The Role of Pain Duration and Pain Intensity on the Effectiveness of App-Delivered Self-Management for Low Back Pain (selfBACK): Secondary Analysis of a Randomized Controlled Trial

Background Clinical guidelines for nonspecific low back pain (LBP) recommend self-management tailored to individual needs and capabilities as a first-line treatment. Mobile health solutions are a promising method for delivering tailored self-management interventions to patients with nonspecific LBP. However, it is not clear if the effectiveness of such self-management interventions depends on patients’ initial pain characteristics. High pain intensity and long-term symptoms of LBP have been associated with an unfavorable prognosis, and current best evidence indicates that long-term LBP (lasting more than 3 months) requires a more extensive treatment approach compared to more acute LBP. The artificial intelligence–based selfBACK app supports tailored and evidence-based self-management of nonspecific LBP. In a recent randomized controlled trial, we showed that individuals who received the selfBACK app in addition to usual care had lower LBP-related disability at the 3-month follow-up compared to those who received usual care only. This effect was sustained at 6 and 9 months. Objective This study aims to explore if the baseline duration and intensity of LBP influence the effectiveness of the selfBACK intervention in a secondary analysis of the selfBACK randomized controlled trial. Methods In the selfBACK trial, 461 adults (18 years or older) who sought care for nonspecific LBP in primary care or at an outpatient spine clinic were randomized to receive the selfBACK intervention adjunct to usual care (n=232) or usual care alone (n=229). In this secondary analysis, the participants were stratified according to the duration of the current LBP episode at baseline (≤12 weeks vs >12 weeks) or baseline LBP intensity (≤5 points vs >5 points) measured by a 0-10 numeric rating scale. The outcomes were LBP-related disability measured by the Roland-Morris Disability Questionnaire (0- to 24-point scale), average LBP intensity, pain self-efficacy, and global perceived effect. To assess whether the duration and intensity of LBP influenced the effect of selfBACK, we estimated the difference in treatment effect between the strata at the 3- and 9-month follow-ups with a 95% CI. Results Overall, there was no difference in effect for patients with different durations or intensities of LBP at either the 3- or 9-month follow-ups. However, there was suggestive evidence that the effect of the selfBACK intervention on LBP-related disability at the 3-month follow-up was largely confined to people with the highest versus the lowest LBP intensity (mean difference between the intervention and control group −1.8, 95% CI −3.0 to −0.7 vs 0.2, 95% CI −1.1 to 0.7), but this was not sustained at the 9-month follow-up. Conclusions The results suggest that the intensity and duration of LBP have negligible influence on the effectiveness of the selfBACK intervention on LBP-related disability, average LBP intensity, pain self-efficacy, and global perceived effect. Trial Registration ClinicalTrials.gov NTC03798288; https://clinicaltrials.gov/study/NCT03798288 International Registered Report Identifier (IRRID) RR2-10.2196/14720

Approx. Percentage of Users (starters) still using the app as recommended after 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 four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o�ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "app-delivered self-management"

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
subitem not at all important 1 2 3 4 5 essential 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Svaret ditt 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study subitem not at all important Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "In a recent randomized controlled trial, we showed that individuals who received the SELFBACK app in addition to usual care had lower LBP-related disability at 3 months followup compared to those who received usual care only."; "To explore if baseline duration and intensity of LBP influence the effectiveness of the SELFBACK intervention in a secondary analysis of the SELFBACK randomized controlled trial."

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 brie�y explain why the item is not applicable/relevant for your study "The artificial intelligence-based SELFBACK app supports tailored and evidence-based selfmanagement" 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. o�ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials essential Does your paper address subitem 1b-iii? Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "adults (≥18 years) who sought care for non-specific LBP in primary care or at an outpatient spine clinic were randomized". Outcomes were measured by web-based questionnaires "Outcomes were LBP-related disability measured by the Roland Morris Disability Questionnaire...." 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "usual care (n=232) or usual care alone (n=229)", "there was no difference in effect for patients with different duration or intensity of LBP at either 3 or 9 months follow-up". Use/uptake not described here Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons.
(Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "The results suggest that the intensity and duration of LBP have negligible influence on the effectiveness of the SELFBACK intervention on LBP-related disability, average LBP intensity, pain self-efficacy and global perceived effect" subitem not at all important 1 2 3 4 5 essential 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) Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Clinical guidelines recommend self-management tailored to individual needs and capabilities as a first-line treatment of non-specific LBP. Supporting self-management by digital interventions, such as mobile apps, has been suggested as a viable approach to improve and reinforce self-management interventions"; "Previous studies have shown that high LBP intensity and long-term symptoms are associated with less favorable prognosis and poorer outcomes among patients in a primary care setting. Moreover, current best evidence indicates that LBP lasting >3 months requires a broader and more extensive treatment approach than acute or sub-acute LBP. It is therefore conceivable that baseline duration and intensity of LBP influence the effectiveness of digital and individually tailored self-management interventions for non-specific LBP, and such knowledge can assist clinicians in selecting patients best suited for this type of self-management support." subitem not at all important Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study See answer to item 2a-i above Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "In this secondary analysis of the SELFBACK RCT we therefore explore if baseline LBP intensity and duration of the current LBP episode influence the effectiveness of the SELFBACK intervention" CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS...

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 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "This secondary analysis is based on data from the SELFBACK multicenter RCT with two parallel arms"; "then randomized to the SELFBACK intervention or usual care (control group) in a 1:1 ratio using a computer-generated sequence stratified by country"; "The methods and primary results of the RCT have been published in previous studies and are only briefly described here" Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants 3b-i) Bug fixes, Downtimes, Content Changes Bug �xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug �xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in�uenced study design such as staff changes, system failures/downtimes, etc. [2].
Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "We recruited adults (≥18 years) with non-specific LBP who had consulted a primary care clinician (i.e., general practitioner, physiotherapist, or chiropractor) in the Trondheim Municipality in Norway or in the region of Southern Denmark, or who had undergone a clinical examination at an outpatient spine clinic (Spine Centre of Southern Denmark). Inclusion criteria were to have experienced LBP within the preceding 8 weeks, a score of mild to moderate LBP-related disability rated as 6 points or higher on the Roland-Morris Disability Questionnaire (RMDQ), having a smartphone, and access to email."; "Exclusion criteria were inability to carry out the intervention (i.e., mental or physical conditions that limited participation, inability to perform physical exercise, or problems with speaking, reading or understanding Danish or Norwegian), fibromyalgia, previous spinal surgery, current pregnancy, or current participation in other studies related to LBP."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari�ed.

Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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. o�ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con�rmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "We recruited adults (≥18 years) with non-specific LBP who had consulted a primary care clinician (i.e., general practitioner, physiotherapist, or chiropractor)". More details are available in the published protocol and main effect evaluation of the RCT.

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.

4b) Settings and locations where the data were collected
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

Svaret ditt
Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "in the Trondheim Municipality in Norway or in the region of Southern Denmark"

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.
subitem not at all important 1 2 3 4 5 essential 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "After giving informed consent, the participants completed a web-based questionnaire" 4b-ii) Report how institutional affiliations are displayed Report how institutional a�liations are displayed to potential participants [on ehealth media], as a�liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Mention names, credential, a�liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con�ict of interest" section or mentioned elsewhere in the manuscript).

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

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

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

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Svaret ditt 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/screencapture video, and/or providing �owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti�c reporting.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Svaret ditt

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci�c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "The intervention was delivered as an adjunct to usual care and has been described in detail in a previous study. In brief, participants randomized to the intervention group were instructed to install the SELFBACK app to their smartphone and to wear a step-detecting wristband (Mi Band 3, Xiaomi) connected to the app." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "The SELFBACK app contains three main components of self-management: recommendations of physical activity (i.e., number of steps), video instructions for strength and flexibility exercises, and daily educational content. Weekly self-management recommendations are provided for each component, and the recommendations are tailored to individual characteristics, symptoms, and progression by using the case-based reasoning methodology, a branch of knowledge-driven AI. The app also includes tools such as goal setting, mindfulness audios, pain-relieving exercises, and sleep reminders, as well as general educational content related to LBP. The participants received encouraging push notifications triggered by their self-management behavior to motivate and reinforce the desired behavior. The design, architecture, and functions of the SELFBACK system, as well as the development of the evidence-based content, have been described in detail in previous studies." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

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

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).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Svaret ditt

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 brie�y explain why the item is not applicable/relevant for your study "The participants received encouraging push notifications triggered by their selfmanagement behavior to motivate and reinforce the desired behavior. The design, architecture, and functions of the SELFBACK system, as well as the development of the evidence-based content, have been described in detail in previous studies" CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS...
subitem not at all important 1 2 3 4 5 essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 5-xii) Describe any co-interventions (incl. training/support) Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "The intervention was delivered as an adjunct to usual care and has been described in detail in a previous study" CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS...
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 brie�y explain why the item is not applicable/relevant for your study "Outcomes were LBP-related disability measured by the RMDQ (range 0-24, higher scores indicate higher LBP-related disability), average LBP intensity the preceding week measured on a numeric rating scale (NRS) by the question "Please indicate your average back pain level during the last week on a scale from 0 (no pain) to 10 (worst pain imaginable)", pain self-efficacy measured by the Pain Self-Efficacy Questionnaire (range 0-60, higher scores indicating greater confidence), and overall improvement measured by the Global Perceived Effect scale (range -5 ["very much worse"] to 5 ["very much better"]). Outcomes were measured at baseline, 6 weeks, 3 months, 6 months, and 9 months. Main outcome in the RCT was LBP-related disability measured by the RMDQ at 3 months follow-up. Outcomes were not completely prespecified for the secondary analyses of the current study.
6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].
Does your paper address subitem 6a-i? essential 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de�ned/measured/monitored (logins, log�le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text Svaret ditt 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

Svaret ditt
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS... 6b) Any changes to trial outcomes after the trial commenced, with reasons 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 Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Not applicable to this study on secondary outcomes 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 brie�y explain why the item is not applicable/relevant for your study

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CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS... 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 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Not applicable for this study Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "using a computer-generated sequence" and "The methods and primary results of the RCT have been published in previous studies and are only briefly described here." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS...

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 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "randomized to the SELFBACK intervention or usual care (control group) in a 1:1 ratio using a computer-generated sequence stratified by country (Norway or Denmark) and type of care provider (general practitioner, physiotherapist, chiropractor, or outpatient clinic)." and "The methods and primary results of the RCT have been published in previous studies and are only briefly described here." Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "using a computer-generated sequence" and "The methods and primary results of the RCT have been published in previous studies and are only briefly described here." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS... 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 brie�y explain why the item is not applicable/relevant for your study Not described in the current manuscript, but referred to previous publications from the trial "The methods and primary results of the RCT have been published in previous studies and are only briefly described here."

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 cointerventions (if any).

Does your paper address subitem 11a-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Not described in the current manuscript, but referred to previous publications from the trial "The methods and primary results of the RCT have been published in previous studies and are only briefly described here." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS...
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) 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

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Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study not relevant as comparator is usual care CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS... 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Intention-to-treat analysis was used to estimate mean group differences with 95% confidence intervals (CIs) from constrained longitudinal data analysis using a linear mixed model. In this model, the intervention and control group have a common baseline mean, and all follow-up time points are included in the analysis. Dependency between repeated measures was accounted for by including a random intercept for each subject. To assess whether duration and intensity of LBP modified the effect of the intervention we first estimated the stratified treatment effect (i.e., within each duration and intensity group) at 3 and 9 months and then calculated the between-group difference in treatment effect with 95% CI and associated P-value. All analyses were adjusted for the two variables used to stratify the randomization (i.e., country and care provider) as well as level of education (<10, 10-12, ≥12 years of schooling), gender (male, female), and age (years). Additionally, estimates stratified by LBP duration were adjusted for baseline LBP intensity the preceding week (continuous, 0-10 points), whereas estimates stratified by pain intensity were adjusted for duration of the current LBP episode measured at baseline (<1, 1-4, 5-12, >12 weeks) as well as average baseline LBP intensity (continuous, 0-10 points) (the latter adjustment accounted for variation in LBP intensity within the strata)." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS...
subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Intention-to-treat analysis was used to..." Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Svaret ditt

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained o�ine or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.
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 Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Svaret ditt

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study 13b) For each group, losses and exclusions after randomisation, together with reasons subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study " Figure 1: Flow of participants through the trial" 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 brie�y explain why the item is not applicable/relevant for your study " Figure 1: Flow of participants through the trial"

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

14a) Dates defining the periods of recruitment and follow-up
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the �gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

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Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Participants were recruited from March 8th to December 14th, 2019." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi�cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 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, quali�cation, expertise, etc.) and centers (volume) in each group Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

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Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Not applicable for this study Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study " Table 1 shows baseline characteristics of the study participants..." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS...

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 brie�y explain why the item is not applicable/relevant for your study " Table 1 shows baseline characteristics of the study participants..."

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide de�nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci�c pre-de�ned time points of interest (in absolute and relative numbers per group). Always clearly de�ne "use" of the intervention. Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Not reported in this manuscript, but published previously

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

Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study online supplement Table 1 and 2 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de�nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de�ned (e.g., timeout after idle time) [1] (report under item 6a).
Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Not applicable for this study Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Not applicable for this study

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

19) All important harms or unintended effects in each group
(for speci�c 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 brie�y explain why the item is not applicable/relevant for your study 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 brie�y explain why the item is not applicable/relevant for your study ""For participants with high LBP intensity at baseline there was a larger difference between the control and the SELFBACK group than for those with lower pain intensity. However, the numerical differences were small and with confidence intervals that included the null value."

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Svaret ditt

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 brie�y explain why the item is not applicable/relevant for your study The current study is a subgroup study of the primary RCT, and the limitations described in this paper is related to the design of the subgroup analyses. Elaboration on the limitation in ehealth trials is elaborated on in the primary RCT publication: doi:10.1001/jamainternmed.2021.4097 21) Generalisability (external validity, applicability) of the trial findings

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Svaret ditt 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 cointerventions) 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.

25)
Sources of funding and other support (such as supply of drugs), role of funders X27) Conflicts of Interest (not a CONSORT item) subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study The full trial protocol, describing the RCT can be accessed here; https://www.researchprotocols.org/2019/12/e14720/. Trial protocol for the current subgroup study have not been published.
Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "This project has received funding from the European Union Horizon 2020 research and innovation programme under grant agreement No. 689043".

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (�nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention. STOP -Save this form as PDF before you click submit To generate a record that you �lled 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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