The diagnostic accuracy of umbilical cord procalcitonin in predicting early-onset neonatal infection

Thi Thanh Binh Nguyen; Diep Anh Truong Thi; Quang Vinh Truong; Thi Ny Pham

doi:10.1371/journal.pone.0316987

Peer Review History

Original SubmissionNovember 13, 2024
8 Dec 2024 Decision Letter - Benjamin M. Liu, Editor PONE-D-24-51453The Diagnostic Accuracy of Umbilical Cord Procalcitonin in Predicting Early-Onset Neonatal Infection PLOS ONE Dear Dr. Nguyen, 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 22 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. 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PCT's role in other infections should be introduced and more references should be cited, with this one (PMID: 33337932) as an example (citing is optional) 2. "Early diagnosis is essential for optimizing treatment outcomes.": More references need to be cited, with these ones (PMID: 38042947 and 39221481) as examples (citing is optional) 3. "exposure to bacteria triggers an inflammatory response in the fetus, increasing levels of pro-inflammatory cytokines like interleukin-6, interleukin-10": In this statement bacteria should be changed to pathogens. More references should be cited, with this one (PMID: 38556084) as an example (citing is optional). [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: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: 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. 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(Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Although this research introduces a very important problem and may be a fetal one but, I don't think the manuscript added a new findings, as it is clear in the discussion part. Sample size needs to increase to give a reliable results ****** 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 ******** [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.0316987.r001
Revision 1
17 Dec 2024 Author Response Respond to Editor and Reviewers 1. Comment 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 Reply 1: Thank you for your suggestion. We have followed up the guideline for preparing manuscript. 2. Comment 2. Thank you for stating the following financial disclosure: “This work was supported by research funds from Hue University (DHH 2023 – 04–202).” 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. Reply 2: Thank you for your suggestion. We have added this one in the rebuttal letter. This work was supported by research funds from Hue University, Viet Nam (DHH 2023 – 04–202). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. 3. Comment 3: Please provide a complete Data Availability Statement in the submission form, ensuring you include all necessary access information or a reason for why you are unable to make your data freely accessible. If your research concerns only data provided within your submission, please write "All data are in the manuscript and/or supporting information files" as your Data Availability Statement. Reply 3: Thank you for your suggestion. We have added this one in the manuscripts. 4. When completing the data availability statement of the submission form, you indicated that you will make your data available on acceptance. We strongly recommend all authors decide on a data sharing plan before acceptance, as the process can be lengthy and hold up publication timelines. Please note that, though access restrictions are acceptable now, your entire data will need to be made freely accessible if your manuscript is accepted for publication. This policy applies to all data except where public deposition would breach compliance with the protocol approved by your research ethics board. If you are unable to adhere to our open data policy, please kindly revise your statement to explain your reasoning and we will seek the editor's input on an exemption. Please be assured that, once you have provided your new statement, the assessment of your exemption will not hold up the peer review process. Reply 4: As data consists in the manuscript, it can be shared publicly. We have deposited data into the Supporting Information. 5. 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. Reply 5: We have thoroughly reviewed and updated. 6. We note that there is identifying data in the Supporting Information file <data.csv>. Due to the inclusion of these potentially identifying data, we have removed this file from your file inventory. Prior to sharing human research participant data, authors should consult with an ethics committee to ensure data are shared in accordance with participant consent and all applicable local laws. Data sharing should never compromise participant privacy. It is therefore not appropriate to publicly share personally identifiable data on human research participants. The following are examples of data that should not be shared: -Name, initials, physical address -Ages more specific than whole numbers -Internet protocol (IP) address -Specific dates (birth dates, death dates, examination dates, etc.) -Contact information such as phone number or email address -Location data -ID numbers that seem specific (long numbers, include initials, titled “Hospital ID”) rather than random (small numbers in numerical order) Data that are not directly identifying may also be inappropriate to share, as in combination they can become identifying. For example, data collected from a small group of participants, vulnerable populations, or private groups should not be shared if they involve indirect identifiers (such as sex, ethnicity, location, etc.) that may risk the identification of study participants. Additional guidance on preparing raw data for publication can be found in our Data Policy (https://journals.plos.org/plosone/s/data-availability#loc-human-research-participant-data-and-other-sensitive-data) and in the following article: http://www.bmj.com/content/340/bmj.c181.long. Please remove or anonymize all personal information (<specific identifying information in file to be removed>), ensure that the data shared are in accordance with participant consent, and re-upload a fully anonymized data set. Please note that spreadsheet columns with personal information must be removed and not hidden as all hidden columns will appear in the published file. Reply 6: Thank you for your critical point regarding data sharing. We have thoroughly reviewed all variables and data in the Excel file. There is no sensitive information that can be identified, as explained above. Additional Editor Comments: Editor's comments: Comment 1. PCT's role in other infections should be introduced and more references should be cited, with this one (PMID: 33337932) as an example (citing is optional). Reply 1: Thank you for your suggestion. We added this information into the introduction of the revised manuscript and provided the following citations you recommended. “Previous studies have shown that, PCT is an early inflammatory marker with high specificity in response to severe systemic infections. It can be used for early detection, assessment of severity, and prognosis of the diseases.” 7. Abdollahi A, Shoar S, Nayyeri F, Shariat M. Diagnostic Value of Simultaneous Measurement of Procalcitonin, Interleukin-6 and hs-CRP in Prediction of Early-Onset Neonatal Sepsis. Mediterr J Hematol Infect Dis. 2012;4(1):e2012028. 8. Liu BM, Hill HR. Role of Host Immune and Inflammatory Responses in COVID-19 Cases with Underlying Primary Immunodeficiency: A Review. J Interferon Cytokine Res. 2020;40(12):549-54. Comment 2. "Early diagnosis is essential for optimizing treatment outcomes.": More references need to be cited, with these ones (PMID: 38042947 and 39221481) as examples (citing is optional). Reply 2: Thank you for your suggestion. We cited the following references for this point in the revised manuscript. 2. Huetz N, Launay E, Gascoin G, Leboucher B, Savagner C, Muller JB, et al. Potential impact of umbilical-cord-blood procalcitonin-based algorithm on antibiotics exposure in neonates with suspected early-onset sepsis. Frontiers in pediatrics. 2020;8:127. 3. Liu BM. Epidemiological and clinical overview of the 2024 Oropouche virus disease outbreaks, an emerging/re-emerging neurotropic arboviral disease and global public health threat. J Med Virol. 2024;96(9):e29897. 4. Liu BM, Mulkey SB, Campos JM, DeBiasi RL. Laboratory diagnosis of CNS infections in children due to emerging and re-emerging neurotropic viruses. Pediatr Res. 2024;95(2):543-50. Comment 3. "exposure to bacteria triggers an inflammatory response in the fetus, increasing levels of pro-inflammatory cytokines like interleukin-6, interleukin-10": In this statement bacteria should be changed to pathogens. More references should be cited, with this one (PMID: 38556084) as an example (citing is optional). Reply 3: Thank you. We edited this part in the revised manuscript and cited the following references: 14. Mangogna A, Agostinis C, Ricci G, Romano F, Bulla R. Overview of procalcitonin in pregnancy and in pre-eclampsia. Clin Exp Immunol. 2019;198(1):37-46. 15. Liu BM, Li NL, Wang R, Li X, Li ZA, Marion TN, et al. Key roles for phosphorylation and the Coiled-coil domain in TRIM56-mediated positive regulation of TLR3-TRIF-dependent innate immunity. J Biol Chem. 2024;300(5):107249. 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: Partly Reply 1: Thank you. Our study aimed to provide more evidence to support recommendations on using umbilical cord PCT for early EOI diagnosis, addressing the current lack of consensus in the literature. About sample size, we also mentioned our limitations in this study. However, this study was conducted over a period of more than one year. During this time, we followed nearly 2765 newborns born in our hospital, monitoring all risk factors and early-onset infections. From this cohort, we obtained a sample size of 126 cases, including 44 cases of EOI. To provide further clarity on the research process and data collection, we included this information in the methods section of the revised manuscript. 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know Reply 2: Thank you. We have carefully rechecked our data and statistical analysis. We have confirmed the accuracy of our original findings and will retain the current results. 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: Although this research introduces a very important problem and may be a fetal one but, I don't think the manuscript added a new findings, as it is clear in the discussion part. Sample size needs to increase to give a reliable results. Reply 3: We are very grateful for the supportive feedback on our manuscript and its research content. We hope to have the opportunity to publish our research findings to contribute more evidence for the early diagnosis of neonatal early-onset infection, a challenge that persists in neonatology, and make a substantial contribution to the neonatal field. Regarding sample size, we also mentioned our limitations in this study. However, this study was conducted over a period of more than one year. During this time, we followed nearly 2765newborns born in our hospital, monitoring all risk factors and early-onset infections. From this cohort, we obtained a sample size of 126 cases, including 44 cases of EOI. https://doi.org/10.1371/journal.pone.0316987.r002
20 Dec 2024 Decision Letter - Benjamin M. Liu, Editor The Diagnostic Accuracy of Umbilical Cord Procalcitonin in Predicting Early-Onset Neonatal Infection PONE-D-24-51453R1 Dear Dr. Nguyen, 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 will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, 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, Benjamin M. Liu, MBBS, PhD, D(ABMM), MB(ASCP) Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0316987.r003
Formally Accepted
7 Jan 2025 Acceptance Letter - Benjamin M. Liu, Editor PONE-D-24-51453R1 PLOS ONE Dear Dr. Nguyen, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, 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 customercare@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. Benjamin M. Liu Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0316987.r004

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