Assessing the Efficacy of an Educational Smartphone or Tablet App With Subdivided and Interactive Content to Increase Patients’ Medical Knowledge: Randomized Controlled Trial

Background Modern health care focuses on shared decision making (SDM) because of its positive effects on patient satisfaction, therapy compliance, and outcomes. Patients’ knowledge about their illness and available treatment options, gained through medical education, is one of the key drivers for SDM. Current patient education relies heavily on medical consultation and is known to be ineffective. Objective This study aimed to determine whether providing patients with information in a subdivided, categorized, and interactive manner via an educational app for smartphone or tablet might increase the knowledge of their illness. Methods A surgeon-blinded randomized controlled trial was conducted with 213 patients who were referred to 1 of the 6 Dutch hospitals by their general practitioner owing to knee complaints that were indicative of knee osteoarthritis. An interactive app that, in addition to standard care, actively sends informative and pertinent content to patients about their illness on a daily basis by means of push notifications in the week before their consultation. The primary outcome was the level of perceived and actual knowledge that patients had about their knee complaints and the relevant treatment options after the intervention. Results In total, 122 patients were enrolled in the control group and 91 in the intervention group. After the intervention, the level of actual knowledge (measured on a 0-36 scale) was 52% higher in the app group (26.4 vs 17.4, P<.001). Moreover, within the app group, the level of perceived knowledge (measured on a 0-25 scale) increased by 22% during the week within the app group (from 13.5 to 16.5, P<.001), compared with no gain in the control group. Conclusions Actively offering patients information in a subdivided (per day), categorized (per theme), and interactive (video and quiz questions) manner significantly increases the level of perceived knowledge and demonstrates a higher level of actual knowledge, compared with standard care educational practices. Trial Registration International Standard Randomized Controlled Trial Number ISRCTN98629372; http://www.isrctn.com/ISRCTN98629372 (Archived by WebCite at http://www.webcitation.org/73F5trZbb)

Is this a full powered effectiveness trial or a pilot/feasibility trial? * Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the fourdigit number at the end of the DOI, to be found at the bottom of each published article in JMIR) TITLE AND ABSTRACT 1a) TITLE: Identi6cation as a randomized trial in the title 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 otine 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 brieuy explain why the item is not applicable/relevant for your study "educational smartphone or tablet app with subdivided and interactive content " 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 brieuy 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 brieuy explain why the item is not applicable/relevant for your study The study population in this trial are patients with knee complaints. However, since we believe the intervention can be used for many different conditions, we have chosen to focus on the mechanism of knowledge delivery in general. 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 brieuy explain why the item is not applicable/relevant for your study "An interactive app that, in addition to standard care, actively sends informative and pertinent content to patients about their illness on a daily basis by means of push notiUcations in the week prior to their consultation. " subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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) 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 brieuy explain why the item is not applicable/relevant for your study Patients in the intervention group received an email message containing the download instructions for the app and their personal access code.
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. otine), 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 otine 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) 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 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 brieuy explain why the item is not applicable/relevant for your study Patients who called to the hospital to schedule their appointment with the orthopedic surgeon were invited to consider participation in the study. If they were willing to participate, they were registered in the online portal for the study and received al the information necessary.
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 brieuy explain why the item is not applicable/relevant for your study "In total 122 patients were enrolled in the control group and 91 in the intervention group. " 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. METHODS 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 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 brieuy explain why the item is not applicable/relevant for your study "It is hypothesized that compared to the above mentioned standard practices of educating patients, the use of an interactive app would lead to an increase in their acquisition of knowledge (perceived and actual) about their illness and treatment options. Additionally, there will be a relative increase in reported patient satisfaction concerning their level of knowledge and the amount of information available. It was also hypothesized that using the interactive app would positively inuuence patients' general satisfaction with consultations and their conUdence in the treatment choices they made." 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 brieuy explain why the item is not applicable/relevant for your study "Patients who considered participation were controlled and randomly assigned by a computer to either a control or app group as soon as they were registered in the online system by the hospital staff. Participants were not informed of which group they were assigned to, although both groups received an email with all the information about the study." subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants 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 brieuy explain why the item is not applicable/relevant for your study No changes were made after trial commencement 3b-i) Bug Uxes, Downtimes, Content Changes Bug Uxes, 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 Uxes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have inuuenced 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 brieuy explain why the item is not applicable/relevant for your study N/A 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 brieuy explain why the item is not applicable/relevant for your study "The eligibility of patients was assessed during their Urst contact with the hospital to schedule their appointment with the orthopedic surgeon. Participants were required to be uuent in Dutch and in the possession of an email address and a smart phone or tablet. At least ten days between scheduling the appointment and the hospital visitation were required, to give patients in the app group the chance to experience the intervention." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4a-i) Computer / Internet literacy Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clariUed.
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 brieuy explain why the item is not applicable/relevant for your study "Participants were required to be uuent in Dutch and in the possession of an email address and a smart phone or tablet". Also patients mobile device proUciency was assessed using the Mobile Device ProUciency Questionnaire (MDPQ16) 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. otine), 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 conUrmation, 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 brieuy explain why the item is not applicable/relevant for your study "The eligibility of patients was assessed during their Urst contact with the hospital to schedule their appointment with the orthopedic surgeon" and "Patients who considered participation were controlled and randomly assigned by a computer to either a control or app group as soon as they were registered in the online system by the hospital staff." 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 brieuy explain why the item is not applicable/relevant for your study "both groups received an email with all the information about the study. From this email, patients who chose to participate in the study could directly give their online informed consent and Ull out a baseline questionnaire" 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 brieuy explain why the item is not applicable/relevant for your study "Six hospitals (four non-academic teaching hospitals, one general hospital, and one specialized orthopedic clinic) were selected. Adult patients (40 years or older), referred by their general practitioner (GP) with knee complaints due to OA were asked to participate in the study between April to September 2017." 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 brieuy explain why the item is not applicable/relevant for your study "Both concepts were measured using self-report questionnaires which were designed speciUcally for this study." 4b-ii) Report how institutional ajliations are displayed Report how institutional ajliations are displayed to potential participants [on ehealth media], as ajliations 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 suTcient details to allow replication, including how and when they were actually administered 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 brieuy explain why the item is not applicable/relevant for your study Patients called the hospital to schedule their appointment with the orthopedic surgeon, at that point the study was introduced. None of the participating hospitals displayed any information about the study on their website or in the clinic.

5-i) Mention names, credential, ajliations of the developers, sponsors, and owners
Mention names, credential, ajliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conuict 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 brieuy explain why the item is not applicable/relevant for your study "In this study the Patient Journey App (Interactive Studios, Rosmalen, The Netherlands) was used as the intervention". This information is also displayed in the CoI section: "The principal investigator, Thomas Timmers, is one of the cofounders of Interactive Studios. Interactive Studios is the company that developed the application used in this study." essential 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.
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 brieuy explain why the item is not applicable/relevant for your study No, the app is already available for 2 years. All the functionality and mechanisms that were utilised during the study were already available.

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 brieuy explain why the item is not applicable/relevant for your study "During the study no major changes or revisions to the app took place. " 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 brieuy explain why the item is not applicable/relevant for your study It is nog addressed speciUcally in the paper. The app is available for over 2 years now, at over 40 hospitals. Its software lifecycle, from development to testing and releasing is part of the standard routine of the developing company.

5-v)
Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing uowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing uowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiUc 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 brieuy explain why the item is not applicable/relevant for your study There is a lengthy description of the intervention, the content and the mechanisms used. Also Ugure 1 displays examples of the intervention itself.

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 brieuy explain why the item is not applicable/relevant for your study All the content that was created for the app has been transferred to the participating hospitals.

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 speciUc 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 brieuy explain why the item is not applicable/relevant for your study "Patients allocated to the app group, received an additional email after completing the baseline questionnaire. This email contained download instructions for the app, a Google Play and Apple App Store download link, and the patients' personal code. " 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 brieuy explain why the item is not applicable/relevant for your study Several factors, some of which are dijcult to change, contribute to poor memory acquisition, including: patient age, patient level of education, the fact that too much information is provided in too little time, and that is likely exasperated by doctors' busy schedules and their dijcult use of language and jargon. On the other hand, there are numerous factors that can positively inuuence patient recall. For example, subdividing the delivery of information and the explicit categorization of content. Furthermore, the usage of questions and feedback to test (and reuect) patients' knowledge as well as, the speciUc modality of information transmission contribute to patient recall of medical information. Indeed, people tend to remember 20% auditory information, 40% of read information, and up to 80% of information acquired from interactive education. And "In this study the Patient Journey App (Interactive Studios, Rosmalen, The Netherlands) was used as the intervention. By using push notiUcations, we actively offered patients information about knee OA, (conservative and operative) treatment options, risks, rehabilitation, and expectancies in a subdivided (daily) and categorized (per theme) manner. Information was presented on an interactive timeline using text, photos, and video content (Figure 1). Interactive quiz-like questions were used to test their knowledge, providing direct feedback on the given answer."

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 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 brieuy explain why the item is not applicable/relevant for your study "Patients used the app in the seven days prior to the Urst consultation with their orthopedic surgeon. Push-notiUcations were sent daily at 10:00 AM"

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21generalizability).
Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieuy explain why the item is not applicable/relevant for your study Patients received an email with the download instructions for the app.

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 de6ned pre-speci6ed 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 brieuy explain why the item is not applicable/relevant for your study "Both groups simultaneously received the same questionnaires again on two separate occasions: 2 days prior to the arranged consultation and one day after the consultation. Per questionnaire, a maximum of two email reminders was sent. " 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 brieuy explain why the item is not applicable/relevant for your study "This email contained download instructions for the app, a Google Play and Apple App Store download link, and the patients' personal code. " 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 brieuy explain why the item is not applicable/relevant for your study "The primary outcome measure was patient knowledge about the illness and the available treatment options. We divided knowledge into 2 concepts: perceived available treatment options. We divided knowledge into 2 concepts: perceived knowledge (i.e., how much do patients think they know) and actual knowledge (i.e., how much do the patients actually know). Both concepts were measured using self-report questionnaires which were designed speciUcally for this study, addressing the earlier mentioned Uve most important topics for the Urst consultation. In the perceived knowledge questionnaire, patients received 5 questions, with answers ranging from 1 (no knowledge at all) to 5 (best imaginable knowledge). The perceived knowledge questionnaire had a sum score ranging from 5 to 25. Perceived knowledge was measured at baseline and two days before the consultation ( Table 1). The actual knowledge questionnaire required patients to answer 12 questions, each ranging from 0 (incorrect answer) to 3 points (correct answer). The absolute knowledge questionnaire had a sum score range from 0 to 36. Actual knowledge was measured only once, two days before the consultation." And "As secondary outcomes, we assessed patients' satisfaction with the provided information, satisfaction with their level of knowledge, and their need for more information. This questionnaire was developed for this trial. Numeric Rating Scale (NRS) scores were used to measure these outcomes. Questions concerning satisfaction had a range from 0 (not satisUed at all) to 10 (very satisUed). Questions concerning the need for more information had a range from 0 (no need at all) to 10 (very much in need of). Satisfaction and the need for more information were measured at baseline and two days before the consultation. Furthermore, one day after the consultation, we measured overall satisfaction with the consultation with an NRS score from 0 (not satisUed at all) to 10 (very satisUed). We also determined the level at which patients felt they had made a decision about their treatment together with their physician with a NRS score, ranging from 0 (strongly disagree) to 10 (strongly agree). Furthermore, the following items were measured: the type of treatment chosen (conservative, operative, I don't know), how sure patients were about their choice (NRS, from 0 (not sure at all) to 10 (very sure)) and whether their complaints were, in the end, actually due to knee osteoarthritis (yes, no, I don't know). All tertiary outcomes were measured one day after the consultation. This questionnaire was developed for this trial. We also translated the mobile device proUciency questionnaire into Dutch ("Since a Dutch version of this questionnaire was not available, it was translated from English to Dutch by three researchers independently. After reaching a consensus about the Dutch translation, it was translated back into English by a certiUed translation agency. No major differences to the original version were identiUed").
We created some of the questionnaires in corporation with surgeons from different hospitals ("The content for the app was compiled based on the input of 10 orthopedic surgeons from various hospitals, the Dutch option grid for knee osteoarthritis, [29] and information booklets from three participating hospitals. The Uve most important topics, as agreed upon by the surgeons, were: 1) knee anatomy and the origin of the complaints, 2) different types of conservative and operative treatments, 3) risks of surgery, 4) rehabilitation after total knee replacement, and 5) expectations after total knee replacement. These topics also formed the base for the questionnaires addressing perceived and actual knowledge. ") 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was deUned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was deUned/measured/monitored (logins, logUle analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial. Copy and paste relevant sections from manuscript text "Patients used the app in the seven days prior to the Urst consultation with their orthopedic surgeon. Push-notiUcations were sent daily at 10:00 AM".
And "In our study, the median number of times patients viewed the information in the week prior to the consultation was 25 (Q1-Q3: 12-39). Sending push notiUcations had a direct effect on usage of the app in terms of patients opening the app, viewing information, watching a video or answering a quiz-like question." 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text Your 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 brieuy explain why the item is not applicable/relevant for your study There were no changes to the trial outcomes after the trial had commenced 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 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.
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 brieuy explain why the item is not applicable/relevant for your study "A priori sample size calculation (α = 0.05, (1-β) = 0.80) based on a reported difference of 11.7% in knowledge between orthopedic patients using a decision aid or not [31] resulted in a minimum requirement of 83 patients in each studyarm. Our primary analysis was conducted using an intention-to-treat approach, and therefore included all randomized patients. " 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 brieuy explain why the item is not applicable/relevant for your study N/A 31-03-18 14(03 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Pagina 33 van 56 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oi…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 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 brieuy explain why the item is not applicable/relevant for your study "Patients who considered participation were controlled and randomly assigned by a computer to either a control or app group as soon as they were registered in the online system by the hospital staff. " 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 brieuy explain why the item is not applicable/relevant for your study There was nog restriction to the randomisation. 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 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 brieuy explain why the item is not applicable/relevant for your study "Patients who considered participation were controlled and randomly assigned by a computer to either a control or app group as soon as they were registered in the online system by the hospital staff. " 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 brieuy explain why the item is not applicable/relevant for your study "Patients who considered participation were controlled and randomly assigned by a computer to either a control or app group as soon as they were registered in the online system by the hospital staff. " 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).

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address 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 brieuy explain why the item is not applicable/relevant for your study "blinded for the treating physician".
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 brieuy explain why the item is not applicable/relevant for your study In the information letter the patients received, it was clearly stated that the control group would receive standard care (e.g. information through website or brochure) and patients randomised to the intervention group would receive access to the app.
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 brieuy explain why the item is not applicable/relevant for your study N/A 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 brieuy explain why the item is not applicable/relevant for your study "Our primary analysis was conducted using an intention-to-treat approach, and therefore included all randomized patients. Normally distributed continuous variables were presented as a mean value with the standard deviation (SD) and statistically compared between the groups using independent Student T-tests. Non-normally distributed variables were presented as a median value (Mdn) with the interquartile range (IQR) and statistically compared between the groups using the Mann-Whitney U tests. Categorical variables were presented as number and percentage and compared between groups using Chi-square tests.
Within group differences were tested using paired Student T-tests in the case of normally distributed data or Wilcoxon Signed Rank tests in the case of nonparametric data. P values of ≤0.05 were assumed to indicate a signiUcant difference. A "per protocol" analysis was performed for all primary and secondary outcomes to also examine to the robustness of our main results. All data were analyzed using IBM SPSS Statistics for Macintosh, version 22.0, (Armonk, USA)." 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 brieuy explain why the item is not applicable/relevant for your study "Patients who missed the baseline measurement or both the follow-up questionnaires were registered as lost to follow-up. Patients whose email address was incorrectly recorded, and therefore did not receive an invitation, were registered as "email address unknown or incorrect." Neither were included in the analysis. " 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 brieuy explain why the item is not applicable/relevant for your study N/A, there were no signiUcant differences in baseline characteristics.
subitem not at all important 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 brieuy explain why the item is not applicable/relevant for your study "Patients who were willing, received an email with all the necessary study information required for informed consent. Patients were offered at least two days to reuect on the information. In the case of any questions, patients were informed that they could contact the local research coordinator from each speciUc hospital by phone or email. Patients indicated their consent by signing an online informed consent form." 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 13b) For each group, losses and exclusions after randomisation, together with 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 brieuy explain why the item is not applicable/relevant for your study In the patient information letter, we have described the fact that using the intervention is not harmful, it might only beneUt patients since they receive the information through an additional channel.
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 brieuy explain why the item is not applicable/relevant for your study A patient CONSORT uow diagram is available in the ms Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT uow 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 brieuy explain why the item is not applicable/relevant for your study A patient CONSORT uow diagram is available in the ms 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 Ugures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the Ugure 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 brieuy explain why the item is not applicable/relevant for your study A patient CONSORT uow diagram is available in the ms 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 brieuy explain why the item is not applicable/relevant for your study "Between May and August 2017, a total of 307 patients considered participation in the study". 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signiUcant 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 brieuy explain why the item is not applicable/relevant for your study N/A, this did not happen during the study 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 brieuy explain why the item is not applicable/relevant for your study The trial stopped after we had included enough patients.
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 subitem not at all important 1 2 3 4 5 essential 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 brieuy explain why the item is not applicable/relevant for your study A table with patient characteristics at baseline is provided in the ms 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 brieuy explain why the item is not applicable/relevant for your study These items are available in the patiënt characteristics table 16-i) Report multiple "denominators" and provide deUnitions Report multiple "denominators" and provide deUnitions: 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 speciUc pre-deUned time points of interest (in absolute and relative numbers per group). Always clearly deUne "use" of the intervention.
subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con6dence interval) Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieuy explain why the item is not applicable/relevant for your study "Unfortunately, 22% of patients in the app group did not download the app, for unknown reasons. Perhaps the instructions were too complex, or the patients had trouble with the initial download from the App or Play Store. This demonstrates the necessity to offer support to patients for the initial usage of interventions like these. Nevertheless, the level of adherence was high (70%)." And "In our study, the median number of times patients viewed the information in the week prior to the consultation was 25 (Q1-Q3: 12-39). Sending push notiUcations had a direct effect on usage of the app in terms of patients opening the app, viewing information, watching a video or answering a quiz-like question.".

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 brieuy explain why the item is not applicable/relevant for your study Your answer subitem not at all important 1 2 3 4 5 essential 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 brieuy explain why the item is not applicable/relevant for your study "Our primary analysis was conducted using an intention-to-treat approach, and therefore included all randomized patients".
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 deUnitions 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 deUned (e.g., timeout after idle time) [1] (report under item 6a).
Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieuy explain why the item is not applicable/relevant for your study "Unfortunately, 22% of patients in the app group did not download the app, for unknown reasons. Perhaps the instructions were too complex, or the patients had trouble with the initial download from the App or Play Store. This demonstrates the necessity to offer support to patients for the initial usage of interventions like these. Nevertheless, the level of adherence was high (70%)." And "In our study, the median number of times patients viewed the information in the week prior to the consultation was 25 (Q1-Q3: 12-39). Sending push notiUcations had a direct effect on usage of the app in terms of patients opening the app, viewing information, watching a video or answering a quiz-like question.".
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-speci6ed from exploratory 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 brieuy explain why the item is not applicable/relevant for your study For the presentation of the absolute knowledge questionnaire (correct answer or not) the information is presented both as a relative and an absolute number 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 brieuy explain why the item is not applicable/relevant for your study "Patient Knowledge Acquisition: Two days prior to consultation, the app group had a 52% higher level of actual knowledge (app: Mean 26.4 (SD 7.4), control: Mean 17.4 (SD 6.8), P < 0.001) ( Figure 3 and Table 3). The level of perceived knowledge was 26% higher in the app group (app: Mean 16.5 (SD 3.9), control: Mean 13.0 (SD 4.1), P < 0.001).".
And "Comparison within groups revealed an increase in perceived knowledge in the app group (baseline: Mean 13.1 (SD 4.6), two days prior to consultation: Mean 16.5, SD 3.9, P < 0.001). This was not the case in the control group (baseline: Mean 13.5 (SD 4.1), two days prior to consultation: Mean 13.6 (SD 4.2), P = 0.778) (Figure 4)."

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 brieuy explain why the item is not applicable/relevant for your study Analysis based on the per protocol method also resulted in the main outcomes being in favor of the app group, albeit somewhat more pronounced ( 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 brieuy explain why the item is not applicable/relevant for your study N/A as we did not receive any feedback a part from the quantitative feedback we requested on for instance satisfaction with the information.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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).
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 brieuy explain why the item is not applicable/relevant for your study "In this study, we primarily investigated the possible effects of actively sending subdivided, categorized, and interactive information through an app on patients' knowledge of knee complaints and their treatment options. Additionally, patient satisfaction with provided information, knowledge, and the consultation were measured, as well as, patient self-reported conUdence in treatment choice". Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieuy explain why the item is not applicable/relevant for your study "Future research is needed to show the generalizability of this concept and to demonstrate the (long-term) effects of this intervention on the Unal choice patients made regarding their treatment, and the effect to which they were satisUed with this choice."

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.

21) Generalisability (external validity, applicability) of the trial 6ndings
NPT: External validity of the trial Undings according to the intervention, comparators, patients, and care providers or centers involved in the trial 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 brieuy explain why the item is not applicable/relevant for your study "Unfortunately, 22% of patients in the app group did not download the app, for unknown reasons. Secondly, we only included patients in possession of an email address and a smartphone or tablet. These criteria could limit the generalizability of the results. However, the majority of the sample did use email ( Finally, we did not consider individual preferences of patients regarding education on treatment options, nor their desire, or the lack of it, to participate in SDM. Earlier research has shown that some older people feel like "the doctor knows best" and that "their own knowledge is superuuous in the decisionmaking process"."

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 brieuy explain why the item is not applicable/relevant for your study "This study focused on patients being referred to an orthopedic surgeon by their GP with complaints indicating knee OA. We hypothesize that neither the illness or the (phase of the) treatment limits the extent to which this type of intervention could be useful in improving patient education. Future research is needed to show the generalizability of this concept and to demonstrate the (long-term) effects of this intervention on the Unal choice patients made regarding their treatment, and the effect to which they were satisUed with this choice." 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 brieuy explain why the item is not applicable/relevant for your study Now that the RCT has ended, hospitals can use the information from the app and the outcomes of the study as they wish, implementing it in routine care.
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 brieuy explain why the item is not applicable/relevant for your study The trial was approved by the regional Medical Ethical Board (Maxima Medisch Centrum, Eindhoven, The Netherlands), reference number N16.130. Also a trial number has been requested at the Netherlands Trial Registry but it is not yet available.
Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieuy explain why the item is not applicable/relevant for your study It is uploaded with the ms 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 brieuy explain why the item is not applicable/relevant for your study "Funding: None Financial support: Interactive Studios offered the application used in this study free of charge." X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (Unancial 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 brieuy explain why the item is not applicable/relevant for your study "The principal investigator, Thomas Timmers, is one of the co-founders of Interactive Studios. Interactive Studios is the company that developed the application used in this study. The co-authors declare that the research was conducted in the absence of any other commercial or Unancial relationships that could be construed as a potential conuict of interest. Moreover, all authors have completed the ICMJE uniform disclosure form " 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?
the fact that during the study no major changes or revisions were made to the app How much time did you spend on going through the checklist INCLUDING making changes in your manuscript *

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