PONE-D-24-24609Enhancing trauma cardiopulmonary resuscitation simulation training with the use of virtual reality (Trauma SimVR): Protocol for a randomized controlled trial

PLOS ONE

Dear Dr. Hafner,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by Oct 20 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Anne Lee Solevåg, M.D., Ph.D.

Academic Editor

PLOS ONE

Journal requirements: 1. When submitting your revision, we need you to address these additional requirements. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf. 2. When completing the data availability statement of the submission form, you indicated that you will make your data available on acceptance. We strongly recommend all authors decide on a data sharing plan before acceptance, as the process can be lengthy and hold up publication timelines. Please note that, though access restrictions are acceptable now, your entire data will need to be made freely accessible if your manuscript is accepted for publication. This policy applies to all data except where public deposition would breach compliance with the protocol approved by your research ethics board. If you are unable to adhere to our open data policy, please kindly revise your statement to explain your reasoning and we will seek the editor's input on an exemption. Please be assured that, once you have provided your new statement, the assessment of your exemption will not hold up the peer review process. 3. Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please move it to the Methods section and delete it from any other section. Please ensure that your ethics statement is included in your manuscript, as the ethics statement entered into the online submission form will not be published alongside your manuscript.  4. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. 

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Partly

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Partly

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: No

Reviewer #2: No

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: No

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Simulation training is regarded as a major element of patient safety and preparation for time-critical life-threatening medical emergencies, i.e. severe trauma and cardiac arrest. Despite the high benefit of in-situ simulation training in such scenarios, it is rarely carried out due to the complexity of the scenarios to be practiced and the high equipment and personnel expenditure required.

Extended reality (XR) is becoming increasingly important in medical simulation training as it allows immersive realistic training scenarios undertaken with less expensive equipment. Virtual reality (VR) is currently the most common variant of XR in this context.

The presented study protocol intends to compare the effectiveness of VR-based and E-learning-based preparation for in-situ training of in-hospital traumatic cardiac arrest (TCA)- a rare, but extremely challenging, scenario. The hypothesis is that this blended-learning approach is of superior educational value and could improve the management skills in TCA.

Strengths of the paper:

The criteria for recruitment and eligibility, the randomization procedure, the assignment of the participants to the comparison groups, the primary and secondary endpoints of the study and the chosen measurement methods are well chosen und clearly described. The secondary endpoints “influence of gender and personality” could give valuable insight into potential additional requirements or needs of important user subgroups. Tables and figures are clear and easy to interpret. The SPIRIT checklist was used to report all study protocol items. The protocol fulfills the respective legal, ethical and security requirements, was approved by the local ethics committee and the study has been registered in clinicaltrial.gov. In addition the protocol will also be reviewed by the data protection commission. The statistic procedures are well described, suitable and possible confounders are adequately taken into account. The cited literature sources are appropriate and mostly up to date.

Points where I would like to suggest a revision:

The authors state that (Page 3, lines 81 ff) the preparation training will “equip learners with the skills and knowledge necessary for in-person simulation training and to improve their performance in TCA management skills”. Unfortunately, only scarce information is provided about the specific learning objectives and contents, as well as the media technology and didactic implementation of the e-learning and VR training. The presentation of these points is particularly important because the treatment of traumatic cardiac arrest is a very complex task that requires a) theoretical knowledge of the mechanisms and treatment principles of trauma and resuscitation, b) manual or technical skills to eliminate the underlying causes, e.g. tension pneumothorax, and c) excellent management or non-technical skills. This makes it difficult to answer the questions whether learning objectives and content of the two methods are comparable. I therefore would recommend to describe the intended interventions in more detail. More details would also enhance the understanding of the setting of the in-situ simulation training (details see below).

Related to the chosen endpoints and their significance I would suggest a more detailed discussion of potential limitations (details see below).

Page 5, lines 115 ff:

“Participants will then complete either the e-learning course (control group) or the VR training

(intervention group) over a two-week period, both focusing on the same content”.

E-Learning:

Which kind of media are used? As trauma shockroom management depends not only on clinical skills but also on communication and management skills: To what extent are these “non-technical skills” addressed? Does the e-learning contain intervening questions that encourage participants to self-reflect? Are there other interactive elements, i.e. clicking on answer options, e.g. to select a cause of cardiac arrest or to decide on a specific diagnostic or therapeutic measure, or abstracted manual actions such as applying a pelvic sling, insertion of a chest tube?

VR training:

Will a head-mounted display (HMD) be used? If so, what type? Can you present the technical specs (i.e. as supplement data)? Does the VR “training” represent training in the narrower sense of the word, i.e. is it interactive and allows active clinical decisions, or is does it consist of mere passive tracking of the content presented?

If the former is true, could you describe the types of interaction?

Page 6, lines 122 ff:

How long is the interval between completion of Phase 2 and Start of Phase 3?

Page 7, Table 1:

Several secondary endpoints are measured to assess the participant´s subjective impressions and attitudes (i.e. level of enjoyment, learning process, self-confidence). Are these measurements based on validated test instruments? If not, what reasons spoke against? There are widely recognized assessment tools in this area, i.e. TEI (Training Evaluation Inventory).

Secondary objective: “Critical action #1: time from the onset of cardiac arrest to the start of chest

compressions (as defined in Table 2)”.

According to current resuscitation guidelines, chest compression is of secondary importance to other measures in traumatic cardiac arrest: German S3 updated guideline on the treatment of severe/multiple injuries: “Recommendation 2.3.4 [translated into English]: “Resuscitation of traumatic cardiac arrest should focus on the immediate, simultaneous treatment of reversible causes and takes priority over chest compressions”. ERC guidelines 2021 (Lott et al.): „In cardiac arrest caused by hypovolaemia, cardiac tamponade or tension pneumothorax, chest compressions are unlikely to be as effective as in normovolaemic cardiac arrest and may reduce residual spontaneous cardiac output. Therefore, chest compressions take a lower priority than addressing the reversible causes. Chest compressions must not delay immediate treatment of reversible causes.”

Could this potentially limit the significance of the primary endpoint “start of chest compressions”?

Page 7, Table 1: Secondary objectives: “To evaluate the difference in gaze behavior using eye-tracking technology between randomized groups”.

How is the quality of eye tracking (i.e. spatial precision and spacial accuracy) ensured?

Page 8, line 151: Inclusion criteria: “Only people who do not need eyeglasses for using VR”

How can this be interpreted and how do you practically handle this problem? Do interns wearing eye glasses and willing to participate in the study first test a VR system / HMD before they definitively decide to participate or to withdraw from the trial? Since the high percentage of people dependent on visual aids, this is not a mere theoretical question….

Page 9, lines 170-171: Additional VR orientation module: What is the duration of this module? Will it be mandatory for all participants In the VR group?

Page 9, lines 184-186:

Is the duration of the familiarization phase standardized? Do the participants familiarize themselves individually or as a whole group? Is there an instructor who assists during this phase i.e. explaining the use of the manikin functions?

Page 9, lines 187-188 and page 10, lines 200-205:

Does the virtual patient in the scenario already present with a cardiac arrest (i.e. at the moment of the virtual hand-over by the EMS team) or does the cardiac arrest develop after a predetermined short latency?

Medical scenarios: Is there always a single injury/medical problem leading to the cardiac arrest or maybe also a combination of underlying causes?

Does the “high-fidelity” manikin used in the study display clinical signs like cyanosis, recap time, breath sounds, subcutaneous emphysema, obstructed airway (which could facilitate clinical decision making)?

Is a single type of manikin used or do the manikins vary, i.e. according to scenario? What age group (Child? adolescent? adult? Young adult? old adult?) and sex does the manikin used in the study represent?

Page 10, lines 215-217:

“These critical actions are interconnected, and the primary outcome is, therefore, the time taken to execute the most critical action in the assessment scenario (critical action #3).”

In practice, when carrying out life-saving measures, it will take some time until a) they have been carried out after being initiated and b) until the success of the measures can be assessed. Only then can further decisions be made and further measures ordered. Consecutively

a) the term “time taken to execute” may be difficult to interprete or be misleading and

b) the problem of eventually simultaneously necessary actions is not addressed nor solved

page 13: Line 264-266:

“Specifically, the defined AOIs for analysis are the manikin's head/airway, the manikin's thorax, the vital signs monitor, and the ventilator monitor”.

The AOI mentioned are certainly important. However, the role of the trauma leader also includes distributing tasks sensibly within the team and supervising the respective team members. Therefore, it may also be useful to take into account the frequency and duration of the traumaleader´s gaze on team members, i.e. in order to recognize inappropriate actions or “underemployment”.

Page 17, lines 370 ff: Study limitations:

Traumatic cardiac arrest is an extremely demanding emergency, the successful management of which requires a high level of clinical expertise and the leadership and cooperation of a large interdisciplinary and interprofessional team. The assumption that a single, relatively short preparatory teaching unit for physicians who are at the beginning of their clinical training could lead to a significant difference in performance between the two study groups is therefore very optimistic...

Debriefing is an essential element of simulation training and regarded as an important prerequiste for learning success. However, in the study design, debriefing is only planned if the patient has been declared dead prematurely. What is the reason to exclude all other participants from debriefing?

Further remarks:

The Files S2 and S3 are not provided within the manuscript.

Thank you very much for the opportunity to examine this very exciting topic for medical education and training!

Reviewer #2: Line 105: Phase 2 to 3

Line 110-111: information on the list participants preparation, allocation concealment blinding is to be stated.

Line 112-113: the type of randomization is to be stated.

The detail of the intervention and control is be provided e.g. content, topics, time to complete the entire course (e-earning, VR) over the period of two-week

The assessment period/time point is to be mentioned.

Line 141-142: Secondary objectives are too many. Suggest to reduce and combine some of the objectives

Line 160: Sample size calculation not clear. More information such as primary outcome, 1 tailed or r tailed test, measures estimate, formula or software was used are to be stated.

Line 208-209: the sentence requires revision.

Line 292: effect size index, 95%CI are be added where applicable.

The statistical software including publisher name and its version used in the analysis is to be stated.

Flow chart of the study is to be provided.

Line 209: ERC, ALS are to be spelled out.

Line 242: the number of raters and who are they to be clearly stated.

Line 258: the sentence requires revision.

Page 13: the person who performed the eye tracking is to be stated.

Line 298: the reason/rationale to use non parametric tests is to be mentioned.

Line 307 & 309: the sentence requires revision.

Line 309: one-tailed or two-tailed test for Fisher's exact test is to be stated.

Line 323: what about missing data for secondary outcome? if the missing data is significant, what is the solution to address it? The variables with the possible censored data (if any) other than primary outcome is to be highlighted.

Line 324: the sentence ‘boxplots and scatterplots could be used to illustrate calculation’ is misleading.

Language version of the tools/inventories used in the study are to be stated.

The write-up on the statistical methods could be enhanced by organizing it in a more systematic manner and flow.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

**********

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

Enhancing trauma cardiopulmonary resuscitation simulation training with the use of virtual reality (Trauma SimVR): Protocol for a randomized controlled trial

PONE-D-24-24609R1

Dear Ms. Hafner

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Anne Lee Solevåg, M.D., Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Dear authors,

Thank you for revising the manuscript!

The points noted have all been carefully revised.

I wish you every success in carrying out the study!

Reviewer #2: The authors have diligently and thoroughly addressed all comments. There are no further comments.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

**********