Prognostic value of baseline carotid blood flow in critically ill children with septic shock

Fatma Mamdouh; Hafez Bazaraa; Ahmed Baz; HebatAllah Fadel Algebaly

doi:10.1371/journal.pone.0251154

Peer Review History

Original SubmissionNovember 12, 2020
11 Jan 2021 Decision Letter - Vincenzo Lionetti, Editor PONE-D-20-35629 Prognostic Value of Baseline Carotid Blood Flow in Critically Ill Children with Septic Shock PLOS ONE Dear Dr. Algebaly, 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 reviewers are required. ============================== Please submit your revised manuscript by Feb 21 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 2. We noticed you have some minor occurrence of overlapping text with the following previous publications, which needs to be addressed: https://rd.springer.com/article/10.1007/s40477-014-0139-9?code=897273d4-47ee-4cff-8464-94a130407a9e https://westjem.com/videos/can-emergency-physicians-perform-common-carotid-doppler-flow-measurements-to-assess-volume-responsiveness.html https://theultrasoundjournal.springeropen.com/articles/10.1186/s13089-017-0065-0 We would like to make you aware that copying extracts from previous publications, especially outside the methods section, word-for-word is unacceptable. In addition, the reproduction of text from published reports has implications for the copyright that may apply to the publications. 3. Please ensure you have discussed any potential limitations of your study in the Discussion, including study design, sample size and/or potential confounders. 4. Please provide a sample size and power calculation in the Methods, or discuss the reasons for not performing one before study initiation. 5. Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified what type you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). 6. Thank you for including your ethics statement: "I-071017 Ethical committee of cairo university, faculty of medicine written consent was obtained from parents". a. Please amend your current ethics statement to confirm that your named institutional review board or ethics committee specifically approved this study. b. Once you have amended this/these statement(s) in the Methods section of the manuscript, please add the same text to the “Ethics Statement” field of the submission form (via “Edit Submission”). For additional information about PLOS ONE ethical requirements for human subjects research, please refer to http://journals.plos.org/plosone/s/submission-guidelines#loc-human-subjects-research 7. Please include a separate caption for each figure in your manuscript. [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: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes ****** 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: No ****** 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: The evaluation of the haemodynamic status in critical patient with septic shock has an important prognostic value. An easy-to-measure indicator helps to monitor the unstable patient admitted to the ICU. The manuscript is well written and describes a simple and useful method for monitoring cardiac output in critical patients The statistical analysis is well done and the data reported are exhaustive. The language in submitted articles is clear, correct, and easy to understand without errors. The data presented in the manuscript support the final conclusions. Reviewer #2: The authors evaluated the value of carotid artery ultrasound analysis in prediction of mortality in paediatric patients with septic shock. For this purpose, they enrolled forty children with septic shock and concluded that carotid blood flow (CBF) assessment may be a useful prognostic marker in this setting. Specific comments: - The changes in CBF reported in this analysis might simply reflect the blood flow redistribution typical of septic shock. In fact, the changes were larger in cold than in warm shock. Hence, the reduction of CBF might be a feature of more advanced shock. The authors should comment on this: what is their view on this point? What is the potential clinical usefulness of the index? Should it just reflect advanced disease, would it have an actual impact on patient management? - Which is the additive prognostic value of CBF over the traditional clinical parameters of hemodynamic impairment and/or hypo-perfusion of peripheral organs and tissues (lactate, indices of multi-organ failure, CVP)? - ROC Curve in Figure 2 does not match with results provided in Results Section [AUC (95% CI): 0.3 (0.11 – 0.48), p=0.035]. Please check. - In the Results Section the authors stated: “Correlation analysis revealed significant correlation between CBF and age (r=0.42, p=0.008), weight (r=0.38, p=0.017), surface area (r=0.38, p=0.017) and SV (r=0.49, p=0.001)”. Correlations are indeed significant, but modest according to the “r” coefficients. ****** 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: 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.0251154.r001
Revision 1
19 Feb 2021 Author Response Response to reviewers Dear Sir, It was great pleasure to allow me to improve the manuscript. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates : Reformatting according to PLOS ONE requirements. 2. We noticed you have some minor occurrence of overlapping text with the following previous publications, which needs to be addressed: https://rd.springer.com/article/10.1007/s40477-014-0139-9?code=897273d4-47ee-4cff-8464-94a130407a9e https://westjem.com/videos/can-emergency-physicians-perform-common-carotid-doppler-flow-measurements-to-assess-volume-responsiveness.html https://theultrasoundjournal.springeropen.com/articles/10.1186/s13089-017-0065-0 Introduction was modified to avoid the overlapping text with previous publications to 3. Please ensure you have discussed any potential limitations of your study in the Discussion, including study design, sample size and/or potential confounders. Study limitations section was added. Lines 188-191 first, our study is a single center , with small number of septic shock patients. Second, we did not observe if the changes in the cerebral autoregulation in pediatric septic shock could impact the carotid blood flow. Also, whether targeting increase carotid blood flow will improve survival or not needs further study. 4.Please provide a sample size and power calculation in the Methods, or discuss the reasons for not performing one before study initiation. Considering the pilot nature of the study, we did not perform a priori sample size calculation. The number of patients included in the study was limited by logistic issues. Lines 85-86 4.Please provide additional details regarding participant consent.In the ethics statement in the Methods and online submission information, please ensure that you have specified what type you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). The study protocol was approved by Cairo university faculty of medicine ethical committee with written consent with approval number "I-071017. Line 52-53 5.Please include a separate caption for each figure in your manuscript. Attached after the corresponding paragraph. Line 124 Line 142. Reviewer #2: The authors evaluated the value of carotid artery ultrasound analysis in prediction of mortality in paediatric patients with septic shock. Specific comments: - The changes in CBF reported in this analysis might simply reflect the blood flow redistribution typical of septic shock. In fact, the changes were larger in cold than in warm shock. Hence, the reduction of CBF might be a feature of more advanced shock. The authors should comment on this: what is their view on this point? What is the potential clinical usefulness of the index? Should it just reflect advanced disease, would it have an actual impact on patient management? Lines 180-187: The Surviving Sepsis Campaign International Guidelines for the Management of Septic Shock in Children 2020 reported that distinction between cold and warm shock if advanced hemodynamic monitoring is available may be helpful to assess patient physiology and direct inotropes and vasopressor therapy. We could observe that the carotid blood flow is less in patients with cold compared to warm shock type. However, the higher SVRI in cold shock could explain the reduction of carotid blood flow and whether that fluid augmentation and aiming at normalization of SVRI could influence the outcome needs to be explored. - Which is the additive prognostic value of CBF over the traditional clinical parameters of hemodynamic impairment and/or hypo-perfusion of peripheral organs and tissues (lactate, indices of multi-organ failure, CVP)? Line 167-168: The use point-of-care ultrasound to estimate the carotid blood flow is a rapid, easy to learn and noninvasive method for prognostic evaluation in critically unstable children who may not tolerate any invasive maneuver. - ROC Curve in Figure 2 does not match with results provided in Results Section [AUC (95% CI): 0.3 (0.11 – 0.48), p=0.035]. Please check. Line 140: [AUC (95% CI): 0.71 (0.52 – 0.89), p=0.035], sensitivity:71.4%, specifity:53.8% - In the Results Section the authors stated: “Correlation analysis revealed significant correlation between CBF and age (r=0.42, p=0.008), weight (r=0.38, p=0.017), surface area (r=0.38, p=0.017) and SV (r=0.49, p=0.001)”. Correlations are indeed significant, but modest according to the “r” coefficients. Line 126: Correlation analysis revealed modest significant correlation between CBF and age (r=0.42, p=0.008 Attachments Attachment Submitted filename: response to reviewers.docx https://doi.org/10.1371/journal.pone.0251154.r002
18 Mar 2021 Decision Letter - Vincenzo Lionetti, Editor PONE-D-20-35629R1 Prognostic Value of Baseline Carotid Blood Flow in Critically Ill Children with Septic Shock PLOS ONE Dear Dr. Algebaly, 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. ============================== ACADEMIC EDITOR: All issues highlighted during revision are required. ============================== Please submit your revised manuscript by May 02 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: 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. [Note: HTML markup is below. Please do not edit.] 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 #1: All comments have been addressed Reviewer #2: (No Response) ******** 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 #1: (No Response) Reviewer #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: (No Response) 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 #1: (No Response) Reviewer #2: No ****** 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 #1: (No Response) 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 #1: (No Response) Reviewer #2: I am happy with the changes and the authors' response. Some minor points still to address: - Can you please provide inter and intra-observer reproducibilty data of CBF? - Please provide a figure showing different patterns of CBF in different groups. ****** 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 #1: No 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.0251154.r003
Revision 2
10 Apr 2021 Author Response Dear Sir, It was great pleasure to allow me to improve the manuscript. 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. Reference list was revised and non of the papers were retracted Reference 12 was missing and I added it to the reference section. Reviewer #2: I am happy with the changes and the authors' response. Some minor points still to address: - Can you please provide inter and intra-observer reproducibilty data of CBF? - Please provide a figure showing different patterns of CBF in different groups. Studies were performed on ten healthy children before start of the study to evaluate interobserver and intraobserver reproducibility, the radiologist and the intensivist blinded to each other's results alternately performed two measurements on each patient. Intraobserver reproducibility was assessed between the observations by same observer. The intensivist performed the carotid flow scan and all the stored images were reviewed by the expert radiologist. Figure 1 about subgroups: Attachments Attachment Submitted filename: response to reviewers.docx https://doi.org/10.1371/journal.pone.0251154.r004
21 Apr 2021 Decision Letter - Vincenzo Lionetti, Editor Prognostic Value of Baseline Carotid Blood Flow in Critically Ill Children with Septic Shock PONE-D-20-35629R2 Dear Dr. Algebaly, 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 #1: 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 #1: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: 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 #1: 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 #1: 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 #1: (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 #1: No https://doi.org/10.1371/journal.pone.0251154.r005
Formally Accepted
24 Jun 2021 Acceptance Letter - Vincenzo Lionetti, Editor PONE-D-20-35629R2 Prognostic Value of Baseline Carotid Blood Flow in Critically Ill Children with Septic Shock Dear Dr. Algebaly: 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.0251154.r006

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