A Mobile Device App to Reduce Time to Drug Delivery and Medication Errors During Simulated Pediatric Cardiopulmonary Resuscitation: A Randomized Controlled Trial

Background During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusion is both complex and time-consuming, placing children at higher risk than adults for medication errors. Following an evidence-based ergonomic-driven approach, we developed a mobile device app called Pediatric Accurate Medication in Emergency Situations (PedAMINES), intended to guide caregivers step-by-step from preparation to delivery of drugs requiring continuous infusion. Objective The aim of our study was to determine whether the use of PedAMINES reduces drug preparation time (TDP) and time to delivery (TDD; primary outcome), as well as medication errors (secondary outcomes) when compared with conventional preparation methods. Methods The study was a randomized controlled crossover trial with 2 parallel groups comparing PedAMINES with a conventional and internationally used drugs infusion rate table in the preparation of continuous drug infusion. We used a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin in the shock room of a tertiary care pediatric emergency department. After epinephrine-induced return of spontaneous circulation, pediatric emergency nurses were first asked to prepare a continuous infusion of dopamine, using either PedAMINES (intervention group) or the infusion table (control group), and second, a continuous infusion of norepinephrine by crossing the procedure. The primary outcome was the elapsed time in seconds, in each allocation group, from the oral prescription by the physician to TDD by the nurse. TDD included TDP. The secondary outcome was the medication dosage error rate during the sequence from drug preparation to drug injection. Results A total of 20 nurses were randomized into 2 groups. During the first study period, mean TDP while using PedAMINES and conventional preparation methods was 128.1 s (95% CI 102-154) and 308.1 s (95% CI 216-400), respectively (180 s reduction, P=.002). Mean TDD was 214 s (95% CI 171-256) and 391 s (95% CI 298-483), respectively (177.3 s reduction, P=.002). Medication errors were reduced from 70% to 0% (P<.001) by using PedAMINES when compared with conventional methods. Conclusions In this simulation-based study, PedAMINES dramatically reduced TDP, to delivery and the rate of medication errors.


2 3 4 5 subitem not at all important essential
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 brieoy explain why the item is not applicable/relevant for your study "Simulated Pediatric Cardiopulmonary Resuscitation" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.

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) 1 2 3 4 5 subitem not at all important 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 brieoy explain why the item is not applicable/relevant for your study "Randomized controlled crossover trial with two parallel groups comparing PedAMINES to a conventional drugs infusion rate table in the preparation of continuous drug infusion. We used a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin in the shock room of a tertiary care pediatric emergency department."

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) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study "pediatric emergency nurses"

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. ofoine), 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 ofoine 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) 1 2 3 4 5 subitem not at all important 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) 1 2 3 4 5 subitem not at all important essential 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 brieoy explain why the item is not applicable/relevant for your study "Twenty nurses were randomized"

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) 1 2 3 4 5 subitem not at all important essential

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 brieoy explain why the item is not applicable/relevant for your study INTRODUCTION 2a) In INTRODUCTION: ScientiUc background and explanation of rationale

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as standalone 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) 1 2 3 4 5 subitem not at all important essential 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 brieoy explain why the item is not applicable/relevant for your study Yes: "Prolonged resuscitation time may result from drug preparation [11].
During some critical situations such as post-cardiac arrest ROSC, or septic shock, preparing intravenous (IV) vasoactive drugs for continuous infusion is particularly challenging. Quickly, accurately and safely preparing and administering drugs in a stressful environment is complex and time-consuming [12][13][14]. The need for individual specific weight-based drug doses calculation and preparation, and a lower dosing-error tolerance[15] place children at higher risk than adults for errors [16][17][18] and may result in life-threatening outcomes" "To address these problems, we followed a cognitive and evidencebased ergonomic driven approach[20] to develop an innovative and customizable tablet application, called PedAMINES (Pediatric Accurate Medication IN Emergency Situations). This application was designed to support nurses and physicians step-by-step from order to delivery of a wide range of drugs in real-time, including those requiring continuous infusion [21]. The development of the application was followed by a study aiming to assess its impact on error rate and time needed between drug prescription and administration." "We hypothesized that PedAMINES would first reduce drug preparation time and time to delivery, and second reduce medication errors during pediatric CPRs when compared to conventional preparation methods." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 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 brieoy explain why the item is not applicable/relevant for your study "A prospective, randomized controlled crossover trial with two parallel groups".

2a-ii) Scienti/c background, rationale: What is known about the (type of) system
Allocation ratio is described in the Randomization and blinding section: "We randomly assigned nurses in a 1:1 ratio" https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons 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 brieoy explain why the item is not applicable/relevant for your study "No changes were made on the application or on the intervention during the study."

3b-i) Bug /xes, Downtimes, Content Changes
Bug Uxes, 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 Uxes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have inouenced study design such as staff changes, system failures/downtimes, etc. [2].
1 2 3 4 5 subitem not at all important essential 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 brieoy explain why the item is not applicable/relevant for your study "No changes were made on the application or on the intervention during the study."

4a) Eligibility criteria for participants
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 brieoy explain why the item is not applicable/relevant for your study "Certified pediatric emergency nurses were eligible if they were actively practicing in our PED. Shift-working nurses were randomly recruited on the day of the study by a blinded, non-investigator, person on a random list."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clariUed.

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 brieoy explain why the item is not applicable/relevant for your study Not applicable because participants were recruited from our Pediatric Emergency Department. This statement is described in subitem 4a-ii (see below).

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. ofoine), 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 conUrmation, phone calls) were used to detect/prevent these.
1 2 3 4 5 subitem not at all important essential 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 brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full "Certified pediatric emergency nurses were eligible if they were actively practicing in our PED. Shift-working nurses were randomly recruited on the day of the study by a blinded, non-investigator, person on a random list."

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study "Written informed consent was obtained from all participants before their voluntary involvement." 4b) Settings and locations where the data were collected 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 brieoy explain why the item is not applicable/relevant for your study "The study was conducted in a PED of a tertiary hospital"
1 2 3 4 5 subitem not at all important essential 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 brieoy explain why the item is not applicable/relevant for your study Not applicable. Outcomes were recorded/assessed in real-time by the study investigators during the resuscitation scenario: "Data collected during the scenario included 1) TDP, 2) TDD, and 3) final delivered drug concentration in µg/ml and infusion rate in µg/kg/min. All the actions (i.e. primary and secondary outcomes) performed by the nurses during the scenario were automatically recorded and stored by the responsive simulator detectors and by several video cameras. To avoid assessment bias, two evaluators then independently reviewed these video recordings. In case of disagreement, a third independent evaluator helped reach a consensus. All actions performed with PedAMINES were automatically saved locally in log-files for further analysis."

4b-ii) Report how institutional af/liations are displayed
Report how institutional afUliations are displayed to potential participants [on ehealth media], as afUliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Not applicable / Not a required item because our results were not biased by this point.

5)
The interventions for each group with sufUcient details to allow replication, including how and when they were actually administered

5-i) Mention names, credential, af/liations of the developers, sponsors, and owners
Mention names, credential, afUliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conoict of interest" section or mentioned elsewhere in the manuscript). https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 1 2 3 4 5 subitem not at all important essential

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 brieoy explain why the item is not applicable/relevant for your study "Conflicts of Interest / competing interests: Some authors are the owners of the application PedAMINES"

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 brieoy explain why the item is not applicable/relevant for your study "The development of PedAMINES followed a user-centered approach with ED caregivers, as well as software developers and ergonomists. This team worked tightly together and the app development was mainly based on CPR observations and focus groups [21]."

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).
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study "No changes were made on the application or on the intervention during the study.""

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 brieoy explain why the item is not applicable/relevant for your study "All the actions (i.e. primary and secondary outcomes) performed by the nurses during the scenario were automatically recorded and stored by the responsive simulator detectors and by several video cameras. To avoid assessment bias, two evaluators then independently reviewed these video recordings. In case of disagreement, a third independent evaluator helped reach a consensus. All actions performed with PedAMINES were automatically saved locally in log-files for further analysis."

5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing ]owcharts of the algorithms used
Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing oowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiUc 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 brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full "(see Multimedia Appendix 2)."

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 brieoy explain why the item is not applicable/relevant for your study Not applicable. The application PedAMINES is a mobile tablet application and not an online application on a website. Digital preservation of PedAMINES therefore does not relies on an URL.

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 speciUc 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).

2 3 4 5
subitem not at all important essential 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 brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full Not applicable. The application PedAMINES is a mobile tablet application and was provided for the purpose of this study. PedAMINES is not yet available for downloading on applications stores. subitem not at all important essential Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
Partially applicable to our study: "The development of PedAMINES followed a user-centered approach with ED caregivers, as well as software developers and ergonomists. This team worked tightly together and the app development was mainly based on CPR observations and focus groups [21]. In the present study, six drugs for continuous infusion and 19 drugs for direct IV injection were listed in the application PedAMINES and at the nurse's disposal."

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 brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full "When entering the shock room, the nurses were asked to assist the physician to perform a 2-minute full course massage/ventilation (15/2 ratio) maneuver for a child with asystole to increase their own stress level. Based on the American Heart Association (AHA) pediatric cardiac arrest algorithm for asystole, a bolus of 0.01 mg/kg epinephrine (0.1 mL/kg of 1:10,000 concentration) was then administered. ROSC ensued with hypotension. At that time, a clinical statement to recognize the life-threatening condition of the patient, including his weight and age, was given to the nurses. The nurses were then asked to prepare a 5 µg/kg/min continuous infusion of dopamine for a 7 kg boy either with the help of PedAMINES first (allocation group A) or following the conventional method first (i.e. Shann's infusion rate table [22], group B. Multimedia Appendix 1). All participants had equal experience and competence with the Shann method. At the end of the instruction, the timed scenario began. To ensure that participants heard and understood the order correctly, they had to confirm it verbally and written transcriptions were checked and video-recorded. When the drug was ready to be injected, the nurse was asked to deliver it to the patient using a syringe pump already in place. The nurse was then asked to perform a 1-minute "washout" distraction maneuver by aspirating secretions in the throat of the manikin. At this moment, the crossover occurred. The nurse was asked to prepare a 0.1 µg/kg/min continuous infusion of norepinephrine by crossing the procedure (i.e. group A allocation having used PedAMINES before was asked to use the conventional method, whereas group B allocation having used the conventional method before was asked to use PedAMINES. See Figure 1)."

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 brieoy explain why the item is not applicable/relevant for your study "Consistent with standard emergency medicine practice, we created resuscitation teams composed by the study-participating nurse, a Pediatric Advanced Life Support (PALS) Instructor-certified emergency pediatrician leading the resuscitation, and a second nurse (both part of the investigators team) to assist with resuscitation by performing chest compressions and bag-valve-mask ventilation according to the pediatrician instructions. A certified-technician was operating the simulator. Except for the participating nurse, the members of the resuscitation team were unchanged across all the scenarios and were the investigators of the study." "Study participants were neither involved in the design of the application, nor in the study design, choice of outcome measures, or study conduct. A senior specialized nurse in pediatric emergency medicine, simulation and teaching, being an investigator of the study, has participated in the app and study design."

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).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full Not applicable. The application PedAMINES was used once on the day of study participation. No prompts/reminders were therefore required.

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 standalone 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.
1 2 3 4 5 subitem not at all important essential 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 brieoy explain why the item is not applicable/relevant for your study "On the day of participation, nurses were given a survey collecting data regarding their demographics, nursing and computer experience. After random allocation, each participating nurse received a standardized 5minute training session on how to use the app PedAMINES to familiarize them uniformly with the application." 6a) Completely deUned pre-speciUed 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 brieoy explain why the item is not applicable/relevant for your study "The primary outcome was the elapsed time in seconds, in each allocation group, between the oral prescription by the physician and drug delivery (TDD) by the nurse. TDD included time to drug preparation completion by the nurse (TDP). The secondary outcome was the medication dosage error rate in each allocation group, during the sequence from drug preparation to drug injection." "Data collected during the scenario included 1) TDP, 2) TDD, and 3) final delivered drug concentration in µg/ml and infusion rate in µg/kg/min. All the actions (i.e. primary and secondary outcomes) performed by the nurses during the scenario were automatically recorded and stored by the responsive simulator detectors and by several video cameras." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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].
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 6a-i?

Copy and paste relevant sections from manuscript text
Not applicable because no online questionnaires were used for the purpose of this study.

6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de/ned/measured/monitored
Describe whether and how "use" (including intensity of use/dosage) was deUned/measured/monitored (logins, logUle 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 "All actions performed with PedAMINES were automatically saved locally in log-files for further analysis. Data were manually retrieved and entered into a Microsoft Excel spreadsheet"

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). Copy and paste relevant sections from manuscript text "At the end of the scenario, a two question questionnaire using a tenpoint Likert scale (scored from one to ten to avoid neutral answers) was submitted to participants. The questionnaire measured 1) the overall stress perceived (the question was "On a scale of 1 to 10, how much stress did you feel during the whole resuscitation scenario?"), and 2) the satisfaction about the preparation method used during the resuscitation scenario (the question was "On a scale of 1 to 10, how much satisfaction did you get during the resuscitation scenario with the help of PedAMINES, and with the help of the infusion rate table?")." 6b) Any changes to trial outcomes after the trial commenced, with reasons 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 brieoy explain why the item is not applicable/relevant for your study "No changes were made on the application or on the intervention during the study." 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed

7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size
Describe whether and how expected attrition was taken into account when calculating the sample size.

Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full emergency nurses has shown a median TDD of 69 seconds for the first dose of vasoactive drug to be given as direct IV infusion [23]. Assuming a standard deviation (SD) of 9 seconds for TDD in each group (based on a similar SD of 10 seconds estimated by Moreira et al. [23]), nine participants per group were required. To prevent a potential loss of power due to misspecification of assumptions, it was necessary to recruit ten nurses per group (total sample size: 20 nurses). In case of a carryover effect, this sample size calculation was sufficient to evaluate PedAMINES's effect within the first period of the trial." 7b) When applicable, explanation of any interim analyses and stopping guidelines 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 brieoy explain why the item is not applicable/relevant for your study Not applicable. No interim analyses were required because each participants was assessed once during the study period.
8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 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 brieoy explain why the item is not applicable/relevant for your study "We randomly assigned nurses in a 1:1 ratio with an online software [50]." 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study "We randomly assigned nurses in a 1:1 ratio" "Blinding to the purpose of the study during recruitment was maintained to minimize preparation bias." No restrictions were applied. 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 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 brieoy explain why the item is not applicable/relevant for your study "Allocation concealment was ensured with sealed envelopes and was not released until the nurses started the scenario." "with an online software[50]." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 brieoy explain why the item is not applicable/relevant for your study "We randomly assigned nurses in a 1:1 ratio with an online software [50]." "Shift-working nurses were randomly recruited on the day of the study by a blinded, non-investigator, person on a random list. Written informed consent was obtained from all participants before their voluntary involvement." "After random allocation, each participating nurse received a standardized 5-minute training session on how to use the app PedAMINES to familiarize them uniformly with the application. Then, the nurses were asked to perform a 15-minute highly realistic CPR scenario, including post-return of spontaneous circulation (ROSC)." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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

11a-i) Specify who was blinded, and who wasn't
Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).
1 2 3 4 5 subitem not at all important essential 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 brieoy explain why the item is not applicable/relevant for your study "Blinding to the purpose of the study during recruitment was maintained to minimize preparation bias. Nurses were unblinded after randomization."

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 brieoy explain why the item is not applicable/relevant for your study "Nurses were unblinded after randomization." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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)

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 brieoy explain why the item is not applicable/relevant for your study "crossover trial with two parallel groups" 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 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 brieoy explain why the item is not applicable/relevant for your study "Primary outcome: for TDD (and TDP), the mean times were reported with 95%CI for each arm and each study period to investigate a potential carryover effect. Since a carryover effect was suspected, intervention arms were compared within each study period using Ttests for independent groups. No paired data were compared. Secondary outcomes: the rate of medication errors was the proportion of nurses making a preparation error. The rate of medication errors was reported with 95%CI (Clopper-Pearson's method) with each method and by study period to investigate a potential carryover effect. The error rates for each method were globally assessed and compared using McNemar's test since observations were paired. Differences in error rates were reported with 95% confidence intervals. Errors were also measured as the deviation in percent from the amount of delivered drug compared to the original dose prescribed by the physician. Absolute deviation was analyzed. The mean (SD) difference in deviation obtained with each method was reported with 95%CI. A t-test for paired data was used to compare interventions. Mean differences were also reported by randomized group and by crossover period. Means and SD were determined for stress and satisfaction scores of individuals for each questionnaire item and reported with descriptive statistics."

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]). Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study "To prevent a potential loss of power due to misspecification of assumptions, it was necessary to recruit ten nurses per group (total sample size: 20 nurses). In case of a carryover effect, this sample size calculation was sufficient to evaluate PedAMINES's effect within the first period of the trial."

12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
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 brieoy explain why the item is not applicable/relevant for your study Not applicable. No subgroups were analyzed in this study.

X26-i) Comment on ethics committee approval
1 2 3 4 5 subitem not at all important essential

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 brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full "The study was approved by the institutional ethics committee and a trial registration number was not required. Written informed consent was obtained from all participants before their voluntary involvement. It was conducted in accordance with the principles of the Declaration of Helsinki, the standards of Good Clinical Practice, and Swiss regulatory requirements."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained ofoine 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 brieoy explain why the item is not applicable/relevant for your study "Written informed consent was obtained from all participants before their voluntary involvement."

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) 1 2 3 4 5 subitem not at all important essential

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 brieoy explain why the item is not applicable/relevant for your study "All actions performed by the nurses were sequentially saved locally on the device in historic files to preserve informations that can be retrieved at any time for debriefing or medico-legal purposes. Historic files can also be erased or safely exported and saved on the institutional electronic health record." No patients were used in this study. Only nurses were assessed and their privacy preserved. Only the investigators of the study had access to the data. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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 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 brieoy explain why the item is not applicable/relevant for your study "twenty certified pediatric emergency nurses participated and completed the study with no drop-out" 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ]ow 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 brieoy explain why the item is not applicable/relevant for your study "with no drop-out (See Figure 2)"

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 Ugures or tables demonstrating usage/dose/engagement.
Copy and paste relevant sections from the manuscript or cite the Ugure 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 brieoy explain why the item is not applicable/relevant for your study "See Figure 2" 14a) Dates deUning the periods of recruitment and follow-up 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 brieoy explain why the item is not applicable/relevant for your study "In June 2015"

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical "secular events" fell into the study period, e.g., signiUcant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 1 2 3 4 5 subitem not at all important essential

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 brieoy explain why the item is not applicable/relevant for your study Not applicable. This study relied on a mobile application; not on a labile web software/ressource. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 14b) Why the trial ended or was stopped (early) 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 brieoy explain why the item is not applicable/relevant for your study Not applicable. The study was completed.

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, qualiUcation, expertise, etc.) and centers (volume) in each group 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 brieoy explain why the item is not applicable/relevant for your study "The demographic results are summarized in Table 1."

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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full "The demographic results are summarized in Table 1." 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

16-i) Report multiple "denominators" and provide de/nitions
Report multiple "denominators" and provide deUnitions: 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 speciUc pre-deUned time points of interest (in absolute and relative numbers per group). Always clearly deUne "use" of the intervention.
1 2 3 4 5 subitem not at all important essential 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 brieoy explain why the item is not applicable/relevant for your study " Figure 2"

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 brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full Not applicable. Intent to treat is not relevant for this study design.
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% conUdence interval) 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 brieoy explain why the item is not applicable/relevant for your study recorded times was lower with PedAMINES (TDP upper range value = 222 seconds, TDD = 320 seconds) than with the conventional method (TDP upper range value = 545 seconds (8 out of 10 measures were higher than 222), TDD = 657 seconds) (Figure 3). In the study period two, the TDP was decreased by 54.7 seconds (95%CI 10.3 to 99.1, P = .02) with PedAMINES and TDD by 54.9 seconds (95%CI 1.6 to 108.2, P = .04) (Figure 3)." "Table 2" " Figure 3" "Of the 20 drug doses delivered with PedAMINES, none (0%) was associated with medication errors. Of the 20 drug doses prepared with conventional methods, 14 were incorrect (70%; 95%CI 45.7 to 88.1, P < 0.001). Among the eight errors committed during the first study period, 5 (63%) were critical overdose errors ranging from 100% to 5233% (mean 1864%) of the normal prescribed dose (See Table 3). Among the 6 errors committed during the second study period, 3 (50%) ranged from 19% to 138% (mean 59%) of the normal prescribed dose and 2 (33%) miscalculated preparations reached the right final dosage by chance (Table 3)." " Table 3" "Questionnaire about perceived Stress and Satisfaction The questionnaire was completed and returned by 100% of participants. Participants rated the overall perceived stress to be 7.1 (95%CI 6.1 to 8.1) on the Likert scale. Participants reported higher satisfaction when using PedAMINES for the preparation of drugs rather than conventional methods (9.3 +/-1.2 vs 3.6 +/-2.1, P < 0.001)."

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 deUnitions 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 deUned (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 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 brieoy explain why the item is not applicable/relevant for your study Not applicable. No binary outcomes in this study 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-speciUed from exploratory 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 brieoy explain why the item is not applicable/relevant for your study Not applicable. No other analyses done in this study.

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).

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 brieoy explain why the item is not applicable/relevant for your study

19-ii) Include qualitative feedback from participants or observations from staff/researchers
Include qualitative feedback from participants or observations from staff/researchers, if available, on https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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 brieoy explain why the item is not applicable/relevant for your study "Participants reported higher satisfaction when using PedAMINES for the preparation of drugs rather than conventional methods (9.3 +/-1.2 vs 3.6 +/-2.1, P < 0.001)." DISCUSSION 22) Interpretation consistent with results, balancing beneUts and harms, and considering other relevant evidence NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group

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).
1 2 3 4 5 subitem not at all important essential 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 brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full "To our knowledge, this is the first study to investigate the benefit of a mobile application to improve delivery of continuous drug infusion during pediatric CPR. We found that time for preparation and time to delivery of vasoactive drugs for continuous infusion, as well as medication errors were dramatically reduced with the use of PedAMINES."

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 brieoy explain why the item is not applicable/relevant for your study "Although the survival rate has complex and numerous components, it would be interesting in further studies to determine whether saving time and decreasing medication errors thanks to the use of PedAMINES would translate into increase in patient survival in real life." "Further studies comparing PedAMINES and smart pumps would be valuable." "A large multi-center randomized trial is further needed to assess this assumption in primary and secondary care hospitals." 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.

21-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 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study

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

Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study OTHER INFORMATION 23) Registration number and name of trial registry 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 brieoy explain why the item is not applicable/relevant for your study Our study was not registered in advance of its conduct. But the study was approved by our local ethics committee that had full access to the original research protocol, ensuring that the study's design and statistical analysis where determined prior to the conduct of the study. Moreover, according to simulation experts A. Cheng and D.B. Raemer (Simul Healthc. 2014 Dec;9(6):350-2), if we regard simulation as translational science with outcomes categorized as T1 (results achieved in the simulated setting), T2 (improved health care delivery in the real clinical setting), and T3 (improved patient outcomes), then interpretation of the ICMJE definition might be that T1-level studies would not require registration, whereas T2-and T3-level studies would require registration. In our opinion, our trial was a T1-level study and, as for many other simulation studies, we have not registered it.

24) Where the full trial protocol can be accessed, if available
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 brieoy explain why the item is not applicable/relevant for your study Not applicable: No online protocol available as a RCT registration was not required.

25)
Sources of funding and other support (such as supply of drugs), role of funders https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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 brieoy explain why the item is not applicable/relevant for your study "All authors declare: no source of funding; no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work; no other relationships or activities that could appear to have influenced the submitted work."

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (Unancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.

Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study "Some authors are the owners of the application PedAMINES that will be available in a near future on the Google Play Store and the Apple Store. The authors declare therefore a direct financial interest to market this application."

About the CONSORT EHEALTH checklist
As a result of using this checklist, did you make changes in your manuscript? * yes, major changes yes, minor changes no What were the most important changes you made as a result of using this checklist? https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full How much time did you spend on going through the checklist INCLUDING making changes in your manuscript *

minutes
As a result of using this checklist, do you think your manuscript has improved? * yes no Autre :

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 yes no Autre :

Any other comments or questions on CONSORT EHEALTH
Because the CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, which was not the purpose of this study (we assessed our own offline application PedAMINES), this questionnaire is not fully relevant for our study.
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