Hearing Rehabilitation With a Chat-Based Mobile Auditory Training Program in Experienced Hearing Aid Users: Prospective Randomized Controlled Study

Background Hearing rehabilitation with auditory training (AT) is necessary to improve speech perception ability in patients with hearing loss. However, face-to-face AT has not been widely implemented due to its high cost and personnel requirements. Therefore, there is a need for the development of a patient-friendly, mobile-based AT program. Objective In this study, we evaluated the effectiveness of hearing rehabilitation with our chat-based mobile AT (CMAT) program for speech perception performance among experienced hearing aid (HA) users. Methods A total of 42 adult patients with hearing loss who had worn bilateral HAs for more than 3 months were enrolled and randomly allocated to the AT or control group. In the AT group, CMAT was performed for 30 minutes a day for 2 months, while no intervention was provided in the control group. During the study, 2 patients from the AT group and 1 patient from the control group dropped out. At 0-, 1- and 2-month visits, results of hearing tests and speech perception tests, compliance, and questionnaires were prospectively collected and compared in the 2 groups. Results The AT group (n=19) showed better improvement in word and sentence perception tests compared to the control group (n=20; P=.04 and P=.03, respectively), while no significant difference was observed in phoneme and consonant perception tests (both P>.05). All participants were able to use CMAT without any difficulties, and 85% (17/20) of the AT group completed required training sessions. There were no changes in time or completion rate between the first and the second month of AT. No significant difference was observed between the 2 groups in questionnaire surveys. Conclusions After using the CMAT program, word and sentence perception performance was significantly improved in experienced HA users. In addition, CMAT showed high compliance and adherence over the 2-month study period. Further investigations are needed to validate long-term efficacy in a larger population. Trial Registration Clinical Research Information Service (CRiS) KCT0006509; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22110&search_page=L

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) 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") 23. 6. 26.오후 9:14 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGl… 6/45 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.

선택해제
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 "Chatbot-Delivered Mobile Auditory Training Program"

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 There is no non-web-based components.
23. 6. 26.오후 9:14 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGl… 7/45 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 "in Experienced Hearing Aids Users" 1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Mention key features/functionalities/components of the intervention and comparator in the abstract.If possible, also mention theories and principles used for designing the site.Keep in mind the needs of systematic reviewers and indexers by including important synonyms.(Note: Only report in the abstract what the main paper is reporting.If this information is missing from the main body of text, consider adding it) 선택해제 23. 6. 26.오후 9:14 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGl… 8/45 subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-i?* Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "In the AT group, CMAT was performed for 30 minutes a day for 2 months, and no intervention was provided in the control group." 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) 선택해제 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 "A total of 42 adult hearing loss patients who had worn bilateral hearing aids for more than 3 months were enrolled and randomly allocated to the AT or control group."23. 6. 26. 오후 9:14 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGl… 9/45

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 INTRODUCTION 2a) In INTRODUCTION: Scientific background and explanation of rationale Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The AT group (n=19) showed better improvement in word and sentence perception tests compared to control group (n=20, p<0.05) and no significant difference was observed in phoneme and consonant perception tests.All participants were able to use CMAT without any difficulties and 85 % (17/20) of the AT group completed required training session."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 brie y explain why the item is not applicable/relevant for your study "However, no significant difference was observed between the two groups in questionnaire surveys."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 brie y explain why the item is not applicable/relevant for your study "Several mobile and/or web-based AT programs have been introduced in the last decade.However, many mobile-based AT applications are simple gamified training programs for pediatric patients and most of them have no clinical validation to support their efficacy [16].Even though a state-of-the-art review showed AT to be effective for improving auditory perceptions [17], it is unclear whether mobile-based training will still be effective.Digital therapeutics are expected to change the future of the healthcare system; however, clinical validation should be performed to prove their effectiveness first [18].In addition, the effect of AT on experienced HA users is inconsistently reported while the effect of AT on novel HA users is relatively clear.Of the 16 studies included in a state-of-the-art review on AT, only three investigated experienced HA users, and only one of these studies showed improvements in speech perception [19][20][21]."2a-ii) Scientific background, rationale: What is known about the (type of) system Scienti c background, rationale: What is known about the (type of) system that is the object of the study (be sure to discuss the use of similar systems for other conditions/diagnoses, if appropiate), motivation for the study, i.e. what are the reasons for and what is the context for this speci c study, from which stakeholder viewpoint is the study performed, potential impact of ndings [2].Brie y justify the choice of the comparator.Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Although AT is known to improve hearing performance and lower the hearing aid return rate, it has been not sufficiently provided to hearing loss patients due to its poor time-and costeffectiveness [7][8][9].In our previous randomized controlled trial, we reported significant improvements in consonant perception and subjective satisfaction after 8 weeks of AT consisting of in-hospital face-to-face education and at-home self-training among HA users [10].However, we experienced the limitations of in-hospital training programs during the COVID-19 pandemic and it led us to consider a mobile-based AT program."

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 "Therefore, this prospective randomized controlled study was conducted to investigate the efficacy of our novel chatbot-delivered mobile AT (CMAT) program for hearing rehabilitation in experienced HA users in three respects: speech perception ability, subjective satisfaction and training compliance."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 "A prospective, randomized, controlled trial with an unblinded study setting was carried out.
[...] The randomization was provided by pre-made random cards with a 1:1 allocation ratio, and the cards were opened after obtaining informed consent."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 Not applicable.No changes to methods were done after trial commencement.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. [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 brie y explain why the item is not applicable/relevant for your study Not applicable.No technical changes were undertaken after trial commencement.

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 "Study eligibility criteria were as below.
(2) Bilateral moderate to severe sensorineural hearing loss patients (mean threshold of pure tone audiometry measured at 500, 1000, 2000, and 4000 Hz was 41 to 80 dB HL and air-bone gap less than 15 dB HL).

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 "(4) Exclusion: [...] or difficulties in using the program and coordinating hearing tests."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 "Our novel CMAT program was developed in the form of a web-based program that can be accessed from computers, tablets and smartphones.However, all subjects were connected with a smartphone in this clinical trial to avoid device bias.","All participants completed audiologic tests, speech perception tests and questionnaires at the 0-, 4-, and 8-week visits." 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 "Bilateral HA users were recruited from the department of otorhinolaryngology-head and neck surgery at a tertiary referral center between September 2021 and December 2021.[...] and the cards were opened after obtaining informed consent."

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 "All participants completed audiologic tests, speech perception tests and questionnaires at the 0-, 4-, and 8-week visits, and the results were collected using the Excel program (Microsoft, Redmond, WA, USA)." 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 Not relevant."All participants completed audiologic tests, speech perception tests and questionnaires at the 0-, 4-, and 8-week visits, [...]"

4b-ii) Report how institutional affiliations are displayed
Report how institutional a liations are displayed to potential participants [on ehealth media], as a liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Nota 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 brie y explain why the item is not applicable/relevant for your study 내 답변 23. 6. 26.오후 9:14 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 17/45 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 "Jaehyuk Lee, is the developer of the software (NARA INFORMATION, Co., LTD, Seoul, Republic of Korea)."

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

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 Not applicable.No changes to methods were done after trial commencement.

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 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 "Figure 1. Operation schematic diagram of chatbot-delivered auditory training program."

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 brie y explain why the item is not applicable/relevant for your study Not applicable; The program is in preparation for commercialization.

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 Not applicable; The program is in preparation for commercialization.

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
Describe mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework [6] used to design them (instructional strategy [1], behaviour change techniques, persuasive features, etc., see e.g., [7,8] for terminology).This includes an in-depth description of the content (including where it is coming from and who developed it) [1]," whether [and how] it is tailored to individual circumstances and allows users to track their progress and receive feedback" [6].This also includes a description of communication delivery channels and -if computer-mediated communication is a component -whether communication was synchronous or asynchronous [6].It also includes information on presentation strategies [1], including page design principles, average amount of text on pages, presence of hyperlinks to other resources, 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 "Our novel CMAT program was developed in the form of a web-based program that can be accessed from computers, tablets and smartphones.However, all subjects were connected with a smartphone in this clinical trial to avoid device bias.When a subject accessed a provided link, the ID and password given during subject registration were required to be entered, and a page was provided to additionally confirm the consent form for clinical trials and collection of personal information.Afterward, a problem was presented in a chatbot delivery.Participants could choose one of four answers and a message was shown giving feedback when a problem was resolved.All subjects were instructed to train in a quiet place while wearing their HAs."

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 brie y explain why the item is not applicable/relevant for your study "Randomly assigned ten-word and ten-sentence questions were provided to be solved in one session, and the participants included in the ATG were asked to repeat the session three times a day, similar to our previous study."23. 6. 26

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 brie y explain why the item is not applicable/relevant for your study 내 답변

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc.It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

Does your paper address subitem 5-xi? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The log-in time and the number of questions solved were automatically collected by the program; however, prompts to use the CMAT were not provided."

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 "Participants allocated to the auditory training group (ATG) were provided instructions about the CMAT program by a co-author (Jaehyuk Lee) and were encouraged to use it daily for 8 weeks."

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 "Among these measured outcomes, speech perception tests were used as the primary endpoint, and questionnaire results were used as the secondary endpoint." 23. 6. 26.오후 9:14 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 24/45

Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text 내 답변 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.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 내 답변 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 Not applicable.No changes to trial outcomes were done.

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.선택해제 23. 6. 26.오후 9:14 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 26/45 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 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 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 "Assuming that the effect of offline auditory training and CMAT would be similar, the number of target subjects was determined in the same way as in our previous study [10].For statistical significance at 0.05 confidence level with 80% power, the sample size required for the two groups was estimated as 18 patients per group.Allowing for a 10% dropout rate, 42 patients were estimated to be required in total."

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.No interim analysis was done.

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 "The randomization was provided by pre-made random cards with a 1:1 allocation ratio, and the cards were opened after obtaining informed consent."

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 "The randomization was provided by pre-made random cards with a 1:1 allocation ratio, and the cards were opened after obtaining informed consent."https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 27/45 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Copy and paste relevant sections from the manuscript (include quotes in quotation 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 " 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 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 "The randomization was provided using pre-made random cards with a 1:1 allocation ratio, prepared by a Contract Research Organization (Medical Excellence, Seoul, South Korea).The cards were then opened by the healthcare provider after obtaining informed consent."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 "A prospective, randomized, controlled trial with an unblinded study setting was carried out." 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 brie y explain why the item is not applicable/relevant for your study 내 답변 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 Not applicable; no placebo provided.Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Statistical analysis was conducted using SAS Version 9.4 (SAS Institute, Cary, NC).The Shapiro-Wilk test was used to examine the normality of the measured variables.Data were expressed as mean, standard deviation (SD), and percentage.P values were calculated using the Chi-square test or Fisher's exact test for categorical variables, the Mann-Whitney test or independent t-test for two independent variables, the Wilcoxon rank sum test or paired t-test for continuous variables.Speech perception tests and questionnaire surveys were analyzed with a linear mixed-effect model and post-hoc test.Bonferroni correction was used in case of multiple comparisons and adjusted p-values are presented.Correlation between two variables was analyzed by Pearson's correlation test.Differences were considered significant when the p-value was less than 0.05."

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 brie y explain why the item is not applicable/relevant for your study Not applicable.No imputation techniques were used.

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 Not applicable; no subgroup 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 내 답변

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 내 답변 23. 6. 26.오후 9:14 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 31/45 subitem not at all important 1 2 3 4 5 essential 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 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 brie y explain why the item is not applicable/relevant for your study 내 답변 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

*
Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "A total of 42 participants were initially enrolled after informed consent was obtained.Twenty-one patients were randomly allocated to ATG and CG each, and one participant was subsequently withdrawn from ATG due to withdrawal of consent.During the study follow-up duration of 2 months, one participant in ATG was excluded from analysis due to low compliance (CMAT completion rate < 50%), and one participant in CG was excluded for refusing to perform speech perception tests.Therefore, 19 participants in ATG and 20 participants in CG were analyzed.(Fig. 2) None of the participants in ATG had any problems using CMAT during the study."

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 내 답변 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 "Bilateral HA users were recruited from the department of otorhinolaryngology-head and neck surgery at a tertiary referral center between September 2021 and December 2021."," [...]

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 내 답변 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.The study was not terminated earlier.

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 "Table 1. Clinical characteristics of the participants."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.

선택해제
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 "Table 1. Clinical characteristics of the participants."

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.
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 35/45 subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address subitem 16-i?* Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Except for one participant who withdrew consent from ATG, all subjects (n=20) in the intervention group accessed the CMAT program in a mobile environment.One of 20 participants (5 %) was excluded from the analysis of this study because the duration of CMAT use was less than 50 % of the recommended time.The remaining 19 participants (95 %) completed at least 50 % of the training sessions and 17 (85 %) completed more than the required sessions.Log-in time, completion rate and score of all participants were collected by the CMAT program and analyzed.Mean (SD) of daily application log-in time was 20.3 (11.4) minutes in the first month and 20.4 (10.7) minutes in the second.The completion rate was higher than our recommendation; 123.7 (71.4) % in the first month and 128.5 (61.3) % in the second month.There were no statistically significant differences among these variables (P > .05,Wilcoxon signed rank test).(Fig. 5A)"

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 Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Except for the vowel imitation test, the initial scores of all tests were high in CG, and the initial consonant imitation test showed a statistically significant difference.(adjusted P = .009,Mann-Whitney test with Bonferroni correction) Therefore, the 4 kHz threshold of the right ear was adjusted because high-frequency hearing loss is a well-known factor for hearing perception, when analyzing the linear mixed model [29].In the Ling-6-sound test, mean (SD) percent of correct answers significantly improved from 75.4 (17.0) % to 89.7 (9.1) % in ATG (Time post hoc P = .004,linear mixed model), and from 80.8 (15.6) % to 91.7 (8.6) % in CG. (Time post hoc P = .008,linear mixed model) There was a significant difference in inter-group analysis (P = .53,linear mixed model) In the vowel imitation test, significant improvement was observed only in ATG (58.8 (18.7) % to 74.3 (14.6) % (Time post hoc P < .001,linear mixed model), and there was no significant difference in CG (Time post hoc P = .15,linear mixed model).In the consonant imitation test, significantly better scores were observed after 2 months in both ATG (84.2 (14.6) % to 92.5 (9.4) %, Time post hoc P = .03,linear mixed model) and.CG (83.9 (17.5) % to 94.3 (7.6) %, Time post hoc P = .002,linear mixed model).However, the inter-group analysis showed no statistically significant difference in either condition.(P > .05,linear mix model) In the open-set mono-syllable test, the percent of correct answers significantly increased from 62.3 (16.7) % to 75.9 (11.6) % in ATG (Time post hoc P < .001,linear mixed model) and from 70.9 (11.5) % to 81.1 (12.3) % in CG (Time post hoc P = .003,linear mixed model).However, there was no statistically significant difference on inter-group analysis.(P = .36,linear mix model) In the bi-syllable condition, the percent of correct answers was significantly improved from 76.1 (18.1) % to 88.6 (9.3) % only in ATG (Time post hoc P < .001,linear mixed model) and not in CG (Time post hoc P = .19,linear mixed model).The inter-group analysis showed significantly better results in ATG (P = .04,linear mix model).In the K-CID test, the percentage of correct answers was significantly improved in both groups; 82.3 (15.5) % to 94.0 (7.2) % (Time post hoc P < .001,linear mixed model) in ATG and 90.2 (9.5) % to 96.8 (5.7) % in CG (Time post hoc P = .001,linear mixed model).The inter-group analysis showed significant improvement in ATG (P = .03,linear mixed model).In addition, almost the same results were obtained when analyzing after performing arcsine transformation on the percentage values.All results of the speech perception tests are presented in Table 2 and Figure 4."

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).
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 37/45 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory subitem not at all important 1 2 3 4 5 essential Does your paper address 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 내 답변 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 Not applicable; no binary outcomes.

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 "There was no significant difference between the two groups in all three types of questionnaire surveys (P > .05,linear mixed model).Detailed results are described in supplementary 1."

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).Copy and paste relevant sections from the manuscript (include quotes in quotation 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 내 답변 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 "None of the participants in ATG had any problems using CMAT during the study."

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

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

Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 내 답변 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 "In this study, we developed a new CMAT program in the Korean language and confirmed its effectiveness in improving speech perception abilities with high compliance in experienced bilateral HA users." 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 내 답변

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.Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "Thirdly, this study was not blinded, and the potential risk of a Type I error should be considered."

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 내 답변 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.
) Identify the mode of delivery in the title : Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status. ) 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 선택해제 Does your paper address subitem 1a-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).Note: In traditional o ine 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) 23. 6. 26.오후 9:14 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGl… 11) Problem and the type of system/solution https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 12/45 2b) In INTRODUCTION: Specific objectives or hypotheses METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address subitem 2a-ii?* 23. 6. 26.오후 9:14 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 15and locations where the data were collected 4a-iii) Information giving during recruitment 23. 6. 26.오후 9:14 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 16interventions for each group with sufficient details to allow replication, including how and when they were actually administered 4b-i) Report if outcomes were (self-)assessed through online questionnaires ) Mention names, credential, affiliations of the developers, sponsors, and owners 26. 오후 9:14 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 18/45 subitem not at all important 26. 오후 9:14 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 19/45subitem not at all important ) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used 23. 6. 26.오후 9:14 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 20/45 subitem not at all important [1].23. 6. 26.오후 9:14    CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 21/45subitem not at all important address subitem 5-viii?* . 오후 9:14 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 22 23. 6. 26.오후 9:14 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 23defined pre-specified primary and secondary outcome measures, including how and when they were assessed 5-xii) Describe any co-interventions (incl.training/support) Describe any co-interventions (incl.training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention.This includes training sessions and support [1].It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability.
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].