Testing Digital Methods of Patient-Reported Outcomes Data Collection: Prospective Cluster Randomized Trial to Test SMS Text Messaging and Mobile Surveys

Background Health care delivery continues to evolve, with an effort being made to create patient-centered care models using patient-reported outcomes (PROs) data. Collecting PROs has remained challenging and an expanding landscape of digital health offers a variety of methods to engage patients. Objective The aim of this study is to prospectively investigate two common methods of remote PRO data collection. The study sought to compare response and engagement rates for bidirectional SMS text messaging and mobile surveys following orthopedic surgery. Methods The study was a prospective, block randomized trial of adults undergoing elective orthopedic procedures over 6 weeks. The primary objective was to determine if the method of digital patient engagement would impact response and completion rates. The primary outcome was response rate and total completion of PRO questionnaires. Results A total of 127 participants were block randomized into receiving a mobile survey (n=63) delivered as a hyperlink or responding to the same questions through an automated bidirectional SMS text messaging system (n=64). Gender, age, number of comorbidities, and opioid prescriptions were similar across messaging arms. Patients receiving the mobile survey were more likely to have had a knee-related surgery (n=50, 83.3% vs n=40, 62.5%; P=.02) but less likely to have had an invasive procedure (n=26, 41.3% vs n=39, 60.9%; P=.03). Overall engagement over the immediate postoperative period was similar. Prolonged engagement for patients taking opioids past postoperative day 4 was higher in the mobile survey arm at day 7 (18/19, 94.7% vs 9/16, 56.3%). Patients with more invasive procedures showed a trend toward being responsive at day 4 as compared to not responding (n=41, 59.4% vs n=24, 41.4%; P=.05). Conclusions As mobile patient engagement becomes more common in health care, testing the various options to engage patients to gather data is crucial to inform future care and research. We found that bidirectional SMS text messaging and mobile surveys were comparable in response and engagement rates; however, mobile surveys may trend toward higher response rates over longer periods of time. Trial Registration ClinicalTrials.gov NCT03532256; https://clinicaltrials.gov/ct2/show/NCT03532256


1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 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 Testing Digital Methods of Patient-Reported Outcomes Data Collection: A prospective, cluster randomized trial to test text messaging and mobile surveys 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 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 OBJECTIVES: To prospectively investigate two common methods of remote patient-reported outcomes data collection. The study sought to analyze response and engagement rates through two modalities including bi-directional text messaging or mobile surveys.
METHODS: Prospective, block randomized trial of adult patients undergoing elective sports medicine and orthopedic procedures over 6 weeks. The primary objective was to determine if the method of digital patient engagement would impact response and completion rates. The primary outcome was response rate and total competition of patient reported outcomes questionnaires.
RESULTS: 127 participants were block randomized into either receiving a mobile survey (n=63) delivered as a hyperlink or were asked the same questions through an automated conversational text messaging (n=64). Gender, age, number of comorbidities, number of opioid tablets prescribed were similar across messaging arms. Overall engagement over the immediate post-operative was similar between the messaging arms. Prolonged engagement past post-operative day 4 was higher in the mobile survey arm at day 7 (95% vs. 56%).
Patients with more invasive procedures showed a trend toward being responsive at day 4 as compared to non-responders.
CONCLUSIONS: As digital platforms become more commonly used in health care, testing the various options to engage patients to gather data is crucial to inform future care and research. We found that globally bi-directional text messaging and mobile surveys were comparable in response and engagement rates, however mobile surveys may trend toward higher response rates over longer periods of time.

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 OBJECTIVES: To prospectively investigate two common methods of remote patient-reported outcomes data collection. The study sought to analyze response and engagement rates through two modalities including bi-directional text messaging or mobile surveys.
METHODS: Prospective, block randomized trial of adult patients undergoing elective sports medicine and orthopedic procedures over 6 weeks. The primary objective was to determine if the method of digital patient engagement would impact response and completion rates. The primary outcome was response rate and total competition of patient reported outcomes questionnaires.
RESULTS: 127 participants were block randomized into either receiving a mobile survey (n=63) delivered as a hyperlink or were asked the same questions through an automated conversational text messaging (n=64). Gender, age, number of comorbidities, number of opioid tablets prescribed were similar across messaging arms. Overall engagement over the immediate post-operative was similar between the messaging arms. Prolonged engagement past post-operative day 4 was higher in the mobile survey arm at day 7 (95% vs. 56%).
Patients with more invasive procedures showed a trend toward being responsive at day 4 as compared to non-responders.
CONCLUSIONS: As digital platforms become more commonly used in health care, testing the various options to engage patients to gather data is crucial to inform future care and research. We found that globally bi-directional text messaging and mobile surveys were comparable in response and engagement rates, however mobile surveys may trend toward higher response rates over longer periods of time. 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 Your answer 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (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 briefly explain why the item is not applicable/relevant for your study Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The purpose of this study was to prospectively investigate a component of digital health patient engagement and PRO data collection. A common clinical scenario, post-operative follow-up, has been a unique area of study for digital health. In response to the opioid epidemic, clinicians seek PRO data on acute pain management to inform quality improvement (QI) efforts and prescribing. Less is known about which types of digital engagement are best suited to engage post-operative patients for continuous QI. The objective of this study was to prospectively investigate and compare two widely used methods of digital interaction and PRO data capture following elective, outpatient surgeries. We compared response and overall completion rates of a post-operative patient engagement delivered through conversational text messaging versus mobile surveys. To our knowledge, this is the first study to compare patient engagement commonly used modalities using two distinct approaches. would provide a robust and deep understanding to support care remotely.5 As digital strategies continue to expand, research has yet to describe the optimal ways to reach patients and capture PROs. Indeed, less is known about the various methods of engaging, collecting and monitoring patient reported data in remote fashions. Testing varying approaches would provide clinicians and researchers critical data and inform the use of effective strategies.
Research in areas of mobile health (mhealth) has grown dramatically in the past decade.8 Health care providers have attempted to use mhealth to track medication adherence9,10, encourage healthy ehaviors11, boost home monitoring12, and institute automated 'hovering' to track chronic disease.13 The rapid growth is likely largely due scalability, accessibility, and lack of large federal regulations. The evidence generated by these studies has not been well defined or characterized.14,15 In today's digital era, what is the best way to interact with patients remotely? How do researchers and providers build systems which efficiently capture meaningful patient-centered data?
METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 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 purpose of this study was to prospectively investigate a component of digital health patient engagement and PRO data collection. A common clinical scenario, post-operative follow-up, has been a unique area of study for digital health. In response to the opioid epidemic, clinicians seek PRO data on acute pain management to inform quality improvement (QI) efforts and prescribing. Less is known about which types of digital engagement are best suited to engage post-operative patients for continuous QI. The objective of this study was to prospectively investigate and compare two widely used methods of digital interaction and PRO data capture following elective, outpatient surgeries. We compared response and overall completion rates of a post-operative patient engagement delivered through conversational text messaging versus mobile surveys. To our knowledge, this is the first study to compare patient engagement commonly used modalities using two distinct approaches.
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 This was a prospective, block randomized trial of adult patients (age 18 or older) undergoing elective sports medicine and orthopedic procedures (clinicaltrails.gov NCT03532256). This study was approved as a quality improvement study by the University of Pennsylvania's Institutional Review Board. The study took place over 6 weeks. The primary objective was to determine if the method of digital patient engagement would impact response and completion rates. The primary outcome was response rate and total competition of patient reported outcomes questionnaires. 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants Does your paper address CONSORT subitem 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 Eligible patients included all adult patient undergoing an elective, outpatient sports medicine surgeries (including knee, hip, shoulder and elbow) and prescribed an acute opioid for postoperative pain. Acute opioid pain medications included oxycodone, acetaminophenoxycodone (Percocet), hydromorphone, or hydrocodone. Exclusion criteria included no access to a SMS-capable device or no acute opioid prescription.

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 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 Eligible patients included all adult patient undergoing an elective, outpatient sports medicine surgeries (including knee, hip, shoulder and elbow) and prescribed an acute opioid for postoperative pain. Acute opioid pain medications included oxycodone, acetaminophenoxycodone (Percocet), hydromorphone, or hydrocodone. Exclusion criteria included no access to a SMS-capable device or no acute opioid prescription.

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 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 Prior to this study, the research team had previously worked with the Institution's legal, privacy and patient safety departments in order to obtain remote, text message-based consent for data collection. This was an intentional design of a larger institutional program aimed to understand acute opioid prescribing. The approach allows for remote consent in an attempt to offload clinical providers and improve the scale of engaging eligible patients.
Following an elective, outpatient surgery within the Department of Orthopaedics, patients receive a brief initial text message within a two-day period following the procedure. This message informs the patient of 1) safe text messaging data practices; 2) links to further information regarding follow up research study; 3) offers the ability to opt-in or opt-out of further messaging. Patients consent via a simple text response of "yes." Enrolled patients were then sent text messages on post-operative days number 4, 7, 10, and 14. Patients were block randomized to receiving either 1) a hyperlink to a web based mobile survey or 2) automated, chatbot questions in a conversational text messaging fashion. Mobile survey questions and conversational questions were identical and included questions on patientreported pain intensity, use of prescribed pain medications, and ability to control pain. Block randomization was used to achieve balance in the two groups across demographics, procedure date, and dates of mobile engagement.
Importantly, in accordance with institutional approval, individuals who either 1) did not respond, 2) opted-out, or 3) self-reported no further planned use of acute opioid medications were not subsequently messaged. For example, if a participant completed either the mobile survey or conversational messaging on post-operative day 4 and indicated they were no longer planning on using their opioid prescription, no further messaging was sent on day 7, 14, 21 or 28. Participants who did not respond to any messaging, would receive a reminder message within 30 minutes, if that also did not trigger a response then no further messaging was sent. subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
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 This was a prospective, block randomized trial of adult patients (age 18 or older) undergoing elective sports medicine and orthopedic procedures (clinicaltrails.gov NCT03532256). This study was approved as a quality improvement study by the University of Pennsylvania's Institutional Review Board. The study took place over 6 weeks. The primary objective was to determine if the method of digital patient engagement would impact response and completion rates. The primary outcome was response rate and total competition of patient reported outcomes questionnaires. 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Enrolled patients were then sent text messages on post-operative days number 4, 7, 10, and 14. Patients were block randomized to receiving either 1) a hyperlink to a web based mobile survey or 2) automated, chatbot questions in a conversational text messaging fashion. Mobile survey questions and conversational questions were identical and included questions on patient-reported pain intensity, use of prescribed pain medications, and ability to control pain. Block randomization was used to achieve balance in the two groups across demographics, procedure date, and dates of mobile engagement.

4b-ii) Report how institutional affiliations are displayed
Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 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 Your answer

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 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?
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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 Enrolled patients were then sent text messages on post-operative days number 4, 7, 10, and 14. Patients were block randomized to receiving either 1) a hyperlink to a web based mobile survey or 2) automated, chatbot questions in a conversational text messaging fashion. Mobile survey questions and conversational questions were identical and included questions on patient-reported pain intensity, use of prescribed pain medications, and ability to control pain. Block randomization was used to achieve balance in the two groups across demographics, procedure date, and dates of mobile engagement. 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 Enrolled patients were then sent text messages on post-operative days number 4, 7, 10, and 14. Patients were block randomized to receiving either 1) a hyperlink to a web based mobile survey or 2) automated, chatbot questions in a conversational text messaging fashion. Mobile survey questions and conversational questions were identical and included questions on patient-reported pain intensity, use of prescribed pain medications, and ability to control pain. Block randomization was used to achieve balance in the two groups across demographics, procedure date, and dates of mobile engagement.

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 Your answer

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 Enrolled patients were then sent text messages on post-operative days number 4, 7, 10, and 14. Patients were block randomized to receiving either 1) a hyperlink to a web based mobile survey or 2) automated, chatbot questions in a conversational text messaging fashion. Mobile survey questions and conversational questions were identical and included questions on patient-reported pain intensity, use of prescribed pain medications, and ability to control pain. Block randomization was used to achieve balance in the two groups across demographics, procedure date, and dates of mobile engagement.

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 Importantly, in accordance with institutional approval, individuals who either 1) did not respond, 2) opted-out, or 3) self-reported no further planned use of acute opioid medications were not subsequently messaged. For example, if a participant completed either the mobile survey or conversational messaging on post-operative day 4 and indicated they were no longer planning on using their opioid prescription, no further messaging was sent on day 7, 14, 21 or 28. Participants who did not respond to any messaging, would receive a reminder message within 30 minutes, if that also did not trigger a response then no further messaging was sent.
6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Descriptive summary statistics were used to characterize the study population, using mean ± standard deviation for age, and frequencies and percentages for categorical variables including gender, type of surgery, opioid tablet quantity, comorbidities and invasiveness of the procedure. To determine differences in response rate at Day 4, between messaging arms and categorical demographic variables, Fisher's exact test was used. To determine difference in response at day 4 by age, Student's t-test was used. To determine if there were differences in opioid use over time, Kaplan Meier product limit method with a log-rank test was used. All analyses were performed using SAS statistical software (version 9.4, SAS Institute, Cary NC). 6b) Any changes to trial outcomes after the trial commenced, with reasons 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 defined/measured/monitored (logins, logfile 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 Your answer 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text Your answer 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 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 There were no changes needed throughout.

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 Not applicable to 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 briefly explain why the item is not applicable/relevant for your study This was a prospective, block randomized trial of adult patients (age 18 or older) undergoing elective sports medicine and orthopedic procedures (clinicaltrails.gov NCT03532256). This study was approved as a quality improvement study by the University of Pennsylvania's Institutional Review Board. The study took place over 6 weeks. The primary objective was to determine if the method of digital patient engagement would impact response and completion rates. The primary outcome was response rate and total competition of patient reported outcomes questionnaires. 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 briefly explain why the item is not applicable/relevant for your study This was a prospective, block randomized trial of adult patients (age 18 or older) undergoing elective sports medicine and orthopedic procedures (clinicaltrails.gov NCT03532256). This study was approved as a quality improvement study by the University of Pennsylvania's Institutional Review Board. The study took place over 6 weeks. The primary objective was to determine if the method of digital patient engagement would impact response and completion rates. The primary outcome was response rate and total competition of patient reported outcomes questionnaires.
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 Not needed for this study.
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 Your answer must have a minimum of 25 characters.
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 This was a prospective, block randomized trial of adult patients (age 18 or older) undergoing elective sports medicine and orthopedic procedures (clinicaltrails.gov NCT03532256). This study was approved as a quality improvement study by the University of Pennsylvania's Institutional Review Board. The study took place over 6 weeks. The primary objective was to determine if the method of digital patient engagement would impact response and completion rates. The primary outcome was response rate and total competition of patient reported outcomes questionnaires.

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 This was not blinded. 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

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

Your answer
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 Patients were block randomized to receiving either 1) a hyperlink to a web based mobile survey or 2) automated, chatbot questions in a conversational text messaging fashion. Mobile survey questions and conversational questions were identical and included questions on patient-reported pain intensity, use of prescribed pain medications, and ability to control pain. Block randomization was used to achieve balance in the two groups across demographics, procedure date, and dates of mobile engagement. 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 Descriptive summary statistics were used to characterize the study population, using mean ± standard deviation for age, and frequencies and percentages for categorical variables including gender, type of surgery, opioid tablet quantity, comorbidities and invasiveness of the procedure. To determine differences in response rate at Day 4, between messaging arms and categorical demographic variables, Fisher's exact test was used. To determine difference in response at day 4 by age, Student's t-test was used. To determine if there were differences in opioid use over time, Kaplan Meier product limit method with a log-rank test was used. All analyses were performed using SAS statistical software (version 9.4, SAS Institute, 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 No imputation was needed in this study. 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 Descriptive summary statistics were used to characterize the study population, using mean ± standard deviation for age, and frequencies and percentages for categorical variables including gender, type of surgery, opioid tablet quantity, comorbidities and invasiveness of the procedure. To determine differences in response rate at Day 4, between messaging arms and categorical demographic variables, Fisher's exact test was used. To determine difference in response at day 4 by age, Student's t-test was used. To determine if there were differences in opioid use over time, Kaplan Meier product limit method with a log-rank test was used. All analyses were performed using SAS statistical software (version 9.4, SAS Institute, Cary NC).

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 Your answer

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

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 Your answer 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 Over 6 weeks, 127 participants were block randomized into either receiving a mobile survey (n=63) delivered as a hyperlink or were asked the same series of questions through an automated system, chatbot using conversational text messaging (n=64). 57% were male, mean age 38.5 ± 13.9 years, and 73% (n=90) were having a knee procedure. Gender, age, number of comorbidities, number of opioid tablets prescribed were similar across messaging arms (Table 1). Patients receiving the mobile survey were more likely to be having a knee procedure (83% vs 63%, p=.015) but less likely to have an invasive procedure (41% vs 61%, p=.032).
Overall engagement over the immediate post-operative was similar between the messaging arms (Table 2). Using conversational, automated text messaging the response rate was 47% vs. 49% using a hyperlink to a mobile survey. For those patients resuming opioids past 4 days, prolonged engagement past post-operative day 4 was higher in the mobile survey arm at day 7 (95% vs. 56%). Amongst no-responders, the majority of patient drop off occurred at day 4 (76% vs 94% for conversational vs mobile survey respectively). Patients with more invasive or hip procedures showed a trend toward being responsive at day 4 as compared to non-responders (Table 3). subitem not at all important 1 2 3 4 5 essential 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 Over 6 weeks, 127 participants were block randomized into either receiving a mobile survey (n=63) delivered as a hyperlink or were asked the same series of questions through an automated system, chatbot using conversational text messaging (n=64). 57% were male, mean age 38.5 ± 13.9 years, and 73% (n=90) were having a knee procedure. Gender, age, number of comorbidities, number of opioid tablets prescribed were similar across messaging arms (Table 1). Patients receiving the mobile survey were more likely to be having a knee procedure (83% vs 63%, p=.015) but less likely to have an invasive procedure (41% vs 61%, p=.032).
Overall engagement over the immediate post-operative was similar between the messaging arms (Table 2). Using conversational, automated text messaging the response rate was 47% vs. 49% using a hyperlink to a mobile survey. For those patients resuming opioids past 4 days, prolonged engagement past post-operative day 4 was higher in the mobile survey arm at day 7 (95% vs. 56%). Amongst no-responders, the majority of patient drop off occurred at day 4 (76% vs 94% for conversational vs mobile survey respectively). Patients with more invasive or hip procedures showed a trend toward being responsive at day 4 as compared to non-responders (Table 3).

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.

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 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
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 This was a prospective, block randomized trial of adult patients (age 18 or older) undergoing elective sports medicine and orthopedic procedures (clinicaltrails.gov NCT03532256). This study was approved as a quality improvement study by the University of Pennsylvania's Institutional Review Board. The study took place over 6 weeks. The primary objective was to determine if the method of digital patient engagement would impact response and completion rates. The primary outcome was response rate and total competition of patient reported outcomes questionnaires.

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" 14b) Why the trial ended or was stopped (early)

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group 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 was not stopped early.
Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes this is included in table 1. 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 Not applicable in this study.

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. subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, this is included throughout the paper.

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
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 Analytic section included in results and reported in tables. 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 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory 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

Your answer
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 This is included in analysis, results, and tables. 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 Included in the results section.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or 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 No harms or unintended effects. 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 briefly explain why the item is not applicable/relevant for your study This study has two key findings within the context of mobile patient engagement and data capture. First, immediate post-operative digital patient engagement and research consent are feasible. We deployed a prospective, direct-to-patient approach in obtaining mobile consent for longitudinal capture of patient-reported outcomes for post-operative pain and pain management. A key element is that no identifiable patient health information (PHI) was sent over text messaging or through surveys. Prior studies, aiming to understand patients' pain and use of pain medications following surgeries have been limited by retrospective design, telephone or paper surveys, and recall bias. We worked collaboratively within the health system to develop an approach which offloads busy clinical providers from obtaining additional written consent during pre-operative visits and reaches out to patients 4 days following their procedure. Patients in this study were verbally notified of post-operative mobile engagement, and then received the first message on post-operative day 4 prompting them for consent. This mobile consent process may be further studied to decrease inperson time, allow for researchers to link important research and other patient information, and offer patients the ability to opt-out at any through a simple text message. Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events. Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This study has limitations. It represents an approach and data collected from a single division of Sports Medicine at a single academic medical center and thus is not generalizable. Furthermore, the completion rates represent selection bias in patients who have a mobile device and opt-in to completing either mobile survey or the bi-directional text messaging. Those patients receiving a mobile link to a survey must have had a smartphone and thus may represent a select population. Patients also were undergoing elective, outpatient procedures and may represent a population that is healthier, younger, and were 'primed' during their pre-operative appointment that they will receive this message.

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 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
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 was a prospective, block randomized trial of adult patients (age 18 or older) undergoing elective sports medicine and orthopedic procedures (clinicaltrails.gov NCT03532256).
Your answer must have a minimum of 25 characters.

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 briefly explain why the item is not applicable/relevant for your study Appendix attached.
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 Yes, funding is included.

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.
About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no Your answer must have a minimum of 25 characters.
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?

Your answer
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript *