Peer Review History

Original SubmissionJune 23, 2022
Decision Letter - Mao-Shui Wang, Editor

PONE-D-22-17884Amikacin liposome and Mycobacterium avium complex: A systematic reviewPLOS ONE

Dear Dr. Nasiri,

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 Nov 28 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,

Mao-Shui Wang

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 submitting the above manuscript to PLOS ONE. During our internal evaluation of the manuscript, we found significant text overlap between your submission and previous work in the introduction, methods and results section of your manuscript. We would like to make you aware that copying extracts from previous publications, especially outside the methods section, word-for-word is unacceptable. In addition, the reproduction of text from published reports has implications for the copyright that may apply to the publications. Please revise the manuscript to rephrase the duplicated text, cite your sources, and provide details as to how the current manuscript advances on previous work. Please note that further consideration is dependent on the submission of a manuscript that addresses these concerns about the overlap in text with published work. We will carefully review your manuscript upon resubmission and further consideration of the manuscript is dependent on the text overlap being addressed in full. Please ensure that your revision is thorough as failure to address the concerns to our satisfaction may result in your submission not being considered further.

3. Thank you for stating the following financial disclosure: 

The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

At this time, please address the following queries:

a) Please clarify the sources of funding (financial or material support) for your study. List the grants or organizations that supported your study, including funding received from your institution. 

b) State what role the funders took in the study. If the funders had no role in your study, please state: “The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.”

c) If any authors received a salary from any of your funders, please state which authors and which funders.

d) If you did not receive any funding for this study, please state: “The authors received no specific funding for this work.”

Please include your amended statements within your cover letter; we will change the online submission form on your behalf.

4. Thank you for stating the following in the Acknowledgments Section of your manuscript: 

This study was supported by the Research Department of the School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran (Grant number: 32969) and is part of the scientific activities of the GTN (Gloal Tuberculosis Network).

We note that you have provided funding information that is not currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. 

Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: 

The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Please include your amended statements within your cover letter; we will change the online submission form on your behalf.

5. 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. 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: N/A

Reviewer #2: I Don't Know

**********

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

**********

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: No

**********

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: The overall manuscript is well presented and thorough. The main drawback from this study is that it is centred around 4 studies only which makes comparisons to others difficult. My suggestion for the authors is to perhaps revise the manuscript and compare against injectable amikacin in clinical cohorts for M. avium treatment. This would mean that the current study can be used as a summary of clinical studies to make clinically informed decisions on whether LAI is beneficial compared to conventional routes of amikacin delivery.

Reviewer #2: Major comments

The current manuscript was carried out to evaluate the outcomes and adverse events of liposomal amikacin for inhalation in patients with MAC pulmonary disease. The undertaken issue is interesting and worth disseminating. However, several changes are needed before the manuscript is accepted for publication.

Specific comments

Abstract

Line 7-8: “patients who have not responded to conventional treatment...”

Please simplify to “refractory MAC pulmonary disease”

Line 9: “patients with MAC disease”

Please revise to “MAC pulmonary disease”

Line 17: “early sustainable, and durable negative sputum culture”

What is the definition of “sustainable, and durable”? Please clarify it in manuscript.

Introduction

Line 1: I suggest describing the basic information of NTM before mentioning the NTM pulmonary disease.

Line 4: “presence of baseline lung comorbidities”

Please describe the lung comorbidities in this sentence.

Example) bronchiectasis, previous TB, cystic fibrosis

Line 5-6: “The prevalence of MAC is increasing globally,”

Please revise to “MAC infection”.

Discussion

Line 1: “The incidence and prevalence of MAC”

Please revise to “MAC infection”

Line 5-6: “in the regimen for patients with advanced or previously treated disease”

What is the definition of “advanced or previously treated disease”? This sentence is little bit unclear. Please revise it.

Line 7-12

These sentences are repeated from lines 18-27 of the introduction part. Please revise or remove the repeated parts in the manuscript.

Line 19-20: “Likewise, inhaled antibiotic can achieve positive outcomes in cases of M. tuberculosis infection.”

The meaning of this sentence is unclear. Does “positive” mean early negative sputum conversion or improved sputum culture conversion rate? Please clarify it.

Line 23: “Phase 2 clinical described its safety and efficacy…”

Please revise to “Phase 2 clinical trials”

Acknowledgement

Line 3: “Gloal Tuberculosis Network”

Revise to “Global Tuberculosis Network”

**********

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

Dear Editor

We thank the editor and the reviewers for their comments on our manuscript. Below is our response to each point raised by the academic editor and reviewers. We hope that we satisfyingly addressed them and that the manuscript will be now suited for publication.

Sincerely,

On behalf of all authors,

Mohammad Javad Nasiri

Response to Editor comments:

Thank you for considering our manuscript. We thank the editor and reviewers for their thoughtful critique and comments. We have carefully edited the manuscript as requested by you and have provided a point-by-point response below. Please find the revised version included. The revisions are highlighted in yellow in the resubmitted manuscript. We hope this meets the established reputation for the quality of your esteemed journal.

1) Thanks for pointing this out. The manuscript is updated with PLOS ONE's style requirements.

2) Thanks for your fair and constructive comment. The duplicated text is rephrased word by word.

3) Thanks for pointing this out. All your queries about financial disclosure are addressed in cover letter and Funding Statement section of the online submission form

4) Thanks for pointing this out. The acknowledgement is corrected (Page 14, line: 267) and funding information is addressed in cover letter and Funding Statement section of the online submission form.

5) Thanks for pointing this out. The data availability statement and captions for Supporting Information files (search strategy and data extraction form) are added. (Page 14, lines: 260-263)

Response to reviewer 1

We appreciate the time and attention you spent in reviewing our manuscript and your thoughtful critique and comment.

Brief descriptions of some clinical cohorts and systematic reviews about safety and efficacy of injectable amikacin are added to the discussion section of manuscript and highlighted in yellow, for comparing the benefits of LAI against conventional routes of amikacin delivery. (Page 12, lines: 213-224)

Response to reviewer 2

Thank you for your willingness to consider our initial manuscript “Amikacin liposome and Mycobacterium avium complex: A systematic review”. We have carefully considered all comments and revised and improved some parts of the original manuscript as requested. We hope this meets the established reputation for the quality of your esteemed journal. The revisions are highlighted in yellow in the resubmitted manuscript.

1) Thanks for your fair and constructive comment. The simplification has been done. (Page 3, lines: 36 and 37)

2) Thanks for pointing this out. The phrase that you are looking for is added. (Page 3, line: 38)

3) Thanks for your recommendation. The term "sustainable" has been changed to "sustained". Sustained and durable culture conversion is defined by negative sputum culture results for 12 months during treatment and for 3 months after treatment respectively. (Page 3, lines: 44-46)

4) Thanks for your suggestion. The basic information of NTM is added. (Page 4, lines: 55-57)

5) Thanks for your recommendation. The description (chronic obstructive pulmonary disease (COPD), bronchiectasis, and cystic fibrosis) is added to the text. (Page 4, lines: 60 and 61)

6) Thanks for your suggestion. The phrase has been revised. (Page 4, line: 63)

7) Thanks for pointing this out. The phrase that you are looking for is added. (Page 11, line: 207)

8) Thanks for your suggestion. This sentence has been clarified (advanced or previously treated MAC lung disease). (Page 12, line: 212)

9) Thanks for your recommendation. Some of the mentioned sentences have been deleted and some parts have been revised. (Page 12, Lines: 225-227)

10) Thanks for your fair and constructive comment. To clarify the sentence, it is changed to “Likewise, inhaled antibiotic can be effective and practically feasible in cases of M. tuberculosis infection”. (Page 13, lines: 234-235)

11) Thanks for pointing this out. The phrase that you are looking for is added. (Page 13, line: 238)

12) Thanks for pointing this out. The acknowledgement has been corrected in order to journal requirements. And your revised phrase is added in financial information section in online submission form. (Page 14, line: 267)

Attachments
Attachment
Submitted filename: Response to Reviewers.docx
Decision Letter - Mao-Shui Wang, Editor

Amikacin liposome and Mycobacterium avium complex: A systematic review

PONE-D-22-17884R1

Dear Dr. Nasiri,

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,

Mao-Shui Wang

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 #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 #2: Yes

**********

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

Reviewer #2: N/A

**********

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 #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 #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 #2: All comments raised in a previous review have been addressed, and this manuscript is now acceptable for publication.

**********

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 #2: No

**********

Formally Accepted
Acceptance Letter - Mao-Shui Wang, Editor

PONE-D-22-17884R1

Amikacin liposome and Mycobacterium avium complex: A systematic review

Dear Dr. Nasiri:

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. Mao-Shui Wang

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 .