Effects of a Smartphone-Based Out-of-Hospital Screening App for Neonatal Hyperbilirubinemia on Neonatal Readmission Rates and Maternal Anxiety: Randomized Controlled Trial

Background Neonatal hyperbilirubinemia is one of the leading causes of neonatal readmission—especially severe hyperbilirubinemia and its complications—and it influences disease burden as well as neonatal and maternal health. Smartphones have been shown to have satisfactory accuracy in screening neonatal bilirubin levels, but the impact of this technology on neonatal health care service and maternal health outcomes is still unknown. Objective The aim of this study was to evaluate the impact of a smartphone-based out-of-hospital neonatal jaundice screening program on neonatal readmission rates for jaundice and related maternal anxiety. Methods This was a 2-arm, unblinded, randomized controlled trial with 30 days of intervention and follow-up periods. From August 2019 to August 2020, healthy mother-infant dyads were recruited on-site from 3 public hospitals in Hainan, China. Intervention group mothers used the smartphone app to routinely monitor neonatal jaundice at home under the web-based guidance of pediatricians. Control group participants received routine care. The primary study outcome was the neonatal readmission rate due to jaundice within 30 days of the first hospital discharge. The secondary outcome was the maternal anxiety score associated with neonatal jaundice. The data were collected through a self-assessed questionnaire. All participants were included in the analysis (intention-to-treat). Results In this study, 1424 mother-infant dyads were recruited, comprising 1424 mothers and 1424 newborns. The median age of the mothers was 29 (IQR 26-32) years, and there were 714 (50.1%) male neonates. These mother-infant dyads were randomly assigned to the intervention group and the control group, with 712 dyads in each group; only 1187 of these dyads completed the follow-up. We found that the adjusted 30-day neonatal readmission rate due to jaundice reduced by 10.5% (71/605, 11.7% vs 141/582, 24.2%; 95% CI 5%-15.9%; odds ratio 0.4, 95% CI 0.3-0.5; P<.001) and the relevant maternal anxiety mean score decreased by 3.6 (95% CI –4.4 to –2.8; β=–3.6, 95% CI –4.5 to –2.8; P<.001) in the intervention group compared to those in the routine care group. Conclusions Our study shows that the smartphone-based out-of-hospital screening method for neonatal hyperbilirubinemia decreased the neonatal readmission rate within 30 days from the first discharge and improved maternal mental health to some degree, thus demonstrating the usefulness of this screening app for follow-up in pediatric care. Trial Registration China Clinical Trial Registration Center, ChiCTR2100049567; http://www.chictr.org.cn/showproj.aspx?proj=64245

CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5 -description of the intervention) may also be applicable for other study designs.
The goal of the CONSORT EHEALTH checklist and guideline is to be a) a guide for reporting for authors of RCTs, b) to form a basis for appraisal of an ehealth trial (in terms of validity) CONSORT-EHEALTH items/subitems are MANDATORY reporting items for studies published in the Journal of Medical Internet Research and other journals / scienti c societies endorsing the checklist.
As the CONSORT-EHEALTH checklist is still considered in a formative stage, we would ask that you also RATE ON A SCALE OF 1-5 how important/useful you feel each item is FOR THE PURPOSE OF THE CHECKLIST and reporting guideline (optional).
Mandatory reporting items are marked with a red *. In the textboxes, either copy & paste the relevant sections from your manuscript into this form -please include any quotes from your manuscript in QUOTATION MARKS, or answer directly by providing additional information not in the manuscript, or elaborating on why the item was not relevant for this study.
Is this a full powered effectiveness trial or a pilot/feasibility trial? * Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) TITLE AND ABSTRACT 1a) TITLE: Identification as a randomized trial in the title yes 其他: subitem not at all important 1 2 3 4 5 essential 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") 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 o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.

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Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like  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 brie y explain why the item is not applicable/relevant for your study Not applicable. There were not involved non-web-based components or important cointerventions in our reaearch.
1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "Out-of-Hospital Screening for Neonatal Hyperbilirubinemia Using a Smartphone App: a Randomized Controlled Trial" 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 brie y explain why the item is not applicable/relevant for your study Yes, like this "This was a two-arm, unblinded, randomized controlled trial with 30 days of intervention and follow-up periods. From August 2019 to August 2020, healthy mother-infant dyads were recruited on site from three public hospitals in Hainan Province, China. Intervention group mothers used the smartphone APP to routinely monitor neonatal jaundice at home under the online guidance of paediatricians. Control group participants receive routine care." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGl… 11/58 subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "Intervention group mothers used the smartphone APP to routinely monitor neonatal jaundice at home under the online guidance of paediatricians." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-iii? Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "From August 2019 to August 2020, healthy mother-infant dyads were recruited on site from three public hospitals in Hainan Province, China." "The data was collected through self-assessed questionnaire." 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like  Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "Mobile communication devices have been widely used in the healthcare sector. And such emerging information technologies may help overcome the barriers existing in routine monitoring of neonatal jaundice. Several clinical trials have found that smartphone-based jaundice testing was accurate and cost-effective in identifying neonates with high levels of TSB" "On the basis of routine care, we have established a smartphonebased, family-physician collaborative mechanism for out-of-hospital jaundice screening mechanism. One randomized controlled trial (RCT) was conducted to evaluate whether this smartphone-based intervention could affect the relevant 30-day neonatal readmission and maternal anxiety compared with the routine care." Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes., like this "One randomized controlled trial (RCT) was conducted to evaluate whether this smartphone-based intervention could affect the relevant 30-day neonatal readmission and maternal anxiety compared with the routine care." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "This study was an unblinded, parallel-assignment RCT conducted at three public hospitals in Hainan Province of China, from August 2019 to September 2020. Participants were randomly assigned to either the smartphone-based intervention group or the routine-care control group, and were followed up for 30 days." Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No. There is no change on methods after trial commencement.

3b-i) Bug fixes, Downtimes, Content Changes
Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No. There was no system change after trial commenced.
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like  Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "Eligible mother was at least 16 years old with clear understanding and communication skills, owned a smartphone and was able to use it." 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "Qualified mother-infant dyads were identified and screened face to face by trained obstetric nurses prior to discharge from hospital." subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "Qualified mother-infant dyads were identified and screened face to face by trained obstetric nurses prior to discharge from hospital. All enrolled samples were aware of the trial objective and process, written informed consent was obtained from mothers at study entry." Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "On the 31st day after mother-infant dyad discharged from hospital, the maternal and neonatal outcomes were collected by trained obstetric nurses through telephone follow-up, and the last questionnaire survey was completed in September 2020. " "At recruitment, maternal and neonatal basic demographic characteristics were collected through a self-assessed questionnaire. " 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 brie y explain why the item is not applicable/relevant for your study Yes, like this "On the 31st day after mother-infant dyad discharged from hospital, the maternal and neonatal outcomes were collected by trained obstetric nurses through telephone follow-up, and the last questionnaire survey was completed in September 2020." "Mothers were asked to answer: "Has your baby gone to the hospital again because of jaundice in the past 30 days?", and the corresponding options were Yes or No." " Secondary outcome was the maternal anxiety score associated with neonatal jaundice, which was measured by a self-designed scale (Multimedia Appendix 1). The scale consisted of 10 items with 4-level scoring method, and from "never happened" to "always happened", the scores were coded with 1 to 4 points respectively. The higher the total score (range: 10-40 points), the more serious the anxiety. It has good internal consistency with Cronbach's alpha=0.91. Questions were answered by mothers whose neonate developed jaundice after discharge home. " "At recruitment, maternal and neonatal basic demographic characteristics were collected through a self-assessed questionnaire. " 4b-ii) Report how institutional affiliations are displayed 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable. "From August 2019 to August 2020, mother-infant dyads were recruited on site from three public hospitals in Hainan Province, China." Participants were recruited directly.

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).
Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like  essential 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 brie y explain why the item is not applicable/relevant for your study Yes, like this "The Jaundice Mobile Monitoring App used in this study is a publicly available, free downloadable software in China that allows remote, non-invasive, and self-service jaundice monitoring and early warning. It is used in combination with a jaundice colorimetric card which is required to place on the chest of the child. After judging the image quality, light environment, and skin area, the App will automatically scan and take photos to obtain a clear image of the newborn skin. Once the cloud server receives the image data, jaundice value will be automatically calculated and displayed (automated image-based bilirubin test, AIB), along with an indication of the risk level of neonatal jaundice (Low risk: 2.6~10.1mg/L; medium risk: 10.2~17.1mg/L; high risk: ≥17.2mg/L). A clinical trial conducted to evaluate the screening accuracy of this App found strong concordance between AIB and TSB (r=0.97)"

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b). Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No major change was made after the App was launched.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "A clinical trial conducted to evaluate the screening accuracy of this App found strong concordance between AIB and TSB (r=0.97)" essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The source code can be acquired by contacting author.

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

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like  Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "The Jaundice Mobile Monitoring App used in this study is a publicly available, free downloadable software in China that allows remote, non-invasive, and self-service jaundice monitoring and early warning."

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. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "The Jaundice Mobile Monitoring App used in this study is a publicly available, free downloadable software in China that allows remote, non-invasive, and self-service jaundice monitoring and early warning. It is used in combination with a jaundice colorimetric card which is required to place on the chest of the child. After judging the image quality, light environment, and skin area, the App will automatically scan and take photos to obtain a clear image of the newborn skin. Once the cloud server receives the image data, jaundice value will be automatically calculated and displayed (automated image-based bilirubin test, AIB), along with an indication of the risk level of neonatal jaundice (Low risk: 2.6~10.1mg/L; medium risk: 10.2~17.1mg/L; high risk: ≥17.2mg/L). A clinical trial conducted to evaluate the screening accuracy of this App found strong concordance between AIB and TSB (r=0.97)" "Intervention group mothers received free appropriative jaundice colorimetric cards and installed the Jaundice Mobile Monitoring App on their smartphones at hospital discharge. And they were instructed by trained obstetric nurses about data uploading method. Meanwhile, they were required to detect neonatal bilirubin values using the App when needed after returning home. We assigned a paediatrician from the hospital where the delivery took place to each mother, and bound the mother's and the doctor's versions of Jaundice Mobile Monitoring App together, both parties could use the App platform for communication and consultation. Paediatricians would be able to access the dynamic changes and risk prompts of neonatal bilirubin values synchronously, so as to judge the infants' situation and guide the mother to take correct actions. If neonatal bilirubin was considered to be at high risk level or the condition was quite severe, the paediatrician would alert mother to bring the child return to hospital for further examination and specialist treatment. In addition, paediatricians would supervise and remind mothers to measure newborn infants' jaundice level every day through the App."

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability). subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "Intervention group mothers received free appropriative jaundice colorimetric cards and installed the Jaundice Mobile Monitoring App on their smartphones at hospital discharge. And they were instructed by trained obstetric nurses about data uploading method. Meanwhile, they were required to detect neonatal bilirubin values using the App when needed after returning home. We assigned a paediatrician from the hospital where the delivery took place to each mother, and bound the mother's and the doctor's versions of Jaundice Mobile Monitoring App together, both parties could use the App platform for communication and consultation. Paediatricians would be able to access the dynamic changes and risk prompts of neonatal bilirubin values synchronously, so as to judge the infants' situation and guide the mother to take correct actions. If neonatal bilirubin was considered to be at high risk level or the condition was quite severe, the paediatrician would alert mother to bring the child return to hospital for further examination and specialist treatment. In addition, paediatricians would supervise and remind mothers to measure newborn infants' jaundice level every day through the App." 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). subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "We assigned a paediatrician from the hospital where the delivery took place to each mother, and bound the mother's and the doctor's versions of Jaundice Mobile Monitoring App together, both parties could use the App platform for communication and consultation." 5-xii) Describe any co-interventions (incl. training/support) Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like  essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "On the 31st day after mother-infant dyad discharged from hospital, the maternal and neonatal outcomes were collected by trained obstetric nurses through telephone follow-up, and the last questionnaire survey was completed in September 2020. The primary outcome was the neonatal readmission rate due to jaundice, which was defined as the ratio of the number of neonates readmit to hospitals for jaundice within 30 days of first discharge to the total number of neonates in each group. Mothers were asked to answer: "Has your baby gone to the hospital again because of jaundice in the past 30 days?", and the corresponding options were Yes or No. Secondary outcome was the maternal anxiety score associated with neonatal jaundice, which was measured by a selfdesigned scale (Multimedia Appendix 1). The scale consisted of 10 items with 4-level scoring method, and from "never happened" to "always happened", the scores were coded with 1 to 4 points respectively. The higher the total score (range: 10-40 points), the more serious the anxiety. It has good internal consistency with Cronbach's alpha=0.91. Questions were answered by mothers whose neonate developed jaundice after discharge home. In addition, the intervention group mothers were also asked to rate the Jaundice Mobile Monitoring AppAPP in five aspects (convenience, trustworthiness, recommendation, generalizability and satisfaction), so as to assess the acceptability of the AppAPP. " 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9]. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text Yes, like this "On the 31st day after mother-infant dyad discharged from hospital, the maternal and neonatal outcomes were collected by trained obstetric nurses through telephone follow-up, and the last questionnaire survey was completed in September 2020. " "Secondary outcome was the maternal anxiety score associated with neonatal jaundice, which was measured by a self-designed scale (Multimedia Appendix 1). The scale consisted of 10 items with 4-level scoring method, and from "never happened" to "always happened", the scores were coded with 1 to 4 points respectively. The higher the total score (range: 10-40 points), the more serious the anxiety. It has good internal consistency with Cronbach's alpha=0.91. " 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text Yes, like this "Meanwhile, they were required to detect neonatal bilirubin values using the App when needed after returning home." 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 Yes, like this "On the 31st day after mother-infant dyad discharged from hospital, the maternal and neonatal outcomes were collected by trained obstetric nurses through telephone follow-up" Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No change to trial outcomes after the trial commenced. Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "A sample size calculation was preformed based on primary outcome. Based on previous studies and our hypothesis that the 30-day neonatal readmission rate due to jaundice would relatively reduce 50% in this trial, as well as considered about 10% attrition rate, we estimated that about 600 neonates were needed for each group to ensure the difference could be detected at 80% power (α= .05, 2-sided), i.e., a total requirement of 1200 mother-infant dyads at least." Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable. So we did not provide the explanation of any interim analyses and stopping guidelines.
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 brie y explain why the item is not applicable/relevant for your study Yes, like this "After baseline information were collected, the trained obstetric nurses carried out simple randomization (draw of lots), and allocated each mother-infant dyad to the intervention and control groups." Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "simple randomization (draw of lots)" Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "After baseline information were collected, the trained obstetric nurses carried out simple randomization (draw of lots), and allocated each mother-infant dyad to the intervention and control groups." 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 brie y explain why the item is not applicable/relevant for your study Yes, like this "Qualified mother-infant dyads were identified and screened face to face by trained obstetric nurses prior to discharge from hospital" "After baseline information were collected, the trained obstetric nurses carried out simple randomization (draw of lots), and allocated each mother-infant dyad to the intervention and control groups." 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering cointerventions (if any). Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "This study was an unblinded, parallel-assignment RCT" "Because of the nature of the intervention, it was not possible to blind participants, nor the pediatric nurses who were responsible for participant recruitment and follow-up" 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. participants knew which intervention was the "intervention of interest" and which one was the "control" 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "Participants randomized to the control group received routine care. Under the National Basic Public Health Service Program in China[26], the primary health care institutions conduct newborn home visits (within 1 week of hospital discharge) and full-term health management for newborns (28-30 days after birth). Neonates with high risk factors such as low birth weight and prematurity are visited more frequently according to the actual situation. " "Participants randomized to the intervention group received routine care and the smartphone-based, family-physician collaborative neonatal jaundice screening mechanism. That is, under the remote guidance of a paediatrician, mother monitored routinely neonatal jaundice at home using a smartphone App." subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "All analysis followed intention-to-treat principles, including all the randomly assigned mother-infant dyads. We examined the distributions of baseline characteristics using descriptive statistics, and Pearson chi-square test, Student t-test and Wilcoxon rank sum test were applied to compare the difference between two groups. We conducted analysis using a binary logistic regression model for primary outcome and a multiple linear regression model for secondary outcome, respectively, and reported the odds ratio (OR), regression coefficient (β) and 95% confidence intervals (CI). We adjusted all models for observed baseline maternal and neonatal characteristics (maternal age, nation, education level, employment status, medical insurance, residence, convenience of access to health care, economic status and neonatal gender, gestational age, birth weight, feeding patterns, parity, status of jaundice before discharge, delivery method). We added some post hoc analysis. Firstly, based on least squares regression and identity link function, the generalized linear models were used to enable estimation of adjusted risk difference (RD) for binary outcome and adjusted mean difference (MD) for continuous outcome. Besides, we fitted a linear mixed-effects repeated measures model to maternal anxiety scores at baseline and follow-up, thus capturing whether there was greater improvement in the smartphone-based intervention group than in control group. Sensitivity analysis were done to assess the robustness of the primary and secondary outcomes analysis. We carried out multivariate imputation using chained equations to impute all missing data, including outcomes failure to followed up. " 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] essential Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "We carried out multivariate imputation using chained equations to impute all missing data, including outcomes failure to followed up." Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "We adjusted all models for observed baseline maternal and neonatal characteristics (maternal age, nation, education level, employment status, medical insurance, residence, convenience of access to health care, economic status and neonatal gender, gestational age, birth weight, feeding patterns, parity, status of jaundice before discharge, delivery method)" "We added some post hoc analysis." "Sensitivity analysis were done to assess the robustness of the primary and secondary outcomes analysis." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "The Ethics Committee of Maternal and Child Health Hospital of Hainan Province approved the trial protocol, and all participants provided written informed assent."

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

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 brie y explain why the item is not applicable/relevant for your study Yes, like this "Paediatricians would be able to access the dynamic changes and risk prompts of neonatal bilirubin values synchronously, so as to judge the infants' situation and guide the mother to take correct actions. If neonatal bilirubin was considered to be at high risk level or the condition was quite severe, the paediatrician would alert mother to bring the child return to hospital for further examination and specialist treatment." Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "From August 2019 to August 2020, we screened 5635 mother-infant dyads in three public hospitals, and 1424 were eligible (Figure 1). Among them, 712 were randomly classified into the smartphone-based intervention group; 712 into routine-care control group. On the 31st day of intervention, 605 intervention group and 582 control group mother-infant dyads were followed up and available for analysis, others were lost because of refusal to follow up, drop-outs, etc., with a total retention rate of 83.4%. " "Figure 1"and " subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this " On the 31st day of intervention, 605 intervention group and 582 control group mother-infant dyads were followed up and available for analysis, others were lost because of refusal to follow up, drop-outs, etc., with a total retention rate of 83.4%. " " Figure 1" 13b-i) Attrition diagram Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other gures or tables demonstrating usage/dose/engagement. Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study Yes，like this "From August 2019 to August 2020, we screened 5635 mother-infant dyads in three public hospitals, and 1424 were eligible" "On the 31st day of intervention, 605 intervention group and 582 control group mother-infant dyads were followed up and available for analysis" 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No critical "secular events" fell into the study period.

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, quali cation, expertise, etc.) and centers (volume) in each group subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.
Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like  Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "The median age of mothers was 29 years old (IQR=26-32), 460 (32.3%) lived in rural areas, and the mean (SD) maternal anxiety score associated with neonatal jaundice was 19.6(6.3) (Table 1). 714 neonates were male (50.1%), 899 (63.1%) were natural delivery and most of them were breastfed 1062 (74.6%) ( Table 2). Baseline characteristics were well balanced between the two groups. Moreover, similar demographic characteristics were observed between those who completed this trial and uncompleted (Multimedia Appendix 2). "

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention. Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "Among them, 712 were randomly classified into the smartphone-based intervention group; 712 into routine-care control group. On the 31st day of intervention, 605 intervention group and 582 control group mother-infant dyads were followed up and available for analysis, others were lost because of refusal to follow up, drop-outs, etc., with a total retention rate of 83.4%."

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "All analysis followed intention-to-treat principles, including all the randomly assigned mother-infant dyads" subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "Within 30 days of the first hospital discharge, 412 (68.1%) and 408 (70.1%) neonates in intervention and control groups who were successfully followed up appeared jaundice symptoms, respectively, with no statistical difference between the two groups. The smartphone-based intervention was significantly associated with a decrease (11.7 vs 24.2; RD, 12.5%; 95%CI，-16.8% to -8.2%) in the neonatal readmission rate due to jaundice (OR, 0.4; 95% CI, 0.3~0.6). After adjusting the model, our intervention remained observably effective in reducing the risk of readmission (OR, 0.4; 95% CI, 0.3~0.5), although the degree of reduction was smaller (RD, -10.5%; 95%CI, -15.9% to -5.0%) ( Table 3)." "Maternal anxiety scores associated with neonatal jaundice were apparently lower in smartphone-based intervention group compared with the control group (MD, -3.7; 95% CI, -4.6 to -2.9). The adjusted model showed a similar intervention effect (MD, -3.6; 95% CI, -4.5 to -2.8) ( Table 3). " 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a).
Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable. 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "Within 30 days of the first hospital discharge, 412 (68.1%) and 408 (70.1%) neonates in intervention and control groups who were successfully followed up appeared jaundice symptoms, respectively, with no statistical difference between the two groups. The smartphone-based intervention was significantly associated with a decrease (11.7 vs 24.2; RD, 12.5%; 95%CI，-16.8% to -8.2%) in the neonatal readmission rate due to jaundice (OR, 0.4; 95% CI, 0.3~0.6). After adjusting the model, our intervention remained observably effective in reducing the risk of readmission (OR, 0.4; 95% CI, 0.3~0.5), although the degree of reduction was smaller (RD, -10.5%; 95%CI, -15.9% to -5.0%) ( Table 3)." Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "We performed a post hoc analysis to examine whether improvement in maternal anxiety could be explained by underlying temporal trends. There were 347 intervention group and 348 control group neonates developed jaundice both at baseline and during intervention period follow-up. For these participants, maternal anxiety is shown in Figure 2. From baseline to 31st day follow-up, the mean maternal anxiety score of intervention group reduced by 4.14 (95%CI, -4.9-3.4), however, the control group slightly increased by 1.4 (95%CI, 0.5 to 2.4). Similarly, maternal anxiety scores were significantly lower in intervention group than control group at post-intervention follow-up (Adjusted difference, -4.2, 95% CI, -5.1 to -3.3). "

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 brie y explain why the item is not applicable/relevant for your study 您的回答 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 brie y explain why the item is not applicable/relevant for your study There were no harms or unintended effects in each group. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "More than half of intervention group mothers rated Jaundice Mobile Monitoring App as relatively or very convenient (58.1%) and relatively or very credible (51.0%) in measuring their child's jaundice. 87.1% of mothers were willing to recommend this App to people in need, and 87.7% held a positive attitude towards the necessity of promoting this App on a wide scale. In terms of satisfaction, only 11.1% of mothers showed dissatisfaction with the App. (Multimedia Appendix 4)." 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). Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "In this smartphone-based RCT, we found that the intervention had a significant impact on the neonatal readmission for jaundice within 30 days of the initial discharge, mainly manifested as the readmission rate in intervention group was 10.5% (-15.9% to -5.0%) lower than control group. In contrast with control group, maternal anxiety symptoms induced by neonatal jaundice were also less severe in those who installed and used the Jaundice Mobile Monitoring App."

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 brie y explain why the item is not applicable/relevant for your study Yes, like this "Although it can be regarded as a good auxiliary screening tool for neonatal jaundice in some cases, there is a scope to improve the acceptability of Jaundice Mobile Monitoring App. For example, the proportion of mothers who explicitly expressed satisfaction was less than 50%. The potential reason may be that the App was developed by a non-healthcare provider, leading to some concerns about the accuracy and credibility of its information. In this regard, we suggest that on the premise of ensuring the quality of jaundice screening technology, telemedicine guidance from healthcare professionals should be facilitated, and related units should optimize their publicity and promotion strategies."

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "Although research results have important clinical implications, several limitations should be recognized. Firstly, as we did not restrict the hospitals to which participants were readmitted, it was not possible to obtain and check all neonates' visit records from three study hospitals, so self-reported data was uniformly used in all outcomes. While some recall bias was inevitable, the short follow-up period (only 30 days) and the fact that parents usually attach importance to neonatal health and remember relatively well whether or not their child visited a doctor again, so the recall bias was minimized. Secondly, due to the unavailability of return visit records, we could not assess whether or not our intervention increased the readmission rate related to worsening neonatal hyperbilirubinemia, despite a significant drop in the overall rate. However, our intervention approaches are unlikely to delay admission to hospital for serious jaundice under the guidance of paediatricians. Finally, the trial was limited by the study site, in comparison with other reports [27,28,31], the 30-day neonatal readmission rate due to jaundice was higher in our study. This is partly due to inconsistent post-discharge follow-up period across studies, but may also be due to the high prevalence of neonatal hyperbilirubinemia in Hainan Province, China, a region with severe erythrocyte glucose 6 phosphate dehydrogenase (G6PD) deficiency [41,42]. It may affect the applicability of our findings to other populations. Therefore, it is necessary to validate the effectiveness of the intervention in a larger sample or in a cross-cultural context."

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, like this "The application of smartphone App in the monitoring of neonatal jaundice fit in with the widespread use of mobile technology currently, and the global Internet usage rate has reached 65.6% as of March 31, 2021[39]. The previous cost-benefit analysis found that for every 1 RMB invested in the smartphone-based, out-of-hospital screening mechanism for neonatal jaundice, 18.76 RMB was saved in the treatment cost of later neonatal jaundice [40]. The characteristics of low cost and high accessibility make Jaundice Mobile Monitoring App more practical for areas with backward medical conditions or inconvenient treatment. Meanwhile, this family-centered jaundice monitoring may contribute to alleviating the shortage of paediatric specialists, promoting the implementation of basic public health service program." 21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other cointerventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

X27) Conflicts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study Yes, like  X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
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 brie y explain why the item is not applicable/relevant for your study Yes, like  As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?

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How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * We spend 3 hours on going through the checklist INCLUDING making changes in your manuscript.
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