Peer Review History

Original SubmissionJune 4, 2020
Decision Letter - Davor Plavec, Editor

PONE-D-20-16968

Non-invasive ventilation with pursed lips breathing mode for patients with COPD and hypercapnic respiratory failure

PLOS ONE

Dear Dr. Herzmann,

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.

This is an interesting topic. The title of the article should be renamed to “Non-invasive ventilation with pursed lips breathing mode for patients with COPD and hypercapnic respiratory failure: a retrospective analysis”. It should be clearly stated in the Abstract and the Methods section that this is a hypothesis generating study. Although there is a Limitations paragraph in the Discussion section because of the several important limitations to the study this section should be discussed in significantly more detail together with how could this influence the results (sample size, selection bias, conflict of interest, etc.). In the light of what was said the conclusions should be rewritten.

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We look forward to receiving your revised manuscript.

Kind regards,

Davor Plavec, MD, MSc, PhD, Prof.

Academic Editor

PLOS ONE

Additional Editor Comments:

This is an interesting topic. The title of the article should be renamed to “Non-invasive ventilation with pursed lips breathing mode for patients with COPD and hypercapnic respiratory failure: a retrospective analysis”. It should be clearly stated in the Abstract and the Methods section that this is a hypothesis generating study. Although there is a Limitations paragraph in the Discussion section because of the several important limitations to the study this section should be discussed in significantly more detail together with how could this influence the results (sample size, selection bias, conflict of interest, etc.). In the light of what was said the conclusions should be rewritten.

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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:

'SR: I have read the journal's policy and the authors of this manuscript have the following competing interests: I invented the PLBV and have co-developed the Vigaro device within the scope of a consulting contract with FLO medical.

CL: I have read the journal's policy and the authors of this manuscript have the following competing interests. I report personal fees from Chiesi, Gilead, Janssen, Lucane, Novartis, Oxoid,  Berlin Chemie and Thermofisher outside the submitted work.

CH: I have read the journal's policy and the authors of this manuscript have the following competing interests. I report personal fees from Janssen outside the submitted work.

CJ, KIG and LK: The authors have declared that no competing interests exist.'

a. 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.

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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

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

Reviewer #1: I Don't Know

Reviewer #2: I Don't Know

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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: Yes

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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

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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: Authors have good knowledge of physiological process of breathing,

Their idea of applying another mode of NIV similar to the well established exercise of breathing with pursed lips and its implementation into praxis in problematic COPD patients is very fresh and promising.

The problem is very low number of investigated subjects and the retrospective manner of study. In these circumstances I do not feel myself enough competetent to assess statistical analysis.

Some results are unexpected, it is difficult to explain how the pCO2 was not lower with such improvement of exercise capacity measured by 6MWT. The only possibility that drop on my mind is that the measurement of pCO2 in capillary sample is not accurate enough, and that arterial sample is more appropriate, so in hypothetical next similar study it should be implemented.

All results show that the new method PLBV decrease hyperinflation, which contribute significantly to the quality of life, what is one of the most important goals in management of COPD, thus putting the PLBV on the important place in treatment of severe COPD patients.

Reviewer #2: Interesting results of the retrospective analyse, prompt the prospective study. Nothing major to correct. Accent to the quality of life and exercise tolerance over the lung function and blood gasses in COPD management.

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Reviewer #1: Yes: Sanja Popović-Grle

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.]

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Revision 1

Dear Editor,

please find enclosed the revised manuscript as suggested in your email dated July 13th, 2020.

As suggested, the following amendments were made:

1) The Competing Interests section now reads as follows:

SR invented the PLBV and has co-developed the Vigaro within the scope of a consulting contract with FLO medical.

CL reports personal fees from Chiesi, Gilead, Janssen, Lucane, Novartis, Oxoid, Berlin Chemie and Thermofisher outside the submitted work.

CH reports personal fees from Janssen outside the submitted work.

CJ, KIG and LK have no conflicting interests to declare.

This does not alter our adherence to PLOS ONE policies on sharing data and materials.

2) All details regarding the approval of the ethics committee were moved to the last paragraph of the Material and Methods section of the manuscript.

Decision Letter - Davor Plavec, Editor

Non-invasive ventilation with pursed lips breathing mode for patients with COPD and hypercapnic respiratory failure: a retrospective analysis

PONE-D-20-16968R1

Dear Dr. Herzmann,

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,

Davor Plavec, MD, MSc, PhD, Prof.

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

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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: I Don't Know

Reviewer #2: I Don't Know

**********

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: Explanations about some unexpected results previously mentioned in my review are now very good addressed and have logic pathophysiology rational.

Reviewer #2: (No Response)

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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

Formally Accepted
Acceptance Letter - Davor Plavec, Editor

PONE-D-20-16968R1

Non-invasive ventilation with pursed lips breathing mode for patients with COPD and hypercapnic respiratory failure: a retrospective analysis

Dear Dr. Herzmann:

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. Davor Plavec

Academic Editor

PLOS ONE

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