PONE-D-21-28704Feasibility of wireless continuous monitoring of vital signs without using alarms on a general surgical ward: a mixed methods studyPLOS ONE

Dear Dr. Leenen,

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, in particular: - Statistical analysis (consider consultation of statistical services available to you)- Lack of a control group (historical comparison group or thorough explanation of limitations and the drawn conclusions)- Discussion on non-ICU / ICU applicability- Use of complication grading (eg. https://www.assessurgery.com/clavien-dindo-classification/ )- Assessment of other vital parameters (eg. BP blood pressure etc.)? If none, explain limitations of clinical use or further requirements for clinical implementation? Please submit your revised manuscript by Dec 23 2021 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,

David Benjamin Lumenta, MD PhD

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. In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found. PLOS defines a study's minimal data set as the underlying data used to reach the conclusions drawn in the manuscript and any additional data required to replicate the reported study findings in their entirety. All PLOS journals require that the minimal data set be made fully available. For more information about our data policy, please see http://journals.plos.org/plosone/s/data-availability.

Upon re-submitting your revised manuscript, please upload your study’s minimal underlying data set as either Supporting Information files or to a stable, public repository and include the relevant URLs, DOIs, or accession numbers within your revised cover letter. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. Any potentially identifying patient information must be fully anonymized.

Important: If there are ethical or legal restrictions to sharing your data publicly, please explain these restrictions in detail. Please see our guidelines for more information on what we consider unacceptable restrictions to publicly sharing data: http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Note that it is not acceptable for the authors to be the sole named individuals responsible for ensuring data access.

We will update your Data Availability statement to reflect the information you provide in your cover letter.

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. 

[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 editor,

I’ve reviewed the manuscript "Feasibility of wireless continuous monitoring of vital signs without using alarms on a general surgical ward: a mixed methods study". I would like to congratulate the authors for providing an interesting and well planed designed explanatory sequenctial mixed method study.

However, I would like to share my points of critique with you:

Major concers:

For the evaluation of the "Usefullness, Satisfaction, and Ease of use" questionnaire (7-Likert scale), means and standard deviation were used. This is not statistically permissible for in particular for Likert items. Likert-items often present statistical skewness and therefore non-parametric descritpive statistics must be used here (median, range). As sum scores within the individual sub-categories (usefullness, satisfaction, ease of learning, ease of use), means including standard deviation are possible. I recommend re-analyses of the Likert items and on the basis of this a re-evaluation of the results. Moreover, results of Shapiro-Wilk test are missing.

In line 233 continuous monitoring are described as usefull with a mean score of 4.4 (standard deviation +/- 1.0). A score around 4 is described as "neutral". I recommend an adjustment of the interpretation of the results regarding usefullness. In addition, add a table (supplement) with an exact itemization of the Likert scale points 1-7. Within aggregated scores information for the reader get possibly lost.

The discussion is in its current form too superficial. I believe there are many aspects that can be discussed.

For example a little more discussion on why we need these wireless continuous monitoring on a non-ICU ward, why a non-ICU without continuous monitoring should implement continuous monitoring systems and a comparison of advantages and disadvantages of this wireless system (without alarms). The discussion would really benefit.

Minor concerns

Line 42: Amount of professionals are missing.

Line 43: Range of Likert scale is missing.

Line 116/117: An explanation why 45 professionals were chosen to provide sufficient data? (power calculation / study reference?)

Line 91/120: 4 month period or 3 month period?

Line 116/229/table2/table3: 45 or 46 professionals? Please correct the discrepancy.

Line 166: For completeness add answers of 7-point Likert scale.

Line 118/184/235: Focus group of about 6-7 nurses are mentioned in "sample size". Whereas in "qualitative data" two focus groups with four professionals and in "acceptability ny healthcare professionals 9 nurses are described. Please correct the discrepancy.

Line 184/185: For completeness add themes of topic list of focus groups.

Line 203: Please add reference after mentioned stages.

Line 205/206: For completeness add who conducted second, third, fourth and fifth stage.

Line 118/235: For completeness add recruitment information for focus group. Special criteria for inlcuding in the focus group? Random allocation?

Line 233/234/table3: Please add score range.

Table 3: Descriptions within the brackets are missing. (standard deviation? percentage?)

Line 346: For more clarity please add Clavien-Dindo classification for I and II complications.

Reviewer #2: Dear authors,

thank you for the opportunity to review the manuscript, “Feasibility of wireless continuous monitoring of vital signs without using alarms on a general surgical ward: a mixed methods study in which you "

This is an up-to-date evaluation modern wearable devices for vital sign monitoring, which have recently become available for patients. Their use without alarms aims to improve alarm fatigue and inefficiencies at the workplace, which is an issue that should definitely be addressed again and again to improve working conditions ant the patient’s outcome.

This is, in principle, a well-structured / logically structured study on the basis of an acceptable data pool. However, prior a possible publication, I would like to share my thoughts on the manuscript:

- Since the continuous vital sign monitoring are a completely new concept on many general wards, the study is lacking a control group. You mainly addressed the opinion of healthcare professionals on the system, but the main question, whether there is a clear advantage of using continuous monitoring of vital signs for patients is not answered. It would be desirable to compare your study collective to a reference group, where “normal” monitoring is performed. Due to the lacking control group, it is not clear whether postoperative complications or deviations in vital signs requiring intervention be noticed earlier and therefore prevent complications, reduce mortality, etc.

- Please insert the hospital name in line 92/93

- In line 109 you state that biosensor-patch was attached postoperatively, however I would recommend giving the short description of the system prior to those statements in the methods part.

- You state that HR and RR were exclusively measured. How accurate can these vital parameters be monitored with wearable devices compared to e.g. ECG? Since you performed the study on a general ward vital signs such as blood pressure are of utmost importance as well - did you measure those parameters additionally?

- How was the time frame of every four hours for the routinely assessment of the vital signs trend determined?

- With a continuous monitoring and assessment of vital sign trends a faster anticipation and action upon changed patient status may be feasible, but how can acute deviations of vitals signs which require intervention be managed?

- Table 2: work experience “(years)” is missing.

- It would be desirable to provide a brief “outlook” on necessary changes/improvements. Throughout the manuscript, the authors list a few examples with regards to this (e.g. limited digital tools for interpretation of vital signs). Furthermore, a statement regarding a possible use of these systems on ICUs could be added.

Thank you.

**********

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: No

Reviewer #2: No

[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.

Feasibility of wireless continuous monitoring of vital signs without using alarms on a general surgical ward: a mixed methods study

PONE-D-21-28704R1

Dear Dr. Leenen,

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,

David Benjamin Lumenta, MD PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

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 #1: All comments have been addressed

Reviewer #2: All comments have been addressed

**********

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 #1: Yes

Reviewer #2: Yes

**********

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

Reviewer #1: Yes

Reviewer #2: I Don't Know

**********

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 #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. 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 author, thank you for addressing all my previously mentioned comments. Thereby the manuscript significantly improved. I have no further comments on your paper prior to publication.

Reviewer #2: Dear authors,

Thank you very much for the revised version of the manuscript, which improved a lot. All previously raised concerns have been addressed. No further concerns were found.

**********

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: No