Peer Review History

Original SubmissionSeptember 6, 2021
Decision Letter - Chun Chieh Yeh, Editor

PONE-D-21-28885Budget impact analysis of HARMONIC FOCUS™+ Shears for mastectomy and breast-conserving surgery with axillary lymph node dissection compared with monopolar electrocautery from an Italian hospital perspectivePLOS ONE

Dear Dr. Piemontese,

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Chun Chieh Yeh, M.D., Ph.D.

Academic Editor

PLOS ONE

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2. Thank you for stating the following financial disclosure:

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“I have read the journal's policy and the authors of this manuscript have the following competing interests: TG, NJ, VP, AP and GAT are paid employees of Johnson & Johnson. LS is a paid employee of Costello Medical, UK, who was contracted by Johnson & Johnson to conduct the assist in developing the model and provide medical writing support in preparation of the manuscript.”

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Additional Editor Comments:

Thank you for submitting this remarkable work. After comprehensive reviewing, the referees gave some comments to your work. We wish you could provide specific and timely response and revisions for their comments. Decision will be made based on your response. Thanks.

[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

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

Reviewer #1: Yes

Reviewer #2: Yes

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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: A good article with good statistical analysis on a certo common surgical operation. I think the article Is writer in a good english.the article could have a big impact on guide Lines and influenze the choiche of the Harmonic scalpel for axillary dissection.

Reviewer #2: The Authors performed a really interesting study Budget impact analysis of HARMONIC FOCUS™+ Shears for mastectomy and breast-conserving surgery with axillary lymph node dissection compared with monopolar electrocautery. It is in interesting topic. The paper is well written and interesting in all its field demonstrating a remarkable experience in the treatment of breast cancer.

In my opinion in patients undergoing surgery for breast cancer, one of the unsolved problems is the seroma formation. In order to better analyse this topic, I suggest considering the paper:

" Gambardella C, Clarizia G, Patrone R, Offi C, Mauriello C, Romano R, Filardo M, Conzo A, Sanguinetti A, Polistena A, Avenia N, Conzo G. Advanced hemostasis in axillary lymph node dissection for locally advanced breast cancer: new technology devices compared in the prevention of seroma formation. BMC Surg. 2019 Apr 24;18(Suppl 1):125. doi: 10.1186/s12893-018-0454-8."

“Docimo G, Limongelli P, Conzo G, Gili S, Bosco A, Rizzuto A, Amoroso V, Marsico S, Leone N, Esposito A, Vitiello C, Fei L, Parmeggiani D, Docimo L. Axillary lymphadenectomy for breast cancer in elderly patients and fibrin glue. BMC Surg. 2013;13 Suppl 2(Suppl 2):S8. doi: 10.1186/1471-2482-13-S2-S8. Epub 2013 Oct 8. PMID: 24266959; PMCID: PMC3851152.”

“Parisi S, Ruggiero R, Gualtieri G, et al. Combined LOCalizer™ and Intraoperative Ultrasound Localization: First Experience in Localization of Non-palpable Breast Cancer. In Vivo. 2021;35(3):1669-1676. doi:10.21873/invivo.12426”

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Reviewer #1: No

Reviewer #2: No

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Revision 1

Associate Editor:

General comments: Thank you for submitting this remarkable work. After comprehensive reviewing, the referees gave some comments to your work. We wish you could provide specific and timely response and revisions for their comments. Decision will be made based on your response. Thanks.

Authors’ response: Thank you very much for your positive feedback on our manuscript. In line with the helpful comments from peer review, we have revised our manuscript accordingly. Please find these addressed point-by-point below.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming.

Authors’ response: We have thoroughly reviewed the provided guidance and have made minor formatting changes throughout the manuscript, including adjusting headings and abbreviating journal names within the bibliography, to ensure that it meets PLOS ONE’s style requirements. We have also named each of the resubmitted files as per the provided guidance.

2. Thank you for stating the following financial disclosure: “This study was funded by Johnson & Johnson. Support for third-party writing assistance for this article, provided by Costello Medical, UK, was funded by Johnson & Johnson in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).” Please state what role the funders took in the study. If the funders had no role, please state: ""The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript."" If this statement is not correct you must amend it as needed. Please include this amended Role of Funder statement in your cover letter; we will change the online submission form on your behalf.

Authors’ response: The Role of Funder statement should read as follows: “This study was funded by Johnson & Johnson. Alessandra Piemontese, Thibaut Galvain, Vito Parago, Giovanni A. Tommaselli and Nadine Jamous are all employees of Johnson & Johnson. Support for third-party writing assistance for this article, provided by Costello Medical, UK, was funded by Johnson & Johnson in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).”

3. 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: TG, NJ, VP, AP and GAT are paid employees of Johnson & Johnson. LS is a paid employee of Costello Medical, UK, who was contracted by Johnson & Johnson to conduct the assist in developing the model and provide medical writing support in preparation of the manuscript.” 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.

Authors’ response: The Competing Interests statement should read as follows: “I have read the journal's policy and the authors of this manuscript have the following competing interests: TG, NJ, VP, AP and GAT are paid employees of Johnson & Johnson. At the time of writing the manuscript, LS was a paid employee of Costello Medical, UK, who was contracted by Johnson & Johnson to conduct the assist in developing the model and provide medical writing support in preparation of the manuscript. This does not alter our adherence to PLOS ONE policies on sharing data and materials.”

4. We note that you have stated that you will provide repository information for your data at acceptance. Should your manuscript be accepted for publication, we will hold it until you provide the relevant accession numbers or DOIs necessary to access your data. If you wish to make changes to your Data Availability statement, please describe these changes in your cover letter and we will update your Data Availability statement to reflect the information you provide.

Authors’ response: There is no additional, repository information that needs to be made available prior to publication. All model inputs and their sources (including citations), and a detailed description of the model design and structure, have been provided within the manuscript.

5. PLOS requires an ORCID iD for the corresponding author in Editorial Manager on papers submitted after December 6th, 2016. Please ensure that you have an ORCID iD and that it is validated in Editorial Manager.

Authors’ response: The ORCID iD for the corresponding author is: 0000-0002-7397-3546.

Reviewer 1:

General comments: A good article with good statistical analysis on a certo common surgical operation. I think the article Is writer in a good english.the article could have a big impact on guide Lines and influenze the choiche of the Harmonic scalpel for axillary dissection.

Authors’ response: We thank you for your thorough review of this manuscript and generous feedback.

Reviewer 2:

General comments: The Authors performed a really interesting study Budget impact analysis of HARMONIC FOCUS™+ Shears for mastectomy and breast-conserving surgery with axillary lymph node dissection compared with monopolar electrocautery. It is in interesting topic. The paper is well written and interesting in all its field demonstrating a remarkable experience in the treatment of breast cancer.

Authors’ response: We thank you for your thorough review of this manuscript and generous feedback. Responses to your comments can be found below.

1. In my opinion in patients undergoing surgery for breast cancer, one of the unsolved problems is the seroma formation. In order to better analyse this topic, I suggest considering the paper:

a) " Gambardella C, Clarizia G, Patrone R, Offi C, Mauriello C, Romano R, Filardo M, Conzo A, Sanguinetti A, Polistena A, Avenia N, Conzo G. Advanced hemostasis in axillary lymph node dissection for locally advanced breast cancer: new technology devices compared in the prevention of seroma formation. BMC Surg. 2019 Apr 24;18(Suppl 1):125. doi: 10.1186/s12893-018-0454-8."

b) “Docimo G, Limongelli P, Conzo G, Gili S, Bosco A, Rizzuto A, Amoroso V, Marsico S, Leone N, Esposito A, Vitiello C, Fei L, Parmeggiani D, Docimo L. Axillary lymphadenectomy for breast cancer in elderly patients and fibrin glue. BMC Surg. 2013;13 Suppl 2(Suppl 2):S8. doi: 10.1186/1471-2482-13-S2-S8. Epub 2013 Oct 8. PMID: 24266959; PMCID: PMC3851152.”

c) “Parisi S, Ruggiero R, Gualtieri G, et al. Combined LOCalizer™ and Intraoperative Ultrasound Localization: First Experience in Localization of Non-palpable Breast Cancer. In Vivo. 2021;35(3):1669-1676. doi:10.21873/invivo.12426”

Authors’ response: To better recognise the burden of seroma formation on patients undergoing surgery for breast cancer, we have updated the Introduction (page 4, lines 71–74) and Discussion (pages 12–13, lines 256–259) sections to highlight its incidence and potential impact, including delays to adjuvant treatments, and reduced rates observed with HARMONIC FOCUS™+ versus electrocautery, respectively, with reference to Gambardella (2019) and Docimo (2013), as follows:

“…increased risk of complications including lymphedema and seroma,[8, 10] the latter of which affects up to 85% of patients undergoing ALND and is a source of significant morbidity.[11, 12] Seroma formation may also delay adjuvant treatments such as chemotherapy and, as a result, affect oncological outcomes.[12]”

“These data are supported by Italian real-world evidence demonstrating improvements in clinical outcomes, for example, reduced seroma formation rate, with HARMONIC FOCUS™+ versus electrocautery following ALND.[12]”

We have not however incorporated Parisi (2021) into the manuscript as, after thoroughly reviewing the study, we were unable to identify any results pertaining to, or any mention of, seroma formation in patients undergoing surgery for breast cancer. We therefore feel that Parisi (2021) does not bear sufficient relevance to the topic of seroma formation, or the manuscript overall, to warrant its inclusion. However, if you have any suggestions for where Parisi (2021) might fit within the manuscript, please do let us know and we would be more than happy to take them into consideration.

Attachments
Attachment
Submitted filename: Response to Reviewers_1.docx
Decision Letter - Chun Chieh Yeh, Editor

Budget impact analysis of HARMONIC FOCUS™+ Shears for mastectomy and breast-conserving surgery with axillary lymph node dissection compared with monopolar electrocautery from an Italian hospital perspective

PONE-D-21-28885R1

Dear Dr. Piemontese,

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.

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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,

Chun Chieh Yeh, M.D., Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Thanks for your timely revision. Based on your revised work, our referee considered your work if worthy of publication at its current content. Congratulation again for your great work.

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

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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 #2: Yes

**********

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

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 #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: (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 #2: Yes: Claudio Gambardella

Formally Accepted
Acceptance Letter - Chun Chieh Yeh, Editor

PONE-D-21-28885R1

Budget impact analysis of HARMONIC FOCUS+ Shears for mastectomy and breast-conserving surgery with axillary lymph node dissection compared with monopolar electrocautery from an Italian hospital perspective

Dear Dr. Piemontese:

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. Chun Chieh Yeh

Academic Editor

PLOS ONE

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