PONE-D-20-29197

Reliability of heart rate and respiration rate measurements with a wireless accelerometer in postbariatric recovery

PLOS ONE

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2. We noted that submitted this study as a clinical trial, but according to your description and the WHO definition of clinical trials we would not consider this a clinical trial. This is because you do not assess the effects of the wearable device on health outcomes. In order to avoid confusion we would suggest that you avoid referring to this study or its parent as a clinical trial. We also suggest removing any references to TREND in your flow diagram.

3. Thank you for including your ethics statement: "The study population is a subset of the overall study population of the TRICA study. The TRICA Study NCT03923127 (NL7602, PJ-013483 FLAGSHIP Transitional Care Study  Formal approval for this study was obtained from the ethical committee (W19.001). Written informed consent was obtained from all participants prior to commencing any research procedures."   

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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

Reviewer #3: No

Reviewer #4: Yes

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

Reviewer #1: No

Reviewer #2: Yes

Reviewer #3: No

Reviewer #4: N/A

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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: No

Reviewer #2: Yes

Reviewer #3: No

Reviewer #4: 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: No

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: 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 presents an interesting study on the use of a wearable device, called Healthdot, towards continuous monitoring of heart rate and respiratory rate in post-bariatric surgery patients. The paper is mostly focussed on a clinical study using an existing wearable device, rather than any novel technical / engineering perspective in design, development or data analytics. The following points are of concern:

1. The paper lacks substantial references. Example: in introduction please refer to several previous literature of use of wearables for continuous monitoring, introduce what are the challenges in bariatric surgery that requires particularly monitoring of heart rate etc. The motivation for use particularly in bariatric surgery is not clear.

2. The paper concludes that the device may be suitable for long term monitoring in home but not particularly suitable for bariatric patients for short term monitoring after surgery, based on the results. The finding is interesting, but it clashes with the idea of the use of the device in post-bariatric surgery monitoring. There is also no comparison or reference to any other wearable device which has been used in post-surgical monitoring.

3. A lot of data was excluded because of low quality. How does that affect the practical use of the device?

4. For heart rate monitoring outliers in healthdot data observed in Fig. 3. This is further reflected in Figs. 4 and 5. Is there an explanation for those outliers?

5. The process of time synchronization of reference data and healthdot measurements (section: Data preprocessing) lacks clarity.

6. In Data Preprocessing, it is observed that only internally stored data was evaluated, however, for practical purposes, it will be the transmitted data that will be used, right? If it has lower sampling frequency then will it perform poorly? Has that been studied?

7. In Data Preprocessing, what does actual logging mean and how is it measured?

8. All figures are of very poor quality.

Reviewer #2: In this paper, the authors assessed the reliability of heart rate and respiration rate measured by the Healthdot in comparison to the gold standard, the bedside patient monitor. The work is technically sound and well written. Please find the comments below.

1. Each paragraph should be aligned.

2. There are a lot of data being labelled “low data quality”. Please explain the reasons.

3. Perhaps the authors can include the Healthdot datasheet in appendix since some limitations arises from the hardware itself such as 5-minute interval update.

Reviewer #3: PONE-D-20-29197: statistical review

SUMMARY. This study compares measurements of heart rate and respiration rate, as taken by a novel wireless device to measurements made by the gold standard, the bedside patient monitor. The statistical analysis is based on the Balnd-Altam method, which tests the agreement between two different assays. I have two major concerns about this paper, which require a full revision of the statistical analysis.

MAJOR ISSUES:

1) As far as I know, the Bland-Altam method assumes independent data. The data of this study are however repeated measures and, as such, they are dependent. The authors say that they use the "Bland-Altman method for repeated measurements" (line 145), perhaps alluding to some kind of correction to account for dependent observations. However, this is not clarified. Anyway, the standard approach to repeated measures analysis relies on random effects models. The statistical analysis should be fully revised by taking this approach.

2) We do know something about the subjects under study (age, gender,, BMI, weight). However, this information was not used in the study. Why? Do we know that these covariates do not influence the measurements? Can the sample be considered homogeneous? Does the covariate distribution reflect the distribution of the population of interest? The analysis should be revised by accounting for the available covariates:\\. Under this setting, random effects models provide a flexible framework to analyze repeated measurements, conditionally on covariate values.

Reviewer #4: The author assessed the reliability of heart rate and respiration rate measured by the accelerometer-based device ,Healthdot, compared to the gold standard, the bedside patient monitor, during the postoperative period in bariatric patients. However, the manuscript do little contribute anything new and is not very referable. In whole, the paper cannot be accepted by PLOS ONE.

Other comments:

1. the full name of HeartRand RespR should be given in Abstract when mentioned for the first time.

2. Too few references.

3. On Line 165, ‘…nearly 20.5 hours of HeartR data were used in the analysis’. but on line 173, 473 min excluded,14.6hours available, which is ambiguous.

4. Figure 2, different line types should be used for comparison.

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Reviewer #1: Yes: M Palaniswami

Reviewer #2: No

Reviewer #3: No

Reviewer #4: No

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Reliability of heart rate and respiration rate measurements with a wireless accelerometer in postbariatric recovery

PONE-D-20-29197R1

Dear Dr. Scheerhoorn,

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,

Bijan Najafi

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 #2: All comments have been addressed

Reviewer #3: 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

Reviewer #3: (No Response)

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

Reviewer #2: Yes

Reviewer #3: (No Response)

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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

Reviewer #3: (No Response)

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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

Reviewer #3: (No Response)

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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)

Reviewer #3: (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.

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

Reviewer #3: No