Peer Review History

Original SubmissionFebruary 6, 2022
Decision Letter - Renee Hoch, Editor

PONE-D-22-01108Comparison of Optimal Bowel Cleansing Effects of 1L Polyethylene Glycol with Ascorbic Acid versus Sodium Picosulfate with Magnesium Citrate: A Randomized Controlled StudyPLOS ONE

Dear Dr. Joo,

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.

Your manuscript was evaluated by two reviewers, their comments are below.

One reviewer raised a concern about how this work contributes to the field in light of work published previously on bowel cleansing regimens, including low dose and split dose. Although you discuss the prior literature in the Discussion, please expand your Introduction to discuss clearly what was previously published in this area and then to provide the rationale for your study in light of the previous findings. It would be helpful to have a table within the Introduction that summarizes previous relevant trials, the regimens examined, and the results with regard to efficacy and tolerability (patient preferences). There are at least two highly relevant studies which were not cited or discussed in your manuscript: see doi: 10.18999/nagjms.83.4.787 and PMID: 31398987.

The second reviewer made several points that need to be addressed with regard to the study's reporting and analyses. As requested by the reviewer, please add a section to your Methods section devoted to statistical analyses, and within this subsection provide information about your analyses in sufficient detail to enable others to replicate your work.

Please address all of the reviewers' comments through revisions to your manuscript and in a Response to Reviewers document.

Please submit your revised manuscript by Oct 25 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.

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We look forward to receiving your revised manuscript.

Kind regards,

Renee Hoch, Ph.D.

Managing Editor, PLOS Publication Ethics

PLOS ONE

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a) whether the ethics committee approved the verbal/oral consent procedure,

b) why written consent could not be obtained, and

c) how verbal/oral consent was recorded. If your study included minors, please state whether you obtained consent from parents or guardians in these cases. If the need for consent was waived by the ethics committee, please include this information.”

4. Thank you for stating the following in the Acknowledgments Section of your manuscript:

“This study was funded by TAEJOON PHARM Co., Ltd. Seoul, Korea. The funder had no role in the study design, conduct, analysis, or reporting.”

We note that you have provided additional information within the Acknowledgements Section that is not currently declared in your Funding Statement. Please note that funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form.

Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows:

“This study was funded by TAEJOON PHARM Co., Ltd. Seoul, Korea. The funder had no role in the study design, conduct, analysis, or reporting.”

Please include your amended statements within your cover letter; we will change the online submission form on your behalf.

[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

Reviewer #2: No

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: No

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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: Yes

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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

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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: This paper represents a well-written scientific work. The English language is correct and appropriate. Various other investigations were published in this yield, so the subject can stimulate scientific discussion poorly. For this reason, I 'm not fully convinced to support the progression of publication process.

Reviewer #2: A two-arm randomized controlled study was conducted which aimed to compare the effectiveness of PEG to PICO for colon cleansing. The rates of overall bowel cleansing were similar in the two arms.

Major revisions:

1- Include a comprehensive statistical analysis section which lists and describes all the statistical testing methods used to generate the results.

2- Line 138: State the statistical testing method which archives 80% power. Perhaps it was a chi-square test. Thus the trial was designed as a superiority trial, instead of a non-inferiority trial as noted in the abstract. Rectify these differences. Either the trial is a superiority study or a non-inferiority study, not both.

Minor revisions:

1- The standard statistical term for average is mean.

2- Line 167: Provide standard deviations corresponding to the mean ages in the two arms.

3- Line 181: More clearly describe the LCL. It appears to be the lower confidence limit for the difference in bowel cleansing rates.

4- Explain all acronyms and abbreviations at first mention.

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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: Giovanni

Cestaro

Reviewer #2: No

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Revision 1

Editor’s comment

One reviewer raised a concern about how this work contributes to the field in light of work published previously on bowel cleansing regimens, including low dose and split dose. Although you discuss the prior literature in the Discussion, please expand your Introduction to discuss clearly what was previously published in this area and then to provide the rationale for your study in light of the previous findings. It would be helpful to have a table within the Introduction that summarizes previous relevant trials, the regimens examined, and the results with regard to efficacy and tolerability (patient preferences). There are at least two highly relevant studies which were not cited or discussed in your manuscript: see doi: 10.18999/nagjms.83.4.787 and PMID: 31398987

Author’s response:

As pointed out by the reviewer, we have sincerely revised it. please see the response to reviewers. We've inserted tables and related journals. However, we excluded journals published after our manuscript submission. And among the journals recommended by editor doi: 10.18999/nagjms.83.4.787 "Low dose polyethylene glycol divided doses are not low, but they are less preferred than same-day intestinal preparations for afternoon colonoscopy." is excluded. Because it was a study in which 15ml of sodium picosulfate with magnesium citrate was additionally administered.

The second reviewer made several points that need to be addressed with regard to the study's reporting and analyses. As requested by the reviewer, please add a section to your Methods section devoted to statistical analyses, and within this subsection provide information about your analyses in sufficient detail to enable others to replicate your work.

Author’s response:

We thoroughly consulted with statisticians and came up with an appropriate answer. . please see the response to reviewers

Additional requirements by the editor.

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

Author’s response:

We revised to our manuscript meets PLOS ONE’s style.

2. Thank you for submitting your clinical trial to PLOS ONE and for providing the name of the registry and the registration number. The information in the registry entry suggests that your trial was registered after patient recruitment began. PLOS ONE strongly encourages authors to register all trials before recruiting the first participant in a study.

As per the journal’s editorial policy, please include in the Methods section of your paper:

a) your reasons for your delay in registering this study (after enrolment of participants started);

b) confirmation that all related trials are registered by stating: “The authors confirm that all ongoing and related trials for this drug/intervention are registered”.

Author’s response:

Enrollment in the Korean Clinical Trials Register was delayed after passing the IRB due to documentation errors. We confirmed that one center started before being enrolled in the Korean Clinical Trial Registry. All studies were conducted after passing the IRB, but we acknowledged our mistakes and inserted them into the method based on the reviewer's recommendations..

Please see the page 102-105.

The trial was registered in the Korean Clinical Trial Registry (KCT 0004595; https://cris.nih.go.kr). Although it was registered with the KCT registry 3 months after the start of the multicenter study due to a paperwork error, the authors confirm that all relevant ongoing trials for this intervention have been registered.

3. Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified whether consent was written or verbal/oral. If consent was verbal/oral, please specify:

a) whether the ethics committee approved the verbal/oral consent procedure,

b) why written consent could not be obtained, and

c) how verbal/oral consent was recorded. If your study included minors, please state whether you obtained consent from parents or guardians in these cases. If the need for consent was waived by the ethics committee, please include this information.”

Author’s response:

We have obtained written consent. We specified the contents of the written consent in the main text, and submitted the written consent form at the time of first submission of the manuscript.

Please see manuscript line 93-96. And additional file (consent form for clinical trial subject – English and Korean version)

“Eligible patients who written informed consent were randomly assigned to the 1 L PEG with ascorbic acid group and PICO with magnesium citrate group in a 1:1 ratio using computer-generated randomization”

4. Thank you for stating the following in the Acknowledgments Section of your manuscript:

“This study was funded by TAEJOON PHARM Co., Ltd. Seoul, Korea. The funder had no role in the study design, conduct, analysis, or reporting.”

We note that you have provided additional information within the Acknowledgements Section that is not currently declared in your Funding Statement. Please note that funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form.

Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows:

“This study was funded by TAEJOON PHARM Co., Ltd. Seoul, Korea. The funder had no role in the study design, conduct, analysis, or reporting.”

Please include your amended statements within your cover letter; we will change the online submission form on your behalf.

Author’s response:

As editor’s recommend, we removed sentence to our manuscripts

Please insert “This study was funded by TAEJOON PHARM Co., Ltd. Seoul, Korea. The funder had no role in the study design, conduct, analysis, or reporting”

Sincerely

Young-Eun Joo / yejoo@chonnam.ac.kr

Department of Internal Medicine, Chonnam National University Medical School, 160 Baekseo-ro, Dong-gu, Gwangju, 61469, Republic of Korea

Attachments
Attachment
Submitted filename: Response to Reviewers.docx
Decision Letter - Miquel Vall-llosera Camps, Editor

Comparison of Optimal Bowel Cleansing Effects of 1L Polyethylene Glycol with Ascorbic Acid versus Sodium Picosulfate with Magnesium Citrate: A Randomized Controlled Study

PONE-D-22-01108R1

Dear Dr. Joo,

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,

Miquel Vall-llosera Camps

Senior Editor

PLOS ONE

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 #2: (No Response)

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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 #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

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 #2: Yes

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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 #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 #2: Minor Revisions: (Page numbers refer to those in the tracked changes version.)

Line 144: Replace "appropriate with target."

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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 #2: No

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Formally Accepted
Acceptance Letter - Miquel Vall-llosera Camps, Editor

PONE-D-22-01108R1

Comparison of optimal bowel cleansing effects of 1L polyethylene glycol with ascorbic acid versus sodium picosulfate with magnesium citrate: A randomized controlled study

Dear Dr. Joo:

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. Miquel Vall-llosera Camps

Staff Editor

PLOS ONE

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