PONE-D-24-28307Penehyclidine for postoperative nausea and vomiting in patients receiving general anesthesia: A systematic review and meta-analysis protocolPLOS ONE

Dear Dr. Zhou,

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.

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We look forward to receiving your revised manuscript.

Kind regards,

Jose A. Calvache, MD, MSc, PhD

Academic Editor

PLOS ONE

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Additional Editor Comments:

Dear Authors,

We kindly ask you to carefully review and address each comment made by Reviewers 1 and 2 in detail. Their feedback is essential for improving the quality and clarity of your manuscript. Please ensure that your revisions respond directly to the reviewers' concerns and provide clear justifications for any points where changes were not made. This will facilitate a smoother review process moving forward. Certaily, please take into account each detail of PRISMA declaration to enhance completeness, with special detail to: https://www.prisma-statement.org/protocols

Thank you for your attention to this matter.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Partly

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Partly

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

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Reviewer #1: Yes

Reviewer #2: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: I am very grateful for the opportunity to review this project on a very important topic due to its high incidence in the postoperative period. I have some questions and comments to be addressed by the authors.

Type of participants:

Will the review include patients from all age groups or just one group such as adults or pediatric patients?

Will it include inpatients or outpatients? Or both?

Types of interventions

Will the clinical trials that will be included be of the drug as a single medication or in combination with other antiemetics?

Types of outcome measures

Please, I would like to ask the authors to state whether they will obtain information on the incidence rate or a cumulative incidence. Also, please clarify whether they will be inpatients, undergoing day surgery or both types.

Regarding secondary outcome measures, I would like to ask you to clarify what will happen with other categories of PONV such as patients who presented combined nausea and vomiting and also those who suffered from another type of less common event such as vomiting without previous nausea.

Finally, what measures will you take in the event that PONV events have been measured or quantified with different standardized scales in the clinical trials included in your review?

Literature selection

The authors state that the search will be in English. What will happen with manuscripts that meet the inclusion criteria and have abstracts in English, but the full text is in a language other than English?

Reviewer #2: Line 49, remove the “,” before “and”.

Line 54, remove the “,” before “and”.

Line 55, remove the “,” before “including”.

Line 103, remove the “,” before “or”.

Line 107, remove the “,” before “or”.

Line 110 – 133, I don’t find coherent that the primary outcome is the incidence of postoperative nausea and vomiting (whether early or late) and as a secondary outcome, again, look for the incidence of postoperative nausea and vomiting but separately. From the way in which the primary outcome is described, I inferred that the incidence of nausea and vomiting will be reported separately regardless of the time at which they occur. I think they could be unified.

Line 126, Which standardized scale?

Line 128, Which standardized scale?

Line 142, postoperative is not a Mesh term, change to “postoperative period”

Line 143, postanaesthetic: repeated term.

Line 143, emetic is not a Mesh term, change to “emetics”

Line 143, emesis and retching are not Mesh terms.

Line 144, randomized, randomly and trial are not Mesh terms.

Line 148 y 149, Pubmed search strategy is confusing, unclear and contains terms that did not yield any results in PubMed; it needs to be reviewed and restructured. If you are going to use free terms, please describe what they are and specify in which databases you would use these terms.

Line 222 – 224, please provide the reference from which you extracted the Jadad scores.

Line 230 – 277, the discussion is superficial and does not provide strong context on the use of penehyclidine. I also don’t find that it offers relevant information other than has already been published in other articles.

Nothing is mentioned in the introduction or discussion about the important adverse effects of penehyclidine, such as the risk of addiction and withdrawal from the drug.

I find an article that requires substantive changes to achieve interest in the reader, it is an article still with a long way to go in terms of construction and execution, perhaps it could be an article of interest when the final results are presented, currently I do not find this protocol in optimal conditions to be published in PLOS ONE.

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Reviewer #1: No

Reviewer #2: No

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Attachments

Attachment

Submitted filename: Considerations PLOS ONE article.docx

PONE-D-24-28307R1Penehyclidine for postoperative nausea and vomiting in patients receiving general anesthesia: A systematic review and meta-analysis protocolPLOS ONE

Dear Dr. Zhou,

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 Jan 19 2025 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,

Jose A. Calvache, MD, MSc, PhD

Academic Editor

PLOS ONE

Journal Requirements:

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.

Additional Editor Comments (if provided):

Dear authors,

Thank you for your meticulous efforts in addressing all the reviewers' suggestions and incorporating the feedback into your manuscript. Your commitment to improving the quality of your work is greatly appreciated, and it reflects your dedication to advancing scientific research.

However, certain aspects need to be addressed before moving forward with the editorial process, particularly concerning the assessment of the certainty of the evidence. The Jadad scale, as mentioned in your protocol, is outdated and no longer considered a standard in systematic reviews. Instead, we strongly recommend revising and modifying the entire section to incorporate the GRADE approach (https://gdt.gradepro.org/app/handbook/handbook.html), which is the current standard. This adjustment is a mandatory recommendation to enhance the quality of the protocol.

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[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.

Penehyclidine for postoperative nausea and vomiting in patients receiving general anesthesia: A systematic review and meta-analysis protocol

PONE-D-24-28307R2

Dear Dr. Zhou,

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.

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Kind regards,

Kuo-Cherh Huang

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: