Effects of intraoperative hemodynamic management on postoperative acute kidney injury in liver transplantation: An observational cohort study

François Martin Carrier; Marie-Pierre Sylvestre; Luc Massicotte; Marc Bilodeau; Michaël Chassé

doi:10.1371/journal.pone.0237503

Peer Review History

Original SubmissionApril 29, 2020
1 Jul 2020 Decision Letter - Ehab Farag, Editor PONE-D-20-12508 Effects of intraoperative hemodynamic management on postoperative acute kidney injury in liver transplantation: an observational cohort study. PLOS ONE Dear Dr. Carrier, 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 Aug 14 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. 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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, Richard Hodge (on behalf of Academic Editor Ehab Farag, MD FRCA FASA) Associate 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. In your ethics statement, 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. 3. We note that your study involved tissue/organ transplantation. Please provide the following information regarding tissue/organ donors for transplantation cases analyzed in your study. a. Please provide the source(s) of the transplanted tissue/organs used in the study, including the institution name and a non-identifying description of the donor(s). b. Please state in your response letter and ethics statement whether the transplant cases for this study involved any vulnerable populations; for example, tissue/organs from prisoners, subjects with reduced mental capacity due to illness or age, or minors. - If a vulnerable population was used, please describe the population, justify the decision to use tissue/organ donations from this group, and clearly describe what measures were taken in the informed consent procedure to assure protection of the vulnerable group and avoid coercion. - If a vulnerable population was not used, please state in your ethics statement, “None of the transplant donors was from a vulnerable population and all donors or next of kin provided written informed consent that was freely given.” 4. In the Methods, please provide detailed information about the procedure by which informed consent was obtained from organ/tissue donors or their next of kin. In addition, please provide a blank example of the form used to obtain consent from donors, and an English translation if the original is in a different language. 5. Please indicate whether the donors were previously registered as organ donors. If tissues/organs were obtained from deceased donors or cadavers, please provide details as to the donors’ cause(s) of death. 6. Please provide the participant recruitment dates and the period during which transplant procedures were done (as month and year). 7. Please discuss whether medical costs were covered or other cash payments were provided to the family of the donor. If so, please specify the value of this support (in local currency and equivalent to U.S. dollars). 8. We noted in your submission details that a portion of your manuscript may have been presented or published elsewhere: 'Results presented in this manuscript have not been published elsewhere. However, analyses from the same cohort of patients have been previously published (Carrier FM et al. Effects of vasopressors on postoperative acute kidney injury after liver transplantation: an observational cohort study. Transplantation 2019).' Please clarify whether this publication was peer-reviewed and formally published. If this work was previously peer-reviewed and published, in the cover letter please provide the reason that this work does not constitute dual publication and should be included in the current manuscript. 9. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. 10. Please amend either the title on the online submission form (via Edit Submission) or the title in the manuscript so that they are identical. 11. 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. 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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 ****** 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: Excellent paper on the subject of AKI after orthotopic liver transplantation. the authors compared outcome of vasopressors with volume resuscitation during liver transplant. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). 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Revision 1
14 Jul 2020 Author Response Dear Editorial Board, Thank you for the thorough revision of our manuscript. You may find below detailed answers to comments. As requested, some of the comments were addressed directly in the cover letter. We hope we addressed all raised concerns. Best regards, François M. Carrier and co-authors Editor’s comments 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. We revised the manuscript accordingly. 2. In your ethics statement, 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. We had access to patients’ chart numbers to be able extract needed data from patients electronic medical file. Some data was available in a data set already authorized by our IRB and other data had to be manually extracted from electronic file. We did not keep any nominal information outside chart numbers. At the end of the work, we created a coded data set (patient ID number with corresponding chart number in a different protected file) that we kept in a secured server at the research center. We added more information regarding this in the “data sources and measurement” section in page 10. 3. We note that your study involved tissue/organ transplantation. Please provide the following information regarding tissue/organ donors for transplantation cases analyzed in your study. a. Please provide the source(s) of the transplanted tissue/organs used in the study, including the institution name and a non-identifying description of the donor(s). Organ donation in the Province of Quebec is managed by our national organ procurement organization, Transplant Québec. Most organs are allocated within the province, but some of them may come from other Canadian provinces. Donors information is completely anonymized and unknow to recipients. However, for research purposes, some anonymized donor characteristics were available in our institutional database. This data was not available at the time the first version of this manuscript was written but is now available through our institutional data management system. After authorization from our IRB, we accessed this data and extracted available donor characteristics. We added them in table 1 in page 14 of the manuscript (as well as in table S1) to describe the donor population. b. Please state in your response letter and ethics statement whether the transplant cases for this study involved any vulnerable populations; for example, tissue/organs from prisoners, subjects with reduced mental capacity due to illness or age, or minors. - If a vulnerable population was used, please describe the population, justify the decision to use tissue/organ donations from this group, and clearly describe what measures were taken in the informed consent procedure to assure protection of the vulnerable group and avoid coercion. - If a vulnerable population was not used, please state in your ethics statement, “None of the transplant donors was from a vulnerable population and all donors or next of kin provided written informed consent that was freely given.” We added this sentence in the first paragraph of the methods section (page 8). 4. In the Methods, please provide detailed information about the procedure by which informed consent was obtained from organ/tissue donors or their next of kin. In addition, please provide a blank example of the form used to obtain consent from donors, and an English translation if the original is in a different language. We added a sentence about this (page 8) and provided a blank example of the form used to obtain consent in the supplementary material (appendix 1). 5. Please indicate whether the donors were previously registered as organ donors. If tissues/organs were obtained from deceased donors or cadavers, please provide details as to the donors’ cause(s) of death. Some donors were previously registered in either the Régie de l’assurance maladie du Québec (RAMQ) organ donor registry or in the organ donor registry managed by the Chambre des notaires du Québec (https://www.transplantquebec.ca/node/107). For those who were not registered, consent was obtained from their next of kin who may act as the surrogate decision maker according to the Quebec medical law. For those who were registered, consent was also obtained from the surrogate decision maker; in Quebec, registries are only informative of patient willingness. In recipients’ charts, we do not have the information regarding donor registration status. Donor information is strictly confidential and only medical information regarding donor characteristics were available and cross-linked as previously described. We added a sentence in page 8 to better explain this. 6. Please provide the participant recruitment dates and the period during which transplant procedures were done (as month and year). The period during which transplant procedures were done was already reported in the “setting and participant sub-section” of the “methods” section. We added dates of data extraction in page 7. 7. Please discuss whether medical costs were covered or other cash payments were provided to the family of the donor. If so, please specify the value of this support (in local currency and equivalent to U.S. dollars). In Canada, no financial reimbursement is provided to donor families. Our health system is 100% public and nationalized. We added a sentence in page 8 to report this. 8. We noted in your submission details that a portion of your manuscript may have been presented or published elsewhere: 'Results presented in this manuscript have not been published elsewhere. However, analyses from the same cohort of patients have been previously published (Carrier FM et al. Effects of vasopressors on postoperative acute kidney injury after liver transplantation: an observational cohort study. Transplantation 2019).' Please clarify whether this publication was peer-reviewed and formally published. Yes, this publication was peer-reviewed and formally published. We updated the reference (Carrier FM, Chassé M, Sylvestre M-P, Girard M, Legendre-Courville L, Massicotte L, et al. Effects of Intraoperative Fluid Balance During Liver Transplantation on Postoperative Acute Kidney Injury: An Observational Cohort Study. Transplantation. 2020;104: 1419–1428.) since the previous one was a “online first” publication. If this work was previously peer-reviewed and published, in the cover letter please provide the reason that this work does not constitute dual publication and should be included in the current manuscript. Done. Please see the cover letter. All reported results in this manuscript are genuine and new and address a new research question. 9. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. Done. Data may be available upon request only, as per national regulations (province of Quebec). Please see the cover letter. 10. Please amend either the title on the online submission form (via Edit Submission) or the title in the manuscript so that they are identical. Done. 11. 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 Done. Attachments Attachment Submitted filename: Answers_plos_one.docx https://doi.org/10.1371/journal.pone.0237503.r002
29 Jul 2020 Decision Letter - Ehab Farag, Editor Effects of intraoperative hemodynamic management on postoperative acute kidney injury in liver transplantation: an observational cohort study PONE-D-20-12508R1 Dear Dr. François Martin Carrier 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, Ehab Farag, MD FRCA FASA Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0237503.r003
Formally Accepted
30 Jul 2020 Acceptance Letter - Ehab Farag, Editor PONE-D-20-12508R1 Effects of intraoperative hemodynamic management on postoperative acute kidney injury in liver transplantation: an observational cohort study Dear Dr. Carrier: 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. Ehab Farag Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0237503.r004

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