Dear Dr. Gong,

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Sreeram V. Ramagopalan

Academic Editor

PLOS ONE

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1. When submitting your revision, we need you to address these additional requirements.-->--> -->-->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. 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Martin Law Firm for work related to the Cook Celect IVC filter litigation, and from the Siegfried and Jensen Law Firm for work related to Vioxx litigation; chairs a Cardiac Scientific Advisory Board for UnitedHealth; was a participant/participant representative of the IBM Watson Health Life Sciences Board; is a member of the Advisory Board for Element Science, the Advisory Board for Facebook, and the Physician Advisory Board for Aetna; and is the co-founder of HugoHealth, a personal health information platform, and co-founder of Refactor Health, an AI-augmented data management platform for healthcare. -->-->Wade Schulz is an investigator for a research agreement, through Yale University, from the Shenzhen Center for Health Information for work to advance intelligent disease prevention and health promotion; collaborates with the National Center for Cardiovascular Diseases in Beijing; is a technical consultant to HugoHealth, a personal health information platform, and cofounder of Refactor Health, an AI-augmented data management platform for healthcare; is a consultant for Interpace Diagnostics Group, a molecular diagnostics company.-->-->Guannan Gong is the founder of CtrlTrial Inc., an AI-augmented patient screening platform for clinical trials. -->--> -->-->We note that one or more of the authors are employed by a commercial company. -->--> -->-->a. 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Reviewers' comments:

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #1: No

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

Reviewer #1: I Don't Know

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3. Have the authors made all data underlying the findings in their manuscript fully available??>

The PLOS Data policy

Reviewer #1: No

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4. Is the manuscript presented in an intelligible fashion and written in standard English??>

Reviewer #1: Yes

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Reviewer #1:  Liu and colleagues report their analysis of the integrity of real-time electronic health records (EHR) data for use in clinical research, in which they assess the stability and completeness of the recorded information in the Yale New Haven Health (YNHH) clinical data warehouse and conclude that a time lag of 4-7 days are required for records to stabilise to ensure validity for research. The work is interesting and has merit to other researchers who can utilise the framework in assessing the integrity of other local EHR systems, however I do feel the findings presented are likely to be very specific to the YNHH context, and thus the external validity of the results is uncertain.

Major comments

1. The methods section would benefit from further description of the YNHH dataset, e.g. patients that are included, sector of healthcare etc. How records enter the YNHH dataset, does each clinical encounter generate a new record, who inputs the data, etc?

2. The methods section would benefit from revision to make it clearer which samples of data used are in the analysis, currently the methods refers only to data between April/May 2025, however the axes of figures 3-5 shows data spanning July/Nov 2024, and results section also describes additional methods relating to data in November 2024. It’s not fully clear to me why the dates would change for these different assessments so this should be spelled out. It would also be helpful to know if there was any rationale for the choice of baseline dates selected and why 26 snapshots were used?

3. The results section is very descriptive and contains few statistical results, which are instead included in an appendix. I would strongly suggest adding more summary statistics to support assertions being made.

4. Conclusions “Our findings indicate that real-time EHR data require 4–7 days for discharge information stabilization and systematic monitoring of demographic field consistency to ensure research validity.” I would probably suggest revising this statement slightly to acknowledge that this is a finding within the YNHH dataset, as external validity is not proven.

Minor

5. The first benchmark assessment relates to ‘clinical actions such as additions, deletions, and merges’ – I would suggest defining exactly what ‘clinical actions’ means as it is not entirely clear to me and I’m assuming it refers to specific clinical events or healthcare encounters than have happened, and the additions, deletions or merges occur if an update has been made to either add a new event or more accurately reflect one which has taken place?

6. Race and ethnicity data were shown to be frequently updated, do you have any further insight into how race/ethnicity data are collected? Are they self-assigned or healthcare provider assigned categories? The latter tends be more prone to data quality issues therefore specifying this would be informative.

7. Careful review needed to check all acronyms spelled out at first use eg. BM-1 /consider if even needs to be abbreviated

8. Figures 3 and 4 – I am curious to understand if there is any explanations for the apparent spike in patient numbers on 09/27/24 ?

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Reviewer #1: No

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Dear Dr. Gong,

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.

plosone@plos.org

• A 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 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,

Sreeram V. Ramagopalan

Academic Editor

PLOS One

Journal Requirements:

1. If the reviewer comments include a recommendation to cite specific previously published works, please review and evaluate these publications to determine whether they are relevant and should be cited. There is no requirement to cite these works unless the editor has indicated otherwise. 

2. 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.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

Reviewer #1: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions??>

Reviewer #1: Yes

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

Reviewer #1: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available??>

The PLOS Data policy

Reviewer #1: Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English??>

Reviewer #1: Yes

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Reviewer #1: Liu and colleagues have responded positively to all prior comments and the manuscript and its reporting is far strengthened by the revisions. One minor remaining comment I have relates to description of methods lingering the results section. For BM-2, it is suggested that this deeper analysis was conducted due the findings of BM-1. It would be helpful to state this earlier in the methods section, and ideally differentiate what analyses were pre-specified and which were post-hoc, which it sounds like BM-2 may have been.

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what does this mean? ). If published, this will include your full peer review and any attached files.

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Reviewer #1: No

**********

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Assessment of the Integrity of Real-Time Electronic Health Record Data used in Clinical Research

PONE-D-25-49671R2

Dear Dr. Gong,

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.

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Kind regards,

Sreeram V. Ramagopalan

Academic Editor

PLOS One

Additional Editor Comments (optional):

Reviewers' comments: