rm=full#gid=O 5150 "Co-interventions not applicable for this study" "patients with knee osteoarthritis" 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 0 0 0 0 0 essential Does your paper address subitem 1 b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

b-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 0 0 0 0 0 essential

Does your paper address subitem 1 b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study hltps://docs.google.com/formslclle/1 FAipQLSfZBSU p1 bwOc_ OimqcS64RdfiAFvmrTSkZQL2-30809ht..5Sw/viewform?hl=en _ US&form key=dGI Kd2Z2Q11NSGQOTH 11 azM 5MS 1aWWc6MA&rm=full#gid=O "Patients with knee OA aged 30 -80 years who were eligible to receive hylan G-F 20 and were familiar with smartphone technology were enrolled in this randomized, multicenter, open-label study. Patients who had a body mass index (BMI) >35 were excluded. All patients received a single 6-mL injection of hylan G-F 20 and wore the Jawbone monitor. The patients were then randomized 1:1 to Jawbone and OA GO (Group A; n=107) with visible feedback ("unblinded") or Jawbone only (Group B; n=104) with no visible feedback ("blinded"). The primary endpoint was mean change from baseline in steps per day at day 90 between Groups A and B." Revised 1 b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials subitem not at all important 0 0 0 0 0 essential

Does your paper address subitem 1 b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 1 b-iv) RESULTS section in abstract must contain use data "All patients received a single 6-mL injection of hylan G-F 20 and wore the Jawbone monitor. The patients were then randomized 1:1 to Jawbone and OA GO (Group A; n=107) with visible feedback ("unblinded") or Jawbone only (Group B; n=104) with no visible feedback ("blinded")." "open-label study" "The primary endpoint was mean change from baseline in steps per day at day 90 between Groups A and B."
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript). or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials
Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome-if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important 0 0 0 0 0 essential

Does your paper address subitem 1 b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Walking has been shown to significantly reduce symptoms and the risk of functional limitations due to knee OA [19,20]. In one study, patients with OA of the knee who walked ≥6,000 steps/day reduced the risk of developing a functional limitation by half within the next 2 years [19]. This suggests that walking may maintain knee function. However, strategies to encourage adherence to regular walking are clearly needed. The use of mobile applications (apps) in health care may be one such strategy to increase physical activity and enhance OA management. However, there are currently no published data on the use of mobile apps for the management of knee OA." "The objective of the current study was to examine the impact on mobility in knee OA patients who were treated with hylan G-F 20 and standard of care follow up plus a mobile smartphone app (OA GO) and a wearable activity monitor (Jawbone ® UP 24™) versus hylan G-F 20 and standard of care follow up alone over 90 days. We hypothesized that patients using the OA GO app and a wearable activity monitor would experience a positive impact on their mobility compared with those not using the app." "To date, there is no disease-modifying therapy available for OA [11]. Optimal management of knee OA requires a combination of both pharmacologic (eg, oral or topical analgesics or intra-articular therapies [viscosupplementation, corticosteroids]) and nonpharmacologic methods (eg, weight loss, exercise, and physical activity) [12][13][14][15]. However, despite the well-recognized benefits of exercise and the promotion of physical activity by many professional societies [12,13,15], there is no standard exercise or education program and no clear benefit of one exercise program over another [13]. Information about the benefits of exercise is readily available [12,13,15] but rarely incorporated into patient behavior [16,17], and adherence to such programs by patients with knee OA is poor [16,17]. There is also no consensus on which measures or combination of measures should be used to assess physical function in patients with knee OA [18], complicating the initial assessment and tracking of progress in mobility improvement." Revised 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 briefl)' explain why the item is not applicable/relevant for your study

3b-i) Bug fixes, Downtimes, Content Changes
Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes imponant changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc.
[2]. 1 2 3 4 5 subitem not at all imponant ( 0 0 0 () essential Does your paper address subitem 3b-i? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study hltps://docs.google.com/formslclle/1 FAipQLSfZBSU p1 bwOc_ OimqcS64RdfiAFvmrTSkZQL2-30809ht..5Sw/viewform?hl=en _ US&form key=dGI Kd2Z2Q11NSGQOTH 11 azM 5MS 1aWWc6MA&rm=full#gid=O 11/50 "Consecutive patients with knee OA whom the physician investigator decided to treat with one 6-mL injection of hylan G-F 20 (in accordance with the US label) who consented and qualified were enrolled in this prospective, open-label, multicenter, randomized, parallel-group study.""Patients were randomized 1:1 (stratified by site) to Group A or Group B." No important changes to trial after commencement.

4a) Eligibility criteria for participants
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

4a-l) Computer /Internet literacy
Computer /Internet literacy is often an implicit Hde facto• eligibility criterion -this should be explicitly clarified.

Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No important changes made during the trial.
"Consecutive patients with knee OA whom the physician investigator decided to treat with one 6-mL injection of hylan G-F 20 (in accordance with the US label) who consented and qualified were enrolled in this prospective, open-label, multicenter, randomized, parallel-group study. Study sites and physicians were recruited using a detailed questionnaire and site qualification visit. Patients were recruited from the selected private community based practices and research only practice sites. All eligible patients were able to read and understand English and provided informed consent prior to starting the study. " "To be included in the study, all patients must have had unilateral knee OA and have been suitable for treatment with hylan G-F 20 based on the decision of the physician investigator. Study sites were requested to report whether or not a knee examination was performed or X-ray was taken but the results of these examinations were not captured." "Patients were excluded if they were aged <30 years or ˃80 years, were unfamiliar with smartphones, or had baseline pain >9 on the 11point numeric pain rating scale (NPRS; pain ratings could range from 0, no pain; to 5, moderate pain; to 10, worst possible pain) in the target-for-treatment knee while walking on a flat surface. Patients with bilateral disease were excluded, with the exception of patients who were treated in only one knee and had contralateral knee pain <4 on NPRS while walking on a flat surface. Patients whose baseline daily step average was <500 or >8000 as assessed during the screening and run-in phases were not eligible. Also excluded were patients who had a body mass index (BMI) >35 or life expectancy <12 months; were currently using a wearable activity monitor or analogous device; had planned surgery on any lower extremity joint or any significant medical condition that would interfere with study participation; were chronic narcotic users; or were pregnant/breastfeeding or likely to become pregnant. The protocol did not specifically exclude patients based on use of previous intra-articular injections (cortisone or hyaluronic acid)." Revised 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial. or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasianonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.
1 2 3 4 5 subitem not at all important 0 0 0 0 0 essential Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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 briefly explain why the item is not applicable/relevant for your study 4b) Settings and locations where the data were collected Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms or briefly explain why the item is not applicable/relevant for your study

4b-i) Repon if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise. subitem not at all important () 0 0 0 0 essential Does your paper address subitem 4b-i? * hltps://docs.google.com/formslclle/1 FAipQLSfZBSU p1 bwOc_ OimqcS64RdfiAFvmrTSkZQL2-30809ht..5Sw/viewform?hl=en _ US&form key=dGI Kd2Z2Q11NSGQOTH 11 azM 5MS 1aWWc6MA&rm=full#gid=O 14150 "All eligible patients were able to read and understand English and provided informed consent prior to starting the study." "Consecutive patients with knee OA whom the physician investigator decided to treat with one 6-mL injection of hylan G-F 20 (in accordance with the US label) who consented and qualified were enrolled in this prospective, openlabel, multicenter, randomized, parallel-group study." "Patients were recruited from the selected private community based practices and research only practice sites." "The study consisted of 5 visits: screening and baseline (days −7 and 1) with follow-up visits at days 7, 30 and day 90, last visit. The main study duration was 90 days. A post-study adherence check in Group A patients occurred at day 180, when data were downloaded from the app (no visit)."

Revised
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 briefl)' explain wh)' the item is not applicable/relevant for your study

4b-ii) Report how institutional affiliations are displayed
Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 1 2 3 4 5 subitem not at all important 0 0 0 0 0 essential

Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Outcomes were not assessed through online questionnaires.
Not applicable, institutions not displayed during this study.
Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a ·conflict of interest" section or mentioned elsewhere in the manuscript).
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this"to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain wh)' the item is not applicable/relevant for your study

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study hltps://docs.google.com/formslclle/1 FAipQLSfZBSU p1 bwOc_ OimqcS64RdfiAFvmrTSkZQL2-30809ht..5Sw/viewform?hl=en _ US&form key=dGI Kd2Z2Q11NSGQOTH 11 azM 5MS 1aWWc6MA&rm=full#gid=O 16150 "Participants wore a commercially available activity monitor (Jawbone UP 24) on their wrists and were instructed to remove the monitor only during the weekly charging times and in situations where the device would be submerged in water." The mobile app, OA GO, was developed by the sponsor of the study, Sanofi.

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 briefly explain why the item is not applicable/relevant for your study

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable. Study was focused on clinical impact of using a wearable activity monitor and smartphone application and not on development of the application.
Not applicable to this study. Intervention did not undergo major changes during the study. App was self-contained and not linked to external sites.
Does your paper address subitem 5-iv? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting. subitem not at all important () 0 0 0 0 essential

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

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. Screenshots of app are included in the manuscript.

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 briefl)' explain wh)' the item is not applicable/relevant for your study

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained Haccess 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).
1 2 3 4 5 subitem not at all important 0 0 0 0 0 essential Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefl)' explain wh)' the item is not applicable/relevant for your study Not applicable, application is not Web-based.
"Patients were randomized 1:1 (stratified by site) to Group A or Group B. Group A patients were provided with regular follow-up plus an unblinded wearable activity monitor and a mobile app (OA GO) (Figure 1). The OA GO app (downloaded to a trial-sponsored iPhone 5 or newer) provided motivational messages and requested that the patient enter pain and mood data on a once-daily basis." "Group B was provided with regular follow-up plus a blinded wearable activity monitor, with instructions to wear the monitor at all times except during weekly charging and water activities. The patients in Group B received standard-ofcare instructions and education (information on the benefits of walking in a brochure available from the Arthritis Foundation) but did not have access to activity recorded by the wearable activity monitor." subitem not at all important 0 0 0 0 0 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 briefly explain why the item is not applicable/relevant for your study

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.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this"to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study hltps://docs.google.com/formslclle/1 FAipQLSfZBSU p1 bwOc_ OimqcS64RdfiAFvmrTSkZQL2-30809ht..5Sw/viewform?hl=en _ US&form key=dGI Kd2Z2Q11NSGQOTH 11 azM 5MS 1aWWc6MA&rm=full#gid=O 2Q150 "The OA GO app (downloaded to a trial-sponsored iPhone 5 or newer) provided motivational messages and requested that the patient enter pain and mood data on a once-daily basis." "The OA GO app combined continuously retrieved data from the wearable activity monitor with data entered by the patient to display the patient's daily step count, calories burned, and sleep. Daily and monthly cumulative activity trends were available for the patient to review."

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the a-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).
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, em ails, 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). "The OA GO app (downloaded to a trial-sponsored iPhone 5 or newer) provided motivational messages and requested that the patient enter pain and mood data on a once-daily basis. Trial coordinators demonstrated app use, provided charging instructions for the Jawbone UP 24, and set the daily step goal based on patient's baseline steps per day during screening. The OA GO app combined continuously retrieved data from the wearable activity monitor with data entered by the patient to display the patient's daily step count, calories burned, and sleep. Daily and monthly cumulative activity trends were available for the patient to review." Group A "Trial coordinators demonstrated app use, provided charging instructions for the Jawbone UP 24, and set the daily step goal based on patient's baseline steps per day during screening." "The patients in Group B received standard-of-care instructions and education (information on the benefits of walking in a brochure available from the Arthritis Foundation) but did not have access to activity recorded by the wearable activity monitor." "The study consisted of 5 visits: screening and baseline (days −7 and 1) with follow-up visits at days 7, 30 and day 90, last visit."

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

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. subitem not at all important 0 0 0 0 0 essential Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Investigators did not provide prompts to use the app.
"Trial coordinators demonstrated app use, provided charging instructions for the Jawbone UP 24, and set the daily step goal based on patient's baseline steps per day during screening." 6a) Completely defined pre-specified primary and secondary outcome measuresJ including how and when they were assessed Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9]. "The primary endpoint was mean change from baseline to day 90 in mobility as measured by steps per day. Baseline steps per day was the average over at least 3 days, and last assessment was the average steps per day over the 7 days immediately preceding the last visit. Change was calculated as the difference between the 2 averages. Use of average steps per day avoided bias due to any one particularly good or bad day for the patient. The secondary endpoints were mean percentage change from baseline in steps per day at each assessment visit (average of a 7-day period); and at day 90, mean percentage change from baseline in the 6-minute walk test (distance and pain assessed by the NPRS); patient and physician satisfaction with treatment; percentage change in Patient Activation Measure (PAM)-13 questionnaire score [21]; percentage change in sleep captured by the wearable activity monitor (light, sound, and duration of sleep); and Visual Analog Mood Scale VAMS) assessment. Treatment-emergent adverse events (TEAEs) were also assessed. For Group A, the satisfaction of patients and physicians was captured using survey questionnaires. The patient survey consisted of 7 questions: the first 6 were answered on a 7-point Likert scale related to the extent to which the patients experienced changes (−3 to +3, where 0=no change), and the seventh was a 4point scale asking about their likelihood of using the device in the future (not at all likely to very likely). Valid questionnaires were those in which at least 4 of the first 6 questions were answered. A physician survey was similarly constructed with a final question, using the 4-point scale, which asked whether they would recommend the device in the future (not likely to very likely). Physicians answered the survey at day 90, before viewing the data, and must have answered at least 3 of the first 4 questions. All responses to survey questions were based on patient and physician observations and opinions." The PAM-13 [21] was used to assess patients' knowledge, skills, and confidence for self-management at randomization and last visit, with responses given on a Guttman-like scale that ranged from 1 to 4 (strongly disagree to strongly agree). Unanswered items were scored as missing. Raw scores ranged from 13 to 52, with higher scores indicating more activation; raw scores were converted to activation scores, which ranged from 0 to 100, with a score of 100 corresponding to the highest degree of activation." Not applicable. The study did not use online questionnaires.
Describe whether and how •use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial. subitem not at all important 0 0 0 0 0 essential Does your paper address subltem 6a·il? CQ.~Y' and paste relevant sections from manuscriJ:)t text

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). "For Group A, the satisfaction of patients and physicians was captured using survey questionnaires. The patient survey consisted of 7 questions: the first 6 were answered on a 7-point Likert scale related to the extent to which the patients experienced changes (−3 to +3, where 0=no change), and the seventh was a 4-point scale asking about their likelihood of using the device in the future (not at all likely to very likely). Valid questionnaires were those in which at least 4 of the first 6 questions were answered. A physician survey was similarly constructed with a final question, using the 4-point scale, which asked whether they would recommend the device in the future (not likely to very likely). Physicians answered the survey at day 90, before viewing the data, and must have answered at least 3 of the first 4 questions. All responses to survey questions were based on patient and physician observations and opinions." 6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms or briefly explain wh)' the item is not applicable/relevant for your study 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 7a-l) 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.
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No changes to trial outcomes after the trial commenced.

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 briefl)' explain why the item is not applicable/relevant for your study

Ba) Method used to generate the random allocation sequence
NPT: When applicable, how care providers were allocated to each trial group

Does your paper address CONSORT subitem Sa? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study hltps://docs.google.com/formslclle/1 FAipQLSfZBSU p1 bwOc_ OimqcS64RdfiAFvmrTSkZQL2-30809ht..5Sw/viewform?hl=en _ US&form key=dGI Kd2Z2Q11NSGQOTH 11 azM 5MS 1aWWc6MA&rm=full#gid=O 26/'50 "A sample size of 200 randomized (172 evaluable) patients (100 randomized [86 evaluable] per group) was estimated to provide 80% power to detect an average increase in the change from baseline steps per day of 25% for Group A compared with Group B, assuming a 2-sided significance level of 5%. The variability was expected to be similar in the 2 groups, and an estimate of 58% for the coefficient of variation was used in this calculation [24]. The sample size of 200 randomized patients assumed a drop-out rate of 15%" Not relevant for this study, there were no interim analyses.

Bb) Type of randomisation; details of any restriction (such as blocking and block size)
Does your paper address CONSORT subitem Sb? * 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 briefl)' explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study hltps://docs.google.com/formslclle/1 FAipQLSfZBSU p1 bwOc_ OimqcS64RdfiAFvmrTSkZQL2-30809ht..5Sw/viewform?hl=en _ US&form key=dGI Kd2Z2Q11NSGQOTH 11 azM 5MS 1aWWc6MA&rm=full#gid=O 'Zl/50 "The randomization scheme was generated by the study sponsor and stratified by site. Sealed envelopes, numbered in an ascending order for use, were provided to each site. The envelopes were opened according to ascending sequence to ensure proper randomization." "Patients were randomized 1:1 (stratified by site) to Group A or Group B." Revised 1 0) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 1 0? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 11 a) 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 11 a-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). Randomization envelopes containing a six-digit randomization number were used. The envelope contained places for the signature of the person opening the envelope, the nine digit patient identification number, and the date and time the envelope was opened. After entering the patient number, date and time, the envelope could be opened where the site would find a card containing the same randomization number that appeared on the envelope and the treatment assignment. The envelope with its contents was put in the patient's file.
"Consecutive patients with knee OA whom the physician investigator decided to treat with one 6-mL injection of hylan G-F 20 (in accordance with the US label) who consented and qualified were enrolled in this open-label, multicenter, randomized, parallel-group study.""Patients were randomized 1:1 (stratified by site) to Group A or Group B. The randomization scheme was generated by the study sponsor and stratified by site." Revised subitem not at all important ( 0 0 0 0 essential Does your paper address subitem 11 a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 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 11 a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Revised
Revised (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 11 b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms or briefly explain why the item is not applicable/relevant for your study 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 briefly explain wh)' the item is not applicable/relevant for your study

12a-i) Imputation techniques to deal with attrition I missing values
Imputation techniques to deal with attrition I 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] "Participants wore a commercially available activity monitor (Jawbone UP 24) on their wrists and were instructed to remove the monitor only during the weekly charging times and in situations where the device would be submerged in water." Both groups received "...standard-ofcare instructions (information on the benefits of walking in a brochure available from the Arthritis Foundation)..." "All efficacy endpoints were analyzed in the modified intent-to-treat population, which included all randomized patients who had both a baseline value and an on-treatment value for the primary endpoint on or after day 30. All efficacy endpoint data comparing change from baseline between groups were obtained from an analysis of covariance model with baseline mean steps per day as the covariate and treatment assignment and pooled site as class variables. They are presented as least squares (LS) means with 95% confidence intervals (CIs). Statistical analyses were based on initial verification of parametric model assumptions, and a rank analysis of covariance was then considered if conditions for a parametric model were not met."

Revised
Revised 1 2 3 4 5 subitem not at all important 0 0 0 0 0 essential 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 briefly explain why the item is not applicable/relevant for your study

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 briefl)' explain wh)' the item is not applicable/relevant for your study

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
hltps://docs.google.com/formslclle/1 FAipQLSfZBSU p1 bwOc_ OimqcS64RdfiAFvmrTSkZQL2-30809ht..5Sw/viewform?hl=en _ US&form key=dGI Kd2Z2Q11NSGQOTH 11 azM 5MS 1aWWc6MA&rm=full#gid=O 31/50 "All efficacy endpoints were analyzed in the modified intent-to-treat population, which included all randomized patients who had both a baseline value and an on-treatment value for the primary endpoint on or after day 30." In cases of permanent discontinuation of device use, the patient data from the last visit were considered as last assessment in data analysis.
Primary and secondary endpoints were analyzed and presented in this manuscript. 1 2 3 4 5 subitem not at all important () 0 0 0 () essential

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

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

Does your paper address subltem X26-il?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this"to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study hltps://docs.google.com/formslclle/1 FAipQLSfZBSU p1 bwOc_ OimqcS64RdfiAFvmrTSkZQL2-30809ht..5Sw/viewform?hl=en _ US&form key=dGI Kd2Z2Q11NSGQOTH 11 azM 5MS 1aWWc6MA&rm=full#gid=O 32/50 "The protocol complied with the 18 th World Health Congress (Helsinki, 1964) recommendations and applicable amendments, and with any applicable country-specific laws, regulations, and guidelines. The protocol was approved by relevant ethics committees and/or institutional review boards." The patients must have been able to read, understand and sign an informed consent form, understand requirements for follow-up visits and must have been willing to provide information at the scheduled evaluations.

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 0 0 0 0 0 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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study hltps://docs.google.com/formslclle/1 FAipQLSfZBSU p1 bwOc_ OimqcS64RdfiAFvmrTSkZQL2-30809ht..5Sw/viewform?hl=en _ US&form key=dGI Kd2Z2Q11NSGQOTH 11 azM 5MS 1aWWc6MA&rm=full#gid=O 33150 Temporary discontinuation may have been considered by the investigator because of suspected adverse events or complaint. The patients may have withdrawn from treatment if they decided to do so, at any time and irrespective of the reason, or this may have been the investigator's decision.

13b) For each group, losses and exclusions after randomisation, together with reasons
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

13b·i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of panicipants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other f1gures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study  (Figure 2)." Please see Figure 2 in the manuscript for this information.

14a) Dates defining 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 briefl)' explain why the item is not applicable/relevant for your study

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical"secular eventsH fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 1 2 3 4 5 subitem not at all important 0 0 0 0 0 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 briefly explain why the item is not applicable/relevant for your study  (Figure 2)." The study was initiated and first patient enrolled on December 1, 2014 and the last patient completed on September 9, 2015.
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 briefly explain why the item is not applicable/relevant for your study Not applicable for this study, no critical "secular events" fell within the study period.

15) A table showing baseline demographic and clinical characteristics for each group
Not applicable, the trial was not stopped early.

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/lnternet/ehealth literacy of the participants, if known. subitem not at all important () 0 0 0 (I 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 briefly explain why the item is not applicable/relevant for your study

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1 ], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defmed time Please see Table 1 in the manuscript, patient demographics and baseline characteristics.
Please see Table 1 in the manuscript, patient demographics and baseline characteristics.
points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.
1 2 3 4 5 subitem not at all important 0 0 0 0 0 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 briefly explain why the item is not applicable/relevant for your study

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "usersN, with the appropriate caveats that this is no longer a randomized sample (see 18-i).

Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study hltps://docs.google.com/formslclle/1 FAipQLSfZBSU p1 bwOc_ OimqcS64RdfiAFvmrTSkZQL2-30809ht..5Sw/viewform?hl=en _ US&form key=dGI Kd2Z2Q11NSGQOTH 11 azM 5MS 1aWWc6MA&rm=full#gid=O 38150 N for each group in each analysis is presented in the figures in the manuscript.
Because this was an open-label study, "All efficacy outcomes were analyzed in the modified intent-to-treat population, which included all randomized patients who had both a baseline value and an on-treatment value for the primary endpoint on or after day 30." Revised 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Efficacy results are presented as least squares means with 95% confidence intervals, for example, "Improvement in mobility at day 90 was significantly greater in Group A than in Group B. LS mean change in number of steps/day was 1199 vs 467, a mean difference of 732 steps (95% CI [127,1337]; P = .03)." Not applicable for this study. Metrics such as average session length were not measured.

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 briefly explain wh)' the item is not applicable/relevant for your study

18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory
Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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). Binary outcomes are not applicable for this study.
Not applicable, only primary and secondary outcomes were analyzed and presented in this manuscript.

Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

19) All important harms or unintended effects in each group
(for specific guidance see CONSORT for harms) Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1 ], technical problems. and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2]. Not applicable for this study, subgroup analysis comparing only users was not done.
"The occurrence of TEAEs was similar in the 2 groups ( No major AEs related to the device or protocol occurred." Also see Table  2 in the manuscript.

Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

19-ii) Include qualitative feedback from participants or observations from staff/researchers
Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers. subitem not at all important 0 0 0 0 0 essential

Does your paper address subltem 19-il?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A greater number of Group A patients (68, 65.4%) reported they would be likely or very likely to use the devices compared with patients (36, 34.6%) who reported that they would be somewhat likely or not at all likely to do so ( Figure 5). Seventy-six physicians answered surveys for 104 patients; 70 of 104 (67.3%) physician surveys reported physicians to be likely or very likely to recommend use of the devices versus 34 (32.7%) surveys reporting physicians to be who would only be somewhat likely or not at all likely to recommend their use ( Figure 5)." Revised 22) Interpretation consistent with results, balancing benef1ts 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).
not in the ms, or briefly explain why the item is not applicable/relevant for your study

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. "These results also highlight the amenability of patients and physicians to using mobile health technology in the treatment of OA and suggest further investigation is warranted." "The patients studied may not be fully representative of the general OA population with respect to gender distribution (women are at higher risk for knee OA than men [42]), and activity levels as inclusion/exclusion criteria were such that patients with low levels (<500 steps/day) and high levels (>8000 steps/day) of baseline activity were not eligible for enrollment. Patients with a BMI >35 were also excluded from the study. In addition, the Kellgren -Lawrence grade of patients' knee OA was not collected, so data could not be stratified and analyzed in relation to radiographic disease severity, which might have been helpful in clarifying some of the study results such as the PAM-13 scores. The patient and physician satisfaction survey collected important feedback but is not an externally validated instrument. Moreover, the study was short-term, having been conducted over 90 days. Finally, the study did not include an arm in which patients used the motivating app and did not receive an injection, nor did it include an arm in which patients used the motivating app and received a saline injection (often designated as placebo)." Revised NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial 21-i) Generalizability to other populations Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations 1 2 3 4 5 subitem not at all important () 0 0 0 0 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 not in the ms, or briefly explain why the item is not applicable/relevant for your study 21-11) 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 ( 0 0 0 () 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 briefly explain why the item is not applicable/relevant for your study hltps://docs.google.com/formslclle/1 FAipQLSfZBSU p1 bwOc_ OimqcS64RdfiAFvmrTSkZQL2-30809ht..5Sw/viewform?hl=en _ US&form key=dGI Kd2Z2Q11NSGQOTH 11 azM 5MS 1aWWc6MA&rm=full#gid=O 45150

"Implication of Current Study Findings
Use of the OA GO app provides direct feedback on mobility function and pain (whereby steps and mobility become surrogates for pain and function, assuming there are no other reasons for decreased activity), which should give a more valid and reliable report of pain over time as it does not rely on patient recall of pain experienced. In contrast, visual analog scales [35] and the Western Ontario and McMaster Universities Osteoarthritis Index (used to assess pain, stiffness, and physical function over a specific time frame [ie, the last 48 hours] in clinical trials [36]) are both subjective measures that rely on patients thinking back to how they perceived they were feeling. Furthermore, symptoms of OA are often variable depending on a number of factors, including patients' activity level [7] and changes in the weather [37], suggesting that pain should be assessed in the context of ongoing physical activity levels. This technology, therefore, is an objective measure of functional improvement over time resulting from clinical interventions provided to patients, making it not only a motivating device for patients, but also an important research tool."

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 briefly explain wh)' the item is not applicable/relevant for your study 24) Where the full trial protocol can be accessed, if available Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study hltps://docs.google.com/formslclle/1 FAipQLSfZBSU p1 bwOc_ OimqcS64RdfiAFvmrTSkZQL2-30809ht..5Sw/viewform?hl=en _ US&form key=dGI Kd2Z2Q11NSGQOTH 11 azM 5MS 1aWWc6MA&rm=full#gid=O 46/'50 Not applicable for this study, wearable activity monitor and smartphone app were used in real-world settings.
"After working with the FDA to initiate registration of the trial, the sponsor deemed the study not eligible to be posted on ClinicalTrials.gov considering that clinical studies using devices whereby the primary outcome measure relates solely to feasibility, and not to health outcomes, are excluded from registration. The FDA concurred there was not a requirement to register the trial at that time." 25) Sources of funding and other support (such as supply of drugs), role of funders Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefl)' explain wh)' the item is not applicable/relevant for your study X27) Conflicts of Interest (not a CONSORT item) X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
"Sanofi Biosurgery, LLC funded the study." not in the ms, or briefly explain why the item is not applicable/relevant for your study About the CONSORT EHEALTH checklist As a result of using this checklist, did you make changes in your manuscript? * 0 yes, major changes 0 yes, minor changes 0 no What were the most important changes you made as a result of using this checklist?
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * As a result of using this checklist, do you think your manuscript has improved? * hltps://docs.google.com/formslclle/1 FAipQLSfZBSU p1 bwOc_ OimqcS64RdfiAFvmrTSkZQL2-30809ht..5Sw/viewform?hl=en _ US&form key=dGI Kd2Z2Q11NSGQOTH 11 azM 5MS 1aWWc6MA&rm=full#gid=O 48150 Investigators did not develop the smartphone application.
Six hours.

Revised
Increased details on population studied and randomization procedure.

STOP-Save this form as PDF before you click submit
To generate a record that you filled 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.
When you submit your (revised) paper to JMIR, please upload the PDF as supplementary f1le.
Don't worry if some text in the textboxes is cut off, as we still have the complete information in our database. Thank you! Some additional details were added to the manuscript.