PONE-D-21-19437

Physical restraint of dementia patients in acute care hospitals during the COVID-19 pandemic: A cohort analysis in Japan

PLOS ONE

Dear Dr. Imanaka,

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The manuscript is well assessed by two reviewers; however, several revisions are required in the present form. See the reviewers' comments carefully and respond them appropriately.

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Academic Editor

PLOS ONE

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2. Please report the codes used for extracting the outcome of interest (use of physical restraints) from the database

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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: Yes

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

Reviewer #1: Yes

Reviewer #2: Yes

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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?

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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: In the background of the study, please describe how dose COVID-19 affect the care of patient with dementia in the hospital? is there visitation restriction? Isolation policy? Relocation of patient with dementia due to COVID case segregation? Manpower shortage? Dose hospital without COVID affected by those regulations?

Please explain what is "136 Hp with 97,233 admissions"

Please explain and elaborate why BMI is choosen as one of the parameter to group patients?

In figure 2, before COVID, hospital takes COVID cases already have higher percentage of restraint in the hospital. Is it because the hospital is less well trained in dementia care? No geriatric specialist? If a hospital already prone to restraint dementia patient (lack of geriatric culture), COVID -19 will only aggregate it. Will be good to explain as this may make the comparison between the hospitals become unfair.

Reviewer #2: General comments

The authors conducted a retrospective cohort study to assess the impact of regulatory changes, consequent to the pandemic, on physical restraint use among elderly dementia patients in acute care hospitals in Japan. Main finding suggests elderly dementia patients who require personal care might be more likely to be physically restrained during the COVID-19 pandemic in hospitals receiving COVID-19-positive patients. The result was notable and very interesting. However, I have some concerns that should be addressed regarding the methodology and interpretation of results.

Specific comments

Major

It would be better to provide more detailed definitions of the state of emergency declaration and Group 1/2. Is the state of emergency nationwide or only for a specific region? Why was the deadline set at July 4, 2020? Did the group 1 receive COVID-19 patients only after the state of emergency was declared or not regardless of the time of declaration?

L.195-205 This second paragraph is a general statement and does not seem to be relevant to the results of this study. Therefore, by changing this paragraph to a comparison of this study with past studies on physical restraint, the authors can make this study more unique. For example, comparing the study of physical restraint with other social changes such as endemics or epidemics of other infectious diseases, disasters, or terrorism.

L.209-222 This paragraph is the reason why physical restraint increased after the COVID-19 pandemic. It does not explain why group 1 has more physical restraints than group 2. This is because if the state of emergency had been declared at the national level, group 2 would have been recommended the same social distance as group 1. If it is due to social distance, the authors should divide the hospitals according to whether they are in an epidemic area or not, not whether they accept COVID-19 patients or not. Smaller hospitals may not be accepting COVID-19 patients even in epidemic areas. It would be better to reconsider the difference in patient factors between Group 1 and Group 2.

L. 223-241 The restriction of visits seems to be done regardless of the acceptance of COVID-19 patients. As stated in L237-240, the changes in the nursing side seems to be a strong factor. It may be better to move L237-240 to the first half of this paragraph and elaborate further.

Minor

It may be easier for readers to read the abstract if it is divided into Introduction, methods, results, and conclusion.

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Reviewer #1: No

Reviewer #2: No

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Physical restraint of dementia patients in acute care hospitals during the COVID-19 pandemic: A cohort analysis in Japan

PONE-D-21-19437R1

Dear Dr. Imanaka,

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.

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Kind regards,

Masaki Mogi

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

No further comment.

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: All comments have been addressed

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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

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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

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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: (No Response)

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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.

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Reviewer #2: No