PONE-D-20-04499

Medical use of cocaine and perioperative morbidity following sinonasal surgery- a population study

PLOS ONE

Dear Dr MacNeil,

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.

We would appreciate receiving your revised manuscript by Apr 24 2020 11:59PM. When you are 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.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter.

To enhance the reproducibility of your results, we recommend that if applicable you deposit your laboratory protocols in protocols.io, where a protocol can be assigned its own identifier (DOI) such that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols

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). This letter should be uploaded as separate file and labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. This file should be uploaded as separate file and labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. This file should be uploaded as separate file and labeled 'Manuscript'.

Please note while forming your response, if your article is accepted, you may have the opportunity to make the peer review history publicly available. The record will include editor decision letters (with reviews) and your responses to reviewer comments. If eligible, we will contact you to opt in or out.

We look forward to receiving your revised manuscript.

Kind regards,

Eng Ooi

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 http://www.plosone.org/attachments/PLOSOne_formatting_sample_main_body.pdf and http://www.plosone.org/attachments/PLOSOne_formatting_sample_title_authors_affiliations.pdf

2. In ethics statement in the manuscript and in the online submission form, please provide additional information about the patient records used in your retrospective study. Specifically, please ensure that you have discussed whether all data were fully anonymized before you accessed them and/or whether an IRB or ethics committee waived the requirement for informed consent. If patients provided informed written consent to have data from their medical records used in research, please include this information.

3. We noticed you have some minor occurrence(s) of overlapping text with the following previous publication(s), which needs to be addressed:

doi.org/10.1097/MD.0000000000001106

In your revision ensure you cite all your sources (including your own works), and quote or rephrase any duplicated text outside the Methods section. Further consideration is dependent on these concerns being addressed.

[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

Reviewer #3: Yes

**********

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

Reviewer #1: No

Reviewer #2: Yes

Reviewer #3: 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: No

Reviewer #2: Yes

Reviewer #3: 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: Yes

Reviewer #3: 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 is a nicely written manuscript on an important topic with a large # of patients across different institutions with opposite practices regarding cocaine use in sinonasal surgery. I generally agree with the conclusions, which do belong in the published literature, but there are some modifications that could make it an even better manuscript.

1. Can the authors comment on the impact, if any, of the differences between groups noted in Table 1? The standardized differences for some reached the threshold of relevance.

2. Some power calculation is needed, especially since the authors are trying to establish a “negative” conclusion.

3. The fisher exact test is not appropriate for large volume data. I believe chi-square is the correct test and do not believe this would change the conclusion. In fact, I suspect the borderline significance of the 30 day findings would be lost (further supporting the authors’ assertions) using the correct but more stringent test.

4. The authors state: “Due to potential risk of patient re-identification, institutional policies prohibit the presentation of results of 5 or fewer individuals. Furthermore, exact p-value for the primary outcome could not be presented to avoid the exact number of event rates from being back calculated.” Although knowing the exact number may not change the conclusions at all, It seems IRB approval could allow identification of the individual cases to determine if there were common features that could be identified to account for the event.

5. Are there any other questions that can be answered from this large dataset – intraoperative events, bleeding, postop pain?

Reviewer #2: Overall an informative study, showing a positive safety profile for cocaine use during sinonasal surgery. This is particularly relevant for those institutions that use cocaine for their procedures. I have suggested the authors consider these points.

Page 4 Line 56-57: Specific reference to Ontario, is this relevant to the paper?

Page 4 Line 61-63: Is there a reference to support the use of cocaine for post operative pain, and additionally the duration of effect.

Page 8 Paragraph starting Line 144: Are the range of cocaine doses known for the institutions that use cocaine?

Could the authors summarize the previous largest studies on cocaine use in sinonasal surgery, there seems to be a lack of discussion of the literature. (major revision)

Page 13 Paragraph starting Line 224: This paragraph is repetitive and should be restricted.

The authors have postulated that a larger study is not possible. This statement assumes the authors have intimate knowledge of all international databases and their capabilities, which I think is speculative.

Additionally, a statement of “best available data” should instead relate back to why this study is successful given the low event rate, which is the size of the population included.

Page 13 Line 227-228: The sentence starting “We included” is repetitive.

Page 14 Line 242: Is case complexity relevant – could the authors refer to case complexity of already reported cocaine associated morbidity. The previously referenced systematic review showed a range of case complexities at risk.

Reviewer #3: The statistical analysis appears sound, but Im not a statistician so I did not delve into the statical analysis of the study. Overall this study will appeal to ENT surgeons who still use cocaine for their surgical patients, thus appeal to a narrow range of readers.

**********

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: Yes: Dr Jae Murphy

Reviewer #3: 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 to be viewed.]

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 us at figures@plos.org. Please note that Supporting Information files do not need this step.

Attachments

Attachment

Submitted filename: PONE_cocaine study.pdf

PONE-D-20-04499R1

Medical use of cocaine and perioperative morbidity following sinonasal surgery- A population study

PLOS ONE

Dear Dr. MacNeil,

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 Jul 09 2020 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: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols

We look forward to receiving your revised manuscript.

Kind regards,

Eng Ooi

Academic Editor

PLOS ONE

Additional Editor Comments (if provided):

The responses and revisions with regards to addressing the reviewers comments have been useful. I have a comment and recommend a minor revision. Line 66 to 67 ... lasts for hours after the patient is reversed from anesthesia.... references indicate that a second application of cocaine is needed within an hour of the first application to continue significant effects. Can you please specify how long, instead of simply stating for hours, you would expect the anesthetic effect to last for from the initial application of intranasal cocaine in preparation for endoscopic sinus surgery.

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

[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.

Medical use of cocaine and perioperative morbidity following sinonasal surgery- A population study

PONE-D-20-04499R2

Dear Dr. MacNeil,

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,

Eng Ooi

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: