Mobile Remote Monitoring of Intimate Partner Violence Among Pregnant Patients During the COVID-19 Shelter-In-Place Order: Quality Improvement Pilot Study

Background Intimate partner violence (IPV) is one of the leading causes of pregnancy-related death. Prenatal health care providers can offer critical screening and support to pregnant people who experience IPV. During the COVID-19 shelter-in-place order, mobile apps may offer such people the opportunity to continue receiving screening and support services. Objective We aimed to examine cases of IPV that were reported on a prenatal care app before and during the implementation of COVID-19 shelter-in-place mandates. Methods The number of patients who underwent voluntary IPV screening and the incidence rate of IPV were determined by using a prenatal care app that was disseminated to patients from a single, large health care system. We compared the IPV screening frequencies and IPV incidence rates of patients who started using the app before the COVID-19 shelter-in-place order, to those of patients who started using the app during the shelter-in-place order. Results We found 552 patients who started using the app within 60 days prior to the enforcement of the shelter-in-place order, and 407 patients who used the app at the start of shelter-in-place enforcement until the order was lifted. The incidence rates of voluntary IPV screening for new app users during the two time periods were similar (before sheltering in place: 252/552, 46%; during sheltering in place: 163/407, 40%). The overall use of the IPV screening tool increased during the shelter-in-place order. A slight, nonsignificant increase in the incidence of physical, sexual, and psychological violence during the shelter-in-place order was found across all app users (P=.56). Notably, none of the patients who screened positively for IPV had mentions of IPV in their medical charts. Conclusions App-based screening for IPV is feasible during times when in-person access to health care providers is limited. Our results suggest that the incidence of IPV slightly increased during the shelter-in-place order. App-based screening may also address the needs of those who are unwilling or unable to share their IPV experiences with their health care provider.

This is not a randomized trial

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 Yes, the title includes "Mobile Remote Monitoring" 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 No, non-web-based components and co-interventions are not included in this study

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 Yes, the title includes "Among Pregnant Patients" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, the methods section of the abstract states, "Frequencies of voluntary IPV screening and incidence identi ed through a prenatal care app disseminated to patients of a single large healthcare system were compared for those initiating app use before and during sheltering-in-place."

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) https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 11/58 subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No. This is a study only of patient self-reports and did not involve healthcare providers.
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 Yes, the methods section of the abstract speci es that patients were "identi ed through a prenatal care app disseminated to patients of a single large healthcare system." 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 Yes, the results section states, "There were 552 users in the 60 days prior to enforced sheltering-in-place and 407 users from enforcement until the order was lifted."

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. 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 Yes, the conclusion section states, "With comparable rates both before and during sheltering-in-place, app-based screening for IPV is feasible during times with limited in-person access to healthcare providers and are suggestive of increases in IPV experience during sheltering-in-place. "

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) 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 Yes: "Here we examine cases of IPV reported to a healthcare system through a prenatal app in a single U.S. county in the two months pre-and post-sheltering-inplace mandates" 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 No. This study was not a randomized controlled trial and therefore did not have speci c allocation methods. All respondents received the app and the data from all users is analyzed. However, the recruitment methods are explained in detail: "The internal protocol for prescribing MHP was to send a link to patients' phones inviting them to use the app as part of their routine prenatal care. Users were able to follow the link to a unique download code in the Android or App store.
No individual was able to download and onboard to the app unless they were a recipient of a text message-based prescription for the app from their healthcare providers' o ce."

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 No changes to methods were made to methods throughout the course of the study.

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 No changes were made to the intervention throughout the course of the study. 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 Yes, eligibility requirements are discussed in detail. Eligibility includes, "all pregnant patients at their rst prenatal appointment starting in January, 2020" and analyses were limited to "pregnant residents of Allegheny Co, PA prescribed the app at an inperson visit."

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 Yes, the Methods section states "By virtue of smartphone ownership and completion of the downloading and onboarding process, all users were smartphone and internet literate. " 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 Yes, recruitment is explained: "A large academic health system prescribed the MyHealthyPregnancyTM (MHP) app to all pregnant patients at their rst prenatal appointment." Other than this initial appointment, there were no face-to-face components of this intervention. Participants were fully identi able to their provider and through the app. Because this was prescribed through and recorded in their medical chart, it is not possible to have multiple identities.

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 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 Yes, the paper addresses information provided to the participants: "App users consented to share identi able data with their healthcare provider and for research purposes and anonymized aggregate data for publication. Participants did not receive any nancial compensation for app use. All app use was considered part of routine prenatal care and analyses were approved by the health system's QI review board." In addition, "All app users are noti ed in MHP that their provider may not see or respond to any given risk noti cation and immediate actions that the user can take to minimize their risk are offered (e.g. prompts to call 9-1-1, prompts to call their prenatal care provider, or watchful waiting, depending on the seriousness of the risk that is identi ed)." 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 Yes, the paper states, "All app users were offered an opportunity to screen for IPV through the app, receiving Your answer in-app messaging that stated, 'Are you concerned about your safety? Take the pregnancy safety quiz. <button> Go to quiz'." This screening was not mandatory and was located in a speci c area of the app dedicated to screening tools. 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 Yes, the paper states, "All app users were offered an opportunity to screen for IPV through the app, receiving Your answer in-app messaging that stated, 'Are you concerned about your safety? Take the pregnancy safety quiz. <button> Go to quiz'." This screening was not mandatory and was located in a speci c area of the app dedicated to screening tools. 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 This is not explicitly addressed in the paper, as there are not explicit a liations identi ed in the app. However, as this app is presented by the providers as part of routine prenatal care, it is assumed that all users associate it with their primary prenatal care health system.

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 Yes, under con icts of interest, the paper states, "Naima Health LLC provided the data for this study. Your answer No nancial or material compensation was provided to fund this work. Dr. Castillo-Mora is a full-time employee of Naima Health LLC. Drs. Krishnamurti, Davis, and Simhan are co-founders and equityholders of Naima Health LLC, but did not receive compensation for this work or for the dissemination of this tool.

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 We cite our original publication on the development and testing of the app "A large academic health system prescribed the MyHealthyPregnancyTM (MHP) app [14]" We also describe the app's functionality "MHP applies machine learning algorithms to patient-entered data to model each patient's likelihood of adverse pregnancy events (e.g. hypertension, premature delivery), including psychosocial risks. It then offers relevant resources (e.g. connection to a local women's shelter), as well as notifying their provider in real-time. All app users are noti ed in MHP that their provider may not see or respond to any given risk noti cation and immediate actions that the user can take to minimize their risk are offered (e.g. prompts to call 9-1-1, prompts to call their prenatal care provider, or watchful waiting, depending on the seriousness of the risk that is identi ed). "

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 Yes, the manuscript states, "A large academic health system prescribed the MyHealthyPregnancyTM (MHP) app [14] to all pregnant patients at their rst prenatal appointment starting in January, 2020 (Apple v.1.4.7; Android v.1.8). "

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 The manuscript states, "All content was developed in conjunction with and reviewed by a clinical education team employed by the healthcare system." -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 Intimate partner violence screenings are publicly available. Backend code for the MHP app is proprietary. However, the authors are willing to provide, upon request, guidance and best practices to other app developers on implementing intimate partner violence screening.

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 There is no public url to download the application as it is currently available by prescription only. The Naima Health website is publicly available.

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 Yes. The paper explains, "The internal protocol for prescribing MHP was to send a link to patients' phones inviting them to use the app as part of their routine prenatal care. Users were able to follow the link to a unique download code in the Android or 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 As a brief report with limited work count, this level of detail is not included in this manuscript and the framework for the app development has been detailed in a previous publication in JMIR Mhealth Uhealth. Additional detail will be provided upon request of peer reviewers or the journal editor.

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.

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 Yes, "The internal protocol for prescribing MHP was to send a link to patients' phones inviting them to use the app as part of their routine prenatal care" and "For participants with positive responses to IPV screening questions, individual charts were reviewed for the presence of a positive IPV screen as well as all in-person interactions with the system (i.e., emergency room, routine prenatal care, specialist care, and physical therapy appointments) during the course of their pregnancy." Other than providers prescribing the app to users and researchers reviewing charts, there was no other outside human involvement in this study.

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 Yes, the paper explains, "All app users were offered an opportunity to screen for IPV through the app, receiving in-app messaging that stated, "Are you concerned about your safety? Take the pregnancy safety quiz. <button> Go to quiz". This screening was not mandatory and was located in a speci c area of the app dedicated to 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 Yes, the paper describes the other interventions provided through the app: "MHP applies machine learning algorithms to patient-entered data to model each patient's likelihood of adverse pregnancy events Your answer (e.g. hypertension, premature delivery), including psychosocial risks. It then offers relevant resources (e.g. connection to a local women's shelter), as well as notifying their provider in real-time. All app users are noti ed in MHP that their provider may not see or respond to any given risk noti cation and immediate actions that the user can take to minimize their risk are offered (e.g. prompts to call 9-1-1, prompts to call their prenatal care provider, or watchful waiting, depending on the seriousness of the risk that is identi ed)." 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 Yes, "Use of the in-app IPV risk assessment " is inferred as completion of a risk screening.
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 Qualitative feedback was not obtained from participants.

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 No changes to outcomes were made throughout this study.

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 No. This is a descriptive study and not a randomized controlled trial. As such, a speci c sample size was not calculated and attrition rates were not taken into account.
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 Our starting and stopping points were dictated by local mandates (pre-and postenforced sheltering-in-place.

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 is a descriptive study and not a randomized controlled trial. All pre-and postcomparisons are dependent on local government policy. There was no random allocation.
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 is a descriptive study and not a randomized controlled trial. All pre-and postcomparisons are dependent on local government policy. There was no random allocation. 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 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 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 This is a descriptive study and not a randomized controlled trial. All pre-and postcomparisons are dependent on local government policy. There was no random allocation.
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 is a descriptive study and not a randomized controlled trial. All pre-and postcomparisons are dependent on local government policy. There was no random allocation.
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 This is a descriptive study and not a randomized controlled trial. All pre-and postcomparisons are dependent on local government policy. There was no blinding.
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 This is a descriptive study and not a randomized controlled trial. All pre-and postcomparisons are dependent on local government policy. Participants were aware of sheltering-in-place mandates and awareness of their own app user.
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 No, this is not relevant to this study because a placebo or sham intervention was not used. 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 Yes, the paper states "Frequencies of IPV screening and incidence were calculated and compared between the pre-and post-sheltering-in-place cohorts. All frequencies of IPV were then queried against the patient's Your answer chart to determine if any IPV had been documented by a healthcare provider. Analyses were completed in R version 3.6.0." Clustering by care providers/centers did not need to be addressed because this was a single-center study.

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 We did not impute secondary outcomes (rates of positive screens) for those who elected not to screen for IPV (primary outcome). The purpose of the study was the feasibility of use of the tool for screening so imputation is not relevant to that goal.

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 Additional analyses such as subgroup analyses and adjusted analyses were not performed.

X26-i) Comment on ethics committee approval
Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, "All app use was considered part of routine prenatal care and analyses were approved by the health system's QI review board" 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 Yes, "App users consented to share identi able data with their healthcare provider and for research purposes and anonymized aggregate data for publication"

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)

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 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 Yes, "The app was password protected with a password set by the user. The app included a password reset function that required and a 24/7 hotline was available for all technical troubleshooting. Intimate partner violence screenings were not stored or accessible in the app after completion to minimize the risk of privacy violations to the app users." 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 "The MHP app onboarded 552 users in the 60 days prior to enforced sheltering-inplace (Jan 23 to March 22, 2020) and 407 users from enforcement until the order was lifted (March 23 to May 15, 2020)" Participants were not randomized and all received the intended treatment. Copy and paste relevant sections from the manuscript (include quotes in quotation 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, "The MHP app onboarded 552 users in the 60 days prior to enforced sheltering-in-place (Jan 23 to March 22, 2020) and 407 users from enforcement until the order was lifted (March 23 to May 15, 2020)... Use of the in-app IPV risk assessment among newly onboarded patients did not differ signi cantly, from before sheltering-in-place 46% (252/552) to during sheltering-in-place 40% (163/407)"

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 There were no losses or exclusions. Participants who did not choose to ll out the IPV risk assessments were documented as part of the analyses.
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 Participant logins and overall app use were not tracked over time as part of this study.
14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., 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 Yes, "The MHP app onboarded 552 users in the 60 days prior to enforced sheltering-in-place (Jan 23 to March 22, 2020) and 407 users from enforcement until the order was lifted (March 23 to May 15, 2020)." This study is structured around an instance of a secular event. 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

15) A
The study period was ended on May 15th, 2020, because the shelter-in-place mandate (secular event) was lifted on this day.

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, " Table 1 shows the demographics of patients onboarded prior to and during the sheltering-in-place order."

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.

16) For each group, number of participants (denominator) included in each
analysis and whether the analysis was by original assigned groups subitem not at all important 1 2 3 4 5 essential Does your paper address 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 The paper provides the education status of participants.

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 Yes, "Use of the in-app IPV risk assessment among newly onboarded patients did not differ signi cantly, from before sheltering-in-place 46% ( 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)

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 Intention-to-treat analysis is not applicable here since participants were not randomised.
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 "Use of the in-app IPV risk assessment among newly onboarded patients did not differ signi cantly, from before sheltering-in-place 46% ( 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 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 This is not applicable to the study because completing the measures was optional for all participants. Therefore metrics of use were not tracked outside of how many newly onboarded patients completed the IPV measures: "Use of the in-app IPV risk assessment among newly onboarded patients did not differ signi cantly, from before sheltering-in-place 46% (252/552) to during sheltering-in-place 40% (163/407) (two-sample Chi-squared test of proportions, 95% CI: -12% to -0.01%; p = .10), although there was a slight decrease." 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 Not applicable as only absolute rates are compared 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 Additional analyses such as subgroup analyses and adjusted analyses were not performed.

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 Subgroup analysis was not performed. 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 Harms or unintended effects were not observed throughout the course of 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 Privacy breaches and unexpected/unintended incidents were not observed throughout the course of the study. Some technical problems (e.g., a small subset of users required a prescription to be resent to their phone etc) were reported to the hotline during this time period but were not categorized here as the sample consists of only those who had onboarded.

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 Qualitative feedback was not obtained from participants. The paper discusses possible limitations of the study: "While our results are suggestive of increases in incidence of IPV during sheltering-in-place, our sample size could not support detection of statistically signi cant differences. Another limitation of this work is that we were unable to determine whether app-users who screened positive for IPV actually connected with the resources offered to them through the app. However, we are currently working on a system for a warm handoff to resources among those screening positive for IPV who wish to connect with them. While our app users re ect the general population of patients our health system serves, it is also possible that those choosing not to use MHP are also more likely to experience IPV, which would result in less effective screening than we are able to discern from our data." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, the paper states, "Here we nd stable self-screening for IPV using a prenatal care app during Your answer sheltering-in-place conditions. This nding suggests that, during social isolation, there is sustained use of technology to disclose risk.
Given that the positive instances of IPV identi ed using this tool were not captured in routine in-person screening suggests that the app may be addressing the needs of patients who are unable or prefer not to disclose risk directly to their provider." Copy and paste relevant sections from the manuscript (include quotes in quotation 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

22-ii) Highlight unanswered new questions, suggest future research
The paper suggests possible avenues for new research: "App-based screening may serve as a complementary form of care for those with limited ability to interact with their healthcare provider or other social networks.Such technologies may offer an additional form of connection during such times."

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 The paper discusses possible limitations of the study: "While our results are suggestive of increases in incidence of IPV during sheltering-in-place, our sample size could not support detection of statistically signi cant differences. Another limitation of this work is that we were unable to determine whether app-users who screened positive for IPV actually connected with the resources offered to them through the app. However, we are currently working on a system for a warm handoff to resources among those screening positive for IPV who wish to connect with them. While our app users re ect the general population of patients our health system serves, it is also possible that those choosing not to use MHP are also more likely to experience IPV, which would result in less effective screening than we are able to discern from our data."

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 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 This study is not generalizable to populations beyond pregnant people. "While our results are only suggestive that there is greater willingness to report IPV in an app in comparison to an in-person encounter, offering app-based IPV risk screening paired with appropriate resources is one way to address the needs of pregnant people experiencing violence during and beyond social isolation."

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

OTHER INFORMATION
23) Registration number and name of trial registry 24) Where the full trial protocol can be accessed, if available 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 Yes, the paper addresses various elements that might impact app use outside of a study setting: "Our number of positive screens across both the pre-and postsheltering-in-place period re ect the lower end of national estimates of IPV and it is unlikely that we are capturing all instances of IPV among app-users (another possibility is that those experiencing IPV may not be using smartphones or apps as frequently). As such, it is important to consider that app-based screening alone will not necessarily capture all instances of IPV, particularly if the abusive partner controls smartphone use. Our results also suggest that app-based screening may capture a different set of at-risk patients, which would make app-based and inperson assessments complementary." 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 No, this study was not a randomized controlled trial and therefore was not registered.

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 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 This is not applicable as this was not a registered trial.
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: "Dr. Krishnamurti's time in preparing the manuscript was supported, in part, by NIH KL2 TR001856. The content is solely the responsibility of the authors and does not necessarily represent the o cial views of the NIH. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication." 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 Yes, "Naima Health LLC provided the data for this study. No nancial or material compensation was provided Your answer to fund this work. Dr. Castillo-Mora is a full-time employee of Naima Health LLC. Drs. Krishnamurti, Davis, and Simhan are co-founders and equity-holders of Naima Health LLC, but did not receive compensation for this work or for the dissemination of this tool." 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?
I edited the title and added in some content about privacy and security measures.
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript *

working days
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 Potentially, depending no time commitments and constraints Clear selection