Effectiveness of a Mobile App Intervention for Preparing Preschool Children and Parents for Day Surgery: Randomized Controlled Trial

Background Day surgery allows families to return home quickly. Only a few approaches to preparing for day surgery have demonstrated how digital solutions can support families and children. Objective This study aims to evaluate the effectiveness of a mobile app intervention on preschool children’s fear and pain and parents’ anxiety and stress in preparing children for day surgery. Methods This study was conducted at the Pediatric Day Surgical Department of a university hospital in Finland between 2018 and 2020. Parents of children (aged 2-6 y) who were in a queue for elective day surgery were randomized into the intervention group (IG; n=36) and control group (CG; n=34). The CG received routine preparations, whereas the IG was prepared using a mobile app. Parents’ and children’s outcomes were measured using validated scales at 4 different points: at home (T1 and T4) and at the hospital (T2 and T3) before and after surgery. Group differences were analyzed using statistical methods suitable for the material. Results Before surgery, parents in both groups experienced mild anxiety, which decreased after surgery. Parental anxiety did not differ between groups preoperatively (P=.78) or postoperatively (P=.63). Both groups had less anxiety at home after surgery compared with before. The IG showed a significant decrease (P=.003); the CG also improved (P=.002). Preoperatively at home, most parents in both groups experienced no stress or mild stress (P=.61). Preoperatively at the hospital, parents in both groups experienced mild stress; however, parents in the IG experienced more stress during this phase (P=.02). Parents in the IG experienced significantly less stress postoperatively than those in the CG (P=.05). Both groups showed decreased stress levels from before to after surgery (IG: P=.003; CG: P=.004) within each group. There were no significant differences in children’s pain levels between the groups and measurement points. This was observed before surgery at home (P=.25), before surgery at the hospital (P=.98), and after surgery at the hospital (P=.72). Children’s fear decreased more in the IG (P=.006) than in the CG (P=.44) comparing the phases before and after surgery at home. Fear did not differ between the IG and CG preoperatively at home (P=.20) or at the hospital (P=.59) or postoperatively at the hospital (P=.62) or at home (P=.81). Conclusions The mobile app intervention did not reduce anxiety or pain. However, it was observed that parents in the IG experienced substantially heightened stress levels before surgery at the hospital, which decreased significantly after surgery at home. In addition, fear levels in children in the IG decreased over time, whereas no significant change was observed in the CG. These results are important for developing health care service chains and providing families with innovative and customer-oriented preparation methods. Trial Registration ClinicalTrials.gov NCT03774303; https://classic.clinicaltrials.gov/ct2/show/NCT03774303


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. 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 T y h j e n n ä v a l i n t a 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 Effectiveness of a mobile application intervention for preparing preschool children and parents for day surgery: a randomized controlled trial 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 "Parents of children (ages 2-6 years) who were in a queue for elective day surgery were randomized into intervention (IG, n=36) and control (CG, n=34) groups. The CG received routine preparation while the IG was prepared using a mobile application." 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) T y h j e n n ä v a l i n t a 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 "Parents of children (ages 2-6 years) who were in a queue for elective day surgery were randomized into intervention (IG, n=36) and control (CG, n=34) groups. The CG received routine preparation while the IG was prepared using a mobile application." subitem not at all important 1 2 3 4 5 essential 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). 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) T y h j e n n ä v a l i n t a 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 "Parents and children's outcomes were measured using validated scales at four different points: at home (T1, T4) and hospital (T2, T3), before and after surgery. Group differences were analyzed using statistical methods suitable for the material." subitem not at all important 1 2 3 4 5 essential 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) T y h j e n n ä v a l i n t a 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 "Before surgery, parents in both groups experienced mild anxiety and stress, which decreased after the surgery. Parental anxiety did not differ between the groups preoperatively (P=.78) or postoperatively (P=.63). Both groups had less anxiety at home after surgery than before, with the IG showing a significant decrease (P=.003) and the CG also improving (P=.002 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 "The aim of this study was to evaluate the effectiveness of a mobile application intervention for preparing preschool children and their parents for pediatric day surgery. In this study, children's pain and fear, and parents` anxiety and stress, were measured at home and hospital before and after day surgery. The first hypothesis was that parents of the intervention group would show lower levels of anxiety and stress at home and hospital before and after the day surgery than parents in the control group. The second hypothesis was that preschool children of the intervention group would show lower levels of pain and fear at home and hospital before and after the day surgery than preschool children in the control group." 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 employed a two-armed randomized controlled trial (RCT) design." subitem not at all important 1 2 3 4 5 essential 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 "There were no changes made to the methods after the trial commenced."

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. [2].
T y h j e n n ä v a l i n t a 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 "There were no changes made to the methods after the trial commenced." 4a) Eligibility criteria for participants subitem not at all important 1 2 3 4 5 essential 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 "The study was conducted between January 2018 and May 2020 at the Pediatric Day Surgical Department of one University Hospital in Finland. Participants included the parents of preschool children (2-6 years old) who were due to undergo elective day surgery under general anesthesia. The other inclusion criteria are listed in Table 1. The mobile application was available for use for 3-4 weeks before the operation, so that parents had sufficient time to use the mobile application to prepare for their child's surgery."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed. 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 "Parents with access to an Android or iOS phone, iPad, or an internet browser." 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 "The application contained information for both parents and children, presented in various formats including video, photo and written instructions. Contents included images of the day surgery unit, instructions for the surgery and pain care, information on how to get to the hospital and the ward, notifications and the necessary forms. After registering on the application, users' information was passed on to the hospital, allowing health care professionals (HCPs) to keep track of a family's preparation for the surgery. The application also included a video describing the progression through surgery at the hospital (arrival to discharge, along with information about some non-pharmacological pain management methods), from both the child's and parent's perspective. This version did not have a chat feature."

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.
T y h j e n n ä v a l i n t a 4b) Settings and locations where the data were collected Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A pediatric surgeon assessed the need for surgery and put the child in the surgery queue. After planning the surgery, the schedule went to secretaries who had been trained by the researcher to facilitate the study. Patients suitable for the study were selected from the schedule according to the selection criteria. Each month, the secretaries provided the researcher with information about the number of study families identified and their details. The researcher then called the families and asked about their willingness to participate in the study. After receiving oral consent, the secretaries sent the families written informed consent forms relating to the study, instructions, and questionnaires. The parents were informed about the study both verbally and in writing. Families in the IG also received instructions for logging in to the mobile application and using the application, through which they could access instructions for preparing for the surgery. The CG received the conventional preparation instructions." 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 "The study was conducted between January 2018 and May 2020 at the Pediatric Day Surgical Department of one University Hospital in Finland. Participants included the parents of preschool children (2-6 years old) who were due to undergo elective day surgery under general anesthesia. The other inclusion criteria are listed in Table 1. The mobile application was available for use for 3-4 weeks before the operation, so that parents had sufficient time to use the mobile application to prepare for their child's surgery." subitem not at all important 1 2 3 4 5 essential 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 "The forms sent home to parents were coded using the same code that was used for T2 and T3. The questionnaires designed for parents with children were organized in a manner such that each page featured only one meter and provided concise instructions for completing it." subitem not at all important 1 2 3 4 5 essential 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 4b-ii) Report how institutional affiliations are displayed 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 Oma vastauksesi subitem not at all important 1 2 3 4 5 essential 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 Section Application use by parents subitem not at all important 1 2 3 4 5 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 Section Developing and piloting the mobile application subitem not at all important 1 2 3 4 5 essential

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 Oma vastauksesi subitem not at all important 1 2 3 4 5 essential 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 Section Validity, reliability, and rigor subitem not at all important 1 2 3 4 5 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

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 Oma vastauksesi subitem not at all important 1 2 3 4 5 essential

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

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 We Assessing user engagement on our application presents a significant challenge. Metrics such as login frequency and session duration are not entirely reliable indicators of user activity. Though we have yet to establish a dependable way of tracking questionnaire completion rates, we have observed that parents have consistently exhibited timely task and survey completion behaviors. This is evidenced by the nearly 100% acknowledgement rates for timeline events.

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 "The intervention was developed through multi-professional collaboration, taking into account expert input from nurses and physicians involved in pediatric day surgery. The development process also took into consideration that each hospital, family and child is unique. The information provided in the application was easy to understand, using a simple timeline and incorporating the routine preparation material received by the CG. The purpose of the timeline was to inform users about the phases of surgery and give information to families at the relevant time. (Figure 2). " subitem not at all important 1 2 3 4 5 essential 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 application contained information for both parents and children, presented in various formats including video, photo and written instructions. Contents included images of the day surgery unit, instructions for the surgery and pain care, information on how to get to the hospital and the ward, notifications and the necessary forms. After registering on the application, users' information was passed on to the hospital, allowing health care professionals (HCPs) to keep track of a family's preparation for the surgery. The application also included a video describing the progression through surgery at the hospital (arrival to discharge, along with information about some non-pharmacological pain management methods), from both the child's and parent's perspective. This version did not have a chat feature." subitem not at all important 1 2 3 4 5 essential 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.
T y h j e n n ä v a l i n t a 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 "The application contained information for both parents and children, presented in various formats including video, photo and written instructions. Contents included images of the day surgery unit, instructions for the surgery and pain care, information on how to get to the hospital and the ward, notifications and the necessary forms. After registering on the application, users' information was passed on to the hospital, allowing health care professionals (HCPs) to keep track of a family's preparation for the surgery. The application also included a video describing the progression through surgery at the hospital (arrival to discharge, along with information about some non-pharmacological pain management methods), from both the child's and parent's perspective. This version did not have a chat feature." 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 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 "On arrival at the hospital, parents brought the written consent form along with the first stage assessment (T1), which they had completed at home. This first baseline assessment included general demographic data, along with parents' self-reported stress and anxiety, and children`s reported pain and fear. After the physician had met the child and made the final decision for surgery, a nurse collected follow-up data in the hospital before the child's procedure (T2) and after the surgery, and before the child was discharged from the hospital (T3). In the second (T2) and third (T3) measurements, parents were asked to rate the stress they experienced. After the child and parents returned home, one parent took the study-related measures for three days at home, 1-3 times a day depending on the assessment (T4). In the second assessment parents selfreported their anxiety and stress and their child's self-reported pain and fear regarding the care (Figure 1). The forms sent home to parents were coded using the same code that was used for T2 and T3. The questionnaires designed for parents with children were organized in a manner such that each page featured only one meter and provided concise subitem not at all important 1 2 3 4 5 essential 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].
Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text "After receiving oral consent, the secretaries sent the families written informed consent forms relating to the study, instructions, and questionnaires. The parents were informed about the study both verbally and in writing. Families in the IG also received instructions for logging in to the mobile application and using the application, through which they could access instructions for preparing for the surgery. The CG received the conventional preparation instructions. On arrival at the hospital, parents brought the written consent form along with the first stage assessment (T1), which they had completed at home. This first baseline assessment included general demographic data, along with parents' self-reported stress and anxiety, and children`s reported pain and fear. After the physician had met the child and made the final decision for surgery, a nurse collected follow-up data in the hospital before the child's procedure (T2) and after the surgery, and before the child was discharged from the hospital (T3). In the second (T2) and third (T3) measurements, parents were asked to rate the stress they experienced. After the child and parents returned home, one parent took the study-related measures for three days at home, 1-3 times a day depending on the assessment (T4). In the second assessment parents self-reported their anxiety and stress and their child's self-reported pain and fear regarding the care (Figure 1). The forms sent home to parents were coded using the same code that was used for T2 and T3. The questionnaires designed for parents with children were organized in a manner such that each page featured only one meter and provided concise instructions for completing it." subitem not at all important 1 2 3 4 5 essential 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 "Parents randomized to the IG received instructions for downloading the free BuddyCare application (Android or iOS) and its activation code 3-4 weeks before their child's surgery. Alternatively, the parents could access a web-based application portal via a web browser.
The application reminded users about important instructions to be followed two weeks before and one week after the surgery. Hospital staff assigned a start date, time limit, and expiration date for various tasks and instructions, based on their assessment of when particular information was relevant to the child and their family. The timeline employed color-coding and spacers to make it easy for both children and family members to comprehend. The family was also able to access information in different formats based on their preferences. All the children and parents undergoing the same surgery received the same information at the same time. Forms filled out through the application went directly to hospital staff. Hospital staff could monitor the utilization rate of the application throughout, but its contents were not modified during the study. No problems with the application were reported during the study period. Families who did not use the application were contacted directly. In this study, we utilized the TIDieR ( 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 changes to trial outcomes after the trial commenced 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 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 "According to a study by Kain et al. (2009), 46% of all parents experience anxiety before surgery, as measured by the State-Trait Anxiety Inventory (STAI). To determine our sample size, we used the findings from Kain et al.'s study, which had an intervention group with a mean of 39.7 and a standard deviation of 11.5, and a control group with a mean of 48.6 and a standard deviation of 13.1. Our study focused on the primary outcome of parental anxiety, as measured by the STAI scale. An independent samples t-test with a two-sided alpha value of 0.05 and 80% power estimated that 50 participants would be required for the study, with 25 participants in each group (intervention and control). We adjusted the sample size to account for a potential 30% drop-out rate. As a result, the final sample consisted of 71 participants, with 36 in the intervention group and 35 in the control group. A total of 71 parents were recruited and randomized [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) 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 Oma vastauksesi 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 eligible participants were stratified into five strata according to the age of the child undergoing surgery (2, 3, 4, 5, and 6 years), and then randomized into each group at a 1:1 ratio. We used stratified simple randomization to keep the groups as similar as possible [46]. The researcher prepared two envelopes in advance, with one for 2-year-olds and the other for children up to the age of six. A total of 10 notes were placed into each age group envelope, five of which were allocated into the intervention group (IG) and the remaining five allocated into the control group (CG). Following ethical guidelines, after a telephone conversation with each set of parents, the researcher took one note from the envelope corresponding to the child's age group to determine whether the family was allocated to the IG or CG. Both researcher and participants were unaware of which group they were allocated to prior to the study. A flow chart of the study is presented in Figure 1." 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 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 eligible participants were stratified into five strata according to the age of the child undergoing surgery (2, 3, 4, 5, and 6 years), and then randomized into each group at a 1:1 ratio. We used stratified simple randomization to keep the groups as similar as possible [46]. The researcher prepared two envelopes in advance, with one for 2-year-olds and the other for children up to the age of six. A total of 10 notes were placed into each age group envelope, five of which were allocated into the intervention group (IG) and the remaining five allocated into the control group (CG). Following ethical guidelines, after a telephone conversation with each set of parents, the researcher took one note from the envelope corresponding to the child's age group to determine whether the family was allocated to the IG or CG. Both researcher and participants were unaware of which group they were allocated to prior to the study. A flow chart of the study is presented in Figure 1." 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 "The eligible participants were stratified into five strata according to the age of the child undergoing surgery (2, 3, 4, 5, and 6 years), and then randomized into each group at a 1:1 ratio. We used stratified simple randomization to keep the groups as similar as possible [46]. The researcher prepared two envelopes in advance, with one for 2-year-olds and the other for children up to the age of six. A total of 10 notes were placed into each age group envelope, five of which were allocated into the intervention group (IG) and the remaining five allocated into the control group (CG). Following ethical guidelines, after a telephone conversation with each set of parents, the researcher took one note from the envelope corresponding to the child's age group to determine whether the family was allocated to the IG or CG. Both researcher and participants were unaware of which group they were allocated to prior to the study. A flow chart of the study is presented in Figure 1." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 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 eligible participants were stratified into five strata according to the age of the child undergoing surgery (2, 3, 4, 5, and 6 years), and then randomized into each group at a 1:1 ratio. We used stratified simple randomization to keep the groups as similar as possible [46]. The researcher prepared two envelopes in advance, with one for 2-year-olds and the other for children up to the age of six. A total of 10 notes were placed into each age group envelope, five of which were allocated into the intervention group (IG) and the remaining five allocated into the control group (CG). Following ethical guidelines, after a telephone conversation with each set of parents, the researcher took one note from the envelope corresponding to the child's age group to determine whether the family was allocated to the IG or CG. Both researcher and participants were unaware of which group they were allocated to prior to the study. A flow chart of the study is presented in Figure 1." 1 2 3 4 5 essential 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering 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 "The study design also made blinding difficult. It was impossible to blind the nurses because they needed to know which parents were in the CG so that they could call them the day before the surgery." subitem not at all important 1 2 3 4 5 essential 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 "When a surgery was confirmed, hospital staff added the child, surgery type, and schedule into the application. The application then automatically selected the material suitable to that child and family. Hospital staff could monitor the family's use of the application and receive and accept completed forms through the application. The application also reminded the family about how to tell the child about the surgery and offered other preparation instructions essential to the operation. The mobile application contained all the necessary information about the child's surgery and made it possible to complete pre-information forms. It enabled parents to access information at convenient times whether they were at home, at work, travelling or during their free time. Parents also had the option of getting in touch with the hospital if problems arose with the application.
Parents randomized to the IG received instructions for downloading the free BuddyCare application (Android or iOS) and its activation code 3-4 weeks before their child's surgery. " 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address 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 "The CG received routine preparation while the IG was prepared using a mobile li i " 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 "Descriptive statistics (frequencies with percentages, medians with interquartile range (IQR) and means with standard deviation (SD)) were used to express the parents' characteristics and study variables. The analyses were performed using IBM SPSS statistical software for Windows (version 28; SPSS Inc., Chicago, IL). " subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 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]).
T y h j e n n ä v a l i n t a 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 "The resulting missing values could not be substituted with mean values due to the small size of the sample."

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
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 "Descriptive statistics (frequencies with percentages, medians with interquartile range (IQR) and means with standard deviation (SD)) were used to express the parents' characteristics and study variables. The distributions of the measured variables were verified. The anxiety levels of the parents were found to have a normal distribution, and parametric tests were used to examine the results. However, the stress levels of the parents, as well as the pain and fear levels of the children, had abnormal distributions. As a result, non-parametric tests were utilized to analyze those variables. Intention-to-treat analysis was performed, which meant that all parents with children participating in the study were analyzed in the groups to which they were initially randomized. Parents' stress was re-categorized into three categories: no stress (VRSS = 0), mild stress (1) and moderate to intense stress (2-5).
Child's pain, assessed by the child, was re-categorized into three categories: no pain (WBS = 0), moderate pain (2-4), and severe pain (6-10). The significance of between-group differences in the variables measured was assessed using the t-test (S-Anxiety sum score), Chi-square test (categorized study variables), or Mann-Whitney U-test (child's pain, assessed by parents and nurse (VAS) and child's fear (FAS)). Changes between each assessment were analyzed separately for IG and CG using paired samples t-test (S-Anxiety sum score), sign-test (categorized study variables) or Wilcoxon signed-rank test (child's pain, assessed by parents and child's fear) with Benjamini-Hochberg correction with false positive rate of 0.05 for multiple comparisons. In the analysis of change, data from those who replied for all assessments were used (T1, T2, T3 and T4). The threshold for statistical significance was set at p-value≤0.05. The analyses were performed using IBM SPSS statistical software for Windows (version 28; SPSS Inc., Chicago, IL). " Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This study received ethical approval from the Northern Ostrobothnia Regional Ethics Committee Board (EETTMK:53/2017) in June 2017. 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 The parents were informed about the study both verbally and in writing.

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

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) T y h j e n n ä v a l i n t a 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 "Ethical considerations were respected at all stages of the study, including the voluntary participation of family members, the right to information about the research before and throughout data collection, the right to ask questions, the right to be treated with respect and honesty, the right to suspend research, and the right to ask questions. Subjects' privacy and data protection were ensured throughout the data collection process [60]." 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A total of 71 children and their parents were recruited for the study. The IG comprised 36 participants (loss rate 22.2 %) and the CG 34 (loss rate 23.5 %). A total of 54 responses from participants in the IG (n = 28) and CG (n = 26) were analyzed (participation rate 76.1 %) (Figure 1)." 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 14b) Why the trial ended or was stopped (early) 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" T y h j e n n ä v a l i n t a 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 The event in question did not occur.
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 The event in question did not occur.

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known. Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study " Table 2. Comparison of baseline demographic information between the intervention (n=28) and control (n=26) groups."

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.
T y h j e n n ä v a l i n t a 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 "Descriptive statistics (frequencies with percentages, medians with interquartile range (IQR) and means with standard deviation (SD)) were used to express the parents' characteristics and study variables. The distributions of the measured variables were verified. The anxiety levels of the parents were found to have a normal distribution, and parametric tests were used to examine the results. However, the stress levels of the parents, as well as the pain and fear levels of the children, had abnormal distributions. As a result, non-parametric tests were utilized to analyze those variables. Intention-to-treat analysis was performed, which meant that all parents with children participating in the study were analyzed in the groups to which they were initially randomized.
1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
T y h j e n n ä v a l i n t a 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 "Intention-to-treat analysis was performed, which meant that all parents with children participating in the study were analyzed in the groups to which they were initially randomized." 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 "Overall, parental anxiety decreased from the preoperative assessment (mean 36.3; SD 10.3) to the postoperative assessment (mean 29.4; SD 6.9) the average change being -7.0 (95% Cl -9.8 to -4.1; P < 0.001). Separately, within group changes were -7.0 (95% CI -11.3: -2.6) in the IG and -7.0 (-11.0; -3.0) in the CG. (Figure 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).
T y h j e n n ä v a l i n t a 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 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 The results of the process, such as usage metrics and usage intensity, were described with different parameters.
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 Oma vastauksesi 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 The study presented additional analyses, including subgroup and adjusted analyses, categorized as pre-specified or exploratory.

19) All important harms or unintended effects in each group
(for speci c guidance see CONSORT for harms)

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).
T y h j e n n ä v a l i n t a 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 The presented findings are based on a randomized trial and are clearly displayed.
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 Copy and paste relevant sections from the manuscript (include quotes in quotation 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 Another publication will be released in relation to this matter.
subitem not at all important 1 2 3 4 5 essential 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
T y h j e n n ä v a l i n t a Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The analysis is coherent with the findings, taking into account both advantages and disadvantages.
subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation 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 importance of researching the topic is rightly highlighted subitem not at all important 1 2 3 4 5 essential 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial

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.
T y h j e n n ä v a l i n t a 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 It is of utmost importance to tackle any potential biases that could arise due to the trial's limitations.This is also how we do it.

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 T y h j e n n ä v a l i n t a 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 Although the sample size is small, the results can serve as a starting point for a follow-up study. However, the generalizability of these findings may be uncertain.
subitem not at all important 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.
T y h j e n n ä v a l i n t a Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study These are taken into account.

24)
Where the full trial protocol can be accessed, if available 25) Sources of funding and other support (such as supply of drugs), role of funders X27) Conflicts of Interest (not a CONSORT item) Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "This study was registered at ClinicalTrials.gov (NCT03774303)." Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "This study was registered at ClinicalTrials.gov (NCT03774303)." 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 About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no 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.
T y h j e n n ä v a l i n t a 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

CRediT authorship contribution statement
As a result of using this checklist, did you make changes in your manuscript? * yes no Muu: yes no Muu: What were the most important changes you made as a result of using this checklist?

Oma vastauksesi
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * I spent about one hour going through the checklist.
As a result of using this checklist, do you think your manuscript has improved? * Would you like to become involved in the CONSORT EHEALTH group?
This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document T y h j e n n ä v a l i n t a

Any other comments or questions on CONSORT EHEALTH
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