Assessing Telemedicine Efficiency in Follow-up Care With Video Consultations for Patients in Orthopedic and Trauma Surgery in Germany: Randomized Controlled Trial

Background Telemedicine can help mitigate important health care challenges, such as demographic changes and the current COVID-19 pandemic, in high-income countries such as Germany. It gives physicians and patients the opportunity to interact via video consultations, regardless of their location, thus offering cost and time savings for both sides. Objective We aimed to investigate whether telemedicine can be implemented efficiently in the follow-up care for patients in orthopedic and trauma surgery, with respect to patient satisfaction, physician satisfaction, and quality of care. Methods We conducted a prospective randomized controlled trial in a German university hospital and enrolled 60 patients with different knee and shoulder conditions. For follow-up appointments, patients received either an in-person consultation in the clinic (control group) or a video consultation with their physician (telemedicine group). Patients’ and physicians’ subsequent evaluations of these follow-up appointments were collected and assessed using separate questionnaires. Results On the basis of data from 52 consultations after 8 withdrawals, it was found that patients were slightly more satisfied with video consultations (mean 1.58, SD 0.643) than with in-clinic consultations (mean 1.64, SD 0.569), although the difference was not statistically significant (P=.69). After excluding video consultations marred by technical problems, no significant difference was found in physician satisfaction between the groups (mean 1.47, SD 0.516 vs mean 1.32, SD 0.557; P=.31). Further analysis indicated that telemedicine can be applied to broader groups of patients and that patients who have prior experience with telemedicine are more willing to use telemedicine for follow-up care. Conclusions Telemedicine can be an alternative and efficient form of follow-up care for patients in orthopedic and trauma surgery in Germany, and it has no significant disadvantages compared with in-person consultations in the clinic. Trial Registration German Clinical Trials Register DRKS00023445; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023445


1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Follow-up Care With Video Consultations" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer

1a-iii) Primary condition or target group in the title
Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Assessing Telemedicine Efficiency in German Follow-up Care With Video Consultations for Patients in Orthopedic and Trauma Surgery: A Randomized Controlled Trial" 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 Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "For their follow-up appointments, patients received either an in-person consultation in the clinic (control group) or a video consultation with their physician (telemedicine group)."

1b-ii) Level of human involvement in the METHODS section of the ABSTRACT
Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "For their follow-up appointments, patients received either an in-person consultation in the clinic (control group) or a video consultation with their physician (telemedicine group)." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A prospective randomized controlled trial conducted in a German university hospital enrolled 60 patients with different knee and shoulder conditions. For their follow-up appointments, patients received either an in-person consultation in the clinic (control group) or a video consultation with their physician (telemedicine group). Patients' and physicians' subsequent evaluations of these follow-up appointments were collected and assessed using separate questionnaires." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Based on data from 52 consultations after 8 withdrawals, it was found that patients were slightly more satisfied with video consultations (mean 1.58) than with in-clinic ones (mean 1.64), although the difference was not statistically significant (P=.690). After excluding video consultations marred by technical problems, no significant difference was found in physician satisfaction between the groups (mean 1.47 vs 1.32, P=.310). Further analysis indicated that telemedicine can be applied to broader groups of patients, and that patients who have prior experience with telemedicine are more willing to use it for follow-up care." Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Telemedicine can be an alternative and efficient form of follow-up care in orthopedic and trauma surgery in Germany, and it has no significant disadvantages compared with inperson consultations in the clinic."

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in " Methods" under 5) subitem not at all important 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 briefly explain why the item is not applicable/relevant for your study "The aim of our randomized controlled trial is to investigate whether telemedicine can be used efficiently in follow-up care for orthopedic and trauma surgery patients in Germany. To answer this question, the RCT compares an in-personal consultation in a German university hospital (Level 1 trauma center) with the use of telemedicine, namely a video consultation between physician and patient. All consultations were for follow-up care of knee and shoulder patients who displayed a variety of conditions, had previously been treated in the clinic, and were eligible to participate in the study. For their video consultation, patients did not have to travel to the clinic, but could have their follow-up appointment online regardless of their location. The subsequent evaluation of telemedicine and its efficiency focuses on patient satisfaction, physician satisfaction, and quality of care. It is hoped that studying telemedicine in broad-based use for follow-up care and analyzing its effects comprehensively will contribute to informing healthcare providers' decisionmaking in future." 2a-ii) Scientific background, rationale: What is known about the (type of) system Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "One important tool for overcoming these challenges and guaranteeing effective healthcare in the medium to long term could be the use of telemedicine. Telemedicine offers the ability to provide medical care through real-time video consultations, without the need for personal contact and regardless of location. This could free up clinical resources, improve access to care, and increase safety for patients and medical staff. Telemedicine is already being applied successfully in various medical fields, but its use has so far been less common in orthopedic and trauma surgery. Since the outbreak of the COVID-19 pandemic, however, the need for telemedicine has risen considerably in these fields as well." "Prior research, however, has so far left several questions unaddressed. One of them is whether the use of telemedicine is efficient not only for a restricted number of individual diseases, but also for a wider range of medical conditions. Another important question concerns the viability of deploying telemedicine under realistic conditions and cost constraints in clinical practice: It is not clear whether telemedicine remains viable for a wider range of medical conditions when offered without incurring the additional cost of human resources required to support patients in video consultations, as in an outpatient clinic. Furthermore, it is questionable whether international study results can be transferred to the German healthcare system, especially since studies show that German patients are skeptical regarding the use of telemedicine." Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The aim of our randomized controlled trial is to investigate whether telemedicine can be used efficiently in follow-up care for orthopedic and trauma surgery patients in Germany." 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The study was conducted as an open, prospective, interventional, 1:1 randomized, and controlled monocenter trial at a German university hospital (University Hospital Giessen, Department of Trauma, Hand-and Reconstructive Surgery). The randomized and controlled design is based on the Consolidated Standards of Reporting Trials (CONSORT). With the parallel implementation of an intervention group, which received follow-up care through a real-time video consultation, and a control group, which received a standard follow-up consultation in the clinic, the effects of telemedicine on follow-up care were examined" Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable for our study.
subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants 3b-i) Bug fixes, Downtimes, Content Changes Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].
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 Technical irregularities in 42% of the video consultations conducted involving image problems, sound problems, and internet problems.
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 briefly explain why the item is not applicable/relevant for your study "Inclusion criteria: "(1) Patients need the ability to consent, as well as the mental and physical ability to participate in the telemedical consultation.
(2) Patients' conditions require no more than a visual examination. For legal reasons, (3) a previous outpatient or inpatient stay at the clinic is required, and (4) patients have to be 18 years or older. To be able to use telemedicine, it is assumed that (5) patients own a computer, laptop, tablet or smartphone, including a microphone and camera, and (6) they have a stable internet connection. Finally, (7) patients have to speak German in order to understand the declaration of consent." As well as specified ICD-10 codes. "Exclusion criteria: "Patients with (1) neurological diseases that do not allow the use of computer systems, and (2) patients with a diagnosis of dementia, blindness or deafness are excluded. Also, patients are excluded if they (3) have a need for in-person presence and onsite diagnostics or treatments (eg, medical imaging, laboratory, stitches, drainage) or (4) have to be touched or moved by the treating physician. This ensures that patients who require personal contact with a physician are not put at risk. Finally, (5) a lack of willingness to participate in the study or (6) the failure to consent are further exclusion criteria."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "To be able to use telemedicine, it is assumed that (5) patients own a computer, laptop, tablet or smartphone, including a microphone and camera, and (6) they have a stable internet connection." "Patients with (1) neurological diseases that do not allow the use of computer systems, and (2) patients with a diagnosis of dementia, blindness or deafness are excluded." 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 webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.
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 "After initial screening for inclusion and exclusion criteria, patients were asked either at the clinic or by telephone if they would like to participate in the study during their next follow-up appointment." subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 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 "To be able to participate, patients had to provide informed consent after receiving written as well as oral information. Consent could be withdrawn at any time without providing reasons." 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 "At the end of the recruitment process, depending on the treatment arm, the patients received an appointment either in the clinic or for a video consultation." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Intervention group: "Immediately after the video consultation, patients received login details via email and were asked to evaluate the consultation via online questionnaires." Control group: "Directly after the consultation, patients of the control arm were asked to fill out the questionnaires at the clinic."

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) 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 Not applicable for our study.
5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).

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

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 Not applicable for our study.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information 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-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 Not applicable for our study.

5-v)
Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable for our 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.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable for our 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 "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 briefly explain why the item is not applicable/relevant for your study "On the day of their appointment, patients received login details for the video consultation from their physicians via text message or email. No additional registration was required for the video consultation. At the arranged time, both the attending physician and the patient logged in to the software program and the video consultation was conducted." subitem not at all important 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 "The online video consultation used the web-based software CLICKDOC of the German telemedicine provider CGM Mobile Services GmbH. This software is certified for and widely used in the German healthcare system. On the day of their appointment, patients received login details for the video consultation from their physicians via text message or email. No additional registration was required for the video consultation. At the arranged time, both the attending physician and the patient logged in to the software program and the video consultation was conducted. Patients were able to use a computer, laptop, tablet or smartphone to join the video consultation."

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.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Study participants who were assigned to the intervention arm received a one-time telemedical follow-up via a real-time videoconference instead of a standard consultation in the department."

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 briefly explain why the item is not applicable/relevant for your study Intervention group: "At the arranged time, both the attending physician and the patient logged in to the software program and the video consultation was conducted." Control group: "Study participants, who were assigned to the control group attended a standard follow-up consultation at the university hospital. This follow-up was conducted by the same physicians, who also treated the intervention arm." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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).
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 "On the day of their appointment, patients received login details for the video consultation from their physicians via text message or email."

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 briefly explain why the item is not applicable/relevant for your study "Patients in the intervention group also received written instructions on how to perform the video consultation to minimize potential technical difficulties." 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The primary outcome patient satisfaction was measured using the ZAP questionnaire of the National Association of Statutory Health Insurance Physicians (NASHIP) in Germany." "Immediately after the video consultation, patients received login details via email and were asked to evaluate the consultation via online questionnaires." "Physician satisfaction as one of the secondary outcome parameters was assessed by questionnaires that the physicians answered following each patient consultation. The questionnaires were self-designed and differed slightly depending on the study arm." "To be able to evaluate quality of care as a further secondary outcome, patients received the German version of the "EQ-5D-5L" questionnaire from the EuroQol Group during enrollment." "After 3 months, the questionnaire was completed again to measure the impact of the interventions on health-related quality of life." Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Any changes to trial outcomes after the trial commenced, with reasons 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A group comparison of patient satisfaction with telemedicine in a study by Sharareh & Schwarzkopf (2014) served as the basis for our sample size calculation. This resulted in approximately 17 study participants for each group to achieve a power of 90% in a 2-sided ttest for independent samples with a global significance level of 5%. The sample size was increased by 10% for both groups to accommodate potential dropouts or withdrawals, and by another 10% to counteract a potentially skewed distribution of patient satisfaction. This resulted in a case number of 21 patients per randomization arm. To take into account the possible loss of power when using non-parametric methods, the sample size was finally increased to 30 patients per arm and thus to a total of 60 enrollments." Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Termination criteria were established for the individual study participants. (1) The occurrence of disease symptoms that required the physical presence of the patient in the clinic.
(2) Occurrence of technical problems that could not be solved in the short term. (3) Voluntary termination of the study at any time by the study participant, without giving reasons and without any disadvantage for the further treatment. These criteria as well as unexcused absences from the consultation resulted in the recording of the study participants as dropouts/withdrawals. Patients were then treated regularly and independently of the study in the clinic.
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 briefly explain why the item is not applicable/relevant for your study "Following a 2-armed parallel group design, patients enrolled in the study were randomly assigned at a 1:1 ratio to either the intervention arm (telemedicine follow-up) or the control arm (in-person follow-up consultation in the clinic)." 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 briefly explain why the item is not applicable/relevant for your study "To ensure better balance between the arms while minimizing predictability, block randomization with randomly selected block sizes of 4, 6, and 8 was applied. One member of the study staff organized the allocation of the blocks, while a different member performed the randomization of the patients." 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 "For this purpose, sealed envelopes were used." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "One member of the study staff organized the allocation of the blocks, while a different member performed the randomization of the patients." 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 briefly explain why the item is not applicable/relevant for your study "Given that the intervention was a video consultation, blinding of physicians or patients was not possible." subitem not at all important 1 2 3 4 5 essential 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Due to the study design, patients knew whether they were in the intervention group or control group.
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 briefly explain why the item is not applicable/relevant for your study Not applicable for our study.
subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Differences between the two study arms were analyzed using the Mann-Whitney U test or Fisher exact test, and effect sizes were reported by Pearson's correlation coefficient (r) or Cramer's V." "In addition, the Wilcoxon signed-rank test was applied to evaluate the longitudinal data of the EQ-5D-5L VAS." 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 briefly explain why the item is not applicable/relevant for your study "Data were analyzed based on intention-to-treat."

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential 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 briefly explain why the item is not applicable/relevant for your study "For patient and physician satisfaction, a subgroup analysis based on medical indication was performed." "To examine the suitability of telemedicine for follow-up appointments in more detail, and to investigate for which patients telemedicine is most appropriate, a binary logistic regression was performed."

X26-i) Comment on ethics committee approval
Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The local ethics committee of the University of Giessen reviewed and permitted the study. In addition, the study was registered at the German Clinical Trials Register (ID:DRKS00023445 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 briefly explain why the item is not applicable/relevant for your study "To be able to participate, patients had to provide informed consent after receiving written as well as oral information. Consent could be withdrawn at any time without providing reasons."

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 briefly explain why the item is not applicable/relevant for your study "If technical problems were noted, patients were contacted by phone and scheduled for a clinic visit as needed."

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 13b) For each group, losses and exclusions after randomisation, together with reasons 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 "A total of 60 patients agreed to participate in the study and were randomized. 30 patients were allocated to the intervention arm and 30 patients to the control arm. After randomization, 8 patients withdrew from the study. None of these patients were excluded by the physicians. Thus, 26 patients in the intervention arm and 26 patients in the control arm could be analyzed." 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 Can be found in the CONSORT flow diagram.
subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up

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

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 Not applicable for our study.
Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Patients were recruited and attended their follow-up appointments between September 2020 and April 2021. The last questionnaires for the second data collection of the EQ-5D-5L were sent out in July 2021." subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early)

15) A table showing baseline demographic and clinical characteristics for each
group NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 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 While study period: COVID-19 pandemic.
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 our study.
subitem not at all important 1 2 3 4 5 essential 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 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 briefly explain why the item is not applicable/relevant for your study Can be found in Table 1: Demographic characteristics of patients.

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.

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 Can be found in Table 1: Demographic characteristics of patients.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.
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 "In total, 100% of patients in the intervention arm and 90% (26/29) of patients in the control arm completed the questionnaires after the follow-up appointment. Of the physician questionnaires, 100% in the telemedicine group and 96% (25/26) in the control group were completed. In the intervention group, 100% of the EQ-5D-5L questionnaires were returned at baseline and 69% (18/26) after 3 months; in the control group, 88% (23/26) of the questionnaires were returned at baseline and 58% (15/26) after 3 months."

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).
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 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 "Data were analyzed based on intention-to-treat." 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 subitem not at all important 1 2 3 4 5 essential "Although group comparison showed that patients were slightly more satisfied with telemedicine follow-up (mean 1.58) than with in-person follow-up in the clinic (mean 1.64), the difference was not statistically significant (P=.690) ( Table 2)." "The waiting time (P<.001), atmosphere (P<.001), and punctuality of the appointment (P=.002) were more satisfying for patients in the telemedicine group than in the control group, with medium to strong effects (r=.440 to r=.760)." "A strong effect was also evident in the preference for the next follow-up appointment between the groups (V=.542). Whereas patients in the control group would prefer to visit the clinic again (64.0%), almost all patients in the telemedicine group (88.5%) would choose telemedicine for their next follow-up appointment (P<.001)." "Physicians in the control group were significantly more satisfied with follow-up appointments (mean 1.32) than those in the telemedicine group (mean 2.42) (P=.001, r=.466), as shown in Table 3." "However, a further group comparison, in which video consultations with technical irregularities were removed, revealed no significant group differences in physician satisfaction (mean 1.47 & 1.32, P=.310). In addition, there were no significant differences in the ability to address all relevant medical questions. For the next follow-up appointment, physicians would recommend a telemedical consultation for most patients regardless of the study arm (73.1% telemedicine group; 64.0% control group; P=.555)." "As shown in Table 4, differences in quality of life between the groups were not significant, neither at baseline (P=.242) nor after treatment (P=.686). The difference in quality of life before and after the follow-up appointment also did not meet statistical significance between the intervention and the control arm (P=.187). In this case, the group size has changed, because only complete data sets could be considered for analysis. In both groups, the perceived average quality of life increased after treatment, although not significantly (telemedicine group: mean 69.77 to 70.44, P=.934; control group: mean 66.30 to 69.33, P=.108)." 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).
17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory 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 Not applicable for our study.
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 why the item is not applicable/relevant for your study Can be found in the Tables.
subitem not at all important 1 2 3 4 5 essential 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 "Although group comparison showed that patients were slightly more satisfied with telemedicine follow-up (mean 1.58) than with in-person follow-up in the clinic (mean 1.64), the difference was not statistically significant (P=.690) ( Table 2). This result was not affected by a subgroup analysis of the 2 medical indications, namely knee or shoulder." "Subgroup analysis showed that this difference was also significant for the treatment of shoulder patients (P=.006), but not for knee patients (P=.076). However, a further group comparison, in which video consultations with technical irregularities were removed, revealed no significant group differences in physician satisfaction (mean 1.47 & 1.32, P=.310)." "Binary logistic regression was used to examine for which patients telemedicine follow-up is appropriate. For this purpose, the potential influence of different variables on patients' preference for their next follow-up appointment was analyzed (

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).

19) All important harms or unintended effects in each group
(for specific guidance see CONSORT for harms) subitem not at all important 1 2 3 4 5 essential 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 Not applicable for our study.
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 "High number of video consultations with technical irregularities (42%, 11/26)"

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 briefly 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 briefly explain why the item is not applicable/relevant for your study Not applicable for our study.
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 briefly explain why the item is not applicable/relevant for your study "The aim of this study was to investigate whether telemedicine can be used efficiently for outpatient orthopedic and trauma surgery follow-up care in Germany at an university hospital from the perspective of patients, physicians, and the quality of care. Our data analysis shows that the use of telemedicine has no significant drawbacks compared with traditional clinical consultations in almost all aspects studied. Patients were even slightly more satisfied with telemedicine regardless of their medical condition, although the difference was not statistically significant. In addition to overall satisfaction, the authors also analyzed more specific indicators of satisfaction. Aspects such as waiting time, atmosphere and punctuality could be improved by using telemedicine."

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 briefly explain why the item is not applicable/relevant for your study Not applicable for our study.
subitem not at all important 1 2 3 4 5 essential 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial

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.
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 briefly explain why the item is not applicable/relevant for your study "The use of pen-and-paper questionnaires on the one hand and online questionnaires on the other could also have led to discrepancies. In particular, all questions had to be completed in the online questionnaires, but the same was not true for pen-and-paper questionnaires completed in the clinic. For organizational reasons, however, no uniform implementation was possible. This problem also arose for comparable studies. On the other hand, studies show that patients usually provide similar health-related answers regardless of survey formats. Finally, when evaluating the results, it should be noted that all recruited patients consented to participating in telemedicine. This might have led to a bias in favor of higher satisfaction with telemedicine from the start, which explains why our data do not show results for the population. Short of forcing patients to participate in telemedicine, a procedure which appears both unethical in principle and unfeasible in clinical practice, there is no acceptable way of addressing this limitation." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 briefly explain why the item is not applicable/relevant for your study "In sum, our results suggest that the effective implementation of telemedical follow-up care ideally meets several conditions. First, the appropriateness of telemedicine should be assessed for each patient individually, and suitable patients should be supported in overcoming any initial uncertainties. Second, if any medical issues cannot be clarified in a video consultation, or if problems occur, additional in-clinic treatment should always be possible, as was the case in the present study. Third, technical irregularities should be monitored over the long term, as telemedicine is beneficial only if the physicians using it are satisfied with its workability."

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.

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 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 Not applicable for our study.
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 why the item is not applicable/relevant for your study "German Register for Clinical Trials, ID: DRKS00023445" 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 The full trial protocol can be requested from the corresponding author.

X27) Conflicts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential 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 briefly explain why the item is not applicable/relevant for your study The research did not receive funding from an external body.

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.
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 briefly explain why the item is not applicable/relevant for your study Conflicts of Interest: None declared.
yes, major changes yes, minor changes no yes no Other: 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?
Not applicable for our study.
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * I spent two hours to complete the checklist.
As a result of using this checklist, do you think your manuscript has improved? * We have already adapted the paper to the CONSORT Statement when it was writte yes no Other: 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.
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