Peer Review History

Original SubmissionAugust 9, 2024
Decision Letter - Sidra Kaleem Jafri, Editor

PONE-D-24-28949Verifying the accuracy of Japanese version of the pediatric delirium assessment scale: SOS-PD and the high accuracy of family assessments of pediatric deliriumPLOS ONE

Dear Dr. Matsuishi,

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 Mar 09 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.

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,

Sidra Kaleem Jafri

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 note that the grant information you provided in the ‘Funding Information’ and ‘Financial Disclosure’ sections do not match.

When you resubmit, please ensure that you provide the correct grant numbers for the awards you received for your study in the ‘Funding Information’ section.

3. We note that you have indicated that there are restrictions to data sharing for this study. For studies involving human research participant data or other sensitive data, we encourage authors to share de-identified or anonymized data. However, when data cannot be publicly shared for ethical reasons, we allow authors to make their data sets available upon request. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions.

Before we proceed with your manuscript, please address the following prompts:

a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information, data are owned by a third-party organization, etc.) and who has imposed them (e.g., a Research Ethics Committee or Institutional Review Board, etc.). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent.

b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of recommended repositories, please see https://journals.plos.org/plosone/s/recommended-repositories. You also have the option of uploading the data as Supporting Information files, but we would recommend depositing data directly to a data repository if possible.

Please update your Data Availability statement in the submission form accordingly.

4. 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.

5. 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. 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: Yes

**********

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: Yes

**********

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: Dear authors here are some recommendations for improving the manuscript:

- Provide a more detailed analysis or discussion regarding the inclusion of children under 3 months of age, as this group was not part of the original study. Explain how this age group might influence the results, and if possible, provide separate analyses or interpretations for this subgroup.

- While the study highlights the high accuracy of family assessments, consider expanding the discussion on the implications of this finding. For example, how might healthcare systems integrate family assessments in clinical practice? Are there any potential drawbacks or risks associated with relying on family observations in different ICU settings?

- Make the data availability statement clearer by indicating how interested researchers can request access to the data for future studies. Even if the data are restricted, providing a clear path for legitimate academic requests would enhance transparency and reproducibility.

- Since the study mainly involved cardiac patients and many participants were under 12 months old, consider providing a more detailed discussion about the generalizability of the findings to other pediatric ICU populations. If possible, compare your findings with studies conducted in other patient populations.

- Since the current study used experienced researchers to evaluate the SOS-PD, further validation by bedside nurses in a real-world PICU setting would be beneficial. You could recommend that future studies aim to evaluate the SOS-PD with the typical clinical staff who will be using the scale daily.

- While the statistical methods were appropriate, it might help to add a brief explanation or reference for certain techniques like the ROC curve analysis and the ICC for readers who may not be familiar with these terms. This would make the paper more accessible to a wider audience.

- Recommend that healthcare institutions consider providing structured training programs for the use of the SOS-PD scale, especially in translating research findings into everyday clinical practice. Highlight the importance of training both healthcare professionals and family members to enhance early detection of pediatric delirium.

Reviewer #2: Overall good work, however following revisions are suggested:

Page 7: Study design: Please mention the type of observational study.

Page 7: Participants: You mentioned that you have used the scale with infants based on experience, please cite any studies that have been done on infants in the past.

Page 8: Time Course: mention the duration between each test such as the first test was administered on the first day of admission, the second test was administered after a few hours etc.

Page 9: Translation Procedure: make a flow chart for the procedure so that it is easier for the reader to understand.

There aren’t enough references in the “Discussion” section. Please also add material related to the scoring with infants.

**********

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: Yes:  Ahmed Alhatemi

Reviewer #2: Yes:  Vardah Bharuchi

**********

[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.

Revision 1

#1: Thank you very much for your thoughtful and constructive feedback. Your suggestions have been invaluable in strengthening the manuscript. We greatly appreciate your attention to detail and the depth of analysis you have provided. Below, we have outlined how we have addressed each of your recommendations.

Reviewer #1: Dear authors here are some recommendations for improving the manuscript:

- Provide a more detailed analysis or discussion regarding the inclusion of children under 3 months of age, as this group was not part of the original study. Explain how this age group might influence the results, and if possible, provide separate analyses or interpretations for this subgroup.

Answer: Thank you for your feedback. In response, we have explained the inclusion of children under 3 months of age in our study. The decision was based on our experience with other pediatric delirium tools and the applicability of SOS-PD to this younger population. The Japanese version of SOS-PD showed high reliability in this subgroup, with a weighted kappa and ICC of 0.96, supporting its validity for infants. Although including this age group presents challenges due to developmental differences, we found the scale effective in identifying pediatric delirium. We hope this analysis addresses your concerns.

- While the study highlights the high accuracy of family assessments, consider expanding the discussion on the implications of this finding. For example, how might healthcare systems integrate family assessments in clinical practice? Are there any potential drawbacks or risks associated with relying on family observations in different ICU settings?

Answer:We agree that family assessments have great potential for improving pediatric delirium detection. In response, we expanded the discussion on integrating family assessments into clinical practice, suggesting that structured tools like SOS-PD can guide families in identifying behavior changes for earlier delirium detection. However, we acknowledge potential risks, such as misinterpretation by family members without clinical expertise. Therefore, family assessments should complement, not replace, clinical evaluations. Additionally, in some ICU settings where family access may be restricted, we suggest exploring alternative methods, like phone consultations or digital tools, to involve families in assessments.

- Make the data availability statement clearer by indicating how interested researchers can request access to the data for future studies. Even if the data are restricted, providing a clear path for legitimate academic requests would enhance transparency and reproducibility.

Answer: Thank you for your suggestion. In response, we have updated the data availability statement to specify that researchers interested in accessing the data for future studies may contact Dr. Yujiro Matsuishi, the co-corresponding author. This ensures a clear path for academic requests and enhances transparency.

- Since the study mainly involved cardiac patients and many participants were under 12 months old, consider providing a more detailed discussion about the generalizability of the findings to other pediatric ICU populations. If possible, compare your findings with studies conducted in other patient populations.

Answer: Thank you for your valuable comment. We have expanded the discussion on the generalizability of our findings to other pediatric ICU populations. While this study primarily involved cardiac patients, and many participants were under 12 months of age, we emphasize that the findings should be considered within the context of various pediatric ICU populations. The PICU is a diverse environment that treats patients with different underlying conditions, and in our hospital, cardiac surgery patients are the primary population. This is similar to PICUs worldwide that treat a significant number of post-cardiac surgery patients. However, in PICUs that focus on trauma or other specialties, the prevalence of delirium and its underlying causes may differ.

As such, further research is necessary to explore the applicability of the Japanese SOS-PD across various PICU populations. Comparing our findings with studies in other types of PICUs, such as those focusing on trauma, neurological conditions, or respiratory diseases, will help establish the broader generalizability of these findings and validate the effectiveness of the Japanese SOS-PD in diverse clinical settings.

We hope this addition addresses your comment thoroughly and provides a clearer understanding of the broader implications of our findings.

- Since the current study used experienced researchers to evaluate the SOS-PD, further validation by bedside nurses in a real-world PICU setting would be beneficial. You could recommend that future studies aim to evaluate the SOS-PD with the typical clinical staff who will be using the scale daily.

Answer: Thank you for your valuable suggestion. We agree that structured training programs for the use of the SOS-PD scale are essential. We recommend that healthcare institutions implement training for both healthcare professionals and family members to ensure consistent use of the scale. Training healthcare staff, particularly nurses and physicians, will help them accurately identify pediatric delirium and intervene early. Additionally, educating family members to recognize signs of delirium can further enhance early detection.

We believe such programs will bridge the gap between research and clinical practice, improving outcomes for pediatric patients.

- While the statistical methods were appropriate, it might help to add a brief explanation or reference for certain techniques like the ROC curve analysis and the ICC for readers who may not be familiar with these terms. This would make the paper more accessible to a wider audience.

Answer: Thank you for your suggestion. In response, we have added brief explanations of the ROC curve analysis and the intraclass correlation coefficient (ICC) to make the paper more accessible to a wider audience. The ROC curve helps evaluate a test's diagnostic performance by comparing sensitivity against 1-specificity at different cut-off points, while ICC measures the consistency of repeated measurements. We believe these additions will clarify the statistical methods for readers who may not be familiar with these terms.

- Recommend that healthcare institutions consider providing structured training programs for the use of the SOS-PD scale, especially in translating research findings into everyday clinical practice. Highlight the importance of training both healthcare professionals and family members to enhance early detection of pediatric delirium

Answer: Thank you for your insightful suggestion. We agree that structured training programs for the use of the SOS-PD scale are essential, particularly when translating research findings into everyday clinical practice. In response to your comment, we recommend that healthcare institutions consider implementing comprehensive training programs for both healthcare professionals and family members.

We hope this addresses your suggestion and thank you for your thoughtful input.

Reviewer #2: Thank you very much for your thoughtful and constructive feedback. We greatly appreciate your valuable suggestions, which have significantly helped improve the manuscript. Below, we have outlined how we have addressed each of your comments.

Reviewer #2: Overall good work, however following revisions are suggested:

Page 7: Study design: Please mention the type of observational study.

Answer: Thank you for your suggestion. In response, we have clarified that the study is a prospective cohort observational study in the revised manuscript.

Page 7: Participants: You mentioned that you have used the scale with infants based on experience, please cite any studies that have been done on infants in the past.

Answer: Thank you for your comment. In response, we clarified that although no direct studies on infants using the SOS-PD exist, our experience with the Japanese version of the Cornell Pediatric Delirium Assessment (CPAD) in newborns, where we validated its reliability and validity, led us to extend the inclusion criteria. We will also reference relevant studies to support our approach.

Page 8: Time Course: mention the duration between each test such as the first test was administered on the first day of admission, the second test was administered after a few hours etc.

Answer: Thank you for your helpful comment. In response, we have revised the description of the time course to clarify that tests were consistently administered during routine team rounds, which occurred every Monday at 1 PM. As a result, there was always a one-week interval between evaluations, ensuring consistent timing between assessments. This revision emphasizes the regularity of the evaluations and the weekly interval between tests.

We hope this addresses your comment and provides the clarity you were seeking.

Page 9: Translation Procedure: make a flow chart for the procedure so that it is easier for the reader to understand.

There aren’t enough references in the “Discussion” section. Please also add material related to the scoring with infants.

Answer: In response to your comment regarding the translation procedure, we have created a flow chart to visually represent the steps involved in translating SOS-PD from English (E) to Japanese (J). This flow chart should make it easier for readers to understand the process and follow the steps taken during the translation.

Additionally, we have increased the number of references in the "Discussion" section to strengthen the arguments and provide additional context. We also addressed the use of the scale with infants, citing relevant studies to support the validity and reliability of the scale in this age group.

We hope these revisions meet your expectations and enhance the clarity and depth of the manuscript.

Decision Letter - Sidra Kaleem Jafri, Editor

Verifying the accuracy of Japanese version of the pediatric delirium assessment scale: SOS-PD and the high accuracy of family assessments of pediatric delirium

PONE-D-24-28949R1

Dear Dr. Matsuishi,

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,

Sidra Kaleem Jafri

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Formally Accepted
Acceptance Letter - Sidra Kaleem Jafri, Editor

PONE-D-24-28949R1

PLOS ONE

Dear Dr. Inoue,

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

You will receive further instructions from the production team, including instructions on how to review your proof when it is ready. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few days 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.

You will receive an invoice from PLOS for your publication fee after your manuscript has reached the completed accept phase. If you receive an email requesting payment before acceptance or for any other service, this may be a phishing scheme. Learn how to identify phishing emails and protect your accounts at https://explore.plos.org/phishing.

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. Sidra Kaleem Jafri

Academic Editor

PLOS ONE

Open letter on the publication of peer review reports

PLOS recognizes the benefits of transparency in the peer review process. Therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. Reviewers remain anonymous, unless they choose to reveal their names.

We encourage other journals to join us in this initiative. We hope that our action inspires the community, including researchers, research funders, and research institutions, to recognize the benefits of published peer review reports for all parts of the research system.

Learn more at ASAPbio .