Peer Review History

Original SubmissionNovember 12, 2021
Decision Letter - Claudio Andaloro, Editor

PONE-D-21-36009Development of protective equipment for endoscopic treatment and surgery in otorhinolaryngologyPLOS ONE

Dear Dr. Matsuwaki,

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 pay attention to more clearer figures and results

Please submit your revised manuscript by Apr 14 2022 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,

Claudio Andaloro

Academic Editor

PLOS ONE

Journal Requirements:

When submitting your revision, we need you to address these additional requirements.

1. 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. Thank you for stating the following in the Competing Interests section: 

I have read the journal's policy and the authors of this manuscript have the following competing interests: 

This research and development endeavor was conducted in collaboration with Olympus Medical Systems Corporation and a gastrointestinal endoscopist (Dr. Daisuke Kikuchi). Matsuwaki Clinic Shinagawa and Olympus Medical Systems Corporation have concluded an advisory agreement regarding this development. 

Please confirm that this does not alter your adherence to all PLOS ONE policies on sharing data and materials, by including the following statement: "This does not alter our adherence to  PLOS ONE policies on sharing data and materials.” (as detailed online in our guide for authors http://journals.plos.org/plosone/s/competing-interests).  If there are restrictions on sharing of data and/or materials, please state these. Please note that we cannot proceed with consideration of your article until this information has been declared. 

Please include your updated Competing Interests statement in your cover letter; we will change the online submission form on your behalf.

3. We note that Figure 2 includes an image of a participant in the study. 

As per the PLOS ONE policy (http://journals.plos.org/plosone/s/submission-guidelines#loc-human-subjects-research) on papers that include identifying, or potentially identifying, information, the individual(s) or parent(s)/guardian(s) must be informed of the terms of the PLOS open-access (CC-BY) license and provide specific permission for publication of these details under the terms of this license. Please download the Consent Form for Publication in a PLOS Journal (http://journals.plos.org/plosone/s/file?id=8ce6/plos-consent-form-english.pdf). The signed consent form should not be submitted with the manuscript, but should be securely filed in the individual's case notes. Please amend the methods section and ethics statement of the manuscript to explicitly state that the patient/participant has provided consent for publication: “The individual in this manuscript has given written informed consent (as outlined in PLOS consent form) to publish these case details”. 

If you are unable to obtain consent from the subject of the photograph, you will need to remove the figure and any other textual identifying information or case descriptions for this individual.

4. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

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

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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: No

**********

4. 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

**********

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: This study is indeed essential and relevant to be carried out. The paper was well written with acceptable figures. My only concern is that the actual p values were not stated, either in the text or figure legends. Additionally, since the sample size was small, including an effect size analysis is beneficial to support the p values.

Reviewer #2: This manuscript is the study to validate the protective equipment for endoscopic 'treatment and surgery'. The simulated situations are droplet spread and aerosal simulation model. The protective equipment are: suction-capable mask, sleeves and cover for suction. The main result is reduction of droplet and aerosal diffusion from there protective equipment.

There are some issues needed to be elucidated.

1) The main result has been displayed in two bar graphs but not in the table. The actual parameter/value will be easier and clearer for verification of 95% Confidence interval and p-value.

2) The author mention about the number of test as 'five times' but these values have not been shown in the figures.

3) The title mention about 'endoscopic treatment and surgery' but the testing situation was conducted by 'flexible endoscope' which unusual for 'surgery' in ENT.

4) The displayed pictures are difficult for reader to follow the method. More simplified, eg cartoon/drawing, should be done for clarification.

**********

6. 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.

Revision 1

Response to Reviewers’ Comments

Reviewer #1: This study is indeed essential and relevant to be carried out. The paper was well written with acceptable figures. My only concern is that the actual p values were not stated, either in the text or figure legends. Additionally, since the sample size was small, including an effect size analysis is beneficial to support the p values.

Reply:

Thank you for your encouraging comment.

I have added p-values to the legend of Fig.4 and p-values and the effect sizes in Table 1 in the revised manuscript (lines 243-256).

Reviewer #2: This manuscript is the study to validate the protective equipment for endoscopic 'treatment and surgery'. The simulated situations are droplet spread and aerosol simulation model. The protective equipments are: suction-capable mask, sleeves and cover for suction. The main result is reduction of droplet and aerosol diffusion from there protective equipment.

There are some issues needed to be elucidated.

1) The main result has been displayed in two bar graphs but not in the table. The actual parameter/value will be easier and clearer for verification of 95% Confidence interval and p-value.

Reply:

Thank you for your comment.

I have added p-values to the legend of Fig.4. I have also added 95% confidence interval values and p-values as well as the effect sizes to Table 1 in the revised manuscript (lines 243-256)

2) The author mention about the number of test as 'five times' but these values have not been shown in the figures.

Reply:

Thank you for pointing this out.

I have indicated the number of tests as “n=5” in the revised version of Fig. 4 and in Table 1 (lines 243-245). I have also added it to the legend of Fig. 4 (lines 246-256).

3) The title mention about 'endoscopic treatment and surgery' but the testing situation was conducted by 'flexible endoscope' which unusual for 'surgery' in ENT.

Reply:

Thank you for your constructive feedback.

During surgery, a rigid scope is used. Since the patient is anesthetized during surgery, the risk of splashing due to the patient sneezing, etc., is low. Therefore, the insertion sleeve need not be attached to the rigid scope or treatment tool, and only the surgical mask should be used.

During outpatient treatments, in addition to the outpatient mask, the insertion sleeve is attached to the flexible endoscope or the rigid endoscope and used in combination to reduce the risk of splashing.

In the experiment, the surgical scene (Nos. 1 and 2 in Fig. 4) and the outpatient scene (Nos. 3-6 in Fig. 4) are shown. The flexible endoscope is used only for evaluation in outpatient situations. This content is described in the Experiments section on (lines 145-156).

4) The displayed pictures are difficult for reader to follow the method. More simplified, eg cartoon/drawing, should be done for clarification.

Reply:

Thank you for this valuable suggestion.

Cartoon drawings have been added to Fig. 2 to help the readers understand the outpatient and surgical procedures. I hope that this will also help address the query raised in Comment 3. I also added a cartoon drawing to Fig. 5 to clearly present the experimental procedures.

Attachments
Attachment
Submitted filename: Response to reviewers.docx
Decision Letter - Claudio Andaloro, Editor

Development of protective equipment for endoscopic treatment and surgery in otorhinolaryngology

PONE-D-21-36009R1

Dear Dr. Matsuwaki,

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 for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, 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,

Claudio Andaloro

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: All my concerns have been satisfactorily addressed by the authors and the paper looks much better now. As such, this paper can be accepted for publication.

Reviewer #2: The manuscript has been revised according to the reviewer comments. The comments have been reposed clearly point-by-point.

**********

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: Yes: Pongsakorn Tantilipikorn MD PhD

Formally Accepted
Acceptance Letter - Claudio Andaloro, Editor

PONE-D-21-36009R1

Development of protective equipment for endoscopic treatment and surgery in otorhinolaryngology

Dear Dr. Matsuwaki:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. 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.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Claudio Andaloro

Academic Editor

PLOS ONE

Open letter on the publication of peer review reports

PLOS recognizes the benefits of transparency in the peer review process. Therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. Reviewers remain anonymous, unless they choose to reveal their names.

We encourage other journals to join us in this initiative. We hope that our action inspires the community, including researchers, research funders, and research institutions, to recognize the benefits of published peer review reports for all parts of the research system.

Learn more at ASAPbio .