The Effect and Feasibility of mHealth-Supported Surgical Site Infection Diagnosis by Community Health Workers After Cesarean Section in Rural Rwanda: Randomized Controlled Trial

Background The development of a surgical site infection (SSI) after cesarean section (c-section) is a significant cause of morbidity and mortality in low- and middle-income countries, including Rwanda. Rwanda relies on a robust community health worker (CHW)–led, home-based paradigm for delivering follow-up care for women after childbirth. However, this program does not currently include postoperative care for women after c-section, such as SSI screenings. Objective This trial assesses whether CHW’s use of a mobile health (mHealth)–facilitated checklist administered in person or via phone call improved rates of return to care among women who develop an SSI following c-section at a rural Rwandan district hospital. A secondary objective was to assess the feasibility of implementing the CHW-led mHealth intervention in this rural district. Methods A total of 1025 women aged ≥18 years who underwent a c-section between November 2017 and September 2018 at Kirehe District Hospital were randomized into the three following postoperative care arms: (1) home visit intervention (n=335, 32.7%), (2) phone call intervention (n=334, 32.6%), and (3) standard of care (n=356, 34.7%). A CHW-led, mHealth-supported SSI diagnostic protocol was delivered in the two intervention arms, while patients in the standard of care arm were instructed to adhere to routine health center follow-up. We assessed intervention completion in each intervention arm and used logistic regression to assess the odds of returning to care. Results The majority of women in Arm 1 (n=295, 88.1%) and Arm 2 (n=226, 67.7%) returned to care and were assessed for an SSI at their local health clinic. There were no significant differences in the rates of returning to clinic within 30 days (P=.21), with high rates found consistently across all three arms (Arm 1: 99.7%, Arm 2: 98.4%, and Arm 3: 99.7%, respectively). Conclusions Home-based post–c-section follow-up is feasible in rural Africa when performed by mHealth-supported CHWs. In this study, we found no difference in return to care rates between the intervention arms and standard of care. However, given our previous study findings describing the significant patient-incurred financial burden posed by traveling to a health center, we believe this intervention has the potential to reduce this burden by limiting patient travel to the health center when an SSI is ruled out at home. Further studies are needed (1) to determine the acceptability of this intervention by CHWs and patients as a new standard of care after c-section and (2) to assess whether an app supplementing the mHealth screening checklist with image-based machine learning could improve CHW diagnostic accuracy. Trial Registration ClinicalTrials.gov NCT03311399; https://clinicaltrials.gov/ct2/show/NCT03311399


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 "mHealth technology supporting community health worker led-surgical site infection diagnosis" 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 "community health workers" have distinct co-intervention support that was not evaluated as part of 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 "surgical site infection...after cesarean section" Your response is too large. Try shortening some answers.
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 Participants "were randomized into three post-operative arms: 1) home visit, 2) phone call, and 3) routine health center follow-up. A CHW-led, mHealth-supported SSI diagnostic protocol was delivered in intervention arms. We assessed intervention completion in each intervention arm and used logistic regression to assess impact on return to care."

1b-ii) Level of human involvement in the METHODS section of the ABSTRACT
Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The SSI diagnostic protocol was conducted by community health workers as indicated by "CHW/mHealth" intervention and "CHW-led, mHealth-supported SSI diagnostic protocol" 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
Your response is too large. Try shortening some answers. 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

Your answer
Your response is too large. Try shortening some answers. Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "In much of sub-Saharan Africa, networks of community health workers (CHWs) provide home-based care to pregnant women, postpartum women after vaginal delivery, and followup care for children under the age of five. However, women delivering via c-section can only access follow-up care at their local health center. In complementary work from our team, we found that geographical and financial barriers can lead to delays in return to care after discharge. This delayed or lack of access to care may contribute to post-c-section SSI rates, which our group reported to be 10.9% in the district where this study took place. Strengthening the CHW workforce to provide SSI screening and home-based care to women who deliver via c-section could reduce barriers to care and lead to earlier detection and treatment of SSIs. However, it is not known if home-based care by CHWs is feasible or improves access to care in this context." "In this paper, we describe two CHW-mobile health (mHealth) interventions to diagnose SSIs -a CHW administering a mobile phone-based SSI protocol to a patient either during a home visit or by phone call -following c-section in rural Rwanda. Here, we compare these two interventions to the standard of care via a three-arm randomized control trial (ClinicalTrials.gov NCT03311399) and describe the feasibility of the two interventions in this context." Your response is too large. Try shortening some answers. Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Rates of cesarean section (c-section) births are increasing in low-and middle-income countries (LMICs), including in sub-Saharan Africa [1]. Increased access to timely c-sections can prevent maternal and neonatal mortality, but also carries risk of peri-operative complications. Surgical site infections (SSIs) are a significant cause of morbidity and mortality globally, but the magnitude of the risk is significantly higher in LMICs. In sub-Saharan Africa, post-c-section SSI rates range from 7-48%, in part due to geographic and infrastructural barriers that delay or prevent patients from accessing care post-operatively." The current system of post-operative c-section care in rural Rwanda requires women to independently return to the health center for wound checks. Women who experience vaginal delivery, however, receive home-based follow-up care via a network of community health workers, which limits the necessity for these women to travel to their respective health centers. The out-of-pocket expenses associated with travel to health center has been associated with catastrophic expenditures. This study is intended to demonstrate the effectiveness and feasibility of the intervention to improve return to care for women with potential SSI after c-section and reduce need to return to health center if no SSI.
Your response is too large. Try shortening some answers. We hypothesize that the mHealth/CHW SSI diagnosis protocol will improve return to care for women developing SSI after c-section. "In this paper, we describe two CHW-mobile health (mHealth) interventions to diagnose SSIs -a CHW administering a mobile phone-based SSI protocol to a patient either during a home visit or by phone call -following c-section in rural Rwanda." 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 randomized study included three arms: Arm 1, where the sCHW visited a participant's home on POD 10 (±3 days) and administered the SSI screening protocol; Arm 2, where the sCHW called the participant and administered the SSI screening protocol over the phone on POD 10 (±3 days); and Arm 3, where the participant received the standard of care. In Arm 2, the sCHW made calls while sitting in the study office and made three call attempts before deeming a patient to be inaccessible. If a participant in Arm 1 or 2 was suspected to have an SSI by the responses to the screening protocol, the sCHW was prompted to refer her to a nearby health center for proper management." "The study staff enrolled and randomized eligible participants at discharge, independent of any patient factors, to one of the three study arms" in a one-one-one ratio.

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 There were no important changes to methods after trial commencement. Eligibility criteria remained consistent throughout.

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
Your response is too large. Try shortening some answers. 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 "This study included women aged ≥18 years who received a c-section at KDH between November 2, 2017 and September 4, 2018 and were residents of Kirehe District. Women who developed an SSI while inpatient or remained inpatient at KDH on postoperative day (POD) 10 were excluded as they were not able to participate in a POD 10 visit if so randomized. Women who resided in Mahama Refugee Camp and therefore not covered by the CHW network were also excluded."

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 Not applicable. Participants were not using the mHealth technology, only study staff and study community health workers who were trained on the protocol.
Your response is too large. Try shortening some answers. 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 "The study staff enrolled and randomized eligible participants at discharge, independent of any patient factors, to one of the three study arms" while in person at Kirehe District Hospital. Participant identities were confirmed at each stage of the intervention and for each arm of the study. Arm 1 participants were visited at home by community health workers, arm 2 participants were contacted by phone, and arm 3 participants had no further contact with study staff, but were identified in medical records at local health centers to track return to care.

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.
Your response is too large. Try shortening some answers. 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 study was conducted at Kirehe District Hospital (KDH) -a 233-bed facility operated by the Rwanda Ministry of Health (RMOH) and supported by Partners In Health (PIH), in the Eastern Province of Rwanda. KDH serves a catchment area of 364,000 people including patients from Mahama Refugee Camp, which comprises over 50,000 people." Data was also collected during home visits, in rural Rwanda villages, for Arm 1 participants and via phone for Arm 2 participants. For all participants, data was collected at "each health center in the catchment area and KDH had a study-specific patient registry to document return to care... Data collectors contacted each woman on POD 30 to validate what was captured in the registry and to ensure that no follow-up visits were missed."

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. 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable to this study as it was not a recorded outcome.

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) 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
Your response is too large. Try shortening some answers. 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
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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.
Your response is too large. Try shortening some answers. subitem not at all important 1 2 3 4 5 essential 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 "Health centers' data may not have been consistent in quality due to variations in study patient tracking and data collection processes across sites. Targeted interventions, including calling health centers weekly with a list of expected enrolled patients and monthly in-person audits of each health center's registry, were implemented to improve patient tracking. We also called all patients on POD 30 regarding their follow-up activities and SSI diagnoses. There was 100% agreement between data from registries and phone calls for 228 patients from Arms 1 and 2 captured in both" 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
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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 Your answer

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 Participants did not directly access the mHealth technology used in the intervention. Participants were not compensated for participating in this trial. Your response is too large. Try shortening some answers. 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 "Previously, we led a seven-month SSI protocol development study at KDH to identify a simple screening protocol with high accuracy to diagnose SSIs. Three questions -fever since discharge from the hospital, increasing pain since discharge, and presence of discolored wound discharge -were found to have sufficient sensitivity and specificity for SSI diagnosis prior to study start." This SSI screening protocol was converted into a REDCap application used in our mHealth/CHW intervention.
"All consenting participants' demographic and socioeconomic data were collected using a self-reported questionnaire administered by a trained study data collector. "This randomized study included three arms: Arm 1, where the sCHW visited a participant's home on POD 10 (±3 days) and administered the SSI screening protocol; Arm 2, where the sCHW called the participant and administered the SSI screening protocol over the phone on POD 10 (±3 days); and Arm 3, where the participant received the standard of care. In Arm 2, the sCHW made calls while sitting in the study office and made three call attempts before deeming a patient to be inaccessible. If a participant in Arm 1 or 2 was suspected to have an SSI by the responses to the screening protocol, the sCHW was prompted to refer her to a nearby health center for proper management." Theoretical framework. The community health worker network in Rwanda has been successful in reducing maternal and neonatal mortality through home-based follow-up care for women following vaginal delivery. Leveraging this existing infrastructure to improve postoperative care for women after c-section would increase the likelihood for the intervention to be successfully integrated into current systems for care delivery. The challenge this intervention seeks to address is to improve a community health worker's ability to diagnose an SSI with sufficient accuracy and specificity to enable home-or phonebased follow-up care without requiring women to return to health centers.
Your response is too large. Try shortening some answers.

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
Your response is too large. Try shortening some answers. 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 Our study team prompted study-trained community health workers to use the mHealth SSI protocol during home visits or via phone.

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.
Your response is too large. Try shortening some answers.
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/formResponse?hl=en_US&edit2=2_ABaOnud60P… 29/58 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 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 "We hired four study CHWs (sCHWs) using RMOH criteria though a community-led process.
The sCHWs received a four-week training on the Rwandan health sector, post-c-section follow-up, operating mHealth tools, best practices in wound photography, basic SSI physiopathology (including signs and symptoms of an infection), and how to examine surgical wounds and change wound dressings." 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 Secondary outcome: "For the feasibility assessment, for each implementation indicator in Arms 1 and 2, we reported the percentage of visits where that specific task was completed" as recorded in REDCap by study community health workers after each visit/phone call.
Your response is too large. Try shortening some answers. subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text

Your answer
Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There were no changes to trial outcome after commencement.
Your response is too large. Try shortening some answers. subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 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 "The anticipated sample size was 364 patients per arm, for a total of 1,092 patients [12]. We anticipated an SSI rate of 15%, which would result in 55 SSIs per arm. Assuming an 80% return to care rate in the two intervention arms and a 40% return to care rate in the standard of care arm, we would have 81% power to detect a difference between the two intervention arms as compared to the routine care arm." 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 "Seven months into the study, a Data and Safety Monitoring Board reviewed study participants' safety, data quality, and midterm outcomes, and deemed it appropriate to continue to study completion." Your response is too large. Try shortening some answers. 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The study staff enrolled and randomized eligible participants at discharge, independent of any patient factors, to one of the three study arms." At discharge, the enrolled patients were randomized to one of the three study arms. Study staff prepared study packets, in sealed envelopes numbered consecutively. REDCap application was used to randomly generate arm assignments to each packet.

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 The study used simple randomization (one-one-one).
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 "Study staff prepared study packets, in sealed envelopes numbered consecutively. REDCap application was used to randomly generate arm assignments to each packet." Your response is too large. Try shortening some answers. 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 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 "A REDCap application was used to randomly generate arm assignments to each packet."

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 "Study staff prepared study packets, in sealed envelopes numbered consecutively." Your response is too large. Try shortening some answers.

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 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 The two intervention arms used different methods for delivery for the same mHealth SSI screening protocol. In "Arm 1, ... the sCHW visited a participant's home on POD 10 (±3 days) and administered the SSI screening protocol; Arm 2, ... the sCHW called the participant and administered the SSI screening protocol over the phone on POD 10 (±3 days)." Your response is too large. Try shortening some answers. 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 "We used a Fisher's exact test at α=0.05 significance level to assess the association between patients' return to care and interventions implemented in Arms 1 and 2 as compared to Arm 3 (standard of care). We then used a logistic regression model to assess the impact of study interventions on return to care, controlling for potential confounders that were unbalanced at baseline. In this primary analysis, we excluded anyone without information on return to care by POD 30 from analyses. We used Chi-squared tests to assess for differences in having information about return to care by study arm and by patient demographics."

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 also conducted a sensitivity analysis, whereby any individual missing information on return to care was presumed to have not returned to care." Your response is too large. Try shortening some answers. Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Eligible women gave informed consent prior to participation. Study team members provided information in Kinyarwanda, including details of the three study arms and the right to withdraw from the study or refrain from giving information at any stage."

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
Your response is too large. Try shortening some answers. RESULTS 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "In total, 1,166 women were enrolled," and "1,025 women" were not excluded from the study. "335 were randomized to Arm 1, 334 to Arm 2, and 356 to Arm 3" all of whom received the intended treatment and were analyzed for the primary outcome.
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 "In total, 1,166 women were enrolled, of which 107 were excluded (95 residents of Mahama Refugee Camp and 12 patients who developed an SSI while at the hospital). The 30 participants who remained in hospital after discharge to attend to their admitted neonates and the four participants who were assigned to one arm but inadvertently received the follow-up of another arm were also removed from analysis." Your response is too large. Try shortening some answers.

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

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
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 Patient participants were recruited post-c-section "between November 2, 2017 and September 4, 2018".
Follow-up was conducted on postoperative day 10 (±3 days) and postoperative day 30.
Your response is too large. Try shortening some answers. 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The trial ended when we achieved the enrollment numbers needed to power the study.
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15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not relevant to this trial. Participants were not asked to access digital materials.

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.
Your response is too large. Try shortening some answers. 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

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
Your response is too large. Try shortening some answers. 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 Primary outcome (return to care): "We had information on return to care for 896 (87.4%) women. Women in Arm 2 were marginally, but non-significantly, more likely to have this information recorded (P=.062). There were no differences in having this documented among key demographics, except women with higher monthly incomes were more likely to have information on return to care recorded (P=.031). In the primary analyses, there was no difference in care-seeking behavior between the three arms. All women had high rates of returning to clinic before POD 30 (99.7% in Arm 1, 98.4% in Arm 2, and 99.7% in Arm 3; P=.209 (crude); P=.186 (adjusted)) ( Table 4). Reasons for returning to care were not significantly different between groups, with similar percentages of women returning for either routine wound care (89.4% in Arm 1, 88.6% in Arm 2, and 90.3% in Arm 3; P=.080) or for a specific concern related to their c-section (10.6% in Arm 1, 11.4% in Arm 2, and 9.7% in Arm 3; P=.080). There were similar rates of nurse-diagnosed SSIs in each group (11.9% in Arm 1, 11.6% in Arm 2, and 9.3% in Arm 3; P=.542) ( Table 4). In the sensitivity analysis, difference in return to care rates by study arm remained insignificant (P=.193 (crude); P=.257 (adjusted))." Secondary outcome (feasibility of intervention): "Of women in Arm 1, 295 (88.1%) were successfully visited in their homes and had the full SSI assessment completed by the sCHW ( Table 2). The primary reasons for non-completion in Arm 1 were prolonged hospitalization of either mother or baby or an inability to contact the mother to confirm the home visit appointment. Of women in Arm 2, 67.7% were successfully called and assessed over the phone by a sCHW for an SSI. The primary reasons for non-completion in Arm 2 were the woman not owning a phone, poor network coverage, or the phone belonging to another person, such as a husband or neighbor, who could not connect the sCHW with the mother. Women in Arm 1 had slightly higher rates of reporting SSI symptoms as compared to women in Arm 2 (Table 3)." Your response is too large. Try shortening some answers. 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 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
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18) Results of any other analyses performed, including subgroup analyses and
adjusted analyses, distinguishing pre-specified from exploratory Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study For our primary outcome measure (return to care), "nearly all patients in our study returned to care at least once by POD 30, with no significant difference in follow-up between arms." "In the primary analyses, there was no difference in care-seeking behavior between the three arms. All women had high rates of returning to clinic before POD 30 (99.7% in Arm 1, 98.4% in Arm 2, and 99.7% in Arm 3; P=.209 (crude); P=.186 (adjusted)) ( Table 4)." Among those with 30-day follow-up data, number of patients who returned to care (n=889): arm 1: n=283 (99.7%), arm 2: n=298 (98.4%), arm 3: n=308 (99.7%). P=.209 Patients who returned to care with a nurse-diagnosed SSI (n=871): arm 2: 33 (11.9%), arm 2: 34 (11.6%), arm 3: 28 (9.3%). P= .542 Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No subgroup analyses were included in this manuscript.
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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 The intervention utilized practices that are regularly implemented as a part of community health worker follow-up care, and as such were not deemed to pose a harm to participants.
Your response is too large. Try shortening some answers. 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 There were no privacy breaches during the implementation and analysis phase of the study. "De-identified data were collected and managed using REDCap" and computers hosting the data were password-encrypted and kept either locked in storage or in study staff possession.

19-ii) Include qualitative feedback from participants or observations from staff/researchers
Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.
Your response is too large. Try shortening some answers. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 Primary outcome (return to care): "nearly all patients in our study returned to care at least once by POD 30, with no significant difference in follow-up between arms." Secondary outcome (feasibility of intervention): "we observed that home-based follow-up care of participants allows the sCHW to enter the women's homes, physically examine them, and take a photo of their wound. With close to 90% of participants in Arm 1 successfully visited and assessed for SSI, we found that home visits are a feasible way to conduct postc-section care...On the other hand, SSI screening by phone excluded close to 30% of women."

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.

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
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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 had several limitations. Health centers' data may not have been consistent in quality due to variations in study patient tracking and data collection processes across sites. Targeted interventions, including calling health centers weekly with a list of expected enrolled patients and monthly in-person audits of each health center's registry, were implemented to improve patient tracking. We also called all patients on POD 30 regarding their follow-up activities and SSI diagnoses. There was 100% agreement between data from registries and phone calls for 228 patients from Arms 1 and 2 captured in both [11]. Secondly, we could not accurately or consistently capture dates of health center visits. As a result, we do not know when within POD 30 women returned to care and whether there were differences between the intervention arms and the control arm. Additional research is needed to assess how CHW interventions affect the timeliness of return to care for post-csection SSI evaluation." Your response is too large. Try shortening some answers.

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

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
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About the CONSORT EHEALTH checklist
Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The National Institute of Health grant number NIH Grant 1R21EB022369" X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study