Acceptance and Commitment Therapy Delivered via a Mobile Phone Messaging Robot to Decrease Postoperative Opioid Use in Patients With Orthopedic Trauma: Randomized Controlled Trial

Background Acceptance and commitment therapy (ACT) is a pragmatic approach to help individuals decrease avoidable pain. Objective This study aims to evaluate the effects of ACT delivered via an automated mobile messaging robot on postoperative opioid use and patient-reported outcomes (PROs) in patients with orthopedic trauma who underwent operative intervention for their injuries. Methods Adult patients presenting to a level 1 trauma center who underwent operative fixation of a traumatic upper or lower extremity fracture and who used mobile phone text messaging were eligible for the study. Patients were randomized in a 1:1 ratio to either the intervention group, who received twice-daily mobile phone messages communicating an ACT-based intervention for the first 2 weeks after surgery, or the control group, who received no messages. Baseline PROs were completed. Two weeks after the operative intervention, follow-up was performed in the form of an opioid medication pill count and postoperative administration of PROs. The mean number of opioid tablets used by patients was calculated and compared between groups. The mean PRO scores were also compared between the groups. Results A total of 82 subjects were enrolled in the study. Of the 82 participants, 76 (38 ACT and 38 controls) completed the study. No differences between groups in demographic factors were identified. The intervention group used an average of 26.1 (SD 21.4) opioid tablets, whereas the control group used 41.1 (SD 22.0) tablets, resulting in 36.5% ([41.1-26.1]/41.1) less tablets used by subjects receiving the mobile phone–based ACT intervention (P=.004). The intervention group subjects reported a lower postoperative Patient-Reported Outcome Measure Information System Pain Intensity score (mean 45.9, SD 7.2) than control group subjects (mean 49.7, SD 8.8; P=.04). Conclusions In this study, the delivery of an ACT-based intervention via an automated mobile messaging robot in the acute postoperative period decreased opioid use in selected patients with orthopedic trauma. Participants receiving the ACT-based intervention also reported lower pain intensity after 2 weeks, although this may not represent a clinically important difference. Trial Registration ClinicalTrials.gov NCT03991546; https://clinicaltrials.gov/ct2/show/NCT03991546

yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one or more outcomes inconclusive: more research is needed Other: Approx. Percentage of Users (starters) still using the app as recommended after 3 months * intervention is only for 2 weeks following surgery. Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Delivered via a mobile phone messaging robot"

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").

Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "postoperative opioid utilization in orthopaedic trauma patients"

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT
Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "the intervention group, who received twice-daily mobile phone messages communicating an ACT-based intervention for the first two weeks after surgery, or the control group, who received no messages" 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 briefly explain why the item is not applicable/relevant for your study Your answer subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 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)

INTRODUCTION 2a) In INTRODUCTION: Scientific background and explanation of rationale
Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Eighty-two subjects were enrolled in the study. Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 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 briefly explain why the item is not applicable/relevant for your study "Public health concerns regarding opioid medications persist and healthcare systems are currently seeking solutions to the ongoing epidemic [1]." "Acceptance and Commitment Therapy (ACT) is a specific behavior therapy that employs a pragmatic approach to help individuals decrease avoidable suffering and live according to self-identified personal values [11,12]. " "Acceptance and Commitment Therapy has proven to be effective across multiple studies and patient populations in the treatment of pain [13]. Several studies report a high value for ACT in the management of chronic pain when compared to standard pharmacological treatment alone [13][14][15][16]." "However, traditional ACT interventions have required a clinic based, interdisciplinary team approach, which is not always feasible for both patients and healthcare systems [17,18]." "Evolving communication methods, such as automated mobile phone messaging [4,[19][20][21], for healthcare purposes are increasingly important as patients prefer these communication methods for delivering and receiving medical information [22]." "Healthcare teams caring for patients with traumatic orthopaedic injuries have traditionally utilized opioid medication in the post-operative setting and these patients are at risk for prolonged opioid utilization in the postoperative period. We theorized the combination of ACT delivered via automated mobile phone messaging may help to decrease pain and opioid utilization in the acute postoperative setting. The aim of this prospective randomized controlled trial was to evaluate the effectiveness of ACT delivered via an automated mobile messaging robot on (1) decreasing early postoperative opioid utilization and (2) pain-related patient reported outcomes (PROs) in the first two weeks following surgery for acute, traumatic orthopaedic injuries." 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 briefly explain why the item is not applicable/relevant for your study "Additionally, every week of continued opioid utilization represents an increased risk of eventual misuse by patients [3]. Previous studies have found orthopaedic trauma patients utilize a decreasing amount of opioid medication in the first two postoperative weeks with six to fifteen days being the optimal opioid utilization period [4,5]. In line with these findings, previous studies have utilized a two-week postoperative period to assess opioid medication consumption in surgical patients [4]." " [11]. Acceptance and Commitment Therapy has proven to be effective across multiple studies and patient populations in the treatment of pain [13]. Several studies report a high value for ACT in the management of chronic pain when compared to standard pharmacological treatment alone [13][14][15][16]." "Software driven, automated mobile phone messaging robots are low cost tools that can deliver predefined text-based information and receive incoming responses with high reliability when patients either prefer or it is necessary to communicate at distance [19,23]. This technology demonstrates high efficacy as part of the treatment of conditions ranging from hypertension to substance abuse [24][25][26], and also has proved effective in increasing perioperative communication after hip and knee arthroplasty [27],and collecting pain and opioid medication data from patients following orthopaedic trauma and hand procedures [4,19]." 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 briefly explain why the item is not applicable/relevant for your study "The aim of this prospective randomized controlled trial was to evaluate the effectiveness of ACT delivered via an automated mobile messaging robot on (1) decreasing early postoperative opioid utilization and (2) pain-related patient reported outcomes (PROs) in the first two weeks following surgery for acute, traumatic orthopaedic injuries." Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were randomized into either the control or intervention group using a standard online random number generator with a range set from 1 to 10 and a 1:1 ratio by a research assistant. Due to the nature of this study, subjects and the enrolling research assistant were not blinded to the participant's study group following randomization" subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Adults presenting to a university hospital level 1 trauma center indicated for operative fixation of a traumatic upper or lower fracture were considered for the study (Table 2). Exclusion criteria are listed in Table 3. Eligible patients were approached prior to surgery by a research assistant in a private room. Individuals not excluded by screening questions and interested in participating underwent the informed consent process (Table 3). " "One-hundred and twenty-five individuals were approached regarding the study over the fivemonth enrollment period between February and June 2019. Two patients were excluded at this time as they were non-English-speaking, and an additional 24 were excluded due to not utilizing mobile phone messaging or not having a personal mobile phone. This resulted in a total of 99 eligible people who were presented the study, 17 of which declined participation ( Figure 1). Eighty-two subjects were enrolled, and six dropped from the study after providing consent due to various issues: one lost to follow-up, one withdrew at follow-up, one had incomplete follow-up, one operative plan changed to arthroplasty, and two subjects remained inpatient for over 7 days of the study period ( Figure 1). "

3b-i) Bug fixes, Downtimes, Content Changes
Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].
Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 4a) Eligibility criteria for participants subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Adults presenting to a university hospital level 1 trauma center indicated for operative fixation of a traumatic upper or lower fracture were considered for the study (Table 2). Exclusion criteria are listed in Table 3. Eligible patients were approached prior to surgery by a research assistant in a private room. Individuals not excluded by screening questions and interested in participating underwent the informed consent process (Table 3)."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 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. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Adults presenting to a university hospital level 1 trauma center indicated for operative fixation of a traumatic upper or lower fracture were considered for the study (Table 2). "

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 briefly explain why the item is not applicable/relevant for your study "Eligible patients were approached prior to surgery by a research assistant in a private room. Individuals not excluded by screening questions and interested in participating underwent the informed consent process (Table 3). During consent, all subjects were informed of the outcomes of interests, different study arms, and that no changes would be made to their care in terms of postoperative medication, regardless of study participation. " Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The study was performed at single center university hospital in Iowa City, IA, USA. "

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 briefly explain why the item is not applicable/relevant for your study "At the time of consent subjects were required to complete paper forms comprising a basic demographics questionnaire and baseline PROs consisting of the Patient-Reported Outcome Measure  Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 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, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).

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

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

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

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

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 briefly explain why the item is not applicable/relevant for your study Your answer subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer

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

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This item is not applicable to the study because subjects were enrolled into an automated unidirectional mobile phone messaging application at the time of consent. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The intervention group received twice-daily, text based mobile messages communicating an ACT-based intervention for the first two weeks following surgery (Multimedia Appendix 2). Control group subjects did not receive the ACT intervention or any other form of mobile message communications. The mobile messaging ACT protocol consisted of twice per day mobile messages, morning and evening, starting on postoperative day (POD) one and ending on POD 14. These mobile phone messages provided participants with an ACT-based intervention that was developed in collaboration with a pain psychologist (VK) specializing in ACT for chronic pain. These messages utilized all the principles presented in Table 1 with the objective of helping recipients understand and develop better coping skills in relation to their postoperative pain. An example message from Day 1 is below: "Maintaining focus on what you value most in life is sometimes difficult after surgery. Do not let the momentary discomforts due to surgery take away from what you want most in life. Pick 3 things that matter most to you in life. Remind yourself of these 3 things you value most during your recovery process." Outside of the mobile messaging intervention, both groups received the same standard postoperative care, healthcare team communications, and instructions for completing study follow-up. "

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

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

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

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study this is not applicable as the mobile phone messages themselves contained the intervention and did not require that patients access another application.No reminders for maintaining pill counts were included in the study protocol.
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 briefly explain why the item is not applicable/relevant for your study This study had no co-interventions including training as the study only involved standard mobile phone messaging. Subjects falling under the categories of "No personal mobile phone with text messaging capabilities" or "Poor familiarity reading or sending mobile messages" were excluded from study participation.
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Baseline PROs were completed. Two weeks after operative intervention, follow-up was obtained in the form of an opioid medication pill count and postoperative administration of PROs. Mean number of opioid tablets utilized by patients were calculated and compared between groups. Mean PRO scores were also compared between groups." "At the time of consent subjects were required to complete paper forms comprising a basic demographics questionnaire and baseline PROs consisting of the Patient-Reported Outcome Measure Information System (PROMIS) Pain Intensity 1A Short form, PROMIS Pain Intensity 3A Short form, PROMIS Pain Interference 8A Short form, and PROMIS Emotional Distress-Anxiety 8A Short form. Following completion of all PROs, participants were then randomized to their study group. " "The primary outcomes for this study was the amount of opioid pain medication consumed by subjects, and secondary outcomes analyzed were net change from baseline PRO scores at two-week follow-up. " "The method that participants employed to report their opioid medication consumption, and how PROs were captured during follow-up was recorded (Table 4). Subjects using their pill bottle to confirm the remaining number of opioid pain medication tablets from their discharge prescription on POD 14 were denoted as reporting a pill count. Cases where subjects or their care facility kept a log of tablet consumption were classified as reporting a daily log. Subjects reporting the number of tablets they used without the use of a log or pill count were designated as providing an estimate. " 7b) When applicable, explanation of any interim analyses and stopping guidelines Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This is not relevant to our study as there were no changes to trial outcomes after the trial commenced.

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 briefly explain why the item is not applicable/relevant for your study Your answer 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 briefly explain why the item is not applicable/relevant for your study This is not relevant to our study as no analysis were conducted outside of the two data collection points and we provided no specific stopping guidelines as participants could choose to remove consent at any time per our informed consent document.

Does your paper address CONSORT subitem 8a? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were randomized into either the control or intervention group using a standard online random number generator with a range set from 1 to 10 and a 1:1 ratio by a research assistant. Due to the nature of this study, subjects and the enrolling research assistant were not blinded to the participant's study group following randomization." Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were randomized into either the control or intervention group using a standard online random number generator with a range set from 1 to 10 and a 1:1 ratio by a research assistant. Due to the nature of this study, subjects and the enrolling research assistant were not blinded to the participant's study group following randomization." 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 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "At the time of consent subjects were required to complete paper forms comprising a basic demographics questionnaire and baseline PROs consisting of the Patient-Reported Outcome Measure Information System (PROMIS) Pain Intensity 1A Short form, PROMIS Pain Intensity 3A Short form, PROMIS Pain Interference 8A Short form, and PROMIS Emotional Distress-Anxiety 8A Short form. Following completion of all PROs, participants were then randomized to their study group." Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Eligible patients were approached prior to surgery by a research assistant in a private room. Individuals not excluded by screening questions and interested in participating underwent the informed consent process (Table 3). During consent, all subjects were informed of the outcomes of interests, different study arms, and that no changes would be made to their care in terms of postoperative medication, regardless of study participation. " "Participants were randomized into either the control or intervention group using a standard online random number generator with a range set from 1 to 10 and a 1:1 ratio by a research assistant. " "Subjects who received an odd number from the 1-10 range set on the random number generator were placed in the intervention group, while subjects given an even number were placed in the control group. " 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 subitem not at all important 1 2 3 4 5 essential 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

Does your paper address subitem 11a-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Due to the nature of this study, subjects and the enrolling research assistant were not blinded to the participant's study group following randomization." 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".

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "During consent, all subjects were informed of the outcomes of interests, different study arms, and that no changes would be made to their care in terms of postoperative medication, regardless of study participation. " Participants were aware there was only one intervention.

Does your paper address CONSORT subitem 11b? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This does not apply to this study as there is only a single intervention and subjects in the control group did not receive any mobile phone messages.
subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "To evaluate whether the intervention versus control group had a lower opioid utilization on average, we determined the number of tabs and MME taken in each group and compared means using t-tests. " "A separate power analysis was calculated for the PRO portion of the study and determined a total of 36 subjects would provide 80% power to detect a ten-point difference (1 standard deviation) in t-scores for the PROMIS instruments at an alpha level of .05. Statistical analyses were performed using SAS software version 9.4 (SAS Institute, Inc., Cary, NC)."

12a-i) Imputation techniques to deal with attrition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Eighty-two subjects were enrolled, and six dropped from the study after providing consent due to various issues: one lost to follow-up, one withdrew at follow-up, one had incomplete follow-up, one operative plan changed to arthroplasty, and two subjects remained inpatient for over 7 days of the study period (Figure 1). This resulted in a final population 76 subjects (38 per study group). The enrollment period concluded once a powered sample for the primary aim was obtained. "

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participant characteristics were described using mean± standard deviation (SD) or median (min-max) for continuous variables and frequencies (percentages) for categorical variables. Visual review of histograms and results of the Shapiro-Wilk test of continuous variables revealed only age and body mass index (BMI) were not normally distributed. Between group differences were evaluated using t-tests or Wilcoxon Rank Sum Tests (age and BMI) for continuous variables and chi-square or exact tests for categorical variables, as appropriate."

X26-i) Comment on ethics committee approval
Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This randomized controlled trial was registered with ClinicalTrials.gov (NCT03991546) and reporting is consistent with CONSORT guidelines (Multimedia Appendix 1 Does your paper address subitem X26-ii? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Eligible patients were approached prior to surgery by a research assistant in a private room. Individuals not excluded by screening questions and interested in participating underwent the informed consent process (Table 3). During consent, all subjects were informed of the outcomes of interests, different study arms, and that no changes would be made to their care in terms of postoperative medication, regardless of study participation. "

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study These procedures are explained during the informed consent process and not described in the manuscript .

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "One-hundred and twenty-five individuals were approached regarding the study over the fivemonth enrollment period between February and June 2019. Two patients were excluded at this time as they were non-English-speaking, and an additional 24 were excluded due to not utilizing mobile phone messaging or not having a personal mobile phone. This resulted in a total of 99 eligible people who were presented the study, 17 of which declined participation (Figure 1). Eighty-two subjects were enrolled, and six dropped from the study after providing consent due to various issues: one lost to follow-up, one withdrew at follow-up, one had incomplete follow-up, one operative plan changed to arthroplasty, and two subjects remained inpatient for over 7 days of the study period ( Figure 1). This resulted in a final population 76 subjects (38 per study group)." subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "One-hundred and twenty-five individuals were approached regarding the study over the fivemonth enrollment period between February and June 2019. Two patients were excluded at this time as they were non-English-speaking, and an additional 24 were excluded due to not utilizing mobile phone messaging or not having a personal mobile phone. This resulted in a total of 99 eligible people who were presented the study, 17 of which declined participation (Figure 1). Eighty-two subjects were enrolled, and six dropped from the study after providing consent due to various issues: one lost to follow-up, one withdrew at follow-up, one had incomplete follow-up, one operative plan changed to arthroplasty, and two subjects remained inpatient for over 7 days of the study period (Figure 1)."

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

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "One-hundred and twenty-five individuals were approached regarding the study over the fivemonth enrollment period between February and June 2019." "The primary outcome for this study was the amount of opioid pain medication consumed by subjects, and secondary outcomes analyzed were net change from baseline PRO scores at two-week follow-up. " 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This trial was not stopped early. Enrollment for the trial was stopped once the powered sample of follow-ups had been achieved. The remaining few subjects without completed follow-up at that time were still utilized in the analysis, which is why we had 76 subjects instead of the powered sample of 74 needed. analysis and whether the analysis was by original assigned groups Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study These are all provided in table format within the manuscript. " Table 4: Comparison of subject demographics by enrolled study group"

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This trial utilized subjects who were familiar and comfortable with mobile phone messaging. No further digital divide issues were assessed in terms of internet or computer literacy. Demographics such as age and sex were included in the analysis.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Areas where multiple denominators could exist, such as in the demographics comparison, contained footnotes to clarify if the enrolled or final study population denominator was used. Table 4 footnote: "Data calculated using final study population only (N=38)." All available data collected was utilized for analysis, except in the case of follow-up data from patients who were determined ineligible after enrollment.

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 briefly explain why the item is not applicable/relevant for your study Your answer 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 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 briefly explain why the item is not applicable/relevant for your study "Utilizing a previous study of opioid medication usage in orthopaedic trauma patients [4], the sample size estimated to observe a 30% decrease in opioid utilization among two groups required a total of 74 subjects to achieve 80% power at an alpha of .05. " "A separate power analysis was calculated for the PRO portion of the study and determined a total of 36 subjects would provide 80% power to detect a ten-point difference (1 standard deviation) in t-scores for the PROMIS instruments at an alpha level of .05. " The precision of the effect size and its validity is based on the power analysis. This intervention is an adjunct to operative treatment .

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

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory 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 briefly explain why the item is not applicable/relevant for your study No binary outcomes were present in 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 briefly explain why the item is not applicable/relevant for your study No subgroup or adjusted analysis were performed in 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 specific guidance see CONSORT for harms) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study All effects observed by the research team, reported by healthcare treatment teams, and, and by study participants were reported in the study. No harmful effects, including privacy breaches were reported during the study .

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].

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

Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This randomized trial delivered an ACT-based intervention via an automated mobile messaging robot to post-operative orthopaedic patients. The subjects who received the ACT-based mobile phone intervention utilized a lower number of opioid tablets and consumed less MME in the first two weeks after their injury. We also found the intervention group reported less pain intensity and pain interference at two-week follow-up. This data demonstrates that ACT-based automated mobile messaging protocols may be effective in reducing the amount of opioid medication utilized and may positively affect postoperative PROs in patients undergoing operative fixation of their acute fractures. " "In this study we utilized ACT and a mobile phone messaging robot to assess whether these tools in combination could decrease opioid utilization and improve individual's perception of their early recovery from injury. Prior work has demonstrated a quicker time to opioid cessation and a decrease in postoperative opioid utilization (14% less in the ACT group) when utilizing in office ACT based treatments [17,18]. Subjects receiving the ACT intervention via automated mobile phone message reported over 36% less opioid tablets and more than 34% less MME consumed than corresponding control subjects who did not receive ACT. Our findings suggest that software-based communication utilizing ACT through a mobile phone has the potential to have a large impact on utilization of postoperative pain medication by patients in the first weeks after surgery for fractures. Further study is required to determine if these effects are long lasting and to determine which injuries and patients get the greatest benefit. " Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Further study is required to determine if these effects are long lasting and to determine which injuries and patients get the greatest benefit. In addition, future investigations and trials should consider the effect of software delivery of ACT and other behavioral therapies on different cohorts of patients. " "Future research efforts may benefit from employing alternative PRO measures to identify the effects of ACT-based interventions including assessment of psychologic flexibility. Future research may also consider possible modification of our study protocol to include a longer intervention period and more than one follow-up data point. Future work may also consider designing an ACT based tool that is more focused on demonstrating an effect on PROs. "

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 findings
NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Several limitations were present in this study. First, we were limited to a single Level 1 trauma center, which may affect the reproducibility of our results across other healthcare settings. Next, the exclusion criteria for this study were extensive, and thus the results may not be generalizable to the entire scope of orthopaedic trauma patients. We attempted to include a diverse set of injuries and yet exclude patients with a high likelihood of confounding problems from open fractures or prolonged initial hospitalization. Future studies assessing the effects of ACT-based interventions like ours should aim for less restrictive exclusion criteria to apply this intervention to a larger, more diverse population. The research assistants were not blinded to the patient's study group. Additionally, patients understood the outcomes of interest in this study which could be susceptible to reporting bias. In addition, participants were not blinded to their treatment group."

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 subitem not at all important 1 2 3 4 5 essential

23) Registration number and name of trial registry
Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Future studies assessing the effects of ACT-based interventions like ours should aim for less restrictive exclusion criteria to apply this intervention to a larger, more diverse population. " "First, we were limited to a single Level 1 trauma center, which may affect the reproducibility of our results across other healthcare settings."

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 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 X27) Conflicts of Interest (not a CONSORT item) Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This randomized controlled trial was registered with ClinicalTrials.gov (NCT03991546) and reporting is consistent with CONSORT guidelines (Multimedia Appendix 1). " Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The intervention group received twice-daily, text based mobile messages communicating an ACT-based intervention for the first two weeks following surgery (Multimedia Appendix 2)." Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This study was possible thanks for a generous grant from the Orthopaedic Trauma Association. " subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
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?
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As a result of using this checklist, do you think your manuscript has improved? * Would you like to become involved in the CONSORT EHEALTH group?
This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document