Analysis of Documentation Speed Using Web-Based Medical Speech Recognition Technology: Randomized Controlled Trial

Background Clinical documentation has undergone a change due to the usage of electronic health records. The core element is to capture clinical findings and document therapy electronically. Health care personnel spend a significant portion of their time on the computer. Alternatives to self-typing, such as speech recognition, are currently believed to increase documentation efficiency and quality, as well as satisfaction of health professionals while accomplishing clinical documentation, but few studies in this area have been published to date. Objective This study describes the effects of using a Web-based medical speech recognition system for clinical documentation in a university hospital on (1) documentation speed, (2) document length, and (3) physician satisfaction. Methods Reports of 28 physicians were randomized to be created with (intervention) or without (control) the assistance of a Web-based system of medical automatic speech recognition (ASR) in the German language. The documentation was entered into a browser’s text area and the time to complete the documentation including all necessary corrections, correction effort, number of characters, and mood of participant were stored in a database. The underlying time comprised text entering, text correction, and finalization of the documentation event. Participants self-assessed their moods on a scale of 1-3 (1=good, 2=moderate, 3=bad). Statistical analysis was done using permutation tests. Results The number of clinical reports eligible for further analysis stood at 1455. Out of 1455 reports, 718 (49.35%) were assisted by ASR and 737 (50.65%) were not assisted by ASR. Average documentation speed without ASR was 173 (SD 101) characters per minute, while it was 217 (SD 120) characters per minute using ASR. The overall increase in documentation speed through Web-based ASR assistance was 26% (P=.04). Participants documented an average of 356 (SD 388) characters per report when not assisted by ASR and 649 (SD 561) characters per report when assisted by ASR. Participants' average mood rating was 1.3 (SD 0.6) using ASR assistance compared to 1.6 (SD 0.7) without ASR assistance (P<.001). Conclusions We conclude that medical documentation with the assistance of Web-based speech recognition leads to an increase in documentation speed, document length, and participant mood when compared to self-typing. Speech recognition is a meaningful and effective tool for the clinical documentation process.

TITLE AND ABSTRACT 1a) TITLE: IdentiUcation as a randomized trial in the title 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") yes Sonstiges:

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

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").

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

1a-iii) Primary condition or target group in the title
Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial 1 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 "for physicians" 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 to be assisted or not be assisted by web-based medical automatic speech recognition (ASR) in German language"

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 "fully automated web-based medical autom"atic speech recognition (ASR) in German language" 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 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 brieoy explain why the item is not applicable/relevant for your study "mood was self-assessed through a three-stage scale " 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 "A total of 1,455 clinical reports were eligible for further analysis. 718 (49.3%) reports assisted by ASR and 737 (50.7%) reports not assisted by ASR were recorded"

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 The usage of electronic documentation systems in hospitals forces the user to enter content mainly with keyboard, mouse or touchscreen. Automatic speech recognition systems (ASR) are believed to facilitate individual documentation. To measure the effects of using a web-based ASR on report size, report speed and physician satisfaction, we conducted a prospective randomized controlled trial 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 Over time, each participant received the intervention in a random sequence -crossover. For each documentation step a randomization occurred between availability of speech recognition and keyboard or keyboard alone.
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 N/A all participants completed the trial.

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 have been made to the system during the study period.

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 Inclusion criteria was clinical activity of the participating physicians.

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 No further eligibility criteria have been applied (e.g. computer/internet literacy). Since enrollment based on active participation there could be a selection bias for good computer/internet literacy.
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 Physicians from two departments (surgery and non-surgery) were asked to participate during morning meeting. One participant from ENT asked to participate via personal communication. Each participant was known to the study team. Through the enrollment the physician chose an individual user name and password not know to the study team. The username was replaced by a number when storing study information in the database.

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 During a short standardized technical training all participants documented the same uniform standard text using speech or keyboard. After that no further contact between the study team and the participant occurred until the end of the study.
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 recording of the study data was fully-automated stored in an SQL database using web technology. The users identified themselves using username and password.

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
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 After finalization of the documentation step the physician's mood was judged using a three-stage scale (1 = good, 2 = moderate, 3 = bad) by online self-assessment

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)

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

N/A
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).

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 Automatic speech recognition was provided by Nuance Communications Healthcare GmbH Germany. A web-page loading a JavaScript component has been used to connect the physician's PC to a serverbased speech recognition system (SpeechAnywhereServices 1.6 / SpeechMagic Version 7 Release 4 FP4, MultiMed 510.706).

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 N/A all participants first encountered the study web page during first visit with the study team

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 brieoy explain why the item is not applicable/relevant for your study web-based SpeechAnywhereServices 1.6 / SpeechMagic Version 7 Release 4 FP4, MultiMed 510.706 + keyboard versus comparator keyboard only

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study A timestamp was saved together with the study data to check for technical irregularities 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.
1 2 3 4 5 subitem not at all important essential 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 a screenshot of study intervention is available

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 the intervention has been archived in the Internet Archive (spam.doctoresearch.de)

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).
1 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 Through the enrollment the physician chose an individual user name and password not known to the study team to access the study web site. 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
The webpage consisted of a text area, the self-assessment scale and a copy button. No further elements except the intervention "speech bar" were visible or available on the page. See screenshots.

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

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 Since the study was fully-automatted after enrollment no human intervention occurred. For technical questions the hotline of the IT department was reachable.

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 During the study period of 120 day every 30 days a reminder to use the study system has been sent out.

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 A short medical standard report has been documented during enrollment.
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

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 "Use" was documented by storing information on each login and study data with timestamp. See figure within text.

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).

2 3 4 5
subitem not at all important essential

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text N/A no systematic feedback has been applied.
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 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 It has been estimated that the intervention leads to to an increase of 30% of documentation speed in general.
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 N/A 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 The randomization was based on numbers generated by the PHP mt_rand() function.
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 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 restriction applied Simple random allocation has been used -each allocation was independent of the others. 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 reloading a web-page generating a random number used for allocation 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 Enrollment as described "Physicians from the Department of Pediatrics and the Department of Trauma Surgery were asked to participate during morning meetings. One participant from ENT asked to participate via personal communication.". Allocation/Interventions applied fully-automated 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 since this is a web-based trial no participant was blinded. The study team can see the intervention in the database but the analysis is fully automated 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 since keyboard entry is the standard everyone knew that speech is the comparator 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 n/a 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 permutation test

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]).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Attrition was addressed using the permutation test for statistical analysis.

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 n/a X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)

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 no patients involved

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 informed consent was obtained offline face-to-face

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 The study was conducted by approval and according to requirements of the Health Privacy Commissioner of Dusseldorf University Hospital

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 "During a period of 120 days 1,689 documentations were recorded by the study system" 49.99% intervention, 50.01% no intervention 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 A total of 1,455 clinical reports were eligible for further analysis. 718 (49.3%) reports used the intervention and 737 (50.7%) reports not used the intervention. "documentations with > 1000 characters per minute or more than 1 hour documentation time or less than 10 characters have been excluded" leading to 234 losses

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.

2 3 4 5
subitem not at all important essential

Does your paper address subitem 13b-i?
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 n/a web page closed 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 n/a

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 n/a 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 endpoint 120 days 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 Final participants were 21 (75%) interns and 7 (25%) senior physicians. 17 (61%) participants were male and 11 (39%) female. 22 (69%) participants were from a non-surgery department, 6 (21%) from a surgery-department. Table provided 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 no subgroup analysis has been done 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 since each participant was his/her own control group by design the analysis was by original assigned groups

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 all intended to treat have been included in analysis 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 effect size and its precision have been reported

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 "Writing speed is calculated by number of characteristics per minute. The underlying timeframe is text entry time and corrections until finalization of the document. " 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 done 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 n/a

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).
1 2 3 4 5 subitem not at all important essential 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 brieoy explain why the item is not applicable/relevant for your study n/a

19) All important harms or unintended effects in each group
(for speciUc guidance see CONSORT for harms) 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 brieoy explain why the item is not applicable/relevant for your study harms can be defined as correction efforts in this study. This is reported in table.

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 n/a. no technical problem has been observed during the study period

19-ii) Include qualitative feedback from participants or observations from staff/researchers
Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.

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 Personal feedback not written in the paper. No structured feedback was part of the study.

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 "The objective of this study is to compare self-typing with and without assistance by speech recognition to clarify, whether speech recognition is an alternative or useful complement in terms of documentation speed, documentation amount and satisfaction in the self-typing documentation process. "

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 "Further studies have to take into account the overall gain of the availability of clinical point of care documentation and the influence of individual factors, documentation content or specialty on the dictation result." 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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 20-i? *