Impact of periprocedural morphine use on mortality in STEMI patients treated with primary PCI

Dominika Domokos; Andras Szabo; Gyongyver Banhegyi; Laszlo Major; Robert Gabor Kiss; David Becker; Istvan Ferenc Edes; Zoltan Ruzsa; Bela Merkely; Istvan Hizoh

doi:10.1371/journal.pone.0245433

Peer Review History

Original SubmissionOctober 6, 2020
18 Dec 2020 Decision Letter - Vincenzo Lionetti, Editor PONE-D-20-27765 Impact of periprocedural morphine use on mortality in STEMI patients treated with primary PCI PLOS ONE Dear Dr. Hizoh, 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. All issues raised by expert reviewers are required. Please submit your revised manuscript by Jan 29 2021 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, Vincenzo Lionetti, M.D., PhD 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 [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: No 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: 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: Interesting manuscript that analyses the effects of intravenous morphine on patients suffering of STEMI. The follow up reported is important and gives high value to the manuscript, which is well written and with a sound methodology. I have no particular observations. Just the suggestion to underline in the abstract (or in title ?) the fact that only copidogrel was in use in your center. Reviewer #2: The paper is of sure interest for the readership of PLOS ONE, the topic is appealing and the structure is readable with ease. However, the narrative rationale sounds somewhat unbalanced. In particular, it juxtaposes extremely verbose paragraphs to utterly synthetic ones. In other words my suggestion is to encourage authors in improving the flow so to maintain a coherent register. Nevertheless, i believe the paper publishable pending minor revision. My main point against the acceptance in its present form, is based upon the fact that the statistical part (which was frankly over my head) is given in such a synthetic way that is understandable only to a specialized readership. While, i believe important to make it accessible also to non expert and casual readers. In this regard, it is not clear why a test was chosen against an another one, or why the results of a given test are functional to the mastering of decision and assumption. In this way, the ground onto which the discussion section is built sounds rather speculative. ****** 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: Yes:** Prof. Edoardo De Robertis 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. https://doi.org/10.1371/journal.pone.0245433.r001
Revision 1
27 Dec 2020 Author Response Response to Reviewers We thank the Editor and the Reviewers for their constructive criticism. The insightful comments have been carefully addressed. 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 In the revised manuscript, we tried to accomplish the necessary changes according to PLOS ONE's style requirements. 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: No Reviewer #2:I Don't Know Indeed, the applied statistical methods are complex and their detailed description may deteriorate the readability of the paper. Yet, this methodology is necessary to account for the observational nature of the data and may allow an unbiased estimation of the treatment effect. Therefore, we shortened the Statistical Analysis section for improved readability. Nevertheless, for the above reasons and to be in concert with the requirement that “Manuscripts submitted to PLOS ONE are expected to report statistical methods in sufficient detail for others to replicate the analysis performed” we now provide S1 Appendix with detailed methodology. Please see response to Reviewer #2’s comment bellow as well. 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 In the revised manuscript, the analyzed data are available as Supporting Information (S2 Dataset). 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 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: Interesting manuscript that analyses the effects of intravenous morphine on patients suffering of STEMI. The follow up reported is important and gives high value to the manuscript, which is well written and with a sound methodology. I have no particular observations. Just the suggestion to underline in the abstract (or in title ?) the fact that only clopidogrel was in use in your center. Thank you for the comment. The exclusive use of clopidogrel is now emphasized in the abstract as well. (It was also stated in the Methods and Limitation sections of the original manuscript.) Reviewer #2: The paper is of sure interest for the readership of PLOS ONE, the topic is appealing and the structure is readable with ease. However, the narrative rationale sounds somewhat unbalanced. In particular, it juxtaposes extremely verbose paragraphs to utterly synthetic ones. In other words my suggestion is to encourage authors in improving the flow so to maintain a coherent register. Nevertheless, i believe the paper publishable pending minor revision. My main point against the acceptance in its present form, is based upon the fact that the statistical part (which was frankly over my head) is given in such a synthetic way that is understandable only to a specialized readership. While, i believe important to make it accessible also to non expert and casual readers. In this regard, it is not clear why a test was chosen against an another one, or why the results of a given test are functional to the mastering of decision and assumption. In this way, the ground onto which the discussion section is built sounds rather speculative. Thank you for this important remark. Indeed, the applied statistical methods are complex and their detailed description may worsen the readability. Yet, we deliberately sought to use modern, complex statistical methods that may allow an unbiased assessment of the treatment effect despite the observational nature of the data. In the revised manuscript, we shortened the Statistical Analysis section for better legibility. Nevertheless, for the above reasons and to be in concert with the requirement that “Manuscripts submitted to PLOS ONE are expected to report statistical methods in sufficient detail for others to replicate the analysis performed” we now present S1 Appendix with detailed methodology. We think that further explanation of the chosen methodology would be beyond the scope of the present paper. Nevertheless, we include references with DOI numbers / hyperlinks for the reader wishing greater insight into the applied statistical methods. If any further doubt remains regarding the appropriateness of the statistical analysis, we suggest performing a formal statistical review of the manuscript. https://doi.org/10.1371/journal.pone.0245433.r002
4 Jan 2021 Decision Letter - Vincenzo Lionetti, Editor Impact of periprocedural morphine use on mortality in STEMI patients treated with primary PCI PONE-D-20-27765R1 Dear Dr. Hizoh, 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, Vincenzo Lionetti, M.D., PhD 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: 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 #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) ****** 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 https://doi.org/10.1371/journal.pone.0245433.r003
Formally Accepted
5 Jan 2021 Acceptance Letter - Vincenzo Lionetti, Editor PONE-D-20-27765R1 Impact of periprocedural morphine use on mortality in STEMI patients treated with primary PCI Dear Dr. Hizoh: 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 Prof. Vincenzo Lionetti Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0245433.r004

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