Construction of management tools for early warning of prevacuum steam sterilization failure

Xin Zhao; Ting Liu; Ning Ma; Ran Wang; Ying Li; Tong Shen

doi:10.1371/journal.pone.0316322

Peer Review History

Original SubmissionJune 16, 2024
4 Oct 2024 Decision Letter - Mansureh Ghavam, Editor PONE-D-24-20423Construction and practice of early warning model for failure of prevacuum pressure steam sterilization methodPLOS ONE Dear Dr. Shen, 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 Nov 18 2024 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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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: No 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 topic of the article is very relevant, the study presented is quite detailed and the techniques are compatible with the intended results, but the authors should not only review the grammar, but also some typing errors throughout the text. In addition, there are some errors throughout the text, for example: In the Abstract the author mention that they divided the indicators into 4 categories, but they only describe 3. On page 10, penultimate line: the indicator "very familiar" was repeated 3 times and one indicator was missing. If the formula described is correct (Ca=(Ci+Cs)/2), then the result on the penultimate line of page 11 is not correct, despite being higher than required. Reviewer #2: The manuscript is of paramount relevance and has high publication potential. However, there are significant adjustments that need to be made to comply with scientific standards. The main observation is about the method used and the discrepancies between the theme, the objective in the abstract, and the objective at the end of the introduction. The absence of standardized criteria and clarifications on the execution mode of each stage weakened the document. All noted observations were described in the attached document and must be followed to enhance the study's reliability, transparency, and reproducibility. Sincerely, Reviewer. ****** 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: Yes: Rebecca S. C. Santos ******** [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. Attachments Attachment Submitted filename: PONE.pdf https://doi.org/10.1371/journal.pone.0316322.r001
Revision 1
25 Nov 2024 Author Response Dear editor, Thank you for correcting the article "Construction of management tools for early warning of prevacuum steam sterilization failure". We made targeted changes and enhancements to the article after carefully reviewing expert revision opinions, and we have noted the precise changes in the article for your evaluation. Now, the revision ideas and issues raised by the review specialists are described one by one. Reviewer 1: Comment 1: The topic of the article is very relevant, the study presented is quite detailed and the techniques are compatible with the intended results, but the authors should not only review the grammar, but also some typing errors throughout the text. Response 1: Thank you for you comment, we had sent the manuscript to a professional paper polishing agencies, to check grammatical errors and optimize the quality of language expression Comment 2:In addition, there are some errors throughout the text, for example: In the Abstract the author mention that they divided the indicators into 4 categories, but they only describe 3. Response 2: Thank you for your comment, we had revised this mistake and checked the consistency of the preceding text. Comment 3: On page 10, penultimate line: the indicator "very familiar" was repeated 3 times and one indicator was missing. Response 3: Thank you for your comment, we had revised this mistake. Comment 4: If the formula described is correct (Ca=(Ci+Cs)/2), then the result on the penultimate line of page 11 is not correct, despite being higher than required. Response 4: Thank you for your comment, since the questionnaire for expert had been revised in this study, we confounded the results before and after adjustment. We had revised this mistake, and all the statistical results of the questionnaire were uniformly taken as three decimal places. Reviewer 2: Comment 1: I suggest replacing “Construction and practice [...]” with “Construction and clinical validation [...]”. The purpose of the substitution is to clarify the study method employed. Response 1: We had revised the paper title. Comment 2: The objective is incomplete; it is evident that a mixed-methods study was employed, apparently a methodological study followed by a content validation and clinical validation. Clarify this. The employed method also lacks further explanations, even if they seem obvious. What is the study design? How many and what were the phases of development? Based on what methodological framework? What do you consider “specialized consultation”? The results indicate six alert indicators in four categories; this is incomplete, write them out in full, both the indicators and the categories. Response 2:We have revised the Objectives and methods section of the abstract to specify the objectives and methods of the study. The main objectives of the study, including the management tools for the expected construction and the controlled trials, are introduced in the objectives, and the phases of the study and the content planned to be completed in each phase are introduced in the Methods of the abstract. The presentation of indicators and categories was also corrected Comment 3: Insert two more descriptors with greater potential for generalization on the subject. Response 3: We have added three keywords, namely Management tool; Safety margin; Expert consultation Comment 4: Insert the state of the art on the subject, the justification, and the relevance of the study. The inserted objective deviates from what is mentioned in the summary and needs standardization, even if it seems obvious to you. Response 4: We systematically adjusted the background section, adding new content and references around the recent progress of the research topic and the need for research, Comment 5: The study design does not seem clear within the various types of studies that exist and needs to be revised. The methodological reference model used is not mentioned, and it is necessary to follow one for scientific standardization and methodological rigor. The number of phases is implied; make it evident. The recruitment process for specialists and their function is not clear. A data search for identifying the indicators was mentioned; however, the process mentioned earlier was the interview with specialists. Which is the correct method? The terms “control group” and “experimental group” are commonly used for experimental studies, and are not suitable for this study, evaluate the possibility of replacing it with a similar one. Response 5:In this study, expert consultation method was used as the main method to reach a multidisciplinary consensus on the failure risk checklist and the calculation model of early sterilization failure risk. The failure risk checklist was selected and included inspection items unanimously approved by experts based on the results of previous studies. The calculation model of early sterilization failure risk was based on the margin of safety theory in industrial manufacturing, and a consensus was reached on the calculation formula for early warning of sterilization failure using the temperature and pressure sensor readings of pressure sterilizers. In addition, we changed the names of "control group" and "experimental group" to "test group" and "conventional group" during the method validation process. Comment 6: Nine indicators appeared, differing from what is stated in the abstract; minor adjustment needed. Response 6: Thank you for pointing out the error in this article, we have corrected it Response 7: Create a pamphlet regarding the conclusions of your study. Response 7: We systematically adjusted the conclusions and added summary statements Attachments Attachment Submitted filename: Revision letter 20241115.docx https://doi.org/10.1371/journal.pone.0316322.r002
11 Dec 2024 Decision Letter - Mansureh Ghavam, Editor Construction of management tools for early warning of prevacuum steam sterilization failure PONE-D-24-20423R1 Dear Dr. Shen, 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, Mansureh Ghavam Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0316322.r003
Formally Accepted
14 Dec 2024 Acceptance Letter - Mansureh Ghavam, Editor PONE-D-24-20423R1 PLOS ONE Dear Dr. Shen, 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. Mansureh Ghavam Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0316322.r004

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