Digital Versus Conventional Rehabilitation After Total Hip Arthroplasty: A Single-Center, Parallel-Group Pilot Study

Background The demand for total hip arthroplasty (THA) is rising. In the face of rapidly increasing health care costs, ensuring widespread, cost-effective rehabilitation is a priority. Technologies allowing independent home-based rehabilitation may be the key to facilitate access, improve effectiveness, and lower costs of care. Objective The aim of this study was to assess the feasibility of a novel artificial intelligence–powered digital biofeedback system following THA and compare the clinical outcomes against supervised conventional rehabilitation. Methods This was a single-center, parallel-group pilot study, with an 8-week intervention program. Patients were assessed at baseline, during the program (at 4 and 8 weeks), and 3 and 6 months after surgery. The primary outcome was the Timed Up and Go (TUG) score and secondary outcomes were the Hip dysfunction and Osteoarthritis Outcome Scale (HOOS; a patient-reported outcome) and hip range of motion (ROM). Results A total of 66 patients were included: 35 digital physiotherapy (PT) versus 31 conventional. There were no differences at baseline between groups except for lower HOOS quality of life (QoL) subscale scores in the digital PT group. Clinically relevant improvements were noted in both groups at all time points. The digital PT group showed a retention rate of 86% (30/35). Per-protocol analysis revealed a superiority of the digital PT group for all outcome measures. Intention-to-treat analysis revealed the superiority of the digital PT group at all time points for TUG (change between baseline and 4 and 8 weeks: P<.001; change between baseline and 3 and 6 months: P=.001 and P=.005, respectively), with a difference between median changes of −4.79 seconds (95% CI −7.24 to −1.71) at 6 months post-THA. Between baseline and month 6, results were also superior in the digital PT group for the HOOS sports and QoL subscales and all ROM except for standing flexion. Conclusions This study demonstrates this novel solution holds promise in rehabilitation after THA, ensuring better clinical outcomes than conventional rehabilitation while reducing dependence on human resources. Trial Registration ClinicalTrials.gov NCT03045549; https://clinicaltrials.gov/ct2/show/NCT03045549

It is a pilot study and is identi ed as such 1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The title identi es the nature of the intervention by stating "Digital versus conventional rehabilitation (...)"

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
subitem not at all important 1 2 3 4 5 essential 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important 1 2 3 4 5 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 The title identi es the nature of the intervention by stating "Digital versus conventional rehabilitation (...)" 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As can be read in the title: "Digital Versus Conventional Rehabilitation After Total Hip Arthroplasty: a Single-Center, Parallel-Group, Pilot Study"

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT
Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study In order to provide more information on the results of the study, a description of the degree of human involvement could not be mentioned in the abstract. This point was made clear in the methods of the paper https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q… 10/51 subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional o ine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study All assessments were done face-to-face, as explained in the methods section. Adding this information in the methods section does not add any value.
1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Sixty-six patients were included ( 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) Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "This study demonstrates this novel solution holds great promise in rehabilitation after THA, ensuring better clinical outcomes than conventional rehabilitation while reducing dependence on human resources." 2a-i) Problem and the type of system/solution Describe the problem and the type of system/solution that is object of the study: intended as standalone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in " Methods" under 5) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "In the face of galloping healthcare costs, ensuring widespread cost-effective rehabilitation is a priority, but putting this into effect constitutes a challenge, both in terms of logistics and costs.
In recent years, telerehabilitation solutions (i.e. rehabilitation services delivered at home from a remote location through a telecommunication system and information technology) have been developed that allow professionals to remotely monitor rehabilitation programs.These solutions have demonstrated a potential to reduce healthcare costs associated with supervision, facility provision, and transport of patients, while yielding similar, but not superior, clinical outcomes than conventional physical therapy post-THA.
Using a different approach, several authors have compared unsupervised homebased with physiotherapist-led outpatient rehabilitation programs, with both cases showing similar results for patients who comply with the program. However, in studies comparing supervised with unsupervised training, or no recommended training at all, there is a high variability in compliance rates, which is a well-accepted key determinant to therapy success, ranging from 23% to 85%. Copy and paste relevant sections from the manuscript (include quotes in quotation 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. "In a previous study, we have tested a novel digital biofeedback system, based on inertial motion trackers, that enables independent home-based physical rehabilitation under remote monitoring from the clinical team after total knee arthroplasty (TKA). In this study [n=59; NCT03047252], we compared the digital system to conventional face-to-face home-based rehabilitation post-TKA, over an 8-week program. The results demonstrated that this solution was safe and very well accepted, with high compliance and satisfaction levels and, most importantly, that the clinical outcomes were superior to conventional rehabilitation. These encouraging results prompted further studies, with the intent of validating this solution in other therapeutic scenarios." 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 Yes. "The aim of the present single-center, parallel-group, pilot study was to assess patient uptake and system safety in patients submitted to THA, as well as to compare the clinical outcomes of a home-based program using this digital physiotherapy (PT) system against conventional in-person home-based rehabilitation after THA." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "This was a single-center, parallel-group, pilot study, designed to assess patient uptake and safety of a digital physiotherapy system, as well as to compare the clinical outcomes of a home-based program using this home-based digital program against conventional in-person home-based rehabilitation after THA." 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 Yes, no signi cant changes were made.

3b-i) Bug xes, Downtimes, Content Changes
Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].
Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does not apply to our study, as the version was not changed during the study and there were no downtimes.
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "All patients included in this study were referred to post-THA rehabilitation by two independent physicians.
Subjects were included if they were: a) ≥ 18 years old and had: b) clinical and imaging (CT) evidence of hip osteoarthritis as assessed by the orthopaedic surgeon; c) indication for THA according to the patient´s orthopedic surgeon; d) ability to walk (unaided or with assistive device); e) availability of a caregiver to assist the patient after surgery.
Exclusion criteria were: a) admitted for revision THA; b) contralateral hip or knee osteoarthritis severely limiting patient mobility and ability to comply with a rehabilitation program; c) aphasia, dementia or psychiatric comorbidity interfering with communication or compliance to the rehabilitation process; d) respiratory, cardiac, metabolic or other condition incompatible with at least 30 minutes of light to moderate physical activity; e) major medical complications occurring after surgery that prevented the discharge of the patient within 10 days after the surgery; f) other medical and/or surgical complications that prevent the patient from complying with a rehabilitation program; g) blind and/or illiterate patients." 4a-i) Computer / Internet literacy Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This does not apply to our study as we did not use internet/computer literacy as an eligibility criterion. Speci cally, we wanted to see how a non-technologically literate population would interact with the system. Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these.
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 All assessments were made face-to-face.

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "All patients and caregivers were provided with information about the purpose and procedures of the study and provided written informed consent before inclusion. All patient data was anonymized and linked to the patient by a unique study number that did not contain any personal identi ers." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "All consecutive patients admitted for THA between December 19th 2016 and January 16th 2018 were screened pre-and post-operatively for eligibility at Hospital da Prelada, Porto, Portugal, by the two orthopaedic surgeons that oversaw the study -JP and RS. Completion date for the 6 months follow-up assessment was 16th July 2018." 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The primary outcome (TUG) was assessed in person by the investigators The patient reported outcomes scales were handed to the patient in paper sheets which the patients then lled The SWORD device was used in both groups to measure active hip ROM.
4b-ii) Report how institutional a liations are displayed Report how institutional a liations are displayed to potential participants [on ehealth media], as a liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 5) The interventions for each group with su cient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 No institutional a liations were displayed to potential participants, which were recruited by the local orthopaedic surgeons on site.

5-i) Mention names, credential, a liations of the developers, sponsors, and owners
Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).
Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As per the con ict of interest disclosure: "FDC and VB have a shareholder position at SWORD Health, a company that develops and commercializes SWORD related products. AN, IM, JG, MM, IB are employees of SWORD Health but do not have shareholder positions. LT and JL receive honoraria from SWORD Health. JP and RS have no con icts of interest to report.

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is not relevant to the present study, which was conducted using a medical device already certi ed for the European and US markets.

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The version used during the study was the same, and we do not consider this to be a relevant issue in this particular study.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Again, this study was conducted using a medical device already certi ed for the European and US markets.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The sourcecode is trade secret of the company that owns the medical device. Replicability may be ensured by using the medical device to replicate the studies, as it is available in the market.

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

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Patients were enrolled in the study using strict inclusion and exclusion criteria, and were handed the medical device consisting of motion trackers, straps and a tablet which contains the application. subitem not at all important 1 2 3 4 5 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 Yes.
"The system comprises the following elements ( Figure 1): a) Inertial motion trackers Each tracker is comprised of a gyroscope, an accelerometer and a magnetometer, enabling precise movement quanti cation. The trackers are placed on body segments using Velcro® straps, in three speci c positions: I) over the sternal manubrium (red tracker); II) on the anterior surface of the hip (green tracker) and III) over the anterior tibial crest (blue tracker).

b) Mobile App
The app guides the patient through the session, providing video and audio instructions before each exercise, as well as real-time audio and video biofeedback during the exercise. If the patient performs a movement error or assumes an incorrect posture, an error message is displayed, allowing the patient to correct the movement in the following attempts.

c) Web-based Portal
The Portal enables remote result monitoring and exercise prescription/edition by the clinical teams."

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 brie y explain why the item is not applicable/relevant for your study Yes "After the initial assessment, all patients were submitted to elective THA. Surgical technique was the same for all patients -direct lateral approach under regional anesthesia.
Between day one post-op and hospital discharge, all patients were taught how to safely get in and out of bed and were asked to perform alternate ankle exion and extension exercises regularly. All patients performed initial gait training with canes.
After hospital discharge, both groups received an 8-week rehabilitation program starting between day seven and day ten after surgery (see Multimedia Appendix 2 In the digital PT group, patients received an initial visit from the physical therapist, to assess speci c needs and to teach patients and/or caregivers how to set up and use the system. Patients then performed exercise sessions independently, using the system, under asynchronous remote monitoring from the physical therapist (see Multimedia Appendix 2 for more details). Patients were instructed to exercise ve to seven days per week, minimum 30 minutes sessions, but were not excluded in case of lower adherence. Each patient received a telephone call on weeks 2 and 6, to check on patient adaption, review the program and assess adverse events; a face-to-face visit on week 4 to perform an in-depth review of the program; and a termination visit to collect the system. Additional visits were performed when required.
The conventional rehabilitation group received a home-based supervised program provided by a physiotherapist, three times a week, for one hour (see Multimedia Appendix 2 for more details). Patients were also instructed by to perform additional sessions in at least two other days of the week. These were nonmandatory and no record of these sessions was kept." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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).
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 Yes.
"Each patient received a telephone call on weeks 2 and 6, to check on patient adaption, review the program and assess adverse events; a face-to-face visit on week 4 to perform an in-depth review of the program; and a termination visit to collect the system. Additional visits were performed when required.
The conventional rehabilitation group received a home-based supervised program provided by a physiotherapist, three times a week, for one hour (see Multimedia Appendix 2 for more details). Patients were also instructed by to perform additional sessions in at least two other days of the week. These were nonmandatory and no record of these sessions was kept." 5-xi) Report any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability). subitem not at all important 1 2 3 4 5 essential 6a) Completely de ned pre-speci ed primary and secondary outcome measures, including how and when they were assessed Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes Yes.
"Each patient received a telephone call on weeks 2 and 6, to check on patient adaption, review the program and assess adverse events; a face-to-face visit on week 4 to perform an in-depth review of the program; and a termination visit to collect the system. Additional visits were performed when required.
The conventional rehabilitation group received a home-based supervised program provided by a physiotherapist, three times a week, for one hour (see Multimedia Appendix 2 for more details). Patients were also instructed by to perform additional sessions in at least two other days of the week. These were nonmandatory and no record of these sessions was kept."

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text Usage data was given automatically by the device. Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text Yes. "Patients in the digital PT group were asked to report their satisfaction level by answering the question: "On a scale from 0-10 ("0" meaning that you would not recommend and "10" that you would highly recommend) how much would you recommend the system to one of your friends or neighbours?". Thirty-two (91.4%) rated the system with ten, two patients rated the system with nine and one did not answer. " 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 No changes were made. 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 No interim analysis were performed and the treatment was not stopped. 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes.
"Patients were recruited at Hospital da Prelada, Porto, Portugal. Patient allocation was performed using patient address as criterion. Subjects residing in areas outside the administrative limits of the city of Oporto were allocated to the digital PT group, while those residing within the limits were allocated to the conventional rehabilitation group. Patient allocation was performed centrally by one investigator -F.D.C. -and communicated to the responsible for data acquisition only after patient enrollment." 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 Yes. "Patients were recruited at Hospital da Prelada, Porto, Portugal. Patient allocation was performed using patient address as criterion. Subjects residing in areas outside the administrative limits of the city of Oporto were allocated to the digital PT group, while those residing within the limits were allocated to the conventional rehabilitation group. Patient allocation was performed centrally by one investigator -F.D.C. -and communicated to the responsible for data acquisition only after patient enrollment." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "Patients were recruited at Hospital da Prelada, Porto, Portugal. Patient allocation was performed using patient address as criterion. Subjects residing in areas outside the administrative limits of the city of Oporto were allocated to the digital PT group, while those residing within the limits were allocated to the conventional rehabilitation group. Patient allocation was performed centrally by one investigator -F.D.C. -and communicated to the responsible for data acquisition only after patient enrollment" Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. (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) 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "The nature of the study did not allow blinding of the patients. Patient assessment was performed by two investigators -J.P. and R.S -blinded for study groups.
Statistical analysis was performed by a blinded statistician -L.T." 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The nature of the study did not allow blinding of the patients." 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 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 The two interventions were similar and this was made clear in Multimedia Appendix 2.
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 Yes.
"To assess differences in clinical and demographic variables of the patients allocated to the two study groups, independent samples t test or Mann-Whitney U test were used for quantitative variables. For categorical variables, Chi-square test or Fisher's exact test were used.
Outcome analysis was performed using both an intention to treat analysis and a per-protocol analysis. Differences between interventions were evaluated using independent samples t test or Mann-Whitney U test. For non-normally distributed variables, the magnitude of the difference in the medians was assessed using Hodges-Lehman estimator.
Additionally, a repeated measures ANOVA was also performed, with group as an independent factor and time as a within-subjects factor. When necessary, subitem not at all important 1 2 3 4 5 essential 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study In the "intent to treat" analysis missing cases were dealt with transporting the last known assessment forward.
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes.
"Outcome analysis was performed using both an intention to treat analysis and a per-protocol analysis." X26-i) Comment on ethics committee approval subitem not at all important 1 2 3 4 5 essential Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes.
"Ethics approval of research The study was approved by the National Data Protection Commission (authorization number 1476/2017) and by the local ethics committee at Hospital da Prelada (Chair: Dr. Juiz Conselheiro Almeida Lopes). The methods were conducted in accordance with the approved guidelines. All patients and caregivers were provided with information about the purpose and procedures of the study and provided written informed consent before inclusion. All patient data was anonymized and linked to the patient by a unique study number that did not contain any personal identi ers."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained o ine or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.
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.
"The methods were conducted in accordance with the approved guidelines. All patients and caregivers were provided with information about the purpose and procedures of the study and provided written informed consent before inclusion. All patient data was anonymized and linked to the patient by a unique study number that did not contain any personal identi ers." subitem not at all important 1 2 3 4 5 essential RESULTS 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center X26-iii) Safety and security procedures Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes.
"In the digital PT group, patients were asked to rate pain and fatigue on a scale from zero to ten at the end of each session. These were available for remote monitoring through the portal. Patients were also given the direct contact of the assigned physical therapist to report adverse events: pain during exercise, falls and other medical complication (e.g. in ammatory signs or infection on the surgical wound or operated member; thrombophlebitis). Patients in the conventional rehabilitation group performed supervised sessions by a physical therapist, enabling early adverse event detection and reporting." 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 Yes. See consort diagram in the paper.
13b) For each group, losses and exclusions after randomisation, together with reasons subitem not at all important 1 2 3 4 5 essential 14a) Dates de ning the periods of recruitment and follow-up Does your paper address CONSORT subitem 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. There is a CONSORT ow diagram.

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

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No, but we have mentioned retention rates, treatment intensity and adherence.
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 Yes. "One hundred and fty-six (156) patients were assessed for eligibility between 19th December 2016 and 16th January 2018." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study None noted.
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 It was not stopped early.
Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 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.
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 All but technological literacy were mentioned.

16-i) Report multiple "denominators" and provide de nitions
Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c prede ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
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 The n is clearly visible in the tables, and analysis by "intent to treat" or "per protocol" are clearly identi ed in the results section.
subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con dence interval) subitem not at all important 1 2 3 4 5 essential 16-ii) Primary analysis should be intent-to-treat Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, as can be seen in the results section.
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 Yes. See tables 2 and 3 (and also results section) 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a).
17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "Independence of use In the digital PT group, 13 patients (37.1%) required assistance of a caregiver for tracker/strap placement or navigation. Patients requiring assistance were oldermean age 68.0 years; (sd=7.6) versus 57.7 years (sd=6.6) (P=.001).

Patient satisfaction
Patients in the digital PT group were asked to report their satisfaction level by answering the question: "On a scale from 0-10 ("0" meaning that you would not recommend and "10" that you would highly recommend) how much would you recommend the system to one of your friends or neighbours?". Thirty-two (91.4%) rated the system with ten, two patients rated the system with nine and one did not answer.
Therapist-patient interaction Patients in the conventional rehabilitation group had 24 in-person sessions, whereas patients in the digital PT group had 3 face-to-face contacts with the therapist and, on average, 0.6 (range 0-2) extra contacts for technical assistance.
Regarding telephone calls, in addition to the two scheduled calls per protocol, each patient received a median of 4 extra calls (range 0-7), the vast majority due to di culties in interacting with the system. 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 The study had no binary outcomes.
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 Yes. "A repeated measures ANOVA was performed only for variables with normal distribution -TUG (after log-transformation) and hip ROM, and results are summarised in Table 4. While both groups presented an improvement in every dimension evaluated, this analysis revealed a main effect of time, a main effect of group (here with the exception of the standing hip exion ROM) and an interaction between time and group for all outcome measures, in favour of the digital PT group (see Table 4 and Figure 3). "

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. Throughout the results section, a clear distinction is made between "Intent to Treat" and "per Protocol" results subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes.
"In the digital PT group, the adverse event rate was 14.3% (5/35). Three patients were excluded due to signi cant pain during hip abduction, without in ammatory or other warning signs. All three patients recovered spontaneously within 2 weeks. One patient reported in ammatory signs over the surgical wound and another suffered a fall (not during system use), with no need for hospital assistance.
In the conventional rehabilitation group, the adverse event rate was 22.6% (7/31).
One patient required hospital readmission and revision procedure due to a surgical wound infection; one was excluded due to groin pain; two patients reported in ammatory signs over the surgical wound; one patient had a thrombophlebitis; one reported a unilateral lower limb edema (with spontaneous recovery) and one patient suffered a fall, with no need for hospital assistance. "

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].
Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes.
"Patients in the digital PT group were asked to report their satisfaction level by answering the question: "On a scale from 0-10 ("0" meaning that you would not recommend and "10" that you would highly recommend) how much would you recommend the system to one of your friends or neighbours?". Thirty-two (91.4%) rated the system with ten, two patients rated the system with nine and one did not answer. " 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
subitem not at all important 1 2 3 4 5 essential 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes.
"In conclusion, this study demonstrates that, like previously demonstrated for TKA, home-based rehabilitation with this novel digital biofeedback system is feasible and safe following THA, and is associated with high patient satisfaction, albeit with room for improvement in terms of usability by elderly patients."

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.
Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes.
"In conclusion, this study demonstrates that, like previously demonstrated for TKA, home-based rehabilitation with this novel digital biofeedback system is feasible and safe following THA, and is associated with high patient satisfaction, albeit with room for improvement in terms of usability by elderly patients. Plus, to our knowledge, it is the rst study demonstrating that a digital rehabilitation solution can reduce the dependence on human resources while ensuring better clinical outcomes than conventional rehabilitation in the short and medium-term following THA. These promising results justify further investigation, and prove the feasibility of larger, randomized controlled studies, to con rm these ndings." subitem not at all important 1 2 3 4 5 essential 20-i) Typical limitations in ehealth trials Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to nonuse of the intervention/usability issues, biases through informed consent procedures, unexpected events.
Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "This study has several limitations that need to be acknowledged. This was a quasi-randomized study, where patient allocation was performed according to geographical location. This implies that even if no differences were found in demographics, comorbidities, risk factors for adverse and clinical characteristics (except for the QoL subscale of the HOOS), a number of factors (e.g. socioeconomic) may have in uenced the results. Still, almost all the patients resided in urban areas and, as such, the authors speculate that the impact of these aspects is small, but nonetheless needs to be controlled in ensuing studies.
There was a potential selection bias towards more technologically-prone recipients, given the low inclusion rate. To address this, a greater involvement of the clinical teams (doctors and nursing staff) in the wards is required, in order to overcome natural patient skepticism.
The limited context of the clinical set, which was a low-volume orthopedic hospital, may not re ect the reality of other settings. Thus, generalization of the results needs to be con rmed in larger hospitals, and multicentric trials.
The study protocol depicts slight differences between the digital PT group and conventional rehabilitation group that could be confounders. First, total active treatment time was similar between groups. However, the intensity in the digital PT group was highly variable and unsupervised sessions in the conventional group were not taken into consideration. These aspects also need to be homogenized and controlled in future studies. Second, the exercise program was similar in both groups, with the exception of additional exercises which were possible only with a face-to-face intervention. In this sense, while the authors agree that these may be confounding factors, they bene t the conventional group and not the digital intervention group, and therefore do not bias results towards the latter.
There was a notable absence of minor adverse events, in particular after the 8- week period, most likely due to underreporting. In future studies, besides direct telephone contacts at pre-determined time stamps and speci c questioning of adverse events in assessment appointments, event logs should be delivered to the patients for them to ll in." 21) Generalisability (external validity, applicability) of the trial ndings

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes.
"The limited context of the clinical set, which was a low-volume orthopedic hospital, may not re ect the reality of other settings. Thus, generalization of the results needs to be con rmed in larger hospitals, and multicentric trials." 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.
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 inclusion and exclusion criteria were purposedly broad so that the patients included in the study would resemble a routine clinical setting.

OTHER INFORMATION
23) Registration number and name of trial registry 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other support (such as supply of drugs), role of funders 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 Yes. "https://clinicaltrials.gov/ (UI: NCT03045549)." Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes.
"Individual participant data, that underlie the results reported in this article, will be shared after de-identi cation as supplementary information (Multimedia Appendix 1) of this paper. Other documents, namely the study protocol, CONSORT details will also be made permanently available immediately following publication, either through the online version of this paper or at https://clinicaltrials.gov/ (UI: NCT03045549 About the CONSORT EHEALTH checklist 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 brie y explain why the item is not applicable/relevant for your study Yes. "This work was supported by the European Commission through the Project H2020 SME Instrument Phase 2 -Grant Agreement number 672814. The study sponsor, SWORD Health, was involved in study design, data collection and interpretation and writing of the manuscript. All patients included in this study were referred to post-THA rehabilitation by JP and RS, who also served as independent controllers of the study. Decision to submit the manuscript for publication was made by these two independent authors." X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial 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.
Does your paper address subitem X27-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.
" As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?
A sua resposta How much time did you spend on going through the checklist INCLUDING making changes in your manuscript *

hours
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Don't worry if some text in the textboxes is cut off, as we still have the complete information in our database. Thank you! Any other comments or questions on CONSORT EHEALTH A large percentage of the requested information is absolutely irrelevant. Plus, it is an absolute waste of time to be copy-pasting relevant sections of the manuscript, adding absolutely no value. The CONSORT 2010 Checklist is more than enough, and has been the standard for some reason.