PONE-D-22-18985Intensive versus conservative glycaemic control in patients undergoing coronary artery bypass graft surgery: A protocol for systematic review of randomised controlled trials PLOS ONE

Dear Dr. Lv,

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 Sep 01 2022 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:

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• 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: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Ozra Tabatabaei-Malazy

Academic Editor

PLOS ONE

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Additional Editor Comments:

Reviewer#1:

The authors have proposed a protocol for a systematic review on intensive vs. conservative glycemic control in CABG patients. The methods have been well-described, and I hope the authors stick to all these elements, particularly critical appraisal and bias control. Although the review protocol has been already registered in PROSPERO, I suggest these comments be considered in the review:

1- Include the duration of the disease as a confounder in your meta-analysis.

2- I think you can add more variables to the secondary outcomes, such as the need for blood product transfusion, postoperative atrial fibrillation, and rehospitalization.

3- Subanalysis section: Please consider a better wording for "not accompanied of." That does not sound nice!

4- There are some typos and grammatical issues in the manuscript. So please have it checked by an expert.

Reviewer#2:

There are several points in this protocol that require further clarification, as follows:

Introduction:

- The authors clearly have described the condition, how glycemic control during cardiac surgery might affect postoperative outcomes, and how different glycemic control strategies might work.

- The purpose of the study has been explained in a very general way. The authors should specify exactly what research questions this review ultimately answers.

- Place the point after the closing bracket of the citations.

Methods:

- The authors should describe some items of eligibility criteria more clearly and in detail:

1) Regarding the target population, will you include all patients undergoing CABG surgery and intraoperative glycemic control, regardless of their demographic characteristics (e.g., age), background, and past medical history of diabetes mellitus?

2) Regarding types of interventions, please explain clearly what range of blood sugar control you consider to define “intensive” and “conservative” control.

3) Please specify the comparison group more clearly. Will you only include studies that considered high levels of glycemic control target (conservative group) as the comparison group?

4) Since you discussed the eligibility criteria based on the PICOS in the 2.2 subsection, and the outcomes are also one of its items, there is no need to describe the outcomes in a separate section. Please leave the explanation of subsection 2.3, which is about the outcomes, below in subsection 2.2.

5) The authors should describe the report characteristics of studies to be included, such as years considered, language, and publication status. If relevant studies published in all languages are to be included, how to deal with articles that have a language different from the language of the authors?

- Study selection, data synthesis, and risk of bias assessment have been described according to the PRISMA-P statement.

Other comments:

- The authors should arrange the order of the abstract sections according to the main text (Introduction/background, Methods, Discussion).

- The manuscript has some typing mistakes and grammatical errors that need to be corrected

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Partly

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Partly

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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

**********

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

Reviewer #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The authors have proposed a protocol for a systematic review on intensive vs. conservative glycemic control in CABG patients. The methods have been well-described, and I hope the authors stick to all these elements, particularly critical appraisal and bias control. Although the review protocol has been already registered in PROSPERO, I suggest these comments be considered in the review:

1- Include the duration of the disease as a confounder in your meta-analysis.

2- I think you can add more variables to the secondary outcomes, such as the need for blood product transfusion, postoperative atrial fibrillation, and rehospitalization.

3- Subanalysis section: Please consider a better wording for "not accompanied of." That does not sound nice!

4- There are some typos and grammatical issues in the manuscript. So please have it checked by an expert.

Reviewer #2: In this protocol, the authors tried to describe the objectives, eligibility criteria, and planned methodology of their systematic review that will assess the effect of different intraoperative glycemic control strategies on postoperative outcomes. Evidence shows that poor intraoperative glycemic control is a risk factor for postoperative morbidity and mortality. Different strategies are used for intraoperative control of blood sugar, but their effect on postoperative outcomes has been conflicting across studies. Therefore, this systematic review aims to examine this crucial question and, more specifically, to determine the effect intensive glycemic control of blood sugar has on postoperative outcomes versus conservative control. The title is interesting and the protocol has been written according to the PRISMA-P statement. However, there are several points in this protocol that require further clarification, as follows:

Introduction:

- The authors clearly have described the condition, how glycemic control during cardiac surgery might affect postoperative outcomes, and how different glycemic control strategies might work.

- The purpose of the study has been explained in a very general way. The authors should specify exactly what research questions this review ultimately answers.

- Place the point after the closing bracket of the citations.

Methods:

- The authors should describe some items of eligibility criteria more clearly and in detail:

1) Regarding the target population, will you include all patients undergoing CABG surgery and intraoperative glycemic control, regardless of their demographic characteristics (e.g., age), background, and past medical history of diabetes mellitus?

2) Regarding types of interventions, please explain clearly what range of blood sugar control you consider to define “intensive” and “conservative” control.

3) Please specify the comparison group more clearly. Will you only include studies that considered high levels of glycemic control target (conservative group) as the comparison group?

4) Since you discussed the eligibility criteria based on the PICOS in the 2.2 subsection, and the outcomes are also one of its items, there is no need to describe the outcomes in a separate section. Please leave the explanation of subsection 2.3, which is about the outcomes, below in subsection 2.2.

5) The authors should describe the report characteristics of studies to be included, such as years considered, language, and publication status. If relevant studies published in all languages are to be included, how to deal with articles that have a language different from the language of the authors?

- Study selection, data synthesis, and risk of bias assessment have been described according to the PRISMA-P statement.

Other comments:

- The authors should arrange the order of the abstract sections according to the main text (Introduction/background, Methods, Discussion).

- The manuscript has some typing mistakes and grammatical errors that need to be corrected

**********

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: Yes: Akbar Shafiee

Reviewer #2: Yes: Danesh Soltani

**********

[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: Peer review.docx

PONE-D-22-18985R1Intensive versus conservative glycaemic control in patients undergoing coronary artery bypass graft surgery: A protocol for systematic review of randomised controlled trialsPLOS ONE

Dear Dr. Lv,

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 Oct 27 2022 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: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Ozra Tabatabaei-Malazy

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.

Additional Editor Comments:

Reviewer#1:

The authors have well revised the manuscript; however, I can still see some errors in writing, particularly in using the articles (i.e., the). As an example from the abstract, it should be written: "the intensive care unit (ICU), the incidence of postoperative myocardial infarction), the incidence of ....". Or in discussion of the Abstract "There is no certain evidence that which strategy of glycemic...." is better to change "There is no certain evidence to clarify which strategy of glycemic....". Please double check the manuscript for these issues.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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

**********

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

Reviewer #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The authors have well revised the manuscript; however, I can still see some errors in writing, particularly in using the articles (i.e., the). As an example from the abstract, it should be written: "the intensive care unit (ICU), the incidence of postoperative myocardial infarction), the incidence of ...." Please double check the manuscript for these issues.

Reviewer #2: The protocol now contains all of the necessary details to conduct a standard systematic review study. What I'd like to emphasize is that the authors strictly follow the protocol. I have nothing further to add.

**********

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: Yes: Danesh Soltani

**********

[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: Peer review. R1.docx

Intensive versus conservative glycemic control in patients undergoing coronary artery bypass graft surgery: A protocol for systematic review of randomised controlled trials

PONE-D-22-18985R2

Dear Dr. Lv,

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,

Ozra Tabatabaei-Malazy

Academic Editor

PLOS ONE